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Notice

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July 2003 Through September 2003

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

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

ACTION:

Notice.

SUMMARY:

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2003 through September 2003, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that potentially may be covered under Medicare. Finally, this notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations.

Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

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FOR FURTHER INFORMATION CONTACT:

It is possible that an interested party may have a specific information need and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing information contact persons to answer general questions concerning these items. Copies are not available through the contact persons. (See Section III of this notice for how to obtain listed material.)

Questions concerning items in Addendum III may be addressed to Karen Bowman, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-5252.

Questions concerning national coverage determinations in Addendum V may be addressed to Patricia Brocato-Simons, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-0261.

Questions concerning Investigational Device Exemptions items in Addendum VI may be addressed to Sharon Hippler, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C5-13-27, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-4633.

Questions concerning approval numbers for collections of information in Addendum VII may be addressed to Dawn Willinghan, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6141.

Questions concerning all other information may be addressed to Gwendolyn Johnson, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-12-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6954.

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SUPPLEMENTARY INFORMATION:

I. Program Issuances

The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs. These programs pay for health care and related services for 39 million Medicare beneficiaries and 35 million Medicaid recipients. Administration of the two programs involves (1) Furnishing information to Medicare beneficiaries and Medicaid recipients, health care providers, and the public and (2) maintaining effective communications with regional offices, State governments, State Medicaid agencies, State survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, and others. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act). We also issue various manuals, memoranda, and statements necessary to administer the programs efficiently.

Section 1871(c)(1) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register. We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, and to foster more open and transparent collaboration, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the respective 3-month time frame.

II. How To Use the Addenda

This notice is organized so that a reader may review the subjects of manual issuances, memoranda, Start Printed Page 74591substantive and interpretive regulations, national coverage determinations (NCDs), and Food and Drug Administration (FDA)-approved investigational device exemptions (IDEs) published during the subject quarter to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals may wish to review Table I of our first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) published in 1988, and the notice published March 31, 1993 (58 FR 16837). Those desiring information on the Medicare National Coverage Determination Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may wish to review the August 21, 1989, publication (54 FR 34555). Those interested in the revised process used in making NCDs under the Medicare program may review the September 26, 2003, publication (68 FR 55634).

To aid the reader, we have organized and divided this current listing into six addenda:

  • Addendum I lists the publication dates of the most recent quarterly listings of program issuances.
  • Addendum II identifies previous Federal Register documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda.
  • Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manuals.
  • Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register during the quarter covered by this notice. For each item, we list the—
  • Date published;
  • Federal Register citation;
  • Parts of the Code of Federal Regulations (CFR) that have changed (if applicable);
  • Agency file code number; and
  • Title of the regulation.
  • Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCDM (or CIM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision.
  • Addendum VI includes listings of the FDA-approved IDE categorizations, using the IDE numbers the FDA assigns. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B), and identified by the IDE number.
  • Addendum VII includes listings of all approval numbers from the Office of Management and Budget (OMB) for collections of information in CMS regulations in title 42; title 45, subchapter C; and title 20 of the CFR.

III. How To Obtain Listed Material

A. Manuals

Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses:

Superintendent of Documents, Government Printing Office, Attn: New Orders, PO Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-1800, Fax number (202) 512-2250 (for credit card orders); or

National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.

In addition, individual manual transmittals and Program Memoranda listed in this notice can be purchased from NTIS. Interested parties should identify the transmittal(s) they want. GPO or NTIS can give complete details on how to obtain the publications they sell. Additionally, most manuals are available at the following Internet address: http://cms.hhs.gov/​manuals/​default.asp.

B. Regulations and Notices

Regulations and notices are published in the daily Federal Register. Interested individuals may purchase individual copies or subscribe to the Federal Register by contacting the GPO at the address given above. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number.

The Federal Register is also available on 24x microfiche and as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) forward. Free public access is available on a Wide Area Information Server (WAIS) through the Internet and via asynchronous dial-in. Internet users can access the database by using the World Wide Web; the Superintendent of Documents home page address is http://www.gpoaccess.gov/​fr/​index.html, by using local WAIS client software, or by telnet to swais.gpoaccess.gov, then log in as guest (no password required). Dial-in users should use communications software and modem to call (202) 512-1661; type swais, then log in as guest (no password required).

