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Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates

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Start Preamble Start Printed Page 47130

AGENCY:

Centers for Medicare and Medicaid Services (CMS), HHS.

ACTION:

Final rule with comment period.

SUMMARY:

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems, and to implement certain provisions made by the Deficit Reduction Act of 2005 (Pub. L. 109-171), the Medicare Improvements and Extension Act under Division B, Title I of the Tax Relief and Health Care Act of 2006 (Pub. L. 109-432), and the Pandemic and All Hazards Preparedness Act (Pub. L. 109-417). In addition, in the Addendum to this final rule with comment period, we describe the changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. We also are setting forth the rate of increase limits for certain hospitals and hospital units excluded from the IPPS that are paid on a reasonable cost basis subject to these limits, or that have a portion of a prospective payment system payment based on reasonable cost principles. These changes are applicable to discharges occurring on or after October 1, 2007.

In this final rule with comment period, as part of our efforts to further refine the diagnosis related group (DRG) system under the IPPS to better recognize severity of illness among patients, for FY 2008, we are adopting a Medicare Severity DRG (MS DRG) classification system for the IPPS. We are also adopting the structure of the MS-DRG system for the LTCH prospective payment system (referred to as MS-LTC-DRGs) for FY 2008.

Among the other policy decisions and changes that we are making, we are making changes related to: limited revisions of the reclassification of cases to MS-DRGs, the relative weights for the MS-LTC-DRGs; applications for new technologies and medical services add-on payments; the wage data, including the occupational mix data, used to compute the FY 2008 wage indices; payments to hospitals for the indirect costs of graduate medical education; submission of hospital quality data; provisions governing the application of sanctions relating to the Emergency Medical Treatment and Labor Act of 1986 (EMTALA); provisions governing the disclosure of physician ownership in hospitals and patient safety measures; and provisions relating to services furnished to beneficiaries in custody of penal authorities.

DATES:

Effective Date: This final rule with comment period is effective October 1, 2007 and applies to discharges occurring on or after that date.

Comment Date: We will consider public comments only on the provisions of section V., Changes to the IPPS for Capital Related Costs, of the preamble of this final rule with comment period, if we receive them at one of the addresses provided below, no later than 5 p.m. on November 20, 2007.

ADDRESSES:

In commenting on the provisions of section V. of the preamble of this final rule with comment period, please refer to file code CMS-1533-FC.

Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of three ways (no duplicates, please):

1. Electronically. You may submit electronic comments on specific issues in this regulation to http://www.cms.hhs.gov/​eRulemaking. Click on the link “Submit electronic comments on CMS regulations with an open comment period”. (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.)

2. By regular mail. You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1533-FC, P.O. Box 8011, Baltimore, MD 21244-1850.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1533-FC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201, or 7500 Security Boulevard, Baltimore, MD 21244-1850.

(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain proof of filing by stamping in and retaining an extra copy of the comments being filed.)

Comments mailed to the addresses indicated as appropriately for hand or courier delivery may be delayed and received after the comment period.

Submitting Comments: You can assist us by referencing the file code CMS-1533-FC and the specific “issue identifier” that precedes section V., Changes to the IPPS for Capital Related Costs.

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.cms.hhs.gov/​eRulemaking. Click on the link “Electronic Comments on CMS Regulations” on that Web site to view public comments.

Comments received timely will also be available for public inspection, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4:00 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Marc Hartstein, (410) 786-4548, Operating Prospective Payment, Diagnosis Related Groups (DRGs), Wage Index, New Medical Services and Technology Add-On Payments, and Hospital Geographic Reclassifications Issues. Start Printed Page 47131

Tzvi Hefter, (410) 786-4487, Capital Prospective Payment, Excluded Hospitals, Graduate Medical Education, Critical Access Hospitals, and Long-Term Care (LTC)-DRG Issues.

Siddhartha Mazumdar, (410) 786-6673, Rural Community Hospital Demonstration Issues.

Sheila Blackstock, (410) 786-3502, Quality Data for Annual Payment Update Issues.

Thomas Valuck, (410) 786-7479, Hospital Value-Based Purchasing Issues.

Jacqueline Proctor, (410) 786-8852, Disclosure of Physician Ownership in Hospitals.

Marilyn Dahl, (410) 786-8665, Patient Safety Measures Issues.

Fred Grabau, (410) 786-0206, Services to Beneficiaries in Custody of Penal Authorities Issues.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Electronic Access

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Acronyms

ACGME—Accreditation Council for Graduate Medical Education

AMGA—American Medical Group Association

AHA—American Hospital Association

AHIMA—American Health Information Management Association

AHRQ—Agency for Health Care Research and Quality

AMI—Acute myocardial infarction

AOA—American Osteopathic Association

APR DRG—All Patient Refined Diagnosis Related Group System

ASC—Ambulatory surgical center

ASP—Average sales price

AWP—Average wholesale price

BBA—Balanced Budget Act of 1997, Pub. L. 105-33

BBRA—Medicare, Medicaid, and SCHIP [State Children's Health Insurance Program] Balanced Budget Refinement Act of 1999, Pub. L. 106-113

BIPA—Medicare, Medicaid, and SCHIP [State Children's Health Insurance Program] Benefits Improvement and Protection Act of 2000, Pub. L. 106-554

BLS—Bureau of Labor Statistics

CAH—Critical access hospital

CART—CMS Abstraction & Reporting Tool

CBSAs—Core-based statistical areas

CC—Complication or comorbidity

CCR—Cost-to-charge ratio

CDAC—Clinical Data Abstraction Center

CIPI—Capital input price index

CPI—Consumer price index

CMI—Case-mix index

CMS—Centers for Medicare & Medicaid Services

CMSA—Consolidated Metropolitan Statistical Area

COBRA—Consolidated Omnibus Reconciliation Act of 1985, Pub. L. 99-272

CoP—[Hospital] Condition of participation

CPI—Consumer price index

CY—Calendar year

DRA—Deficit Reduction Act of 2005, Pub. L. 109-171

DRG—Diagnosis-related group

DSH—Disproportionate share hospital

ECI—Employment cost index

EMR—Electronic medical record

EMTALA—Emergency Medical Treatment and Labor Act of 1986, Pub. L. 99-272

FDA—Food and Drug Administration

FIPS—Federal information processing standards

FQHC—Federally qualified health center

FTE—Full-time equivalent

FY—Fiscal year

GAAP—Generally Accepted Accounting Principles

GAF—Geographic Adjustment Factor

GME—Graduate medical education

GMEC—Graduate Medical Education Committee

HCAHPS—Hospital Consumer Assessment of Healthcare Providers and Systems

HCFA—Health Care Financing Administration

HCRIS—Hospital Cost Report Information System

HHA—Home health agency

HHS—Department of Health and Human Services

HIC—Health insurance card

HIPAA—Health Insurance Portability and Accountability Act of 1996, Pub. L. 104-191

HIPC—Health Information Policy Council

HIS—Health information system

HIT—Health information technology

HMO—Health maintenance organization

HSA—Health savings account

HSCRC—Maryland Health Services Cost Review Commission

HSRV—Hospital-specific relative value

HSRVcc—Hospital-specific relative value cost center

HQA—Hospital Quality Alliance

HQI—Hospital Quality Initiative

ICD-9-CM—International Classification of Diseases, Ninth Revision, Clinical Modification

ICD-10-PCS—International Classification of Diseases, Tenth Edition, Procedure Coding System

IHS—Indian Health Service

IME—Indirect medical education

IOM—Institute of Medicine

IPF—Inpatient psychiatric facility

IPPS—Acute care hospital inpatient prospective payment system

IRF—Inpatient rehabilitation facility

JCAHO—Joint Commission on Accreditation of Healthcare Organizations

LAMCs—Large area metropolitan counties

LTC-DRG—Long-term care diagnosis-related group

LTCH—Long-term care hospital

MAC—Medicare Administrative Contractor

MCC—Major complication or comorbidity

MCE—Medicare Code Editor

MCO—Managed care organization

MCV—Major cardiovascular condition

MDC—Major diagnostic category

MDH—Medicare-dependent, small rural hospital

MedPAC—Medicare Payment Advisory Commission

MedPAR—Medicare Provider Analysis and Review File

MEI—Medicare Economic Index

MGCRB—Medicare Geographic Classification Review Board

MIEA-TRHCA—Medicare Improvements and Extension Act, Division B of the Tax Relief and Health Care Act of 2006, Pub. L. 109-432

MMA—Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. 108-173

MPN—Medicare provider number

MRHFP—Medicare Rural Hospital Flexibility Program

MSA—Metropolitan Statistical Area

NAICS—North American Industrial Classification System

NCD—National coverage determination

NCHS—National Center for Health Statistics

NCQA—National Committee for Quality Assurance

NCVHS—National Committee on Vital and Health Statistics

NECMA—New England County Metropolitan Areas

NQF—National Quality Forum

NTIS—National Technical Information Service

NVHRI—National Voluntary Hospital Reporting Initiative

OES—Occupational employment statistics

OIG—Office of the Inspector General

OMB—Executive Office of Management and Budget

O.R.—Operating room

OSCAR—Online Survey Certification and Reporting (System)

PMSAs—Primary metropolitan statistical areas

PPI—Producer price index

PPS—Prospective payment system

PRA—Per resident amount

PRM—Provider Reimbursement Manual

ProPAC—Prospective Payment Assessment Commission

PRRB—Provider Reimbursement Review Board

PSF—Provider Specific File

PS&R—Provider Statistical and Reimbursement (System)

QIG—Quality Improvement Group, CMS

QIO—Quality Improvement Organization

RCE—Reasonable compensation equivalent

RHC—Rural health clinic

RHQDAPU—Reporting hospital quality data for annual payment update

RNHCI—Religious nonmedical health care institution Start Printed Page 47132

RRC—Rural referral center

RUCAs—Rural-urban commuting area codes

RY—Rate year

SAF—Standard Analytic File

SCH—Sole community hospital

SFY—State fiscal year

SIC—Standard Industrial Classification

SNF—Skilled nursing facility

SOCs—Standard occupational classifications

SOM—State Operations Manual

SSA—Social Security Administration

SSI—Supplemental Security Income

TEFRA—Tax Equity and Fiscal Responsibility Act of 1982, Pub. L. 97-248

UHDDS—Uniform hospital discharge data set

VBP—Value-based purchasing

Table of Contents

I. Background

A. Summary

1. Acute Care Hospital Inpatient Prospective Payment System (IPPS)

2. Hospitals and Hospital Units Excluded from the IPPS a. Inpatient Rehabilitation Facilities (IRFs) b. Long-Term Care Hospitals (LTCHs) c. Inpatient Psychiatric Facilities (IPFs)

3. Critical Access Hospitals (CAHs)

4. Payments for Graduate Medical Education (GME)

B. Provisions of the Deficit Reduction Act of 2005 (DRA)

C. Provisions of the Medicare Improvements and Extension Act under Division B, Title I of the Tax Relief and Health Care Act of 2006

D. Provisions of the Pandemic and All-Hazards Preparedness Act

E. Issuance of a Notice of Proposed Rulemaking

1. DRG Reclassifications and Recalibrations of Relative Weights

2. Proposed Changes to the Hospital Wage Index

3. Other Decisions and Proposed Changes to the IPPS for Operating Costs and GME Costs

4. Proposed Changes to the IPPS for Capital-Related Costs

5. Proposed Changes to the Payment Rates for Excluded Hospitals and Hospital Units: Rate-of-Increase Percentages

6. Services Furnished to Beneficiaries in Custody of Penal Authorities

7. Determining Proposed Prospective Payment Operating and Capital Rates and Rate of Increase Limits

8. Impact Analysis

9. Recommendation of Update Factors for Operating Cost Rates of Payment for Inpatient Hospital Services

10. Discussion of Medicare Payment Advisory Commission Recommendations

F. Public Comments Received on the Proposed Rule

II. Changes to DRG Classifications and Relative Weights

A. Background

B. DRG Reclassifications

1. General

2. Yearly Review for Making DRG Changes

C. MedPAC Recommendations for Revisions to the IPPS DRG System

D. Refinement of DRGs Based on Severity of Illness

1. Evaluation of Alternative Severity-Adjusted DRG Systems

a. Overview of Alternative DRG Classification Systems

b. Comparative Performance in Explaining Variation in Resource Use

c. Payment Accuracy and Case-Mix Impact

d. Other Issues for Consideration

2. Development of the Medicare Severity DRGs (MS DRGs)

a. Comprehensive Review of the CC List

b. Chronic Diagnosis Codes

c. Acute Diagnosis Codes

d. Prior Research on Subdivisions of CCs into Multiple Categories

e. Medicare Severity DRGs (MS-DRGs)

3. Dividing MS DRGs on the Basis of the CCs and MCCs

4. Conclusion

5. Impact of the MS-DRGs

6. Changes to Case-Mix Index (CMI) from the MS-DRGs

7. Effect of the MS-DRGs on the Outlier Threshold

8. Effect of the MS-DRGs on the Postacute Care Transfer Policy

E. Refinement of the Relative Weight Calculation

1. Summary of RTI's Report on Charge Compression

2. RTI Recommendations

a. Short-Term Recommendations

b. Medium-Term Recommendations

c. Long-Term Recommendations

F. Hospital-Acquired Conditions, Including Infections

1. General

2. Legislative Requirement

3. Public Input

4. Collaborative Effort

5. Criteria for Selection of the Hospital-Acquired Conditions

6. Selection of Hospital-Acquired Conditions

7. Other Issues

G. Changes to Specific DRG Classifications

1. Pre-MDCs: Intestinal Transplantation

2. MDC 1 (Diseases and Disorders of the Nervous System)

a. Implantable Neurostimulators

b. Intracranial Stents

3. MDC 3 (Diseases and Disorders of the Ear, Nose, Mouth, and Throat)—Cochlear Implants

4. MDC 8 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue)

a. Hip and Knee Replacements

b. Spinal Fusions

c. Spinal Disc Devices

d. Other Spinal DRGs

5. MDC 17 (Myeloproliferative Diseases and Disorders, Poorly Differentiated Neoplasm): Endoscopic Procedures

6. Medicare Code Editor (MCE) Changes

a. Non-Covered Procedure Edit: Code 00.62 (Percutaneous angioplasty or atherectomy of intracranial vessel(s))

b. Non-Specific Principal Diagnosis Edit 7 and Non-Specific O.R. Procedures Edit 10

c. Limited Coverage Edit 17

d. Revision to Part 1, Pancreas Transplant Edit A

7. Surgical Hierarchies

8. CC Exclusions List

a. Background

b. CC Exclusions List for FY 2008

9. Review of Procedure Codes in CMS DRGs 468, 476, and 477

a. Moving Procedure Codes from CMS DRG 468 (MS-DRGs 981 through 983) or CMS DRG 477 (MS-DRGs 987 through 989) to MDCs

b. Reassignment of Procedures Among CMS DRGs 468, 476, and 477 (MS-DRGs 981 through 983, 984 through 986, and 987 through 989)

c. Adding Diagnosis or Procedure Codes to MDCs

10. Changes to the ICD-9-CM Coding System

11. Other DRG Issues Addressed in the FY 2008 IPPS Proposed Rule

a. Seizures and Headaches

b. Devices That are Replaced Without Cost or Where Credit for a Replaced Device is Furnished to the Hospital

12. Other MS-DRG Issues Raised in the Public Comments on the Proposed Rule

a. Heart Transplants or Implants of Heart Assist System and Liver Transplants (Pre-MDC)

b. Gliadel® Wafer (MDC 1)

c. Myasthenia Gravis and Acute and Chronic Inflammatory Demyelinating Neuropathies (AIDP-CIDP) (MDC 1)

d. Peripheral and Spinal Neurostimulators (MDC 1 and MDC 8)

e. Stroke and Administration of Tissue Plasminogen Activator (tPA) (MDC 1)

f. Gliasite® Radiation Therapy System (RTS) (MDC 1)

g. Noninvasive Ventilation (MDC 4)

h. Heart Assist Devices (MDC 5)

i. Automatic Implantable Cardioverter-Defibrillators (ACID) Lead and Generator Procedures (MDC 5)

j. Artificial Heart (MDC 5)

k. Vascular Procedures (MDC 5)

l. Coronary Artery Stents (MDC 5)

m. Endovascular Repair of Aortic and Thoracic Aneurysms (MDC 5)

n. O.R. Procedures for Obesity (MDC 10)

o. Penile Restorative Procedures (MDC 12)

p. Female Reproductive System Reconstruction Procedures (MDC 13)

q. Urological and Gynecological Disorders with Grafts or Prosthesis (MDCs 13 and 14)

r. High Dose Interleukin-2 (HD-IL-2) (MDC 17)

s. Computer Assisted Surgery

13. Changes to MS-DRG Logic As a Result of Public Comments

H. Recalibration of DRG Weights

I. MS-LTC-DRG Reclassifications and Relative Weights for LTCHs for FY 2008

1. Background

2. Changes in the LTC-DRG Classifications

a. Background

b. Patient Classifications into DRGs

3. Development of the FY 2008 MS-LTC-DRG Relative Weights

a. General Overview of Development of the MS-LTC-DRG Relative Weights

b. Data

c. Hospital-Specific Relative Value Methodology

d. Treatment of Severity Levels in Developing Relative Weights

e. Low-Volume MS-LTC-DRGs

4. Steps for Determining the FY 2008 MS-LTC-DRG Relative Weights Start Printed Page 47133

J. Add-On Payments for New Services and Technologies

1. Background

2. Public Input Before Publication of a Notice of Proposed Rulemaking on Add-On Payments

3. FY 2008 Status of Technologies Approved for FY 2007 Add-On Payments

a. Endovascular Graft Repair of the Thoracic Aorta

b. Restore® Rechargeable Implantable Neurostimulators

c. X STOP Interspinous Process Decompression System

4. FY 2008 Application for New Technology Add-On Payments

5. Technical Correction

III. Changes to the Hospital Wage Index

A. Background

B. Core-Based Statistical Areas for the Hospital Wage Index

C. Occupational Mix Adjustment to the FY 2008 Wage Index

1. Development of Data for the FY 2008 Occupational Mix Adjustment

2. Timeline for the Collection, Review, and Correction of the Occupational Mix Data

3. Calculation of the Occupational Mix Adjustment for FY 2008

4. 2007-2008 Occupational Mix Survey for the FY 2010 Wage Index

D. Worksheet S-3 Wage Data for the FY 2008 Wage Index

1. Included Categories of Costs

2. Contract Labor for Indirect Patient Care Services

3. Excluded Categories of Costs

4. Use of Wage Index Data by Providers Other Than Acute Care Hospitals under the IPPS

E. Verification of Worksheet S-3 Wage Data

F. Wage Index for Multicampus Hospitals

G. Computation of the FY 2008 Unadjusted Wage Index

1. Method for Computing the FY 2008 Unadjusted Wage Index

2. Expiration of the Imputed Floor

3. CAHs Reverting Back to IPPS Hospitals and Raising the Rural Floor

4. Application of Rural Floor Budget Neutrality

H. Analysis and Implementation of the Occupational Mix Adjustment and the FY 2008 Occupational Mix Adjusted Wage Index

I. Revisions to the Wage Index Based on Hospital Redesignations

1. General

2. Effects of Reclassification/Redesignation

3. FY 2008 MGCRB Reclassifications

4. Hospitals That Applied for Reclassification Effective in FY 2008 and Reinstating Reclassifications in FY 2008

5. Clarification of Policy on Reinstating Reclassifications

6. “Fallback” Reclassifications

7. Geographic Reclassification Issues for Multicampus Hospitals

8. Redesignations of Hospitals under Section 1886(d)(8)(B) of the Act

9. Reclassifications under Section 1886(d)(8)(B) of the Act

10. New England Deemed Counties

11. Reclassifications under Section 508 of Pub. L. 108-173

12. Other Issues

J. FY 2008 Wage Index Adjustment Based on Commuting Patterns of Hospital Employees

K. Process for Requests for Wage Index Data Corrections

L. Labor-Related Share for the Wage Index for FY 2008

M. Wage Index Study Required under Pub. L. 109-432

N. Proxy for the Hospital Market Basket

IV. Other Decisions and Changes to the IPPS for Operating Costs and GME Costs

A. Reporting of Hospital Quality Data for Annual Hospital Payment Update

1. Background

2. FY 2008 Quality Measures

3. New Quality Measures and Program Requirements for FY 2009 and Subsequent Years

a. New Quality Measures for FY 2009 and Subsequent Years

b. Data Submission

4. Retiring or Replacing RHQDAPU Program Quality Measures

5. Procedures for the RHQDAPU Program for FY 2008 and FY 2009

a. Procedures for Participating in the RHQDAPU Program

b. Procedures for Participating in the RHQDAPU Program for FY 2009

c. Chart Validation Requirements

d. Data Validation and Attestation

e. Public Display

f. Reconsideration and Appeal Procedures

g. RHQDAPU Program Withdrawal Requirements

6. Electronic Medical Records

7. New Hospitals

B. Development of the Medicare Hospital Value-Based Purchasing Plan

C. Rural Referral Centers (RRCs)

1. Annual Update of RRC Status Criteria

a. Case-Mix Index

b. Discharges

2. Acquired Rural Status of RRCs

D. Indirect Medical Education (IME) Adjustment

1. Background

2. IME Adjustment Factor for FY 2008

3. Time Spent by Residents on Vacation or Sick Leave and in Orientation

a. Background

b. Vacation and Sick Leave Time

c. Orientation Activities

d. Regulation Changes

E. Payments to Disproportionate Share Hospitals (DSHs): Technical Correction

1. Background

2. Technical Correction: Inclusion of Medicare Advantage Days in the Medicare Fraction of the Medicare DSH Calculation

F. Hospital Emergency Services under EMTALA

1. Background

2. Recent Legislation Affecting EMTALA Implementation

a. Secretary's Authority to Waive Requirements During National Emergencies

b. Provisions of the Pandemic and All-Hazards Preparedness Act

c. Revisions to the EMTALA Regulations

G. Disclosure of Physician Ownership in Hospitals and Patient Safety Measures

1. Disclosure of Physician Ownership in Hospitals

2. Patient Safety Measures

H. Rural Community Hospital Demonstration Program

V. Changes to the IPPS for Capital-Related Costs

A. Background

B. Policy Change

VI. Changes for Hospitals and Hospital Units Excluded from the IPPS

A. Payments to Existing and New Excluded Hospitals and Hospital Units

B. Separate PPS for IRFs

C. Separate PPS for LTCHs

D. Separate PPS for IPFs

E. Determining LTCH Cost-to-Charge Ratios (CCRs) under the LTCH PPS

F. Report of Adjustment (Exceptions) Payments

VII. Services Furnished to Beneficiaries in Custody of Penal Authorities

VIII. MedPAC Recommendations

IX. Other Required Information

A. Requests for Data from the Public

B. Collection of Information Requirements

C. Waiver of Notice of Proposed Rulemaking

Regulation Text

Addendum—Schedule of Standardized Amounts, Update Factors, and Rate-of-Increase Percentages Effective With Cost Reporting Periods Beginning On or After October 1, 2007

I. Summary and Background

II. Changes to the Prospective Payment Rates for Hospital Inpatient Operating Costs for FY 2008

A. Calculation of the Adjusted Standardized Amount

1. Standardization of Base-Year Costs or Target Amounts

2. Computing the Average Standardized Amount

3. Updating the Average Standardized Amount

4. Other Adjustments to the Average Standardized Amount

a. Recalibration of DRG Weights and Updated Wage Index Budget Neutrality Adjustment

b. Reclassified Hospitals—Budget Neutrality Adjustment

c. Imputed Rural Floor—Budget Neutrality Adjustment

d. Case-Mix Budget Neutrality Adjustment

e. Outliers

f. Rural Community Hospital Demonstration Program Adjustment (Section 410A of Pub. L. 108-173)

5. FY 2008 Standardized Amount

B. Adjustments for Area Wage Levels and Cost-of-Living

1. Adjustment for Area Wage Levels

2. Adjustment for Cost-of-Living in Alaska and Hawaii

C. DRG Relative Weights

D. Calculation of the Prospective Payment Rates

1. Federal Rate

2. Hospital Specific Rate (Applicable Only to SCHs and MDHs)

a. Calculation of Hospital Specific RateStart Printed Page 47134

b. Updating the FY 1982, FY 1987, FY 1996, and FY 2002 Hospital Specific Rates for FY 2008

3. General Formula for Calculation of Prospective Payment Rates for Hospitals Located in Puerto Rico Beginning On or After October 1, 2007 and Before October 1, 200

a. Puerto Rico Rate

b. National Rate

III. Changes to Payment Rates for Acute Care Hospital Inpatient Capital-Related Costs for FY 2008

A. Determination of Federal Hospital Inpatient Capital Related Prospective Payment Rate Update

1. Projected Capital Standard Federal Rate Update

a. Description of the Update Framework

b. MedPAC Update Recommendation

2. Outlier Payment Adjustment Factor

3. Budget Neutrality Adjustment Factor for Changes in DRG Classifications and Weights and the GAF

4. Exceptions Payment Adjustment Factor

5. Capital Standard Federal Rate for FY 2008

6. Special Capital Rate for Puerto Rico Hospitals

B. Calculation of the Inpatient Capital-Related Prospective Payments for FY 2008

C. Capital Input Price Index

1. Background

2. Forecast of the CIPI for FY 2008

IV. Changes to Payment Rates for Excluded Hospitals and Hospital Units: Rate-of-Increase Percentages

V. Tables

Table 1A—National Adjusted Operating Standardized Amounts, Labor/Nonlabor (69.7 Percent Labor Share/30.3 Percent Nonlabor Share If Wage Index Is Greater Than 1)

Table 1B—National Adjusted Operating Standardized Amounts, Labor/Nonlabor (62 Percent Labor Share/38 Percent Nonlabor Share If Wage Index Is Less Than or Equal to 1)

Table 1C—Adjusted Operating Standardized Amounts for Puerto Rico, Labor/Nonlabor

Table 1D—Capital Standard Federal Payment Rate

Table 2—Hospital Case-Mix Indexes for Discharges Occurring in Federal Fiscal Year 2006; Hospital Wage Indexes for Federal Fiscal Year 2008; Hospital Average Hourly Wages for Federal Fiscal Years 2006 (2002 Wage Data), 2007 (2003 Wage Data), and 2008 (2004 Wage Data); and 3-Year Average of Hospital Average Hourly Wages

Table 3A—FY 2008 and 3-Year Average Hourly Wage for Urban Areas by CBSA

Table 3B—FY 2008 and 3-Year Average Hourly Wage for Rural Areas by CBSA

Table 4A—Wage Index and Capital Geographic Adjustment Factor (GAF) for Urban Areas by CBSA—FY 2008

Table 4B—Wage Index and Capital Geographic Adjustment Factor (GAF) for Rural Areas by CBSA—FY 2008

Table 4C—Wage Index and Capital Geographic Adjustment Factor (GAF) for Hospitals That Are Reclassified by CBSA—FY 2008

Table 4F—Puerto Rico Wage Index and Capital Geographic Adjustment Factor (GAF) by CBSA—FY 2008

Table 4J—Out-Migration Wage Adjustment—FY 2008

Table 5—List of Medicare Severity Diagnosis-Related Groups (MS-DRGs), Relative Weighting Factors, and Geometric and Arithmetic Mean Length of Stay

Table 6A—New Diagnosis Codes

Table 6B—New Procedure Codes

Table 6C—Invalid Diagnosis Codes

Table 6D—Invalid Procedure Codes

Table 6E—Revised Diagnosis Code Titles

Table 6F—Revised Procedure Code Titles

Table 6G—Additions to the CC Exclusions List

Table 6H—Deletions from the CC Exclusions List

Table 6I—Complete List of Complication and Comorbidity (CC) Exclusions

(Available only through the Internet on the CMS Web site at: http://www.cms.hhs.gov/​AcuteInpatientPPS/​)

Table 7A—Medicare Prospective Payment System Selected Percentile Lengths of Stay: FY 2006 MedPAR Update—March 2007 GROUPER V24.0 CMS DRGs

Table 7B—Medicare Prospective Payment System Selected Percentile Lengths of Stay: FY 2006 MedPAR Update—March 2007 GROUPER V25.0 CMS DRGs

Table 8A—Statewide Average Operating Cost-to-Charge Ratios—July 2007

Table 8B—Statewide Average Capital Cost-to-Charge Ratios—July 2007

Table 8C—Statewide Average Total Cost-to-Charge Ratios for LTCHs—July 2007

Table 9A—Hospital Reclassifications and Redesignations—FY 2008

Table 9C—Hospitals Redesignated as Rural under Section 1886(d)(8)(E) of the Act—FY 2008

Table 10—Geometric Mean Plus the Lesser of .75 of the National Adjusted Operating Standardized Payment Amount (Increased to Reflect the Difference Between Costs and Charges) or .75 of One Standard Deviation of Mean Charges by Medicare Severity Diagnosis-Related Groups (MS-DRGs)—July 2007

Table 11—FY 2008 MS-LTC-DRGs, Relative Weights, Geometric Average Length of Stay, Short-Stay Outlier Threshold, and IPPS Comparable Threshold

Appendix A—Regulatory Impact Analysis

I. Overall Impact

II. Objectives

III. Limitations on Our Analysis

IV. Hospitals Included In and Excluded From the IPPS

V. Effects on Excluded Hospitals and Hospital Units

VI. Quantitative Effects of the Policy Changes Under the IPPS for Operating Costs

A. Basis and Methodology of Estimates

B. Analysis of Table I

C. Effects of the Changes to the DRG Reclassifications and Relative Cost-Based Weights (Column 2)

D. Effects of Wage Index Changes (Column 3)

E. Combined Effects of DRG and Wage Index Changes (Column 4)

F. Effects of the Expiration of the 3-Year Provision Allowing Urban Hospitals That Were Converted to Rural as a Result of the FY 2005 Labor Market Area Changes to Maintain the Wage Index of the Urban Labor Market Area in Which They Were Formerly Located (Column 5)

G. Effects of MGCRB Reclassifications (Column 6)

H. Effects of the Adjustment to the Application of the Rural Floor (Column 7)

I. Effects of Application of the Imputed Floor (Column 8)

J. Effects of the Expiration of Section 508 of Pub. L. 108-173 (Column 9)

K. Effects of the Wage Index Adjustment for Out-Migration (Column 10)

L. Effects of All Changes with CMI Adjustment Prior to Estimated Growth (Column 11)

M. Effects of All Changes with CMI Adjustment and Assumed Estimated (Column 12)

N. Effects of Policy on Payment Adjustments for Low-Volume Hospitals

O. Impact Analysis of Table II

VII. Effects of Other Policy Changes

A. Effects of Policy on Hospital-Acquired Conditions, Including Infections

B. Effects of MS-LTC-DRG Reclassifications and Relative Weights for LTCHs

C. Effects of New Technology Add-On Payments

D. Effects of Requirements for Hospital Reporting of Quality Data for Annual Hospital Payment Update

E. Effects of Policy on Cancellation of Classification of Acquired Rural Status and Rural Referral Centers

F. Effects of Policy Change on Payment for IME and Direct GME

G. Effects of Policy Changes Relating to Emergency Services under EMTALA During an Emergency Period

H. Effects of Policy on Disclosure of Physician Ownership in Hospitals and Patient Safety Measures

I. Effects of Implementation of the Rural Community Hospital Demonstration Program

J. Effects of Policy Changes on Services Furnished to Beneficiaries in Custody of Penal Authorities

VIII. Impact of Changes in the Capital IPPS

A. General Considerations

B. Results

IX. Alternatives Considered

X. Overall Conclusion

XI. Accounting Statement

XII. Executive Order 12866

Appendix B—Recommendation of Update Factors for Operating Cost Rates of Payment for Inpatient Hospital Services

I. Background

II. Inpatient Hospital Update for FY 2008

III. Secretary's Final Recommendation

IV. MedPAC Recommendation for Assessing Payment Adequacy and Updating Payments in Traditional Medicare

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I. Background

A. Summary

1. Acute Care Hospital Inpatient Prospective Payment System (IPPS)

Section 1886(d) of the Social Security Act (the Act) sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. Section 1886(g) of the Act requires the Secretary to pay for the capital-related costs of hospital inpatient stays under a prospective payment system (PPS). Under these PPSs, Medicare payment for hospital inpatient operating and capital-related costs is made at predetermined, specific rates for each hospital discharge. Discharges are classified according to a list of diagnosis-related groups (DRGs).

The base payment rate is comprised of a standardized amount that is divided into a labor-related share and a nonlabor-related share. The labor-related share is adjusted by the wage index applicable to the area where the hospital is located; and if the hospital is located in Alaska or Hawaii, the nonlabor-related share is adjusted by a cost-of-living adjustment factor. This base payment rate is multiplied by the DRG relative weight.

If the hospital treats a high percentage of low-income patients, it receives a percentage add-on payment applied to the DRG-adjusted base payment rate. This add-on payment, known as the disproportionate share hospital (DSH) adjustment, provides for a percentage increase in Medicare payments to hospitals that qualify under either of two statutory formulas designed to identify hospitals that serve a disproportionate share of low-income patients. For qualifying hospitals, the amount of this adjustment may vary based on the outcome of the statutory calculations.

If the hospital is an approved teaching hospital, it receives a percentage add-on payment for each case paid under the IPPS, known as the indirect medical education (IME) adjustment. This percentage varies, depending on the ratio of residents to beds.

Additional payments may be made for cases that involve new technologies or medical services that have been approved for special add-on payments. To qualify, a new technology or medical service must demonstrate that it is a substantial clinical improvement over technologies or services otherwise available, and that, absent an add-on payment, it would be inadequately paid under the regular DRG payment.

The costs incurred by the hospital for a case are evaluated to determine whether the hospital is eligible for an additional payment as an outlier case. This additional payment is designed to protect the hospital from large financial losses due to unusually expensive cases. Any outlier payment due is added to the DRG-adjusted base payment rate, plus any DSH, IME, and new technology or medical service add-on adjustments.

Although payments to most hospitals under the IPPS are made on the basis of the standardized amounts, some categories of hospitals are paid the higher of a hospital-specific rate based on their costs in a base year (the higher of FY 1982, FY 1987, FY 1996, or FY 2002) or the IPPS rate based on the standardized amount. For example, sole community hospitals (SCHs) are the sole source of care in their areas, and Medicare-dependent, small rural hospitals (MDHs) are a major source of care for Medicare beneficiaries in their areas. Both of these categories of hospitals are afforded this special payment protection in order to maintain access to services for beneficiaries. (Until FY 2007, an MDH has received the IPPS rate plus 50 percent of the difference between the IPPS rate and its hospital-specific rate if the hospital-specific rate is higher than the IPPS rate. In addition, an MDH does not have the option of using FY 1996 as the base year for its hospital-specific rate. As discussed below, for discharges occurring on or after October 1, 2007, but before October 1, 2011, an MDH will receive the IPPS rate plus 75 percent of the difference between the IPPS rate and its hospital-specific rate, if the hospital-specific rate is higher than the IPPS rate.)

Section 1886(g) of the Act requires the Secretary to pay for the capital-related costs of inpatient hospital services “in accordance with a prospective payment system established by the Secretary.” The basic methodology for determining capital prospective payments is set forth in our regulations at 42 CFR 412.308 and 412.312. Under the capital IPPS, payments are adjusted by the same DRG for the case as they are under the operating IPPS. Capital IPPS payments are also adjusted for IME and DSH, similar to the adjustments made under the operating IPPS. In addition, hospitals may receive outlier payments for those cases that have unusually high costs.

The existing regulations governing payments to hospitals under the IPPS are located in 42 CFR Part 412, Subparts A through M.

2. Hospitals and Hospital Units Excluded from the IPPS

Under section 1886(d)(1)(B) of the Act, as amended, certain specialty hospitals and hospital units are excluded from the IPPS. These hospitals and units are: rehabilitation hospitals and units; long-term care hospitals (LTCHs); psychiatric hospitals and units; children's hospitals; and cancer hospitals. Religious nonmedical health care institutions (RNHCIs) are also excluded from the IPPS. Various sections of the Balanced Budget Act of 1997 (Pub. L. 105-33), the Medicare, Medicaid and SCHIP [State Children's Health Insurance Program] Balanced Budget Refinement Act of 1999 (Pub. L. 106-113), and the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (Pub. L. 106-554) provide for the implementation of PPSs for rehabilitation hospitals and units (referred to as inpatient rehabilitation facilities (IRFs)), LTCHs, and psychiatric hospitals and units (referred to as inpatient psychiatric facilities (IPFs)), as discussed below. Children's hospitals, cancer hospitals, and RNHCIs continue to be paid solely under a reasonable cost-based system.

The existing regulations governing payments to excluded hospitals and hospital units are located in 42 CFR Parts 412 and 413.

a. Inpatient Rehabilitation Facilities (IRFs)

Under section 1886(j) of the Act, as amended, rehabilitation hospitals and units (IRFs) have been transitioned from payment based on a blend of reasonable cost reimbursement subject to a hospital-specific annual limit under section 1886(b) of the Act and the adjusted facility Federal prospective payment rate for cost reporting periods beginning on or after January 1, 2002 through September 30, 2002, to payment at 100 percent of the Federal rate effective for cost reporting periods beginning on or after October 1, 2002. IRFs subject to the blend were also permitted to elect payment based on 100 percent of the Federal rate. The existing regulations governing payments under the IRF PPS are located in 42 CFR Part 412, Subpart P.

b. Long-Term Care Hospitals (LTCHs)

Under the authority of sections 123(a) and (c) of Pub. L. 106-113 and section 307(b)(1) of Pub. L. 106-554, the LTCH PPS was effective for a LTCH's first cost reporting period beginning on or after October 1, 2002. LTCHs that do not meet the definition of “new” under § 412.23(e)(4) are paid, during a 5-year Start Printed Page 47136transition period, a LTCH prospective payment that is comprised of an increasing proportion of the LTCH Federal rate and a decreasing proportion based on reasonable cost principles. Those LTCHs that did not meet the definition of “new” under § 412.23(e)(4) could elect to be paid based on 100 percent of the Federal prospective payment rate instead of a blended payment in any year during the 5-year transition. For cost reporting periods beginning on or after October 1, 2006, all LTCHs are paid 100 percent of the Federal rate. The existing regulations governing payment under the LTCH PPS are located in 42 CFR Part 412, Subpart O.

c. Inpatient Psychiatric Facilities (IPFs)

Under the authority of sections 124(a) and (c) of Pub. L. 106-113, inpatient psychiatric facilities (IPFs) (formerly psychiatric hospitals and psychiatric units of acute care hospitals) are paid under the IPF PPS. Under the IPF PPS, some IPFs are transitioning from being paid for inpatient hospital services based on a blend of reasonable cost-based payment and a Federal per diem payment rate, effective for cost reporting periods beginning on or after January 1, 2005. For cost reporting periods beginning on or after January 1, 2008, all IPFs will be paid 100 percent of the Federal per diem payment amount. The existing regulations governing payment under the IPF PPS are located in 42 CFR 412, Subpart N.

3. Critical Access Hospitals (CAHs)

Under sections 1814, 1820, and 1834(g) of the Act, payments are made to critical access hospitals (CAHs) (that is, rural hospitals or facilities that meet certain statutory requirements) for inpatient and outpatient services based on 101 percent of reasonable cost. Reasonable cost is determined under the provisions of section 1861(v)(1)(A) of the Act and existing regulations under 42 CFR Parts 413 and 415.

4. Payments for Graduate Medical Education (GME)

Under section 1886(a)(4) of the Act, costs of approved educational activities are excluded from the operating costs of inpatient hospital services. Hospitals with approved graduate medical education (GME) programs are paid for the direct costs of GME in accordance with section 1886(h) of the Act; the amount of payment for direct GME costs for a cost reporting period is based on the hospital's number of residents in that period and the hospital's costs per resident in a base year. The existing regulations governing payments to the various types of hospitals are located in 42 CFR Part 413.

B. Provisions of the Deficit Reduction Act of 2005 (DRA)

The Deficit Reduction Act of 2005 (DRA), Pub. L. 109-171, made a number of changes to the Act relating to prospective payments to hospitals and other providers for inpatient services. The final rule implements amendments made by (1) section 5001(a), which, effective for FY 2007 and subsequent years, expands the requirements for hospital quality data reporting; and (2) section 5001(c), which requires the Secretary to select, by October 1, 2007, at least two hospital-acquired conditions that meet certain specified criteria that will be subject to a quality adjustment in DRG payments during FY 2008.

In this final rule with comment period, we also discuss our development of a plan to implement, beginning with FY 2009, a value-based purchasing plan for section 1886(d) hospitals, in accordance with the requirements of section 5001(b) of Pub. L. 109-171.

C. Provisions of the Medicare Improvements and Extension Act under Division B, Title I of the Tax Relief and Health Care Act of 2006

In this final rule with comment period, we discuss the provisions of section 106(b)(1) of the Medicare Improvements and Extensions Act under Division B, Title I of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA), Pub. L. 109-432, which requires MedPAC to submit to Congress, not later than June 30, 2007, a report on the Medicare wage index classification system applied under the Medicare Prospective Payment System. Section 106(b) of the MIEA-TRHCA requires the report to include any alternatives that MedPAC recommends to the method to compute the wage index under section 1886(d)(3)(E) of the Act.

In addition, we discuss the provisions of section 106(b)(2) of the MIEA-TRHCA, which instructs the Secretary of Health and Human Services, taking into account MedPAC's recommendations on the Medicare wage index classification system, to include in the FY 2009 IPPS proposed rule one or more proposals to revise the wage index adjustment applied under section 1886(d)(3)(E) of the Act for purposes of the IPPS.

We note that we published a notice in the Federal Register on March 23, 2007 (72 FR 13799) that addressed the provisions of section 106(a) of the MIEA-TRHCA relating to the extension of geographic reclassifications of hospitals under section 508 of Pub. L. 108-173 (that expired on March 31, 2007) through September 30, 2007.

D. Provisions of the Pandemic and All-Hazards Preparedness Act

On December 19, 2006, Congress enacted the Pandemic and All-Hazards Preparedness Act, Pub. L. 109-417. Section 302(b) of Pub. L. 109-417 makes two specific changes that affect EMTALA implementation in emergency areas during an emergency period. Specifically section 302(b)(1)(A) of Pub. L. 109-417 amended section 1135(b)(3)(B) of the Act to state that sanctions may be waived for the direction or relocation of an individual for screening where, in the case of a public health emergency that involves a pandemic infectious disease, that direction or relocation occurs pursuant to a State pandemic preparedness plan. In addition, sections 302(b)(1)(B) and (b)(1)(C) of Pub. L. 109-417 amended section 1135(b)(3)(B) of the Act to state that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza) the duration of a waiver or modification under section 1135(b)(3) of the Act (relating to EMTALA) shall be determined in accordance with section 1135(e) of the Act as that subsection applies to public health emergencies.

In this final rule with comment period, we are making changes to the EMTALA regulations to conform them to the sanction waiver provisions of section 302(b) of Pub. L. 109-417.

E. Issuance of a Notice of Proposed Rulemaking

On May 3, 2007, we issued in the Federal Register (72 FR 24680) a notice of proposed rulemaking that set forth proposed changes to the Medicare IPPS for operating costs and for capital-related costs in FY 2008. We also set forth proposed changes relating to payments for GME and IME costs and payments to certain hospitals and units that continue to be excluded from the IPPS and paid on a reasonable cost basis that would be effective for discharges occurring on or after October 1, 2007. Below is a summary of the major changes that we proposed to make:

1. DRG Reclassifications and Recalibrations of Relative Weights

We proposed to adopt a Medicare Severity DRG (MS-DRG) classification system for the IPPS to better recognize severity of illness. We presented the methodology we used to establish the MS-DRGs and discussed our efforts to Start Printed Page 47137further analyze alternative severity-adjusted DRG systems and to refine the relative weight calculations for DRGs.

We presented a proposed listing and discussion of hospital-acquired conditions, including infections, which were evaluated and proposed to be subject to the statutorily required quality adjustment in DRG payments for FY 2008.

We proposed limited annual revisions to the DRG classification system in the following areas: Intestinal transplants, neurostimulators, intracranial stents, cochlear implants, knee and hip replacements, spinal fusions and spinal disc devices, and endoscopic procedures.

We presented our reevaluation of certain FY 2007 applicants for add-on payments for high-cost new medical services and technologies, and our analysis of the FY 2008 applicant (including public input, as directed by Pub. L. 108-173, obtained in a town hall meeting).

We proposed the annual update of the long-term care diagnosis-related group (LTC-DRG) classifications and relative weights for use under the LTCH PPS for FY 2008. We proposed that the LTC-DRGs would be revised to mirror the proposed MS-DRGs for the IPPS.

2. Proposed Changes to the Hospital Wage Index

In section III. of the preamble to the proposed rule, we proposed revisions to the wage index and the annual update of the wage data. Specific issues addressed included the following:

  • The FY 2008 wage index update, using wage data from cost reporting periods that began during FY 2004.
  • Analysis and implementation of the proposed FY 2008 occupational mix adjustment to the wage index.
  • Proposed changes relating to expiration of the imputed rural floor for the wage index and application of budget neutrality for the rural floor.
  • Proposed changes in the determination of the wage index for multicampus hospitals.
  • The proposed revisions to the wage index based on hospital redesignations and reclassifications, including reclassifications for multicampus hospitals.
  • The proposed adjustment to the wage index for FY 2008 based on commuting patterns of hospital employees who reside in a county and work in a different area with a higher wage index.
  • The timetable for reviewing and verifying the wage data that were in effect for the FY 2008 wage index.
  • The labor-related share for the FY 2008 wage index, including the labor-related share for Puerto Rico.

3. Other Decisions and Proposed Changes to the IPPS for Operating Costs and GME Costs

In section IV. of the preamble to the proposed rule, we discussed a number of the provisions of the regulations in 42 CFR Parts 412, 413, and 489, including the following:

  • The reporting of hospital quality data as a condition for receiving the full annual payment update increase.
  • Development of the Medicare value-based purchasing plan and reports on the “listening sessions” held.
  • The proposed updated national and regional case-mix values and discharges for purposes of determining RRC status and a proposed policy change relating to the acquired rural status of RRCs.
  • The statutorily-required IME adjustment factor for FY 2008 and a proposed policy change relating to determining counts of residents on vacation or sick leave and in orientation for IME and direct GME purposes.
  • Proposed changes relating to the waiver of sanctions for requirements for emergency services for hospitals under EMTALA during national emergencies.
  • Proposed policy changes relating to the disclosure to patients of physician ownership of hospitals and patient safety measures.
  • Discussion of the fourth year of implementation of the Rural Community Hospital Demonstration Program.

4. Proposed Changes to the IPPS for Capital-Related Costs

In section V. of the preamble to the proposed rule, we discussed the payment policy requirements for capital-related costs and capital payments to hospitals and proposed changes relating to adjustments to the Federal capital rate to address continuous large positive margins.

5. Proposed Changes to the Payment Rates for Excluded Hospitals and Hospital Units: Rate-of-Increase Percentages

In section VI. of the preamble to the proposed rule, we discussed payments to excluded hospitals and hospital units, and proposed changes for determining LTCH CCRs under the LTCH PPS.

6. Services Furnished to Beneficiaries in Custody of Penal Authorities

In section VII. of the preamble to the proposed rule, we clarified when individuals are considered to be in “custody” for purposes of Medicare payment for services furnished to beneficiaries who are under penal authorities.

7. Determining Proposed Prospective Payment Operating and Capital Rates and Rate-of-Increase Limits

In the Addendum to the proposed rule, we set forth proposed changes to the amounts and factors for determining the FY 2008 prospective payment rates for operating costs and capital-related costs. We also established the proposed threshold amounts for outlier cases. In addition, we addressed the proposed update factors for determining the rate-of-increase limits for cost reporting periods beginning in FY 2008 for hospitals and hospital units excluded from the PPS.

8. Impact Analysis

In Appendix A of the proposed rule, we set forth an analysis of the impact that the proposed changes would have on affected hospitals.

9. Recommendation of Update Factors for Operating Cost Rates of Payment for Inpatient Hospital Services

In Appendix B of the proposed rule, as required by sections 1886(e)(4) and (e)(5) of the Act, we provided our recommendations of the appropriate percentage changes for FY 2008 for the following:

  • A single average standardized amount for all areas for hospital inpatient services paid under the IPPS for operating costs (and hospital-specific rates applicable to SCHs and MDHs).
  • Target rate-of-increase limits to the allowable operating costs of hospital inpatient services furnished by hospitals and hospital units excluded from the IPPS.

10. Discussion of Medicare Payment Advisory Commission Recommendations

Under section 1805(b) of the Act, MedPAC is required to submit a report to Congress, no later than March 1 of each year, in which MedPAC reviews and makes recommendations on Medicare payment policies. MedPAC's March 2007 recommendations concerning hospital inpatient payment policies addressed the update factor for inpatient hospital operating costs and capital-related costs under the IPPS and for hospitals and distinct part hospital units excluded from the IPPS. We addressed these recommendations in Appendix B of the proposed rule. For further information relating specifically to the MedPAC March 2007 reports or to obtain a copy of the reports, contact Start Printed Page 47138MedPAC at (202) 220-3700 or visit MedPAC's Web site at: www.medpac.gov.

F. Public Comments Received on the Proposed Rule

We received approximately 900 timely pieces of correspondence in response to the FY 2008 IPPS proposed rule issued in the Federal Register on May 3, 2007. These public comments addressed issues on multiple topics in the proposed rule. We present a summary of the public comments and our responses to them in the applicable subject matter sections of this final rule with comment period.

II. Changes to DRG Classifications and Relative Weights

A. Background

Section 1886(d) of the Act specifies that the Secretary shall establish a classification system (referred to as DRGs) for inpatient discharges and adjust payments under the IPPS based on appropriate weighting factors assigned to each DRG. Therefore, under the IPPS, we pay for inpatient hospital services on a rate per discharge basis that varies according to the DRG to which a beneficiary's stay is assigned. The formula used to calculate payment for a specific case multiplies an individual hospital's payment rate per case by the weight of the DRG to which the case is assigned. Each DRG weight represents the average resources required to care for cases in that particular DRG, relative to the average resources used to treat cases in all DRGs.

Congress recognized that it would be necessary to recalculate the DRG relative weights periodically to account for changes in resource consumption. Accordingly, section 1886(d)(4)(C) of the Act requires that the Secretary adjust the DRG classifications and relative weights at least annually. These adjustments are made to reflect changes in treatment patterns, technology, and any other factors that may change the relative use of hospital resources.

B. DRG Reclassifications

1. General

As discussed in the preamble to the FY 2007 IPPS final rule (71 FR 47881 through 47971), we are focusing our efforts in FY 2008 on making significant reforms to the IPPS consistent with the recommendations made by MedPAC in its “Report to the Congress, Physician-Owned Specialty Hospitals” in March 2005. MedPAC recommended that the Secretary refine the entire DRG system by taking into account severity of illness and applying hospital-specific relative value (HSRV) weights to DRGs.[1] We began this reform process by adopting cost-based weights over a 3-year transition period beginning in FY 2007 and making interim changes to the DRG system for FY 2007 by creating 20 new CMS DRGs and modifying 32 others across 13 different clinical areas involving nearly 1.7 million cases. As described below in more detail, these refinements were intermediate steps towards comprehensive reform of both the relative weights and the DRG system that is occurring as we undertook further study.

Currently, cases are classified into CMS DRGs for payment under the IPPS based on the principal diagnosis, up to eight additional diagnoses, and up to six procedures performed during the stay. In a small number of DRGs, classification is also based on the age, sex, and discharge status of the patient. The diagnosis and procedure information is reported by the hospital using codes from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM).

The process of forming the DRGs was begun by dividing all possible principal diagnoses into mutually exclusive principal diagnosis areas, referred to as Major Diagnostic Categories (MDCs). The MDCs were formed by physician panels to ensure that the DRGs would be clinically coherent. The diagnoses in each MDC correspond to a single organ system or etiology and, in general, are associated with a particular medical specialty. Thus, in order to maintain the requirement of clinical coherence, no final DRG could contain patients in different MDCs. Most MDCs are based on a particular organ system of the body. For example, MDC 6 is Diseases and Disorders of the Digestive System. This approach is used because clinical care is generally organized in accordance with the organ system affected. However, some MDCs are not constructed on this basis because they involve multiple organ systems (for example, MDC 22 (Burns)). For FY 2007, cases are assigned to one of 538 DRGs in 25 MDCs. The table below lists the 25 MDCs.

Major Diagnostic Categories

[MDCs]

1Diseases and Disorders of the Nervous System.
2Diseases and Disorders of the Eye.
3Diseases and Disorders of the Ear, Nose, Mouth, and Throat.
4Diseases and Disorders of the Respiratory System.
5Diseases and Disorders of the Circulatory System.
6Diseases and Disorders of the Digestive System.
7Diseases and Disorders of the Hepatobiliary System and Pancreas.
8Diseases and Disorders of the Musculoskeletal System and Connective Tissue.
9Diseases and Disorders of the Skin, Subcutaneous Tissue and Breast.
10Endocrine, Nutritional and Metabolic Diseases and Disorders.
11Diseases and Disorders of the Kidney and Urinary Tract.
12Diseases and Disorders of the Male Reproductive System.
13Diseases and Disorders of the Female Reproductive System.
14Pregnancy, Childbirth, and the Puerperium.
15Newborns and Other Neonates with Conditions Originating in the Perinatal Period.
16Diseases and Disorders of the Blood and Blood Forming Organs and Immunological Disorders.
17Myeloproliferative Diseases and Disorders and Poorly Differentiated Neoplasms.
18Infectious and Parasitic Diseases (Systemic or Unspecified Sites).
19Mental Diseases and Disorders.
20Alcohol/Drug Use and Alcohol/Drug Induced Organic Mental Disorders.
Start Printed Page 47139
21Injuries, Poisonings, and Toxic Effects of Drugs.
22Burns.
23Factors Influencing Health Status and Other Contacts with Health Services.
24Multiple Significant Trauma.
25Human Immunodeficiency Virus Infections.

In general, cases are assigned to an MDC based on the patient's principal diagnosis before assignment to a DRG. However, under the most recent version of the CMS GROUPER (Version 24.0), there are 9 DRGs to which cases are directly assigned on the basis of ICD-9-CM procedure codes. These DRGs are for heart transplant or implant of heart assist systems, liver and/or intestinal transplants, bone marrow transplants, lung transplants, simultaneous pancreas/kidney transplants, pancreas transplants, and for tracheostomies. Cases are assigned to these DRGs before they are classified to an MDC. The table below lists the nine current pre-MDCs.

Pre-Major Diagnostic Categories

[Pre-MDCs]

DRG 103Heart Transplant or Implant of Heart Assist System.
DRG 480Liver Transplant and/or Intestinal Transplant.
DRG 481Bone Marrow Transplant.
DRG 482Tracheostomy for Face, Mouth, and Neck Diagnoses.
DRG 495Lung Transplant.
DRG 512Simultaneous Pancreas/Kidney Transplant.
DRG 513Pancreas Transplant.
DRG 541ECMO or Tracheostomy with Mechanical Ventilation 96+ Hours or Principal Diagnosis Except for Face, Mouth, and Neck Diagnosis with Major O.R.
DRG 542Tracheostomy with Mechanical Ventilation 96+ Hours or Principal Diagnosis Except for Face, Mouth, and Neck Diagnosis without Major O.R.

Once the MDCs were defined, each MDC was evaluated to identify those additional patient characteristics that would have a consistent effect on the consumption of hospital resources. Because the presence of a surgical procedure that required the use of the operating room would have a significant effect on the type of hospital resources used by a patient, most MDCs were initially divided into surgical DRGs and medical DRGs. Surgical DRGs are based on a hierarchy that orders operating room (O.R.) procedures or groups of O.R. procedures by resource intensity. Medical DRGs generally are differentiated on the basis of diagnosis and age (0 to 17 years of age or greater than 17 years of age). Some surgical and medical DRGs are further differentiated based on the presence or absence of a complication or comorbidity (CC).

Generally, nonsurgical procedures and minor surgical procedures that are not usually performed in an operating room are not treated as O.R. procedures. However, there are a few non-O.R. procedures that do affect DRG assignment for certain principal diagnoses. An example is extracorporeal shock wave lithotripsy for patients with a principal diagnosis of urinary stones.

Once the medical and surgical classes for an MDC were formed, each diagnosis class was evaluated to determine if complications, comorbidities, or the patient's age would consistently affect the consumption of hospital resources. Physician panels classified each diagnosis code based on whether the diagnosis, when present as a secondary condition, would be considered a substantial CC. A substantial CC was defined as a condition which, because of its presence with a specific principal diagnosis, would cause an increase in the length of stay by at least one day in at least 75 percent of the patients. Each medical and surgical class within an MDC was tested to determine if the presence of any substantial CC would consistently affect the consumption of hospital resources.

A patient's diagnosis, procedure, discharge status, and demographic information is entered into the Medicare claims processing systems and subjected to a series of automated screens called the Medicare Code Editor (MCE). The MCE screens are designed to identify cases that require further review before classification into a DRG.

After patient information is screened through the MCE and any further development of the claim is conducted, the cases are classified into the appropriate DRG by the Medicare GROUPER software program. The GROUPER program was developed as a means of classifying each case into a DRG on the basis of the diagnosis and procedure codes and, for a limited number of DRGs, demographic information (that is, sex, age, and discharge status).

After cases are screened through the MCE and assigned to a DRG by the GROUPER, the PRICER software calculates a base DRG payment. The PRICER calculates the payment for each case covered by the IPPS based on the DRG relative weight and additional factors associated with each hospital, such as IME and DSH payment adjustments. These additional factors increase the payment amount to hospitals above the base DRG payment.

The records for all Medicare hospital inpatient discharges are maintained in the Medicare Provider Analysis and Review (MedPAR) file. The data in this file are used to evaluate possible DRG classification changes and to recalibrate the DRG weights. However, in the FY 2000 IPPS final rule (64 FR 41500), we discussed a process for considering non-MedPAR data in the recalibration process. In order for us to consider using particular non-MedPAR data, we must have sufficient time to evaluate and test the data. The time necessary to do so depends upon the nature and quality of the non-MedPAR data submitted. Generally, however, a significant sample of the non-MedPAR data should be submitted by mid-october for consideration in conjunction with the next year's proposed rule. This Start Printed Page 47140date allows us time to test the data and make a preliminary assessment as to the feasibility of using the data. Subsequently, a complete database should be submitted by early December for consideration in conjunction with the next year's proposed rule.

As we proposed in the FY 2008 IPPS proposed rule, for FY 2008, we are adopting significant changes to the current DRGs. As described in detail below, we proposed significant improvement in the DRG system to recognize severity of illness and resource usage by proposing to adopt Medicare Severity DRGs (MS-DRGs). The changes we proposed (and are adopting in this final rule with comment period) will be reflected in the FY 2008 GROUPER, Version 25.0, and will be effective for discharges occurring on or after October 1, 2007. As noted in the proposed rule, our DRG analysis was based on data from the December 2006 update of the FY 2006 MedPAR file, which contained hospital bills received through December 31, 2006, for discharges occurring in FY 2006. For this final rule with comment period, our analysis is based on more recent data from the March 2007 update of the FY 2006 MedPAR file, which contains hospital bills received through March 31, 2007, for discharges occurring in FY 2006.

2. Yearly Review for Making DRG Changes

Many of the changes to the DRG classifications we make annually are the result of specific issues brought to our attention by interested parties. As we indicated in the proposed rule, we encourage individuals with concerns about DRG classifications to bring those concerns to our attention in a timely manner so they can be carefully considered for possible inclusion in the annual proposed rule and, if included, may be subjected to public review and comment. Therefore, similar to the timetable for interested parties to submit non MedPAR data for consideration in the DRG recalibration process, concerns about DRG classification issues should be brought to our attention no later than early December in order to be considered and possibly included in the next annual proposed rule updating the IPPS.