C. Rulings

We publish rulings on an infrequent basis. Interested individuals can obtain copies from the nearest CMS Regional Office or review them at the nearest regional depository library. We have, on occasion, published rulings in the Federal Register. Rulings, beginning with those released in 1995, are available online, through the CMS Home Page. The Internet address is http://cms.hhs.gov/​rulings.

D. CMS's Compact Disk-Read Only Memory (CD-ROM)

Our laws, regulations, and manuals are also available on CD-ROM and may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, and the stock number is 717-139-00000-3. The following material is on the CD-ROM disk:

  • Titles XI, XVIII, and XIX of the Act.
  • CMS-related regulations.
  • CMS manuals and monthly revisions.
  • CMS program memoranda.

The titles of the Compilation of the Social Security Laws are current as of January 1, 1999. (Updated titles of the Social Security Laws are available on the Internet at http://www.ssa.gov/​OP_​Home/​ssact/​comp-toc.htm.) The remaining portions of CD-ROM are updated on a monthly basis.

Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CD-ROM. We intend to re-visit this issue in the near future and, with the aid of newer technology, we may again be able to include the appendices on CD-ROM.

Any cost report forms incorporated in the manuals are included on the CD-ROM disk as LOTUS files. LOTUS software is needed to view the reports once the files have been copied to a personal computer disk.

IV. How To Review Listed Material

Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the Start Printed Page 74592FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL.

In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most Federal Government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library.

Superintendent of Documents numbers for each CMS publication are shown in Addendum III, along with the CMS publication and transmittal numbers. To help FDLs locate the materials, use the Superintendent of Documents number, plus the transmittal number. For example, to find the Hospice Manual, (CMS Pub. 21) transmittal entitled “Payment of Amounts Owed Medicare,” use the Superintendent of Documents No. HE 22.8/18 and the transmittal number 69.

(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance, Program No. 93.774, Medicare—Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program)

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Dated: December 2, 2003.

Jacquelyn Y. White,

Director, Office of Strategic Operations and Regulatory Affairs.

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Addendum I

This addendum lists the publication dates of the most recent quarterly listings of program issuances.

November 2, 1999 (64 FR 59185)

December 7, 1999 (64 FR 68357)

January 10, 2000 (65 FR 1400)

May 30, 2000 (65 FR 34481)

June 28, 2002 (67 FR 43762)

September 27, 2002 (67 FR 61130)

December 27, 2002 (67 FR 79109)

March 28, 2003 (68 FR 15196)

June 27, 2003 (68 FR 38359)

September 26, 2003 (69 FR 55618)

Addendum II—Description of Manuals, Memoranda, and CMS Rulings

An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the former CIM (now the NCDM) was published on August 21, 1989, at 54 FR 34555. A brief description of the various Medicaid manuals and memoranda that we maintain was published on October 16, 1992, at 57 FR 47468.

Addendum III.—Medicare and Medicaid Manual Instructions

[July 2003 through September 2003]