The actual process of forming the DRGs was, and will likely continue to be, highly iterative, involving a combination of statistical results from test data combined with clinical judgment. We describe in detail below the process we used to develop the MS-DRGs that we proposed and are adopting in this final rule with comment period. In addition, in deciding whether to make further modification to the MS-DRGs for particular circumstances brought to our attention, we considered whether the resource consumption and clinical characteristics of the patients with a given set of conditions are significantly different than the remaining patients in the MS-DRG. We evaluated patient care costs using average charges and lengths of stay as proxies for costs and relied on the judgment of our medical advisors to decide whether patients are clinically distinct or similar to other patients in the MS-DRG. In evaluating resource costs, we considered both the absolute and percentage differences in average charges between the cases we selected for review and the remainder of cases in the MS-DRG. We also considered variation in charges within these groups; that is, whether observed average differences were consistent across patients or attributable to cases that were extreme in terms of charges or length of stay, or both. Further, we considered the number of patients who will have a given set of characteristics and generally preferred not to create a new DRG unless it would include a substantial number of cases.

C. MedPAC Recommendations for Revisions to the IPPS DRG System

In the FY 2006 and FY 2007 IPPS final rules, we discussed a number of recommendations made by MedPAC regarding revisions to the DRG system used under the IPPS (70 FR 47473 through 47482 and 71 FR 47881 through 47939).

In Recommendations 1-3 in the 2005 Report to Congress on Physician Owned Specialty Hospitals, MedPAC recommended that CMS:

  • Refine the current DRGs to more fully capture differences in severity of illness among patients.
  • Base the DRG relative weights on the estimated cost of providing care.
  • Base the weights on the national average of the hospital-specific relative values (HSRVs) for each DRG (using hospital-specific costs to derive the HSRVs).
  • Adjust the DRG relative weights to account for differences in the prevalence of high-cost outlier cases.
  • Implement the case-mix measurement and outlier policies over a transitional period.

As we noted in the FY 2006 IPPS final rule, we had insufficient time to complete a thorough evaluation of these recommendations for full implementation in FY 2006. However, we did adopt severity-weighted cardiac DRGs in FY 2006 to address public comments on this issue and the specific concerns of MedPAC regarding cardiac surgery DRGs. We also indicated that we planned to further consider all of MedPAC's recommendations and thoroughly analyze options and their impacts on the various types of hospitals in the FY 2007 IPPS proposed rule.

For FY 2007, we began this process. In the FY 2007 IPPS proposed rule, we proposed to adopt Consolidated Severity DRGs (CS DRGs) for FY 2008 (if not earlier). However, based on public comments received on the FY 2007 IPPS proposed rule, we decided not to adopt the CS DRGs. Rather, we decided to make interim changes to the existing DRGs for FY 2007 by creating 20 new DRGs involving 13 different clinical areas that would significantly improve the CMS DRG system's recognition of severity of illness. We also modified 32 DRGs to better capture differences in severity. The new and revised DRGs were selected from 40 existing CMS DRGs that contained 1,666,476 cases and represent a number of body systems. In creating these 20 new DRGs, we deleted 8 and modified 32 existing DRGs. We indicated that these interim steps for FY 2007 were being taken as a prelude to more comprehensive changes to better account for severity in the DRG system by FY 2008. In the FY 2007 IPPS final rule, we indicated our intent to pursue further DRG reform through two initiatives. First, we announced that we were in the process of engaging a contractor to assist us with evaluating alternative DRG systems that were raised as potential alternatives to the CS DRGs in the public comments. Second, we indicated our intent to review over 13,000 ICD-9-CM diagnosis codes as part of making further refinements to the current CMS DRGs to better recognize severity of illness based on the work that CMS (then HCFA) did in the mid-1990's to adopt severity DRGs. We describe in detail below the progress we have made on these two initiatives, our actions for FY 2008, and our plans for continued analysis of reform of the DRG system for FY 2009. We note that revising the DRGs to better recognize severity of illness has implications for the outlier threshold, the application of the postacute care transfer policy, the measurement of real case-mix versus apparent case-mix, and the IME and DSH payment adjustments. We discuss these implications in more detail in the following sections.

In the FY 2007 IPPS proposed rule, we discussed MedPAC's recommendations to move to a cost-based HSRV weighting methodology beginning with the FY 2007 IPPS Start Printed Page 47141proposed rule. Although we proposed to adopt HSRV weights for FY 2007, we decided not to adopt the proposed methodology in the final rule after considering the public comments we received on the proposal. Instead, in the FY 2007 IPPS final rule, we adopted a cost-based weighting methodology without the hospital-specific portion of the methodology. The cost-based weights are being adopted over a 3-year transition period in 1/3 increments between FY 2007 and FY 2009. In addition, in the FY 2007 IPPS final rule, we indicated our intent to further study the hospital-specific methodology as well as other issues brought to our attention with respect to the cost-based weights. There was significant concern in the public comments that we account for charge compression—the practice of applying a higher charge markup over costs to lower cost than higher cost items and services—if we are to develop relative weights based on cost. Further, public commenters expressed concern about potential inconsistencies between how costs and charges are reported on the Medicare cost reports and charges on the Medicare claims. In the FY 2007 IPPS final rule, we used costs and charges from the cost report to determine departmental level cost-to-charge ratios (CCRs) to apply to charges on the Medicare claims to determine the cost-based weights. The commenters were concerned about potential distortions to the cost-based weights that would result from inconsistent reporting between the cost reports and the Medicare claims. After publication of the FY 2007 IPPS final rule, we entered into a contract with RTI International to study both charge compression and to what extent our methodology for calculating DRG relative weights is affected by inconsistencies between how hospitals report costs and charges on the cost report and how hospitals report charges on individual claims. Further, as part of its study of alternative DRG systems, the RAND Corporation is analyzing the HSRV cost-weighting methodology.

As we present below, we believe that revisions to the DRG system to better recognize severity of illness and changes to the relative weights based on costs rather than charges are improving the accuracy of the payment rates in the IPPS. We agree with MedPAC that these refinements should be pursued. Although we continue to caution that any system that groups cases will always present some opportunities for providers to specialize in cases they believe to have higher margins, we believe that the changes we have adopted and the continuing reforms we proposed, and are adopting in this final rule with comment period, for FY 2008 will improve payment accuracy and reduce financial incentives to create specialty hospitals.

D. Refinement of DRGs Based on Severity of Illness

For purposes of the following discussions, the term “CMS DRGs” means the DRG system we currently use under the IPPS; the term “Medicare-Severity DRGs (MS-DRGs)” means the revisions that we proposed to make (and are adopting in this final rule with comment period) to the current CMS DRGs to better recognize severity of illness and resource use based on case complexity. Although we have found the terms “CMS DRGs” and “MS-DRGs” useful to distinguish the current DRG system from the DRGs that we proposed to adopt for FY 2008, we invited public comments on how to best refer to both the current DRGs and the proposed DRGs to avoid confusion and improve clarity.

Comment: One commenter responded to our request for name suggestions for the new DRG system. The commenter agreed that the name should differentiate which DRG scheme is being referenced. The commenter did not provide an alternative suggestion.

Response: We agree with the importance of being able to differentiate between the current and the revised DRG system. We believe the name “Medicare Severity DRGs (MS-DRGs)” is an appropriate name for this revised system. Therefore, we are adopting as final our reference to the revised DRG system as the “Medicare Severity DRGs (MS DRGs).”

1. Evaluation of Alternative Severity-Adjusted DRG Systems

In the FY 2007 IPPS final rule, we stated our intent to engage a contractor to assist us with an evaluation of alternative DRG systems that may better recognize severity than the current CMS DRGs. We noted it was possible that some of the alternative systems would better recognize severity of illness and are based on the current CMS DRGs. We further stated that if we were to develop a clinical severity concept using the current CMS DRGs as the starting point, it was possible that several of the issues raised by commenters (in response to the CS DRGs, which, in the FY 2007 IPPS proposed rule, we proposed to adopt for FY 2008 or earlier) would no longer be a concern. We noted that if we were to propose adoption of severity DRGs for FY 2008, we would consider the issues raised by commenters on last year's proposed rule as we continued to make further refinements to account for complexity as well as severity to better reflect relative resource use. We stated that we believed it was likely that at least one of several alternative severity-adjusted DRG systems suggested for review (or potentially a system we would develop ourselves) would be suitable to achieve our goal of improving payment accuracy beginning in FY 2008.

On September 1, 2006, we awarded a contract to the RAND Corporation to perform an evaluation of alternative severity-adjusted DRG classification systems. RAND is evaluating several alternative DRG systems based on how well they are suited to classifying and making payments for hospital inpatient services provided to Medicare patients. Each system is being assessed on its ability to differentiate among severity of illness. A final report is due on or before September 1, 2007.

RAND's draft interim report focused on the following criteria:

  • Severity-adjusted DRG classification systems.

 • How well does each classification system explain variation in resource use?

 • How would the classification system affect a hospital's patient mix?

 • Are the groupings manageable, administratively feasible and understandable?

  • Payment accuracy—What are the payment implications of selected models?

In response to our request, several vendors of DRG systems submitted their products for evaluation. The following products were evaluated by RAND:

3M/Health Information Systems (HIS)

  • CMS DRGs modified for AP-DRG Logic (CMS+AP-DRGs)
  • Consolidated Severity-Adjusted DRGs (CS DRGs)

Health Systems Consultants (HSC)

  • Refined DRGs (HSC-DRGs)

HSS/Ingenix

  • All-Payer Severity DRGs with Medicare modifications (MM-APS-DRGs)

Solucient

  • Solucient Refined DRGs (Sol-DRGs)

Vendors submitted their commercial (off-the-shelf) software to RAND in late September 2006. The five systems were compared to the CMS DRGs that were in effect as of October 1, 2006 (FY 2007). RAND assigned FY 2004 and FY 2005 Medicare discharges from acute care hospitals to the FY 2007 CMS DRGs and Start Printed Page 47142to each of the alternative severity-adjusted DRG systems. RAND's initial analysis provided an overview of each alternative DRG classification system, their comparative performance in explaining variation in resource use, differences in DRG grouping logic, and case mix change.

A Technical Expert Panel comprised of individuals representing academic institutions, hospital associations, and MedPAC was formed in October 2006. The members received the preliminary draft report of RAND's alternative severity-adjusted DRG systems evaluation in early January 2007. The panel met with RAND and CMS on January 18, 2007, to discuss the preliminary draft report and to provide additional comments. RAND incorporated items raised by the panel into its preliminary draft report and submitted a revised interim report to CMS in mid-March 2007. CMS posted RAND's interim report on the CMS Web site in late March 2007. Interested individuals can view RAND's interim report on the CMS Web site at: http://www.cms.hhs.gov/​Reports/​Reports/​itemdetail.asp?​itemID=​CMS1197292. The report may also be viewed on RAND's Web site at http://www.rand.org/​pubs/​online/​health.

At this time, RAND has completed its evaluation of the alternative severity adjusted DRG systems. RAND's interim report reflects its evaluation of five alternative DRG systems using the criteria described above. Since the proposed rule, RAND evaluated the Medicare Severity DRG (MS-DRG) system using the same criteria applied to the other DRG systems. We are continuing to work with RAND to evaluate alternate methodologies for establishing relative weights using the MS-DRGs. Once RAND completes its work on the alternate methodologies for establishing relative weights, we will be in a better position to evaluate the issue of charge compression and potential improvements to our methodology to determine cost-based relative weights. We plan to review RAND's analysis of these issues and determine if it will be appropriate to propose additional adjustments to the MS-DRGs or the relative weight methodology in the FY 2009 IPPS proposed rule.

We instructed RAND to evaluate the MS-DRGs using the same criteria that it applied to the other DRG systems. Consistent with conclusions we made in the IPPS proposed rule, RAND's findings demonstrate that MS-DRGs explain 43 percent of the cost variation; a 9.1 percent improvement over the CMS DRGs. RAND reports that the explanatory power of the MS-DRGs is higher than the CMS+AP-DRGs, but lower than the other systems analyzed. The MS-DRGs have the lowest adjusted R2 values among the severity-adjusted systems in seven MDCs. In three of these MDCs, the R2 values are actually lower than under the CMS DRGs: MDC 19 (Mental Diseases and Disorders), MDC 20 (Alcohol/Drug Use and Alcohol/Drug Induced Organic Mental Disorders) and MDC 22 (Burns). RAND attributes the reduction in R2 values to how the CMS DRGs were collapsed to form the base DRGs and recommends future examination. We agree that RAND's findings provide us with potential issues to examine to further improve the MS-DRGs for FY 2009.

Although RAND's findings related to R2 in certain MDCs are of concern, we believe the MS-DRGs remain an improvement over the current CMS DRGs and have significant advantages over the other DRG systems being evaluated. Specifically, they are more up-to-date because of our review of secondary diagnoses and classification into MCCs and CCs. Further, they are understandable, available in the public domain, and will have fewer transition issues than the other systems. As MS-DRGs are a modification of the current CMS DRGs, they allow for updates and maintenance to continue using the same process as under the current CMS DRGs.

Depending on the criteria being evaluated, the relative merits of each system being evaluated by RAND are different. For instance, the CS DRGs performed well in explaining resource variation but have the highest potential for case-mix growth. Other than the MS-DRGs, the CMS+AP-DRGs did the poorest among the systems evaluated in explaining variation in resource usage but did the best on producing reliable and stable results. The remaining systems generally performed somewhere in between on most of the measures that RAND used in its comparative analysis. The MS-DRGs are the result of modifications to the CMS DRGs to better account for severity. Unlike the other systems, the MS-DRGs are available in the public domain, and as a result, systems implementation and other costs are likely to be at a minimum. As suggested above, RAND found that the MS-DRGs are an improvement over the CMS DRGs and compare favorably to the alternative DRG systems being evaluated on some criteria and not as well on others.

As RAND has completed its evaluation of the alternative DRG systems, including the MS-DRGs, consistent with RAND's findings, we believe it is appropriate at this time to adopt the MS-DRG system for the Medicare IPPS in FY 2008. While there will be an opportunity for the public to comment on RAND's findings, we expect to permanently adopt the MS-DRGs for the IPPS. We do not think it is likely that there will be persuasive public comments suggesting that one of the alternative DRG systems being evaluated by RAND is clearly superior. In our view, none of the systems appears to be clearly superior or inferior to the other systems based on the criteria RAND used for the evaluation. Given the strong support in the public comments for the MS-DRGs and the fact they compare well overall to the alternative DRG systems being evaluated by RAND, we believe it is likely that the MS-DRGs will be the system that Medicare uses permanently for the IPPS. However, because we are interested in public input on this issue, we are making RAND's final report available on the CMS Web Site at: http://www.cms.hhs.gov/​Reports/​Reports/​itemdetail.asp?​itemID=​CMS1197292. The report may also be viewed on RAND's Web site at http://www.rand.org/​pubs/​online/​health.

Interested members of the public can write to the following address to make their views known to us about the RAND Report:

Division of Acute Care, Center for Medicaid Management, 7500 Security Boulevard, C4-08-06, Baltimore, MD 21244, Attn: Mady Hue.

In the FY 2008 IPPS proposed rule, we proposed to adopt the MS-DRGs for FY 2008. We are providing the following update on RAND's progress in evaluating the MS-DRGs against the alternative DRG systems. In the proposed rule, we also invited public comment regarding RAND's preliminary analysis of each vendor-supplied alternative severity-adjusted DRG system described below. A summary of any public comments that we received and our responses to those comments are presented under each subject area.

a. Overview of Alternative DRG Classification Systems

Analysis of how each of the six severity adjusted DRG systems performs began by using the current CMS DRGs as a baseline. Two of the six systems (CS DRGs and MM-APS-DRGs) are derivatives of all-patient severity-adjusted DRG systems that have been modified by their developers for the Medicare population and two of the systems (HSC-DRGs and Sol-DRGs) are all-patient systems that incorporate severity levels into the CMS DRGs. The CMS+AP-DRGs are a combination of CMS DRGs and a modification for the Medicare population of the major CC Start Printed Page 47143(MCC) severity groupings used in the AP-DRG system. (The AP-DRG system was developed by 3M/HIS specifically for the State of New York to capture the non-Medicare population.) The MS-DRG system modifies the current CMS DRGs by collapsing any paired DRGs (DRGs distinguished by the presence or absence of CCs and/or age) into base DRGs and then splits the base DRGs into MCC/CC-severity levels.

Table A below shows how each of the six alternative severity-adjusted systems classifies patients into base DRGs and their corresponding severity levels.

Table A.—Logic of CMS and Alternative DRG Systems

CMS-DRGCMS+AP-DRGHSC-DRGSol-DRGMM-APS-DRGCS DRGMS-DRG
Number of MDCs25252525252525
Number of base DRGs379379391393328270335
Total number of DRGs5386021,2931,261915863745
Number of DRGs 500 discharges97 (18%)97 (16%)374 (29%)474 (38%)115 (13%)113 (13%)38 (5.2%)
Number of CC (severity) subclasses233 (med) or 4 (surg)3 (med) or 4 (surg)343
CC subclassesWith CC, without CC for selected base DRGsWithout CC, With CC for selected base DRGs and Major CC across DRGs within MDCNo CC, Class C CC, Class B CC, Class A CC (Surgical only)Minor/no substantial CCs, Moderate CCs, Major CCs, Catastrophic CCs (Surgical only)Without CC, With CC, With Major CC with some collapsing at base DRG levelMinor, Moderate, Major, Severe with some collapsing at DRG levelWithout CC, With CC, With Major CC with collapsing between severity levels for same base DRG.
Multiple CCs recognizedNoNoNoNoYes (in computation of weight)YesNo.
CC assignment logicPresence/absencePresence/absencePresence/absencePresence/absencePresence/absence18-step processPresence/absence.
MDC assignmentPrincipal diagnosisPrincipal diagnosisPrincipal diagnosisPrincipal diagnosisPrincipal diagnosisPrincipal diagnosis with reroutingPrincipal diagnosis.
Death used in DRG assignmentYes (in selected DRGs)Yes (in selected DRGs)Yes (“early death” DRGs)Yes (“early death” DRGs)Yes (in selected DRGs)NoYes (in selected DRGs and CC assignments).

RAND's evaluation of the logic for each system demonstrated the following:

  • Four systems add severity levels to the base CMS DRGs; the CS DRGs add severity levels to the base APR DRGs, which are comparable but not identical to the base CMS DRGs. Both the CS DRGs and MM-APS-DRGs collapse some base DRGs with low Medicare volume. The MS-DRGs collapse the current CMS DRG splits and either leave the base DRG undivided or divide it into two or three severity levels.
  • The HSC-DRGs and the Sol-DRGs use uniform severity levels for each base DRG (three for medical and four for surgical). The general structure of the MS-DRG logic establishes three severity levels for each base DRG: With MCC, with CC, and without CC. However, CMS consolidated severity levels for the same base DRG if they do not meet specific statistical criteria. The general structure of the MM-APS-DRG logic includes three severity levels for each base DRG, but some severity levels for the same base DRG are consolidated to address Medicare low-volume DRGs and nonmonotonicity issues. Monotonicity is when the average costs for a severity group consistently rise as the severity level of the group increases. For example, in a monotonic system, if within a base DRG there are three severity groups and level 1 severity is less than level 2 severity and level 2 severity is less than level 3 severity, the average costs for a level 3 case would be greater than the average costs for a level 2 case, which would be greater than the average costs for a level 1 case. When a DRG is nonmonotonic, the mean cost in the higher severity level is less than the mean cost in the lower severity level. The general structure of the CS DRGs includes four severity levels for each base DRG. However, severity level consolidations occur to address Medicare low-volume DRGs and nonmonotonicity. The CS DRGs consolidate both adjacent severity levels for the same base DRG and the same severity level across multiple base DRGs (especially for severity level 4).
  • Under the CMS+AP-DRGs and MM-APS-DRGs, each diagnosis is assigned a uniform CC-severity level across all base DRGs (other than CCs on the exclusion list for specific principal diagnoses). The remaining systems assign diagnoses to CC-severity level classifications by groups of DRGs.
  • Under the grouping logic used by all systems other than the CS DRGs, each discharge is assigned to the highest severity level of any secondary diagnosis. The MS-DRGs assign discharges with no CC but certain high cost devices to a higher severity level. The CS DRGs adjust the initial severity level assignment based on other factors, including the presence of additional CCs. None of the other systems adjusts the severity level classification for additional factors or CCs. However, the MM-APS-DRG system handles additional CCs through an enhanced relative weight. Start Printed Page 47144
  • The HSC-DRGs and the Sol-DRGs have a medical “early death” DRG within each MDC. The CS DRGs do not use death in the grouping logic. In addition, most complications of care do not affect the DRG assignment. The MS-DRGs use death in making an assignment in selected DRGs and do not count certain conditions as MCCs and CCs (such as cardiac arrest) in patients who die during the inpatient stay.

b. Comparative Performance in Explaining Variation in Resource Use

In evaluating the comparative performance of each alternative DRG system, RAND used MedPAR data from FY 2004 and FY 2005. RAND excluded data from CAHs, Indian Health Service hospitals, and hospitals that have all-inclusive rate charging practices. Consistent with CMS practice, RAND did not exclude data from Maryland hospitals, which operate under an IPPS waiver. Records that failed edits for data consistency or that had missing variables that were needed to determine standardized costs were also excluded.

RAND reported that evaluation of each alternative severity-adjusted DRG system is a complex process due to differences in how each of the severity levels are applied, the number of severity-adjusted DRGs in each system, and the average number of discharges assigned to each DRG. In addition, the manner in which the DRGs for patients 0 to 17 years of age are assigned in the severity-adjusted systems affects the number of low volume DRGs using Medicare discharges. Low-volume, severity-adjusted DRGs can affect the relative performance of a classification system. However, the percentage of Medicare discharges assigned to these DRGs is small—approximately 0.7 percent in the HSC-DRG and Sol-DRG systems compared to 0.1 percent in the CMS DRGs.

To facilitate compatrisons across the severity-adjusted DRG system, RAND assigned a severity level to each MS-DRG consistent with the method used for the other DRG systems. The severity level is based on the lowest severity level. If a base MS-DRG divided into two DRGs, one for both discharges with no CC and discharges with CCs and the other for discharges with MCCs, RAND assigned Level 0 to the DRG for discharges with no MCC and Level 2 to the DRG for discharges with MCCs. RAND also assigned Severity Level 0 to base DRGs that do not split by CC level. Table B summarizes the distribution of DRGs and discharges across severity levels by classification system, exclusive of MDC 15, ungroupable discharges, and statistical outliers. In comparison to the other severity-adjusted systems, the MS-DRGs have a much higher percentage of discharges assigned to the lowest severity level. This includes base DRGs that are not divided into severity subgroups, the no CC severity level, and the no MCC severity level in those base DRGs that are split based on the presence of a MCC only. Sixty percent of discharges are assigned to Severity Level 0 DRGs compared to only 20 percent in the CS DRG system. There are several reasons for the higher percentage, including the reassessment of CC assignments, the collapsing of the no CC and CC severity levels in 43 base MS-DRGs, and no severity subgroups in 53 base MS-DRGs.

Start Printed Page 47145

Severity-adjusted DRGs are designed to reduce the amount of cost variation within DRGs. To compare how much within-DRG variation occurs in each DRG system, RAND computed the mean standardized cost, standard deviation, and coefficient of variation (CV) for each DRG across the various systems. Each severity-adjusted system has a smaller proportion of DRGs with a CV 100 percent than the CMS DRGs. Seventeen percent of the 511 CMS DRGs to which Medicare patients were assigned in 2005 had a CV 100 percent. In contrast, 8 percent of the 736 MS-DRGs have a CV 100 percent. This is a slightly lower percentage than in the CMS+AP DRGs but slightly higher percentage than the other four severity-adjusted DRG systems. Only 1.7 percent of discharges are assigned to MS-DRGs with a CV 100 percent, which is comparable to the percentage of discharges assigned to DRGs with a CV 100 percent in the CS DRGs and the CMS+AP DRGs. The MM-APS DRGs and CMS+AP DRGs have slightly lower and higher percentages, respectively, of discharges assigned to DRGs with a CV 100 percent.

RAND utilized a general linear regression model to evaluate how well each severity-adjusted DRG system explains variation in costs per case. The initial results demonstrate that all six severity-adjusted DRG systems predict cost better than the CMS DRGs. The CS DRGs have higher adjusted R2 values (explanatory power) than the other severity-adjusted systems in nearly every MDC. In general, the adjusted R2 value for the CS DRGs is 0.4458, a 13-percent improvement over the adjusted R2 value for the CMS DRGs. The HSC-DRGs demonstrate an 11-percent improvement, while the adjusted R2 values for the MM-APS-DRGs and Sol-DRGs are 10.0 percent and 9.7 percent higher, respectively, than the CMS DRG R2 value. The adjusted R2 value for the MS-DRGs is 0.4300, a 9.1 percent improvement over the CMS DRGs. The CMS+AP-DRGs show the smallest improvement, nearly 8 percent.

Another aspect of RAND's evaluation was to identify the validity of each alternative DRG system as a measurement for resource costs. For a base DRG, the severity levels should be monotonic; that is, the mean cost per discharge should increase simultaneously with an increase in the severity level. A distinction between patient groups and varying treatment costs should be accomplished by the severity levels. When a DRG is nonmonotonic, the mean cost in the higher severity level is less than the mean cost in the lower severity level. RAND studied the percentage differences and absolute differences in cost between the severity levels within the base DRGs for each system under evaluation. For the analysis, RAND assigned the severity levels for discharges assigned to the CMS+AP-Start Printed Page 47146DRGs and CS DRGs that include several base DRGs to the base DRG to which they would have been assigned at a lower severity level.

Table C shows the percentage difference between the mean standardized cost for discharges with severity levels 1 through 3 as applicable to the adjacent lower severity level within the base DRG (for example, Base DRG 1 Severity Level 1 compared with Base DRG 1 Severity Level 0). The first column of the table shows the number of DRGs with severity level 0 and the proportion of discharges assigned to those DRGs. The “Other DRGs” column, which is not applicable to the MS-DRGs, includes DRGs for age 0 to 17 years and any DRGs for which there was no base DRG with severity level 0 that could be used in the comparison, for example, no Medicare discharges were assigned to the base DRG severity level 0. For severity level 1 and higher, RAND computed the ratio of the mean cost for that level to the mean cost for the adjacent lower level (for example, mean costDRG Level 2/mean costDRG Level 1) and reported the results by the magnitude of the ratio. RAND used the number of discharges assigned to the higher severity level to calculate the percentage of discharges assigned to each ratio category.

For the two systems (CMS+AP-DRGs and CS DRGs) that include several base DRGs, RAND assigned those discharges to the lower severity level base DRG. Following that methodology, RAND was able to calculate how much more costly the discharges assigned to the consolidated or lower severity levels were than the discharges in the base DRG assigned to the next higher severity level. Results demonstrate that, overall, nonmonotonicity is not a factor across the alternative DRG systems. There are only a small percentage of discharges that are assigned to nonmonotonic DRGs. Unlike the other systems, all severity level 1 or level 2 MS-DRGs were monotonic.

Using the data from severity of illness levels 1 through 3 (except for the MM-APS-DRGs, which do not have a severity of illness level 3), RAND calculated the discharge-weighted mean cost difference between severity levels and the mean ratio of the cost per discharge for the higher severity level to the adjacent lower severity level. The greatest cost discrimination was present in the higher severity levels versus the lower severity levels across all the systems. Unlike the other systems, each MS-DRG was at least 20 percent more costly than the adjacent lower severity DRG. The remaining systems demonstrated equivalent percentage cost differences between the severity levels as shown in Table C below.

Start Printed Page 47147

In examining whether each of the alternative DRG systems provided stability in the relative weights from year to year, RAND compared the relative weights derived from the MedPAR data in FY 2004 to the relative weights data from FY 2005. RAND's results demonstrate that generally, across all the systems, only a small percentage of DRGs had greater than a 5-percent change in relative weights. RAND did not repeat this analysis for the MS-DRGs. However, RAND had no reason to expect that the results would be substantially different for this system. For further details and discussion, we encourage readers to view RAND's full interim report on the CMS Web site at: http://www.cms.hhs.gov/​Reports/​Reports/​itemdetail.asp?​itemID=​CMS1197292. The report may also be viewed on RAND's Web site at http://www.rand.org/​pubs/​online/​health.

c. Payment Accuracy and Case-Mix Impact

Similar to how CMS established the relative weights in the FY 2007 IPPS final rule, RAND used standardized costs as determined by the national CCR and the FY 2005 MedPAR data to construct relative weights for each of the DRG systems being evaluated. RAND analyzed the effect of variations in the explanatory power on the distribution of Medicare payments for each system under evaluation. The preliminary findings indicate payment accuracy is improved by each severity-adjusted system by redistributing payment from lower-cost discharges to higher-cost discharges. However, the total payment redistribution across systems differs and reflects the payment impact of improved explanatory power. Although these findings are estimates, the percent of total payment redistributed was the least under the CMS+AP-DRGs (7.1 percent) and the most under the CS DRGs (11.9 percent). The total payment redistribution under the MS-DRGs is 8.4 percent of the total payment. The redistribution is less than the CS DRG system, the same as the HSC-DRG system, and more than in the other systems, even though some of these systems have higher explanatory power.

Table D shows changes in case-mix index (CMI) by hospital category across alternative severity-adjusted DRG Start Printed Page 47148systems. Results demonstrate that, under the severity-adjusted systems, urban hospitals have a higher average CMI than under the CMS DRGs, and rural hospitals have a lower CMI. The analysis suggests that any system adopted to better recognize severity of illness with a budget neutrality constraint will result in payment redistribution that can be expected to benefit urban hospitals at the expense of rural hospitals. This impact occurs because patients treated in urban hospitals are generally more severely ill than patients in rural hospitals and the CMS DRGs are not currently recognizing the full extent of these differences. For purposes of the study, RAND assumed no behavioral changes in coding practice or the types of patients treated.

On average, the CMI for urban hospitals increases under the severity-adjusted systems, and that for rural hospitals decreases. The change is greatest in the CS DRGs, where the CMI for rural hospitals is 2.4 percent lower than that under the CMS DRGs. The CMI for large urban hospitals (those located in metropolitan areas with more than 1 million population) and other urban hospitals is 0.6 and 0.1 percent higher, respectively, under the CS DRGs. Under the MS-DRGs, there is a slightly larger increase in the average CMI for large urban hospitals, a reduction in the CMI for other urban hospitals, and a smaller reduction for rural hospitals.

The CMI for larger hospitals increases, while that for smaller hospitals decreases across the systems. This result is consistent with a severity-adjusted DRG system shifting payment from less expensive cases to more expensive cases. Larger hospitals tend to have relatively more complex cases and severely ill patients than smaller hospitals do. Teaching hospitals also tend to treat more complex cases, but the impact on these facilities differs by severity-adjusted DRG system. Across all the severity-adjusted systems, nonteaching hospitals have a lower CMI, ranging from a 0.2 percent reduction under the HSC-DRGs and Sol-DRGs to a 0.5 percent reduction under the CS DRGs. In three of the systems (CMS+AP-DRG, HSC-DRG, and MM-APS-DRG), hospitals with large teaching programs (100 or more residents) would experience a larger increase than hospitals with smaller teaching programs. Under the Sol-DRG system, hospitals with large teaching programs would have a 0.1 percent increase, compared with a 0.2 percent increase for hospitals with smaller teaching programs. Under the CS DRG system, the CMI for hospitals with large teaching programs would be about the same, but that for hospitals with smaller teaching programs would increase 0.7 percent relative to the CMS DRGs.

Table D.—CMI Change in Alternative DRG Systems Relative to the CMS DRG CMI

Number of hospitalsNumber of dischargesCMS-DRG CMIPercentage change from CMS-DRG CMI
CMS+AP-DRG (Percent)HSC-DRG (Percent)Sol-DRG (Percent)MM-APS-DRG (Percent)CSDRG (Percent)MS-DRG (Percent)
ALL3,89012,165,7631.000.00.00.00.00.00.0
By Geographic Location:
Large urban areas (pop1 million)1,4855,715,3561.020.50.40.30.60.60.7
Other urban areas (pop1 million )1,1864,578,4471.04−0.2−0.2−0.1−0.20.1−0.3
Rural hospitals1,2191,871,9600.84−1.3−0.9−1.0−1.4−2.4−1.7
Bed Size (Urban):
0--99 beds685611,1390.91−1.0−1.1−1.1−1.3−1.6−1.2
100-199 beds8752,346,9220.930.00.10.00.10.00.0
200-299 beds5112,446,7371.000.10.20.30.30.60.3
300-499 beds4332,965,2161.080.30.30.30.40.80.4
500 or more beds1671,923,7891.170.60.30.20.40.40.5
Bed Size (Rural):
0-49 beds543330,2420.73−2.5−2.1−2.2−2.7−5.0−3.0
50-99 beds398595,5990.80−1.4−1.0−1.1−1.6−2.7−2.0
100-149 beds160415,3670.85−1.1−0.7−0.8−1.2−2.0−1.5
150-199 beds69260,9100.91−0.8−0.6−0.7−0.8−1.5−1.0
200 or more beds49269,8420.99−0.6−0.1−0.1−0.6−0.5−0.9
Urban by Region:
New England129541,4710.990.1−0.2−0.5−0.5−0.6−0.5
Middle Atlantic3701,621,4881.000.0−0.4−0.5−0.3−1.5−0.1
South Atlantic4322,208,3361.040.50.70.70.71.40.7
East North Central4101,856,1641.030.60.70.60.81.50.6
East South Central168696,9431.06−0.2−0.2−0.2−0.2−0.3−0.4
West North Central164657,3221.08−0.3−0.30.0−0.30.3−0.3
West South Central3691,115,4111.050.10.00.10.30.50.3
Mountain153465,0931.080.40.20.50.41.00.7
Pacific4231,016,1351.030.0−0.2−0.1−0.10.20.3
Puerto Rico53115,4400.87−1.1−1.4−0.1−1.2−5.1−1.3
Rural by Region:
New England3449,8420.90−0.6−0.6−0.5−1.1−0.6−1.1
Middle Atlantic68139,6390.85−1.1−0.7−0.7−1.3−1.5−1.4
South Atlantic191409,1160.82−0.8−0.4−0.5−0.9−1.8−1.2
East North Central163290,0690.87−1.1−0.7−0.9−1.3−1.8−1.6
East South Central201328,3260.82−1.5−0.9−1.1−1.4−3.2−1.9
West North Central184240,4490.87−1.6−1.2−1.1−1.8−2.5−2.0
West South Central227266,4190.80−2.1−1.8−1.9−2.0−4.3−2.5
Mountain9180,2190.85−1.2−1.0−0.4−1.3−1.2−1.1
Pacific6067,8810.86−0.9−1.0−1.1−1.4−1.6−1.6
Start Printed Page 47149
By Payment Classification:
Teaching Status:
Non-teaching2,7916,115,1930.92−0.4−0.2−0.2−0.4−0.5−0.4
Fewer than 100 Residents8534,061,4511.040.10.20.20.20.70.2
100 or more Residents2461,989,1191.160.80.30.10.50.00.6
Urban DSH:
Non-DSH7782,574,6401.02−0.10.00.1−0.20.50.0
100 or more beds1,5417,378,0951.050.30.20.20.40.40.4
Less than 100 beds352341,0680.82−0.9−0.8−1.0−1.1−2.0−1.1
Rural DSH:
Non-DSH238300,7470.87−1.4−1.0−0.9−1.7−1.9−1.7
SCH402599,8230.83−1.3−1.0−1.0−1.4−2.4−1.8
RRC132466,3950.92−0.8−0.3−0.5−0.7−1.4−1.1
Other Rural
100 or more beds60135,1460.80−0.9−0.8−1.2−1.3−2.0−1.5
Less than 100 beds387369,8490.74−2.1−1.6−1.7−2.2−4.3−2.6
Urban teaching and DSH:
Both teaching and DSH8294,705,4761.090.50.30.30.50.50.5
Teaching and no DSH2041,108,0921.060.00.10.0−0.10.40.1
No teaching and DSH1,0643,013,6870.95−0.10.10.00.10.10.1
No teaching and no DSH5741,466,5481.00−0.2−0.10.1−0.30.50.0
Rural Hospital Types:
RRC145519,8080.92−0.8−0.4−0.5−0.7−1.4−1.1
SCH423457,1190.79−1.6−1.2−1.2−1.7−3.0−2.1
MDH180164,4530.75−2.1−1.7−1.7−2.3−4.1−2.7
SCH and RRC76266,0270.92−0.9−0.7−0.7−1.1−1.3−1.3
MDH and RRC819,7460.85−1.4−0.6−0.8−1.6−1.9−1.7
Other Rural387444,8070.77−1.6−1.2−1.4−1.8−3.3−2.1

RAND also noted that changes in documentation and coding that increase case mix will occur with each severity adjusted DRG system they evaluated. Increases in CMI after adopting the system could be the result of improved coding rather than increases in actual patient severity. RAND observed that the experience of Maryland hospitals using the APR DRG system provides some indication of the likely impact on case-mix of introducing a severity-adjusted system. RAND also noted that coding behaviors are expected to vary under alternative systems according to RAND. Therefore, the risk of case-mix growth due to improved documentation and coding exists with any system. However, RAND advises that the amount of risk can be assessed based on the logic of the DRG system and result in anticipated changes in coding behavior. For the analysis we presented in the proposed rule, RAND found that the CMS+AP-DRG system may have the lowest risk of case-mix increase, while the CS DRGs present the greatest risk. The remaining systems under evaluation demonstrated equivalent risk, based on the DRG logic and other features specific to each system.

RAND did not repeat the analysis of the potential for documentation and coding improvements to increase case-mix using the MS-DRGs because it only worked with FY 2005 data to evaluate them. Further, CMS did a detailed analysis of the likely impact of documentation and coding improvements on case-mix using the MS-DRGs. Section II.D.6. of the preamble of this rule describes in detail the CMI impact under the MS-DRGs using the State of Maryland's experience and data.

d. Other Issues for Consideration

RAND was asked to examine whether each of the alternative severity-adjusted DRG systems under evaluation appears to contain logic that is manageable, administratively feasible, and understandable. RAND's results describe the extent to which those features are present in the grouping logic of each system. A brief summary of these findings and other discussion points follow. For more complete details of the grouping logic for each system evaluated, we encourage readers to review RAND's interim report at the following CMS Web site: http://www.cms.hhs.gov/​Reports/​Reports/​itemdetail.asp?​itemID=​CMS1197292. The report may also be viewed on RAND's Web site at http://www.rand.org/​pubs/​online/​health.

To increase and promote understanding of a DRG classification system, the grouping logic should include a uniform structure. With the exception of the CS DRGs, RAND found that there is uniformity in the hierarchical structure for assigning discharges to MDCs, DRGs, and severity levels for each system evaluated. The CS DRGs utilize a complex rerouting logic and severity of illness level assignment. However, the result is a higher explanatory power that accounts for limitations in the current system. Therefore, due to the complexities associated with that system, it may not easily be understood. However, if the results yield clinically coherent groups of patients with comparable costs, RAND concluded that the system may be worth exploring further. The HSC-DRG and Sol-DRG grouping logic uses a standard number of severity levels for each base DRG, although the result is an increase in the number of low-volume DRGs. The standard severity level structure provides increased understanding, although as mentioned Start Printed Page 47150previously, low-volume, severity-adjusted DRGs can affect the relative performance of a classification system. The MM-APS-DRGs and CS DRGs use standard DRG severity levels. However, the method of collapsing DRGs varies due to the modifications made for Medicare use. The underlying logic of the MS-DRG system uses standard severity levels, but the criteria for establishing severity subgroups result in severity levels that vary by base DRG. Because the severity levels are often collapsed and the resulting subgroups depend on the particular DRG, it is a more complicated system to understand than those systems that uniformly define subgroups according to RAND. By only collapsing DRGs to determine relative weights, RAND notes it is possible to preserve the underlying DRG structure, which perhaps would lead to a more understandable system.

As stated earlier, there are also several transition issues that require attention when evaluating alternative severity-adjusted DRG systems. In determining how manageable, administratively feasible, and understandable the systems being evaluated are, consideration should be given to how they crosswalk or map to the current CMS DRGs. Because four of the systems under evaluation are based on the underlying CMS DRG grouping logic to establish their base DRGs (CMS+AP-DRGs, HSC-DRGs, Sol-DRGs, and MM-APS-DRGs), the CMS DRGs are able to crosswalk smoothly to these severity-adjusted DRGs. Conversely, crosswalking in reverse or backward mapping from the CMS+AP DRGs to the CMS DRGs is problematic due to the discharges in one severity level of the CMS+AP-DRG system compared to several base CMS DRGs. As expected, the CS DRGs do not crosswalk easily to the CMS DRGs due to the complex grouping logic. The MM-APS-DRGs pose unique complications as well due to the large number (over 1,000) of DRGs. Although the MS-DRGs are based on the CMS DRGs, there are challenges in crosswalking discharges between the two systems because of the revisions in the CC list and the sequential renumbering of the DRGs.

System updates are another important factor that may have serious implications. All of the DRG systems RAND evaluated were reported to make annual updates to reflect ICD-9-CM coding changes. However, the CC severity level assignments for each system have not routinely been reviewed and revised. The CC exclusion list and severity level assignments should be reviewed where appropriate to reflect current patterns of care, according to RAND. RAND found that the MS-DRGs are the most updated of the severity-adjusted DRG systems. CMS reviewed the CC list and severity-level assignments in developing the MS-DRGs. Further, the MS-DRGs incorporate recent refinements in the CMS DRGs to account for complexity as well as severity. According to RAND, the other CMS-based systems use CC lists and severity level assignments that are based on outdated analyses of the effect of a condition on treatment costs from either the 1988 Yale study or the 1994 CMS refinement study. The APR DRGs have not been reviewed for several years and are not as current as the severity-based systems according to RAND.

Accessibility to each of the severity-adjusted DRG system's logic and software is also a concern. Each system RAND analyzed is currently maintained as a proprietary product. In general, all of the vendors indicated a willingness to place their product in the public domain, under certain terms. As such, CMS believes it is likely there would need to be discussion as to whether there would be any limitations (such as the source code as well as the DRG logic) on the availability of the DRG systems to hospitals or competing vendors. None of these concerns would be an issue with the MS-DRGs. RAND further noted that because the MS-DRGs are in the public domain, there should be less disruption to existing arrangements for acquiring and installing the GROUPER software and integrating that software with other hospital systems. The intent of each vendor to provide public access to its GROUPER logic and software is described in further detail in RAND's interim report.

Comment: One commenter supported the efforts of CMS to evaluate several alternatives to the existing DRG system. The commenter expressed appreciation that CMS had incorporated comments submitted by the provider community in setting the criteria for evaluating the various DRG products. This commenter also stated it looked forward to reviewing the final recommendations when the RAND report is released.

Response: We appreciate the commenter's support of our efforts. As we indicated in the proposed rule, we have focused our efforts in response to public comments regarding the refinement of the current DRG system. With the assistance of RAND in the evaluation of alternative severity-adjusted DRG systems, our objective has been to select a classification system that will better recognize severity of illness, utilization of resources, and complexity of services. The ultimate goal of these combined objectives is to greatly improve the payment accuracy of the IPPS.

Comment: Several commenters supported the implementation of a severity-based system. However, they urged CMS to wait until RAND completes the final report before moving forward with a specific system. One commenter articulated its appreciation of the thorough analysis conducted on the other alternative severity-adjusted systems. However, the commenter remains concerned that CMS would consider moving forward with the MS-DRGs in the absence of completing an analysis of them using the same criteria applied to the other systems under review. Other commenters expressed concern that CMS may implement the proposed MS-DRGs for FY 2008 and then switch to a completely different severity-based system in FY 2009, or phase in a different system in subsequent years. One commenter stated that, given the potential for heightened administrative burdens as well as financial consequences, it would seem prudent that CMS invest the needed time and energy to confirm whether its belief in the proposed MS-DRG system can be validated. This same commenter added that by stating it is not precluded from adopting another system for FY 2009, CMS is tacitly acknowledging that the MS-DRG system may not be the best system. Another commenter stated that CMS' request for RAND to evaluate the proposed MS-DRGs indicates it is not satisfied that the MS DRGs are ready for long-term use in the IPPS.

Response: In the proposed rule, we indicated that we asked RAND to evaluate the proposed MS-DRG system using the same criteria it is applying to the other alternative severity-adjusted DRG systems. Our intent in not committing permanently to the MS-DRGs was not to suggest that we were not satisfied with the long-term application of the MS-DRG system or that we had concerns about it being the best system. Rather, we were interested in an objective evaluation of the MS-DRGs by RAND using the same criteria applied to the other alternative severity-adjusted systems. That is, before making a permanent commitment to the MS-DRGs, we were interested in knowing how well it demonstrates the ability to meet the objectives described previously—better recognition of severity of illness, utilization of resources, complexity of services and improved payment accuracy over the current CMS DRG system. While we proposed the MS-DRGs for Start Printed Page 47151implementation in FY 2008, we were further interested in the public's response to the MS-DRGs and RAND's evaluation of them before making a final decision on a permanent DRG system to use for Medicare payment. Specifically, public comments on the FY 2007 IPPS proposed rule asked that CMS show evidence that the alternative system proposed results in an improved payment system compared to the current system, test the degree to which the variation in costs within cases at the DRG level is reduced, maintain the improvements made over the years to account for complexity of service and new technologies, and avoid a proprietary system that lacks transparency. We considered all these factors in the development of the MS-DRGs and had we not provided the proposed MS-DRG system to RAND for evaluation, we would not be able to make a fair comparison and final determination for the best course of action for Medicare long term. At the time of the proposed rule, we were unsure whether RAND would be able to complete its evaluation of the MS-DRGs by the time of this final rule with comment period. However, as summarized above, RAND has completed its analysis of the MS-DRG system and found that it compares favorably to the other DRG systems being evaluated on a number of criteria.

As RAND has completed its evaluation of alternative DRG systems, including the MS-DRGs, consistent with RAND's findings, we believe it is appropriate at this time to adopt the MS-DRG system for Medicare in FY 2008. We believe the MS-DRGs represent an improvement over the current CMS DRGs. While there will be an opportunity for the public to comment on RAND's findings, we expect to permanently adopt the MS-DRGs for the IPPS. We do not believe it is likely that there will be persuasive public comments suggesting that one of the alternative DRG systems being evaluated by RAND is clearly superior. We plan on using RAND's report to continue to examine ways to improve and refine the Medicare inpatient payment system and expect that any future refinements will be based on the MS-DRGs. Therefore, as final policy for FY 2008, we are adopting the MS-DRGs as the new classification system for the IPPS.

Comment: One commenter agreed that CMS should adopt a transparent and publicly available DRG system and applauded the proposed MS-DRGs. The commenter stated that the transparency of the current system has been a critical aspect of its success over the years, and this will be even more important to ensure the successful adoption of the new severity-adjusted system chosen.

Response: We appreciate the commenter's support for the proposal to use MS DRGs. We agree that transparency is an important factor in the selection of a new severity-adjusted DRG system. We refer readers to sections II.D.2. and 3. of the preamble of this final rule with comment period for a complete discussion of the MS-DRGs.

Comment: One commenter stated CMS should consider adopting a more robust severity-based DRG system than the proposed MS-DRGs. The commenter admitted that it regards the APR DRG system highly and indicated it should not be abandoned because it is more complicated to implement and because of the controversy surrounding its suggested implementation. The commenter also noted that, as RAND stated in its preliminary report, it is a more robust, accurate, and precise system, and it was reluctant to see CMS abandon this superior system entirely before receiving RAND's final report and recommendations. Further, the commenter stated that, while the MS-DRGs would unquestionably represent a major improvement over the current CMS DRGs, it believed CMS has the ability and should proceed with introducing a better and more robust system and continue exploring further options while waiting for RAND's final report.

Response: In the FY 2007 proposed rule (71 FR 24015), we proposed to adopt the CS DRGs which were based on a consolidated version of the APR DRGs. We received a significant number of public comments strongly urging us not to move forward with the CS DRGs. These comments are described in detail in the FY 2007 final rule (71 FR 47906 through 47912). Among other concerns, the public comments suggested that the system was overly complex and difficult to understand. Further, there was concern that the logic and source code would not be available in the public domain like the current CMS DRGs and that many of the improvements and refinements made to the CMS DRGs over the years would be abandoned. For these and other reasons, we decided not to adopt the CS DRGs for FY 2007. Our proposed adoption of MS-DRGs did not raise these same concerns in the public comments. Given that the MS-DRGs are a substantial improvement over the current CMS DRGs in their ability to recognize severity of illness and meet other objectives that we set for IPPS payment reform, we believe it is a better system to select for use by Medicare than the CS DRGs or APR DRGs.

Comment: One commenter, a vendor, submitted its DRG product to RAND for evaluation. The commenter expressed its concern that CMS developed a completely new and untested severity system while there are several alternate systems currently under evaluation by RAND. The commenter noted that its product has been in continuous use for 18 years and is based on the original Yale University methodology and developed under contract with the Health Care Financing Administration, now CMS, between 1986 and 1989.

The commenter urged CMS to continue with the current CMS DRGs for one more year. According to the commenter, introducing a new temporary severity system, the MS-DRGs, with the expectation that hospitals move to another system for FY 2009, will create unnecessary havoc for the hospital industry. The commenter noted that it is pleased with the work CMS has done in reviewing 13,549 secondary diagnosis codes to refine the CC list and believed the use of this new list will result in a greatly improved DRG GROUPER. However, the commenter stated it is not fair to compare the FY 2008 MS-DRGs (with the new CC list and new codes) with FY 2006 and FY 2007 alternative severity systems using the unrevised CC list. The commenter recommended that CMS create Version 25.0 CMS DRGs with the new CC list and new codes to allow the vendors of the alternative systems until November or December to incorporate the information into updated versions of their systems. The commenter also suggested that the RAND report deadline could be extended beyond September 1, 2007, to allow the comparison of alternative DRG systems to occur with the revised CC list.

In addition, the commenter believed the MS-DRGs have the following shortcomings:

  • Although CMS' chief concern is Medicare patients, it is shortsighted to ignore non-Medicare patients in the proposed MS-DRG system, as the health care industry often focuses its attention on the Medicare relative value system for all of its hospital patients.
  • The DRG system has always been comprehensive, including all possible ICD-9-CM diagnoses and procedures. Consolidating low-volume procedures and procedures now performed primarily in an outpatient setting creates confusion in the MS-DRG classification system. Procedures such as tonsillectomies, carpal tunnel release, and cataract extractions are different MDCs and are treated by different medical specialists. They are similar Start Printed Page 47152only with respect to historical cost data and only for the time being.
  • Eliminating newborns, maternity, and congenital anomalies from the usual MS-DRG severity level approach does not provide a comprehensive severity system.

Lastly, the commenter indicated that whatever software system is chosen for the public, it should be provided in a modern and accessible software language and format. The commenter recommended a “C” version, on CDs or DVDs, and suggested that continuing to place CMS software into the public domain written in IBM assembler and distributed through the National Technical Information Service (NTIS) on 9-track tapes or 3480 cartridges seems difficult to imagine, as this technology is over 40 years old.

Response: We disagree that we are implementing a “completely new and untested severity system.” While the MS-DRGs constitute a major reform to better recognize severity of illness, they are a refinement of the current CMS DRGs that have been in use for Medicare payment for over 20 years. Further, our proposed rule analysis—subsequently validated by RAND—suggested that they are major improvement over the current CMS DRGs. Most of the other systems represent less updated refinements of the CMS DRGs. While these systems have been in use for other purposes, we note that (other than the APR DRGs that are used for payment in Maryland and the AP DRGs that were used in New York's all payer ratesetting system in the 1990s), the other systems being evaluated have never been used for Medicare payment.

We stated in the FY 2008 IPPS proposed rule that we developed the MS-DRG system in response to public comments received as a result of the FY 2007 proposed rule (in response to the proposed CS DRGs). We also stated we submitted the MS-DRG system to RAND for evaluation and the final report was expected on or before September 1, 2007. At this time RAND has completed the evaluation of alternative severity-adjusted DRG systems, including the MS-DRGs. In the near future, we will post RAND's analysis of the MS-DRG system to the following CMS Web site: http://www.cms.hhs.gov/​Reports/​Reports/​itemdetail.asp?​itemID=​CMS1197292. The report may also be viewed on RAND's Web site at http://www.rand.org/​pubs/​online/​health. This report is referred to as an Addendum to RAND's interim report that was released in March 2007. A completed final report incorporating the evaluation of all six severity adjusted DRG systems into one document will be posted to the CMS Web site after September 1, 2007.

As noted above, we share the commenter's concern about adopting one DRG system this year and potentially another one next year. We believe the MS-DRGs should be the system that is adopted for long-term use by Medicare for IPPS payment. However, we are interested in obtaining further public input on RAND's findings. We do not believe it is likely that there will be persuasive public comments suggesting that one of the alternative DRG systems evaluated by RAND is clearly superior to the MS-DRGs.

We appreciate the commenter's support of our efforts in the review of 13,549 secondary diagnosis codes. We agree that a new, updated CC list greatly improves the ability of a DRG GROUPER to reflect severity of illness and distribute payments more accurately. The intent of RAND's evaluation was to compare each of the alternative DRG systems in its current form. The fact that delays would be necessary to allow the other systems to adopt the improvements that CMS made to the CC list for the MS-DRGs suggests that the other systems would not be ready for implementation as soon. As noted elsewhere, we are interested in adopting comprehensive improvements to the DRG system for severity of illness at the earliest possible date. We do not believe it is in the public interest to delay adopting these improvements to wait for the alternative DRG systems to incorporate refinements to the CC list. Further, we note that CMS first discussed performing a comprehensive review of the CC list over 2 years ago. Each vendor could have undertaken a similar review of the CC list to improve its DRG product at any time.

We disagree with the commenter's assertion that our decision should turn on how the MS-DRGs can be used for non-Medicare payers. As we have stated many times in the past, we encourage private insurers and other non-Medicare payers to make refinements to Medicare's DRG system to better suit the needs of the patients they serve. With respect to the maternity and newborn DRGs, we cannot adopt the same approach to refine these DRGs that we did with the rest of the MS-DRGs because of the extremely low volume of Medicare patients there are in these DRGs. Medicare simply does not have enough cases in these DRGs to apply the same approach we did in the other MDCs. Whether we made revisions to these DRGs or not, private insurers and other private payers would have to develop their own DRGs or relative weights to address the needs of these patients that are not well-represented in the Medicare population. With respect to other pediatric patients, in our view, a significant advantage of the MS-DRGs over the prior CMS DRGs is the fewer number of low volume DRGs. By eliminating pediatric (ages 0 to 17 years) splits, the MS-DRGs will have fewer low-volume DRGs and less instability in the DRG relative weights for the cases paid using these DRGs.

With regards to the software, undere CMS' agreement with its contractor, the software provided by NTIS is the same public domain software that is provided to CMS for use by our system maintainers, regional offices, and fiscal intermediaries.MAC. We will consider this comment as we make updates to our information systems and related contracts.

As stated elsewhere in this final rule with comment period, we are adopting the MS-DRGs for implementation on October 1, 2007 (FY 2008). A detailed discussion summarizing the public comments received in response to the MS-DRG proposal is described in section II.D.2. of the preamble of this final rule with comment period.

2. Development of the Medicare Severity DRGs (MS-DRGs)

As discussed previously, we are committed to continuing our efforts of making refinements to the current CMS DRGs to better recognize severity of illness. In the FY 2007 IPPS final rule, we stated that we had begun a comprehensive review of over 13,000 diagnosis codes to determine which codes should be classified as CCs when present as a secondary diagnosis. We stated that we would also build on the severity DRG work we performed in the mid-1990's. We received a number of public comments on last year's proposed rule that supported the refinement of the current CMS DRGs so that they better recognize severity of illness for FY 2007.

We also committed to performing a more thorough reform of the entire DRG system to better recognize severity of illness for FY 2008. As a result of this broad based analysis, we developed the MS-DRGs that we proposed and are adopting in this final rule with comment period. The MS-DRGs represent a comprehensive approach to applying a severity of illness stratification for Medicare patients throughout the DRGs. As discussed in proposed rule and in section II.D.5. of the preamble of this final rule with comment period, the MS-DRGs maintain the significant advancements in identifying medical technology made Start Printed Page 47153to the DRGs in past years. At the same time, they greatly improve our ability to identify groups of patients with varying levels of severity using secondary diagnoses. Further, they improve our ability to assign patients to different DRG severity levels based on resource use that is independent of the patient's secondary diagnosis—referred to in this discussion as “complexity.” We proposed to adopt the MS-DRGs for FY 2008 and also submitted the system to RAND to be considered as part of its evaluation of alternative DRG systems. In the proposed rule, we encouraged comments on our proposed methodology to establish a severity DRG system and the resulting DRGs.

a. Comprehensive Review of the CC List

Our efforts to better recognize severity of illness began with a comprehensive review of the CC list. Currently, 115 DRGs are split based on the presence or absence of a CC. For these DRGs, the presence of a CC assigns the discharge to a higher weighted DRG. The list of diagnoses designated as a CC was initially created at Yale University in 1980-1981 as part of the project to develop an ICD-9-CM version of the DRGs. The researchers at Yale University developed the ICD-9-CM DRGs using national hospital data with diagnoses and procedures coded in ICD-9-CM from the second half of 1979. Because hospitals only began reporting ICD-9-CM codes in 1979, discharge abstracts at that time were much less likely to fully report all secondary diagnoses. As a result, the Yale University researchers developed a liberal definition of a CC as any secondary diagnosis that “would cause an increase in length of stay by at least 1 day in at least 75 percent of the patients.” Because of the likely underreporting of secondary diagnoses in the 1979 data, the Yale University researchers also used age as a surrogate for identifying patients with a CC. The original version of the ICD-9-CM DRGs assigned patients to a CC DRG if they had a secondary diagnosis on the CC list or if the patient was 70 years or older.

With the implementation of the IPPS in FY 1984, the coding of secondary diagnoses by hospitals dramatically improved. During the first 4 years of the IPPS, the CC definition included the age 70 criterion. With the improved coding and reporting of diagnoses associated with the implementation of the IPPS, the use of age as a surrogate for CCs was no longer necessary. Thus, beginning in FY 1988, the age 70 criterion was removed from the CC definition and a CC DRG was defined exclusively by the presence of a secondary diagnosis on the CC list.

Except for new diagnosis codes that were added to ICD-9-CM after FY 1984 (for example, HIV), the CC list of diagnoses currently used in the CMS DRGs is virtually identical to the CC list created at Yale University. However, there have been dramatic changes not only in the accuracy and completeness of the coding of secondary diagnoses but also in the characteristics of patients admitted to hospitals and the practice patterns within hospitals as well.

Since the implementation of the IPPS, Medicare average length of stay has dropped dramatically from 9.8 days in 1983 to 5.7 days in 2005. The economic incentives inherent in DRGs motivated a change in practice patterns to discharge patients earlier from the hospital. These changes were facilitated by the increased availability of postacute care services, such as nursing homes and home health services, which allowed problems previously requiring continued hospitalization to be effectively treated outside the acute care hospital. Furthermore, there has also been a dramatic shift to outpatient surgery that avoids costly inpatient stays. Many surgical procedures formerly performed in the hospital are now routinely performed on an outpatient basis. As a result, patients admitted to the hospital today are on average more likely to have a CC than when the IPPS was implemented. The net effect of better coding of secondary diagnoses, reductions in hospital length of stay, increased availability of postacute care services, and the shift to outpatient care is that most patients (nearly 80 percent) admitted to a hospital now have a CC. As a result of the changes that have occurred during the 22 years since the implementation of the IPPS, the CC list as currently defined has lost much of its capacity to discriminate hospital resource use.

Currently, 115 CMS DRGs have a CC subdivision. Up until FY 2002, the number of DRGs with a CC subdivision remained essentially unchanged from the original FY 1984 version of the DRGs. As a means of improving the payment accuracy of the DRGs, beginning with the FY 2002 DRG update, each base CMS DRG without a CC subdivision was evaluated to determine if a CC subdivision was warranted. Over the past five DRG updates, only seven base CMS DRGs have had a CC subdivision added. The primary constraint preventing a significant increase in the number of base CMS DRGs with a CC subdivision is the low number of patients who would be assigned to the non-CC group. Thus, the expansion of the number of CMS DRGs subdivided based on a CC is constrained because the vast majority of patients would be assigned to the CC group and few patients would be assigned to the non CC group. To remedy these problems, we reviewed each of the 13,549 secondary diagnosis codes to evaluate their assignment as a CC or non-CC using statistical information from the Medicare claims data and applying medical judgment based on current clinical practice. We refer to this list in this section as the “revised CC list.”

The need for a revised CC list prompted a reexamination of the secondary diagnoses that qualify as a CC. Our intent was to better distinguish cases that are likely to result in increased hospital resource use based on secondary diagnoses. Using a combination of mathematical data and the judgment of our medical advisors, we included the condition on the CC list if it could demonstrate that its presence would lead to substantially increased hospital resource use.

Diagnoses may require increased hospital resource use because of a need for such services as:

  • Intensive monitoring (for example, an intensive care unit (ICU) stay).
  • Expensive and technically complex services (for example, heart transplant).
  • Extensive care requiring a greater number of caregivers (for example, nursing care for a quadriplegic).

There are 3,326 diagnosis codes on the current CC list. Our 2006 review of the CC list reduced the number of diagnosis codes on the CC list to 2,583. Based on the current CC list, 77.66 percent of patients have at least one CC present. Based on the revised CC list from our 2006 review, the percent of patients having at least one CC present would be reduced to 40.34 percent.

b. Chronic Diagnosis Codes

The 1979 data used in the original formation of the CC list often did not have the manifestations of a chronic disease fully coded. As a result, the CC list included many chronic diseases with a broad range of manifestations. Such chronic illness diagnoses usually do not cause a significant increase in hospital resource use unless there is an acute exacerbation present or there is a significant deterioration in the underlying chronic condition. Therefore, in the revised CC list, we removed chronic diseases without a significant acute manifestation. Recognition of the impact of the chronic disease is accomplished by separately coding the acute manifestation. For example, the mitral valve disease codes Start Printed Page 47154(codes 396.0 through 396.9) are assigned to the current CC list. However, unless the mitral valve abnormalities are associated with other diagnoses indicating acute deterioration, such as acute congestive heart failure, acute pulmonary edema, or respiratory failure, they would not be expected to significantly increase hospital resource use. Therefore, the revised CC list did not include the mitral valve codes. Recognition of the contribution of mitral valve disease to the complexity of hospital care would be accomplished by separately coding those diseases on the CC list that are associated with an acute exacerbation or deterioration of the mitral valve disease.

The revised CC list applied the criterion that chronic diagnoses having a broad range of manifestations are not assigned to the CC list as long as there are codes available that allow the acute manifestations of the disease to be coded separately. For some diseases, there are ICD-9-CM codes that explicitly include a specification of the acute exacerbation of the underlying disease. For example, for congestive heart failure, the following codes specify an acute exacerbation of the congestive heart failure:

  • 428.21, Acute systolic heart failure
  • 428.41, Acute systolic and diastolic heart failure
  • 428.43, Acute on chronic systolic heart failure
  • 428.31, Acute diastolic heart failure
  • 428.33, Acute on chronic diastolic heart failure

These congestive heart failure codes are included on the revised CC list. However, the following congestive heart failure codes do not indicate an acute exacerbation and are not included in the revised CC list:

  • 428.0, Congestive heart failure not otherwise specified
  • 428.1, Left heart failure
  • 428.20, Systolic heart failure not otherwise specified
  • 428.22, Chronic systolic heart failure
  • 428.32, Chronic diastolic heart failure
  • 428.40, Systolic and diastolic heart failure
  • 428.9, Heart failure not otherwise specified

As a result of this approach, most chronic diseases were not assigned to the revised CC list. In general, a significant acute manifestation of the chronic disease must be present and coded for the patient to be assigned a CC. We made exceptions for diagnosis codes that indicate a chronic disease in which the underlying illness has reached an advanced stage or is associated with systemic physiologic decompensation and debility. The presence of such advanced chronic diseases, even in the absence of a separately coded acute manifestation, significantly adds to the treatment complexity of the patient. Thus, the presence of the advanced chronic disease inherently makes the reason for admission more difficult to treat. For example, under the revised CC list, stage IV, V, or end-stage chronic renal failure (codes 585.4 through 585.6) are designated as a CC, but stage I through III chronic renal failure (codes 585.1 through 585.3) are not. For obesity, a body mass index over 35 (codes V85.35 through V85.4) is a CC, but a body mass index between 19 and 35 is not. End-stage renal failure and extreme obesity are examples of chronic diseases for which the advanced stage of the disease is clearly specified.

However, for most major chronic diseases, the stage of the disease is not clearly specified in the code. These codes were evaluated based on the consistency and intensity of the physiologic decompensation and debility associated with the chronic disease. For example, quadriplegia (codes 344.00 through 344.09) requires extensive care with a substantial increase in nursing services and more intensive monitoring. Therefore, quadriplegia is considered a CC in the revised CC list.

c. Acute Diagnosis Codes

Examples of acute diseases included on the revised CC list included acute myocardial infarction (AMI), cerebrovascular accident (CVA) or stroke, acute respiratory failure, acute renal failure, pneumonia, and septicemia. These six diseases are representative of the types of illnesses we included on the revised CC list. Other acute diseases were designated as a CC if their impact on hospital resource use would be expected to be comparable to these representative acute diseases. For example, acute endocarditis was included on the CC list but urinary tract infection was not.

The revised CC list is essentially comprised of significant acute disease, acute exacerbations of significant chronic diseases, advanced or end stage chronic diseases and chronic diseases associated with extensive debility. Compared to the existing CC list, the revised CC list requires a secondary diagnosis to have a consistently greater impact on hospital resource use.

The following Table E compares the current CC list and the revised CC list. There are 3,326 diagnosis codes on the current CC list. The CC revisions reduce the number of diagnosis codes on the CC list to 2,583. Based on the current CC list, 77.66 percent of patients have at least one CC present, using FY 2006 MedPAR data. Based on the revised CC list, the percent of patients having at least one CC present is reduced to 40.34 percent. The revised CC list increases the difference in average charges between patients with and without a CC by 56 percent ($15,236 versus $9,743).

Table E.—Comparison of Current CC List and Revised CC List

Current CC listRevised CC list
Codes designated as a CC3,3262,583
Percent of patients with one or more CCs77.6640.34
Percent of patients with no CC22.3459.66
Average charge of patients with one or more CCs$24,538$31,451
Average charge of patients with no CCs$14,795$16,215

The analysis above suggests that merely reviewing and updating the CC list can lead to significant improvements in the ability of the CMS DRGs to recognize severity of illness. Although we could potentially adopt this one change to better recognize severity of illness in the CMS DRGs, we have undertaken additional analyses that further refine secondary diagnoses into MCCs, CCs and non-CCs as described below.

d. Prior Research on Subdivision of CCs into Multiple Categories

(1) Refined DRGs

During the mid-1980s, CMS (then HCFA) funded a project at Yale University to revise the use of CCs in the CMS DRGs. The Yale University project mapped all secondary diagnoses that were considered a CC in the CMS DRGs into 136 secondary diagnosis groups, each of which was assigned a CC complexity level. For surgical patients, each of the 136 secondary diagnosis groups was assigned to 1 of 4 CC complexity levels (non-CC, moderate CC, MCC, and catastrophic CC). For medical patients, each of the 136 secondary diagnosis groups was assigned to 1 of 3 CC complexity levels (non-CC, moderate/MCC, and catastrophic CC). All age subdivisions and CC subdivisions in the DRGs were Start Printed Page 47155eliminated and replaced by the four CC subgroups for surgical patients, or the three CC subgroups for medical patients. The Yale University project did not reevaluate the categorization of secondary diagnosis as a CC versus a non-CC. Only the diagnoses on the standard CC list were used to create the moderate, major, and catastrophic subgroups. All secondary diagnoses in a secondary diagnosis group were assigned the same level, and a patient was assigned to the subgroup corresponding to the highest level secondary diagnosis. The number of secondary diagnoses had no effect on the subgroup assigned to the patient (that is, multiple secondary diagnoses at one level did not cause a patient to be assigned to a higher subgroup). The DRG system developed by the Yale University project demonstrated that a subdivision of the CCs into multiple subclasses would improve the predictability of hospital costs.

(2) 1994 Severity DRGs

We also examined the work we performed in the mid-1990's to revise the CMS DRGs to better recognize severity. In 1993, we reevaluated the use of CCs within the CMS DRGs. The reevaluation excluded the CMS DRGs associated with pregnancy, newborn, and pediatric patients (MDCs 14 and 15 and DRGs defined based on age 0-17). The major CC list from the AP-DRGs that are used for Medicaid payment by New York and other States was used to identify an initial list of MCCs. Using Medicare data, we reevaluated the categorization of each secondary diagnosis as a non-CC, CC, or an MCC. The end result was that 111 diagnoses that were non-CCs in the standard CMS DRGs were made a CC, 220 diagnoses that were a CC were made a non-CC, and 395 CCs were considered an MCC.

All CC splits in the CMS DRGs were eliminated, and an additional 24 DRGs were merged together. The resulting base CMS DRGs were then subdivided into three, two, or no subgroups based on an analysis of Medicare data. The result was 84 DRGs with no subgroups, 124 DRGs with two subgroups, and 85 DRGs with three subgroups. An additional 63 pregnancy, newborn, and pediatric DRGs not evaluated resulted in a total of 652 DRGs.

A patient was assigned to the CC subgroup corresponding to the highest level secondary diagnosis. Multiple secondary diagnoses at one level did not cause a patient to be assigned to a higher subgroup. The categorization of a diagnosis as non-CC, CC, or MCC was uniform across the CMS DRGs, and there were no modifications for specific DRGs. As part of the FY 1995 IPPS proposed rule, we made a complete file of the revised DRG descriptions available to the public. However, we never adopted the revised DRGs (55 FR 27756).

e. Medicare Severity DRGs (MS-DRGs)

We had several options in developing a refinement to the current CMS DRGs to better recognize increased resource use due to severity of illness. One option would involve simply taking the work performed in 1994 and then updating it with all the code changes that have taken place since then. We were reluctant to do this because of changes in medical practices as well as the substantial changes in ICD-9-CM codes since that time. Another option would have been to build on current CMS DRGs which include a number of advancements that better identify medical practices and technologies. Many commenters on the FY 2007 IPPS proposed rule urged us to take the latter approach because they believed the current base CMS DRGs clearly differentiate between the complexities of varying surgical procedures and medical devices. Therefore, we chose the option of developing a new severity DRG system based on the current CMS DRGs.

The development of the 1994 Severity DRGs involved three steps:

  • Consolidation of existing DRGs into base DRGs.
  • Categorization of each diagnosis as an MCC, CC, or non-CC.
  • Subdivision of each base DRG into subclasses based on CCs.

We reviewed and revised each of the three steps and applied them to our current CMS DRGs to develop DRGs that better identify severity of illness among Medicare patients. We refer to this system that we proposed (and are adopting in this final rule with comment period) as the Medicare Severity DRGs (MS-DRGs). The purpose of the MS-DRGs is to more accurately stratify groups of Medicare patients with varying levels of severity.

(1) Consolidation of Existing CMS DRGs into Base MS-DRGs

The first step in our process was the consolidation of existing CMS DRGs into new proposed base MS-DRGs. We combined together the 115 pairs of CMS DRGs that are subdivided based on the presence of a CC. We further consolidated the CMS DRGs that are split on the basis of a major cardiovascular condition, AMI with and without major complication (CMS DRGs 121 and 122), and cardiac catheterization with and without complex diagnoses (CMS DRGs 124 and 125). We also consolidated the three pairs of burn CMS DRGs that were defined based on the presence of a CC or a significant trauma (CMS DRGs 506 and 507; 508 and 509; and 510 and 511). Next, we consolidated the 43 pediatric CMS DRGs that are defined based on age less than or equal to 17. These pediatric CMS DRGs contain a very low volume of Medicare patients. As shown in Table 10 of the FY 2007 IPPS final rule (71 FR 48318), only two of these pediatric CMS DRGs contained more than 100 patients (CMS DRGs 298 and 333). Seventeen of these pediatric DRGs had no patients (CMS DRGs 30, 33, 41, 48, 54, 58, 137, 252, 255, 282, 330, 340, 343, 393, 405, 446, and 448). As we have stated frequently, our primary focus in maintaining the CMS DRGs is to serve the Medicare population. We do not have the data or the expertise to maintain the DRGs in clinical areas that are not relevant to the Medicare population. We continue to encourage users of the CMS DRGs (or MS-DRGs that are being adopted) to make relevant adaptations if they are being used for a non-Medicare patient population.

In addition to the pediatric CMS DRGs defined by the age of the patient, there are a number of CMS DRGs that relate primarily to the pediatric or adult population that have very low volume in the Medicare population, such as male sterilization, tubal interruptions, circumcisions, tonsillectomies, and myringotomies. These CMS DRGs were consolidated into the most clinically similar MS-DRG.

Over the past two decades, the site of service for some elective procedures such as carpal tunnel release, cataract extraction, and laparoscopy has shifted from the inpatient to the outpatient setting, resulting in the CMS DRGs associated with these procedures having very low volume. These CMS DRGs were also consolidated into the most clinically similar MS-DRG. In addition, there were some clinically related CMS DRGs that had significant Medicare patient volume but had no significant difference in resource use. For example, thyroid (CMS DRG 290) and parathyroid (CMS DRG 289) procedures were virtually identical in terms of hospital resource use and were, therefore, consolidated. In total, 34 of these CMS DRGs were consolidated. The DRG consolidations are summarized in Table F below.

Four pairs of MS-DRGs (223 and 224; 228 and 229; 323 and 324; and 551 and 552) were defined based on the presence of a CC or some other condition. For example, MS-DRG 323 is defined based on the presence of a CC or the performance of extracorporeal shock Start Printed Page 47156wave lithotripsy. For these MS-DRGs, the CC condition was removed and the pair of DRGs remains separate but defined based only on the other condition (that is, MS-DRG 323 became urinary stones with extracorporeal shock wave lithotripsy). As was done in the 1994 severity DRG work, we did not consolidate any of the CMS DRGs for maternity or newborn cases.

Before proceeding further, we made one additional change to a base DRG assignment after completing these consolidations. We assigned cranial-facial bone procedures to a new base DRG (Cranial/Facial Bone Procedures). These cases were previously assigned to DRGs 52 and 55 through 63. We also created a new base DRG, MS-DRG 245 (Automatic Implantable Cardiac Defibrillator (ACID) Lead and Generator Procedures). This DRG was created by removing automatic implantable cardiac defibrillator leads and generator procedures from the pacemaker DRG (CMS DRG 551; now new MS-DRGs 242 through 244).

Table F below shows how DRGs in the CMS DRGs (Version 24.0) were consolidated into new base MS DRGs. We refer readers to section II.D.2. of the preamble of the proposed rule and this final rule with comment period for a detailed discussion of CCs and MCCs under the MS-DRG system.

Table F.—DRG Consolidation

CMS-DRG version 24.0DRG descriptionMS-DRGs version 25.0New base MS-DRG description
6Carpal Tunnel Release40 41 42Peripheral Cranial Nerve Other Nervous System Procedure with MCC, with CC, and without CC/MCC.
7, 8Peripheral Cranial Nerve Other Nervous System Procedure.
36Retinal Procedures116 117Intraocular Procedures with and without CC/MCC.
38Primary Iris Procedures.
39Lens Procedures with or without Vitrectomy.
42Intraocular Procedures Except Retina, Iris Lens.
43Hyphema124 125Other Disorders of the Eye with and without MCC.
46, 47, 48Other Disorders of the Eye.
50Sialoadenectomy139Salivary Gland Procedures.
51Salivary Gland Procedures Except Sialoadenectomy.
52Cleft Lip Palate Repair133Other Ear, Nose, Mouth Throat O.R. Procedures with and without CC/MCC.
55Miscellaneous Ear, Nose, Mouth Throat Procedures.
56Rhinoplasty131 132New DRG—Cranial/Facial Bone Procedures with and without CC/MCC.
57, 58Tonsillectomy Adenoidectomy Procedure, Except Tonsillectomy /or Adenoidectomy Only.
59, 60Tonsillectomy /or Adenoidectomy Only.
61, 62Myringotomy with Tube Insertion.
63Other Ear, Nose, Mouth Throat O.R. Procedures.
67Epiglottitis152 153Otitis Media Upper Respiratory Infection with and without MCC.
68, 69, 70Otitis Media Upper Respiratory Infection.
71Laryngotracheitis.
72Nasal, Trauma Deformity154 155 156Other Ear, Nose, Mouth Throat Diagnoses with MCC, with CC, without CC/MCC.
73, 74Other Ear, Nose, Mouth Throat Diagnoses.
185, 186Dental Oral Diseases Except Extractions Restorations157 158 159Dental Oral Diseases with MCC, with CC, without CC/MCC.
187Dental Extractions Restorations.
199Hepatobiliary Diagnostic Procedure for Malignancy420 421 422Hepatobiliary Diagnostic Procedures with MCC, with CC, without CC/MCC.
200Hepatobiliary Diagnostic Procedure for Non-Malignancy.
Start Printed Page 47157
244, 245Bone diseases Specific Arthropathies553 554Bone Diseases Arthropathies with and without MCC.
246Non-Specific Arthropathies.
259, 260Subtotal Mastectomy for Malignancy *584 585Breast Biopsy, Local Excision Other Breast Procedures with and without CC/MCC.
261Breast Procedures for Non-Malignancy Except Biopsy Local Excision.
262Breast Biopsy Local Excision for Non-Malignancy.
267Perianal Pilonidal Procedures579 580 581Other Skin, Subcutaneous Tissue Breast Procedures with MCC, with CC, without CC/MCC.
268Skin, Subcutaneous Tissue Breast Plastic Procedures.
269, 270Other Skin, Subcutaneous Tissue Breast Procedure.
289Parathyroid Procedures625 626 627Thyroid, Parathyroid Thyroglossal Procedures with MCC, with CC, without CC/MCC.
290Thyroid Procedures.
291Thyroglossal Procedures.
294Diabetes 35637Diabetes with MCC, with CC, without CC/MCC.
295Diabetes 35.
338Testes Procedures for Malignancy711 712Testes Procedures with and without CC/MCC.
339, 340Testes Procedures, Non-Malignancy.
342, 343CircumcisionProcedure 64.0 changed to non-O.R. Cases with only this procedure will go to medical DRGs.
351Sterilization, Male729 730Other Male Reproductive System Diagnoses with and without CC/MCC
352Other Male Reproductive System Diagnoses.
361Laparoscopy Incisional Tubal Interruption744 745DC, Conization, Laparascopy Tubal Interruption with and without CC/MCC.
362Endoscopic Tubal Interruption.
363DC, Conization Radio-Implant, for Malignancy.
364DC, Conization Except for Malignancy.
411History of Malignancy without Endoscopy843 844 845Other Myeloproliferative Disease or Poorly Differentiated Neoplasm Diagnosis with MCC, with CC, without CC/MCC.
412History of Malignancy with Endoscopy.
413, 414Other Myeloproliferative Disease or Poorly Differentiated Neoplasm Diagnosis.
465Aftercare with History of Malignancy as Secondary Diagnosis949Aftercare with and without.
466Aftercare without History of Malignancy as Secondary Diagnosis950CC/MCC.
* Codes 85.22 and 85.23 in CMS DRGs 259 and 260 were moved to MS-DRG 582 and 583.

As summarized in Table G, the consolidation resulted in the formation of 335 base MS-DRGs.

Table G.—Consolidation of Current CMS DRGs Into MS DRGs

Number
Current CMS DRGs538
Elimination of CC subgroups−114
Elimination of MCC subgroups−7
Elimination of CC complexity subgroups−5
Start Printed Page 47158
Elimination of age 0-17 subgroups−43
Consolidation due to volume or resource similarity−34
New DRG+1
Revised Base DRGs311
Newborn, maternity and error DRGs+24
Base DRGs for severity subdivision335

The end result of the consolidation of the CMS DRGs in the MS-DRGs was similar to the consolidation performed in the 1994 severity DRGs. The 1994 DRG consolidations resulted in 356 base DRGs plus 2 error DRGs. The number of the 1994 base DRGs is different because new CMS DRGs have been added since 1994, the 43 age 0-17 pediatric CMS DRGs were not consolidated, and some of the volume shifts to outpatient care had not yet occurred in 1994. In the 1994 severity DRGs, 24 DRGs were consolidated due to volume or resource similarity. Sixteen of these 1994 DRG consolidations are included in the 34 consolidations done in the 2007 consolidations. However, due to concerns expressed by our physician consultants, 8 of the DRG consolidations from 1994 were not done. For example, interstitial lung disease (DRGs 92 and 93) was not consolidated with simple pneumonia and pleurisy (DRGs 89, 90, 91) as was done in the 1994 consolidations.

Comment: One commenter expressed concern that the focus of MS-DRGs was on the Medicare population. As a result of this focus, many of the DRGs reflect severity and resource use only for the Medicare population. The commenter stated that certain diagnoses present differently at different ages or actually represent a different disease process. For instance, the commenter stated that hypertension in a child represents a very different disease than for adults. The commenter also stated that CMS DRGs 569 and 570 (Major Small and Large Bowel Procedures with CC and with or without Major Gastrointestinal Diagnosis, respectively) have different costs for a Medicare patient than a child. The commenter also indicated that CMS did not perform updates to MDC 14 (Obstetrics) and MDC 14 (Newborns and Other Neonates with Problems Arising in the Perinatal Period). The commenter stated that the MS-DRGs will not work well for other populations.

Response: The MS-DRGs were specifically designed for purposes of Medicare hospital inpatient services payment. As we stated above, we generally use MedPAR data to evaluate possible DRG classification changes and recalibrate the DRG weights. The MedPAR data only represent hospital inpatient utilization by Medicare beneficiaries. We do not have comprehensive data from non-Medicare payers to use for this purpose. The Medicare program only provides health insurance benefits for people over the age of 65 or who are disabled or suffering from end-stage renal disease. Therefore, newborns, maternity, and pediatric patients are not well-represented in the MedPAR data that we used in the design of the MS-DRGs. We simply do not have enough data to establish stable and reliable DRGs and relative weights to address the needs of non-Medicare payers for pediatric, newborn, and maternity patients. For this reason, we encourage those who want to use MS-DRGs for patient populations other than Medicare make the relevant refinements to our system so it better serves the needs of those patients.

(2) Categorization of Diagnoses

We decided to establish three different levels of CC severity into which we would subdivide the diagnosis codes. The proposed three levels are MCC, CC, and non-CC. Diagnosis codes classified as MCCs reflect the highest level of severity. The next level of severity includes diagnosis codes classified as CCs. The lowest level is for non-CCs. Non-CCs are diagnosis codes that do not significantly affect severity of illness and resource use. Therefore, secondary diagnoses that are non-CCs do not affect the DRG assignment under either the CMS DRGs or the MS-DRGs.

The categorization of diagnoses as an MCC, CC, or non-CC was accomplished using an iterative approach in which each diagnosis was evaluated to determine the extent to which its presence as a secondary diagnosis resulted in increased hospital resource use. In order to begin this iterative process, we started with an initial categorization of each diagnosis as an MCC, CC, or non-CC. As noted previously, the 1994 CC revision began by separating CCs into MCC and CC based on the AP-DRG major CCs. One way to begin this iterative process would have been to use the 1994 CC categorization. However, the 1994 CC categorization was based on FY 1992 data and ICD-9-CM diagnosis codes, which now are 15 years old. Since 1992, 1,897 new diagnosis codes have been added, and 346 diagnosis codes have been deleted. Because the revised CC list (explained in section II.C.2.a. of this preamble) was based on current ICD-9-CM codes and used recent data, we decided to utilize the revised CC list rather than the 1994 categorization as our starting point for determining whether each secondary diagnosis should be an MCC, a CC, or a non-CC.

The revised CC list categorizes each diagnosis as a CC or a non-CC. We decided to use this list in combination with the categorization under the AP-DRGs and the APR DRGs. The AP-DRGs and the APR DRGs are updated annually with current codes and provide a good comparison source to use with the revised CC list. We designated as an MCC any diagnosis that was a CC in the revised CC list and was an AP-DRG major CC and was an APR DRG default severity level 3 (major) or 4 (extensive). We designated as a non-CC any diagnosis that was a non-CC in the revised CC list and was an AP-DRG non-CC and was an APR DRG default severity level of 1 (minor). Any diagnoses that did not meet either of the above two criteria was designated as a CC.

The only exception to our approach was for diagnoses related to newborns, maternity, and congenital anomalies. These diagnoses are very low volume in the Medicare population and were not reviewed for purposes of creating the revised CC list. We used the APR DRGs to categorize these diagnoses. For newborn, obstetric, and congenital anomaly diagnoses, we designated the APR DRG default severity level 3 (major) and 4 (extreme) diagnoses as an MCC, the APR DRG default severity level 2 (moderate) diagnoses as a CC, and the APR DRG default severity 1 (minor) diagnoses as a non-CC. Table H summarizes the number of codes in each CC category.

Table H.—Initial Categorization of CC Codes

Number of codes
MCC1,096
CC4,221
Non CC8,232
Total13,549

This initial CC categorization of diagnosis codes was used to begin the iterative process of determining the proposed final CC categorization for each diagnosis code. Start Printed Page 47159

(3) Additional CC Exclusions

For some CMS DRGs, the presence of specific secondary diagnoses affects the base DRG assignment. For example, in MDC 5 (Diseases and Disorders of the Circulatory System), the presence of an AMI code as the principal diagnosis or as a secondary diagnosis will cause the patient to be assigned to the AMI DRGs (CMS DRGs 121 through 123). Therefore, if the AMI code is present as a secondary diagnosis, it should not be used to assign the CC category for a patient because it is redundant within the definition of the base DRG. Similarly, for MDC 24 (Multiple Significant Trauma), specific combinations of significant trauma as principal or secondary diagnosis cause the assignment to the multiple trauma DRGs (CMS DRGs 484 through 487). Therefore, any secondary diagnosis of trauma is redundant with the definition of the multiple trauma DRGs and should not be used to determine the CC category for a patient. Any secondary diagnoses that are used to assign a specific proposed base MS-DRG were excluded from the determination of the CC category for patients assigned to that base MS-DRG.

Comment: Several commenters asked that we make changes to the CC and exclusion list for codes associated with sepsis. The commenters stated that two Systemic Inflammatory Response Syndrome (SIRS) codes, 995.91 (Sepsis) and 995.92 (Severe sepsis) are CCs under MS-DRGs. The commenters believed that if a patient has SIRS and pneumonia, both conditions should be coded, and that this coding would result in a patient admitted with SIRS being assigned to MS-DRG 871 (Septicemia without Mechanical Ventilation with MCC). The commenters stated that the pneumonia would count as a MCC in this case. The commenters requested that CMS exclude pneumonia from being a MCC when it occurs with sepsis. The commenters believed pneumonia should be excluded as an MCC for a patient with sepsis because it is an underlying and related condition, and that these patients should not be assigned to MS-DRG 871. The commenters stated that the other SIRS codes, 995.93 (Systemic Inflammatory Response Syndrome due to noninfectious process without acute organ dysfunction) and 995.94 (Systemic Inflammatory Response Syndrome due to noninfectious process with acute organ dysfunction) are excluded from acting as a CC for pancreatitis (code 577.0). The commenters asked that CMS not exclude codes 995.93 and 995.94 with code 577.0.

Response: The commenters are mistaken about codes 995.91 and 995.92. While these two codes are not CCs, they are on the MCC list. Our data and the judgment of our medical advisors support the assignment of these codes to the MCC list. Furthermore, we do not believe it is appropriate to exclude pneumonia as an MCC for sepsis and severe sepsis. These patients would be at an extremely high level of severity. SIRS is not always associated with pneumonia but when it is, the patient is at a higher severity level. Therefore, we are not making this change to the CC exclusion list by excluding pneumonia codes from acting as a MCC with code 995.91 and 995.92. On the second issue the commenters raised, they are incorrect that codes 995.91 and 995.92 are excluded from acting as a CC for code 577.0. These codes are not on the CC exclusion list for code 577.0. Therefore, both would act as a MCC for code 577.0. We are not making any changes to the CC exclusion list as a result of these comments.

(4) Analysis of Secondary Diagnoses

The 311 base MS-DRGs (335 total base DRGs minus the MDC 14, MDC 5, and error DRGs) were subdivided into three CC subgroups. Patients were assigned to the subgroup corresponding to the most extreme CC present. All but four of the base MS-DRGs had strictly monotonically increasing average charges across the three CC subgroups (that is, average charges progressively increased from the non-CC to the CC to the MCC subgroups). The four MS-DRGs that failed to have monotonically increasing charges all had at least one CC subgroup with very low volume. For example, the non CC subgroup for the pancreas transplant DRG (CMS DRG 513) had only 2 cases. The overall statistics by CC subgroup for the 311 base MS-DRG are contained in Table I. Patients in the MCC subgroup have average charges that are nearly double the average charges for patients in the CC subgroup. The CC subgroup with the largest number of patients is the non-CC subgroup with 41.1 percent of the patients.

Table I.—Overall Statistics for MS-DRGs Excluding Those in MDCs 14 and 15

CC subgroupNumber of casesPercentAverage charges
Major2,604,69622.2$44,246
CC4,293,74436.624,131
Non-CC4,818,41141.118,435

In order to evaluate the initial assignment of secondary diagnoses to the three CC subclasses, we devised a system that determined the impact on resource use of each secondary diagnosis. For each secondary diagnosis, we measured the impact in resource use for the following three subsets of patients:

(a) Patients with no other secondary diagnosis or with all other secondary diagnoses that are non-CCs.

(b) Patients with at least one other secondary diagnosis that is a CC but none that is an MCC.

(c) Patients with at least one other secondary diagnosis that is an MCC.

Numerical resource impact values were assigned for each diagnosis as follows:

ValueMeaning
0Significantly below expected value for the non-CC subgroup.
1Approximately equal to expected value for the non-CC subgroup.
2Approximately equal to expected value for the CC subgroup.
3Approximately equal to expected value for the MCC subgroup.
4Significantly above the expected value for the MCC subgroup.

Each diagnosis for which Medicare data were available was evaluated to determine its impact on resource use and to determine the most appropriate CC subclass (non-CC, CC, or MCC) assignment. In order to make this determination, the average charge for each subset of cases was compared to the expected charge for cases in that Start Printed Page 47160subset. The following format was used to evaluate each diagnosis:

CodeDiagnosisCnt1C1Cnt2C2Cnt3C3

Count (Cnt) is the number of patients in each subset and C1, C2, and C3 are a measure of the impact on resource use of patients in each of the subsets. The C1, C2, and C3 values are a measure of the ratio of average charges for patients with these conditions to the expected average charge across all cases. The C1 value reflects a patient with no other secondary diagnosis or with all other secondary diagnoses that are non-CCs. The C2 value reflects a patient with at least one other secondary diagnosis that is a CC but none that is a major CC. The C3 value reflects a patient with at least one other secondary diagnosis that is a major CC. A value close to 1.0 in the C1 field would suggest that the code produces the same expected value as a non-CC diagnosis. That is, average charges for the case are similar to the expected average charges for that subset and the diagnosis is not expected to increase resource usage. A higher value in the C1 (or C2 and C3) field suggests more resource usage is associated with the diagnosis and an increased likelihood that it is more like a CC or major CC than a non-CC. Thus, a value close to 2.0 suggests the condition is more like a CC than a non-CC but not as significant in resource usage as an MCC. A value close to 3.0 suggests the condition is expected to consume resources more similar to an MCC than a CC or non-CC. For example, a C1 value of 1.8 for a secondary diagnosis means that for the subset of patients who have the secondary diagnosis and have either no other secondary diagnosis present, or all the other secondary diagnoses present are non-CCs, the impact on resource use of the secondary diagnoses is greater than the expected value for a non-CC by an amount equal to 80 percent of the difference between the expected value of a CC and a non-CC (that is, the impact on resource use of the secondary diagnosis is closer to a CC than a non-CC).

Table J below shows examples of the results.

Table J.—Examples of Impact on Resource Use of Secondary Diagnoses

CodeCnt1C1CntC2C2Cnt3C3CC subclass
401.1, Benign essential hypertension12,3080.95540,1131.7155,2972.384Non CC.
530.81, Esophageal reflux294,6730.986917,0581.639122,0762.302Non CC.
560.1, Paralytic Ileus10,6511.46687,7882.32051,3033.226CC.
491.20, Obstructive chronic bronchitis7,0031.41632,2762.19313,3553.035CC.
410.71, Subendocardial infarction initial episode1,6572.24530,2262.77842,8623.232MCC.
518.81, Acute respiratory failure5,3322.096118,9372.936223,0543.337MCC.

The resource use impact reports were produced for all diagnoses except obstetric, newborn, and congenital anomalies (10,690 diagnoses). These mathematical constructs were used as guides in conjunction with the judgment of our clinical staff to classify each secondary diagnosis reviewed as an MCC, CC or non-CC. Our clinical panel reviewed the resource use impact reports and modified 14.9 percent of the initial CC subclass assignments as summarized in Table K below. The rows in the table are the initial CC subclass categories and the columns are the final CC subclass categories.

Comment: Several commenters acknowledged the detailed description of the methodology used in categorizing secondary diagnoses as MCCs, CCs, or non-CCs. While they were appreciative of the detailed iterative process outlined in the proposed rule (72 FR 24702), the commenters requested that CMS provide the numerical values (the C1 to C3 values) that were assigned to classify each diagnosis as an MCC, CC or non-CC.

Response: We agree that it would be helpful to share the data we developed and used for each individual code as part of our CC evaluation process. We will post this data on the CMS Web site at: http://www.cms.hhs.gov/​AcuteInpatientPPS/​ under the Downloads section.

Table K.—CC Subclass Modifications

Initial CC subclassFinal CC subclass
MCCCCNon-CCTotalPercent
MCC8476209098.5
CC5422,5797373,85836.1
Non-CC02725,6515,92355.4
Total1,3892,9136,38810,690
Percent13.027.259.8

Of the diagnoses initially designated as an MCC, 6.8 percent were made a CC (62/909), and of the diagnoses initially designated as non-CC, 4.6 percent were made a CC (272/5,923). The major shift occurred in the diagnoses initially assigned to the CC subclass. Fourteen percent of the diagnoses initially designated as a CC were made an MCC (542/3858), and 19.1 percent of the diagnoses initially designated a CC were made a non-CC (737/3,858). In determining the CC subclass assigned to a diagnosis, imprecise codes were, in general, not assigned to the MCC or CC Start Printed Page 47161subclass. For example, the congestive heart failure codes have the following CC subclass assignments:

CodeCC subclass assignment
428.21, Acute systolic heart failureMCC.
428.41, Acute systolic diastolic heart failureMCC.
428.43, Acute on chronic systolic heart failureMCC.
428.31, Acute diastolic heart failureMCC.
428.33, Acute on chronic diastolic heart failureMCC.
428.1, Left heart failureCC.
428.20, Systolic heart failure NOSCC.
428.22, Chronic systolic heart failureCC.
428.32, Chronic diastolic heart failureCC.
428.40, Systolic diastolic heart failureCC.
428.0, Congestive heart failure NOSNon-CC.
428.9, Heart failure NOSNon-CC.

The acute heart failure codes are MCCs, and the chronic heart failure codes are CCs. However, Not Otherwise Specified (NOS) heart failure codes are non-CCs. Thus, the precise type of heart failure must be specified in order for an MCC or CC to be assigned.

There are currently 13,549 ICD-9-CM diagnosis codes. The external cause of injury and poisoning codes (E800 through E999) and congenital abnormality codes were not included in our current CC review for the MS-DRGs. We excluded the external cause of injury and poisoning codes from consideration as an MCC or a CC because they describe how an injury occurred, and not the exact nature of the injury. For instance, if a patient fell on the deck of a boat and fractured his or her skull, one would assign an E code to describe the fall on the boat. A separate diagnosis code would be assigned to describe the exact nature of any resulting injury such as a contusion, fractured bone, or skull fracture and concussion. A patient would be assigned to a severity level based on the exact nature of the injury and not the manner in which the injury occurred. Therefore, we decided not to classify any of the E codes as either an MCC or a CC. The congenital abnormality codes describe abnormalities when a baby is born. At times, a beneficiary may live with these congenital abnormalities for years without a problem. The congenital abnormalities may later lead to complications that require hospital admissions. Should these congenital abnormalities lead to medical problems that result in a hospital admission for a Medicare beneficiary, the exact nature of the condition being treated would also be assigned a code. This more precise code would be evaluated to determine whether or not it was an MCC or a CC. Therefore, we decided not to classify congenital abnormality codes as an MCC or a CC, but to instead use the other reported diagnosis codes that better describe the reason for the admission. Excluding the external cause of injury codes, we reviewed 10,690 diagnosis codes.

As was done in our 1994 severity proposal, diagnoses that were closely associated with patient mortality were assigned different CC subclasses, depending on whether the patient lived or died. These diagnoses are:

  • 427.41, Ventricular fibrillation
  • 427.5, Cardiac arrest
  • 785.51, Cardiogenic shock
  • 785.59, Other shock without mention of trauma
  • 799.1, Respiratory arrest

Resource use for patients with these diagnoses who were discharged alive was consistent with an MCC. Resource use for patients with these diagnoses who died was consistent with a non-CC. Further, most patients who died could legitimately have one of these diagnoses coded. As a result, these diagnoses are assigned an MCC subclass for patients who lived and a non-CC subclass for patients who died.

For some secondary diagnoses assigned to the CC subclass, our medical advisors identified specific clinical situations in which the diagnosis should not be considered a CC. In such clinical situations, the CC exclusion list was used to exclude the secondary diagnosis from consideration in determining the CC subgroup, essentially making the secondary diagnosis a non-CC. For example, primary cardiomyopathy (code 425.4) is designated as a CC. However, for patients admitted for congestive heart failure, our medical advisors believed that primary cardiomyopathy should be treated as a non-CC. In order to accomplish that, the congestive heart failure principal diagnoses were added to the CC exclusion list for primary cardiomyopathy as a secondary diagnosis.

The list of diagnosis codes that we proposed to classify as an MCC (which we are adopting in this final rule with comment period) was included in Table 6J in the Addendum to FY 2008 IPPS proposed rule. The diagnosis codes that we proposed to classify as a CC (which are adopting in this final rule with comment period) were included in Table 6K in the Addendum to the proposed rule. The E-codes, which are diagnosis codes used to classify external causes of injury and poisoning, are not included in this list. All E codes are designated as non-CCs under the current CMS DRG system and our evaluation supports this non-CC designation as appropriate. We are including a list of changes to the MCC and CC lists as a result of public comments on the proposed rule later in section II.G.13. of the preamble of this final rule with comment period. We will post a complete final list of the MCC and CC codes on the CMS Web site at: http://www/​cms/​hhs/​gov/​AcuteInpatientPPS/​ under the Files for Download section.

Comment: One commenter supported the basic methodology used to identify MCCs and CCs. The commenter's analysis of discharge data generally confirms the notion that the presence of chronic disease does not usually have material impact on the expected cost of care. The commenter agreed that the emphasis on acute manifestations of chronic diseases is both clinically and financially appropriate. The commenter stated that the current CC list is nearly 25 years old and does not reflect the extent to which clinical practice has changed during that period, with concomitant changes in expected resource use. The commenter further stated that the current CC list also does not reflect the nature of changes in coding practices during that period, changes that have undermined the value of the current CC list. The commenter stated that the elimination of common secondary diagnoses such as code 428.0 (Congestive heart failure, unspecified) Start Printed Page 47162and code 427.31 (Atrial fibrillation) from the CC list will help to restore CC status as a meaningful indicator of differential expected resource use. The commenter also believed that elimination of these diagnosis codes will address the current situation in which nearly 80 percent of Medicare discharges contain one or more CCs.

Response: We agree that it was important to perform a careful review of the CC list to develop lists that more accurately identify patients with significantly different severity levels. We believe that by using both statistical data as well as input from our medical advisors, we were able to develop the MCCs and CCs that do a much better job of classifying Medicare patients with varying levels of severity. We also agree that is important to remove chronic diagnoses from the CC list that do not have a significant impact on severity. We also believe that nonspecific codes such as code 428.0 should not be included on the CC list. The ICD-9-CM coding system has more specific codes to identify the specific type of heart failure. These more specific codes have data supporting their inclusion on the MCC and CC list. Our medical advisors also supported the inclusion of the more specific heart failure codes on the MCC and CC list. We also agree that patients with atrial fibrillation (code 427.31) do not necessarily have a higher level of severity. The Medicare data suggest that when this condition appears on the claim and the patient has no other secondary diagnosis that is a CC, the charge data suggest the condition produces an expected value for a non-CC rather than a CC case. Further in the judgment of our medical advisors, the condition should not be on the CC list. When the atrial fibrillation leads to additional cardiac problems, the additional problems may be represented by codes that are on the MCC or CC list. We agree that by removing codes from the CC list that do not contribute to significantly higher levels of severity, we can better recognize severity of illness and more accurately reimburse hospitals.

We spent extensive time carefully reviewing the ICD-9-CM diagnosis codes to develop the MCC and CC list. Our current CC list for Version 24.0 of the CMS DRGs contains 3,326 codes. The MS-DRGs have 3,342 codes on the MCC list and 4,922 codes on CC list. While we did remove codes from the CC list and add others to the list, we believe that the end result is a better classification of conditions for identifying differences in severity of illness. We appreciate the commenter's support for our efforts.

Comment: Several commenters supported the MCC and CC lists as a better means of identifying severity. The commenters recommended that CMS consider adopting the revised CC list in FY 2008 as an interim step toward IPPS reform. The commenters recommended that CMS delay implementation of the new severity system until FY 2009 but adopt the revised CC list in FY 2008. The commenters stated that by implementing the revised CC list in FY 2008, CMS could move forward in its goal of utilizing a system that more accurately recognizes the severity of illness of patients. The commenters believed this option would allow a more accurate DRG system to be in place while CMS is evaluating the final RAND report to determine which severity-based DRG system to propose for implementation in FY 2009.

Another commenter who supported the move to MS-DRGS and CMS' efforts in creating the MCC and CC lists stated that it had been working with CMS for years to develop a mechanism to appropriately account for the resources involved in the care of patients with severe sepsis. The commenter believed that the MS-DRGs in which severe sepsis is recognized as a major complication, along with acute respiratory distress syndrome, organ failure, and other conditions where resource use is more intense, will go a long way towards better recognition of severity of illness.

One commenter applauded CMS for the work it has put into developing a system that will consider complexity of care as well as severity of illness in determining Medicare payment for hospital inpatient services. The commenter particularly supported the recognition of hemophilia and end-stage renal disease as MCCs. The commenter stated that these conditions clearly meet the criteria for treatment as MCCs because they often require “expensive and technologically complex” services that lead to substantially increased resource use and reflect the highest level of severity. The commenter encouraged CMS to add other diagnoses as the evidence warrants.

Response: Comments and responses on whether to implement MS-DRGs in FY 2008 or at a later date are discussed in detail in section II.D. of the preamble of this final rule with comment period. We appreciate the support for our efforts in creating the MCC and CC lists and agree that it is important to examine data using the system and continue to refine the MCC and CC lists.

Comment: One commenter commended CMS on the systematic way it reviewed 13,549 secondary diagnosis codes to evaluate their assignment as a CC or non-CC using a combination of mathematical data and the judgment of its medical advisors. The commenter stated that, as part of the effort to better recognize severity of illness, CMS conducted the most comprehensive review of the CC list since the creation of the DRG classification. However, the commenter disagreed with the classification of many common secondary diagnoses as non-CCs. Specifically, the commenter questioned threshold levels that were used and at what point in the analysis CMS decided that a code was not a CC. For example, the commenter asked what was considered “intensive monitoring,” inquiring whether intensive monitoring refers to additional nursing care on a daily basis, additional testing, intensive care unit care, extended length of stay, all of these factors, or some other factor. In some instances, the commenter noted that similar or comparable codes within the same group have remained a CC/MCC, while other clinically similar codes or codes requiring similar resources may have been omitted. Without greater transparency, and a code-by-code explanation, the commenter was unable to determine why significant secondary diagnoses requiring additional resources have been removed from the CC list. For the most part, the commenter's analysis concentrated on reviewing current CCs that have been omitted from the revised CC list.

The commenter made the following overall recommendations with regard to the CC list:

  • CMS should make the final revised CC list publicly available as quickly as possible so that hospitals may focus on understanding the impact of the revised CC list, training and educating their coders, and working with physicians for any documentation improvements required to allow the reporting of more specific codes where applicable.
  • CMS should consider additional refinements to the revised CC list and, in particular, address issues where the ICD-9-CM codes may need to be modified to provide the distinction between different levels of severity.
  • In situations where a new code is required, CMS should default to leaving the codes as CCs until new codes can be created.

Response: The process of evaluating both claims data and clinical issues is a challenging one. Our medical advisors performed an extensive evaluation of codes for the MCC and CC lists, combining their medical judgment and claims data. We have reviewed a number of specific codes raised by Start Printed Page 47163commenters and considered whether or not the codes should be a MCC or CC. These numerous code requests are discussed below. Also, as mentioned earlier, we plan to post the data we used to evaluate each code on the CMS Web site. These data may assist the public in making recommendations for additional changes to the MCC and CC lists. Any revisions made to the MS-DRGs or the MCC and CC lists are being made available with this final rule with comment period. As suggested by the commenter, we plan to evaluate further refinements to the MCC and CC lists each year as we obtain additional recommendations and data under the MS-DRG system.

Comment: One commenter acknowledged the significant effort and consideration CMS has given to developing both the mathematical and clinical judgment criteria in determining severity classifications. However, the commenter did not believe it was possible to fully assess the assignment of diagnosis codes in the severity classification because there was an incomplete description of the process in the proposed rule.

Response: As stated earlier, we plan to post on the CMS Web site the data used in analyzing how to classify each ICD-9-CM code as an MCC, CC, or non-CC. Our process for making CC/MCC decisions was an iterative one involving data review and clinical analysis. In the FY 2008 IPPS proposed rule (72 FR 24702 through 24705), we explained in detail our methodology for determining whether a secondary diagnosis qualified as an MCC, CC, or non-CC. Although posting these data results on the CMS Web site may be helpful in illustrating for commenters the data we used in classifying conditions as MCCs, CCs or non-CCs, we note that these data were combined with clinical judgment to make the final determinations. That is, the data were used as an adjunct to the judgment of our medical advisors. Clinical judgment may differ by individual physician. Thus, the data alone may be helpful but not definitive in helping commenters understand the reasons for some of our decisions. Nevertheless, we welcome further public input on potential revisions to the MCC and CC lists for FY 2009. We anticipate making updates to the MCC and CC lists each year as we receive additional recommendations and data. Again, below we respond to comments about specific codes.

Comment: One commenter commended CMS for undertaking a long-overdue comprehensive review and revision of the CC list. However, the commenter stated that more industry input is needed regarding the revised CC and MCC designations in the MS-DRG system. The commenter stated that the brevity of the public comment period, in combination with insufficient detail associated with the process and rationale for categorization of diagnoses as MCCs, CCs, and non-CCs, made it very difficult to conduct a thorough analysis of all of the codes on the MCC and CC lists. Another commenter stated that its members have only had an opportunity to do a cursory comparison of the current CMS CC list to the MS-DRG MCC and CC lists. The commenter stated that it should have the ability to do a complete analysis prior to implementation. The commenter believed such a review would be time intensive and likely to take a number of months of information exchange before it could be completed. Although the commenter acknowledged that the MCC and CC lists were included in the Federal Register notice and posted on the CMS Web site, the commenter believed the review was hampered by a lack of GROUPER software and a GROUPER Definitions Manual from being able to complete their review. The commenter also expressed concern that the analysis of secondary diagnoses was based on charges instead of costs. The commenter stated that if CMS’ intent is to convert to a cost-based structure, a determination of the impact of secondary diagnoses should not be based on charges. The commenter added that this analysis appeared to be inconsistent with the evolution to a cost-based DRG weight system.

Response: We recognize the extensive time that is required by the public in order to perform a review of the MCC and CC lists. However, we note that a DRG Definitions Manual and GROUPER have never been made available until after completion of the final rule in past years and public commenters never before suggested that we need to delay implementation of proposed changes to the IPPS. While we acknowledge that the changes proposed for FY 2008 are significantly more comprehensive than the changes we propose in a typical year, the base DRG assignments under the MS-DRGs are largely unchanged from the prior CMS DRGs. The major changes result from assignment of a case to a DRG severity level using the new classification of secondary diagnoses as MCCs, CCs or non-CCs. For this reason, we made extensive information available to allow public commenters to perform a variety of analyses. The proposed rule included comprehensive lists of the codes that we classified as MCCs and CCs, and we made this information available electronically on the CMS Web site. The FY 2006 MedPAR data that were used to simulate proposed rule policies were made available simultaneous with public display of the FY 2008 proposed rule. This data file included both the CMS DRG assigned to the case using the Version 24.0 GROUPER and the proposed MS-DRG assignment. Further, we provided—at no extra cost to the purchaser—an FY 2005 version of the MedPAR that also included the CMS and MS-DRG assignment at the case level. For these reasons, we do not believe the lack of availability of a GROUPER or a DRG Definitions Manual should have precluded commenters from being able to analyze the revised MCC and CC lists. In fact, we note that a number of public commenters did provide suggestions for further revisions to these lists, suggesting there was ample time to be able to do these analyses.

We have considered the suggestion that we analyze changes to the MCC and CC lists using average costs instead of charges. We adopted a cost-based weighting methodology because of our concern that differential markups among routine and ancillary services made charges a poor proxy for costs when setting relative weights for dissimilar types of cases. That is, different types of cases would use very different mixes of routine and ancillary services with variable markups and could create distortions in relative weights that are based on charges. However, we are less concerned about using charges when comparing cases that share the same primary diagnosis, which are likely to use similar mixes of services when deciding whether to make a DRG change. In these cases, we believe charges may provide a reasonable proxy for costs because the cases use similar services with similar markups.

The methodology that we use to develop cost-based weights is very complex and works well to give us a measure of relative average resource use when combining a high number of cases together in a single DRG. We would need to analyze whether a methodology that tries to determine average costs at the case or code level would provide reliable results for making decisions about MCCs and CCs or DRG changes. Nevertheless, we appreciate this comment and will continue to give it further consideration as we evaluate alternative approaches to updating the MCC and CC lists and the MS-DRGs in the future.

Comment: One commenter stated that CMS should address the inconsistencies Start Printed Page 47164within the CC list identified by its physician and hospital reviewers. The commenter also recommended that, where necessary, CMS should obtain additional input from physicians in the appropriate specialties to determine the standard of care and consequent increased hospital resource use of some of the conditions. The commenter provided a list of conditions that were removed from the revised CC list and urged CMS to maintain them on the CC list.

Response: We agree that the review of codes for the MCC and CC list was a daunting task requiring careful review by our panel of medical advisors. We used a number of physicians in this process, including internists and surgeons, to evaluate the effect of specific codes on a patient's severity levels. When necessary, our panel contacted other medical specialists, such as orthopedists and oncologists, to obtain additional input. We appreciate the CC issues brought to our attention. We reexamined specific codes brought to our attention below. We expect that we will continue to revise and update both the CC list and MCC list as we gain experience and data under the MS-DRG system. We anticipate making additional changes in the future with this added information.

Comment: One commenter stated that, in some cases, the current ICD-9-CM classification system does not adequately distinguish between acute and chronic forms of a condition. In the MS-DRG system, this distinction appears to be critical in predicting resources utilized at the patient level. The commenter recommended that CMS work with the NCHS to make ICD-9-CM code modifications to improve this acute and chronic distinction. Additionally, the commenter suggested that CMS and HHS should take immediate steps for the adoption of ICD-10-CM, as this system is much better than ICD-9-CM at distinguishing clinical severity, which is a key aspect of any severity-adjusted DRG system. The commenter believed that continued use of ICD-9-CM severely limits the ability of a severity-adjusted DRG system to recognize severity of illness.

Response: We encourage anyone with specific recommendations for revisions to the ICD-9-CM diagnosis codes to contact Donna Pickett, National Center for Health Statistics, Centers for Disease Control and Prevention at: (301) 458-4434. Information on requesting changes to the ICD-9-CM diagnosis codes can be found on the Web site at: http://www.cdc.gov/​nchs/​icd9.htm. The Department is continuing to evaluate whether to move to ICD-10.

Comment: One comment disagreed with CMS’ elimination of many chronic conditions from the CC list. The commenter stated that patient care resources are utilized to prevent acute exacerbation of a chronic condition. The commenter believed that to not include these conditions on a CC list is a major flaw in the logic. The commenter supported inclusion of chronic conditions on the CC list as means to recognize the resources utilized to manage these conditions effectively, whether they are currently in an acute phase. The commenter did not mention specific chronic conditions that should be added to the MCC and CC lists.

Response: We address comments on specific conditions below. However, as a general matter, we found the Medicare data do not generally support that chronic or “unspecified” conditions are more resource intensive than conditions with an acute manifestation of a chronic disease that are described by specific codes. After carefully considering this issue, our medical advisors agreed that unspecified or chronic conditions generally are not suggestive of a higher level of severity of illness in and of themselves when there are more specific codes available to further describe the patient's specific condition or an acute manifestation of a chronic disease. We note that unspecified and chronic conditions are very commonly found in the Medicare patient population. The purpose of the MS-DRGs is to identify those conditions that lead to higher severity of illness and resource use relative to the average Medicare patient. These conditions suggest average or less than average resource use across the entire Medicare population. If we were to classify chronic and unspecified conditions as MCCs and CCs, the MS-DRGs ability to better recognize severity of illness would be significantly diminished.

Condition-Specific Comments

We received a number of recommendations of codes to be added to the CC list and the MCC list. We have divided these recommendations into three general categories and will address them accordingly. The three categories are:

  • Nonspecific codes
  • Symptoms, chronic conditions, and low severity conditions
  • High severity codes that were erroneously left off of the CC or MCC list.

The first category of recommendations includes a number of codes that are nonspecific. For instance, one frequent recommendation for addition to the CC list is the nonspecific code 428.0 (Congestive heart failure, unspecified). This code is one of several codes that identify patients who have heart failure. Depending on the degree of certainty by the physician of the exact nature of the heart failure, a code can be assigned to indicate a very specific and acute form of heart failure, or a more general, nonspecific code can be assigned to represent a patient with heart failure, but the exact nature of the heart failure is unknown. Other nonspecific conditions include disorders of a heart valve. If the exact nature of the disorder of a heart valve is known, a specific code can be assigned. If the exact nature or degree of the disorder of the valve is not known, a more general, nonspecific code can be assigned. As discussed earlier in this final rule with comment period, our claims data and the clinical analysis of our medical advisors indicate that patients described by the more general, nonspecific codes are not at a higher severity level. If a patient's condition worsens and develops additional diagnoses or complications, these more specific conditions may be on the CC list or MCC list. The most frequently mentioned, nonspecific code by commenters was code 428.0. Therefore, we will provide a detailed summary of these comments and our response. There were a number of other nonspecific conditions suggested for additions to the CC list. We will address these conditions after summarizing the comments on congestive heart failure.

The second category includes a variety of codes representing symptoms, chronic conditions, and other conditions that do not describe a high level of severity. These conditions do not themselves indicate a high severity level using our mathematical analysis of the claims data combined with the clinical analysis by our medical advisors. As stated earlier, we did not include most chronic conditions on the CC list or the MCC list unless the code also indicates an acute exacerbation that would raise the severity level. If a patient has a chronic condition that deteriorates or develops into an acute complication, the more acute condition or complication may be on the CC list or the MCC list.

The third category of codes includes codes that commenters suggested should have been included on the CC list or the MCC list because they clearly describe a high level of severity. Upon further review, we agree that this third group of codes meet the criteria for being included on the CC list or MCC list. The claims data and our medical advisors' clinical analysis clearly support the addition of these codes to the CC list or the MCC list. Start Printed Page 47165

(a) Codes Representing Nonspecific Conditions

  • Congestive Heart Failure—Code 428.0

Comment: One commenter endorsed the implementation of the revised CC list. The commenter stated that CMS used new criteria for refining the CC and MCC lists, which led to the removal of codes currently on the CC list. The commenter compared the old and revised CC lists and found that the revision added 2,002 codes and dropped 425 codes, for a net increase of 1,577 codes. The commenter stated that, even though the number of added codes far exceeds the number of dropped codes, in the last three MedPAR files, the dropped codes were used an average of 40,864 times, while the added codes were used an average of only 887 times. The commenter stated that many of the dropped codes pertain to unspecified conditions for which more specific codes are available and included on the revised CC list. The highest volume code, code 428.0, was applied to an average of 2.3 million Medicare fee-for-service cases a year during the past 3 years. This code is the most widely used secondary diagnosis code, despite the fact that 12 more specific codes were added in FY 2003. The additional codes are shown in the Table L below.

Table L.—Incidence of Secondary Diagnosis Coding for Heart Failure FY 2004-FY 2006

ICD-9-CM codeDescriptionNew in FY 2003
428.0Congestive heart failure, unspecified
428.1Left heart failure
428.20Systolic heart failure; unspecifiedx
428.21Systolic heart failure; acutex
428.22Systolic heart failure; chronicx
428.23Systolic heart failure; acute on chronicx
428.30Diastolic heart failure; unspecifiedx
428.31Diastolic heart failure; acutex
428.32Diastolic heart failure; chronicx
428.33Diastolic heart failure; acute on chronicx
428.40Combined systolic and diastolic heart failure; unspecifiedx
428.41Combined systolic and diastolic heart failure; acutex
428.42Combined systolic and diastolic heart failure; chronicx
428.43Combined systolic and diastolic heart failure; acute on chronicx
428.9Heart failure, unspecified

The commenter stated that, by making code 428.0 a non-CC, hospitals will react by coding more precisely using the more definitive heart failure codes, raising the CMI, which results in documentation and coding-related overpayments. The commenter argued that, if the revised CC list were implemented before hospitals had a chance to improve their coding to accommodate the revisions, “case-mix creep and IPPS overpayments would ensure.”

Response: This commenter suggests reasons why Medicare should adopt the MS-DRGs over a transition period and does not appear to be opposed to our decision not to classify congestive heart failure as either an MCC or a CC. The commenter also suggests how hospitals will respond to the coding incentives that will be presented by revisions to the MCC and CC lists as well as the MS-DRGs. The issue of adopting the MS-DRGs over a transition is addressed in detail in section II.E. of the preamble of this final rule with comment period. We further address the implications of the coding incentives raised in this public comment in section II.D.6. of the preamble of this final rule with comment period that discusses an adjustment to IPPS rates for improvements in documentation and coding.

Comment: A number of other commenters urged CMS to classify the condition under code 428.0 as a CC. The commenters indicated that code 428.0 identifies an acute condition, not a benign or a chronic condition. Some commenters stated that any inpatient with congestive heart failure requires increased nursing care to closely monitor and assess physical symptoms and vital signs for indications of increased congestion. Patients often need to undergo repeated laboratory studies.

Another commenter stated that the proposed rule incorrectly characterized the diastolic and systolic heart failure codes as congestive heart failure. The commenter pointed out that according to the Fourth Quarter 2002 issue of Coding Clinic for ICD-9-CM, congestive heart failure is not an inherent component of the codes in category 428 for systolic and diastolic heart failure. Therefore, according to Coding Clinic, the commenter stated that code 428.0 should be assigned as an additional code when the patient has systolic or diastolic congestive heart failure. The commenter added that code 428.0 may appropriately be assigned by itself when congestive heart failure is documented, but there is no documentation of systolic or diastolic heart failure. The commenter stated that, in ICD-9-CM, there is no distinction between an acute exacerbation of congestive heart failure and chronic congestive heart failure. Code 428.0 is assigned for both. The commenter added that codes 402.11 (Benign hypertensive heart disease with congestive heart failure) and 402.91 (Unspecified hypertensive heart disease with congestive heart failure) are on the CC list. The commenter suggested that code 428.0 be included on the revised CC list as well.