Transmittal No.Manual/Subject/Publication No.
Intermediary Manual
Part 3—Audits, Reimbursement Program Administration
(CMS-Pub. 13-3)
(Superintendent of Documents No. HE 22.8/6)
1892Frequency of Billing
Provider Education
1893Release Software
1894Review of Form CMS-1450 (previously Form HCFA-1450) for Inpatient and
Outpatient Bills
1895Diabetes Outpatient Self-Management Training Services
1896Mammography Screening
Diagnostic Mammography
Diagnostic and Screening Mammography Performed With New Technologies
Mammography Billing Charts for Billing for Computer Aided Detection Devices
Common Working File Application of Age and Frequency Edits
Hospital Outpatient Partial Hospitalization Services
1897Limitation on Payment for Services to Individuals Entitled to Benefits on the Basis of End-Stage Renal Disease Who Are Covered by Group Health Plans
Definitions
Retroactive Implementation
Processing Claims
Determining the 30-Month Coordination Period During Which Medicare May Be Secondary Payer
Effect of Dual Entitlement
Subsequent Periods of End-Stage Renal Disease Eligibility or Entitlement
Amount of Secondary Medicare Payments Where Group Health Payments in Part for Items and Services
Limitation on Right of Provider or Facility to Charge a Beneficiary
Responsibility of Provider/Providers of Service and Renal Dialysis Facilities
Action When Group Health Payments Erroneously Pay Primary Benefits
Referral to Regional Offices of Cases Involving Taking Into Account Medicare Eligibility or Entitlement and Benefit Differentiation During Coordination Period
Claimant's Right To Take Legal Action Against a Group Health Plan
Medical Services Furnished to End-Stage Renal Disease Beneficiaries by Source Outside Group Health Plan Managed Care Plan
Limitations on Payment for Services to Aged Beneficiaries Who are Covered by a Group Health Plan on the Basis of Current Employment Status
Definitions
Individuals Subject to Limitation on Payment, General
Individuals Not Subject to Limitation on Payment, General
Identification of Cases by Providers of Services
Identification of Cases and Action Where There Is Indication of Possible Group Health Plan Coverage
Action by Provider Where Medicare Is Secondary to Group Health Plan
Limitation on Right of Provider or Facility to Charge a Beneficiary
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Employer Plan Denies Claim for Primary Benefit
Referral of Cases to Regional Offices
Recovery of Mistaken Primary Medicare Payments
Advice to Providers, Physicians, and Beneficiaries
Mistaken Group Health Plan Primary Payments
Claimant's Right to Take Legal Action Against a Group Health Plan
Special Rules for Services Furnished by Source Outside Group Health Plan
Managed Care Health Plan
Medicare as Secondary Payer for Disabled Individuals
1898Payment for Services Furnished by a Critical Access Hospital
Carriers Manual
Part 3—Program Administration
(CMS Pub. 14-3) (Superintendent of Documents No. HE 22.8/7)
1808Mandatory Assignment and Participation Program
Participation Program
Limiting Charge
1809Durable Medical Equipment Regional Carriers—Billing Procedures Related to Advance Beneficiary Notice Upgrades
Providing Upgrades of Durable Medical Equipment Prosthetic, Orthotics, and Supplies Without Any Extra Charge
1810Payment for Physician Services Furnished to Dialysis Inpatients
Dialysis Services (Codes 90935-90999)
1811Release Software
Contractor Testing Requirements
1812Definitions of Lines 1 through 115
Checking Reports
Exhibits
1813Data Element Requirements
Payment to Physician for Purchased Diagnostic Tests
Area Carriers—Physician's Services
Payment Jurisdiction for Services Paid Under the Physician Fee Schedule and Anesthesia Services
Claims Processing Instructions for Payment Jurisdiction for Claims Received On or After April 1, 2004
Payment Jurisdiction for Purchased Services
Jurisdiction for Shipboard Services
Exceptions to Jurisdictional Payment
Exhibit 10
Items 14-33 Physician or Supplier Information
1814Screening Mammography Examinations
Identifying a Screening Mammography Claim and a Diagnostic Mammography Claim
Adjudicating the Claim
Diagnostic and Screening Mammograms Performed With New Technologies
1815Repairs, Maintenance, Replacement, and Delivery
1816Correct Coding Initiative
1817Medicare Secondary Payment General Provisions
Third Party Payer Pays Charges in Full
Physician, Supplier, or Beneficiary Bills Medicare for Primary Benefits
Multiple Insurers
Third Party Payer Pays Primary Benefits When Not Required
Right of Physician or Supplier to Charge Beneficiary
General
Definitions
Current Employment Status
Employer-Sponsored Managed Care Health Plan
Nonconforming Group Health Plan
Recovery of Mistaken Primary Medicare Payments
Advice to Physicians/Suppliers and Beneficiaries
Mistaken Group Health Plan Primary Payments
Claimant's Right to Take Legal Action Against a Group Health Plan
Special Rules for Services Furnished by Source Outside Group Health Plan