Another commenter who objected to the removal of code 428.0 from the CC list stated that, currently, ICD-9-CM codes do not distinguish between acute, chronic, or acute exacerbation of chronic congestive heart failure. All forms of this condition are assigned to code 428.0. The commenter indicated that medical record documentation may not typically include information on whether the congestive heart failure is systolic or diastolic (acute versions of heart failure with this specificity are considered MCCs). The commenter requested that code 428.0 be added as an MCC until a new code can be created to identify acute exacerbation of congestive heart failure. The commenter stated that the fact that there is “congestion” is medically more problematic and more resource intensive and may necessitate care in the intensive care unit and a prolonged Start Printed Page 47166hospital stay. The commenter stated that coding guidelines necessitate that acute pulmonary edema of cardiac origin be assigned code 428.0.

Response: Given the number of public comments on this one condition, our medical advisors reviewed the data and clinical issues surrounding code 428.0 again. They strongly recommend that we not change this code to a CC. There are three reasons for this recommendation. First, as stated earlier, we developed a policy of classifying nonspecific codes as non-CCs when a more specific code was available that identified the more specific nature of the patient's illness. Second, data for this and other nonspecific codes do not support assigning it to a higher severity level. Third, in the clinical judgment of our medical advisors, the use of a nonspecific code means that the physician had not identified a medical condition that indicates the patient is at a higher severity level or requires greater resources. This code is vague and does not provide any description of the exact nature of the heart failure. Data for this very commonly reported code clearly indicate that these patients are at a low severity level. However, claims data and our general policy of assigning nonspecific codes to a lower severity level were not the only factors that we used to classify a code as an MCC, CC, or non-CC. As stated above, the data were only used as an adjunct to the judgment of our medical advisors. In the judgment of our medical advisors, the condition described by code 428.0 does not suggest an increase in patient severity of illness. In this case, 12 more specific codes are available to indicate the more severe forms of heart failure. If the physician includes more precise information in the medical record that would allow the coder to identify a more specific code to describe the type of heart failure, the documentation will reflect that the hospital treated a more severely ill patient and the case will be assigned to a higher severity level.

While we decided to classify code 428.0 as a non-CC based on our policy concerning nonspecific codes, the data, and the judgment of our medical advisors, we note that heart failure is an important national health issue. We believe it is very important for hospitals and physicians to use the most specific codes that describe the incidence of heart failure in their patients. In order to accurately and completely evaluate health care outcomes for the treatment of heart failure, detailed and accurate information is needed on patients with this condition. Physicians and hospitals will undermine efforts to obtain more information on patients with this disease when they use a nonspecific code when there is a more detailed code to describe their patient. We highly encourage physicians and hospitals to work together to use the most specific codes that describe their patients” conditions. Such an effort will not only result in more accurate payment by Medicare but will provide better information on the incidence of this disease in the Medicare patient population.

Comment: As stated earlier, a number of commenters requested CMS to add additional nonspecific codes to the CC list. These codes represent a variety of nonspecific conditions affecting multiple body systems. The commenters stated that the following nonspecific codes may increase the severity level for a patient, and should, therefore, be added to the CC list.

  • 070.70, Unspecified viral hepatitis C
  • 287.30, Primary thrombocytopenia, unspecified
  • 287.5, Thrombocytopenia, unspecified
  • 303.00, Acute alcohol intoxication, unspecified
  • 345.90, Epilepsy, unspecified, without intractable epilepsy
  • 403.90, Hypertensive chronic kidney disease, unspecified, with chronic kidney disease stage I through stage IV, or unspecified
  • 424.0, Mitral valve disorders
  • 424.1, Aortic valve disorders
  • 426.13, Other second degree atrioventricular block
  • 426.6, Other heart block
  • 426.9, Conduction disorder, unspecified
  • 447.6, Arteritis, unspecified
  • 458.9, Hypotension, unspecified
  • 451.2, Thrombophlebitis of lower extremities, unspecified
  • 459.0, Hemorrhage, unspecified
  • 585.5, Chronic kidney disease, unspecified
  • 707.0, Decubitus ulcer, unspecified
  • 780.39, Other convulsions

Response: As previously stated, we did not classify nonspecific codes to the MCC list or the CC list when more specific codes were available to identify the condition of the patient. In general, we found that the data did not support classifying unspecified codes as either MCCs or CCs. Further, after detailed discussions of potential clinical scenarios among our medical advisors, there was a consensus that a specified condition for the patient generally signals higher degree of severity of illness. If the physician was to diagnose additional information about the patient's condition or should the patient's condition worsen, a more precise code would be assigned that may be a CC or an MCC. As a result of these comments, our medical advisors again reviewed these codes and determined that their original decisions were correct. That is, they do not believe that these nonspecific codes should be classified as MCCs or CCs when more specific codes are available that provide more information about patient severity of illness. For these reasons, we are not adding the codes listed above to the CC list.

(b) Symptoms, Chronic Conditions, and Low Severity Conditions

Comment: Commenters requested that we add a number of codes to the CC list that describe symptoms, chronic conditions, and low severity conditions. These conditions include the following codes:

  • 070.54, Chronic viral hepatitis C
  • 250.4x, Diabetes mellitus with renal manifestations
  • 250.5x , Diabetes mellitus with ophthalmic manifestations
  • 250.6 x, Diabetes mellitus with neurological manifestations
  • 250.7x, Diabetes mellitus with peripheral circulatory disorders
  • 250.8x, Diabetes mellitus with other specified manifestations
  • 263.0, Moderate Malnutrition
  • 263.1, Mild malnutrition
  • 276.51, Dehydration
  • 276.52, Hypovolemia
  • 276.6, Fluid overload
  • 276.7, Hyperpotassemia
  • 276.9, Electrolyte and fluid disorders
  • 280.0, Iron deficiency anemias, secondary to blood loss (chronic)
  • 284.8, Aplastic anemias, not elsewhere classified
  • 287.39 Other primary thrombocytopenia
  • 287.4 Secondary thrombocytopenia
  • 303.01 Acute alcohol intoxication, continuous
  • 303.02 Acute alcohol intoxication, episodic
  • 306.00, Blindness
  • 389.9, Deafness
  • 413.9, Angina pectoris
  • 427.31, Atrial fibrillation
  • 428.1, Left heart failure (change from CC to MCC)
  • 451.0, Thrombophlebitis of superficial vessels of lower extremities;
  • 492.8, Other emphysema
  • 496, Chronic airway obstruction, not elsewhere classified
  • 585.3, Chronic kidney disease, stage III (moderate)
  • 599.7, Hematuria
  • 710.0, Systemic lupus erythematosus
  • 731.3, Major osseous defects Start Printed Page 47167
  • 786.03, Apnea
  • 788.20, Urinary retention
  • 799.02, Hypoxemia
  • V45.1, Renal dialysis status

Response: As discussed earlier, we did not assign chronic conditions to the CC list or the MCC list. These conditions do not themselves indicate a high severity level using our mathematical analysis of the claims data combined with the clinical judgment by our medical advisors. As stated earlier, we did not include most chronic conditions on the CC list or the MCC list unless the code also indicates an acute exacerbation that would raise the severity level. If the chronic condition worsens and the patient develops an acute complication, the more specific code for the acute exacerbation would identify the increased level of severity of illness and, if warranted, would be on the CC or the MCC list. We also did not include general symptoms on the CC list because, alone, they do not suggest a high level of severity of illness. Codes identifying symptoms such as hematuria, apnea, or hypoxemia that are found in many patients may indicate a wide range of patient severity and describe a transient finding. Should the physician diagnose a more specific condition that led to the symptoms, more information about the patient and their severity of illness would be known. The specific diagnosis may indicate higher severity of illness and the code that describes it may be included on the CC list or the MCC list. We also did not include conditions on the CC list or the MCC list that do not generally raise the severity level of a patient. If the code describes patients who range from mild to severe, we believe it is best to use additional secondary diagnosis codes that would be reported to better describe the true nature of the patient's condition. These more precise codes may be on the CC list or the MCC list.

Our clinical advisors reviewed claims data and the clinical issues surrounding patients who had the symptoms, chronic diagnoses, and less severe conditions listed above. They recommend that we not add the codes listed above to the CC list because these conditions do not significantly increase a patient's severity of illness. Therefore, we are not adding the codes listed above to the CC list.

(c) High Severity Codes That Were Erroneously Left Off of the CC List or the MCC List

As stated earlier, a number of commenters recommended the addition of codes to the CC list or the MCC list for conditions that the commenters stated clearly represented a high severity level. The commenters provided information on the degree to which these conditions are life threatening and require extensive amounts of resources. The commenters questioned why these conditions were left off of the CC and MCC lists. Commenters recommended the removal of two codes from the CC list because the commenters believed they do not increase the patient's severity level or lead to more resource use. We discuss these conditions below.

Comment: Commenters requested that we add the following five codes to the CC list. The commenters stated that these conditions clearly increase the severity level and lead to more resource use.

  • 285.1, Acute posthemorrhagic anemia
  • 403.91, Hypertensive chronic kidney disease, unspecified, with chronic kidney disease stage V or end stage renal disease
  • 426.53, Other bilateral bundle branch block
  • 426.54, Trifascicular block
  • 451.11, Phlebitis and thrombophlebitis, femoral vein (deep) (superficial)

Response: We agree with the commenters that the five codes listed above should have been included on the CC list. Upon further review of our data and discussions among our medical advisors, there was consensus that these codes describe patients with a higher severity level. Therefore, we are adding them to the CC list.

Comment: Commenters requested that we remove the following two codes from the CC list and make them non-CCs. The commenters indicated that there are more specific heart failure codes that would be assigned along with these codes that would indicate whether or not the patient had a severe form of heart failure. The commenters stated that these two codes do not indicate the exact nature of the heart failure and therefore should not be on the CC list.

  • 402.11, Hypertensive heart disease, benign, with heart failure
  • 402.91, Hypertensive heart disease, unspecified, with heart failure

Response: We agree with the commenters. Upon further review, we do not believe the codes meet the criteria to be considered CCs. The codes do not describe the exact nature of the heart failure. The more specific heart failure codes that would be reported along with these codes would be used to justify the assignment to a high severity level. Therefore, we are removing the two codes from the CC list.

Comment: Commenters requested that we add the following four codes to the MCC list. The commenters indicated that these four codes describe patients at the highest level of severity. Patients with these conditions would use an extensive amount of resources. Furthermore, the commenters added, codes that describe similar conditions are currently on the MCC list. The commenters believed these codes were erroneously excluded from the MCC list.

  • 282.69, Other sickle-cell disease with crisis
  • 345.2, Petit mal status
  • 345.71, Epilepsia partialis continua, with intractable epilepsy
  • 780.01, Coma

Response: We agree that we made an error in excluding these four codes from the MCC list. Therefore, we are adding the four codes to the MCC list. We provide a summary of all the additions and deletions to the CC list and the MCC list at the end of this section.

Additional Comments on CC List

We received several additional comments concerning the CC and MCC lists which we summarize below. Some of the comments involved the commenter's confusion about our proposed CC and MCC lists. Others involved a disagreement with our proposal of not making significant changes to the DRGs to better distinguish severity of illness in pregnancies and newborns, even though they are not a significant part of the Medicare population. We also received recommendations for alternative ways to classify conditions as CCs that do not meet our current criteria. In addition, we received comments on our proposal of not classifying specific conditions as a CC/MCC when the patient dies. We discuss these issues below.

  • Other Myelopathy—Code 336.8

Comment: One commenter requested that we add code 336.8 (Other myelopathy) to the CC list.

Response: Code 336.8 is already on the CC list. Therefore, we are not making any further change for code 336.8.

  • Ascites—Code 789.5

Comment: One commenter requested that we add the code 789.5 (Ascites) to the CC list

Response: We note that code 789.5 is being deleted as of October 1, 2007, when two new codes are being created, code 789.51 (Malignant ascites) and code 789.59 (Other ascites). Both of these new codes are on the CC list. Therefore no additional change is required for ascites.

  • Aplastic Anemias, Not Elsewhere Classified—Code 284.8 Start Printed Page 47168

Comment: One commenter objected to the removal of code 284.8 (Aplastic anemias, not elsewhere classified (NEC)) from the CC list.

Response: Code 284.8 was placed on the MCC list. Thus, while it is not classified as a CC as the comment suggested, it is an MCC. We are maintaining code 284.8 on the MCC list, as we agree that this is a condition that places a patient at a high severity level.

  • Complications of Pregnancy, Childbirth and Puerperium—Codes 630 through 677

Comment: One commenter objected to the removal of codes from category 630 through 677 (Complications of pregnancy, childbirth and puerperium) of the CC list. The commenter was concerned about the number and wide breadth of codes from Chapter 11 of the ICD-9-CM, Complications of pregnancy, childbirth and puerperium (categories 630-677), that are being removed from the CC list . The commenter acknowledged CMS” position that, due to the low volume in the Medicare population, diagnoses related to newborns, maternity and congenital anomalies codes in this section were not reviewed. Of special concern to the commenter were conditions such as infections, acute renal failure, air and pulmonary embolism, cardiac arrest, shock, among others, that are MCCs or CCs and would be coded as such if not for the fact that the ICD-9-CM classification considers problems associated with pregnancy, childbirth and the puerperium to be so clinically significant that they require special combination codes. The combination codes are intended to identify that the presence of the pregnancy complicates the condition. For example, code 415.19 (Other pulmonary embolism and infarction) is an MCC, while code 673.20 (Obstetrical blood-clot embolism, unspecified) is not even a CC.

The commenter recommended that codes in Chapter 11 be carefully evaluated and validated with clinical experts, similar to the process to which the codes in other chapters were submitted. The commenter believed that combination codes should be treated consistently. If the condition is considered a CC or MCC in a nonpregnant patient, the corresponding pregnancy-related combination code also should be a CC or MCC.

Response: As we stated in our proposed rule and elsewhere in this final rule with comment period, we focused our attention in developing the MS-DRGs for the Medicare population. We did not conduct a detailed review of Chapter 11 codes. We encourage other payers who want to use MS-DRG to update the system for their own population. Diagnoses related to newborns, maternity, and congenital anomalies are very low volume in the Medicare population and were not reviewed for purposes of creating the MCC and CC lists. We used the APR DRGs to categorize these diagnoses. This DRG system is used for the all payer ratesetting system in Maryland and will be based on data that better reflects the newborn and maternity population than Medicare. For newborn, obstetric, and congenital anomaly diagnosis, we classified severity level 3 (major) and 4 (extreme) diagnoses as an MCC. We designated default severity level 2 (moderate) diagnoses as a CC and all other diagnoses as a non-CC. We encourage the commenter to review the MCC and CC lists in on the CMS Web site. Many codes in the 630 to 677 range appear on the MCC list.

  • Extreme Immaturity—Code 765.0

Comment: One commenter objected to codes in category 765.0 (Extreme immaturity) not being classified as CCs. The commenter stated that codes in category 765.0 represent infants with a birth weight of less than 1000 gm. The commenter indicated that common problems with very low birthweight babies are low oxygen levels at birth; inability to maintain body temperature; difficulty feeding and gaining weight; infection; breathing problems, such as respiratory distress syndrome; neurological problems, such as intraventricular hemorrhage; gastrointestinal problems, such as necrotizing enterocolitis; and sudden infant death syndrome (SIDS). The commenter stated that while some of these problems have unique ICD-9-CM codes that could be reported, not all of them do (for example, inability to maintain body temperature).

Response: While we appreciate the commenter's concern about the CC classifications for newborns, we state again that we did not examine these newborn codes as part of our development of the MS-DRGs. We focused our efforts on the Medicare population and used the APR DRG classification for newborn diagnoses for Medicare. If the APR DRG classification of this condition were to change, we would also adopt the same designation for Medicare.

  • Exclusion of MCCs and CC When a Patient Dies

Comment: Several commenters addressed codes that represent diagnoses associated with patient mortality. The commenter indicated that, in the proposed rule, CMS noted that diagnoses that were closely associated with patient mortality were assigned different CC subclasses, depending on whether the patient lived or died.

These diagnoses are:

  • 427.41, Ventricular fibrillation;
  • 427.5, Cardiac arrest;
  • 785.51, Cardiogenic shock;
  • 785.59, Other shock without mention of trauma; and
  • 799.1, Respiratory arrest.

The commenters agreed that these diagnoses should be considered MCCs for patients who are discharged alive. However, the commenters disagree with CMS” proposal to make these diagnoses non-CCs when a patient dies. The commenters urged CMS to consider the patient's length of stay or other factors when these codes are reported and count them as an MCC when a patient dies during the admission. The commenters agreed that a patient who expires soon after admission may not have significant resources associated with these conditions. However, the commenters believed that this is not true when a patient has been hospitalized longer, such as for a week.

Response: Our medical advisors examined this issue again and continue to believe it is not appropriate to classify a case as an MCC based on one of the codes above if the patient dies. While we understand the concern of the commenters, we do not believe that a long length of stay patient will necessarily lead to the conclusion that it is appropriate to code these conditions in a patient that dies in the hospital. It is a possible that a terminally ill patient with a long length of stay required no special resuscitation efforts that would suggest higher resource use associated with coding of these conditions. We are concerned that changing our policy to allow use of these codes for a patient that died in the hospital could lead to accurate and widespread coding of the conditions when they are not indicative of a higher patient resource costs. Therefore, we are continuing our policy of classifying the diagnoses listed above as MCCs only if the patient is discharged alive. We will evaluate alternative approaches such as looking at the length of stay and other factors for these patients and make future DRG revisions, as needed.

  • Selected Conditions in Joint Replacement Patients

Comment: One commenter asked that we classify certain codes as MCCs or CCs for patients having a joint replacement. The commenter specifically requested that the following codes be made either MCCs or CCs when occurring in a joint replacement patient: Start Printed Page 47169

  • 731.3, Major osseous defect
  • 278.0, Obesity
  • 278.01, Morbid obesity
  • V85.35, Body mass index 35.0-35.9, adult
  • V85.37, Body mass index 37.0-37.9, adult

Response: We do not believe that we should make further changes to the MS-DRG assignments based on combinations of selected diagnoses. These types of analyses could be done with virtually any MS-DRG and would add significant complexity to the DRG system that we do not believe is warranted at this time. Our medical advisors reviewed both the data and clinical issues surrounding these codes and determined that they would not significantly increase the severity level for Medicare patients on average across all patients. Therefore, they are not CCs. We are not changing these codes to CCs. They will remain non-CC for all cases.

The following table summarizes changes to the proposed MCC (Table 6J) and CC (Table 6K) lists published in the proposed rule. These changes are a result of review of comments and were discussed in detail above. A complete, updated CC and MCC list will be posted on the CMS Web site at: http://www.cms.hhs.gov/​AcuteInpatientPPS/​ under Downloads. We will continue to evaluate our criteria for the development of the CC and MCC list to determine if refinements to these criteria are needed. As we gain data and experience under MS-DRGs, we believe that there may be refinements to these criteria.

Changes to MCC and CC List as a Result of Comments

Add to CC list:
285.1Acute posthemorrhagic anemia.
403.91Hypertensive chronic kidney disease, unspecified, with chronic kidney disease stage V or end stage renal disease.
426.53Other bilateral bundle branch block.
426.54Trifascicular block.
451.11Phlebitis and thrombophlebitis, femoral vein (deep) (superficial).
Remove from CC list:
345.2Petit mal status.
345.71Epilepsia partialis continua, with intractable epilepsy.
402.11Hypertensive heart disease, benign, with heart failure.
402.91Hypertensive heart disease, unspecified, with heart failure.
780.01Coma.
Add to MCC list:
282.69Other sickle-cell disease with crisis.
345.2Petit mal status.
345.71Epilepsia partialis continua, with intractable epilepsy.
780.01Coma.
Remove from MCC list:
None

3. Dividing MS-DRGs on the Basis of the CCs and MCCs

In developing the MS-DRGs, two of our major goals were to create DRGs that would more accurately reflect the severity of the cases assigned to them and to create groups that would have sufficient volume so that meaningful and stable payment weights could be developed. As noted above, we excluded the CMS DRGs in MDCs 14 and 15 from consideration because these DRGs are low volume. As stated previously, we do not have the expertise or data to maintain the CMS DRGs for newborns, pediatric, and maternity patients. We continue to maintain MDCs 14 and 15 without modification in order to have MS-DRGs available for these patients in the rare instance where there is a Medicare beneficiary admitted for maternity or newborn care.

In designating an MS-DRG as one that will be subdivided into subgroups based on the presence of a CC or MCC, we developed a set of criteria to facilitate our decision-making process. In order to warrant creation of a CC or major CC subgroup within a base MS-DRG, the subgroup had to meet all of the following five criteria:

  • A reduction in variance of charges of at least 3 percent.
  • At least 5 percent of the patients in the MS-DRG fall within the CC or MCC subgroup.
  • At least 500 cases are in the CC or MCC subgroup.
  • There is at least a 20-percent difference in average charges between subgroups.
  • There is a $4,000 difference in average charges between subgroups.

Our objective in developing these criteria was to create homogeneous subgroups that are significantly different from one another in terms of resource use, that have enough volume to be meaningful, and that improve our ability to explain variance in resource use. These criteria are essentially the same criteria we used in our 1994 severity analysis. In developing the MS-DRGs, we continued to apply our longstanding policy that each DRG should contain patients who are similar from a clinical perspective.

To begin our analysis, we subdivided each of the base MS-DRGs into three subgroups: non-CC, CC, and MCC. Each subgroup was then analyzed in relation to the other two subgroups using the volume, charge, and reduction in variance criteria. The criteria were applied in the following hierarchical manner:

  • If a three-way subdivision met the criteria, we subdivided the base MS-DRG into three CC subgroups.
  • If only one type of two-way subdivisions met the criteria, we subdivided the base MS-DRG into two CC subgroups based on the type of two-way subdivision that met the criteria.
  • If both types of two-way subdivisions met the criteria, we subdivided the base MS- DRG into two CC subgroups based on the type of two-way subdivision with the highest R2 (most explanatory power to explain the difference in average charges).
  • Otherwise, we did not subdivide the base MS-DRG into CC subgroups.

For any given base MS-DRG, our evaluation in some cases showed that a subdivision between a non-CC and a combined CC/MCC subgroup was all that was warranted (that is, there was not a great enough difference between the CC and MCC subgroups to justify separate CC and MCC subgroups). Conversely, in some cases, even though an MCC subgroup was warranted, there was not a sufficient difference between the non-CC and CC subgroups to justify separate non-CC and CC subgroups.

Based on this methodology, a base MS-DRG may be subdivided according to the following three alternatives, rather than the current “with CC” and “without CC” division.

  • DRGs with three subgroups (MCC, CC, and non-CC).
  • DRGs with two subgroups consisting of an MCC subgroup but with the CC and non-CC subgroups combined. We refer to these groups as “with MCC” and “without MCC.”
  • DRGs with two subgroups consisting of a non-CC subgroup but with the CC and MCC subgroups combined. We refer to these two groups as “with CC/MCC” and “without CC/MCC.”

As a result of the application of these criteria, 745 MS-DRGs were created as shown in the following table. Start Printed Page 47170

Table M.—Number of CC Subgroups

SubgroupsNumber of base MS-DRGsNumber of MS-DRGs
No subgroups5353
Three subgroups152456
Two subgroups: CC and major CC; non-CC4386
Two subgroups: non-CC and CC; major CC63126
Subtotal311721
MDC 142222
Error DRGs22
Total335745

The 745 MS-DRGs represent an increase over the 652 DRGs we proposed in our 1994 CC revision analysis. The increase in the number of DRGs is primarily the result of an increase in the number of proposed base MS-DRGs that are subdivided into three CC subgroups. The distribution of patients across the different types of CC subdivisions is contained in Table N below. The table shows that 51.7 percent of the patients are assigned to base MS-DRGs with three CC subgroups, and only 11.8 percent of the patients are assigned to base MS-DRGs with no CC subgroups.

Table N.—Distribution of Patients by Type of CC Subdivision

CC subdivisionCountPercent
None1,382,81011.8
(MCC and CC), Non-CC629,6395.4
MCC, (CC and Non-CC)3,650,32131.2
MCC, CC, and Non-CC6,054,08151.7

Using Medicare charge data (without applying any criteria to remove statistical outlier cases), the reduction in variance (R2) was computed for current CMS DRGs, the MS-DRGs with all 311 base MS-DRGs subdivided into 3 CC subgroups, and the MS-DRGs collapsed into 745 DRGs. Table O below shows that the R2 for the MS-DRGs with all 311 base MS-DRGs subdivided into 3 CC subgroups (957 DRGs composed of 311 base MS-DRGs subdivided into 3 CC subgroups plus an additional 22 MDC 14 and MDC 15 DRGs as well as 2 error DRGs) is 10.62 percent higher than the current CMS DRGs. Collapsing the 957 MS-DRGs down to 745 MS-DRGs lowers this increase in R2 slightly to 9.41 percent. Although adopting a 3-way split for each base MS-DRG would produce a DRG system with higher explanatory power, the 957 MS-DRGs would not meet the criteria we specified above for subdividing each base DRG. The criteria we specified above would create a monotonic DRG system. We believe that the value of having a monotonic DRG system outweighs the slight decrease in explanatory power. For this reason, we proposed to adopt the 745 MS-DRGs.

Table O.—Explanatory Power (R2) for MS-DRGs

R2Percent change
Current CMS DRG36.19
2007 CMS Severity DRGs with 3 CC Subgroups40.0310.62
2007 CMS Severity DRGs Collapsed to 714 DRGs39.599.41

Comment: One commenter supported our five criteria for establishing severity subgroups. The commenter believed the use of specific quantitative criteria to determine how specific base DRGs are divided into terminal categories that reflect severity levels is logical and designed to ensure that only substantively important differences in resource requirements are recognized by the MS-DRG system. The commenter did note that CMS had not explicitly included statistical significance in these criteria and urged CMS to consider CC or MCC splits only when they meet minimal standards of both size and statistical significance.

Response: We appreciate the commenter's support for our five criteria for establishing severity subgroups. We will consider the commenter's other suggestion as we make further refinements to the MS-DRGs.

Comment: One commenter disagreed with our five criteria for establishing severity subgroups. The commenter stated that these criteria are too restrictive, lack face validity, and create perverse admission selection incentives for hospitals by significantly overpaying for cases without a CC and underpaying for cases with a CC. The commenter recommended that the existing five criteria be modified for low-volume subgroups to assure materiality. For higher volume MS-DRG subgroups, they recommended that two other criteria be considered, particularly for nonemergency, elective admissions. These two criteria are:

  • Is the per-case underpayment amount significant enough to affect admission vs. referral decisions on a case-by-case basis?
  • Is the total level of underpayments sufficient to encourage systematic admission vs. referral policies, procedures, and marketing strategies?

The commenters also recommended refining the five existing criteria for MCC/CC/without subgroups as follows:

  • Create subgroups if they meet the five existing criteria, with cost difference between subgroups ($1,350) substituted for charge difference between subgroups ($4,000).
  • If a proposed subgroup meets criteria # 2 and # 3 (at least 5 percent of discharges in the subgroup and at least 500 cases) but fails one of the others, create the subgroup if either of the following criteria is met:

—At least $1,000 cost difference per case between subgroups; or

—At least $1,000,000 overall cost should be shifted to cases with a CC (or MCC) within the base DRG for payment weight calculations.

The commenter stated that this approach would affect DRGs where the total dollars under consideration may be quite high (for example, in the hundreds of millions), due to large numbers of procedures, but the percentage difference in average charges falls short of the 20 percent difference in average charges between subgroups.

Response: We disagree that the five criteria for establishing severity subgroups are too restrictive and will lead to overpayments for cases without a CC and underpay for cases with a CC. Relative to the current CMS DRGs, the statistical data above suggest that the construction of the MS-DRGs using these criteria will improve payment accuracy. The explanatory of the MS-DRGs to predict resource use is more than 9 percent greater than under the current CMS DRGs. Further, under the current CMS DRGs, nearly 78 percent of patients are in the highest severity level, while only 22.2 percent are in the Start Printed Page 47171highest severity level under the MS-DRGs. In addition to having a better distribution of cases among severity levels, the MS-DRGs have more significant difference in average charges over the different severity levels compared to the current CMS DRGs (72 FR 24706).

The commenter does not appear to disagree with these statistics suggesting that improvements will result from the MS-DRGs. Rather, the commenter is suggesting that we should create more subgroups with smaller differences in average charges (or costs). We do not believe the first two alternative criteria are practical or necessary to apply. They would require us to make subjective judgments about whether a hospital would treat patients or refer them elsewhere solely based on payment incentives. We do not believe it is possible or appropriate for us to make judgments about whether a hospital would decide to treat or not treat a patient based on how much they are paid. Further, with the exception of cardiac specialty hospitals, we have no evidence hospitals are selectively treating or avoiding particular types of patients because of incentives present in Medicare's IPPS payments. The reforms we are making are intended to pay hospitals more accurately for the patients they are already treating and avoid incentives for more specialty hospitals to form. Therefore, we do not believe it is practical or necessary to use the first two criteria suggested by the commenter.

With respect to the last criteria, we note that the MS-DRGs represent a significant expansion in the number of DRGs from 538 in FY 2007 to 745 in FY 2008. The commenter is suggesting that we create additional subgroups with less variation between the subgroups. Payments under a prospective payment system are predicated on averages. Thus, most individual cases within any DRG system will have costs that are either higher or lower than the average for that group. While creating groups that have lower differences in average charges or costs between the groups may lessen variation around the average and improve explanatory power, it will also create more low-volume groups and increase the likelihood that the relative weights will be nonmonotonic and have instability in their values from year to year. We believe the value of a lower number of DRGs outweighs the benefit we would obtain from a slight increase in R2 and the risk of having nonmonotonic DRGs that would come from adopting the commenter's suggestions.

4. Conclusion

We believe the MS-DRGs represent a substantial improvement over the current CMS DRGs in their ability to differentiate cases based on severity of illness and resource consumption. As developed, the MS-DRGs increase the number of DRGs by 207, while maintaining a reasonable patient volume in each DRG. The MS-DRGs increase the explanation of variance in hospital resource use relative to the current CMS DRGs by 9.41 percent. Further, the data shown below in Table P and Table Q illustrate how assignment of cases to different severity of illness subclasses improves in the MS-DRGs relative to the CMS DRGs.

Table P.—Overall Statistics for CMS DRGs

CC subclass—current CMS DRGPercentAverage charges
One or more CCs77.66$24,538
Non-CC22.3414,795

Table Q.—Overall Statistics for MS-DRGs

CC subgroupNumber of casesPercentAverage charges
MCC2,607,35122.2$44,219
CC4,298,36236.624,115
Non-CC4,826,98041.118,416

Under the current CMS DRGs, 78 percent of cases are assigned to the highest severity levels (CC) and the remaining 22 percent are assigned to the lowest severity level (non-CC). Applying the three severity subclasses to FY 2006 data would result in approximately 22 percent of patients being assigned to the severity subgroup with the highest level of severity (MCC), 41 percent being assigned to the lowest severity subclass (non-CC), and the remaining 37 percent being assigned to the middle severity subclass (CC). Adding the new MCC subgroup greatly enhances our ability to identify and pay hospitals for treating patients with high levels of severity. As Table Q above shows, the new subgroups also have significantly different resource requirements. The MCC subgroup contains patients with average charges almost twice as large as for those in the CC group ($44,219 compared to $24,115).

In addition to resulting in improvements in the DRG system's recognition of severity of illness, we believe the MS-DRGs are responsive to the public comments that were made on last year's IPPS proposed rule with respect to how we should undertake further DRG reform. In the FY 2007 IPPS final rule, we identified three major concerns in the public comments about our proposed adoption of CS DRGs:

We received comments after the FY 2007 IPPS final rule suggesting that further adjustments were needed to the proposed DRG system. The commenters believed that the CS DRGs did not incorporate many of the changes to the DRG assignments that have been made over the years to the CMS DRGs. There was significant interest in the public comments in either revising the CS DRGs to reflect these changes or using the CMS DRGs as the starting point to better recognize severity.

We believe that the MS-DRGs are responsive to these suggestions. The MS-DRGs use the CMS DRGs as the starting point for revising the DRGs to better recognize resource complexity and severity of illness. We are generally retaining all of the refinements and improvements that have been made to the base DRGs over the years that recognize the significant advancements in medical technology and changes to medical practice. At the same time, the MS-DRGs greatly improve our ability to identify groups of patients with varying levels of severity. They retain all of the improvements made to the DRGs over the years, while providing a more equitable basis for hospital payment.

We received many comments on the FY 2007 IPPS rule about the potential use of a proprietary DRG system. The comments about the CS DRGs raised compelling issues about the potential government use of a proprietary system, including concerns about the availability, price, and transparency of the source code, logic and documentation of the DRG system. The commenters noted that CMS makes available these resources in the public Start Printed Page 47172domain for purchase through the National Technical Information Service at nominal fees to cover costs. The commenters urged CMS not to adopt a proprietary DRG system that would not be available on the same terms as the current CMS DRGs.

There are no proprietary issues associated with the MS-DRGs. The MS-DRGs will be available on the same terms as the current CMS DRGs through the National Technical Information Service.

We also received other comments on the FY 2007 IPPS rule concerning the use of CS DRGs. The commenters stated that no alternatives to CS DRGs had been evaluated. The commenters suggested that alternative DRG systems can better recognize severity than the CS DRGs and should be evaluated before CMS decides which system to adopt. In response to these concerns, we contracted with RAND Corporation to evaluate several alternative DRG systems, including the MS-DRGs that we proposed and are finalizing in this final rule with comment period for FY 2008.

As indicated above, we believe the MS-DRGs offer significant improvements to the DRG system without many of the liabilities the public commenters on the FY 2007 IPPS rule identified with the CS DRGs. Thus, we believe the MS-DRGs offer significant improvements in recognition of severity of illness and complexity of resources and are adopting them for FY 2008.

Comment: Many commenters supported the MS-DRGs. One commenter stated that “your proposal showcases the best of CMS, evidenced, for example, by an elegant and reasonable framework for severity-adjusted DRGs.” Another commenter stated that it was “about time that Medicare adopted a DRG system that allows for more equitable reimbursement for cases of severe illness with high risk of death or significant morbidity.” Other commenters stated that it was very apparent that CMS dedicated an extensive amount of thought, planning, and resources toward the development of the MS DRGs, and that the system appears to be a very reasonable approach toward stratifying the patient grouping system more distinctly based on the severity of the patient's illness.

Many commenters found the MS-DRGs to represent a reasonable approach to DRG refinement, stating they are, in principle, a positive advancement and will create a more equitable and accurate payment system. Other commenters stated that the MS DRGs are an effective method for incorporating greater refinements to reflect variations in patient severity. Other commenters stated that hospitals providing services to more complex patients should be paid in a manner that reflects the nature of that care. These commenters stated that they do not want to see a payment system that rewards hospital inefficiency and it is reasonable that Medicare reimbursement policy assures that services are appropriately compensated. Other commenters stated that, over time, some DRGs have become more profitable than others. The commenters stated that making adjustments in rates helps to restore balance to the entire hospital inpatient payment system. These commenters endorsed CMS’ efforts to achieve these goals through the adoption of the MS-DRGs.

Other commenters expressed their appreciation for CMS’ recognition and consideration of issues raised in the public comments on last year's proposal to adopt CS DRGs. The commenters indicated that CMS took account of the public comments in crafting this year's MS-DRG proposal. The commenter applauded CMS for addressing many concerns that were expressed regarding CS DRGs. One of these commenters stated that MS-DRGs are significantly superior to the CS DRGs that were proposed last year. One commenter indicated that it had asked CMS to do the following when considering adoption of a new DRG system:

  • Show evidence that the alternative resulted in an improved hospital payment system compared to the existing DRG system;
  • Test the degree to which the variation in costs within cases at the DRG level is reduced;
  • Consider whether there were easier ways to adjust for severity similar to the differentiation of patients in FY 2006 based on the absence or existence of a major cardiovascular diagnosis;
  • Maintain the improvements made to differentiate cases based on complexity in the existing system; and
  • Avoid creating a system that is proprietary and lacks transparency.

The commenter indicated that CMS made a concerted effort to develop a system that incorporates all of these goals and indicated their support for these meaningful improvements to the IPPS. Like this commenter, several other commenters were also in agreement that the proposed DRG system should not be proprietary to avoid limiting public access to the system. Another commenter who expressed appreciation for CMS’ responsiveness to issues raised in last year's IPPS rule indicated that the MS-DRGs are logical, transparent, and nonproprietary, which well suits the needs of the health care community. Other commenters also expressed support for CMS’ decision to make the MS-DRGs nonproprietary, open, and accessible, and available on the same terms as the current DRGs.

Another commenter stated that it had decades of experience doing work with DRG systems and believe that there has been a need for a severity adjustment mechanism in the CMS DRGs to facilitate more accurate payment under the IPPS. In its view, the MS-DRG methodology is an appropriate mechanism to add severity adjustments to IPPS for FY 2008. According to the commenter, the MS-DRGs’ advantages include:

  • They are based on the current CMS DRGs, whose technical features, data structures, and program algorithms have been fine-tuned over the years to accommodate the insertion and deletion of DRGs, changes in code/criteria lists, changes to CC and CC exclusion lists, changes in hierarchy, addition or deletion of DRG criteria, among others.
  • Additional severity adjustments will not require substantial modifications to this basic, extensible, and highly efficient architecture. The architecture will facilitate the addition of new categories necessitated by the introduction of new technologies or the application of the methodology to non-Medicare populations.

The commenter recommended that CMS plan for a more flexible, four-character nomenclature in the severity DRG system as soon as reasonably possible. The commenter noted that all commercially available severity-adjusted DRG systems have adopted a nomenclature that employs an initial 3-digit base DRG designation followed by a 1-digit severity score. This approach is far more flexible and transparent. More importantly, the approach lends itself more readily to the addition of new base DRGs and the evolution of more granular severity-adjustment.

Many commenters were supportive of the MS-DRGs because they were derived from the existing system and, therefore, preserve the numerous policy decisions made over the years and embodied in the CMS DRGs. These commenters appreciated that severity stratifications were created from the existing base DRGs with the result of redistribution within, rather than across, the DRGs. Commenters also stated that the MS-DRGs provide CMS with the flexibility of making DRG reassignments within a base MS-DRG by moving more complex services up a severity level. Other commenters stated that the MS-Start Printed Page 47173DRG system does a better job than last year's proposed CS DRGs or the current CMS DRGs of reflecting advancements in medical technology and other improvements in medical care.

Some commenters stated that, with the development and proposal of MS-DRGs, they saw little reason for CMS to continue assessing and considering alternative patient classification systems in the foreseeable future. These commenters stated that the MS-DRG system is more transparent, accessible, and understandable than the alternative systems being evaluated by RAND.

Some commenters stated that the MS-DRGs provide more accurate grouping for severity of illness while retaining the CMS-DRG refinements to account for more accurate payment of resource utilization. However, these commenters recommended that the implementation of MS-DRGs be delayed for one year to wait for the final RAND report and the availability of a GROUPER. One commenter stated that the MS-DRGs are an excellent attempt to define severity of illness based on DRGs for the Medicare population but urged us not to implement them in FY 2008 unless it is deemed to be the final system adopted from the ones being studied by RAND. Several commenters stated that hospitals will undergo enormous costs to “educationally gear up” for the MS-DRGs. The commenter stated that the hospital community must expend educational dollars in its attempt to improve coding to optimize each case's DRG assignment. These comments were concerned about the burden and expense that would be imposed on hospitals from adopting one significant DRG reform this year and another one next year. A number of other similar comments urged CMS not to move to MS-DRGs if it plans to implement another new severity system in FY 2009.

Response: We appreciate the support for MS-DRGs. We agree that, building on the current DRG system, we have maintained the best aspects of our past efforts while adding additional refinements to better identify severity. We also agree that it is beneficial to consider moving to a four-character nomenclature for MS-DRGs. We have already developed an internal version with four characters, with the fourth character indicating the severity levels. Systems restrictions prevent us from using this four-character numbering system in Medicare's data systems at this time. However, we will continue to evaluate the possibility of moving to such a numbering system.

With respect to the comments about the RAND project and the concern about adopting two different DRG reforms in succeeding years, we note that RAND has completed its evaluation of alternative DRG systems, including the MS-DRGs. Consistent with RAND's findings, we believe it is appropriate at this time to adopt the MS-DRG system for Medicare in FY 2008. While there will be an opportunity for the public to comment on RAND's findings, we expect to permanently adopt the MS-DRGs for the IPPS. We do not believe it is likely that there will be persuasive public comments suggesting that one of the alternative DRG systems being evaluated by RAND is clearly superior.

Comment: One commenter fully endorsed the move to MS-DRGs, but stressed the need of maintaining the current level of transparency in the DRG system, regardless of the chosen methodology. The commenter stated that many companies offer software that hospitals and health plans utilize in managing the billing, coding, and payment for hospital inpatient services under the DRGs. The development of this software is possible only because the current DRG methodology is a transparent system. By that, they mean that members of the public can obtain full access to the details underlying the system by purchasing information and software from the National Technical Information Service (NTIS) at a nominal charge in a timely manner (well in advance of the implementation of changes). The commenter appreciated the agency's commitment in the FY 2007 final rule to “continue to strive to promote transparency in our decision making as well as in future payment and classification systems, as we have done in the past.” The commenter commended CMS for its continued attention to the transparency issue and appreciates CMS' proposal to make the MS-DRGs available on the same terms as they currently do CMS DRGs through NTIS.

Response: We agree that it is important to provide updates and modifications to the DRG system in a transparent manner. We intend to continue our efforts to do so by providing the necessary information through our regulations, Web sites, and through NTIS. The MS-DRGs will be available to the public on the same terms as the CMS DRGs.

Comment: MedPAC reviewed the MS-DRGs and commended CMS for its commitment to improve the accuracy of Medicare payments for hospital acute inpatient services. MedPAC stated that CMS staff had made significant progress toward achieving this goal with the development of MS-DRGs coupled with cost-based weights. MedPAC's analysis showed that MS-DRGs will result in a substantial improvement in payment accuracy. MedPAC took several steps to evaluate the proposed MS-DRGs. First, they examined their face validity. An effective patient classification system, in the context of a payment system, should group together clinically similar cases that have similar costs. In addition, MedPAC stated that relative weights calculated for the classification groups (MS-DRGs) generally should exhibit a consistent hierarchy of values across levels of severity of illness for different conditions. Therefore, one issue is how much costs vary around the mean cost per case for cases grouped within MS-DRGs. Another issue is whether relative weights for different severity levels show the expected hierarchy across most clinical conditions. For comparison, MedPAC also looked at the cost variation and relationships among relative weights for cases grouped in the current DRGs and in the severity categories of the APR DRGs. MedPAC also examined how the MS-DRGs would affect payment accuracy in the IPPS, measured by how closely payments would track costs for different types of cases. MedPAC compared payment accuracy under the MS-DRGs with the results under the current CMS DRGs and the severity categories of the APR DRGs.

MedPAC found that MS-DRGs did a better job of grouping cases with similar costs into the same category. This was expected because the MS-DRGs break out high severity (and high cost) cases with MCCs into separate DRGs. For comparison, MedPAC also calculated the amount of variation in costs among cases within the severity classes of APR DRGs (Version 23). The average absolute difference for the APR DRGs, in turn, was 7.4 percent lower than the value for DRGs. MedPAC stated that this suggests that at least some opportunities are available for further refinement of the MS-DRGs. Although MedPAC found the MS-DRGs were not perfect, and may need to be further refined over time, it believed they represent a significant improvement over the current CMS DRGs. MedPAC's analysis showed that payment accuracy increased substantially when moving from the current DRGs to one based on the MS-DRGs.

Response: We agree with MedPAC that the MS-DRGs represent a significant improvement over the current CMS DRGs. As suggested above, we intend to use RAND's evaluation of the MS-DRGs to make further improvements to it. We appreciate MedPAC's suggestion to use the APR DRGs to also help us identify potential Start Printed Page 47174areas where further improvements can be made to the MS-DRGs.

Comment: One comment stated that the “Crosswalk from CMS DRGs to MS-DRGs” was somewhat misleading. The commenter was concerned that some entities are interpreting it as a one-to-one mapping. The commenter suggested that it be clarified that an individual DRG code cannot be mapped directly to a MS-DRG. The commenter recommended that MS-DRG implementation be delayed so that CMS can release the MS-DRG GROUPER and allow hospitals time to analyze the impact prior to implementation.

Response: After public display of the proposed rule, we were asked to provide additional information on the CMS Web site showing how the current CMS DRGs map to the new MS-DRGs. Although we provided this information, we were concerned about its usefulness because of the very issue raised in this public comment. That is, there is not a one-to-one crosswalk between the 538 DRGs that exist under the CMS DRGs and the 745 MS-DRGs. While this information may not have been as useful as originally anticipated by members of the public that requested it, we believe the fact that there is not a one-to-one crosswalk between the CMS DRGs and the MS-DRGs was well understood by the public based on the description of each system in the proposed rule. In addition, we made other information available to the public that would allow for a detailed analysis of the MS-DRG proposal as well as the continuing transition to cost-based weights. We made available two MedPAR files (FY 2005 and FY 2006) that included the CMS DRG and MS-DRG assignment for each case. In addition, we made available charge-based, cost-based, and blended weights under the CMS DRGs and the blended weights under the MS-DRGs. With this information, we believe the public had detailed information to be able to do a comprehensive analysis of our proposal to adopt MS-DRGs. We do not believe that there should have been any confusion associated with the publicly requested CMS DRG to MS-DRG crosswalk on the CMS Web site, and we do not see this comment as a reason to delay implementation of the MS-DRGs.

Comment: A number of commenters urged CMS to process more than nine diagnosis and six procedure codes. The commenters stated that this particular concern is more acute with MS-DRGs where a hospital needs to make sure that CMS processes codes that are MCCs and CCs because they determine DRG assignment. The commenters also stated that vendors and health care groups make decisions about quality of care based upon the CMS claim file. The commenters asked CMS to commit to a timeframe when it will revise its systems to accept all 25 diagnosis and procedure codes provided via electronic transmissions.

Response: We recognize the importance of using and analyzing as much clinical data from claims as possible. Unfortunately, current system limitations preclude CMS from processing more than nine diagnoses and six procedures at this time. We will continue to review this matter in conjunction with our other information systems priorities.

Comment: Several commenters stated that ICD-10-CM and ICD-10-PCS would provide a much better foundation for a severity-adjusted DRG system than ICD-9-CM. The value of MS-DRGs or any other severity-adjusted DRG system that relies on claims data will be limited by the continued use of an obsolete, non-specific classification system. ICD-10-CM and ICD-10-PCS would provide greater clinical detail, and up-to-date clinical information for capturing information on disease severity, including complications, comorbidities and risk factors, as well as more detailed information on the use of medical technology and its impact on resource utilization and outcomes. The longer adoptions of contemporary classifications are delayed, the more CMS must develop alternatives that become costly to administer and for providers costly to continually implement.

One commenter stated that, in previous years, the commenter's recognition of the industry's need for consistency in medical coding, improved data integrity, and more precise and contemporary data reflecting 21st century medicine has led it to advocate for adoption and coordinated implementation of ICD-10-CM and ICD-10-PCS in their previous comments on the IPPS. The commenter stated that it is unfortunate that, as new initiatives that rely heavily on coded data gain momentum (such as present on admission reporting, pay-for-performance, and DRG refinements to better recognize severity of illness), ICD-10-CM and ICD-10-PCS still have not been implemented as replacements for ICD-9-CM.

One commenter stated that if the obsolete ICD-9-CM coding system had been replaced earlier, claims data that would significantly add to the knowledge needed to measure severity, quality, and other factors under consideration would now be available. The commenter stated that the proposed MS-DRG system and other proposals in this year's proposed rule are excellent examples of how ICD-10-CM and ICD-10-PCS could improve the ability to refine reimbursement systems in order to better reflect severity of illness. The commenter urged CMS and HHS to take immediate action to secure the adoption and implementation of these two classification systems, and supporting transaction standards as early as possible.

Response: We are continuing to carefully analyze issues associated with implementing ICD-10.

Comment: Several commenters opposed the reuse of the current CMS DRG numbers in the MS-DRG system. Although one commenter acknowledged the advantages of maintaining the current 3-digit numerical scheme, it believed the use of the same DRG numbers in both the CMS DRG and MS-DRG systems will create confusion when analyzing longitudinal data, given the same DRG number will have a different meaning in the two systems. The commenter suggested that delaying implementation of a severity-adjusted DRG system until FY 2009 would allow additional time for making more extensive systems modifications, such as adopting an alphanumeric or 4-digit numerical structure for the new DRG system. Another commenter suggested that CMS begin numbering with a 4-digit number so that there will not be confusion about which system is being used.

Response: We agree that it is beneficial to consider moving to a 4-character nomenclature for MS-DRGs. We have already developed an internal version with four characters, with the fourth character indicating the severity levels. Systems restrictions prevent us from using this 4-character numbering system in Medicare's data systems at this time. However, we will continue to evaluate the possibility of moving to such a numbering system in the future. We do not expect the changes to our data systems that would be necessary to adopt a 4-digit DRG numbering system will occur with a year's delay of the MS-DRGs. Therefore, we do not believe that we should delay the improvements in recognition of severity of illness in our payment system for this reason. If there is public interest, we will make our internal 4-digit numbering system available on the CMS Web site to assist the public in understanding the future numbering system we would be likely to adopt. Such information may also be useful to the public to engage in the types of analysis suggested by this public comment. Start Printed Page 47175

Comment: One commenter stated that the Medicare CMS DRG GROUPER is used by some payers for their commercial, non-Medicare business. The commenter understands that CMS may want to move to MS-DRGs for Medicare patients, but is concerned about its continued access to the current GROUPER program, should Medicare decide to replace CMS DRGs with MS-DRGs. The commenter requested that the existing CMS GROUPER remain intact for commercial insurers to utilize for their non-Medicare contracts. The commenter suggested this could be done by keeping the GROUPER in the CMS database with the title “CMS GROUPER.” The commenter stated CMS would not need to update the weights of the CMS GROUPER or make any other adjustments.

Response: The focus of CMS’ efforts is in developing and maintaining a DRG system that is appropriate for its Medicare population. We have, and will continue to, encourage other payers to make any necessary modifications to this program to meet their needs. The current versions of the CMS DRGs will remain in the public domain. However, we do not intend to make any updates to them once we move to the MS-DRGs or another severity DRG system. We do not believe that Medicare should undertake the effort and expense to maintain and update a DRG system that will have no application for Medicare beneficiaries. We encourage other payers to avail themselves of any DRG logic in our nonproprietary system from past years and use this information as appropriate to develop updates and refinements annually to suit the needs of their own patient populations.

5. Impact of the MS-DRGs

Unlike the CS DRGs we proposed last year for FY 2008, the payment impacts from the MS-DRGs we proposed to adopt (and are finalizing in this final rule with comment period) for FY 2008 would largely be redistributive within each base MS-DRG. Such a result occurs because we collapse the current CC/non-CC, age and other distinctions that exist in the CMS DRGs and redivide them based on MCCs, CCs, and non-CCs. Thus, within each base MS-DRG, some cases will be paid more and some less, but the base MS-DRGs are retained so there is no redistribution between types of cases as would have occurred under the proposed CS DRGs. In the proposed rule, we encouraged readers to review Table 5 in the Addendum to the proposed rule for a list of the proposed MS-DRGs and the proposed respective relative weight from the revisions we proposed to better recognize severity of illness to better understand how payment for cases within each base MS-DRG will be affected.

As indicated above, all of the severity DRG systems being evaluated by RAND can be expected to result in similar redistributions in case-mix among hospitals. The payment models used by RAND and CMS (and RTI as well) all assume static utilization. That is, payment impact models simulate the effects of a change in policy, assuming no change to Medicare utilization. Any system adopted to better recognize severity of illness with a budget neutrality constraint will result in case-mix changes that can be expected to benefit urban hospitals at the expense of rural hospitals. This impact occurs because patients treated in urban hospitals are generally more severely ill than patients in rural hospitals and the CMS DRGs are not currently recognizing the full extent of these differences. Similarly, there will be differential impacts among other categories of hospitals (for example, teaching, disproportionate share, large urban, and other urban hospitals) depending on the mix of cases that each hospital treats. The impact of the MS-DRGs can be expected to have similar effects on case-mix as the DRG systems being analyzed by RAND. These conclusions are confirmed by RAND's analysis earlier in this final rule with comment period as well as the payment impacts we illustrated in the proposed rule and again in this final rule with comment period.

Comment: One commenter believed that a “stop loss” provision should be instituted as part of the transition. Similar to that under the IPF PPS, no hospital can receive less than 70 percent of what they would otherwise have been paid under the old system. Another commenter asked that CMS investigate mechanisms for dampening large payment rate fluctuations.

Response: Changes in payments from MS-DRGs will be mitigated in any single year by adopting them over a 2-year transition period. We believe a 2-year transition period for implementation of the MS-DRGs addresses the concern of these commenters. Further information is provided in section II.E. of the preamble of this final rule with comment period about how MS-DRG relative weights are being determined to reflect implementation over a 2-year period.

6. Changes to Case-Mix Index (CMI) From the MS-DRGs

After the 1983 implementation of the IPPS DRG classification system, CMS observed unanticipated growth in inpatient hospital case-mix (the average relative weight of all inpatient hospital cases), which we use as a proxy measurement for severity of illness. We had projected the rate of growth in case-mix for the period 1981 to 1984 to be 3.4 percent. The realized rate of growth during this period, which included the introduction of the IPPS, was 8.4 percent, a variance in excess of 1.6 percent per year. The unexpected growth in payments was due to increases in the hospital case-mix index (CMI) beyond the previously projected trend. Hospitals’ CMI values measure the expected treatment cost of the mix of patients treated by a particular hospital. There are three factors that determine changes in a hospital's CMI:

(a) Admitting and treating a more resource intensive patient-mix (due, for example, to technical changes that allow treatment of previously untreatable conditions and/or an aging population);

(b) Providing services (such as higher cost surgical treatments, medical devices, and imaging services) on an inpatient basis that previously were more commonly furnished in an outpatient setting; and

(c) Changes in documentation (more complete medical records) and coding practice (more accurate and complete coding of the information contained in the medical record).

We note that changes in patient-mix and medical practice signal real changes in underlying resource utilization and cost of treatment. While these changes may have occurred in response to incentives from IPPS policies, they represent real changes in resource needs. In contrast, changes in CMI as a result of improved documentation and coding do not represent real increases in underlying resource demands. For the implementation of the IPPS in 1983, improved documentation and coding were found to be the primary cause in the underprojection of CMI increases, accounting for as much as 2 percent in the annual rate of CMI growth observed post-PPS.[2]

The Medicare Trustees Technical Review Panel [3] has previously determined the annual measured change in CMI for inpatient hospital services to oscillate around an underlying real trend of 1 percent annual growth. In 1991 the Medicare-specific trend in real CMI growth was found in a then-HCFA Start Printed Page 47176funded study [4] to be within a range of 1 to 1.4 percent. In the annual study conducted by CMS, there has been no evidence to support a real case-mix increase in excess of the annually projected 1 percent upper bound in the period. MedPAC findings have echoed this with its recent study of real case-mix change finding growth rates for years 2002, 2003, and 2004 of 1 percent, 0.6 percent, and 0.4 percent, respectively.[5]

In the proposed rule, we indicated that we believe that adoption of the proposed MS-DRGs would create a risk of increased aggregate levels of payment as a result of increased documentation and coding. MedPAC notes that “refinements in DRG definitions have sometimes led to substantial unwarranted increase in payments to hospitals, reflecting more complete reporting of patients' diagnoses and procedures.” MedPAC further notes that “refinements to the DRG definitions and weights would substantially strengthen providers' incentives to accurately report patients' comorbidities and complications.” To address this issue, MedPAC recommended that the Secretary “project the likely effect of reporting improvements on total payments and make an offsetting adjustment to the national average base payment amounts.” [6]

The Secretary has broad discretion under section 1886(d)(3)(A)(vi) of the Act to adjust the standardized amount so as to eliminate the effect of changes in coding or classification of discharges that do not reflect real changes in case-mix. While we modeled the changes to the DRG system and relative weights to ensure budget neutrality, we are concerned that the large increase in the number of DRGs will provide opportunities for hospitals to do more accurate documentation and coding of information contained in the medical record. Coding that has no effect on payment under the current CMS-DRGs may result in a case being assigned to a higher paid DRG under the proposed MS-DRGs. Thus, more accurate and complete documentation and coding may occur because it will result in higher payments under the MS-DRG system. For the proposed rule, we stated that the potential for more accurate and complete documentation and coding will apply equally under the acute IPPS as well as under the LTCH PPS because the same DRGs are used for both payment systems. However, for reasons explained elsewhere in this final rule with comment period, we are limiting this analysis to the IPPS.

CMS in the past has adjusted standardized amounts under the IRF PPS to account for case-mix increases due to improvements in documentation and coding. In 2004, RAND [7] published a technical report as part of the follow-up to the implementation of the IRF PPS. The initial weights used within the IRF PPS were based on a mix of CY 1999 and CY 1998 data. The study reviewed the changes between this base data set and the IRF PPS implementation year of 2002. The report found that the weight per discharge for IRFs had grown by 3.4 percent between the CY 1999 data set and the CY 2002 data set. In a detailed analysis of both statistical patterns in acute stay records and directly measured coding practices, RAND found that the level of case-mix increase associated with documentation and coding-induced changes in the transition year ranged between 1.9 and 5.8 percent, with the upper end of the estimate associated with real declines in resource use. (We note that RAND revised its report in late 2005 to reflect an upper bound of 5.9 percent, instead of the 5.8 percent that we reported in the FY 2006 IRF PPS proposed and final rules.)

We used the results of this analysis to justify a 1.9 percent adjustment to payment rates for IRFs in FY 2006 (70 FR 47904) and a 2.6 percent adjustment to payment rates for IRFs in FY 2007 (71 FR 48370), for a combined total adjustment of 4.5 percent. The implementation year was marked by the transitioning of hospitals to the IRF PPS payment based on cost reports beginning January 1, 2002, and staggered to October 1, 2002. A combination of increased familiarity with the system by providers and the staggered transition could mean that documentation and coding-induced case-mix change continued as hospitals experienced ongoing changes in the early years of the IRF PPS and as the incentives within the system were more widely recognized. We also recognize that significant changes in IRF patient populations may be occurring as a result of recent regulatory changes, such as the phase-in of the 75-percent rule compliance percentage. We intend to continue analyzing changes in coding and case-mix closely, using the most current available data, as part of our ongoing monitoring of the IRF PPS and, based on this analysis, we intend to propose additional payment refinements for IRFs in the future as the analysis indicates such adjustments are warranted.

Furthermore, as part of our analysis of this issue, we considered the recent experience of the State of Maryland with adopting the APR DRG system. Maryland introduced APR DRGs for payment for three teaching hospitals in 2000. Between State fiscal years (SFYs) 2001 and 2005,[8] the remaining hospitals continued to be paid using modified CMS DRGs. In June 2004, the remaining hospitals were notified that Maryland would expand the use of APR DRGs throughout its all payer charge-per-case system beginning in July 2005. Hospitals in Maryland improved coding and documentation in response to the adoption of APR DRGs. As a result of this improved documentation and coding, reported CMI increased at a greater rate than real CMI. Given the similarity between coding incentives using the APR DRGs in Maryland and the MS-DRGs that are being proposed for Medicare, we analyzed Maryland data to develop an adjustment for improved documentation and coding.

For the Maryland analysis, we assume that, in SFY 2005, those hospitals not already being paid under the APR DRG system began acting as if the transition to the new DRG logic had already taken place. This assumption is supported by the following facts: (a) Maryland hospitals were reporting to the Health Services and Cost Review Commission (HSCRC), Maryland's governing body of its all-payer ratesetting system using the APR DRG GROUPER in 2005; (b) hospitals were provided training in coding under the APR DRG GROUPER; (c) hospitals had access to reports based on APR DRG logic; and (d) hospitals were given large amounts of feedback as to their performance under the GROUPER by the HSCRC relative to peer hospitals.

The incentives for Maryland hospitals are to code as completely and accurately as possible because, beginning in July 2005, all Maryland hospitals were paid using APR DRGs. SFY 2005 was an Start Printed Page 47177important year in Maryland, as it marked the beginning of the 2-year period of transition after which a hospital's revenues were reduced if coding was not as complete as a peer hospital. Under the current CMS DRGs, each secondary diagnosis code is recognized as either a CC or non-CC. Hospitals in Maryland and nationally for Medicare only needed to code one secondary diagnosis as a CC when paid using CMS DRGs for the patient to be assigned to a higher-weighted DRG split based on the presence or absence of a CC. Under the APR DRGs, each secondary diagnosis is designated as minor, moderate, major, or extreme. Under the MS-DRGs, each secondary diagnosis is designated as a non-CC, CC, or MCC. Hospitals in Maryland have incentives under the APR DRGs to code until a case is assigned to the highest of the four severity levels within a base DRG. Under the MS-DRGs, hospitals will have incentives to code until a case is assigned to one of up to three severity levels within a base DRG. Although the APR DRGs and the MS-DRGs may be different, we believe that hospitals have the same incentive under both systems to code as completely as possible. For this reason, we believe that the Maryland experience is a reasonable basis for projecting changes in coding practices for the wider national hospital population for the first 2 years of the MS-DRGs.

We believe the analysis presented below provides a reasonable analysis of the potential growth in CMI due to improved documentation and coding. In addition to the similarity between coding incentives under the proposed MS-DRGs and the APR DRGs, we note that Maryland is an all-payer State; therefore, hospitals are paid by all third party payers—not just the State's Medicaid program—using the APR DRGs. Coding has been very important for each hospital's overall revenue for many years, and the incentives are uniform across all third party payers. The transition to APR DRGs was known well in advance of the actual date and, as stated above, hospitals were provided training in coding under the APR DRGs. It is reasonable to expect that hospitals' experience with improved documentation and coding will occur over a period of at least 2 years. Thus, the experience in Maryland may be similar to expectations for case-mix growth for the nation as a whole. Finally, in reviewing the results from Maryland, we note that three large teaching hospitals began using APR DRGs prior to SFY 2005. These facilities generally treat a wider variety of patients with higher acuity that gives them a greater potential for increasing coding under the APR DRG system than other hospitals throughout Maryland. Because these hospitals were paid using the APR DRGs earlier than other Maryland hospitals, we believe data for these hospitals need to be analyzed from an earlier time period. However, based on the consultations with the HSCRC, we believe there were special issues with one of these hospitals that may have made its case-mix growth during the early years of the transition to the APR DRGs atypical of the other teaching hospitals.[9] Therefore, we did not separately analyze the data for this hospital from the earlier time period and, as stated below, included its data with the rest of the Maryland hospitals.

As part of its contract with CMS, 3M Health Information Systems reviewed the Maryland data in the context of our proposed changes to adopt MS-DRGs. 3M grouped Medicare cases in Maryland through both the CMS DRGs Version 24.0 and the proposed MS-DRGs for FY 2008. At our request, 3M deleted two of the three early transition hospitals from the data. It compared the results of the observed growth in case-mix from these data to the same process applied to Medicare data, excluding Maryland hospitals.

The MedPAR data file for Federal fiscal year (FFY) 2006 (October 2005 through September 2006) was used to create relative weights for both CMS DRG Version 24.0 and the MS-DRGs. The MedPAR data file contained 12,794,280 records. In constructing the weights, the following edits were used:

  • Cases with zero covered charges or length of stay were excluded.
  • Cases with length of stay greater than 2 years were excluded.
  • Only hospitals contained in the impact file for the FY 2007 IPPS final rule were included.

The latter criterion excluded providers reimbursed outside of the IPPS, including Maryland hospitals, from the weight calculation. 3M employed standardized charge-based relative weights developed in accordance with the CMS methodology. Cost-based weights were not used and no adjustment to the charge weights was made for application of CMS transfer and postacute care transfer payment policy.

3M further grouped 2 years of MedPAR data from FY 2004 and FY 2005, using CMS DRG Version 24.0 and the MS-DRGs for hospitals nationally. Using 2 years of MedPAR data with one version of each DRG system further required 3M to make adjustments to the data to reflect revisions to ICD-9-CM codes that are made each year. MedPAR data for Maryland IPPS acute care providers within the IPPS data set were similarly assigned to the MS-DRGs and CMS DRGs for FYs 2004 through 2006.

Each Maryland record, exclusive of the two early transition teaching hospitals for the 3 observed years (SFY 2004 to SFY 2006), was assigned to a proposed MS-DRG based on the ICD-9-CM codes the hospital submitted. The same results were obtained from data at the national level using the MS-DRGs. Further, we obtained data from the HSCRC showing the weighted average increase in case-mix for calendar years 2001 to 2003 for the two large academic medical centers that began an early transition to the APR DRGs. In addition, we also obtained case-mix increases under the CMS DRGs for FYs 2004 through 2006. The Medicare Actuary examined the data below:

Start Printed Page 47178

Table R.—Maryland and National Data Used for Case-Mix Adjustment Analysis

FY 2004 to 2005 (percent)FY 2005 to 2006 (percent)FY 2004 to 2006 (percent)
Rest of Maryland MS-DRG CMI Δ2.302.574.93
CY 2000 to FY 2003
Early Transition Hospitals4.46.711.4
National MS-DRG CMI Δ0.472.653.13
National CMS DRG CMI Δ−0.041.201.16
Blend of MS-DRG CMS DRG Δ using 0.47 Percent for 2005 and 1.2 Percent for 20061.68
Difference between Maryland Early Transition Hospitals and National Data9.58
Difference between Rest of Maryland and National Data3.20
Medicare Actuary Estimate (75%/25%) Δ between Early Transition and Rest of Maryland4.8

The data above show that case-mix for hospitals increased by 4.93 percent from SFYs 2004 to 2006, during which Maryland adopted the APR DRGs for most hospitals. Case-mix for the two large teaching hospitals that were paid using the APR DRGs earlier than other hospitals in the State increased by 11.4 percent from SFYs 2001 to 2003. The weighted average increase in Maryland from these two categories of hospitals is 5.58 percent. Case-mix using the MS-DRGs would have increased 0.47 percent in FY 2005 and 2.65 percent in FY 2006. Nationally, Medicare case-mix using the CMS DRGs decreased by 0.04 percent in FY 2005 and increased by 1.2 percent in FY 2006. The Actuary calculated a Medicare case-mix increase nationally over 2 years using a blend of these data from the MS-DRGs for FY 2005 and national Medicare data for FY 2006 from the CMS DRGs. The Actuary did not use either the −0.04 percent for the CMS DRGs or the 2.65 percent for the MS-DRGs to create this blended case-mix because these figures appeared atypical to national trends. Therefore, the Actuary dropped one atypically high and low number from each of the 2 years of data and calculated an average increase of 1.68 percent from FY 2004 to FY 2006. These data demonstrate that the measure of average CMI for Medicare cases is growing more rapidly within Maryland than nationally. Case-mix for the Maryland teaching hospitals and the rest of Maryland increased 9.58 percent and 3.20 percent more, respectively, than the national average over 2 years, suggesting that improved documentation and coding lead to perceived, but not real, changes in case-mix.

The Actuary noted that the case-mix increase in Maryland for two large teaching hospitals over a 2-year period was much higher in the early years of the APR DRGs than other Maryland hospitals (11.4 percent compared to 4.93 percent for the rest of Maryland). Further, teaching hospitals generally treat cases with higher acuity than other hospitals and have more opportunity to improve coding and documentation to increase case-mix than other hospitals. Teaching hospitals also represent a higher proportion of national Medicare data than they do of the data in Maryland. The two early transition teaching hospitals in Maryland account for approximately 10 percent of the Medicare discharges in Maryland. Nationally, teaching hospitals account for approximately 50 percent of Medicare discharges. Therefore, the Actuary believes that the teaching hospitals should be given a higher weight in the national data than they represent in Maryland. However, like other hospitals, teaching hospitals vary in size and patient mix and not all have the same opportunity to improve documentation and coding. Therefore, we believe the weight given to teaching hospitals should be higher than the 10 percent for the two early transition hospitals in Maryland but lower than the 50 percent of discharges that they account for in Maryland. The Actuary gave a weight of 25 percent for teaching hospitals and 75 percent for the rest of Maryland to the excess growth in case-mix over the national average and estimates that an adjustment of 4.8 percent will be necessary to maintain budget neutrality for the transition to the MS-DRGs. This analysis reflects our current estimate of the necessary adjustment needed to maintain budget neutrality for improvements in documentation and coding that lead to increases in case-mix. Consistent with the statute, we will compare the actual increase in case-mix due to documentation and coding to our projection once we have actual data to revise the Actuary's estimate and the adjustment we make to the standardized amounts.

Based on the Actuary's analysis, using the Secretary's authority under section 1886(d)(3)(A)(vi) of the Act to adjust the standardized amount to eliminate the effect of changes in coding or classification of discharges that do not reflect real changes in case mix, we proposed to reduce the IPPS standardized amounts by 2.4 percent each year for FY 2008 and FY 2009. We indicated that we were considering proposing a 4.8 percent adjustment for FY 2008. However, we believed it would be appropriate to provide a transition because we would be making a significant adjustment to the standardized amounts. In the proposed rule, we expressed interest in receiving public comments on whether we should apply the proposed adjustment in a single year, over 2 years, or in different increments than 1/2 of the adjustment each year. Section 1886(d)(3)(A)(vi) of the Act further gives the Secretary authority to revisit adjustments to the standardized amounts for changes in coding or classification of discharges that were based on estimates in a future year. Consistent with the statute, we will compare the actual increase in case mix due to documentation and coding to our projection once we have actual data for FY 2008 and FY 2009 for the FY 2010 and FY 2011 IPPS rules. At that time, if necessary, we may make a further adjustment to the standardized amounts to account for the difference between our projection and actual data.

Comment: Many commenters opposed the documentation and coding adjustment, which they believed would reduce payments to hospitals by $24 billion over the next 5 years. The commenters did not believe this reduction is warranted. They suggested the adjustment for documentation and coding is a “backdoor attempt” to reduce Medicare's inpatient hospital payments. One commenter stated that the documentation and coding Start Printed Page 47179adjustment would result in a total estimated reduction in payment for Pennsylvania hospitals of $67.5 million in FY 2008, and an estimated $1.6 billion over the next 5 years. The commenter stated that such reductions and attempts at backdoor budget cuts would only further erode scarce resources and challenge hospitals in their ability to care for patients. The commenter stated that until MS-DRGs are fully implemented, and CMS can document and demonstrate that any increase in case-mix results from changes in coding practices rather than real changes in patient severity, there should be no documentation and coding adjustment.

Response: We stress that there are no savings attached to this adjustment. This adjustment is not a “backdoor” attempt to reduce Medicare inpatient hospital payments. Without a documentation and coding adjustment, the changes to MS-DRGs would not be budget neutral. Substantial evidence supports our conclusion that the CMI will increase as a result of adoption of MS-DRGs without corresponding growth in patient severity. We have provided evidence from studies going back over 20 years that show that hospitals respond to incentives when payment classifications are changed to improve documentation and coding to receive higher payments. Maryland provides a recent example demonstrating the validity of the finding that hospitals respond to changes in payment classification groups by changing documentation and coding practices. Furthermore, we are not aware of a situation in which a new or revised payment system provided a payment incentive to improve documentation and coding, yet hospitals did not improve documentation and coding.

Comment: Many commenters stated that the documentation and coding adjustment is based on assumptions made with little to no data or experience about how medical record documentation and coding practices will change as a result of the implementation of MS-DRGs. One commenter stated that the proposed adjustment has no basis in actual data or research pertaining to inpatient hospital coding practices. One commenter objected to the −2.4 percent adjustment for documentation and coding stating it could not understand the proposal and noted that the hospitals are utilizing the coding system that the Department of Health and Human Services has created. The commenter stated that if, in fact, the new severity DRGs were designed to better recognize the resources needed to treat the various DRG conditions, the argument can be made that CMS has been underpaying institutions for over 20 years. Other commenters objecting to the documentation and coding adjustment further indicated that hospitals have operated under the current DRG system for 23 years and hospitals are already expert in their ability to maximize coding for payment. These commenters stated that not even in the initial years of the IPPS was coding change found to be in the magnitude of CMS’ proposed FY 2008 and FY 2009 cuts. The commenters stated that the proposed MS-DRGs would be a refinement of the existing system; the underlying classification of patients and “rules of thumb” for coding would be the same. They stated that there is no evidence that an adjustment of 4.8 percent over 2 years is warranted when studies by RAND, cited in the preamble, are looking at claims between 1986 and 1987 at the beginning of the IPPS that showed only a 0.8 percent growth in case-mix due to coding. The commenters stated that even moving from the original reasonable cost-based system to a new patient classification-based PPS did not generate the type of coding changes CMS contends will occur under the MS-DRGs.

Many commenters disagreed with the applicability of generalizing from the experience in Maryland to Medicare. One commenter indicated that MS-DRGs and APR DRGs are two completely different ways to classify patients, and generalizing from one system to the other cannot be done. The existing classification rules will change only marginally with the introduction of MS-DRGs, whereas they are very different under the APR DRG system. Differences include:

  • APR DRGs consider multiple CCs in determining the placement of the patient and, ultimately, the payment. In fact, to be placed in the highest severity level, more than one high-severity secondary diagnosis is required.
  • APR DRGs consider interactions among primary and secondary diagnoses. Thus, factors that increase the severity level for a case under the APR DRGs will not occur under the MS-DRGs.
  • APR DRGs consider interactions among procedures and diagnoses as well. MS-DRGs do not.
  • APR DRGs have four severity subclasses for each base DRG, while MS-DRGs have three tiers, and this is only for 152 base DRGs—106 base DRGs only have two tiers and 77 base DRGs are not split at all.
  • Less than half the number of patient classifications in the MS-DRG system are dependent on the presence or absence of a CC—410 for MS-DRGs versus 863 for APR DRGs.

The commenters believed that all of these differences make the Maryland experience an invalid comparison. They suggested there is significantly less possibility for changes in coding to affect payment under the MS-DRGs.

Another commenter indicated that the CMS analysis is not applicable to Medicare because Maryland hospitals were not paid using a DRG system prior to APR DRG implementation. DRG data were collected for statistical purposes, but DRGs were not used for reimbursement. The commenter added that coding practices under APR DRGs are not necessarily comparable to MS-DRGs because they were not designed for reimbursement purposes. Further, the commenter found that the system logic is not always consistent with nationally recognized coding rules and guidelines, resulting in possible changes in coding practices that do not necessarily represent improved coding. The commenter stated that hospitals have little ability to change their classification and coding practices. Another commenter stated that Maryland's hospitals were paid prior to the APR DRGs under a State ratesetting system where an incentive to code accurately did not significantly affect what a hospital was paid. The commenter stated that APR DRGs are also much more complicated than MS-DRGs. The commenter stated that generalizing the Maryland experience to the rest of the nation's hospitals is an “apples to oranges” comparison.

One commenter also disagreed with CMS’ use of the example of the IRF PPS to justify the coding adjustment. The commenter believed that the IRF experience is an inappropriate comparison. The commenter stated that coding changes seen under the IRF PPS were the result of moving from a cost-based system to a PPS, not the marginal difference of moving from the existing CMS DRGs to the refined MS-DRGs. In addition, coding under the IRF PPS is driven by the Inpatient Rehabilitation Patient Assessment Instrument (IRF-PAI). This tool provides an incentive for IRFs to code in a way that differs from the IPPS, which does not utilize a patient assessment instrument. The commenter believed that coding for the IRF-PAI differs significantly from the longstanding coding rules that inpatient PPS hospitals have followed for the following reasons:

  • The IRF-PAI introduced a new data item into coding—namely, “etiological Start Printed Page 47180diagnosis.” The definition of this new diagnosis and the applicable coding rules are significantly different than the “principal diagnosis” used to determine the DRG. More importantly, the Official Coding Guidelines that apply to all other diagnostic coding do not apply to the selection of the ICD-9-CM etiologic diagnoses codes.
  • The Official Coding Guidelines do not consistently apply to the coding of secondary diagnoses on the IRF-PAI. Several different exceptions to the guidelines have been developed by CMS for the completion of the IRF-PAI.
  • The definition of what secondary diagnoses may be appropriately reported differs under the IRF-PAI from the definition used by other inpatient coders.
  • Most hospitals are already coding as carefully and accurately as possible because of other incentives in the system to do so, such as risk adjustment in various quality reporting systems. Analysis of Medicare claims from 2001 to 2005 suggests that hospitals have been coding CCs at high rates for many years. More than 70 percent of claims already include CCs, and more than 50 percent of claims have at least eight secondary diagnoses (the maximum number accepted in Medicare's DRG GROUPER). Hospitals” assumed ability to use even more CCs under MS-DRGs is very low.

The commenter also indicated that according to an article in the magazine Healthcare Financial Management, the level of coding on claims suggests that the presence of a CC on a bill is not strongly influenced by financial gain. The proportion of surgical cases with a CC code is higher for cases where there is no CC split and, thus, no financial benefit, than on those cases where there is a CC split and a corresponding higher payment. Thus, coding is driven primarily by coding guidelines and what is in the medical record rather than by financial incentives according to this commenter. In addition, the commenter believed that many cases simply do not have additional CCs to be coded. For many claims, additional codes are simply not warranted and not supported by the medical record. Therefore, there is no opportunity for a coding change to increase payment.

The commenter analyzed the all-payer health care claims databases from California, Connecticut, Florida, and Michigan because, unlike the MedPAR files, these databases include all 25 diagnoses reported on the claims. This analysis showed that only 0.25 percent of claims had an MCC or CC appear for the first time in positions 10 through 25. The commenter believed this strongly suggests that hospitals will not be able to “re-order” their secondary diagnoses to appear higher on the claim so that Medicare will pay a higher rate. The commenter's coding experts note that most hospitals use software that automatically re-sorts the secondary diagnoses to ensure that those pertinent to payment are included in positions two through nine.

The commenter also examined secondary diagnosis codes and found that there were relatively few non-specific codes listed among the common secondary diagnoses of discharges without a MCC/CC. The commenter believed that this means hospitals cannot shift large numbers of discharges to MCCs or CCs based on coding a more specific code to replace a nonspecific code.

The commenter further indicated that there is no opportunity for increased payment due to a change in coding for 77 base DRGs under the MS-DRG system, as there is only one severity class and no differentiation in payment. Additionally, there are MS-DRGs that are now split between “with MCC” and “without MCC” (a combined non-CC and CC MS-DRG) that have historically contained a single CC/non-CC split. These DRGs already required secondary diagnosis coding; thus, the codes to qualify the case as an MCC already would have been present. In these cases, it is very unlikely that the medical record would justify an MCC that is not already present in the medical record. Coders must code strictly based on what the physician notes in the chart. Therefore, the commenter believed it is highly unlikely that a coder will be able to select an MCC that was not previously present in the medical record.

One commenter stated that case-mix will and should increase from adoption of the MS-DRGs. According to the comment, changes in case-mix due to improved accuracy in documentation and coding have been observed since the introduction of DRG payments in 1983. These changes have occurred in every refinement of every classification system across every care setting. The commenter stated that changes are driven primarily by the fact that documentation and numbers of diagnoses coded is inevitably incomplete due to time pressures for completion of paperwork and limitations of computer systems to identify this information. If an item is not used and/or not important, it is less well documented. Refinements in patient classification make certain paperwork more important, encouraging providers to improve their documentation and reporting accuracy. This, in turn, increases apparent case mix that depends on these codes according to this commenter. The commenter stated that coding changes that affect CMI are desirable in the long run, since they represent more accurate data and evidence-based care, payments, quality measurement, management decisions, and policy are all enhanced. This increase in accuracy is not only desired, it is necessary to truly reform health care (severity adjusted payments, quality measurement and reporting, value based-purchasing, among others), where “bad data” is frequently cited as an excuse to defer reform efforts. This commenter stated that it is impossible to accurately predict the total magnitude and timing of case-mix changes. Every hospital will have their own documentation and coding accuracy baseline, and their own real CMI based on accurate data for their patient mix. Each will have a different commitment to increasing their accuracy, resources to do so, and learning curve for implementation. The commenter believed that, like any prediction of the future, it will inevitably be wrong, particularly due to its complexity.

Response: Many of the commenters ascribed the term “behavioral offset” to our proposed rule and believed that CMS was pejoratively describing hospital motives. We note that we did not use the term “behavioral offset” to describe the proposed −2.4 percent adjustment to IPPS rates for FYs 2008 and 2009 for changes in documentation and coding. We regret that the term “behavioral offset” has been attributed to us. The proposed rule uses the phrase “documentation and coding adjustment” to refer to the proposed −4.8 percent (−2.4 percent each year for FYs 2008 and 2009) adjustment to the IPPS standardized amounts to maintain budget neutrality for the MS-DRGs consistent with the statute. Further, we believe it is important to address the notion in some of the public comments that CMS believes changes in how services are documented or coded that is consistent with the medical record is inappropriate or otherwise unethical. We do not believe there is anything inappropriate, unethical or otherwise wrong with hospitals taking full advantage of coding opportunities to maximize Medicare payment that is supported by documentation in the medical record. In its public comments, MedPAC recommended an adjustment for improvements in documentation and coding and also noted that hospitals' efforts to improve the specificity and Start Printed Page 47181accuracy of documentation and coding are perfectly legitimate.[10]

We encourage hospitals to engage in complete and accurate coding. Section 1886(d)(3)(A)(vi) of the Act authorizes the Secretary to adjust the standardized amount so as to eliminate the effect of changes in coding or classification of discharges that do not reflect real changes in case-mix. In its public comments, MedPAC indicated that the increases in payments that result from improvements in documentation and coding are not warranted because the increase in measured case-mix does not reflect any real change in illness severity or the cost of care for the patients being treated. Therefore, offsetting adjustments to the PPS payment rates are needed to protect the Medicare program and those who support it through taxes and premiums from unwarranted increases in spending.[11]

In response to the comment that stated, “moving from the original reasonable cost-based system to a new patient classification-based PPS did not generate the type of coding changes CMS contends will occur under the MS-DRGs,” we believe the estimates for improvements in documentation and coding are within the range of those projected under the original IPPS. As stated above, for the implementation of the IPPS in 1983, RAND found that improved documentation and coding were found to be the primary cause in the underprojection of CMI increases, accounting for as much as 2 percent in the annual rate of CMI growth observed post-PPS.[12] This study found a 2 percent annual change in case-mix from improvements in documentation and coding during the original adoption of the IPPS, while we are forecasting a 4.8 percent total increase due to the MS-DRGs. MedPAC's public comments citing a study in Health Affairs found that the original adjustment for anticipated increases in case mix due to documentation and coding “were substantially smaller than the actual change in case mix which increased more than 7 percent from the pre-PPS period to the first full year of the PPS system.” [13] MedPAC further noted that CMI increases due to improvements in documentation can be expected to occur over many years. It stated that the Prospective Payment Assessment Commission (a predecessor of MedPAC) considered case-mix change in developing its annual update recommendations to the Congress and made offsetting adjustments for continuing coding improvements for 10 consecutive years from 1986 to 1995.[14] For these reasons, we disagree with the comment that our forecast of changes in case-mix from improvements in documentation and coding are not within the range of those projected when the original IPPS was implemented.

With respect to comments about the use of the APR DRG system in Maryland to forecast an adjustment for improvements in documentation and coding for Medicare, we agree that there are differences between the APR DRGs being used in Maryland and the MS-DRGs being proposed for use by Medicare. We believe that coding incentives in Maryland under the APR DRGs and nationally under the MS-DRGs are similar, not identical. The Maryland experience provides a useful example to forecast the potential increase in case mix from improvements in documentation because it is a recent and similar change to what we plan to adopt for Medicare. Although the APR DRGs and the MS DRGs may be different, we believe that hospitals have the same incentive under both systems to code as completely as possible. Moreover, as explained above, we estimated CMI growth using the MS DRG and CMS DRG GROUPERs, not APR DRG GROUPER. We used Medicare claims from Maryland hospitals for our analysis, but we grouped the claims under the CMS DRG GROUPER and proposed MS DRG GROUPER.

For these reasons, we continue to believe that the Maryland experience is a reasonable basis for projecting increased case mix in the wider national hospital population for the first 2 years of the MS-DRGs. MedPAC supported using the Maryland experience to forecast potential increases in case mix by stating: “The case-mix reporting changes that occurred in Maryland-when that state adopted APR DRGs in its all payer rate-setting system—provide one of the few recent benchmarks for comparison outside of Medicare's historical experience.” [15]

The reference to the IRF PPS was not intended to suggest that we used the experience with that system to forecast a potential adjustment under the IPPS. Rather, we were merely noting that the adoption of a PPS system for IRFs also produced an increase in case-mix as a result of the new incentives presented by going to a different payment system. The example suggests that there is strong evidence that hospitals—whether they are IRFs, acute care IPPS hospitals, or LTCHs—respond to coding incentives presented by their respective payment systems and will react accordingly. MedPAC's public comments also supported this point. In its public comments on the FY 2008 IPPS proposed rule, MedPAC stated that there were increases in case mix with the introduction of prospective payment systems for IRFs and LTCHs.[16]

The comments about reordering of codes and substituting specific codes for nonspecific codes suggests that hospitals are already maximizing coding opportunities and there is no further changes they can make that would result in an increase in Medicare payment. With respect to reordering of codes, the commenter argues that MCCs and CCs will already be found in the first 9 fields on the Medicare claim and the codes that are stored or processed from fields 10 to 25 cannot be moved up higher on the claim to increase payment. While this public comment suggests that there will be no opportunity to increase case mix by moving secondary diagnoses higher on a claim, another public comment provided a specific estimate of how much this practice could increase case-mix. The commenter examined data from New York State discharges and indicated that if MCC and CC codes that are currently provided beyond the original 9 diagnoses on the claim that are used by Medicare are moved to the first 9 positions, case mix would increase by 0.5 percent. This reaffirms CMS' views that hospitals focus their documentation and coding efforts to maximize reimbursement. Again, we believe these examples provide evidence from the public comments supporting the necessity for us to apply an adjustment for documentation and coding to meet the requirements of the law. Start Printed Page 47182

We believe increases in case-mix do not only have to come from moving codes higher on the claim. A hospital can merely change the order of a principal and secondary diagnosis for closely related conditions to affect payment. The selection of a principal diagnosis that was previously coded as secondary can increase hospital payment. Again, we found a public comment suggesting that reordering of principal and secondary diagnoses can increase case mix. The commenter stated some DRG groups only count a code in “the primary position while others only count a code in a secondary position.” The commenter is noting that many DRGs are split based on the presence or absence of an MCC or CC as a secondary diagnosis. According to the commenter, many Medicare patients have multiple conditions occasioning their admission, suggesting that reordering the principal and secondary diagnosis codes can result in an increase in case-mix.

We also disagree with the comments suggesting that hospitals do not have the opportunity to substitute a specified for an unspecified code to increase case mix. In fact, we believe these incentives will be very strong under the MS-DRGs with the reclassification of many unspecified codes as non-CCs. Again, we found statements in the public comments that support the notion that hospitals will have opportunities to substitute a specified for an unspecified condition to increase case-mix under the MS DRGs. One commenter indicated that the CC list revisions encourage coding of more detailed codes and estimates that switching from “not otherwise specified” codes to detailed codes could increase case mix by 0.5 percent. Another commenter states: “The most dramatic example is ICD-9-CM code 428.0, Congestive heart failure, unspecified, which was applied to an average of 2.3 million Medicare fee-for-service cases a year during the past three years. This was the most widely used secondary diagnosis code, despite the fact that 12 more specific codes were added in FY 2003 * * * if the revised CC list were implemented before hospitals had a chance to improve their coding to accommodate the revisions, then case-mix creep and inpatient prospective payment system (IPPS) overpayments would ensue.”

We further note that many of the public comments arguing against the documentation and coding adjustment also request a year's delay in implementation of the MS-DRGs so “hospitals may focus on understanding the impact of the revised CC list, training and educating their coders, and working with their physicians for any documentation improvements required to allow the reporting of more specific codes where applicable.” We believe this comment provides a strong indication that, even though many public commenters themselves argue against the need for the documentation and coding adjustment, the same commenters would like a year's delay to take the very actions that they say make an adjustment unnecessary. The MS-DRGs are not making any changes to ICD-9-CM codes. While the MS-DRGs do include some consolidations of base DRGs, the major changes from the current DRGs simply involve adding severity levels to many of the new MS-DRGs. The move to MS-DRGs will not necessitate additional data elements or changes in reporting practices. Therefore, hospitals may continue to document and code as they do currently to be paid by Medicare under the MS-DRGs. The only reason hospitals would need a delay in the MS-DRGs is to have more time to understand how their revenues are affected by coding under the new DRG system. In our view, there is a clear indication in these comments that hospitals will change their documentation and coding practices and increase case mix consistent with the payment incentives that are provided by the MS-DRG system.

As further evidence that documentation and coding practices are affected by payment, we note a recent article in the Journal of AHIMA (American Health Information Management Association) which discusses methods for improving clinical documentation in order to increase reimbursement. The article describes a program at a hospital utilizing clinical documentation specialists that work on the hospital treatment floors to encourage improvements in clinical documentation. The article states that one year after implementing the program, the hospital gained an additional $1.5 million in reimbursement. In the second year, the hospital gained $900,000. The article reports a similar program at another hospital where the “the academic hospital was overly conservative in its coding practices and “leaving money on the table.’ ” [17] These examples provide strong support for concluding that there were opportunities under the current CMS DRGs to improve coding and increase payment. With incentives changing under the MS-DRGs, we believe there will be additional opportunities to improve documentation and coding. We believe this article supports our contention that hospital coders and physicians will respond to incentives available under MS-DRGs by improving documentation and coding to increase case-mix.

Comment: One commenter stated that the ICD-9-CM Official Guidelines for Coding and Reporting and the American Hospital Association's Coding Clinic for ICD 9-CM provide official industry guidance on complete, accurate ICD-9-CM coding, without regard to the impact of code assignment on reimbursement. AHIMA's Standards of Ethical Coding stipulate that “coding professionals are expected to support the importance of accurate, complete, and consistent coding practices for the production of quality healthcare data.” The commenter believed that all diagnoses and procedures should be coded and reported in accordance with the official coding rules and guidelines and does not advocate the practice of only coding enough diagnoses and procedures for correct DRG assignment. The commenter stated that increased attention to the quality of coding and documentation as a result of the role coding plays in DRG assignment has led to much-improved coding practices since the adoption of the IPPS in 1983. The commenter further noted that hospitals code more completely so CMS has more complete data to make DRG modifications that would recognize the resource-intensiveness of a diagnosis or procedure.

Response: We believe the commenter's assertion supports our point that improvements in documentation and coding occurred as a result of the payment incentives provided by the IPPS. That is, the commenter is saying that the adoption of the original IPPS in 1983 led hospitals to improve documentation and coding practices because “of the role coding plays in DRG assignment.” The commenter believed that MS-DRGs will not lead to changes in documentation and coding practices and cites—among other sources—AHIMA's Standards of Ethical Coding. AHIMA is a professional association representing more than 51,000 health information professionals who work throughout the healthcare industry whose work is closely engaged with the diagnosis and procedure classification systems that serve to create the DRGs. The article cited above from the July-August issue of the Journal of AHIMA provided documented examples of how hospitals can change coding practices to maximize payments. Thus, there is an Start Printed Page 47183assertion in this comment that official coding rules and guidelines require all diagnoses and procedures to be reported on the claim minimizing opportunities for changes in documentation and coding to increase case mix. However, AHIMA's own professional journal provides strong evidence of opportunities that exist for improvements in coding to increase payment. As we stated previously and suggested by the article in the Journal of AHIMA, we believe that payment incentives lead hospital staff to carefully examine documentation and coding practices, work with physicians to improve the precision of clinical documentation in order to make subsequent changes in coding.

Comment: A number of commenters requested that CMS not make the documentation and coding adjustment until hospitals have had experience with the MS-DRGs. Once the MS-DRGs are fully implemented, the commenters indicated that CMS can investigate whether payments have increased due to coding rather than the severity of patients and determine if an adjustment is necessary. Several commenters stated that CMS is not required to make a prospective adjustment to IPPS rates to account for improvements in documentation and coding and should not do so without an understanding of whether there will even be coding changes in the first few years of the refined system. Another commenter stated that CMS should retrospectively determine the national rate reduction to offset increases in case-mix from improvements in documentation and coding even though the reduction would be made to future rates and would not account for potential increases in payment that would occur until the adjustment is made. The commenter indicated that section 1886(d)(3)(A)(vi) of the Act authorizes just such an adjustment and it is the only way to ensure that the level of the reduction is accurate. All of these commenters argued that CMS can always correct for additional payments made as a result of coding changes in a later year when there is sufficient evidence and an understanding of the magnitude.

One commenter suggested that CMS defer (but not eliminate) adjustments for improvements in documentation and coding. This commenter suggested that CMS make the adjustment at a later time when there is actual data suggesting how much improvements in documentation have increased case mix but that we consider a “stop loss” if initial coding changes appear to far exceed the current 4.8 percent estimate. The commenter indicated that CMS should encourage facilities to improve their documentation and coding accuracy sooner (that is, prior to adjusting for documentation and coding), and not do any MCC/CC consolidations until after coding improvements have occurred (that is, have 3 severity levels for all DRGs).

Another commenter noted that RAND's evaluation of alternative severity DRG systems included an assessment of how coding behaviors are expected to vary under each system. However, RAND did not evaluate the MS-DRGs and further noted that it was not able to empirically assess the relative risk the alternative severity-adjusted systems pose for case mix increases attributable to coding improvement without having the opportunity to observe actual changes in coding behavior when a DRG system is used for payment. The commenter did not believe any payment adjustment to account for case mix increases, which are attributable to coding improvements, should be made until CMS has conducted appropriate research to determine the extent to which improvements in coding becomes an issue under the proposed MS-DRG system. While the design of the MS-DRG system may encourage an increased level of coding specificity, the commenter stated that it is unknown what effect, if any, this might have on the CMI.

Response: RAND did not repeat the analysis of the potential for documentation and coding improvements to increase case mix using the MS-DRGs because it only worked with FY 2005 data to evaluate them. The RAND report refers readers to the analysis CMS did of the likely impact of documentation and coding improvements on case mix using the MS-DRGs.[18]

With respect to delaying making any adjustments for documentation and coding, the commenters are correct that section 1886(d)(3)(A)(vi) of the Act gives the Secretary authority to revisit adjustments to the standardized amounts for changes in coding or classification of discharges that were based on estimates in a future year. We also note that section 1886(d)(4)(C) of the Act requires that “changes in classifications or weighting factors” not increase or decrease aggregate inpatient hospital payments. We believe that Congress has expressed its clear preference that all changes to DRG reclassifications be budget neutral. Substantial evidence indicates that, unless we make an adjustment to account for improvements in documentation and coding, aggregate payments under the IPPS will increase when we adopt MS-DRGs as a result of these improvements in documentation and coding. Further, as discussed above, the independent Office of the Actuary validated the −1.2 percent adjustment to the standardized amount to ensure that improvements in documentation and coding do not increase case-mix and IPPS payments.

In addition, by revisiting the adjustment at a later date when we have actual data, we can ensure that the standardized amounts are permanently set at the level they otherwise would have been had the increase in case mix due to improvements in documentation and coding been known. That is, any overestimate or underestimate of the adjustment for improvements in documentation would not be permanently embedded in the IPPS standardized amount for subsequent years. While any differences between projected and actual data could result in higher or lower payments to hospitals for the intervening years, MedPAC believes that CMS should provide an adjustment that lies somewhere in the middle of its own estimate of 2.0 percent and CMS' estimate of 4.8 percent. In its comments, MedPAC recommended that CMS should adopt an adjustment for improvements in documentation and coding between 1.6 and 1.8 percent per year that would “put both Medicare and the hospital industry at some risk that the actual value will turn out to be higher or lower than the adjustment that is applied.” [19]

Comment: Several commenters agreed with RAND's assertion that the magnitude of coding improvement is likely to vary across hospitals, depending on how strong their current coding practices are and the resources they are able to devote to improving them. One commenter stated that the hospitals that already use the more specific codes and those with a low proportion of cases in split DRGs would receive fewer, if any, overpayments because their case mix indices would not increase as much, or at all. The commenter stated that New York hospitals, in particular, would have less opportunity for coding improvement than other hospitals because the union of the Medicare CC list and the New Start Printed Page 47184York State CC list has 279 more codes than the Medicare CC list alone. Thus, moving from the union of the CC list to the revised CC list would add only 1,298 codes, 279 fewer codes than in the rest of the country. Furthermore, New York hospitals are well-practiced in using specific codes because the New York State AP-DRG grouper differentiates between CCs and major CCs, as the MS-DRG grouper would do. This commenter and others that cited the RAND study agree that CMS' practice of making an across-the-board adjustment to PPS payments to address case mix increases attributable to coding improvements raises an equity issue that CMS needs to consider. The adjustment to the standardized amount for documentation and coding for hospitals that have already improved coding would result in significant payment losses according to the commenter rather than offsetting higher case mix indices. The commenter stated that these changes are not uniform, creating unintended distributional impacts. The commenter stated that the process to make adjustments for documentation and coding is an across the board adjustment to the standardized amount, while actual changes will vary widely. This will create unintended distributional impacts across patient types, providers, and states that will in turn, according to the commenter, create push-back in providers, states, Congress, and potentially the courts.

One of these commenters acknowledged that CMS may not have the option to recoup overpayments on a hospital-specific basis, as is done in New York. The commenter suspected that the proposed documentation and coding adjustment is too high because hospitals in other states—particularly New York—have more experience with secondary diagnosis coding than the Maryland hospitals had before their change to APR DRGs. Therefore, hospitals in other states probably have less opportunity to generate documentation and coding improvements that increase case mix.

Response: We agree that completeness of hospital coding practices may well vary across hospitals. Although we recognize this variability, we believe there will be potential for coding improvements to increase case mix for all hospitals. For instance, as noted above, a hospital can change the order of a principal and secondary diagnosis for closely related conditions to affect payment. The selection of a principal diagnosis that was previously coded as secondary can increase hospital payment. This type of potential coding change to increase case mix could be available to all hospitals irrespective of whether or not they maximized coding in the past. As noted above, a commenter examined data from New York State discharges and indicated that if MCC and CC codes that are currently provided beyond the original 9 diagnoses on the claim that are used by Medicare are moved to the first 9 positions, case mix would increase by 0.5 percent. Thus, this comment indicates that there will be at least some opportunity to increase case mix through improvements in documentation and coding in States like New York that have used sophisticated DRG systems in the past for payment. Similarly, there are public comments suggesting hospitals can select a specified condition in place of an unspecified one to increase payment under the MS-DRGs but that this change in documentation and coding practice will not be applicable in areas of the country where a DRG system is in use that distinguishes between MCCs and CCs. As noted above, congestive heart failure, unspecified appears on an average of 2.3 million cases per year from FY 2004 to FY 2006 or on over 20 percent of the Medicare claims. In our view, billing of an unspecified code on this magnitude of claims suggests potential improvements in coding from substituting a specified for an unspecified code are widespread. While improvements in documentation and coding that increase case mix may be variable, section 1886(d)(3)(A)(vi) of the Act only allows us to apply the adjustments that are a result of changes in the coding or classification of discharges that do not reflect real changes in case mix to the standardized amounts.

Comment: Several commenters indicated that there should be a transition to the MS-DRGs. A number of commenters supported a 4-year transition period for implementing the MS-DRGs. The commenters stated that such a transition would allow hospitals the opportunity to educate their employees and physicians to assure proper, accurate coding, along with allocation of required resources through their budgetary process. The commenters recommended that FY 2008 be used to prepare for and test the MS-DRGs. In FY 2009 through 2011, the DRG weights would be computed as a blend of the MS-DRGs and the current DRGs. These commenters believed a 1-year delay would provide hospitals adequate time to implement and test the new system and adjust operations and staffing for predicted revenues. They also suggested that the 1-year delay would provide CMS adequate time to finalize data and a CC list, introduce and test software for case classification and payment, and train its fiscal agents. It would also allow vendors and State agencies time to incorporate such changes into their respective software and information systems. Other commenters were concerned that CMS would implement the MS-DRGs in FY 2008 and then, as a result of the final RAND report, move to another new system for FY 2009. These commenters urged CMS to delay the implementation of the MS-DRGs if there was a possibility for another completely new system in FY 2009. These commenters stated that hospitals will expend a large number of hours educating their coding staff about the MS-DRGs so that they can attempt to legitimately optimize their payment. Some commenters recommended that CMS implement the MS-DRGs effective October 1, 2007, with a 3-year phase-in approach of the relative weights.

One commenter indicated that CMS should phase in the revised CC list and MS-DRGs to reduce the amount of documentation and coding related overpayments that would be made “in the first place.” The commenter recommended that the MS-DRGs not be implemented in FY 2008. Instead, they recommend that the revised CC list be used with a Version 25.0 of the current CMS DRGs and allow vendors of the alternative severity systems being evaluated by RAND to incorporate this information into an updated version of their systems. The commenter stated that the updated version of the CMS DRGs using the revised CC list would produce a greatly improved DRG GROUPER. The commenter recommended a 5-year phase-in during which the old CC list/CMS-DRG weights and the new CC list/MS-DRG weights would be blended in the following proportions: 80/20 percent in FY 2008, 60/40 percent in FY 2009, 40/60 percent in FY 2010, 20/80 percent in FY 2011, and 0/100 percent in FY 2012. The commenter stated that CMS should release the MS-DRG grouper software as soon as possible and should also encourage vendors to release products as soon as possible that ensure that both old and new CCs are listed among the first eight secondary diagnoses, as these are the only ones that can be used for payment purposes. With respect to the phase-in, the commenter believed it is prudent to begin to use the new CC list/MS-DRGs in FY 2008 so that hospitals are compelled as soon as possible (1) to improve their coding, and (2) to educate Start Printed Page 47185their physicians about complete documentation. However, the commenter would not want the new DRG weights to represent a majority of the blend until they can be based on the first year of corrected data. The FY 2010 weights would be based on the FY 2008 cases, so they would reflect the first year's coding corrections and would presumably be more accurate. Because it can take several years for hospitals and physicians to adjust to new documentation and coding requirements, continuing blended payments in FY 2011 would be important to minimize documentation and coding related overpayments, according to the commenter.

The commenter stated that the goal is to minimize the aggregate level of documentation and coding related overpayments so that hospitals not generating increases in case mix are not unfairly penalized by an across-the-board reduction. If overpayments could be recouped on a hospital-specific basis, the commenter stated that an attenuated phase-in would not be necessary. The commenter stated that they realized that their recommended phase in would be cumbersome because each case would have to be grouped twice to determine the DRG assignment under the CMS DRG and MS-DRG GROUPERS. However, the commenter believed this is the better policy option since the alternative for good-coding hospitals and those with relatively few patients in split DRGs would be to effectively eliminate the IPPS update for 2 years.

Response: We received many comments in support of the MS-DRGs, particularly because they are so structurally similar to the current DRGs, and therefore, we believe that a full year's delay is unwarranted. While the MS-DRGs include some consolidations of base DRGs, the major changes from the current DRGs simply involve adding severity levels to many of the new MS-DRGs. The move to MS-DRGs will not necessitate additional data elements or changes in reporting practices. Providers will be submitting the same clinical information on their claims. In our view, the issues in the comments concerning the need to examine the new system in detail do not justify delaying the move to this new system. We have provided detailed information in both the proposed and final rule as well as on our Web site on the formation of the MS-DRGs. We believe the significant benefits of the new system outweigh concerns by the provider community that they have not had time to analyze the details of the new system. We are confident that once they start working with the new system, they will find it simple to understand and far better at identifying and paying for more costly and severely ill patients. Accordingly, we do not believe that extensive preparation for implementation of the MS DRGs is necessary, and therefore, we are not delaying adoption of the MS-DRGs until FY 2009.

MedPAC also carefully evaluated the options of implementing MS-DRGs in FY 2008 versus deferring the implementation until FY 2009 and agrees with our assessment that there is not sufficient cause to delay the proposed adoption of MS-DRGs beyond FY 2008. While MedPAC agreed that MS-DRGs should be implemented in FY 2008, it also stated that the transition should coincide with the transition to cost-based weights—that is, implement the MS-DRGs over a 2-year period beginning in FY 2008.[20] We agree with MedPAC that the MS-DRGs should be implemented over a 2-year transition period that coincides with the phase-in of cost-based weights. Therefore, we will implement MS-DRGs beginning in FY 2008 over a 2-year transition period where the DRG relative weights will be a blend of 50 percent each of the CMS DRG and MS DRG weights. We have provided more detail in section II.D.2. of the preamble of this final rule with comment period about the DRG relative weight calculations over this 2-year transition period.

There appears to be a suggestion in many of the public comments both here and above that delaying implementation of MS-DRGs will allow the improvements in documentation and coding to occur before they have any financial impact on the Medicare program because hospitals would know and be encouraged to code using the incentives provided under the MS-DRGs, while Medicare would continue to be using the current CMS DRGs for payment. As discussed, one comment suggested that we could lessen the need for the documentation and coding adjustment by minimizing the financial impact of improvements in documentation and coding through a long transition period (5 years). We believe hospitals will not improve documentation and coding consistent with the incentives provided under the MS-DRGs unless they have a financial incentive to do so. As indicated in one public comment, “Documentation and numbers of diagnosis codes is inevitably incomplete due to time pressures for completion of ‘paperwork' and limitation of computer systems to capture this information. If an item is not used and/or not important, it is less well documented.”

If there is a delay in MS-DRGs, the coding incentives that would come with its adoption would not be present and, therefore, likely would not occur. While we appreciate the suggestion for adopting a long transition period to provide an incentive to improve coding but minimize its financial impact on Medicare, such an idea may well just extend the period of time that documentation and coding improvements occur while delaying the improvements in recognition of severity of illness that would result from adopting MS DRGs. Again, we do not believe that either delaying or adopting MS-DRGs over a long period of time will reduce the need to apply a documentation and coding adjustment of the magnitude we estimated. We believe that adopting either of the ideas would only result in us needing to delay or extend the period of time over which the documentation and coding adjustment is applied.

Comment: MedPAC indicated that case-mix might increase more or less than the 4.8 percent we estimated from Maryland's experience. MedPAC recommended an adjustment between 1.6 and 1.8 percent a year for 2 years. This adjustment is based on a comparison between the MS-DRGs in Maryland and nationally (2.0 percent over 2 years) increased:

  • To reflect their view that many hospitals do not respond quickly to improve reporting after major changes in the DRG definitions; and
  • The estimated change in case-mix for hospitals in the rest of the nation may reflect some improvements in documentation and coding in response to changes in the DRG definitions that were adopted in 2006 (such as the refinements to the cardiac care DRGs among others).

MedPAC recommended that we apply an adjustment that is somewhere in the middle between their estimate of 2.0 and the CMS figure of 4.8 percent. According to MedPAC, a middle point in the range of 1.6 to 1.8 percent per year would put both Medicare and the hospital industry at some risk that the actual value will turn out to be higher or lower than the adjustment that is applied. If the actual increase due to improvements in case-mix reporting turns out to be higher, the Medicare program will have paid more than it should have. If the actual increase is lower, the hospitals will have been paid less than they should have. MedPAC noted that we have already stated a willingness to correct for any difference Start Printed Page 47186between our forecast and the actual increase in case mix due to improved coding when data become available in 2009 when we prepare the proposed rule for fiscal year 2010. MedPAC further suggested that CMS plan on taking coding adjustments for longer than two years. CMS may want to adopt a series of adjustments that takes somewhat higher adjustments in the first few years of the MS-DRG changes, on the assumption that history has shown that previous coding adjustments have underestimated the impact of the changes.

Response: We proposed to adjust the IPPS standardized amounts by −2.4 percent each year for FYs 2008 and 2009 for improvements in documentation and coding that will increase case-mix. As we are adopting the MS-DRGs over a 2-year transition period, we do not believe that the incentives to improve documentation and coding will be as strong in the first year as we previously estimated. Further, as suggested above by the evidence when the IPPS was first implemented, MedPAC, and other public comments, it can take several years for hospitals and physicians to adjust their documentation and coding practices in response to payment incentives. For these reasons, we believe the documentation and coding adjustment should be applied over a period of 3 rather than 2 years. We do not agree with MedPAC that a larger adjustment “should be taken in the first few years of the MS-DRGs on the assumption that history has shown that previous coding adjustments have underestimated the impact of changes.” Rather, as stated above, we believe that the coding incentives during the first year of MS-DRGs will be lessened because we are adopting them over a 2-year transition period. Therefore, we believe a smaller adjustment should be applied in the initial year. We continue to believe that our analysis justifies a −4.8 percent adjustment for improvements in documentation and coding at this time. Therefore, we are applying an adjustment of −1.2 percent in this final rule with comment period to the IPPS standardized amounts for FY 2008 and based on current projections will apply adjustments of −1.8 percent each year to the IPPS standardized amounts for FYs 2009 and 2010.

Consistent with the statute, we will compare the actual increase in case-mix due to documentation and coding to our projection once we have actual data to revise the Actuary's estimate and the adjustment we make to the standardized amounts. With these adjustments occurring over 3 rather than 2 years, we will have information in 2009 as we prepare the IPPS rule for FY 2010 to reevaluate how the actual increase in case mix compares to our estimate. We may also have partial year information in 2008 to inform any proposal for FY 2009. Therefore, we will consider revising the planned adjustments for FY 2009 and FY 2010 if information in the Medicare billing data suggests that our projections are either too high or low compared to actual experience.

Based on the Actuary's analysis, using the Secretary's authority under section 1886(d)(3)(A)(vi) of the Act to adjust the standardized amount to eliminate the effect of changes in coding or classification of discharges that do not reflect real changes in case-mix, we are reducing the IPPS standardized amount by −1.2 percent for FY 2008. Section 1886(d)(3)(A)(vi) of the Act further gives the Secretary authority to revisit adjustments to the standardized amounts for changes in coding or classification of discharges that were based on estimates in a future year. Consistent with the statute, we will compare the actual increase in case-mix due to documentation and coding to our projection once we have actual data for FY 2008. At that time, if necessary, we may make a further adjustment to the standardized amounts to account for the difference between our projection and actual data.

7. Effect of the MS-DRGs on the Outlier Threshold

To qualify for outlier payments, a case must have costs greater than Medicare's payment rate for the case plus a “fixed loss” or cost threshold. The statute requires that the Secretary set the cost threshold so that outlier payments for any year are projected to be not less than 5 percent or more than 6 percent of total operating DRG payments plus outlier payments. The Secretary is required by statute to reduce the average standardized amount by a factor to account for the estimated proportion of total DRG payments made to outlier cases. Historically, the Secretary has set the cost threshold so that 5.1 percent of estimated IPPS payments are paid as outliers. The FY 2007 cost outlier threshold is $24,485. Therefore, for any given case, a hospital's charge adjusted to cost by its hospital-specific CCR must exceed Medicare's DRG payment by $24,485 for the case to receive cost outlier payments.

Adoption of the MS-DRGs will have an effect on calculation of the outlier threshold. For the proposed rule and this final rule with comment period, we analyzed how the outlier threshold would be affected by adopting the MS-DRGs. Using FY 2005 MedPAR data, we have simulated the effect of the MS-DRGs on the outlier threshold. By increasing the number of DRGs from 538 to 745 to better recognize severity of illness, the MS-DRGs would be providing increased payment that better recognizes complexity and severity of illness for cases that are currently paid as outliers. That is, many cases that are high-cost outlier cases under the current CMS DRG system would be paid using an MCC DRG under the MS-DRGs and could potentially be paid as nonoutlier cases. For this reason, we expected the FY 2008 outlier threshold to decline from its FY 2007 level of $24,485. We proposed an FY 2008 outlier threshold of $23,015. In this final rule with comment period, we are establishing an FY 2008 outlier threshold of $22,650. In section II.A.4. of the Addendum to this final rule with comment period, we provide a more detailed explanation of how we determined the final FY 2008 cost outlier threshold. We address any comments received on the FY 2008 proposed outlier threshold in section II.A.4. of the Addendum to this final rule with comment period.

8. Effect of the MS-DRGs on the Postacute Care Transfer Policy

Existing regulations at § 412.4(a) define discharges under the IPPS as situations in which a patient is formally released from an acute care hospital or dies in the hospital. Section 412.4(b) defines transfers from one acute care hospital to another. Section 412.4(c) establishes the conditions under which we consider a discharge to be a transfer for purposes of our postacute care transfer policy. In transfer situations, each transferring hospital is paid a per diem rate for each day of the stay, not to exceed the full DRG payment that would have been made if the patient had been discharged without being transferred.

The per diem rate paid to a transferring hospital is calculated by dividing the full DRG payment by the geometric mean length of stay for the DRG. Based on an analysis that showed that the first day of hospitalization is the most expensive (60 FR 45804), our policy provides for payment that is double the per diem amount for the first day (§ 412.4(f)(1)). Transfer cases are also eligible for outlier payments. The outlier threshold for transfer cases is equal to the fixed-loss outlier threshold for nontransfer cases, divided by the geometric mean length of stay for the DRG, multiplied by the length of stay for the case, plus one day. The purpose of the IPPS postacute care transfer payment policy is to avoid providing an incentive for a hospital to transfer Start Printed Page 47187patients to another hospital early in the patients' stay in order to minimize costs while still receiving the full DRG payment. The transfer policy adjusts the payments to approximate the reduced costs of transfer cases.

Beginning with the FY 2006 IPPS, the regulations at § 412.4 specified that, effective October 1, 2005, we make a DRG subject to the postacute care transfer policy if, based on Version 23.0 of the DRG Definitions Manual (FY 2006), using data from the March 2005 update of FY 2004 MedPAR file, the DRG meets the following criteria:

  • The DRG had a geometric mean length of stay of at least 3 days;
  • The DRG had at least 2,050 postacute care transfer cases; and
  • At least 5.5 percent of the cases in the DRG were discharged to postacute care prior to the geometric mean length of stay for the DRG.

In addition, if the DRG was one of a paired set of DRGs based on the presence or absence of a CC or major cardiovascular condition (MCV), both paired DRGs would be included if either one met the three criteria above.

If a DRG met the above criteria based on the Version 23.0 DRG Definitions Manual and FY 2004 MedPAR data, we made the DRG subject to the postacute care transfer policy. We noted in the FY 2006 final rule that we would not revise the list of DRGs subject to the postacute care transfer policy annually unless we make a change to a specific CMS DRG. We established this policy to promote certainty and stability in the postacute care transfer payment policy. Annual reviews of the list of CMS DRGs subject to the policy would likely lead to great volatility in the payment methodology with certain DRGs qualifying for the policy in one year, deleted the next year, only to be reinstated the following year. However, we noted that, over time, as treatment practices change, it was possible that some CMS DRGs that qualified for the policy will no longer be discharged with great frequency to postacute care. Similarly, we explained that there may be other CMS DRGs that at that time had a low rate of discharges to postacute care, but which might have very high rates in the future.

The regulations at § 412.4 further specify that if a DRG did not exist in Version 23.0 of the DRG Definitions Manual or a DRG included in Version 23.0 of the DRG Definitions Manual is revised, the DRG will be a qualifying DRG if it meets the following criteria based on the version of the DRG Definitions Manual in use when the new or revised DRG first became effective, using the most recent complete year of MedPAR data:

  • The total number of discharges to postacute care in the DRG must equal or exceed the 55th percentile for all DRGs; and
  • The proportion of short-stay discharges to postacute care to total discharges in the DRG exceeds the 55th percentile for all DRGs. A short-stay discharge is a discharge before the geometric mean length of stay for the DRG.

A DRG also is a qualifying DRG if it is paired with another DRG based on the presence or absence of a CC or MCV that meets either of the above two criteria.

The MS-DRGs that we proposed to adopt (and are finalizing in this final rule with comment period) for FY 2008 are a significant revision to the current CMS DRG system. Because the new MS-DRGs are not reflected in Version 23.0 of the DRG Definitions Manual, consistent with § 412.4, we proposed to recalculate the 55th percentile thresholds in order to determine which MS-DRGs would be subject to the postacute care transfer policy. Further, under the MS-DRGs, the subdivisions within the base DRGs will be different than those under the current CMS DRGs. Unlike the current CMS DRGs, the MS-DRGs are not divided based on the presence or absence of a CC or MCV. Rather, the MS-DRGs have up to three subdivisions based on: (1) The presence of a MCC; (2) the presence of a CC; or (3) the absence of either an MCC or CC. Consistent with our existing policy under which both DRGs in a CC/non-CC pair are qualifying DRGs if one of the pair qualifies, we proposed that each MS-DRG that shared a base MS-DRG would be a qualifying DRG if one of the MS-DRGs that shared the base DRG qualified. We proposed to revise § 412.4(d)(3)(ii) to codify this policy.

Similarly, we believe that the changes to adopt MS-DRGs also necessitate a revision to one of the criteria used in § 412.4(f)(5) of the regulations to determine whether a DRG meets the criteria for payment under the “special payment methodology.” Under the special payment methodology, a case subject to the special payment methodology that is transferred early to a postacute care setting will be paid 50 percent of the total IPPS payment plus the average per diem for the first day of the stay. Fifty percent of the per diem amount will be paid for each subsequent day of the stay, up to the full MS-DRG payment amount. A CMS DRG is currently subject to the special payment methodology if it meets the criteria of § 412.4(f)(5). Section 412.4(f)(5)(iv) specifies that if a DRG meets the criteria specified under § 412.4(f)(5)(i) through (f)(5)(iii), any DRG that is paired with it based on the presence or absence of a CC or MCV is also subject to the special payment methodology. Given that this criterion would no longer be applicable under the MS-DRGs, we proposed to add a new § 412.4(f)(6) that includes a DRG in the special payment methodology if it is part of a CC/non-CC or MCV/non-MCV pair. We proposed to update this criterion so that it conforms to the proposed changes to adopt MS-DRGs for FY 2008. The revision would make an MS-DRG subject to the special payment methodology if it shares a base MS-DRG with an MS-DRG that meets the criteria for receiving the special payment methodology.

Comment: One commenter urged CMS to “suspend application of the postacute care transfer policy for one year, until sufficient data is available, and then apply the criteria anew to the MS-DRGs.” As an alternative to ceasing the application of the postacute care transfer policy for one year, the commenter recommended that CMS limit the application of the postacute care transfer policy as much as possible until better data are available and not to increase the average length of stay for less complicated DRGs over their current levels.

Response: Under both the CMS DRGs and MS-DRGs, there were two criteria for making a DRG subject to the postacute care transfer policy. These criteria are:

  • The total number of discharges to postacute care in the DRG must equal or exceed the 55th percentile for all DRGs; and
  • The proportion of short-stay discharges to postacute care to total discharges in the DRG must equal or exceed the 55th percentile for all DRGs.

While these criteria are identical under the CMS DRGs and the MS-DRGs, we needed to recalculate the 55th percentile thresholds in order to determine which MS-DRGs would be subject to the postacute care transfer policy to conform the existing policy to the new DRG system. Further, we also needed to make a conforming change to our policy that a DRG is subject to the postacute care transfer policy if it is one of a paired set of DRGs based on the presence or absence of a CC or MCV where one of the DRGs in the set meets the numerical criteria specified above. As the MS-DRGs have subdivisions based on MCC, CCs and non-CCs rather than MCVs, CCs and non-CCs, we needed to amend the regulatory text to reflect the nomenclature of the MS-DRG system. Therefore, our policy for making a DRG subject to the postacute care transfer policy under the MS-DRGs is unchanged other than to make it Start Printed Page 47188conform to the new DRG system. As our policy is unchanged, we do not believe that either suspending or limiting application of the postacute care transfer policy under the MS-DRGs is warranted.

Comment: One commenter opposed CMS’ “proposal to significantly expand the list of the DRGs subject to the postacute care transfer policy.” The commenter, a hospital, noted that “manual processes” would have to take place in order to identify patients meeting the home health criteria. Specifically, the commenter stated that, “hospitals [would] either have to contact patients to determine if they have received home health services within 3 days after discharge or wait for the fiscal intermediary to let the hospital know that a patient received home care that was not planned at the time of discharge which requires coders to review and correct the disposition and for the Business Office to resubmit the claim.”

Response: We note that we did not propose to change or expand the postacute care transfer policy provision in this year's proposed rule. Rather, we applied existing post-acute transfer policy to the new MS-DRG system. Thus, the criteria that would have made a CMS-DRG subject to the postacute care transfer policy last year were the same as those applied to the MS-DRGs for FY 2008. We note that in FY 2007, 190 CMS DRGs of 538 CMS DRGs were subject to the postacute care transfer policy, or about 35 percent. For FY 2008, 273 out of 745 MS-DRGs are subject to the postacute care transfer policy or about 36 percent. Therefore, the proportion of postacute care transfer MS-DRGs subject to the policy is very similar to what it was last year under the CMS DRGs. Thus, we disagree there has been a “significant expansion” of DRGs subject to the postacute care transfer policy. Rather, we are simply conforming the existing postacute care transfer policy to the new MS-DRGs.

In response to the commenter's concern about it being administratively burdensome to identify patients who received home health care services subsequent to discharge from the acute care hospital, we note that, under section 1886(d)(5)(J)(ii)(III) of the Act, the term “qualified discharge” includes a discharge from an IPPS hospital upon which the patient is provided home health services from a home health agency if such services relate to the condition or diagnosis for which the patient received hospital inpatient services. The proposed rule did not make any change to application of the postacute care transfer policy in this circumstance. We note that, in most instances, patients are discharged from the acute hospital with a written plan of care for the provision of home health services, so hospitals would usually know if a patient was going to receive home health care services at the time of discharge. Additionally, we do not expect that the administrative burden of identifying patients discharged to home for the provision of home health services within 3 days will be any greater under the MS-DRG system than it was under the CMS DRG system because the proportion of DRGs subject to the postacute care transfer policy is very similar under both systems.

Comment: One commenter stated that it is unreasonable to categorize all three MS-DRGs in the same base DRG as subject to the postacute care transfer policy if only one of the three meets the criteria. The commenter suggested that, for base MS-DRGs where there are three base-DRGs, two of the three base-DRGs should meet the postacute care transfer criteria (on their own) for all of them to be subject to the postacute care transfer policy and that if only one meets the criteria, none should be subject to the postacute care transfer policy.

Response: Under the CMS DRG system, some DRGs were paired with others (with CC or without CC). Under that system, if one DRG qualified for the postacute care transfer policy, we included its paired DRG so as not to create an incentive for hospitals not to include any code that would identify a complicating or comorbid condition. The same logic applies under the MS-DRG system: If one DRG in a set meets the postacute care transfer criteria, we believe that it is appropriate to include the paired or grouped DRGs so as not to create any coding incentives to bypass the postacute care transfer payment. Therefore, we disagree with the commenter that it is “unreasonable” to include a group of MS-DRGs where only one MS-DRG in the group meets the postacute care transfer criteria on its own. We also note that we apply the same logic to the special-pay MS-DRGs. That is, if an MS-DRG qualifies to receive the special payment methodology, any other MS-DRGs that share the same base MS-DRG also qualify to receive the special payment methodology.

In this final rule with comment period, we are adopting the proposed postacute care transfer policy conforming changes as final.

In addition, § 412.4(f)(3) states that the postacute care transfer policy does not apply to CMS DRG 385 for newborns who die or are transferred. We proposed to make a conforming change to this paragraph to reflect that this CMS DRG would become MS-DRG 789 (Neonates, Died or Transferred to Another Acute Care Facility) under our proposed DRG changes for FY 2008. We did not receive any comments on this proposal and, therefore, are finalizing this conforming change as proposed.

These revisions do not constitute a change to the application of the postacute care transfer policy. Therefore, any savings attributed to the postacute care transfer policy will be unchanged as a result of adopting the MS-DRGs. Consistent with section 1886(d)(4)(C)(iii) of the Act, aggregate payments from adoption of the MS-DRGs cannot be greater or less than those that would have been made had we not made any DRG changes.

We also proposed and are adopting as final technical changes to §§ 412.4(f)(5)(i) and (f)(5)(iv) to correct a cross-reference and a typographical error, respectively.

E. Refinement of the Relative Weight Calculation

In the FY 2007 IPPS final rule (71 FR 47882), effective for FY 2007, we began to implement significant revisions to Medicare's inpatient hospital rates by basing the relative weights on hospitals’ estimated costs rather than on charges. This reform was one of several measured steps to improve the accuracy of Medicare's payment for inpatient stays that include using costs rather than charges to set the relative weights and making refinements to the current CMS-DRGs so they better account for the severity of the patient's condition. Prior to FY 2007, we used hospital charges as a proxy for hospital resource use in setting the relative weights. Both MedPAC and CMS have found that the limitations of charges as a measure of resource use include the fact that hospitals cross-subsidize departmental services in many different ways that bear little relation to cost, frequently applying a lower charge markup to routine and special care services than to ancillary services. In MedPAC's 2005 Report to the Congress on Physician-Owned Specialty Hospitals, MedPAC found that hospitals charge much more than their costs for some types of services (such as operating room time, imaging services and supplies) than others (such as room and board and routine nursing care).[21] Our analysis of the MedPAC report in the FY 2007 IPPS Start Printed Page 47189proposed rule (71 FR 24006) produced consistent findings.

In the FY 2007 IPPS proposed rule, we proposed to implement cost-based weights incorporating aspects of a methodology recommended by MedPAC, which we called the hospital-specific relative value cost center (HSRVcc) methodology. MedPAC indicated that an HSRVcc methodology would reduce the effect of cost differences among hospitals that may be present in the national relative weights due to differences in case mix adjusted costs. After studying Medicare cost report data, we proposed to establish 10 national cost center categories from which to compute 10 national CCRs based upon broad hospital accounting definitions. We made several important changes to the HSRVcc methodology that MedPAC recommended using in its March 2005 Report to the Congress on Physician-Owned Specialty Hospitals. We refer readers to the FY 2007 IPPS proposed rule (71 FR 24007 through 24011) for an explanation and our reasons for the modification to MedPAC's methodology. In its public comments on the FY 2007 IPPS proposed rule, MedPAC generally agreed with the adaptations we made to its methodology. MedPAC further recommended that we expand the number of distinct hospital department CCRs being used from 10 to 13, which we subsequently adopted in the FY 2007 IPPS final rule.

We did not finalize the HSRVcc methodology for FY 2007 because of concerns raised in the public comments on the FY 2007 IPPS proposed rule (71 FR 47882 through 47898). Rather, we adopted a cost-based weighting methodology without the hospital-specific relative weight feature. In response to a comment from MedPAC, we also expanded the number of distinct hospital departments with CCRs from 10 to 13. We indicated our intent to study whether to adopt the HSRVcc methodology after we had the opportunity to further consider some of the issues raised in the public comments. In the interim, we adopted a cost-based weighting methodology over a 3-year transition period, substantially mitigating the redistributive payment impacts illustrated in the proposed rule, while we engaged a contractor to assist us with evaluating the HSRVcc methodology.

Some commenters raised concerns about potential bias in cost-based weights due to “charge compression,” which is the practice of applying a lower percentage markup to higher cost services and a higher percentage markup to lower cost services. These commenters were concerned that our proposed weighting methodology may undervalue high cost items and overvalue low cost items if a single CCR is applied to items of widely varying costs in the same cost center. The commenters suggested that the HSRVcc methodology would exacerbate the effect of charge compression on the final relative weights. One of the commenters suggested an analytic technique of using regression analysis to identify adjustments that could be made to the CCRs to better account for charge compression. We indicated our interest in researching whether a rigorous model should allow an adjustment for charge compression to the extent that it exists. We engaged a contractor, RTI International (RTI), to study several issues with respect to the cost-based weights, including charge compression, and to review the statistical model provided to us by the commenter for adjusting the weights to account for it. We discuss RTI's findings in detail below.

Commenters also suggested that the cost report data used in the cost methodology are outdated, not consistent across hospitals, and do not account for the costs of newer technologies such as medical devices. However, the relationship between costs and charges (not costs alone) is the important variable in setting the relative weights under this new system. Older cost reports also do not include the hospital's higher charges for these same medical devices. Therefore, it cannot be known whether the CCR for the more recent technologies will differ from those we are using to set the relative weights. The use of national average cost center CCRs rather than hospital-specific CCRs may mitigate potential inconsistencies in hospital cost reporting. Nevertheless, in the FY 2007 IPPS final rule, we agreed that it was important to review how hospitals report costs and charges on the cost reports and on the Medicare claims and asked RTI to further study this issue as well.

In summary, we proposed to adopt HSRVcc relative weights for FY 2007 using national average CCRs for 10 hospital departments. Based on public comments concerned about charge compression and the accuracy of cost reporting, we decided not to finalize the HSRVcc methodology, but adopted cost-based weights without the hospital specific feature. In response to comments from MedPAC, we expanded the number of hospital cost centers used in calculating the national CCRs from 10 to 13. Finally, we decided to implement the cost-based weighting methodology gradually, by blending the cost-based and charge-based weights over a 3-year transition period beginning with FY 2007, while we further studied many of the issues raised in the public comments. We refer readers to the FY 2007 IPPS final rule (71 FR 47882) for more details on our final policy for calculating the cost-based DRG relative weights.

1. Summary of RTI's Report on Charge Compression

In August 2006, we awarded a contract to RTI to study the effects of charge compression in calculating DRG relative weights. The purpose of the study was to develop more accurate estimates of the costs of Medicare inpatient hospital stays that can be used in calculating the relative weights per DRG. RTI was asked to assess the potential for bias in relative weights due to CCR differences within the 13 CCR groups used in calculating the cost-based DRG relative weights and to develop an analysis plan that explored alternative methods of estimating costs with the objective of better aligning the charges and costs used in those calculations. RTI was asked to consider methods of reducing the variation in CCRs across services within cost centers by:

  • Modifying existing cost centers and/or creating new centers.
  • Using statistical methods, such as the regression adjustment for charge compression. Some commenters on the FY 2007 IPPS proposed rule suggested that we use a regression adjustment to account for charge compression.

As part of its contract, RTI convened a Technical Expert Panel composed of individuals representing academic institutions, hospital associations, medical device manufacturers, and MedPAC. The members of the panel met on October 27, 2006, to evaluate RTI's analytic plan, to identify other areas that are likely to be affected by compression or aggregation problems, and to propose suggestions for adjustments for charge compression. We posted RTI's draft interim report on the CMS Web site in March 2007. For more information, interested individuals can view RTI's report at the following Web site: http://www.cms.hhs.gov/​Reports/​Reports/​itemdetail.asp?​itemID=​CMS1197292. The report may also be viewed on RAND's Web site at http://www.rand.org/​pubs/​online/​health.

As the first step in its analysis, RTI compared the reported Medicare program charge amounts from the cost reports to the total Medicare charges summed across all claims filed by providers. Using cost and charge data Start Printed Page 47190from the most recent available Medicare cost reports and inpatient claims from IPPS hospitals, RTI was charged with performing an analysis to determine how well the MedPAR charges matched the cost report charges used to compute CCRs. The accuracy of the DRG cost estimates is directly affected by this match because MedPAR charges are multiplied by CCRs to estimate cost. RTI found consistent matching of charges from the Medicare cost report to charges grouped in the MedPAR claims for some cost centers but there appeared to be problems with others. For example, RTI found that the data between the cost report and the claims matched well for total discharges, days, covered charges, nursing unit charges, pharmacy, and laboratory. However, there appeared to be inconsistent reporting between the cost reports and the claims data for charges in several ancillary departments (medical supplies, operating room, cardiology, and radiology). For example, the data suggested that hospitals often include costs and charges for devices and other medical supplies within the Medicare cost report cost centers for Operating Room, Radiology or Cardiology, while other hospitals include them in the Medical Supplies cost center.

RTI found that some charge mismatching results from the way in which charges are grouped in the MedPAR file. Examples include the intermediate care nursing charges being grouped with intensive care nursing charges and electroencephalography (EEG) charges being grouped with laboratory charges. RTI suggested that reclassifying intermediate care charges from the intensive care unit to the routine cost center could address the former problem.

As the second step in its analysis, RTI reviewed the existing cost centers that are combined into the 13 groups used in calculating the national average CCRs. RTI identified CCRs with potential aggregation problems and considered whether separating the charge groups could result in more accurate cost conversion at the DRG level. The analysis led RTI to calculate separate CCRs for Emergency Room and Blood and Blood Administration, both of which had been included in “Other Services” in FY 2007.

During this second step, RTI noted that a variation of charge compression is also present in inpatient nursing services because most patients are charged a single type of accommodation rate per day that is linked to the type of nursing unit (routine, intermediate, or intensive), but not to the hours of nursing services given to individual patients. Unlike the situation with charge compression in ancillary service areas, there are virtually no detailed charge codes that can distinguish patient nursing care use. Therefore, any potential bias cannot be empirically evaluated or adjustments made without additional data.

Next, RTI examined individual revenue codes within the cost centers and used regression analysis to determine whether certain revenue codes in the same cost center had significantly different markup rates. Those revenue codes include devices, prosthetics, implants within the Medical Supplies cost center, IV Solutions within the Drugs cost center, CT scanning and MRI within the Radiology cost center, Cardiac Catheterization within the Cardiology cost center, and Intermediate Care Units within the Routine Nursing Care cost center. Devices, prosthetics, and implants within the Medical Supplies cost center have a lower markup and, as a result, a higher CCR than the remainder of the medical supplies group according to RTI's analysis. Within the Drugs CCR, IV Solutions have a much higher markup and much lower CCR than the other drugs included in the category. Within the Radiology CCR, CT scanning and MRI have higher markups and lower CCRs than the remaining radiology services. RTI's results for Cardiac Catheterization and Intermediate Care Units were ambiguous due to data problems.

RTI's analysis also determined the impact of the disaggregated CCRs on the relative weights. Differences in CCRs alone do not necessarily alter the DRG relative weights. The impact on the relative weights is the result of the interaction of CCR differences and DRG differences in the proportions of the services with different CCRs. In FY 2007, we calculated relative weights using CCRs for 13 hospital departments. The RTI analysis suggests expanding the number of distinct hospital department CCRs from 13 to 19. Of the additional six CCRs, two would result from separating the Emergency Department and Blood (Products and Administration) from the residual “Other Services” category. Four additional CCRs would result from applying a regression method similar to a method suggested in last year's public comments to three existing categories: supplies, radiology, and drugs. This method, as adapted by RTI, used detailed coding of charges to disaggregate hospital cost centers and derive separate, predicted alternative CCRs for the disaggregated services. RTI's analysis suggests splitting Medical Supplies into one CCR for Devices, Implants, and Prosthetics and one CCR for Other Supplies; splitting Radiology into one CCR for MRIs, one CCR for CT scans, and one CCR for Other Radiology; and splitting Drugs into one CCR for IV Solutions and one CCR for Other Drugs.

RTI's draft report provides the potential impacts of adopting these changes to the CCRs. We note that RTI's analysis was based on Version 24.0 of the CMS DRGs. Because the proposed MS-DRGs were under development for the FY 2008 IPPS proposed rule, they were unavailable to RTI for their analysis. The results of RTI's analysis may be different if applied to the MS-DRGs. However, it seems reasonable to believe that the impact of RTI's suggestions will be consistent using Version 24.0 of the CMS DRGs and the MS-DRGs, as both systems generally use the same base DRGs while applying different subdivisions to recognize severity of illness. Of all the adjusted CCRs, the largest impact on weights came from accounting for charge compression in medical supplies for devices and implants. The impact on weights from accounting for CCR differences among drugs was modest. The impact of splitting MRI and CT scanning from the radiology CCR was greater than the impact of modifying the Drugs CCRs, but less than the impact of splitting the Medical supplies group. Separating Emergency Department and Blood Products and Administration from the “Other Services” category would raise the CCR for other services in the group.

RTI found that disaggregating cost centers may have a mitigating effect on the impact of transitioning from charge-based weights to cost-based weights. That is, the changes being suggested by RTI will generally offset (fully or more than fully in some cases or in part in other cases) the impacts of fully implemented cost-based weights that we are adopting over the FY 2007-FY 2009 transition period. Thus, RTI's analysis suggests that expanding the number of distinct hospital department CCRs used to calculate cost-based weights from 13 to 19 will generally increase the relative weights for surgical DRGs and decrease them for the medical DRGs compared to the fully implemented cost-based weights to which we began transitioning in FY 2007.

2. RTI Recommendations

In its report, RTI provides recommendations for the short term, medium term, and long term, to mitigate aggregation bias in the calculation of relative weights. We summarize RTI's Start Printed Page 47191recommendations below and respond to each of them.

a. Short-Term Recommendations

Most of RTI's short-term recommendations have already been described above. The most immediate changes that RTI recommends implementing include expanding from 13 distinct hospital department CCRs to 19 by:

  • Disaggregating “Emergency Room” and “Blood and Blood Products” from the “Other Services” cost center;
  • Establishing regression-based estimates as a temporary or permanent method for disaggregating the Medical Supplies, Drugs, and Radiology cost centers; and
  • Reclassifying intermediate care charges from the intensive care unit cost center to the routine cost center.

We believe these recommendations have significant potential to address issues of charge compression and potential mismatches between how costs and charges are reported in the cost reports and on the Medicare claims.

RTI's recommendations show significant promise in the short term for addressing issues raised in the public comments on the cost-based weights in the FY 2007 IPPS proposed rule. However, in the time available for the development of the proposed rule, we were unable to investigate how RTI's recommended changes may interact with other potential changes to the DRGs and to the method of calculating the DRG relative weights. As we noted above, RTI's analysis was done on the Version 24.0 of the CMS DRGs and not the MS-DRGs we proposed for FY 2008. For the proposed rule and this final rule with comment period, we were not able to examine the combined impacts of the MS-DRGs and RTI's recommendations. In addition, we believe it is also important to consider that, in the FY 2007 IPPS final rule (71 FR 47897), we anticipated undertaking further analysis of the HSRVcc methodology over the next year in conjunction with the research we were to do on charge compression. Analysis of the HSRVcc methodology will be part of the second phase of the RAND study of alternative DRG systems to be completed by September 1, 2007, that has not been completed in time for this final rule with comment period. As a result, we have also been unable to consider the effects of the HSRVcc methodology together with the MS-DRGs and RTI's recommendations. Finally, we note that in order to complete the analysis in time for the proposed rule or this final rule with comment period, RTI's study used only hospital inpatient claims. However, hospital ancillary departments typically include both inpatient and outpatient services within the same department and only a single CCR covering both inpatient and outpatient services can be calculated from Medicare cost reports. Although we believe that applying the regression method used by RTI to only inpatient services is unlikely to have had much impact for the adjustments recommended by RTI, the preferred approach would be to apply the regression method to the combined inpatient and outpatient services. The latter approach would ensure that any potential CCR adjustments in the IPPS would be consistent with potential CCR adjustments in the OPPS. We hope to expand their analysis to incorporate outpatient services during the coming year.

Although we did not propose to adopt RTI's recommendations for FY 2008, we solicited public comments on expanding from 13 CCRs to 19 CCRs. Again, we noted that RTI's analysis suggests significant improvements that could result in the cost-based weights from adopting its recommendations to adjust for charge compression. Therefore, we also expressed interest in public comments on whether we should proceed to adopt the RTI recommended changes for FY 2008 in the absence of a detailed analysis of how the relative weights would change if we were to address charge compression while simultaneously adopting an HSRVcc methodology together with the MS-DRGs. Given the change in the impacts that were illustrated in last year's FY 2007 IPPS final rule (71 FR 47915-47916), going from a hospital-specific to a nonhospital-specific cost-weighting methodology, we believe that sequentially adjusting for charge compression and later adopting an HSRVcc methodology could create the potential for instability in IPPS payments over the next 2 years (that is, payments for surgical DRGs would increase and payment for medical DRGs would decrease if we were to adopt the RTI recommended changes for FY 2008, but could potentially reverse direction if we were to adopt an HSRVcc methodology for FY 2009). Again, we solicited public comments on all of these issues before making a final decision as to whether to proceed with the RTI's short-term recommendations in the final rule for FY 2008.

Comment: Many commenters commented on whether we should proceed in adopting the recommendations made by RTI in its January 2007 report, particularly concerning changes in cost reporting practices and the additional, regression-based CCRs. Several commenters focused on problems highlighted by RTI with the inconsistent and varying methods in which hospitals group their charges in MedPAR and report costs and charges on the Medicare cost report, which can result in distortions in the DRG weights. Some commenters asserted that mismatching is not caused by the failure of hospitals to prepare their cost reports correctly, as appeared to be suggested by the RTI study. Other commenters noted that RTI recommends the incorporation of edits to reject cost reports or require more intensive review by auditors to resolve the lack of uniformity in cost reporting. However, the commenters believed that such edits or audits will not solve the mismatch problem because hospitals' reporting is consistent with the cost reporting instructions. The commenters described that, currently, cost report instructions included with the CMS Form-339 allow for three methods of reporting Medicare charges. The method selected by each hospital is specific to its information systems and based on the method that most accurately aligns Medicare program charges on Cost Report Worksheet D-4 (inpatient) and/or Worksheet D, Part IV (outpatient) with the overall cost and charges reported on Worksheets A and C. Many hospitals elect to allocate some or all of the Medicare program charges from the Medicare Provider Statistical and Reimbursement (PSR) data to various lines in the cost report based on hospital-specific financial system needs. Under this scenario, total hospital CCRs are aligned with the hospital's program charges, but would not match the charge groupings used in MedPAR.

Instead of increased edits or cost report rejections, the commenters believed that hospitals must be educated to report costs and charges, particularly for supplies, in a way that is consistent with how MedPAR groups charges. The commenters are launching such an educational campaign, which would encourage consistent reporting that they believe would, in turn, produce consistent groupings of departments within the 13 cost center groups that are currently used to create the cost-based weights, or any future expansion of the categories that may occur. The commenters stated that their educational efforts will take time and CMS should recognize that some hospitals will be in a better position to adopt certain cost report changes more rapidly because the changes may be more expensive and time-consuming for some hospitals to adopt relative to Start Printed Page 47192others. The commenters requested that CMS communicate with its fiscal intermediaries/MAC that such action is appropriate and encouraged for improvements in Medicare's cost-based weights. The commenters were concerned that, without direction from CMS, the fiscal intermediaries/MAC may not allow hospitals to change how they report costs.

Although one commenter supported the education of hospitals in better cost reporting, this commenter opposed mandating hospitals to make these cost reporting changes. One commenter stated that “it is important to note that charge compression results from hospitals' markup practices,” and that the problem would be eliminated if hospitals would use a single markup for all items and services included within all revenue centers. Another commenter asserted that hospitals are not consistent in their cost reporting and the first step should be to issue cost report instructions. The next step would be to allocate audit resources to the fiscal intermediary/MAC in order to determine whether these instructions are properly implemented because reporting of costs and charges does have an indirect effect on payments to hospitals. Another commenter stated that CMS needs to place more emphasis and audit resources toward ensuring that hospitals properly complete their cost reports. However, while another commenter supported scrutiny and auditing for extreme CCRs, the commenter also appreciated that CMS has limited audit resources. One commenter stated that adjustments to revenue codes reported on the standard UB-04 claims forms may also be appropriate to better match charges on claims forms with the charges (and costs) reported on the Medicare cost report. Other commenters stated that the costing of the weights should be done at the UB revenue code level. Given the variety of ways in which hospitals report their costs and charges, it is impossible to make assumptions related to revenue codes across all hospitals without the assistance of the PSR crosswalk, which is submitted with the filed cost report as an attachment to the CMS-339 form. The commenters noted that if CMS is going to continue a transition to cost-based weights, hospitals will need time to align their mapping of cost centers into departments or cost categories for purposes of cost reporting and claims reporting. The accurate costing of claims would be in line with the original MedPAC recommendations.

In light of the cost reporting and MedPAR mismatch problems, the commenters did not believe that a temporary, regression-based adjustment that does not fix the underlying concerns with cost reporting is appropriate. The commenters are concerned that, for the sake of expediency, the use of estimates (a regression analysis approach), as opposed to efforts to collect accurate data at the appropriate cost center level, would be insufficient. In addition, the commenters expressed doubt that a regression model can be easily validated, as the DRG weights are modified on an annual basis. One commenter argued that CMS did not include details of the regression-based adjustment in the proposed rule and, consequently, the commenter could not assess the impact of implementing the adjustment. The commenter agreed with CMS' assessment that RTI's adjustments might change if they are implemented jointly with MS-DRGs, and if estimated using both inpatient and outpatient costs and charges. This commenter, along with others, believed that, at the very least, implementation of the regression-based CCRs should be delayed, and once short-term educational efforts and CMS' long-term cost report evaluation are underway, it would be more appropriate to have an informed discussion on which cost report changes are needed to alleviate the issue of charge compression.

Response: In the FY 2008 IPPS proposed rule (72 FR 24715), we stated that because we did not have sufficient time to investigate how RTI's recommended changes might interact with other possible changes to the DRGs and the DRG relative weights, and because RTI's regression method was only applied to inpatient services and not also outpatient services, we decided not to propose implementing RTI's recommendations for FY 2008. However, we also stated that, despite these concerns, we believe RTI's recommendations have the potential to significantly address the issues of charge compression and potential mismatches between how costs and charges are reported in the cost reports and on the Medicare claims. Therefore, we solicited comments on whether we should expand the 13 CCRs to 19 CCRs for FY 2008.

We have carefully considered all comments, ranging from those urging us to adopt all 19 CCRs in FY 2008, to those believing that the regression-based CCRs should be delayed for at least a year, if used at all. Because of concerns that we and some commenters continue to have about premature adoption of the regression-based CCRs without the benefit of knowing how they will interact with other DRG changes, and the arguments in the comments summarized above concerning cost and claims reporting, we have decided to finalize our proposal to not implement the four regression-based CCRs for medical supplies and devices, IV drugs, and radiology (MRI and CT scans) for FY 2008. However, as we explain in more detail in response to comments below, we are adopting the two cost report-based CCRs for “Emergency Room” and “Blood and Blood Products” for a total of 15 national average CCRs for FY 2008. We believe these changes to the relative weight methodology do not have the disadvantages that are of concern to the commenters. That is, recognizing these additional departments will allow us to use information that is already being reported by hospitals in their cost reports and adopt some of the changes being recommended by RTI without going to a regression-based model at this time.

Many of the concerns in the comments summarized above related to how hospitals' report costs and charges on the cost report and how hospitals include charges on their bills for inpatient services or the way the charges are grouped in the MedPAR. RTI indicated that more precise cost reporting is the best solution to address the issue of charge compression in the long term. Many commenters believed that rather than rely on increased edits and audits to resolve the lack of uniformity in cost reporting, hospitals must be educated to report costs and charges in a manner that is consistent with the way in which MedPAR groups charge, and the commenters were launching an educational campaign accordingly. We agree with the educational initiative of these commenters. Participation in these educational initiatives by hospitals is voluntary. Hospitals are not required to change how they report costs and charges if their current cost reporting practices are consistent with rules and regulations and applicable instructions. However, to the extent allowed under current regulations and cost report instructions, we encourage hospitals to report costs and charges consistently with how the data are used to determine relative weights. We believe achieving this goal is of mutual benefit to both Medicare and hospitals.

The commenters also suggested that CMS should inform the fiscal intermediary/MAC that hospitals may be changing their cost reporting and allocation methodologies in response to the educational initiative, that such action is encouraged, and that more Start Printed Page 47193audit resources should be allocated to fiscal intermediaries/MAC to ensure that any new cost reporting instructions are being implemented properly. First, we intend to notify the fiscal intermediaries/MAC of this cost reporting educational initiative subsequent to the issuance of this final rule with comment period, and provide both fiscal intermediaries/MAC and hospitals with guidance on how to address requests for changes in cost reporting practices from hospitals. Second, each hospital that wishes to change its cost reporting practices must follow the directives at § 413.53(a)(1) of our regulations and PRM-1, section 2203, regarding matching the charges to the costs reported in each cost center. We recommend that the hospital also disclose the changes made in a cover letter with the submission of the cost report.

Commenters submitted suggestions about how MedPAR could be modified to further distinguish categories of charges. As we stated in the proposed rule, we will consider suggestions for adding additional revenue codes to MedPAR in conjunction with other competing priorities for our information systems. We cannot create additional revenue codes. Requests for new revenue codes on hospital bills have to be made to and approved by the National Uniform Billing Committee (NUBC).

Comment: Some commenters were uncertain whether RTI's recommendations to expand certain cost categories through regression analysis is the appropriate solution to address the issue of charge compression and potential inconsistencies in how hospitals report costs and charges. The commenters supported the expansion of categories to include CCRs based on cost centers that already exist on the cost report, such as emergency department and blood products, and possibly others after further examination. Another commenter stated that creating a CCR for blood and blood products will reflect more accurately the cost of blood and will help ensure future IPPS updates will account more adequately for these products. Although one commenter understood that CMS has not been able to analyze the effect of implementing the regression adjustments with the proposed MS-DRGs, the commenter believed that CMS should adopt RTI's adjustment to the CCRs for drugs and IV solutions for FY 2008, and subsequently analyze and report on the effects of this adjustment on MS-DRGs. Another commenter noted that while the RTI regression estimates provide a practical short-term approach to address charge compression for drugs, supplies, and radiology revenue cost centers, this method does not identify all of the charge compression that occurs at each hospital in these revenue centers, nor does it address charge compression that may be occurring in other revenue centers such as cardiology, or the routine and intensive care revenue cost centers where nursing costs per day are currently treated as if they were uniform across patient categories.

Another commenter also asked that CMS remember that the primary use of the cost report is to determine a hospital's costs of treating Medicare patients. The commenter noted that the cost report is still used for cost-based payment for many hospitals, such as CAHs, SCHs, and MDHs, and many State Medicaid plans and other payers also rely on data from the cost report to determine payment rates. Because of these uses, the commenters asked CMS to proceed cautiously with changing the cost report to avoid unintended consequences for hospitals where the cost report determines a significant portion of current payment. The commenter offered its services in reviewing and discussing cost report changes that Medicare may propose. Another commenter recommended that CMS work with hospital finance experts so the most appropriate and accurate instructions are issued, with very specific instructions as to where services are to be classified on the cost report and that subcategories should be eliminated.

Another commenter did not support RTI's recommendations for revising the cost reports to reduce cost and charge misalignment and to create new cost centers because of “the enormous amount of work hospitals would have to perform” to change internal operations and data collection to accommodate the revisions. The commenter expressed concern that this would lead to “rising inefficiency and administrative costs.” This commenter, and others, believed that “clear, detailed instructions from CMS” would be needed to differentiate between a “device,” “implant,” or “IV solution,” and other “new nomenclature that distinguishes and separates tens of thousands of items and drugs, for instance, implantable spinal screws, bandages and bone cement, into specific cost centers” would be necessary.

Response: As we noted in the proposed rule and in response to comments above, we believe that RTI's regression-based CCRs may be a promising means for addressing charge compression in the short term. However, because we do not yet know how the additional regression-based CCRs would interact with the MS-DRGs or with the HSRV methodology, and the significant concerns raised by a number of commenters about adopting regression-based CCRs, we are not adopting the adjustments to address charge compression in the FY 2008 IPPS final rule. We note RTI's long-term recommendations suggest addressing charge compression through adding new cost centers to the cost report and undertaking additional activities such as improvements in how hospitals report costs and charges. Thus, we believe that RTI and many of the public comments conclude that ultimately improved and more precise cost reporting is the best way to minimize charge compression. While we are not adopting the regression-based adjustments to address charge compression, we believe that the FY 2008 IPPS final rule relative weights should take advantage of additional information that is already reported on the cost report. Because the cost report currently allows for the creation of specific CCRs for Emergency Room and Blood and Blood Products, and some commenters expressed explicit support for expanding the number of CCRs based on cost centers that already exist on the cost report, we have decided to separate Emergency Room costs and charges and Blood and Blood Products costs and charges from the current “Other Services” CCR for the purposes of calculating the cost-based portion of the FY 2008 relative weights. That is, in accordance with RTI's short-term recommendation, for FY 2008, we are adding two additional CCRs to the current list of 13 CCRs, for a total of 15 CCRs. We are using line 61 on Worksheets C, Part I and D-4 to create the Emergency Room CCR and lines 46 and 47 on Worksheets C, Part I and D-4 to create a CCR for Blood and Blood Products. We are modifying the table listing the 15 cost center groupings in section II.H. of the preamble of this final rule with comment period accordingly.

With respect to the commenters that asked CMS to remember that the primary use of the cost report is to determine a hospital's costs of treating Medicare patients, we intend to proceed cautiously as the commenters suggest. To the extent that the cost report changes that we make improve consistency and accuracy of cost reporting, these benefits will extend to providers whose payments are based on reasonable costs (CAHs) or otherwise use the cost report to determine hospital-specific rates (SCHs and MDHs). As we stated above, we intend to work with finance and cost report experts in the hospital community if we Start Printed Page 47194decide to modify the cost report or its instructions to address issues with the DRG relative weights. We also understand that hospitals may be concerned about the resources that may be required to adapt to potential cost report changes. Any changes that would be made to the Medicare cost report would be done under the Paperwork Reduction Act and, by law, could not be undertaken without considering the burden that would be imposed on all hospitals.

Comment: Some commenters supported making adjustments to address charge compression. These commenters noted that charge compression was first identified in 2000 and MedPAC and other researchers have also recognized this issue. The commenters recommended implementation of a regression-based adjustment in the FY 2007 final rule and stated that this methodology has been evaluated and validated through RTI's study. Many commenters believe that RTI's results provide ample evidence of charge compression that justifies the implementation of their recommendations for the FY 2008 final rule. Furthermore, commenters stated that RTI's regression-based adjustment is appropriate and can be implemented immediately without any administrative burdens to the hospital. Several commenters emphasized that CMS should make it a priority to apply the regression methodology to the Medical supplies CCR. These commenters noted that in the proposed rule, CMS stated: “of all the adjusted CCRs, the largest impact on weights came from accounting for charge compression in medical supplies for devices and implants,” which demonstrates that a regression approach should be applied at least to disaggregate the medical supplies category into one CCR for “Devices and Implants” and a separate CCR for “Other Supplies.”

One commenter disagreed with the reasons CMS expressed in the proposed rule for delaying implementation of RTI's recommendations, and found them to be “rather insubstantial.” The commenter did not believe that the combined impact of RTI's recommendations and the proposed MS-DRGs need to be studied before CMS could proceed with implementing the regression-based CCRs. The commenter noted that the relative independence of RTI's recommendations from the proposed MS-DRG changes was confirmed by a study commissioned by AdvaMed. The commenter also stated that the fact that RTI's analysis only included inpatient claims is relatively insignificant. The commenter believed that if further adjustments need to be made to incorporate outpatient claims into the regression estimate next year, they can be done with a fairly minor impact. This commenter, and others, urged CMS to implement a regression that uses both inpatient and outpatient claims when making an adjustment for charge compression for the CY 2008 OPPS, and use the same regression in subsequent years for both the IPPS and OPPS.

Another commenter stated that, although it understood that CMS wishes to understand the various interactions of regression-based CCRs with other aspects of the IPPS, the effect of charge compression is “demonstrable and measurable” and should be implemented in FY 2008 for the “sake of payment accuracy.” Another commenter stated that CMS' concern about the interaction between addressing charge compression and other proposed changes appeared “disingenuous, as CMS is proposing so many changes that the interaction of the various components cannot be estimated.” The commenter also questioned CMS' hesitation to make changes to the cost report to accommodate RTI's recommendation due to limited information system resources, time constraints, and inconvenience. The commenter asserted that “hospitals find the defense of scarce resources, compressed implementation lead times and cost justification vis-a-vis outcomes an interesting option for CMS given the fact that it is manifestly unavailable to hospitals who have similar issues.”

Response: We disagree with the notion of the commenter that found us to be “disingenuous” because the “interaction of various components [of the IPPS] cannot be estimated.” We refer the commenter to the payment impact section of the IPPS proposed rule (72 FR 25119) and this final rule with comment period as well as the FY 2007 IPPS proposed rule (71 FR 24025) where we simulate the interaction of a number of different payment reforms including the adoption of cost-based weights, severity DRGs, and other changes. We note that for some categories of hospitals, the impact of adopting MS-DRGs is significant. The RTI work suggests that further changes to the relative weights will also be significant and potentially result in additional redistributions of Medicare payment. In our view, the “interactions of various components” can be determined and before we adopt potential policy options in a final rule, the public should be fully informed on the potential impacts. As we discussed in the FY 2008 proposed rule, we have concerns about implementing regression-based CCRs in the final rule without specifically proposing them because of concerns about how these changes would interact with the transition to MS-DRGs, the calculation of cost-based relative weights, and possibly the HSRV method.

Despite the commenters' support for the regression-based CCRs, we are still concerned about the accuracy of using regression-based estimates to determine relative weights rather than the Medicare cost report. Many public commenters, including several national hospital associations, shared these same concerns. However, we believe that more specific CCRs will improve payment accuracy for several DRGs. Therefore, as we stated above, we are implementing RTI's recommendation to expand the current 13 CCRs to 15 CCRs without the use of a regression-based adjustment.

In the proposed rule, we indicated there was insufficient time to assess how RTI's recommendations may interact with other potential changes to the DRGs and to the method of calculating the DRG relative weights. We noted that RTI's study examined charge compression within Version 24.0 of the CMS DRGs, and we could not examine their interactive effects with the MS-DRGs and be able to timely publish the FY 2008 proposed rule. For this reason, we requested public comment on whether to adopt these changes in the final rule without having fully analyzed them for the proposed rule. While there was strong support for adopting the regression-based charge adjustments in these comments, many other commenters believed that we should provide the public with modeled payment impacts and an opportunity to comment before implementing regression-based CCRs.

We are also continuing to consider whether to adopt an HSRV payment methodology for FY 2009. We anticipate undertaking further analysis of the HSRV methodology and would like to incorporate RTI's recommendations into that analysis. Although its evaluation of alternative severity DRG systems is complete, we are currently working with RAND to study the HSRV methodology. Furthermore, we continue to believe that adjusting for charge compression and later adopting the HSRV methodology could create payment instability over the next 2 years and it would be preferable to consider simultaneously adopting these changes.

Finally, if we were to adopt adjustments for charge compression, the preferred approach would be to apply Start Printed Page 47195the regression method to the combined inpatient and outpatient services. The RTI report discussed the notion that separating services that are generally delivered in outpatient settings might improve the accuracy of CCRs for inpatient services, and these areas include therapeutic radiology, nuclear medicine, chemotherapy, electroconvulsive therapy and outpatient surgery. RTI noted that while these charges are not significant under the IPPS, aggregation bias may be present in these outpatient services which would affect the overall department CCR. Therefore, we will consider expanding our analysis to include outpatient services.

Comment: One commenter urged CMS to separately distinguish intermediate (step-down) level nursing care costs. Another commenter argued that it is illogical that nursing costs are reflected in the relative weights only through flat room and board charges, given that nursing care is a variable, rather than a fixed cost. The commenter asserted that, as a result, a significant amount of money is being misallocated across hospitals for required nursing care. The commenter urged CMS to give serious consideration to the RTI report's recommendation to establish study groups and research options for improving patient-level charging within nursing units, as the outcomes could improve precision in relative resource weights without adding substantial administrative costs to either Medicare or to hospitals. Specifically, the commenter strongly supported the creation of a separate direct and indirect cost center at each hospital and the inclusion of these data in the annual Medicare cost report, the reporting and collection of nursing intensity data, and adjustment of the Medicare payment for severity of illness by modifying the proposed APR DRG severity adjustment formula to incorporate nursing intensity and cost within each diagnosis and severity category. The commenter also mentioned the New York State Medicaid model, which was the first prospective payment system to recognize and reimburse for relative nursing resource consumption levels among DRGs through the use of Nursing Intensity Weights (NIWs). The NIWs, which were developed by an expert panel, have been reevaluated and updated periodically to maintain consistency with changes in the DRG definitions. The commenter recommended that, because this program has been successfully implemented in a large state for a number of years, a Medicare demonstration project based on this model should be launched.

Response: The commenters' raise interesting concerns related to nursing costs that are variable but are reflected in the DRG weights only as fixed costs through flat room and board charges. There are currently no detailed charge codes that can be used to distinguish the intensity in nursing services provided by type of patient. In its report, RTI noted “because intensity of nursing is likely correlated with DRG assignment, this could be a significant source of bias in DRG weights.” Particularly because nursing comprises such a significant portion of hospital costs and charges, we agree that this issue should be further studied. We are interested in knowing whether the public has any ideas for how the relative weight methodology can systematically recognize and reimburse for differences in nursing resource consumption provided across hospital inpatients. We will consider whether we should study the possibility of using NIWs to recognize nursing intensity in the DRG relative weights.

Comment: Commenters supported adopting the regression CCRs to alleviate charge compression, but some commenters were concerned that the application of this adjustment methodology to capital intensive radiology services is premature and requires additional analysis. The commenters noted that the RTI report found that within the Radiology CCR, CT scanning and MRI have higher markups and lower CCRs than the remaining radiology services. Implementing RTI's recommendation to apply a regression method to split Radiology into one CCR each for MRIs, CT scans and Other Radiology could potentially result in lower CCRs for the CT and MRI categories. One commenter cited an analysis conducted by Direct Research, LLC, that found that the majority of hospitals do not allocate the capital costs of MRI and CT scan machines to the radiology cost center. Rather, the capital costs could be allocated more broadly across hospital services on a square footage basis. However, the commenter noted that RTI's analysis for radiology services assumes a detailed capital allocation for these services that results in differential CCRs found in MRIs and CT scans, which the commenter suggested is actually not found in the data. Therefore, the commenters requested that the regression-based CCRs for radiology not be adopted at this time.

Response: We appreciate the comment on the limitations of the regression-based CCR on radiology. This is another example of how changes to cost reporting can potentially improve the accuracy of CCRs for radiology and other departments. In our view, the commenter raises another issue that requires additional analysis before we adopt regression-based adjustments to address charge compression.

Comment: One comment addressed our proposal to move cost report line 54 for EEG out of the Cardiology cost center group into the Laboratory cost center group. The commenter noted that where providers elect to report EEG separately on line 54, this seems appropriate. However, some providers combine EEG with EKG on line 53 (usually because the EEG services are purchased as outside services and not a separate cost center for the hospital). In those instances, moving only the EEG costs would be impossible. The commenter noted that CMS did not indicate what portion of providers separately report EEG services on line 54, but the commenter was concerned that there will be continued mismatching under either grouping. The commenter encouraged CMS to consider expanding the MedPAR database to include separate fields for all revenue codes so that detailed analyses and accurate matching of costs and charges can be performed. The commenter also concurred with CMS' recommendation to move radioisotope costs to the radiology services grouping and out of “other services.”

Response: We responded earlier that suggestions for adding additional revenue codes to MedPAR will be considered in conjunction with other competing priorities for our information systems. In the FY 2008 proposed rule, we decided to move the costs for cases involving EEG from the Cardiology cost center group to the Laboratory Cost center group to maintain consistency with their corresponding EEG MedPAR claims, which are categorized under Laboratory charges. Although the commenter indicated that hospitals may be combining EEG costs with EKG costs on line 53 instead of reporting it as a separate cost on line 54, we believe the MedPAR is clear in categorizing EEG claims under revenue codes 0740 and 0749, and therefore, costs for EEG should be reported on line 54 of the cost report as well. For this reason, we are finalizing our proposal to move the costs for cases involving EEG from the Cardiology cost center group to the Laboratory Cost center for purposes of calculating the DRG relative weights. As described in the FY 2008 IPPS proposed rule, we will also calculate the DRG relative weights for FY 2008 by moving radioisotype costs from the Other Start Printed Page 47196Services CCR to the Radiology Services CCR.

Comment: One commenter was concerned that hospitals do not have consistent charging and billing practices on an inpatient and outpatient basis for the administration of medications by injection and/or infusion at the bedside.

Response: We did not propose any changes on this issue. However, we will consider this issue as we research potential improvements that can be made to how hospitals report costs and charges.

Comment: One commenter stated that it believed it is important for CMS to explicitly recognize the “limitations” of the cost-based weighting methodology and its applicability to non-Medicare patients because this is a “major precedent setting change for the entire hospital field.” The commenter stated that in studies that it conducted, it found that the use of departmental CCRs presents a bias in that the higher unit costs of services provided to children that are labor intensive in terms of nursing and respiratory therapy are not reflected in the department-wide CCRs. The commenter requested that, at a minimum, CMS recognize in the final rule that there are cost issues in the Medicare CCR methodology that have implications for non-Medicare patient populations.

Response: The cost-based relative weights were developed solely using Medicare data. We do not have non-Medicare data that can be used to set DRG relative weights. For this reason, we are concerned that non-Medicare payers may be using our payment systems and rates without making refinements to address the needs of their own populations. As stated earlier, we encourage non-Medicare payers to adapt the MS-DRGs and the relative weight methodology to better serve their needs.

Among its other short-term recommendations, RTI also suggested that we incorporate edits to reject or require more intensive review of cost reports from hospitals with extreme CCRs. This action would reduce the number of hospitals with excluded data in the national CCR computations, and would also improve the accuracy of all departmental CCRs within problem cost reports by forcing hospitals to review and correct the assignment of costs and charges before the cost report is filed. Although we do not have a substantive disagreement with the recommendation, we generally focus our audit resources on areas in which cost report information directly affects payments to individual providers.

RTI further suggested revising cost report instructions to reduce cost and charge mismatching and program charge misalignment in its short-term recommendations. Although RTI suggests such an action could be immediately effective for correcting the reporting of costs and charges for medical supply items that are now distributed across multiple cost centers, we note that changes to improve cost reporting now will not become part of the relative weights for several years because of lags between the submission of hospital reports and our ability to use them in setting the relative weights. Currently, we expect there will continue to be a 3-year lag between a hospital's cost report fiscal year and the year it is used to set the relative weights. Thus, even if it were possible to issue instructions immediately beginning for FY 2008, revised reporting would not affect the relative weights until at least FY 2011. Nevertheless, we agree with this recommendation, and in the proposed rule, we welcomed public input on potential changes to cost reporting instructions to improve consistency between how charges are reported on cost reports and in the Medicare claims. We indicated that we would consider these changes to the cost reporting instructions as we consider further changes to the cost report below.

In the summary of the comments above, we stated that some commenters believed that RTI's recommendation to incoporate edits to reject cost reports or require more intensive audits will not solve the mismatch problem because hospitals' reporting is consistent with cost reporting instructions. The commenters instead recommended that hospitals be educated to report costs and charges in a manner that is consistent with how MedPAR groups charges. However, other commenters supported more intensive auditiing of cost reports. In response to these comments, we stated above that we agree with the initiative to educate hospitals to improve cost reporting and that we intend to inform the fiscal intermediaries/MAC of this educational initiative. We also stated that we intend to provide the fiscal intermediaries/MAC of this educational initiative. We also stated that we intend to provide fiscal intermediaries/MAC and hospitals with guidance on how to address requests for changes in cost reporting practices from hospitals.

Comment: Some commenters supported the use of the Standard Analytic File (SAF) to calculate CCRs, as used by RTI in its study, as the SAF provides more detailed charge data on supplies, drugs and radiology services, which would improve the payment accuracy for those revenue centers with significant charges.

Response: We appreciate the comment on the use of the SAF to calculate national CCRs. The RTI study used the SAF to extract detailed charge information for selected revenue codes with potential aggregation bias and used this information in the creation of the synthetic CCRs. However, because we are not expanding the CCRs using regression adjustments for FY 2008, it is not necessary to use the SAF to compute the relative weights in this final rule with comment period. Rather, we are using the FY 2006 MedPAR file and FY 2005 hospital cost reports to calculate the national CCRs.

Comment: Many commenters noted that, while the proposed rule seems to suggest that methods of addressing charge compression should be considered together with implementation of an HSRV methodology, these two issues (charge compression and HSRV) need not and should not be linked. The commenters reiterated their opposition to implementation of the HSRV methodology, as previously expressed in comments on the FY 2007 proposed rule, arguing that the method is flawed and may even introduce more bias into the relative weight calculations. Another commenter (who also opposed implementation of the HSRV methodology) stated that should the HSRV method be implemented, many DRG weights could move in one direction if the charge compression adjustments were implemented in FY 2008, and then move in the other direction if the HSRV method were to be implemented in FY 2009. This commenter requested that CMS delay both changes for at least one year, and implement the HSRV method and the regression-based CCRs only after issuing a formal proposal with a thorough analysis that is made available to the public for review and comment. One commenter stated that the RTI revisions should be reviewed in combination with the severity-based system recommended by RAND and should not be adopted in FY 2008. The commenter stated that CMS and the provider community should evaluate these recommendations and implement them together in FY 2009. One commenter stated that the combined use of hospital-specific charges and a national CCR will result in a distortion of the DRG weights and a shifting of Medicare payments among hospitals, not based on resource utilization, but rather on a mathematical calculation. This commenter recommended that CMS review the impact of using hospital-specific Start Printed Page 47197charges and costs to determine whether the national CCR has created inaccurate DRG weights.

MedPAC commented that adopting cost-based HSRV weights would result in substantial additional improvements in payment accuracy. MedPAC believed that the HSRV methodology removes all of the differences in the level of costs across hospitals, and is preferable to CMS’ current method used for standardization, which is incomplete and introduces avoidable errors into the computation of payment weights. Two other commenters supported the adoption of the HSRV methodology and strongly opposed the current methodology and believed it is flawed for the following reasons: (1) The proposed formula derives a national average charge based on all hospitals being weighted equally, which disadvantages hospitals located in historically “low charge” States, and results in small, rural hospitals carrying the same weight as large, urban hospitals; (2) The data being used are outdated and do not reflect the cost of new technology; (3) Costs in excess of 25 percent are omitted by CMS from “high cost” hospitals in the cost base, while leaving in all of the charges from those same “high cost” hospitals and assigning a relative value on reduced costs. Since the costs are being excluded, but not the charges, there is a corresponding mismatching of revenues and costs; (4) The data contain only audited data, and hospitals that have not been audited would not be included in the data.

These two commenters stated that CMS should test the sensitivity of weights using various methodological assumptions and share the resulting data with the public. The commenters requested that CMS should “strive” to create a system that improves payments and does not include the “obvious flaws” listed above.

Response: Many commenters expressed their concerns and opposition to the HSRV methodology last year. As we explained in response to those comments in the FY 2007 IPPS final rule, we decided not to adopt the HSRV methodology to standardize charges for FY 2007 but stated that we would undertake further analysis of the method. As we indicated in the FY 2008 IPPS proposed rule, we engaged RAND as the contractor to study alternative DRG systems. The second phase of the RAND study will include evaluating the HSRV methodology; the evaluation report will not be available until after the issuance of this final rule with comment period. Therefore, we will consider those results as we plan changes as part of the FY 2009 IPPS rulemaking process. We intend to carefully analyze how the relative weights would change if we were to adopt regression-based CCRs to address charge compression while simultaneously adopting an HSRV methodology using fully phased-in MS-DRGs. Although many commenters do not believe that the HSRV methodology and addressing charge compression should be linked, we believe, as did one commenter, that sequentially adjusting for charge compression and later adopting the HSRV methodology could create instability in IPPS payments over the next 2 years. Accordingly, we intend to include a detailed description and discussion of RAND's and any other analyses that we may undertake on these issues in the FY 2009 IPPS proposed rule.

In response to the commenters who supported adopting the HSRV methodology and believed it superior to the method used by CMS currently, in the FY 2007 IPPS final rule (71 FR 47883), we stated that there are certain administrative difficulties with adjusting charges to costs using hospital-specific CCRs. Therefore, at least until we have the opportunity to analyze the results of RAND's analysis, we are utilizing national average CCRs to determine cost. We also do not believe that the use of hospital-specific charges together with national average CCRs redistributes Medicare payments among hospitals merely based on a mathematical calculation, as one commenter indicated. On the contrary, a system that improves payment accuracy and moderates the influence of individual hospital reporting practices on a national payment system is not one which haphazardly redistributes payments. We note that, in a report issued in July 2006, the GAO found that CMS's system of national CCRs shows promise to improve payment accuracy because it reduces the impact that individual hospital-reporting practices has on the DRG relative weights (GAO-06-880, “CMS's Proposed Approach to Set Hospital Inpatient Payments Appears Promising”). With respect to the commenters' concerns regarding inappropriate “equal weighting” of hospitals, under CMS' current methodology for computing national CCRs, these concerns were addressed in last year's IPPS final rule. The national CCRs are the sum of all costs divided by the sum of all charges. Thus, all hospitals are not weighted equally. Larger hospitals will have more weight than smaller hospitals in the final CCR calculation.

In response to the commenters' concerns that the data are outdated and do not reflect the costs of new technology, there is an inevitable lag between the availability of information from hospital claims or cost reports and the time it can be used to determine relative weights. We always use the most recent data available to set relative weights. Furthermore, as we noted in the FY 2007 IPPS final rule, CMS' current method of using national average CCRs eliminates the need to match claims (for FY 2008, the 2006 MedPAR) to the time period of the CCRs (for FY 2008, FY 2005 HCRIS), which would be necessary under an HSRV method that uses hospital-specific CCRs. Thus, we can use claims data from one year later under our cost-based weighting methodology. We also note that add-on payments made for the latest advancements in medical technologies may not be included in the 2-year-old hospital claims data that are used to set the relative weights.

Regarding the comments stating that CMS mismatches revenues and costs by omitting excessive costs from “high cost” hospitals in the cost base, while leaving in the charges from those same “high cost” hospitals, we note that this is not actually the case. If a hospital's costs are dropped from the national average CCR calculations, the hospital's charges are also dropped from the national average CCR calculations. Lastly, the commenters' assertion that the cost report data used for CCRs include only audited data is incorrect. If the commenters are referring to the cost report data that CMS uses to calculate the national average CCRs, we note that in accessing data for IPPS hospitals from HCRIS, we select all IPPS hospitals, and do not only select hospitals whose cost reports are audited.

Comment: MedPAC submited comments on the method we use to calculate the national CCRs for the cost-based relative weights. The methodology to calculate the national CCRs is described in section II.H. of the preamble of this final rule with comment period. MedPAC suggested that we standardize the Medicare charges and costs used to calculate the national CCRs from the Medicare cost reports to adjust for differences in local wage levels, IME, and DSH. The standardization would be consistent with the use of national standardized charges by revenue center also used in the calculation of cost-based relative weights from the MedPAR.

Response: While we did not propose any changes to the cost-based relative weights methodology, we appreciate the comment on maintaining consistency Start Printed Page 47198among our data sources. Although we currently standardize charges from the MedPAR file when calculating relative weights, we do not standardize costs and charges from hospital cost reports, as MedPAC recommended. We may consider this recommendation as we continue to refine our methodology for calculating relative weights. However, we note that there would be no need to standarize costs and charges from hospital cost reports under an HSRV methodology.

b. Medium-Term Recommendations

RTI recommended that we expand the MedPAR file to include separate fields that disaggregate several existing charge departments. For compatibility with prior years' data, the new fields should partition the existing ones rather than recombine charges. RTI recommended including additional fields in the MedPAR file for the hospital departments that it statistically disaggregated in its report, as well as intermediate care, observation beds, other special nursing codes, therapeutic radiation and EEG, and possibly others. As with some of RTI's earlier recommendations with respect to cost reports, we will examine this suggestion in conjunction with other competing priorities CMS has been given for our information systems. We have limited information systems resources, and we will need to consider whether the time constraints we have to develop the IPPS final rule, in conjunction with the inconvenience of using the SAF and accounting for charge compression through regression, will justify the infrastructure cost to our information systems of incorporating these variables into the MedPAR.

Finally, RTI's medium-term recommendations include encouraging providers to use existing standard cost centers, particularly those for Blood and Blood Administration and for Therapeutic Radiology, in the current Medicare cost report. We believe this is closely related to the recommendation for improved cost reporting instructions. Therefore, we will consider this recommendation as part of any further effort we may undertake to revise cost reporting instructions or change the cost report.

Comment: Some commenters supported expanding the MedPAR file to include separate fields to disaggregate additional cost centers. One commenter supported this recommendation and suggested that the assignment of revenue codes and charges to revenue centers in MedPAR should be reviewed and changed to better reflect hospital accounting practices as reflected on the Medicare cost report.

Response: We will consider suggestions for modifying MedPAR in conjunction with other competing priorities we have for our information systems. Further, while we support the efforts of the national hospital associations to streamline hospital's reporting practices, we note that CMS does not instruct hospitals in the appropriate revenue codes to use because hospitals have discretion as to where and how they allocate charges based on their own financial system needs.

c. Long-Term Recommendations

RTI's long-term recommendations include adding new cost centers to the Medicare cost report and/or undertaking the following activities:

  • Add “Devices, Implants and Prosthetics” under the line for “Medical Supplies Charged to Patients.” Consider also adding a similar line for IV Solutions as a subscripted line under the line for “Drugs Charged to Patients.”
  • Add CT Scanning and MRI as subscripted lines under the line for “Radiology-Diagnostic.” About one-third of hospitals that offer CT Scanning and/or MRI services are already reporting these services on nonstandard line numbers. More consistent reporting for both cost centers would eliminate the need for statistical estimation on the radiology CCRs.
  • In consultation with hospital industry representatives, determine the best way to separate cardiology cost centers and add a new standard cost center for cardiac catheterization and/or for all other cardiac diagnostic laboratory services. About 20 percent of hospitals already include a nonstandard line on their cost reports for catheterization. Creating a new standard cost center could improve consistency in reporting and substantially improve the program charge mismatching that now occurs.
  • In consultation with hospital industry representatives, consider establishing a new cost center to capture intermediate care units as distinct from routine or intensive care.
  • Establish expert study groups or other research vehicles to study options for improving patient-level charging within nursing units. Nursing accounts for one-fourth of IPPS charges and 41 percent of the computed costs from our claims analysis file. Historically, nursing charges and costs have been assigned to patients without relying on individual measures of service use. Consideration should be given to finding ways to improve precision in nursing cost finding that will improve relative resource weights without adding substantial administrative costs to either the Medicare program or to hospitals.

We agree with RTI that attention should be paid to these issues as we consider changes to the Medicare cost report. The cost report has not been revised in nearly 10 years. During this time, there have been significant changes to the Medicare statute and regulations that have affected the Medicare payment policies. Necessary incremental changes have been made to the Medicare cost report over the years to accommodate the Medicare wage index, disproportionate share payments, indirect and direct graduate medical education payments, reporting of uncompensated care costs, among others. The adoption of cost-based weights for the IPPS beginning in FY 2007 has brought further attention to the importance of the Medicare cost report and how hospitals report costs and charges. We recently began doing a comprehensive review of the Medicare cost report and plan to make updates that will consider its many uses. As we update the cost report, we will give strong consideration to RTI's recommendations and potential long-term improvements that could be made to the IPPS cost-based relative weighting methodology.

Comment: Several commenters made recommendations for how the relative weights would be calculated under a 3-year transition from the current DRGs to the new MS-DRGs. Some commenters suggested three options as follows:

(1) Use two GROUPERs (CMS DRGs and MS-DRGs) and then blend the weights for each individual case.

(2) Blending current DRG weights with MS-DRG weights: To calculate a blended cost-based weight, CMS could first calculate cost-based weights using the current DRGs. CMS could then calculate cost-based weights using the MS-DRGs. The blended weight for each MS-DRG would be based on the weighted average relative weights (based on the current DRGs from which cases group into the new MS-DRGs) and the MS-DRG weight. Under this approach, CMS would continue to calculate cost-based weights for the current DRGs during the first 2 years of the transition period. This approach recognizes that a case has different relative weights in the new system versus the current DRG system.

(3) Blending MS-DRG base and severity level weights: CMS would blend the actual MS-DRG weight with the weight of the base MS-DRG. The base MS-DRG weight is determined by Start Printed Page 47199using expected case mix volume among severity levels. For example, if an MS-DRG was subdivided into two subgroups: with the non-CC DRG accounting for 90 percent of the cases and the other 10 percent in the CC DRG, these ratios would be used to blend the base and the DRG-specific weight. Under this approach, CMS would not have to calculate weights using two different DRG systems. On the other hand, this approach does not use the current system when calculating the blended rates.

The commenters noted that while option 1 would provide the most accurate blended weights, it is the most burdensome to implement because it would require use of two GROUPERs, whereas under options 2 and 3, CMS would only use the blended relative weights, allowing hospitals and Medicare contractors to use only one grouping software.

MedPAC suggested that CMS adopt a 2-year transition period for MS-DRGs to coincide with the remainder of the current transition period for implementing cost-based weights, so as to “balance the payment impacts of implementing severity refinements and cost-based weights.” MedPAC suggested that a 2-year transition might work as follows: CMS could group cases using the MS-DRG grouper beginning in FY 2008, but then use a blended weight for each category. The blended weight for an MS-DRG would reflect partly the weight that would have been assigned under an MS-DRG system with fully implemented cost-based weights. The weight for each MS-DRG in FY 2008 would be a blend of two parts:

  • 50 percent of the average DRG weight that would have been attached to cases in the MS-DRG from the 2006 MedPAR file under a policy of 1/3 charge-based weights and 2/3 cost-based weights. These DRG weights are the ones that would have applied to the same cases under the FY 2008 policy if CMS simply continued the transition to cost-based weights without changing the DRG definitions.
  • 50 percent of the CMS refined weights for the MS-DRG for FY 2008. In FY 2009, cases would be grouped in the MS-DRGs and the weight for each MS-DRG would be a 100 percent cost-based weight.

Response: We have carefully considered each comment in determining whether there should be a transition period for the relative weights computed using MS-DRGs, the length of the transition and how to compute weights during the transition. We also considered how to accommodate a transition to MS-DRG relative weights with the continuing transition to cost-based weights. Although we received strong general support for adopting the MS-DRGs, we do believe that some transition is warranted to mitigate the magnitude of potential changes in payment to hospitals that could occur in one year. Furthermore, we agree with MedPAC that a two-year transition period that coincides with the remainder of the transition period for implementing cost-based weights is appropriate. By having these changes occur simultaneously over the same transition period, we can avoid having large changes in payment that would occur with sequential implementation. Further, we can also accomplish all of the payment reforms according to the same schedule. Accordingly, we are implementing a 2-year transition to MS-DRGs. For FY 2008, the first year of the transition, 50 percent of the relative weight for each MS-DRG will be based on the CMS DRG relative weight and 50 percent will be based on the MS-DRG relative weight. In FY 2009, the relative weights will be based entirely on the MS-DRG relative weight. The blended relative weights for FY 2008 are computed as follows:

First, using the Version 24.0 GROUPER, relative weights are calculated based on 100 percent costs and 100 percent charges, respectively (see section II.H. of the preamble of this final rule with comment period for a description of the cost- and charge-based calculations). Then these weights are blended using two-thirds of the cost-based weights and one-third charge-based weights to establish the CMS DRG portion of the transition weights.

Second, using the Version 25.0 GROUPER, relative weights are calculated based on 100 percent costs and 100 percent charges, respectively (see section II.H. of the preamble of this final rule with comment period for a description of how we compute cost-based and charge-based weights). These weights are then blended using two-thirds of the cost-based weights and one-third charge-based weights to establish the MS-DRG portion of the transition weights.

Under the transition blend we are adopting in this final rule with comment period, we group cases to MS-DRGs (using the Version 25.0 GROUPER), but the payment weight for each DRG is a 50/50 blend of the MS-DRG weight and the CMS DRG weight. Thus, we had to determine a blended weight for each DRG. Using the claims in the FY 2006 MedPAR database that we used to compute cost-based weights under the Version 24.0 GROUPER, we grouped each case to a CMS DRG (using the Version 24.0 GROUPER) and an MS-DRG (using the Version 25.0 GROUPER). Commonly, a set of cases that grouped to a single MS-DRG grouped to two or more CMS DRGs. Therefore, we determined an average CMS DRG weight for all cases that grouped to each MS-DRG. Specifically, we summed the CMS DRG weights of all the cases that grouped to each MS-DRG and then divided that number by the transfer-adjusted case count. To establish the final blended weight for each DRG, we added 50 percent of the MS-DRG weight to 50 percent of the average CMS DRG weight for that MS-DRG. These final blended relative weights are listed in Table 5 of this final rule with comment period.

Comment: Some commenters expressed concern about the continued transition from charge-based weights to cost-based weights, in light of RTI's recommendations to alleviate charge compression on the relative weights and the proposal to introduce MS-DRGs. For FY 2008, we proposed that the relative weights would be based on one-third charges and two-third costs. Some commenters suggested that this transition should be delayed until the public comments associated with cost reporting and charge compression can be addressed. We have also received comments expressing concern on the potential fluctuations in hospital payment if we were to implement both RTI's recommendations on charge compression along with the MS-DRG system. In both cases, commenters suggested delaying the transition from charge-based to cost-based weights by maintaining the relative weights at two-third charges and one-third costs. MedPAC also expressed concern about continuing the transition to cost-based weights. However, unlike the commenter above, MedPAC suggested that CMS discontinue the transition period to cost-based weights and implement 100 percent cost-based weights in FY 2008. MedPAC's recommendation to discontinue the transition to cost-based weights presumed full introduction of the MS-DRGs in FY 2008. The commenters believed the payment fluctuations that will occur with full implementation of MS-DRGs can be mitigated by fully adopting cost weights. However, as suggested above, MedPAC also suggested as an alternative adopting MS-DRG weights according to the same schedule as the cost-based weights.

Response: We appreciate the commenters' expressing concerns about the continued transition to cost-based relative weights and the potential changes in payment from the Start Printed Page 47200application of this methodology. In the FY 2007 IPPS final rule, we discussed our rationale for implementing cost-based weights over a 3-year transition period. We stated that the 3-year transition would mitigate the annual payment effects from the changes to the relative weights while we further study whether to make adjustments to account for charge compression. We believe that the cost-based methodology reduces bias in the relative weights and makes Medicare's payments more accurate for both medical and surgical DRGs. Therefore, any delays in the transition would not further our goal of payment accuracy. We believe that current efforts to improve cost reporting and our decision not to implement regression-based CCRs will alleviate concerns about additional fluctuations in hospital payments from further changes to the relative weight methodology. Furthermore, we believe that, for some types of hospitals (such as rural hospitals), the payment changes from MS-DRGs are the opposite of those that will occur from the transition to cost-based weights. For this reason, we believe a 2-year transition of the MS-DRG system that coincides with the remaining two years of the transition to cost-based weights will reduce the magnitude of annual payment changes and achieve our long-term goal of improvements in payment accuracy. Therefore, we are continuing with the 3-year transition to cost-based weights. For FY 2008, the DRG relative weights will be a blend of 33 percent of charge-based weights and 67 percent of cost-based weights. For the first year of the MS-DRG transition, the relative weights will be a blend of 50 percent of the CMS-DRG weight and 50 percent of the MS-DRG weight.

F. Hospital-Acquired Conditions, Including Infections

1. General

Medicare's IPPS encourages hospitals to treat patients efficiently. Hospitals receive the same DRG payment for stays that vary in length. In many cases, complications acquired in the hospital do not generate higher payments than the hospital would otherwise receive for other cases in the same DRG. To this extent, the IPPS does encourage hospitals to manage their patients well and to avoid complications, when possible. However, complications, such as infections, acquired in the hospital can lead to higher Medicare payments in two ways. First, the treatment of complications can increase the cost of hospital stays enough to generate outlier payments. However, the outlier payment methodology requires that hospitals experience large losses on outlier cases (for example, in FY 2007, the fixed-loss amount was $24,485 before a case qualified for outlier payments, and the hospital then only received 80 percent of its estimated costs above the fixed-loss cost threshold). Second, under the MS-DRGs we are adopting in this final rule with comment period, there are 258 sets of DRGs that are split into 2 or 3 subgroups based on the presence or absence of a major CC (MCC) or CC. If a condition acquired during the beneficiary's hospital stay is one of the conditions on the MCC or CC list, the result may be a higher payment to the hospital under the MS-DRGs. (We refer readers to section II.D. of this final rule with comment period for a detailed discussion of DRG reforms.)

2. Legislative Requirement

Section 5001(c) of Pub. L. 109-171 requires the Secretary to select, by October 1, 2007, at least two conditions that are (a) high cost or high volume or both, (b) result in the assignment of a case to a DRG that has a higher payment when present as a secondary diagnosis, and (c) could reasonably have been prevented through the application of evidence-based guidelines. For discharges occurring on or after October 1, 2008, hospitals will not receive additional payment for cases in which one of the selected conditions was not present on admission. That is, the case will be paid as though the secondary diagnosis was not present. Section 5001(c) provides that we can revise the list of conditions from time to time, as long as the list contains at least two conditions. Section 5001(c) also requires hospitals to submit the secondary diagnoses that are present at admission when reporting payment information for discharges on or after October 1, 2007.

3. Public Input

In the FY 2007 IPPS proposed rule (71 FR 24100), we sought input from the public regarding conditions with evidence-based guidelines that should be selected in order to implement section 5001(c) of Pub. L. 109-171. The comments that we received were summarized in the FY 2007 IPPS final rule (71 FR 48051 through 48053). In the FY 2008 IPPS proposed rule (72 FR 24716), we again sought formal public comment on conditions that we proposed to select under section 5001(c). As discussed below, in this final rule with comment period, we first summarize the comments we received on the FY 2007 IPPS proposed rule. We then explain our detailed proposals included in the FY 2008 proposed rule, followed by a summary of the public comments on each condition proposed and our responses to those public comments.

In summary, the majority of the comments that we received in response on the FY 2007 IPPS proposed rule addressed conceptual issues concerning the selection, measurement, and prevention of hospital-acquired infections. Many commenters encouraged CMS to engage in a collaborative discussion with relevant experts in designing, evaluating, and implementing this section. The commenters urged CMS to include individuals with expertise in infection control and prevention, as well as representatives from the provider community, in the discussions.

Many commenters supported the statutory requirement for hospitals to submit information regarding secondary diagnoses present on admission beginning in FY 2008, and suggested that it would better enable CMS and health care providers to more accurately differentiate between comorbidities and hospital-acquired complications. MedPAC, in particular, noted that this requirement was recommended in its March 2005 Report to Congress and indicated that this information is important to Medicare's value-based purchasing efforts. Other commenters cautioned us about potential problems with relying on secondary diagnosis codes to identify hospital-acquired complications, and indicated that secondary diagnosis codes may be an inaccurate method for identifying true hospital-acquired complications.

A number of commenters expressed concerns about the data coding requirement for this payment change and asked for detailed guidance from CMS to help them identify and document hospital-acquired complications. Other commenters expressed concern that not all hospital-acquired infections are preventable and noted that sicker and more complex patients are at greater risk for hospital-acquired infections and complications. Commenters suggested that CMS include standardized infection-prevention process measures, in addition to outcome measures of hospital-acquired infections.

Some commenters proposed that CMS expand the scope of the payment changes beyond the statutory minimum of two conditions. They noted that the death, injury, and cost of hospital-acquired infections are too high to limit this provision to only two conditions. Commenters also recommended that CMS annually select additional hospital Start Printed Page 47201acquired complications for the payment change. Conversely, a number of commenters proposed that CMS initially begin with limited demonstrations to test CMS' methodology before nationwide implementation. One commenter recommended that CMS include appropriate consumer protections to prevent providers from billing patients for the nonreimbursed costs of the hospital-acquired complications and to prevent hospitals from selectively avoiding patients perceived at risk of complications.

In addition to the broad conceptual suggestions, some commenters recommended specific conditions for possible inclusion in the payment changes, which we discussed in detail in the preamble of the proposed rule and in section II.D.4. of this final rule with comment period. We also discuss throughout section II.D. of the preamble of this final rule with comment period other comments that we have considered in developing hospital-acquired conditions that would be subject to reporting.

As it is not addressed elsewhere, we are responding here to the comment about hospitals billing patients for costs of hospital-acquired complications that are not counted as MCCs and CCs. Section 5001(c) does not make the additional cost of a hospital acquired complication a noncovered cost. The additional costs that a hospital would incur as a result of a hospital-acquired complication remains a covered Medicare cost that is included in the hospital's IPPS payment. Medicare's payment to the hospital is for all inpatient hospital services provided during the stay. The hospital cannot bill the beneficiary for any charges associated with the hospital-acquired complication. With respect to the concern about a hospital avoiding patients that are at high risk of complications, we note that the policy is selecting only those conditions that are “reasonably preventable.” Thus, we are only selecting those conditions where, if hospital personnel are engaging in good medical practice, the additional costs of the hospital-acquired condition will, in most cases, be avoided and the risk of selectively avoiding patients at high risk of complications will be minimized. We further note that Medicare's high cost outlier policy is unaffected by section 5001(c). The hospital's total charges for all inpatient services provided during the stay will continue to be used to determine whether the case qualifies for an outlier payment. Thus, there will continue to be limitations on a hospital's financial risk of treating high cost cases even if, despite the hospital maintaining good medical practice to avoid complications, a reasonably preventable condition occurs after admission. Finally, as stated further below, we are continuing to work to identify exclusions for situations where the policy should not apply for the selected condition.

4. Collaborative Effort

CMS worked with public health and infectious disease experts from the Centers for Disease Control and Prevention (CDC) to identify a list of hospital-acquired conditions, including infections, as required by section 5001(c) of Pub. L. 109-171. As previously stated, the selected conditions must meet the following three criteria: (a) high cost or high volume or both; (b) result in the assignment of the case to a DRG that has a higher payment when present as a secondary diagnosis; and (c) could reasonably have been prevented through the application of evidence-based guidelines. CMS and CDC staff also collaborated on developing a process for hospitals to submit a Present on Admission (POA) indicator with each secondary condition. The statute requires the Secretary to begin collecting this information as of October 1, 2007. The POA indicator is required in order for us to determine which of the selected conditions developed during a hospital stay. The current electronic format used by hospitals to obtain this information (ASC X12N 837, Version 4010) does not provide a field to obtain the POA information. We issued instructions requiring acute care IPPS hospitals to submit the POA indicator for all diagnosis codes, effective October 1, 2007, through Change Request No. 5499, with a release date of May 11, 2007. The instructions specify how hospitals under the IPPS submit this information in segment K3 in the 2300 loop, data element K301 on the ASC X12N 837, Version 4010 claim. Specific instructions on how to select the correct POA indicator for a diagnosis code are included in the ICD-9-CM Official Guidelines for Coding and Reporting. These guidelines can be found at the following Web site: http://www.cdc.gov/​nchs/​datawh/​ftpserv/​ftpicd9/​ftpicd9.htm.

CMS and CDC staff also received input from a number of groups and organizations on hospital-acquired conditions, including infections. Many of these groups and organizations recommended the selection of conditions mentioned in the FY 2007 IPPS final rule, including the following because of the high cost or high volume (frequency) of the condition, or both, and because in some cases preventable guidelines already exist:

  • Surgical site infections. The groups and organizations stated that there were evidence-based measures to prevent the occurrence of these infections which are currently measured and reported as part of the Surgical Care Improvement Program (SCIP).
  • Ventilator-associated pneumonias. The groups and organizations indicated that these conditions are currently measured and reported through SCIP. However, other organizations counseled against selecting these conditions because they believed it was difficult to obtain good definitions and that it was not always clear which ones are hospital acquired.
  • Catheter associated bloodstream infections.
  • Pressure ulcers.
  • Hospital falls. The injury prevention groups included this condition among a group referred to as “serious preventable events,” also commonly referred to as “never events” or “serious reportable events.” A serious preventable event is defined as a condition which should not occur during an inpatient stay.
  • Bloodstream infections/septicemia. Some commenters suggested that we focus on one specific organism, such as staph aureus septicemia.
  • Pneumonia. Some commenters recommended the inclusion of a broader group of pneumonia patients, instead of restricting cases to ventilator-associated pneumonias. Some commenters mentioned that while prevention guidelines exist for pneumonia, it is not clear how effective these guidelines may be in preventing pneumonia.
  • Vascular catheter associated infections. Commenters indicated that there are CDC guidelines for these infections. Other commenters stated that while this condition certainly deserves focused attention by health care providers, there is not a unique ICD 9 CM code that identifies vascular catheter-associated infections. Therefore, these commenters suggested that there would be difficulty separately identifying these conditions.
  • Clostridium difficile-associated disease (CDAD). Several commenters identified this condition as a significant public health issue. Other commenters indicated that, while prevalence of this condition is emerging as a public health problem, there is not currently a strategy for reasonably preventing these infections.
  • Methicillin-resistant staphylococcus aureus (MRSA). Several commenters indicated that MRSA has Start Printed Page 47202become a very common bacteria occurring both in and outside the hospital environment. However, other organizations stated that the code for MRSA (V09.0, Infection with microorganism resistant to penicillins Methicillin-resistant staphylococcus aureus) is not currently classified as a CC. Therefore, the commenters stated that MRSA does not lead to a higher reimbursement when the code is reported.
  • Serious preventable events. As stated earlier, some commenters representing injury prevention groups suggested including a broader group of conditions than hospital falls which should not be expected to occur during a hospital admission. They noted that these conditions are referred to as “serious preventable events,” and include events such as the following: (a) leaving an object in during surgery; (b) operating on the wrong body part or patient, or performing the wrong surgery; (c) air embolism as a result of surgery; and (d) providing incompatible blood or blood products. Other commenters indicated serious preventable events are so rare that they should not be selected as a hospital condition that cannot result in a case being assigned to a higher paying DRG.

5. Criteria for Selection of the Hospital-Acquired Conditions

CMS and CDC staff greatly appreciate the many comments and suggestions offered by organizations and groups that were interested in providing input into the selection of the initial hospital-acquired conditions.

CMS and CDC staff evaluated each recommended condition under the three criteria established by section 1886(d)(4)(D)(iv) of the Act. In order to meet the higher payment criterion, the condition selected must have an ICD-9-CM diagnosis code that clearly identifies the condition and is classified as a CC, or as an MCC (as proposed for the MS DRGs in the proposed rule). Some conditions recommended for inclusion among the initial hospital-acquired conditions did not have codes that clearly identified the conditions. Because there has not been national reporting of a POA indicator for each diagnosis, there are no Medicare data to determine the incidence of the reported secondary diagnoses occurring after admission. To the extent possible, we used information from the CDC on the incidence of these conditions. CDC's data reflect the incidence of hospital-acquired conditions in 2002. We also examined FY 2006 Medicare data on the frequency that these conditions were reported as secondary diagnoses. We developed the following criteria to assist in our analysis of the conditions. The conditions described were those recommended for inclusion in the initial hospital-acquired infection provision.

  • Coding—Under section 1886(d)(4)(D)(ii)(I) of the Act, a discharge is subject to the payment adjustment if “the discharge includes a condition identified by a diagnosis code” selected by the Secretary under section 1886(d)(4)(D)(iv) of the Act. We only selected conditions that have (or could have) a unique ICD-9-CM code that clearly describes the condition. Some conditions recommended by the commenters would require the use of two or more ICD-9-CM codes to clearly identify the conditions. Although we did not exclude these conditions from further consideration, the need to utilize multiple ICD-9-CM codes to identify them may present operational issues. For instance, the complexities associated with selecting septicemia as a hospital-acquired condition subject to section 5001(c) of the DRA may present operational issues in identifying whether or not the condition was present upon admission. The vast number of clinical scenarios that we would have to account for could complicate implementation of the provision.
  • Burden (High Cost/High Volume)—Under section 1886(d)(4)(D)(iv)(I) of the Act, we must select cases that have conditions that are high cost or high volume, or both.
  • Prevention guidelines—Under section 1886(d)(4)(D)(iv)(II) of the Act, we must select codes that describe conditions that could reasonably have been prevented through application of evidence-based guidelines. We evaluated whether there is information available for hospitals to follow to prevent the condition from occurring.
  • MCC or CC—Under section 1886(d)(4)(D)(iv)(III) of the Act, we must select codes that result in assignment of the case to a DRG that has a higher payment when the code is present as a secondary diagnosis. The condition must be an MCC or a CC that would, in the absence of this provision, result in assignment to a higher paying DRG.
  • Considerations—We evaluated each condition above according to how it meets the statutory criteria in light of the potential difficulties that we would face if the condition were selected.

6. Selection of Hospital-Acquired Conditions

We discuss below our analysis of each of the conditions that were raised as possible candidates for selection under section 5001(c) of Pub. L. 109-171 according to the criteria described above in section II.D.5. of the preamble of this final rule with comment period. We also discuss any considerations, which would include any administrative issues surrounding the selection of a proposed condition. For example, the condition may only be able to be identified by multiple codes, thereby requiring the development of special GROUPER logic to also exclude similar or related ICD-9-CM codes from being classified as a CC. Similarly, a condition acquired during a hospital stay may arise from another condition that the patient had prior to admission, making it difficult to determine whether the condition was reasonably preventable. Following a discussion of each condition, we provide a summary that describes how each condition was considered for the proposed rule, whether we are selecting it to be subject to the provision in this FY 2008 IPPS final rule or if it will continue to be considered for the future. In the proposed rule, we presented 13 conditions. The summary discussion and table reflect changes to the order of the conditions. The summary presents the conditions that best meet the statutory criteria and which conditions we are selecting to be subject to the payment adjustment for hospital-acquired conditions beginning in FY 2009. In the proposed rule, we encouraged comments on these conditions. We asked commenters to recommend how many and which conditions should be selected in the FY 2008 IPPS final rule along with justifications for these selections. We also encouraged additional comments on clinical, coding, and prevention issues that may affect the conditions selected. While, in this final rule with comment period, we present these 13 conditions in the order they were proposed, we have re-ranked these conditions based on how well they meet the statutory criteria according to compelling public health reasons in addition to public comment and internal analysis.

We received approximately 127 timely public comments on this section from hospitals and health care systems, provider associations, consumer groups, purchasers, medical device manufacturers, pharmaceutical companies, information technology companies, and health care research organizations.

Comment: Some commenters urged CMS to use discretion in selecting hospital-acquired conditions that will be subject to the statutory provision and suggested that CMS limit the number of conditions selected. A large majority of Start Printed Page 47203commenters strongly supported the inclusion of three of the serious preventable events (object left in surgery, air embolism and blood incompatibility) and generally commented that the remaining conditions are not always preventable or may not have unique codes established.

A number of commenters both supported and opposed the conditions other than the three serious preventable events mentioned above. The commenters were generally optimistic about considering proposed conditions for the future upon resolution of suggested issues. A few commenters proposed that CMS initially begin with limited demonstrations to test CMS’ methodology before nationwide implementation. These commenters specifically mentioned the Michigan Hospital Association Keystone Center.

The commenters who suggested not including conditions other than the three serious preventable events mentioned above noted that sicker and more complex patients are at greater risk for hospital-acquired infections and complications. In particular, the commenters believed some of the conditions proposed are a biological inevitability at a certain predictable rate regardless of safe practice. In addition, the commenters expressed concern about the difficulty of distinguishing between hospital-acquired and community-acquired infections. The commenters also believed that CMS should use incentives to allow hospitals to adopt innovative infection prevention technologies and provide necessary treatments for infections. Finally, a few commenters submitted additional conditions that were not included in the 13 conditions we considered in the proposed rule.

Response: In general, we discuss our responses to each of these comments below in the context of the specific conditions they reference. With respect to the general comment that we should only select the three serious preventable events, we believe there is a significant public health interest in selecting more than just these conditions. According to the commenters, many of the other conditions we considered are not always preventable and, therefore, should not be selected. The statute indicates that the provision should apply to conditions that “could reasonably have been prevented through the application of evidence-based guidelines.” Therefore, for this reason, we are selecting other conditions in addition to the serious preventable events to be subject to this provision in this final rule with comment period. We discuss the application of the statutory criteria to each of the conditions we considered below and why we believe the condition is “reasonably preventable.”

(a) Catheter-Associated Urinary Tract Infections

Coding—ICD-9-CM code 996.64 (Infection and inflammatory reaction due to indwelling urinary catheter) clearly identifies this condition. The hospital would also report the code for the specific type of urinary infection. For instance, when a patient develops a catheter associated urinary tract infection during the inpatient stay, the hospital would report code 996.64 and 599.0 (Urinary tract infection, site not specified) to clearly identify the condition. There are also a number of other more specific urinary tract infection codes that could also be coded with code 996.64. These codes are classified as CCs. If we were to select catheter-associated urinary tract infections, we would implement the decision by not counting code 996.64 and any of the urinary tract infection codes listed below when both codes are present and the condition was acquired after admission. If only code 966.64 were coded on the claim as a secondary diagnosis, we would not count it as a CC.

Burden (High Cost/High Volume)—CDC reports that there are 561,667 catheter-associated urinary tract infections per year. For FY 2006, there were 11,780 reported cases of Medicare patients who had a catheter associated urinary tract infection as a secondary diagnosis. The cases had average charges of $40,347 for the entire hospital stay. According to a study in the American Journal of Medicine, catheter-associated urinary tract infection is the most common nosocomial infection, accounting for more than 1 million cases in hospitals and nursing homes nationwide.[22] Approximately 11.3 million women in the United States had at least one presumed acute community-acquired urinary tract infection resulting in antimicrobial therapy in 1995, with direct costs estimated at $659 million and indirect costs totaling $936 million. Nosocomial urinary tract infection necessitates one extra hospital day per patient, or nearly 1 million extra hospital days per year. It is estimated that each episode of symptomatic urinary tract infection adds $676 to a hospital bill. In total, according to the study, the estimated annual cost of nosocomial urinary tract infection in the United States ranges between $424 and $451 million.

Prevention guidelines—There are widely recognized guidelines for the prevention of catheter-associated urinary tract infections. Guidelines can be found at the following Web site: http://www.cdc.gov/​ncidod/​dhqp/​gl_​catheter_​assoc.html.

CC—Codes 996.64 and 599.0 are classified as CCs in the CMS DRGs as well as in the MS-DRGs.

Considerations—The primary prevention intervention would be not using catheters or removing catheters as soon as possible, both of which are worthy goals because once catheters are in place for 3 to 4 days, most clinicians and infectious disease/infection control experts do not believe urinary tract infections are preventable. While there may be some concern about the selection of catheter associated urinary tract infections, it is an important public health goal to encourage practices that will reduce urinary tract infections. Approximately 40 percent of Medicare beneficiaries have a urinary catheter during hospitalization based on Medicare Patient Safety Monitoring System (MPSMS) data.

As stated above in the Coding section, this condition is clearly identified through ICD-9-CM code 996.64. Code 996.64 is classified as a CC. The hospital would also report the code for the specific type of urinary infection. For instance, when a patient develops a catheter associated urinary tract infection during the inpatient stay, the hospital would report codes 996.64 and 599.0 or another more specific code that clearly identifies the condition. These codes are classified as CCs under the CMS DRGs as well as the MS-DRGs. To select catheter-associated urinary tract infections as one of the hospital-acquired conditions that would not be counted as a CC, we would not classify code 996.64 as a CC if the condition occurred after admission. Furthermore, we would also not classify any of the codes listed below as CCs if present on the claim with code 996.64 because these additional codes identify the same condition. The following codes represent specific types of urinary infections. We did not include codes for conditions that could be considered chronic urinary infections, such as code 590.00 (Chronic pyelonephritis, without lesion or renal medullary necrosis). Chronic conditions may indicate that the condition was not acquired during the current stay. We would not count code 996.64 or any of the following codes representing acute urinary Start Printed Page 47204infections if they developed after admission and were coded together on the same claim.

  • 112.2 (Candidiasis of other urogenital sites)
  • 590.10 (Acute pyelonephritis, without lesion of renal medullary necrosis)
  • 590.11 (Acute pyelonephritis, with lesion of renal medullary necrosis)
  • 590.2 (Renal and perinephric abscess)
  • 590.3 (Pyeloureteritis cystica)
  • 590.80 (Pyelonephritis, unspecified)
  • 590.81 (Pyelitis or pyelonephritis in diseases classified elsewhere)
  • 590.9 (Infection of kidney, unspecified)
  • 595.0 (Acute cystitis)
  • 595.3 (Trigonitis)
  • 595.4 (Cystitis in diseases classified elsewhere)
  • 595.81 (Cystitis cystica)
  • 595.89 (Other specified type of cystitis, other)
  • 595.9 (Cystitis, unspecified)
  • 597.0 (Urethral abscess)
  • 597.80 (Urethritis, unspecified)
  • 599.0 (Urinary tract infection, site not specified)

We believe the condition of catheter-associated urinary tract infection meets all of our criteria for selection as one of the initial hospital-acquired conditions. We can easily identify the cases with ICD-9-CM codes. The condition is a CC under both the CMS DRGs and the MS-DRGs. The condition meets our burden criterion with its high cost and high frequency. There are prevention guidelines on which the medical community agrees to avoid catheter-associated urinary tract infections. We believe this condition best meets the criteria discussed. Therefore, we proposed the selection of catheter-associated urinary tract infections as one of the initial hospital-acquired conditions.

We encouraged comments on both the selection of this condition and the related conditions that we proposed to exclude from being counted as CCs.

Comment: Most commenters suggested that a large number of physicians believe urinary tract infections may not be preventable after several days of catheter placement. A few commenters submitted the following statement from the proposed rule (72 FR 24719): “once catheters are in place for 3-4 days, most clinicians and infection control experts do not believe UTIs are preventable.” The commenters also noted the potential difficulty in identifying this condition at admission.

Still other commenters believed this condition is difficult to code because the ICD-9-CM codes do not distinguish between catheter-associated inflammation and infection. The commenters asked CMS to consider a new code for “inflammatory reaction from indwelling catheter” distinct from “catheter associated urinary tract infection.”

In addition, the commenters noted that prevention guidelines are still being debated. The commenters referenced the prevention guideline published in 1981 and posted on the Web site at: http://www.cdc.gov/​ncidod/​dhqp/​gl_​catheter_​assoc.html.

A few commenters also recommended exceptions for this condition, including patients with immunosuppression, patients who have a catheter placed for therapeutic installation of antimicrobial/chemotherapy agent, patients with sustained urinary tract trauma, and patients in need of permanent use of a catheter.

Commenters stated that Medicare reimbursement does not cover the increased cost of antibiotic-coated catheters which have been shown to reduce the incidence of catheter infections. These same commenters asked CMS to change Medicare payment policy to encourage the application of proven existing technology.

Commenters provided two potential examples of unintended consequences if this condition is to be implemented. First, the commenters believed that physicians and hospitals will increase urinalysis testing to identify urinary tract infections prior to admission. Second, the commenters suggested that physicians and hospitals will use more antibiotics to “clean” the urine of bacteria upon admission.

Response: CMS seeks to reduce the incidence of preventable catheter associated urinary tract infections by reducing unnecessary and inappropriate use of indwelling urinary catheters in hospitalized Medicare patients. There is widespread evidence that catheters may lead to an increased risk of infection if they are in place for several days. In addition, there are prevention guidelines to assist physicians in determining how long a urinary catheter should be left in place that can prevent catheter-associated urinary tract infections. Therefore, we believe that catheter-associated urinary tract infections are reasonably preventable by following well-established prevention guidelines, and we are selecting this condition.

Concerning the request for the creation of a new code for “inflammatory reaction from indwelling catheter,” we recommend the commenter contact the CDC. The CDC is responsible for maintaining the diagnosis part of the ICD-9-CM codes. We encourage commenters to send specific requests for new or revised ICD-9-CM diagnosis codes to Donna Pickett, CDC, at 3311 Toledo Road, Room 2402, Hyattsville, MD 20782, or via e-mail to dfp4@cdc.gov. Additional information on requesting a new ICD-9-CM diagnosis code may be obtained from the Web site at: http://www.cdc.gov/​nchs/​icd9.htm.

The commenters are correct that prevention guidelines for avoiding catheter-associated urinary tract infections are scheduled to be updated by CDC's Healthcare Infection Control Practices Committee (HICPAC). The National Quality Forum (NQF) is currently working to update hospital-acquired infection definitions. The effort currently underway will update prevention guidelines that have been in place since 1981. We believe the ongoing effort to update prevention guidelines for avoiding catheter-associated urinary tract infections provides further evidence that this condition is a strong candidate to be selected because of how well it meets the statutory criteria.

We appreciate the many comments urging CMS to consider implementing exceptions for catheter-associated urinary tract infections when it is a hospital-acquired condition but is not preventable. We will carefully consider these suggestions as we plan for the implementation of this new requirement in FY 2009.

With respect to the comment about encouraging the use antibiotic-coated catheters, we continue to work in cooperation with device companies and other associations to ensure that Medicare beneficiaries receive the most current therapeutic modalities. We annually update Medicare inpatient hospital payment rates to reflect hospital resource use for the latest medical technology and other innovations in how care is delivered.

We do not agree there will be significant unintended consequences of selecting catheter-associated urinary tract infections. As stated earlier, we believe this condition is generally avoidable if medical professionals carefully follow longstanding prevention guidelines. We believe hospitals, physicians, and others that treat Medicare patients will focus on taking medically appropriate steps to determine the length of time a catheter is in place. We do not believe it is inappropriate to perform a urinalysis upon admission to the hospital if clinically indicated. We would not Start Printed Page 47205consider doing so an unintended consequence.

We appreciate all the public comments on this condition, and have considered all of these points of view. We believe this condition meets the criteria of the DRA:

  • There are unique codes that identify catheter-associated urinary tract infections that are currently considered to be a CC under the MS-DRGs;
  • Prevention guidelines currently exist and will be updated prior to the October 1, 2008 implementation date of this provision; and
  • As shown above, catheter-associated urinary tract infections are high cost/high volume conditions.

Therefore, in this final rule with comment period, we are selecting the condition of catheter-associated urinary tract infections to be subject to the provision beginning October 1, 2008.

(b) Pressure Ulcers

Coding—Pressure ulcers are also referred to as decubitus ulcers. The following codes clearly identify pressure ulcers.

  • 707.00 (Decubitus ulcer, unspecified site)
  • 707.01 (Decubitus ulcer, elbow)
  • 707.02 (Decubitus ulcer, upper back)
  • 707.03 (Decubitus ulcer, lower back)
  • 707.04 (Decubitus ulcer, hip)
  • 707.05 (Decubitus ulcer, buttock)
  • 707.06 (Decubitus ulcer, ankle)
  • 707.07 (Decubitus ulcer, heel)
  • 707.09 (Decubitus ulcer, other site)

Burden (High Cost/High Volume)—This condition is both high-cost and high volume. For FY 2006, there were 322,946 reported cases of Medicare patients who had a pressure ulcer as a secondary diagnosis. These cases had average charges for the hospital stay of $40,381.

Prevention guidelines—Prevention guidelines can be found at the following Web sites: http://www.npuap.org/​positn1.html and http://www.ncbi.nlm.nih.gov/​books/​bv.fcgi?​rid=​hstat2.chapter.4409.

CC—Decubitus ulcer codes are classified as CCs under the CMS DRGs. Codes 707.00, 707.01, and 707.09 are CCs under the MS-DRGs. Codes 707.02 through 707.07 are considered MCCs under the MS-DRGs. As discussed earlier, MCCs result in even larger payments than CCs.

Considerations—Pressure ulcers are an important hospital acquired complication. Prevention guidelines exist (non-CDC) and can be implemented by hospitals. Clinicians may state that some pressure ulcers present on admission cannot be identified (skin is not yet broken (Stage I) but damage to tissue is already done and skin will eventually break down). However, by selecting this condition, we would provide hospitals the incentive to perform careful examination of the skin of patients on admission to identify decubitus ulcers. If the condition is present on admission, the provision will not apply. In the proposed rule, we proposed to include pressure ulcers as one of our initial hospital-acquired conditions. This condition can be clearly identified through ICD-9-CM codes. These codes are classified as a CC under the CMS DRGs and as a CC or MCC under the MS-DRGs. Pressure ulcers meet the burden criteria because they are both high cost and high frequency cases. There are clear prevention guidelines. While there is some question as to whether all cases with developing pressure ulcers can be identified on admission, we believe the selection of this condition will result in a closer examination of the patient's skin on admission and better quality of care. We welcomed comments on the proposed inclusion of this condition.

Comment: A majority of commenters supported the intent of selecting the condition of pressure ulcers, but had concerns about how the provision would be implemented in practice. A large majority of commenters believed hospitals will more carefully examine the skin of patients if this condition is selected. However, many commenters cited difficulty in detecting stage 1 pressure ulcers on admission, particularly in certain patient populations.

The commenters cited the Guidance to Surveyors for Long-Term Care Facilities (CMS Manual System Pub. 100-07, State Operations Provider Certification issued November 2004, page 5), noting CMS” previous acknowledgment that some pressure ulcers are “unavoidable.” The commenters cited evidence of an increased risk of pressure ulcer reoccurrence after a patient has had at least one stage IV ulcer.

The commenters expressed concern about how this condition will be coded upon admission. The commenters also suggested that present-on-admission coding of pressure ulcers will rely solely on physicians' notes and diagnoses, according to Medicare coding rules. The commenters were concerned that the current ICD-9-CM codes for pressure ulcers are not precise enough to delineate differences in wound depth, which is an important factor for determining the severity of an ulcer.

The commenters recommended that CMS supplement ICD-9-CM codes for pressure ulcers with severity adjustments for complications and comorbidities that are present on admission. Because patients with pressure ulcers often have other complicating conditions, the commenters stated that it is unlikely that pressure ulcers would potentially be the only secondary diagnosis that would change the DRG assignment from one without a CC to one with a CC. Lastly, the commenters noted that accurate identification of a pressure ulcer requires the education and expertise of a trained physician.

The commenters suggested that CMS should exclude patients enrolled in the Medicare hospice benefit and patients with certain diagnoses that make them more highly prone to pressure ulcers such as hemiplegia, quadriplegia, wasting syndrome, with advanced AIDS and/or protein malnutrition associated with a variety of serious end stage illnesses.

Response: We appreciate the overwhelming public support for the intent of selecting this condition, provided we can address the concerns raised in the public comments. We acknowledge the commenters' concern that CMS previously stated some pressure ulcers are “unavoidable.” However, we believe improved screening to identify pressure ulcers upon admission for inpatient care will increase the quality of care. By screening patients entering the hospital for pressure ulcers, the ulcers will be discovered earlier and improve treatment of this preventable condition. We agree that the POA coding of pressure ulcers will rely on the attending physician, who has primary responsibility for documenting and diagnosing a patient's clinical conditions. Pressure ulcers that are identified through screening upon admission that are documented properly will continue to be assigned to a higher paying DRG.

With respect to the comment about patients with pressure ulcers having other complications and comorbidities, we note that many of the new MS-DRGs are subdivided into two or more severity levels. We will continue to evaluate the need for additional severity levels within base MS-DRGs. On the specific issue of the MS-DRGs that include pressure ulcers, we note that these MS-DRGs are already divided into three severity levels as follows:

  • MS-DRG 573 (Skin Graft /or Debridement for Skin Ulcer or Cellulitis with MCC) Start Printed Page 47206
  • MS-DRG 574 (Skin Graft /or Debridement for Skin Ulcer or Cellulitis with CC)
  • MS-DRG 575 (Skin Graft /or Debridement for Skin Ulcer or Cellulitis without CC/MCC)

We are aware that many patients with pressure ulcers may also have other comorbid and complicating conditions that will continue to assign the patient to a higher paying DRG. We do not believe this fact should preclude physicians and hospitals from screening patients for pressure ulcers upon admission. As we indicated in the proposed rule (72 FR 24726), we believe only a minority of cases will have one of the selected conditions as the only CC or MCC present on the claim. However, we believe it will continue to lead to improvements in the quality of care. We believe the selection of this condition will lead the physician and hospital to perform a proper skin exam upon admission, leading to earlier identification and treatment of pressure ulcers.

With respect to the comment that accurate identification of a pressure ulcer requires the education and expertise of a trained physician, we agree. Hospitals should be using properly educated and trained physicians to identify and treat pressure ulcers (as well as all other medical conditions).

We appreciate all the public comment on this condition, and have considered all of these points of view. We believe the condition of pressure ulcers meets the criteria of the DRA:

  • There are unique codes that identify pressure ulcers that are currently considered to be a CC or an MCC under the MS-DRGs;
  • Prevention guidelines to avoid pressure ulcers currently exist; and
  • As shown above, pressure ulcers are high-cost/high-volume conditions. Therefore, in this final rule with comment period, we are selecting the condition of pressure ulcers to be subject to the payment adjustment for hospital acquired conditions beginning October 1, 2008. We referred the matter concerning the need for additional, detailed ICD-9-CM codes to the CDC. We believe further specificity in the ICD-9-CM codes will aid in distinguishing early from late stage pressure ulcers prior to the implementation date of this provision on October 1, 2008.

Serious Preventable Events

Serious preventable events are events that should not occur in health care. The injury prevention community has developed information on serious preventable events. CMS reviewed the list of serious preventable events and identified those events for which there was an ICD-9-CM code that would assist in identifying them. We identified four types of serious preventable events to include in our evaluation. These include leaving an object in a patient; performing the wrong surgery (surgery on the wrong body part, wrong patient, or the wrong surgery); air embolism following surgery; and providing incompatible blood or blood products. Three of these serious preventable events have unique ICD-9-CM codes to identify them. There is not a clear and unique code for surgery performed on the wrong body part, wrong patient, or the wrong surgery. Each of these events is discussed separately.

(c) Serious Preventable Event—Object Left in during Surgery

Coding Retention of a foreign object in a patient after surgery is identified through ICD-9-CM code 998.4 (Foreign body accidentally left during a procedure).

Burden (High Cost/High Volume)—For FY 2006, there were 764 cases reported of Medicare patients who had an object left in during surgery reported as a secondary diagnosis. The average charges for the hospital stay were $61,962. This is a rare event. Therefore, it is not high volume. However, an individual case will likely have high costs, given that the patient will need additional surgery to remove the foreign body. Potential adverse events stemming from the foreign body could further raise costs for an individual case.

Prevention guidelines—There are widely accepted and clear guidelines for the prevention of this event. This event should not occur. Prevention guidelines for avoiding leaving objects in during surgery are located at the following Web site: http://www.qualityindicators.ahrq.gov/​psi_​download.htm.

CC—This code is a CC under the CMS DRGs as well as under the MS DRGs.

Considerations—There are no significant considerations for this condition. There is a unique ICD-9-CM code and wide agreement on the prevention guidelines. We proposed to include this condition as one of our initial hospital-acquired conditions. The cases can be clearly identified through an ICD-9-CM code. This code is a CC under both the CMS DRGs and the MS-DRGs. There are clear prevention guidelines. While the cases may not meet the high frequency criterion, they do meet the high-cost criterion. Individual cases can be high cost. In the proposed rule, we welcomed comments on including this condition as one of our initial hospital-acquired conditions.

Comment: A large majority of commenters supported CMS' efforts to identify the condition of “object left in surgery” as one that should not occur in the hospital setting. The commenters supported selecting this condition in this year's IPPS rule.

The commenters applauded CMS for identifying a hospital acquired condition that has discrete ICD-9-CM codes and known methods of prevention. In addition, a few commenters noted that prevention guidelines for this condition are fully identified and endorsed by the NQF. MedPAC also complimented CMS for its efforts to identify “object left in surgery” and stated that CMS should not allow a case to be classified as a CC/MCC if this “never event” occurs during a patient's stay.

The commenters urged CMS to make exceptions for objects deliberately left in place in surgery as opposed to accidental retained foreign objects. The commenters noted that a patient may return to the hospital months or years after an object was left in during surgery, and it is necessary to have POA codes to identify patients that return to a different hospital to have the object removed. All of the commenters recognized that this event can cause great harm to patients.

Response: We believe exceptions for this condition are not necessary. The code that identifies this event, 998.4 (Foreign body accidentally left during a procedure) specifically states that the object was accidentally left in during the surgery. This code would not be assigned if a device or implant was deliberately implanted into a patient. In addition, as stated earlier, we recognize the important role of the attending physician in designating whether or not the serious preventable event occurred during the current admission. We agree with the commenters that a patient may return to the hospital months or years after the surgery to have the foreign object removed. In this circumstance, the hospital would code the condition as present on admission and the provision would not apply. By documenting the event early, the correct POA code can be applied. We agree with the commenters that this serious preventable event should be selected as a hospital-acquired condition in this final rule with comment period. Therefore, we are including this condition in the list of those to be implemented in FY 2009. Start Printed Page 47207

(d) Serious Preventable Event—Air Embolism

Coding—An air embolism is identified through ICD-9-CM code 999.1 (Complications of medical care, NOS, air embolism).

Burden (High Cost/High Volume)—This event is rare. For FY 2006, there were 45 reported cases of air embolism for Medicare patients. The average charges for the hospital stay were $66,007.

Prevention guidelines—there are clear prevention guidelines for air embolisms. This event should not occur. Serious preventable event guidelines can be found at the following Web site: http://www.qualityindicators.ahrq.gov/​psi_​download.htm.

CC—This code is a CC under the CMS DRGs and is an MCC under the MS-DRGs.

Considerations—There are no significant considerations for this condition. There is a unique ICD-9-CM code and wide agreement on the prevention guidelines. In addition, as stated earlier, the condition is a CC under the CMS DRGs and an MCC under the MS-DRGs. While the condition is rare, it does meet the cost burden criterion because individual cases can be expensive. Therefore, air embolism is a high-cost condition because average charges per case are high. In the proposed rule, we welcomed comments on the proposal to include this condition.

Comment: A large number of commenters supported CMS' efforts to select this condition as one that should not occur in the hospital setting. The commenters considered this an appropriate condition to include for the final rule. The commenters applauded CMS for identifying a hospital acquired condition that has discrete ICD-9-CM codes and known methods of prevention.

In addition, the commenters noted that prevention guidelines for this condition are fully identified and endorsed by the NQF. MedPAC also complimented CMS for its efforts to identify “air embolism” and stated that CMS should not allow a case to be classified as a CC/MCC if this “never event” occurs during a patient's stay.

The commenters urged CMS to make exceptions for situations when air embolism is technically unavoidable because of a special surgical procedure. All of the commenters recognized that this event can cause great harm to patients.

Response: We appreciate the support for the selection of this condition. We also welcome specific recommendations that would clearly define an appropriate exception to this condition, including any appropriate ICD-9-CM diagnosis and procedure codes which the commenter believes clearly define such an occurrence and the justification for an exception. At this point, we do not believe such an exception is necessary.

We agree with commenters that this serious preventable event should be included in the FY 2008 final rule. Therefore, we are including the condition of air embolism in the list of those to be implemented in FY 2009.

(e) Serious Preventable Event—Blood Incompatibility

Coding—Delivering ABO-incompatible blood or blood products is identified by ICM-9-CM code 999.6 (Complications of medical care, NOS, ABO incompatibility reaction).

Burden (High Cost/High Volume)—This event is rare. Therefore, it is not high volume. For FY 2006, there were 33 reported cases of blood incompatibility among Medicare patients, with average charges of $46,492 for the hospital stay. Therefore, individual cases have high costs.

Prevention guidelines—There are prevention guidelines for avoiding the delivery of incompatible blood or blood products. The event should not occur. Serious preventable event guidelines can be found at the following Web site: http://www.qualityindicators.ahrq.gov/​psi_​download.htm

CC—This code is a CC under the CMS DRGs as well as the MS-DRGs.

Considerations—There are no significant considerations for this condition. There is a unique ICD-9-CM code which is classified as a CC under the CMS DRGs as well as the MS-DRGs. There is wide agreement on the prevention guidelines. While this may not be a high-volume condition, average charges per case are high. Therefore, we believe this condition is a high-cost condition and, therefore, meets our burden criterion. We proposed to include this condition as one of our initial hospital acquired conditions.

Comment: A large number of commenters supported CMS' efforts to identify “blood incompatibility” as one condition that should not occur in the hospital setting. The commenters considered this an appropriate condition to include for FY 2009. The commenters applauded CMS for identifying a hospital acquired condition that has discrete ICD-9-CM codes and known methods of prevention. In addition, the commenters noted that prevention guidelines for this condition are fully identified and endorsed by the NQF. MedPAC also complimented CMS for its efforts to identify “blood incompatibility” and stated that CMS should not allow a case to be classified as a CC/MCC if this “never event” occurs during a patient's stay.

The commenters urged CMS to make exceptions for situations when blood incompatibility is technically unavoidable in emergencies when patients deliberately receive unmatched blood. All of the commenters recognized that this event can cause great harm to patients.

Response: As suggested by commenters, hospitals should not be transfusing incompatible blood. The condition meets the criteria for being selected. It is a potential hospital acquired condition that has discrete ICD-9-CM codes and known methods of prevention. Prevention guidelines for this condition are fully identified and endorsed by the NQF. We acknowledge that there may a rare emergency where a hospital does not have compatible blood available for transfusion. We welcome specific recommendations that would define circumstances where blood incompatibility is unavoidable, including any appropriate ICD-9-CM diagnosis and procedure codes, which the commenters believe clearly define such an occurrence. If providers can provide such a clinical scenario that can be identified by existing or new ICD-9-CM codes, we will consider excluding this situation from the provision. We agree with the commenters that this serious preventable event should be included in the FY 2008 final rule. Therefore, we are including the condition of blood incompatibility in the list of those to be implemented in FY 2009.

(f) Staphylococcus Aureus Bloodstream Infection/Septicemia

Coding—ICD-9-CM Code 038.11 (Staphylococcus aureus septicemia) identifies this condition. However, the codes selected to identify septicemia are somewhat complex. The following ICD-9-CM codes may also be reported to identify septicemia:

  • 995.91 (Sepsis) and 995.92 (Severe sepsis). These codes are reported as secondary codes and further define cases with septicemia.
  • 998.59 (Other postoperative infections). This code includes septicemia that develops postoperatively.
  • 999.3 (Other infection). This code includes but is not limited to sepsis/septicemia resulting from infusion, injection, transfusion, and vaccination (ventilator-associated pneumonia is also included here). Start Printed Page 47208

Burden (High Cost/High Volume)—CDC reports that there are 290,000 cases of staphylococcus aureus infection annually in hospitalized patients of which approximately 25 percent are bloodstream infections or sepsis. For FY 2006, there were 29,500 cases of Medicare patients who had staphylococcus aureus infection reported as a secondary diagnosis. The average charges for the hospital stay were $82,678. Inpatient staphylococcus aureus result in an estimated 2.7 million days in excess length of stay, $9.5 billion in excess charges, and approximately 12,000 inpatient deaths per year.

Prevention guidelines—CDC guidelines are located at the following Web site: http://www.cdc.gov/​ncidod/​dhqp/​gl_​intravascular.html.

CC—Codes 038.11, 995.91, 998.59, and 999.3 are classified as CCs under the CMS DRGs and as MCCs under the MS-DRGs.

Considerations—Preventive health care associated bloodstream infections/septicemia that are preventable are primarily those that are related to a central venous/vascular catheter, a surgical procedure (postoperative sepsis) or those that are secondary to another preventable infection (for example, sepsis due to catheter-associated urinary tract infection). Otherwise, physicians and other public health experts may argue whether septicemia is reasonably preventable. The septicemia may not be simply a hospital acquired infection. It may simply be a progression of an infection that occurred prior to admission. Furthermore, physicians cannot always tell whether the condition was hospital-acquired. We examined whether it might be better to limit the septicemia cases to a specific organism (for example, code 038.11 (Staphylococcus aureus septicemia)). CDC staff recommended that we focus on staphylococcus aureus septicemia because this condition is a significant public health issue. As stated earlier, there is a specific code for staphylococcus aureus septicemia, code 038.11. Therefore, the cases would be easy to identify. However, as stated earlier, while this type of septicemia is identified through code 038.11, coders may also provide sepsis code 995.91 or 995.92 to more fully describe the staphylococcus aureus septicemia. Codes 995.91 and 995.92 are reported as secondary codes and further define cases with septicemia. Codes 995.91 and 995.92 are CCs under the CMS DRGs and MCCs under the MS-DRGs.

  • 998.59 (Other postoperative infections). This code includes septicemia that develops postoperatively.
  • 999.3 (Other infection). This code includes but is not limited to sepsis/septicemia resulting from infusion, injection, transfusion, and vaccination (ventilator-associated pneumonia is also indexed here).

To implement this condition as one of our initial ones, we would have to exclude the specific code for staphylococcus aureus septicemia, 038.11, and the additional septicemia codes, 995.91, 995.92, 998.59, and 999.3.

We acknowledge that there are additional issues involved with the selection of this condition that may involve developing an exclusion list of conditions present on admission for which we would not apply a CC exclusion to staphylococcus aureus septicemia. For example, a patient may come into the hospital with a staphylococcus aureus infection such as pneumonia. The pneumonia might develop into staphylococcus aureus septicemia during the admission. It may be appropriate to consider excluding cases such as those of patients admitted with staphylococcus aureus pneumonia that subsequently develop staphylococcus aureus septicemia from the provision. In order to exclude cases that did not have a staphylococcus aureus infection prior to admission, we would have to develop a list of specific codes that identified all types of staphylococcus aureus infections such as code 482.41 (Pneumonia due to staphylococcus aureus). We likely would not apply the new provision to cases of staphylococcus aureus septicemia if a patient were admitted with staphylococcus aureus pneumonia. However, if the patient had other types of infections, not classified as being staphylococcus aureus, and then developed staphylococcus aureus septicemia during the admission, we would apply the provision and exclude the staphylococcus aureus septicemia as a CC. We were not able to identify any other specific ICD-9-CM codes that identify specific infections as being due to staphylococcus aureus.

Other types of infections, such as urinary tract infections, would require the reporting of an additional code, 041.11 (Staphylococcus aureus), to identify the staphylococcus aureus infection. This additional coding presents administrative issues because it will not always be clear which condition code 041.11 (Staphylococcus aureus) is describing. We do not believe it would be appropriate to make code 041.11, in combination with other codes, subject to the hospital-acquired conditions provision until we better understand how to address the administrative issues that would be associated with their selection. Therefore, we would exclude staphylococcus aureus septicemia cases with code 482.41 reported as being subject to the hospital-acquired conditions provision. Stated conversely, we would allow staphylococcus aureus septicemia to count as a CC if the patient was admitted with staphylococcus aureus pneumonia.

We recognize that there may be other conditions which we should consider for this type of exclusion. We proposed to include staphylococcus aureus bloodstream infection/septicemia (code 038.11) as one of our initial hospital-acquired conditions. We also proposed to exclude codes 995.91, 998.59, and 999.3 from counting as an MCC/CC when they were reported with code 038.11. The condition can be clearly identified through ICD 9 CM codes that are classified as CC under the CMS DRGs and MCCs under the MS-DRGs. The condition meets our burden criterion by being both high cost and high volume. There are prevention guidelines which we acknowledge are subject to some debate among the medical community. We also acknowledge that we would have to exclude this condition if a patient were admitted with a staphylococcus aureus infection of a more limited location, such as pneumonia. In the proposed rule, we encouraged commenters to make suggestions on this issue and to recommend any other appropriate exclusion for staphylococcus aureus septicemia. We also encouraged comments on the appropriateness of selecting staphylococcus aureus septicemia as one of our proposed initial hospital acquired conditions.

Comment: Many commenters opposed CMS' proposed selection of this condition as part of the FY 2008 final rule. There were a minority of commenters who strongly supported the selection of this condition. These commenters noted the existence of technologies that allow the physician to determine the presence of Staphylococcus Aureus upon admission. Many more commenters stated that accurately identifying staphylococcus aureus septicemia on admission will be difficult, particularly in patients who may have a staphylococcus aureus infection in a limited location. Several commenters referenced the FY 2008 IPPS proposed rule, which stated “physicians cannot always tell whether the condition was hospital acquired.” Other commenters also noted that there is still debate Start Printed Page 47209among physicians regarding the prevention guidelines for staphylococcus aureus septicemia. The proliferation of changes in coding guidelines presents coding problems for hospitals to accurately identify present-on-admission status according to some comments. Specifically, the commenters noted that codes to identify sepsis are very complex and have had recent changes. For instance, there is a code that currently includes septicemia that develops postoperatively, but does not clearly distinguish between intravascular and catheter-associated sources of septicemia. The commenters also suggested that additional coding may be necessary to accurately identify this condition in the many forms it often presents upon admission. Some commenters suggested that the addition of codes may create a challenge for coding staff to identify the correct code.

A large majority of commenters urged CMS to narrow the category for staphylococcus aureus septicemia to include only patients for whom it is reasonably clear that the hospital was the source of the infection and that it could have been reasonably prevented.

Response: We appreciate the plethora of comments regarding staphylococcus aureus septicemia. The commenters were very insightful and presented the challenges of selecting this condition in the FY 2008 final rule.

We agree that the recent proliferation of ICD-9-CM codes for this condition will make it difficult to code and could present an administrative burden on hospitals. In addition, we are sensitive to the difficulty of identifying when a disease has progressed to sepsis or septicemia. Given the course of progression to septicemia, it can be very difficult for a clinician to appropriately diagnose staphylococcus aureus septicemia as present on admission.

While we acknowledge the many concerns raised by the commenters, we continue to believe that hospital acquired staphylococcus aureus septicemia remains a significant public health issue. We are aware of the continued need to prevent Staphylococcus Aureus septicemia in the hospital setting. Therefore, we plan to engage in a collaborative discussion with relevant experts to identify the circumstances when staphylococcus aureus septicemia is preventable. If we can identify when staphylococcus aureus septicemia is a reasonably preventable condition and have codes to distinguish those situations, we will consider this condition for future years. We appreciate the many comments and suggestions as we consider staphylococcus aureus septicemia for selection in the future, and look forward to receiving more public input to identify only instances when this condition is preventable.

Therefore, we are not selecting this condition in this final rule with comment period. We plan to collaborate with the public on this important public health issue and continue to consider the condition for selection in the FY 2009 final rule. We encourage and welcome public comment to further evaluate this condition.

(g) Ventilator Associated Pneumonia (VAP) and Other Types of Pneumonia

Coding—Pneumonia is identified through the following codes:

  • 073.0 (Ornithosis with pneumonia)
  • 112.4 (Candidiasis of lung)
  • 136.3 (Pneumocystosis)
  • 480.0 (Pneumonia due to adenovirus)
  • 480.1 (Pneumonia due to respiratory syncytial virus)
  • 480.2 (Pneumonia due to parainfluenza virus)
  • 480.3 (Pneumonia due to SARS-associated coronavirus)
  • 480.8 (Pneumonia due to other virus not elsewhere classified)
  • 480.9 (Viral pneumonia, unspecified)
  • 481 (Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia])
  • 482.0 (Pneumonia due to Klebsiella pneumoniae)
  • 482.1 (Pneumonia due to Pseudomonas)
  • 482.2 (Pneumonia due to Hemophilus influenzae [H. influenzae])
  • 482.30 (Pneumonia due to Streptococcus, unspecified)
  • 482.31 (Pneumonia due to Streptococcus, Group A)
  • 482.32 (Pneumonia due to Streptococcus, Group B)
  • 482.39 (Pneumonia due to other Streptococcus)
  • 482.40 (Pneumonia due to Staphylococcus, unspecified)
  • 482.41 (Pneumonia due to Staphylococcus aureus)
  • 482.49 (Other Staphylococcus pneumonia)
  • 482.81 (Pneumonia due to Anaerobes)
  • 482.82 (Pneumonia due to Escherichia coli [E. coli])
  • 482.83 (Pneumonia due to other gram-negative bacteria)
  • 482.84 (Pneumonia due to Legionnaires' disease)
  • 482.89 (Pneumonia due to other specified bacteria)
  • 482.9 (Bacterial pneumonia unspecified)
  • 483.0 (Pneumonia due to Mycoplasma pneumoniae)

There is not a unique code that identifies ventilator-associated pneumonia. The creation of a code for ventilator-associated pneumonia was discussed at the September 29, 2006 meeting of the ICD-9-CM Coordination and Maintenance Committee meeting. Many issues and concerns were raised at the meeting concerning the creation of this proposed new code. It has been difficult to define ventilator-associated pneumonia. We plan to continue working closely with the CDC to develop a code that can accurately describe this condition for implementation in FY 2009. CDC will address the creation of a unique code for this condition at the September 28-29, 2007 ICD-9-CM Coordination and Maintenance Committee meeting.

While we list 27 pneumonia codes above, our clinical advisors do not believe that all of the codes mentioned could possibly be associated with ventilator-associated pneumonia. Our clinical advisors specifically question whether the following codes would ever represent cases of ventilator-associated pneumonia: 073.0, 480.0, 480.1, 480.2, 480.3, 480.8, 480.9, and 483.0. Therefore, we have a range of pneumonia codes, all of which may not represent cases that could involve ventilator-associated pneumonia. In addition, we do not have a specific code that uniquely identifies cases of ventilator-associated pneumonia.

Burden (High Cost/High Volume)—CDC reports that there are 250,205 ventilator-associated pneumonias per year. Because there is not a unique ICD-9-CM code for ventilator-associated pneumonia, there is not accurate data for FY 2006 on the number of Medicare patients who had this condition as a secondary diagnosis. However, we did examine data for FY 2006 on the number of Medicare patients who listed pneumonia as a secondary diagnosis. There were 92,586 cases with a secondary diagnosis of pneumonia, with average charges of $88,781. According to the journal Critical Care Medicine, patients with ventilator-associated pneumonia have statistically significantly longer intensive care lengths of stay (mean = 6.10 days) than those who do not (mean = 5.32-6.87 days). In addition, patients who develop ventilator-associated pneumonia incur, on average, greater than or equal to $10,019 in additional hospital costs compared to those who do not.[23] Start Printed Page 47210Therefore, we believe that this is a high-volume condition.

Prevention guidelines—Prevention guidelines are located at the following Web site: http://www.cdc.gov/​ncidod/​dhqp/​gl_​hcpneumonia.html. However, it is not clear how effective these guidelines are in preventing pneumonia. Ventilator-associated pneumonia may be particularly difficult to prevent.

CC—All of the pneumonia codes listed above are CCs under the CMS DRGs and under the MS-DRGs, except for the following pneumonia codes which are non-CCs: 073.0, 480.0, 480.1, 480.2, 480.3, 480.8, 480.9, 483.0. However, as mentioned earlier, there is not a unique ICD-9-CM code for ventilator-associated pneumonia. Therefore, this condition does not currently meet the statutory criteria for being selected.

Considerations—Hospital-acquired pneumonias, and specifically ventilator-associated pneumonias, are an important problem. However, based on our work with the medical community to develop specific codes for this condition, we have learned that it is difficult to define what constitutes ventilator-associated pneumonia. Although prevention guidelines exist, it is not clear how effective these are in preventing pneumonia. Clinicians cannot always tell which pneumonias are acquired in a hospital. In addition, as mentioned above, there is not a unique code that identifies ventilator-associated pneumonia. There are a number of codes that capture a range of pneumonia cases. It is not possible to specifically identify if these pneumonia cases are ventilator-associated or arose from other sources. Because we cannot identify cases with ventilator-associated pneumonia and there are questions about its preventability, we did not propose to select this condition as one of our initial hospital-acquired conditions. However, we welcomed public comments on how to create an ICD-9-CM code that identifies ventilator-associated pneumonia, and we encouraged participation in our September 28-29, 2007 ICD-9-CM Coordination and Maintenance Committee meeting where this issue will be discussed. We indicated that we would reevaluate the selection of this condition in FY 2009.

Comment: Some commenters urged CMS to select ventilator-associated pneumonia at this time. Most commenters recommended that CMS delay selecting this condition until a unique code is established.

Some commenters submitted an evidence-based peer-reviewed American Association for Respiratory Care (AARC) Clinical Practice Guideline (CPG) on strategies that should be disseminated and available to hospitals for the prevention of ventilator associated pneumonia. The CPG can be found at http://www.rcjournal.com/​cpgs/​09.03.0869.html. Concurrently, the AARC acknowledges that more research needs to be done in this area.

A majority of commenters believed this condition can be reasonably prevented through evidence-based medicine guidelines. These commenters noted that current unique codes for this condition are absent. These commenters urged CMS to consider the development of an explicit ICD-9-CM code for this ventilator-associated pneumonia and to select it at a later date.

Response: At the time of publication of this final rule with comment period, there is not a code associated with ventilator-associated pneumonia. Therefore, this condition does not currently meet the statutory criteria for being selected. However, the ICD-9-CM Coordination and Maintenance Committee will meet September 27-28, 2007, to discuss the creation of a unique ICD-9-CM code for this condition. Further information of the Committee's activities on diagnosis code issues can be found at the Web site: http://www.cdc.gov/​nchs/​icd9.htm. We believe that once this condition has a unique code, it should be further considered for selection beginning in FY 2009.

We believe that ventilator-associated pneumonia meets some of the criteria for being selected. There are guidelines for prevention of ventilator-associated pneumonia within CDC evidence based guidelines for healthcare associated pneumonia. More information can be found at: http://www.cdc.gov/​ncidod/​dhqp/​gl_​hcpneumonia.html. Furthermore, we are aware that the American Thoracic Society and the Infectious Disease Society of America collaborated to produce guidelines on the prevention of ventilator-associated pneumonia. As indicated above, most pneumonias are CCs. Therefore, it is reasonable to believe that ventilator-associated pneumonia will also be classified as a CC once a new code is created to identify it. At that time, we can further consider whether the condition is reasonably preventable and should be subject to this provision.

We appreciate all the public comment on this condition, and considered all of the respondents' point of view. While we acknowledge the clinical challenge of clearly identifying ventilator-associated pneumonia, we believe that once this condition has a unique ICD-9-CM code, coupled with well-known prevention guidelines that are the result of evidence-based medicine, we will give strong consideration for selecting this condition for FY 2009, and including it in the FY 2009 IPPS proposed rule.

(h) Vascular Catheter-Associated Infections

Coding—The proposed rule noted that the code used to identify vascular catheter associated infections is ICD-9-CM code 996.62 (Infection due to other vascular device, implant, and graft). This code includes infections associated with all vascular devices, implants, and grafts. It does not uniquely identify vascular catheter associated infections. Therefore, there was not a unique ICD-9-CM code for this infection at the time of the proposed rule. CDC and CMS staff requested that the ICD-9-CM Coordination and Maintenance Committee discuss the creation of a unique ICD-9-CM code for vascular catheter associated infections because the issue is important for public health. The proposal to create a new ICD-9-CM was discussed at the March 22 23, 2007 meeting of the ICD-9-CM Coordination and Maintenance Committee. A summary of this meeting can be found at: http://www.cdc.gov/​nchs/​icd9.htm. In the proposed rule, we indicated that coders would have to assign code 996.62 plus an additional code for the infection such as septicemia to identify vascular catheter-associated infections. Therefore, a list of specific infection codes would have to be developed to go along with code 996.62 if CDC did not create a code for vascular catheter-associated infections. If the vascular catheter-associated infection was hospital-acquired, the DRG logic would have to be modified so that neither the code for the vascular catheter associated infection along with the specific infection code would count as a CC. However, even if these actions were taken, we were concerned that code 996.62 is not specific to vascular catheter-associated infections.

Burden (High Cost/High Volume)—CDC reports that there are 248,678 central line associated bloodstream infections per year. It appears to be both high cost and high volume. However, we were not able to identify Medicare data on these cases because there is no existing unique ICD-9-CM code.

Prevention guidelines—CDC guidelines are located at the following Web site: http://www.cdc.gov/​ncidod/​dhqp/​gl_​intravascular.html.

CC—Code 996.62 is a CC under the CMS DRGs and the MS-DRGs. However, as stated earlier, this code is broader than vascular catheter associated infections. Therefore, at the time of the Start Printed Page 47211proposed rule, there was not a unique ICD-9-CM code to identify the condition, and it did not meet the statutory criteria to be selected. However, the proposed rule indicated that we will be seeking to create a code(s) to identify this condition and may select it as a condition under the provision beginning in FY 2009.

Considerations—There was not yet a unique ICD-9-CM code to identify this condition at the time of the proposed rule. In the proposed rule, we indicated that if a code were created prior to October 1, 2007, we would be able to specifically identify these cases. Some patients require long-term indwelling catheters, which are more prone to infections. Ideally catheters should be changed at certain time intervals. However, circumstances might prevent such practice (for example, the patient has a bleeding diathesis). In addition, a patient may acquire an infection from another source which can colonize the catheter. As mentioned earlier, coders would also assign an additional code for the infection, such as septicemia. Therefore, a list of specific infection codes would have to be developed to go along with code 996.62. If the vascular catheter-associated infection was hospital-acquired, the DRG logic would have to be modified so that neither the code for the vascular catheter-associated infection along with the specific infection code would count as a CC. Without a specific code for infections due to a catheter, it would be difficult to identify these patients. Given the current lack of an ICD-9-CM code for this condition, we did not propose to include it as one of our initial hospital-acquired conditions. However, we believed it showed merit for inclusion in future lists of hospital acquired conditions once we had resolved the coding issues and were able to better identify the condition in the Medicare data. We indicated that we would reevaluate the selection of this condition in FY 2009.

We encouraged comments on this condition which was identified as an important public health issue by several organizations that provided recommendations on hospital-acquired conditions. We indicated that we were particularly interested in receiving comments on how we should handle additional associated infections that might develop along with the vascular catheter-associated infection.

Comment: Some commenters stated there was not a unique ICD-9-CM code for vascular catheter-associated infection. Therefore, the condition does not meet the criteria for being selected. These commenters requested that CMS consider creating an explicit code for catheter-associated infections and selecting the condition at that time. One commenter recommended that CMS examine selecting vascular-catheter associated infections and identify the condition using the CPT codes for insertion of a central venous catheter. Other commenters recommend selecting the condition and rely on the use of specific codes for the insertion of catheters to supplement the existing code 996.62 (Infection and inflammatory reaction due to other vascular device, implant, and graft). The commenters believed that this alternative approach may reduce the need to rely on a unique code for catheter associated blood stream infection (CA-BSI). Some commenters noted that it is possible to screen for bloodstream infections upon admission. Other commenters suggested that CMS exempt vascular surgery, implantable device codes, and other obvious sources of existing conditions that cause blood stream infection prior to catheter placement. Finally, the commenters suggested that CMS exclude long-term catheter insertions such as the tunneled central venous catheter using codes 365.57 through 365.66.

Response: Since the publication of the FY 2008 IPPS proposed rule, CDC has created a new code for vascular catheter-associated infection. The new code 999.31, (Infection due to central venous catheter) will become effective on October 1, 2007. It is available for public viewing along with other new codes listed on the CMS Web site at: http://www.cms.hhs.gov/​ICD9ProviderDiagnosticCodes/​Downloads/​new_​diagnosis_​codes_​2007.pdf. This new code will address commenters concerns regarding coding for this condition.

We appreciate all the public comment on this condition, and have considered all of these points of view. For the proposed rule, our only barrier to selecting vascular catheter-associated infections was the absence of a unique code to identify the condition. As CDC has since created a code to identify vascular catheter-associated infections, we believe the condition meets the criteria for being selected:

  • There are unique codes that identify vascular catheter-associated infections as a CC under the MS-DRGs;
  • Prevention guidelines exist to avoid vascular catheter-associated infections; and
  • As shown above, vascular catheter-associated infections are high-volume conditions.

At this time, we have not decided whether there are specific clinical situations where a vascular catheter associated infection would not be considered preventable. We will consider exceptions to the policy in the circumstances provided in the public comments. We will consider these suggestions before the provision becomes effective in FY 2009.

(i) Clostridium Difficile-Associated Disease (CDAD)

Coding—This condition is identified by ICD-9-CM code 008.45 (Clostridium difficile).

Burden (High Cost/High Volume)—CDC reports that there are 178,000 cases per year in U.S. hospitals. For FY 2006, there were 110,761 reported cases of Medicare patients with CDAD as a secondary diagnosis, with average charges for the hospital stay of $52,464. Therefore, this is a high-cost and high-volume condition.

Prevention guidelines—Prevention guidelines are not available. Therefore, we do not believe this condition can reasonably be prevented through the application of evidence-based guidelines.

CC—Code 008.45 is a CC under the CMS DRGs and the MS-DRGs.

Considerations—CDAD is an emerging problem with significant public health importance. If found early CDAD cases can easily be treated. However, cases not diagnosed early can be expensive and difficult to treat. CDAD occurs in patients on a variety of antibiotic regiments, many of which are unavoidable, and therefore preventability is an issue. We did not propose to include CDAD as one of our initial hospital acquired conditions at this time, given the lack of prevention guidelines. We welcomed public comments on CDAD, specifically on its preventability and whether there is potential to develop guidelines to identify it early in the disease process and/or diminish its incidence. We indicated that we would reevaluate the selection of this condition in FY 2009.

Comment: Commenters noted the current clinical debate surrounding this condition reveals that it is very difficult to prevent in all cases; it can be prevalent within the hospital setting. In addition, some commenters noted this condition may be caused by the treatment protocol prescribed for a principal diagnosis; it can also occur if the patient is immune-compromised. Finally, some commenters stated that a significant percentage of CDAD is unavoidable, and it is difficult to distinguish community acquired from hospital acquired CDAD. Commenters Start Printed Page 47212also urged CMS to delay selection of this condition because there is a lack of unique codes, complication codes, and guidelines for prevention of this condition.

Response: This condition meets two of the three statutory criteria. There is an ICD-9-CM code for CDAD. The code is 008.45 (Clostridium difficile). Therefore, the condition can be clearly identified through the use of ICD-9-CM codes. Code 008.45 is also a CC under the CMS DRGs and the MS-DRGs. Also, as shown above, CDAD occurs with significant frequency in the Medicare population and is a high cost condition. However, prevention guidelines for this condition are currently unavailable. As suggested by the commenters, leading clinicians believe this condition may not be reasonably preventable because it can occur as a result of broad spectrum antibiotic administration, which is often unavoidable. Although we agree with these commenters, we are also aware of the public interest in this issue and will continue to be interested in selecting this condition if treatment protocols evolve to the point where CDAD is a preventable condition and prevention guidelines are developed.

We are not selecting this condition for implementation in the FY 2008 final rule. It does not currently meet the statutory guidelines for being selected because there are no prevention guidelines. Nevertheless, we will consider adopting this condition in the future if prevention guidelines to avoid CDAD are developed.

(j) Methicillin-Resistant Staphylococcus Aureus (MRSA)

Coding—MRSA is identified by ICD-9-CM code V09.0 (Infection with microorganisms resistant to penicillins). One would also assign a code(s) to describe the exact nature of the infection.

Burden (High Cost/High Volume)—For FY 2006, there were 95,103 reported cases of Medicare patients who had MRSA as a secondary diagnosis. The average charges for these cases were $31,088. This condition is a high-cost and high-volume infection. MRSA has become a very common bacterium occurring both in and outside of the hospital environment.

Prevention guidelines—CDC guidelines are located at the following Web site: http://www.cdc.gov/​ncidod/​dhqp/​pdf/​ar/​mdroGuideline2006.pdf.

CC—Code V09.0 is not a CC under the CMS DRGs and the MS-DRGs. The specific infection would be identified in a code describing the exact nature of the infection, which may be a CC.

Considerations—As stated earlier, preventability may be hard to ascertain since the bacteria have become so common both inside and outside the hospital. There are also considerations in identifying MRSA infections because hospitals would report the code for MRSA along with additional codes that would describe the exact nature of the infection. We would have to develop a list of specific infections that could be the result of MRSA. We did not propose to include MRSA as one of our initial hospital-acquired conditions because the condition is not a CC. We recognize that associated conditions may be a CC. In the proposed rule, we welcomed comments on the proposal not to include this condition. Should there be support for including this condition, we requested recommendations on what codes might be selected to identify the specific types of infections associated with MRSA.

Comment: Commenters displayed a high level of interest in this condition, not only as a hospital-acquired condition, but also as a broader public health problem that continues to affect Medicare beneficiaries. Commenters noted that MRSA is both high volume and high cost, referring to the language in the proposed rule. For this reason, many commenters believed this condition should be given a unique ICD-9-CM code to be tracked in FY 2008. Furthermore, the commenters urged CMS to include it on the list of conditions for FY 2009 for which reimbursement may be withheld. Medical device companies that provide products to screen for MRSA commented in support of selecting the condition.

However, a large number of commenters had reservations about selecting this condition because MRSA is not a CC or MCC under the new MS-DRGs. Most commenters acknowledged the clear prevention guidelines for MRSA. However, they contend that there remains debate on whether MRSA is reasonably preventable. These commenters indicated MRSA is ubiquitous and may be colonizing in so many potential patients that it is difficult to determine if it is acquired in a hospital. The commenters also noted current literature reveals a strain of community acquired MRSA that may be difficult to detect upon admission to the hospital.

Response: We acknowledge the strong public health interest in reducing the number of MRSA related infections. However, MRSA does not currently meet the statutory criteria to be selected. Although there is an ICD-9-CM code to identify MRSA and CDC has prevention guidelines to reduce its incidence, we do not believe that there is a consensus among public health experts that MRSA is preventable. The public comments and the literature on this condition reveal a vigorous debate over whether MRSA is really community-acquired rather than hospital acquired given the significant potential number of patients that can be colonized with MRSA prior to admission. While this concern may be possible to address through screening patients for MRSA upon admission, the condition is not currently identified as a CC or MCC under the MS-DRGs. If present as a secondary diagnosis, the presence of MRSA alone does not lead to higher Medicare payment. Our data do not suggest that presence of MRSA alone will lead to higher hospital costs that would justify classifying it as a CC or MCC. Therefore, as the condition is not an MCC or CC, it does not meet the statutory criteria for being selected at this time.

Although we are not selecting MRSA at this time, we believe it is a precursor to several other conditions that we have selected. MRSA may be a precursor to catheter associated urinary tract infections, vascular catheter-associated infections, and mediastinitis after coronary artery bypass graft (CABG) surgery—a surgical site infection that we have selected and is discussed in more detail below.

(k) Surgical Site Infections

Coding—Surgical site infections are identified by ICD-9-CM code 998.59 (Other postoperative infection). The code does not tell the exact location or nature of the postoperative wound infection. The code includes wound infections and additional types of postoperative infections such as septicemia. The coding guidelines instruct the coder to add an additional code to identify the type of infection. To implement this condition we would have to remove both code 998.59 and the specific infection from counting as a CC if they occurred after the admission. We would have to develop an extensive list of possible infections that would be subject to the provision. We may also need to recommend the creation of a series of new ICD-9-CM codes to identify various types of surgical site infections, should this condition merit inclusion among those that are subject to the proposed hospital-acquired conditions provision.

Burden (High Cost/High Volume)—CDC reports that there are 290,485 surgical site infections each year. As stated earlier, there is not a unique code for surgical site infection. Therefore, we examined Medicare data on patients Start Printed Page 47213with any type of postoperative infection. For FY 2006, there were 38,763 reported cases of Medicare patients who had a postoperative infection. These patients had average charges for the hospital stay of $79,504. We are unable to determine how many of these patients had surgical site infections.

Prevention guidelines—CDC guidelines are available at the following Web site: http://www.cdc.gov/​ncidod/​dhqp/​gl_​surgicalsite.html.

CC—Code 998.59 is a CC under the CMS DRGs and the MS-DRGs.

Considerations—As mentioned earlier, code 998.59 is not exclusive to surgical site infections. It includes other types of postoperative infections. Therefore, code 998.59 does not currently meet the statutory criteria for being subject to the provision because it does not uniquely identify surgical site infections. To identify surgical site infections, we would need new codes that provide more detail about the type of postoperative infection as well as the site of the infection. In addition, one would report both code 998.59 as well a more specific code for the specific type of infection, making implementation difficult. While there are prevention guidelines, it is not always possible to identify the specific types of surgical infections that are preventable. Therefore, we did not propose to select surgical site infections as one of our proposed hospital-acquired conditions at this time. However, we welcomed public comments on whether we can develop criteria and codes to identify preventable surgical site infections that would assist us in reducing their incidence. We indicated that we were exploring ways to identify surgical site infections and would reevaluate this condition in FY 2009.

Comment: A number of commenters specifically requested that CMS consider selecting mediastinitis after coronary artery bypass graft (CABG) surgery. Commenters noted that mediastinitis is a postoperative infection that can arise after CABG.

Commenters stated that the condition meets the criteria set forth in the DRA. According to the comments, mediastinitis is a frequently occurring and costly infection that will develop after CABG surgery. The commenters noted that there are unique codes to identify mediastinitis and prevention guidelines that are backed by evidence based medicine have been developed.

Response: We agree that mediastinitis meets the statutory criteria for being selected.

Coding—There are unique ICD-9-CM codes to identify the condition. The ICD-9-CM code for mediastinitis is 519.2.

Burden (High Cost/High Volume)—We examined Medicare data on patients who received a CABG operation (with codes 36.10-36.19) and also had mediastinitis (ICD-9-CM code 519.2) as a secondary diagnosis. For FY 2006, there were 108 reported cases of Medicare patients who had this postoperative infection after CABG. These patients had average charges for the hospital stay of $304,747. Therefore, mediastinitis is a high-cost condition.

Prevention guidelines—The CDC surgical site infection prevention guidelines are backed by evidence based medicine. Further information can be found at: http://www.cdc.gov/​ncidod/​dhqp/​gl_​surgicalsite.html.

We are selecting this condition because it meets the statutory criteria and was suggested in the public comments. We would identify the coronary artery bypass graft procedures through procedure codes 36.10 through 36.19. Therefore, when a patient has a coronary artery bypass graft performed (code 36.10 through 36.19), and a secondary diagnosis of mediastinitis (code 519.2) is reported that was not present on admission, we will not count mediastinitis as an MCC beginning October 1, 2009.

“Surgical site infections” is a broad category, and we were looking for assistance from the public for ways to identify specific surgical site infections. We appreciate the suggestion to select mediastinitis after CABG surgery when it is a hospital acquired condition. We are selecting this condition for implementation in this FY 2008 final rule. We welcome additional recommendations for other types of surgical site infections that could also be selected and look forward to working with stakeholders and the public as we consider additional surgical site infections in the future.

(l) Serious Preventable Event—Surgery on Wrong Body Part, Patient, or Wrong Surgery

Coding—Surgery performed on the wrong body part, wrong patient, or the wrong surgery would be identified by ICD-9-CM code E876.5 (Performance of inappropriate operation). This diagnosis code does not specifically identify which of these events has occurred.

Burden (High Cost/High Volume)—As stated earlier, there are not unique ICD-9-CM codes which capture surgery performed on the wrong body part or the wrong patient, or the wrong surgery. Therefore, we examined Medicare data on the code for performance of an inappropriate operation. For FY 2006, there was one Medicare case reported with this code, and the patient had average charges for the hospital stay of $24,962. This event is rare. Therefore, it is not high volume. Individual cases could have high costs. However, we were unable to determine the impact with our limited data.

Prevention guidelines—There are guidelines to ensure that the correct surgery was performed on the correct patient or correct patient's body part. This event should not occur. Further information and prevention guidelines can be found at: http://www.ahrq.gov/​clinic/​ptsafety/​.

CC—This code is not a CC under the CMS DRGs and the MS-DRGs. Therefore, it does not meet the criteria for selection under section 1886(d)(4)(D)(iv) of the Act. However, Medicare does not pay for performing surgery on the wrong body part or patient, or performing the wrong surgery. These services are not considered to be reasonable and necessary and are excluded from Medicare coverage.

Considerations—There are significant considerations for the selection of this condition. There is not a unique ICD-9-CM code that would describe the nature of the inappropriate operation. All types of inappropriate operations are included in code E876.5. Unlike other conditions, performance of an inappropriate operation is not a complication of a prior medical event that was medically necessary. Rather, in this case, there was a needed intervention but it was done to either the wrong body part or the wrong patient, or was not the correct operation. Thus, a service was completed that was not reasonable and necessary and Medicare does not pay for any inpatient service associated with the wrong surgery. It is not necessary for us to select this condition because Medicare does not pay for it under any circumstances.

Comment: A majority of commenters agreed that there are not unique codes to identify wrong surgery. In addition, these commenters pointed out that there are guidelines to ensure that the correct surgery is being performed on the correct patient or correct patient's body part. These commenters stated that wrong surgery is a serious preventable event that should not occur.

One commenter urged CMS to rank the condition—surgery on wrong body part, wrong patient, or wrong surgery (wrong site surgery)—higher in our list of hospital-acquired conditions. This commenter stated that wrong site surgery may not be rare, but rather may be quite prevalent. The commenter disagreed with CMS' belief that wrong Start Printed Page 47214site surgery should not be considered as a complication because it is a risk of being in a hospital. The commenter recommended the development of specific codes for wrong site surgery.

Response: With respect to this latter comment, the commenter may have misunderstood our discussion of this issue in the proposed rule. We never asserted wrong site surgery is not a complication because it is a risk of being in a hospital. Rather, we stated the event itself is wrong and should never occur. Unlike CCs and MCCs, wrong surgery is not a complication of a prior medical event that was medically necessary. Wrong surgery is not a CC or an MCC because the entire event itself should never occur, is not reasonable and necessary and should not result in any payment to the hospital or physician. We are not selecting wrong surgery because it is not an event for which Medicare should pay less; it is an event for which Medicare should pay nothing at all.

As stated in the proposed rule, there is not a unique ICD-9-CM code that identifies surgery performed on the wrong body part or the wrong patient, or the wrong surgery. Code E876.5 (Performance of inappropriate operation) does not describe what specifically was wrong with the surgery, such as whether it was performed on the wrong side, the wrong patient, or if the wrong surgery were performed. In examining Medicare data on the code for performance of an inappropriate operation, we found only one case reported in FY 2006. We agree this is a serious issue that requires close examination and monitoring.

The proposed rule indicated that wrong surgery (right patient, wrong surgery, right surgery, wrong patient, etc.) is not a reasonable and necessary service. Therefore, it is not covered by Medicare and should not be paid. Wrong surgery is not a CC and does not meet the criteria of the statute. As stated above, there are generally recognized guidelines hospitals and physicians must follow to ensure that the correct surgery was performed on the correct patient or correct patient's body part. This event should not occur. If hospitals fail to ensure the correct surgery is performed, there are other provisions in the regulations to address this alarming event. For instance, a hospital must meet the CoPs in order to participate in Medicare. If wrong surgery was performed, the hospital could be out of compliance with the Surgical Services CoP, the Quality Assessment and Performance Improvement CoP, or potentially others. Performance of wrong surgery may suggest a systems failure or systems that do not comply with the CoPs that should be further investigated. We are interested in promoting a culture of safety and are interested in helping hospitals improve their performance. The hospital would have an opportunity to develop and present a plan of correction to avoid termination of its participation in Medicare by addressing the deficiencies that resulted in an incorrect surgery being performed. The final action that would be taken would depend on the individual circumstances and whether the hospital has addressed the problem to reduce the chance of a similar occurrence in the future. In any event, we reiterate that the way for Medicare to address wrong surgery is not through this provision that does not pay extra for preventable hospital complications when we should be paying nothing at all, but instead through Medicare's regulations that ensure that every Medicare provider meets basic quality of care standards.

(m) Falls and Fractures, Dislocations, Intracranial Injury, Crushing Injury, and Burns

Coding—There is no single code that shows that a patient has suffered a fall in the hospital. Codes would be assigned to identify the nature of any resulting injury from the fall such as a fracture, contusion, concussion, etc. There is a code to indicate that a patient fell from bed, code E884.4 (Fall from bed). One would then assign a code that identifies the external cause of the injury (the fall from the bed) and an additional code(s) for any resulting injury (a fractured bone).

Burden (High Cost/High Volume)—As stated earlier, there is not a code to identify all types of falls. Therefore, in the FY 2008 IPPS proposed rule, we examined Medicare data on the number of Medicare beneficiaries who fell out of bed. For FY 2006, there were 2,591 cases reported of Medicare patients who fell out of bed. These patients had average charges of the hospital stay of $24,962. However, depending on the nature of the injury, costs may vary in specific cases.

Prevention guidelines—Falls may or may not be preventable. Serious preventable event guidelines can be found at the following Web site: http://www.qualityindicators.ahrq.gov/​psi_​download.htm.

CC—Code E884.4 is not a CC under the CMS DRGs or the MS-DRGs.

Considerations—There are not clear codes that identify all types of falls. Hospitals would also have to use additional codes for fractures and other injuries that result from the fall. In addition, depending on the circumstances, the falls may or may not be preventable. We did not propose the inclusion of falls as one of our initial hospital-acquired conditions because we could only identify a limited number of these cases, and they were not classified as CCs. However, we welcomed public comments on how to develop codes or coding logic that would allow us to identify injuries that result from falls in the hospital so that Medicare would not recognize the higher costs associated with treating patients who acquire these conditions in the hospital.

Comment: Several commenters stated that the category of falls is not appropriate for inclusion as one of the hospital-acquired conditions. Specifically, the commenters noted that it is impossible to prevent all falls, and the definition of what constitutes a “preventable fall” is not well-defined. Several commenters strongly recommended the inclusion of falls for the final rule because falls and their resulting injuries are an important public health safety issue. However, these commenters did not give further details or recommendations to CMS regarding how to identify falls and related injuries as a hospital-acquired condition that would be subject to this provision.

Response: With respect to the comment that not all falls are preventable, we reiterate that the statutory provision authorizes the Secretary to select conditions that “could reasonably have been prevented through the application of evidence based guidelines.” We believe that injuries that occur in the hospital due to falls are preventable. As discussed earlier, we received a couple of comments urging us to include falls as one of our hospital acquired conditions. We recognize that preventable injuries are an important patient safety issue. Therefore, we considered additional ways to identify patients who had preventable injuries that occurred in the hospital. We examined the use of a combination of External cause of injury codes and the specific injury to identify these cases. We identified five external causes of injury codes that would identify falls in a hospital. These include:

  • E884.2 Fall from chair
  • E884.3 Fall from wheelchair
  • E884.4 Fall from bed
  • E884.5 Fall from other furniture
  • E884.6 Fall from commode

These codes clearly identify certain types of falls. If coded for an inpatient, they could identify that the fall occurred in the hospital. If these codes appeared Start Printed Page 47215on a claim along with a fracture or trauma code that did not reflect that the condition was present on admission, we could conclude that the injury was a result of a fall in the hospital that should not be counted as an MCC or CC. However, we identified potential problems in using the external cause of injury codes. There is a separate field on the electronic claim to report one external cause of injury code. However, hospitals do not report the POA indicator with this field. Therefore, we will not be able to tell if the external cause of injury code is identifying an event that occurred before or after admission.

Hospitals can also report external cause of injury codes as a secondary diagnosis. If the hospital lists the external cause of injury code among the secondary diagnoses, the hospital would be assigning a Present on Admission indicator to the external cause of injury code. In these cases, we would be able to identify that one of the five types of falls indicated above occurred after admission. We could use this information along with the ICD-9-CM diagnosis code for the specific type of injury, such as a fracture, to not allow the specific injury to count as a MCC or CC, since it would be the result of a preventable injury. In our analysis of the use of an external cause of injury code, we believe this approach is too complicated to identify preventable injuries. Therefore, we focused on simply identifying injuries that should not occur during a hospitalization. If a preventable injury occurs during a hospitalization, it should be included on our list of hospital acquired conditions.

We reviewed diagnosis codes contained in the Injury and Poisoning Chapter of ICD-9-CM and attempted to develop a list of codes that could identify potential adverse events that may or may not have been the result of a fall occurring in the hospital setting. After reviewing each category of diagnosis codes, we identified the following injuries that should not occur during a patient's hospitalization. The generic categories of injuries are as follows:

  • Fractures—ICD-9-CM code range 800 through 829
  • Dislocations—ICD-9-CM code range 830 through 839
  • Intracranial injury—ICD-9-CM code range 850 through 854
  • Crushing injury—ICD-9-CM code range 925 through 929
  • Burns—ICD-9-CM code range 940 through 949
  • Other and unspecified effects of external causes—ICD-9-CM code range 991 through 994

In our view, the above conditions should not occur after admission to the hospital. That is, if the patient is admitted to the hospital without a crushing injury, a burn, fracture, dislocation, among others, we can see no reason why such an event would not be preventable while the patient is in the hospital. None of these injuries should occur after admission. We believe this range of conditions offers a relatively uncomplicated method to determine if an injury or trauma is acquired in the hospital. This range of conditions meets the statutory criteria for being selected when they are MCCs or CCs. First, they are identifiable with ICD-9-CM codes. Second, injuries that occur as a result of a fall in the hospital complicate the care and treatment of the patient. Fractures and dislocations and other injuries are common in the Medicare population. There were more than 175,000 fractures and other traumatic injuries in the above range of codes for FY 2006. Third, hospital acquired injuries included in this range of codes should not occur and are preventable. Although we have not identified specific prevention guidelines for the conditions described by the above range of codes, we believe these types of injuries and trauma should not occur in the hospital, and we look forward to working with CDC and the public in identifying research that has or will occur that will assist hospitals in following the appropriate steps to prevent these conditions from occurring after admission.

We welcome public comments on additions and deletions to this injury list as well as our findings on the use of a combination of external cause of injury codes and injury codes to identify patients that acquired an injury in the hospital due to a fall. We also welcome any additional suggestions to identify cases where preventable injuries, such as falls, occur during hospitalization. We will review all recommendations in the FY 2009 IPPS rule in order to further refine our policy to identify preventable injuries and ensure that Medicare does not pay extra by counting them as MCC or CCs.

(n) Other Conditions Suggested Through Comment: Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE)

Comment: A number of commenters encouraged CMS to select Venous Thromboembolism (VTE), which includes both Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), as a preventable condition. The commenters noted that prophylactic measures exist to avoid these conditions and they are preventable if these steps are followed.

The commenters asserted that this condition meets the DRA criteria requirements for a condition eligible for a payment adjustment in that it involves high cost and high volume (according to the 2006 MedPAR data, DVT resulted in more than 180,000 discharges with a mean standardization cost of $17,410 and PE in more than 100,000 discharges with a mean standardization cost of $20,742), and results in assignment to a higher paying DRG if present as a secondary diagnosis. The commenters also noted that both DVT and PE have ICD-9-CM codes that are on the MCC and CC lists. In addition, this condition can be prevented in accordance with evidence-based guidelines. These commenters cited Geerts, et al., Prevention of Venous Thromboembolism: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy, Chest, 126: 338S-400S (2004). The commenters acknowledged DVT and PE are identified by multiple codes, but asserted that administrative issues surrounding the selection of this condition could be resolved. They requested that CMS consider selecting DVT and PE as preventable complications for which hospitals will not receive additional payments.

Response: We appreciate these comments suggesting that we add DVT and PE to our list of conditions that would be subject to the hospital acquired conditions provision. A DVT is a blood clot that forms in a vein, most commonly in the lower extremity. It can arise secondary to a number of clinical circumstances, including prolonged inactivity or bedrest, or from extended periods of time with the lower extremity in a bent position. It can also arise in the setting of a hypercoagulable state such as that which occurs with a number of malignancies, where the blood has an increased propensity to form clots, and it is also more common in patients taking oral contraceptives, particularly in conjunction with regular tobacco use. A PE is a clot that occurs in one of the pulmonary arteries that supplies a portion of the lung, most commonly when part or all of a DVT migrates to the pulmonary vessels from its original location, although it can also occur in the absence of a DVT, and it is a particularly serious event that is often life threatening. We refer readers to the current medical literature to further define DVT and PE.

We agree that there are circumstances where these conditions are preventable, Start Printed Page 47216and where the condition meets the statutory criteria to be selected. These conditions can be identified by unique ICD-9-CM codes. DVT can be identified through codes 453.40 (Venous embolism and thrombosis of unspecified deep vessels of lower extremity), 453.41 (Venous embolism and thrombosis of deep vessels of proximal lower extremity), and 453.42 (Venous embolism and thrombosis of deep vessels of distal lower extremity). All three codes are on the CC list. PE is identified through codes 415.10 (Iatrogenic pulmonary embolism and infarction) and 415.19 (Other pulmonary embolism and infarction). Both of these codes are on the MCC list. The commenters provided Medicare data showing that these conditions are both frequent and high cost in the Medicare population. Finally, the commenters have identified prevention guidelines backed by evidence based medicine to avoid DVTs and PEs. Therefore, at least in some circumstances, these conditions meet the statutory criteria for being selected.

We appreciate the collaborative efforts of other organizations to further define the prevention guidelines for this condition. We recognize that routine admission physical examinations should include efforts to detect a DVT. Although we believe DVTs and PEs may be preventable in certain circumstances (such as when an otherwise healthy patient is having elective surgery on a lower extremity), it is possible that a patient may have a DVT upon admission that goes unidentified, and it is also possible that DVT may occur because of other circumstances, such as an occult malignancy. If a DVT is clinically suspected upon admission to the hospital, the definitive diagnosis of a DVT can be made with a Doppler ultrasound examination or intravenous venogram, or both. We anticipate that it is not feasible to perform these studies on every hospitalized patient. In the case of a patient who is admitted with a clinically unapparent DVT that is not detected, the hospital will have followed all typical patient care protocols yet the DVT went undiagnosed upon admission. It may remain undetected until the patient exhibits symptoms of either the DVT or a PE that is unrelated to the patient's principal diagnosis. In these circumstances, we believe the DVT or PE should continue to be counted as an MCC or CC because, in our view, the condition either was unidentifiable prior to admission or did not likely occur as a result of poor management of the patient while they were in the hospital. We believe it is very important to select DVTs and PEs only when they are preventable through following standard prevention guidelines. We will seek to identify clearly defined instances of preventable DVT and PE that should not occur in the hospital setting which will help to further increase hospital quality of care.

We appreciate suggestions on how to identify DVTs and PEs that are preventable hospital acquired conditions. If we can identify only those circumstances where DVTs and PEs are preventable and meet the statutory criteria for being selected, we likely would make them subject to the provision in the FY 2009 IPPS final rule. We welcome comments on this issue and look forward to working with stakeholders to identify instances of preventable DVTs and PEs prior to implementation of this provision on October 1, 2008.

(o) Other Conditions Suggested Through Public Comment: Legionnaires’ Disease

Comment: One commenter suggested that CMS select Legionnaire's disease. The commenter asserted that this condition is high cost/high volume: CDC estimates between 8,000 and 18,000 cases per year. Due to underreporting and underdiagnosis, only 2 to 10 percent of cases are reported. Death occurs in 10 to 15 percent of cases. In addition, the commenter cited established prevention guidelines: CDC prevention guidelines are available and widely distributed. Finally, the commenter stated that Legionnaires’ disease is identified by ICD-9-CM code 482.84.

Response: While there may be a discrete ICD-9-CM code to identify Legionnaires’ disease, it is not typically a hospital acquired condition. Legionnaires’ disease is usually acquired outside of a hospital from a contaminated water supply that may or may not have any relation to a particular institution. Any outbreak of Legionnaires’ disease suggests a significant public health emergency that should be addressed by public health resources rather than by a particular Medicare payment policy.

(p) CMS Response to Additional Comments

We welcomed any comments on the clinical aspects of the conditions and on which conditions should be selected for implementation on October 1, 2008. We also solicited comments on any problematic issues for specific conditions that may support not selecting them as one of the initial conditions. We encouraged comments on how some of the administrative problems can be overcome if there is support for a particular condition.

Commenters did not raise any general administrative concerns. Rather, a number of commenters addressed the potential for an appeals process and POA coding issues. We have included the comment and response for each issue below:

  • Appeals Process:

Comment: A large number of commenters requested clarification from CMS on how hospitals appeal CMS decisions that a particular patient may fall under the hospital-acquired conditions policy and, therefore, is not eligible for higher payment through assignment to the higher CC/MCC level of the MS-DRG. They asked CMS to provide specific instructions for hospitals to follow for appealing a decision.

Response: We do not believe a separate appeals process is necessary for the payment adjustment for hospital-acquired conditions because existing procedures provide adequate opportunity for review. Under 42 CFR § 412.60(d), a hospital has 60 days after the date of the notice of the initial assignment of a discharge to a DRG to request a review of that assignment. The hospital may submit additional information as a part of its request. A hospital that believes a discharge was assigned to the incorrect DRG as a result of the payment adjustment for hospital-acquired conditions may request review of the DRG assignment by its fiscal intermediary or MAC.

However, we note that section 1886(d)(7)(B) of the Act, as amended by section 5001(c)(2) of the DRA, provides that there shall be no administrative or judicial review of the establishment of DRGs, including the selection and revision of codes under the payment adjustment for hospital acquired conditions. Therefore, although a hospital may request review of a DRG assignment in a particular case, the statute does not provide for review of the codes we select to be subject to the payment adjustment for hospital-acquired conditions.

  • POA Coding

Comment: Commenters suggested that all secondary diagnoses coded as present on admission be used to support the development of new complication rate measures and other quality indicators in the future. They suggested that CMS should develop special Grouper logic to exclude similar ICD-9-CM codes. The commenters stated that reducing hospital payments for a condition present upon admission, but not documented, is too punitive. Start Printed Page 47217

Many commenters submitted the experiences of two States that already use present-on-admission coding. They believed it takes several years and intense educational efforts to achieve reliable data and therefore there must be a strong clinical training component.

The commenters recommended that CMS implement the collection of the POA indicator but delay the implementation of any conditions that are dependent on its use until physicians and hospitals have an appropriate level of experience.

Response: We refer commenters to the Change Request No. 5499 released on May 11, 2007, for answers to additional questions regarding present-on-admission coding. We remind commenters that the DRG payment adjustment based on the POA indicator is not applicable until October 1, 2008. It is important to note that hospitals will gain experience in reporting POA information during FY 2008 prior to it having a payment impact in FY 2009.

  • Prevention Guidelines

Comment: A small number of commenters questioned the feasibility and reliability of current prevention guidelines. The commenters supported CMS’ goal of encouraging improvements in health care and reducing the number of preventable infections, but believed that hospitals must be reimbursed appropriately for providing the care patients need. The commenters believed that CMS should be sure that hospitals are not penalized for infections that originated outside the hospital or that are caused by factors beyond the hospital's control.

The commenters suggested that CMS should recognize that, even with the best infection control practices, some infections will occur anyway. They added that reducing payments for all cases in which those infections occur could harm hospitals’ ability to purchase and provide advanced drugs and treatment modalities or invest in other infection control technologies.

Response: We address each concern regarding prevention guidelines in the respective response for each condition. We are committed to improving quality and decreasing the number of hospital-acquired conditions. In that goal, we have chosen these specific conditions because they fulfill the criteria outlined in the DRA: the conditions have unique codes that are MCCs or CCs; the conditions are high volume, high cost or both; and the conditions can be reasonably prevented through the application of evidence-based guidelines.

  • Academic Centers/Hospitals with high risk patients:

Comment: Commenters representing academic centers and hospitals with high risk patient populations urged CMS to consider excluding patients considered to be high risk such as those that are more susceptible to infections.

Response: As indicated above, we are selecting conditions that are “reasonably preventable” through application of evidence-based guidelines and meet the other statutory criteria. In response to comments on each of the conditions considered, we indicated that we are researching whether to establish exceptions to the conditions for specific clinical circumstances where the condition may not be preventable. The determination of whether a patient is “high risk” will depend on the specific circumstances of the patient and the condition under consideration. We do not believe it is possible to classify a patient generally as “high risk” in all the circumstances where the provision could potentially apply. As we indicated above, we welcome public comments on clinical scenarios where a specific condition may not be reasonably preventable in the hospital and how to identify and distinguish those circumstances from other situations where the condition is preventable.

7. Other Issues

Under section 1886(d)(4)(D)(vi) of the Act, “[a]ny change resulting from the application of this subparagraph shall not be taken into account in adjusting the weighting factors under subparagraph (C)(i) or in applying budget neutrality under subparagraph (C)(iii).” Subparagraph (C)(i) refers to DRG classifications and relative weights. Therefore, the statute requires the Secretary to continue counting the conditions selected under section 5001(c) of the DRA as MCCs or CCs when updating the relative weights annually. Thus, the higher costs associated with a case with a hospital-acquired MCC or CC will continue to be assigned to the MCC or CC DRG when calculating the relative weight but payment will not be made to the hospital at one of these higher-paying DRGs. Further, subparagraph (C)(iii) refers to the budget neutrality calculations that are done so aggregate payments do not increase as a result of changes to DRG classifications and relative weights. Again, the higher costs associated with the cases that have a hospital-acquired MCC or CC will be included in the budget neutrality calculation but Medicare will make a lower payment to the hospital for the specific cases that includes a hospital-acquired MCC or CC. Thus, to the extent that the provision applies and cases with an MCC or CC are assigned to a lower-paying DRG, section 5001(c) of the DRA will result in cost savings to the Medicare program. We note that the provision will only apply when the selected conditions are the only MCCs and CCs present on the claim. Therefore, if a nonselected MCC or CC is on the claim, the case will continue to be assigned to the higher paying MCC or CC DRG, and there will be no savings to Medicare from the case. We believe the provision will apply in a small minority of cases because it is rare that one of the selected conditions will be the only MCC or CC present on the claim.

To summarize, we appreciate all of the comments on hospital-acquired conditions and look forward to continued input as we plan to implement these hospital-acquired conditions. Below is the list of conditions that we are selecting in this FY 2008 final rule. These conditions will be made subject to the provision beginning on October 1, 2008 (FY 2009).

  • Serious Preventable Event—Object Left in Surgery
  • Serious Preventable Event—Air Embolism
  • Serious Preventable Event—Blood incompatibility
  • Catheter-Associated Urinary Tract Infections
  • Pressure Ulcers (Decubitus Ulcers)
  • Vascular Catheter-Associated Infection
  • Surgical Site Infection—Mediastinitis After Coronary Artery Bypass Graft (CABG) Surgery
  • Hospital Acquired Injuries—Fractures, Dislocations, Intracranial Injury, Crushing Injury, Burn, and Other Unspecified Effects of External Causes

We will also propose the following conditions for consideration in the FY 2009 IPPS proposed rule. We will work diligently to address issues surrounding these conditions and propose to select these conditions in the FY 2009 IPPS final rule.

  • Ventilator Associated Pneumonia (VAP)
  • Staphylococcus Aureus Septicemia
  • Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE)

Finally, we list below the set of conditions that signal further analysis for future implementation.

  • Methicillin Resistant Staphylococcus Aureus (MRSA)
  • Clostridium Difficile-Associated Disease (CDAD)
  • Wrong Surgery—Provision not applicable because Medicare should not pay less; it should not pay at all.Start Printed Page 47218

Table 1.—Hospital-Acquired Conditions

(in rank order)

ConditionConsidered in NPRMProposed in NPRMSelected in FY 2008 final ruleMay be considered in future rulemaking
1. Serious Preventable Event—Object left in surgeryYesYesYesN/A.
2. Serious Preventable Event—Air embolismYesYesYesN/A.
3. Serious Preventable Event—Blood incompatibilityYesYesYesN/A.
4. Catheter-Associated Urinary Tract InfectionsYesYesYesN/A.
5. Pressure Ulcers (Decubitus Ulcers)YesYesYesN/A.
6. Vascular Catheter-Associated InfectionYesNo (No FY 2008 code)Yes (Code Created for FY 2008)N/A.
7. Surgical Site Infection—Mediastinitis after Coronary Artery Bypass Graft (CABG) surgeryYes (All surgical site infections, not just Mediastinitis)No (No unique codes)Yes (Comments suggested Mediastinitis which has unique code)N/A.
8. FallsYesNo (Coding not unique)Yes (Operational difficulties will be overcome by FY 2009)Expand to all hospital acquired injuries, adverse events.
9. Ventilator Associated Pneumonia (VAP)YesNo (Coding not unique)No (Coding not unique)Yes—FY 2009 IPPS final rule (Pursuing code with CDC).
10. Staphylococcus Aureus SepticemiaYesYesNo (Must identify subset where preventable)Yes—FY 2009 IPPS final rule.
11. Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE)NoNoNoYes—FY 2009 IPPS final rule (Work to identify situations where it should be preventable).
12. Methicillin Resistant Staphylococcus Aureus (MRSA)YesNoNoYes.
13. Clostridium Difficile—Associated Disease (CDAD)YesNoNoYes.
Other: Medicare Does not Pay For:
14. Wrong SurgeryYesNoNoProvision not Applicable. Medicare should not pay at all.

G. Changes to Specific DRG Classifications

1. Pre-MDCs: Intestinal Transplantation

In the FY 2005 IPPS final rule (69 FR 48976), we reassigned intestinal transplant cases from CMS DRG 148 (Major Small and Large Bowel Procedures with CC) and CMS DRG 149 (Major Small and Large Bowel Procedures without CC) to CMS DRG 480 (Liver Transplant and/or Intestinal Transplantation). In the FY 2006 IPPS final rule (70 FR 47286), we continued to evaluate these cases to see if a further DRG change was warranted. While we found that intestinal only transplants and combination liver-intestine transplants have higher average charges than other cases in CMS DRG 480, these cases are extremely rare (there were only 4 cases in FY 2004) and the insufficient number of cases did not warrant creating a separate DRG.

For FY 2008, we examined the September 2006 update of the FY 2006 MedPAR file and found 1,208 cases assigned to CMS DRG 480. In section II.C. of the preamble of the FY 2008 IPPS proposed rule, we proposed to split CMS DRG 480 into two severity levels: MS-DRG 005 (Liver Transplant and/or Intestinal Transplant with MCC) and MS-DRG 006 (Liver Transplant and/or Intestinal Transplant without MCC). The following table displays our results:

MS-DRGNumber of casesAverage length of stayAverage charges
MS-DRG 006—All cases44610.05$129,519
MS-DRG 006—Intestinal transplant cases only334354,793
MS-DRG 005—All cases76222.25243,271
MS-DRG 005—Intestinal transplant cases only940.22460,089
MS-DRG 005—Intestinal and liver transplant1561,179,425

Under the MS-DRGs, 10 of 13 intestinal transplant cases are assigned to proposed MS-DRG 005 based on the secondary diagnosis of the patient. The three remaining intestinal transplant cases do not have an MCC and would Start Printed Page 47219be assigned to MS-DRG 006, absent further changes to the DRG logic. These three intestinal transplants have average charges of approximately $354,793 and an average length of stay of 34 days. Average charges and length of stay for these three cases are more comparable to the average charges of approximately $243,271 and average length of stay of 22.25 days for all cases assigned to proposed MS-DRG 005. For this reason, we proposed to move all intestinal transplant cases to MS-DRG 005. As part of the proposal, we proposed to redefine proposed MS-DRG 005 as “Liver Transplant with MCC or Intestinal Transplant.” The presence of a liver transplant with MCC or an intestinal transplant would assign a case to the higher severity level. We also proposed to redefine proposed MS-DRG 006 as “Liver Transplant without MCC”.

Comment: Two commenters supported the proposed reassignment of intestinal transplants to MS-DRG 005. One commenter stated that CMS should continue to evaluate the frequency of this procedure and reassign it to an appropriate DRG reflective of its high resource utilization.

Response: We appreciate the support of the commenters and agree that when we receive sufficient data, we will again consider a separate intestinal transplant DRG.

Comment: One commenter supported separate MS-DRGs for intestinal transplants and combination liver-intestine transplants. The commenter cited that the data from the Milliman 2005 U.S. Organ and Tissue Transplant Cost Estimates and Discussion Research Report supports separate MS-DRGs. This report provided data for 58 intestine only transplants with estimated first year billed charges of $813,600 and 47 liver-intestine transplants with estimated first year billed charges of $830,200.

Response: The report submitted by the commenter does not indicate whether the patients cited in the study were Medicare. Further, it is not clear whether the identified costs were hospital inpatient only or total. For these reasons, we are not using these data to make an MS-DRG assignment. However, we are open to considering, to the extent feasible, reliable, validated data other than MedPAR data in annually recalibrating and reclassifying the DRGs.

In this final rule with comment period, we are adopting as final our proposal to reassign intestinal transplantation cases to MS-DRG 005. We are also redefining MS-DRG 005 as “Liver Transplant with MCC or Intestinal Transplant” and MS-DRG 006 as “Liver Transplant without CC”.

2. MDC 1 (Diseases and Disorders of the Nervous System)

a. Implantable Neurostimulators

We received a joint request from three manufacturers to review the DRG assignment for cases involving neurostimulators. The commenters are concerned that:

  • Neurostimulator cases may be assigned to 30 different DRGs in 12 different MDCs depending upon the patient's principal diagnosis.
  • Neurostimulator cases represent a small proportion of the total cases in their assigned DRG and have higher costs.
  • The 11 new ICD-9-CM codes created beginning in FY 2007 that identify pain are assigned to MDC 23 (Factors Influencing Health Status and Other Contacts With Health Services) rather than MDC 1 (Diseases and Disorders of the Nervous System). The manufacturers were concerned that these pain codes will be a common principal diagnosis for patients who receive a neurostimulator and will be assigned to MDC 23, which contains a wide variety of dissimilar diagnoses. The new ICD-9-CM codes are: 338.0 (Central pain syndrome), 338.11 (Acute pain due to trauma), 338.12 (Acute post-thoracotomy pain), 338.18 (Other acute postoperative pain), 338.19 (Other acute pain), 338.21 (Chronic pain due to trauma), 338.22 (Chronic post-thoracotomy pain), 338.28 (Other chronic postoperative pain), 338.29 (Other chronic pain), 338.3 (Neoplasm related pain (acute)(chronic)), and 338.4 (Chronic pain syndrome).

The manufacturers recommended that we:

  • Reroute all spinal and peripheral neurostimulator cases into a common set of base DRGs.
  • Reclassify ICD-9-CM pain codes 338.0 through 338.4 currently assigned to MDC 23 into MDC 1 when reported as the principal diagnosis.
  • Revise surgical CMS DRGs in MDC 1 based on whether the patient received a major device.
  • Split the single surgical CMS DRG in MDC 19 (Mental Diseases and Disorders) and MDC 23 into two CMS DRGs: one CMS DRG for minor procedures as defined by CMS DRGs 477 (Non-Extensive O.R. Procedure Unrelated to Principal Diagnosis) and CMS DRG 468 (Extensive O.R. Procedure Unrelated to Principal Diagnosis) and one CMS DRG for major procedures.
  • Create a new CMS DRG in MDC 1 for major devices.

The manufacturers recognized that implementing a re-routing feature in the CMS DRG system would be a major undertaking and, alternatively, suggested reassigning the pain codes to MDC 1 as an interim step. In the FY 2008 IPPS proposed rule, we noted that we agreed with this suggestion. With respect to the suggestion to split the single surgical CMS DRG in MDCs 19 and 23 into two CMS DRGs and create a major device CMS DRG within MDC 1, in the FY 2008 IPPS proposed rule, we encouraged commenters to examine the assignment of neurostimulator cases under the MS-DRGs to determine whether the changes we proposed to adopt to better recognize severity in the CMS DRG system would address these concerns.

The implantation of a neurostimulator requires two types of procedures. First, the surgeons implant leads containing electrodes into the targeted section of the brain, spine, or peripheral nervous system. Second, a neurostimulator pulse generator is implanted into the pectoral region and extensions from the neurostimulator pulse generator are tunneled under the skin and connected with the proximal ends of the leads. Hospitals stage the two procedures required for a full system neurostimulator implant.

There are separate ICD-9-CM procedure codes that identify the implant of the leads and the insertion of the pulse generator. The three codes for the leads insertion are: 02.93 (Implantation or replacement of intracranial neurostimulator lead(s)); 03.93 (Implantation or replacement of spinal neurostimulator lead(s)); and code 04.92 (Implantation or replacement of peripheral neurostimulator lead(s). The five codes for the insertion of the pulse generator are: 86.94 (Insertion or replacement of single array neurostimulator pulse generator, not specified as rechargeable); 86.95 (Insertion or replacement of dual array neurostimulator pulse generator, not specified as rechargeable); 86.96 (Insertion or replacement of other neurostimulator pulse generator); 86.97 (Insertion or replacement of single array rechargeable neurostimulator pulse generator); and 86.98 (Insertion or replacement of dual array rechargeable neurostimulator pulse generator).

The patient's principal diagnosis determines the MDC assignment. Implant of a cranial, spinal or peripheral neurostimulator will result in assignment of the case to a surgical DRG within that MDC. Although the manufacturers are correct that neurostimulator cases can potentially be assigned to many different CMS DRGs Start Printed Page 47220based on the patient's principal diagnosis, they also provided data that showed that nearly 90 percent are assigned to 6 different CMS DRGs that cross two MDCs. In MDC 1, neurostimulator cases are assigned to four CMS DRGs: CMS DRG 7 (Peripheral and Cranial Nerve and Other Nervous System Procedures with CC); CMS DRG 8 (Peripheral and Cranial Nerve and Other Nervous System Procedures without CC); CMS DRG 531 (Spinal Procedures with CC); and CMS DRG 532 (Spinal Procedures without CC). In MDC 8 (Disease and Disorders of the Musculoskeletal System and Connective Tissue), neurostimulator cases are assigned to two CMS DRGs: CMS DRG 499 (Back and Neck Procedures Except Spinal Fusion with CC); and CMS DRG 500 (Back and Neck Procedures Except Spinal Fusion without CC).

With very limited exceptions, such as tracheostomies and certain types of transplants, the principal diagnosis is fundamental to the assignment of a case to an MDC within the DRG system. By relying on the patient's principal diagnosis, the DRG system will group together patients who are clinically similar. As indicated in the proposed rule, for this reason, we were concerned about adopting the suggestion that all neurostimulator cases be rerouted to a common DRG irrespective of the patient's principal diagnosis. We believe such a step would be fundamentally inconsistent with the idea of creating common groups of patients who are clinically similar based on diagnosis and procedures. For this reason, we do not believe that a rerouting step should be adopted that would group together all neurostimulator cases.

However, in the FY 2008 IPPS proposed rule, we agreed with the manufacturers' suggestion that the new ICD-9-CM codes created in FY 2007 for central and chronic pain syndrome and chronic pain (codes 338.0, 338.21 through 338.29, and 338.4) should be assigned to MDC 1 when present as the principal diagnosis. The manufacturers requested that we reclassify the pain codes (338.0 through 338.4) from MDC 23 to MDC 1. Our medical consultants advised that the acute pain codes (codes 338.11 through 338.19) should remain in MDC 23 because the acute pain is not a neurological condition. According to the manufacturers, the National Center for Health Statistics' (NCHS) choice in locating the pain codes within ICD-9-CM's Nervous System chapter has much clinical validity, particularly for chronic pain. The manufacturers further noted that acute pain is typically self-limited, a symptomatic response to an immediate insult that serves the body as a warning sign. However, chronic pain is unrelenting and serves no warning or protective function. It is a disease process of its own accord, according to the commenters.

The manufacturers described pain as follows. Broadly, there are two main categories of pain: Nociceptive and neuropathic. Nociceptive pain is caused by sensory neurons, called nociceptors, responding to tissue damage. This type of pain is the body's normal response to injury. The pain is usually localized and time-limited. That is, when the tissue damage heals, the pain typically resolves. Acute pain is typically nociceptive. In general, nociceptive pain is typically treated with anti-inflammatories and, in more severe cases, with opioids via a morphine pump for example.

In contrast, neuropathic pain is caused by malfunctioning or pathologically altered nervous pathways stemming from injury to the nervous system, either as a direct result of trauma to a nerve (phantom limb syndrome, reflex symp