Managed Care Health Plan
Medicare Secondary Payer Provisions for Working Aged Individuals
Individual Not Subject to Medicare Secondary Payer Provision
Exception for Small Employers in Multi-Employer and Multiple Employer Group Health Plan
Dually Entitled Individuals
General
Individuals Not Subject to Medicare Secondary Payer Provision
Items and Services Furnished On or After January 1, 1987 and Before August 10, 1993 (Date of Enactment of Omnibus Budget Reconciliation Act of 1993)
1818Filing the Request for Payment
1819Special Requirements for Claims for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
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1820Medicare Physician Fee Schedule Database 2004 File Layout
Maintenance Process for the Medicare Physician Fee Schedule Database
Carriers Manual
Part 4—Professional Relations
(CMS Pub. 14-4)
(Superintendent of Documents No. HE 22.8/7-4)
28Provider of Services or Supplier Information
Program Memorandum Intermediaries
(CMS Pub. 60A)
(Superintendent of Documents No. HE 22.8/6-5)
A-03-057Medicare Program-Update to the Hospice Payment Rates, Hospice Cap, Hospice Wage Index and the Hospice for Fiscal Year 2004
A-03-058Change in Methodology for Determining Payment for Outliers Under the Acute Care Hospital Inpatient and Long-Term Care Hospital Prospective Payment System
A-03-059Addition of Patient Status Code 43, Deletion of Patient Status Codes 71 and 72, and Information on New Patient Status Code 65
A-03-060Medicare Program—Update to the Prospective Payment System for Home Health Agencies for Fiscal Year 2004
A-03-061Tentative Settlement Requirements for Cost Reports from Home Health Agencies and Skilled Nursing Facilities That Have No Reimbursement Impact
A-03-062Department of Veterans Affairs Claims Adjudication Services Project System Changes Needed
A-03-063Installation of Version 30 of the Provider Statistical and Reimbursement Reporting System
A-03-064X12N 837 Institutional Health Care Claim Companion Document
A-03-065New Common Working File Edits to Ensure Accurate Coding and Payments for Discharge and/or Transfer Policies Under the Inpatient Prospective Payment System
A-03-066Hospital Outpatient Prospective Payment System Implementation Instructions
A-03-067The Supplemental Security Income Medicare Beneficiary Data for Fiscal Year 2002 for Inpatient Prospective Payment System Hospitals
A-03-068Informing Beneficiaries About Which Local Medical Review Policy and/or National Coverage Determination Is Associated With Their Claim Denial
A-03-069October Outpatient Code Editor Specification Version (V4.3)
A-03-070Inclusion of the State of New York in Demonstration for Settlement of Payments for Home Health Services to Dual Eligibles and Instructions for Processing Fiscal Year 2000 Claims Under the Demonstration. Regional Home Health Intermediaries Only.
A-03-071Retroactive Correction of Provider Statistical and Reimbursement System Report Data Related to Mammography and Outpatient Therapy Services
A-03-072Instructions for Provider Credit Balance Reporting Related Activities
A-03-073Fiscal Year 2004 Inpatient Prospective Payment System, Long Term Care Hospital, and Other Billing Changes
A-03-074Inpatient Rehabilitation Facility Annual Update: Prospective Payment System Pricer Changes for Fiscal Year 2004
A-03-075Medicare Part A Skilled Nursing Facility Prospective Payment System Update
A-03-076October 2003 Update of the Hospital Outpatient Prospective Payment System
A-03-077October Medicare Outpatient Code Editor Specification Version 19.0 for Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System
A-03-078Reimbursement for Automated Multi-Channel Chemistry Tests for End-Stage Renal Disease Beneficiaries
A-03-079Installation of Version 31 of the Provider Statistical and Reimbursement Reporting System
A-03-080End-Stage Renal Disease Reimbursement for Automated Multi-Channel Chemistry Test
A-03-081Conflicting Policies With Provider Reimbursement Manual 15-1, Section 2771
A-03-082Clarification for Billing Under the 2300 Provider Number by Hospital-Based Renal Dialysis Facilities
Program Memorandum
Carriers
(CMS Pub. 60B)
(Superintendent of Documents No. HE 22.8/6-5)
B-03-050Multiple Primary Payers on Part B Claims-Revision to Change Request 2050
B-03-051Therapy Modifier Bypass for Ambulance Claims
B-03-052Addition of Temporary “Q” Codes for Drugs Used in Infusion Pumps
B-03-053Healthcare Provider Taxonomy Codes Crosswalk
B-03-054Establishing and Maintaining Provider and Supplier Enrollment Data in Provider kEnrollment, Chain and Ownership System as Needed for Use By the Railroad Medicare Carrier to Pay Claims
B-03-055Common Working File crossover Editing for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Claims During an Inpatient Stay
B-03-056Durable Medical Equipment Regional Carriers—Additional Instructions for Health Insurance Portability and Accountability Act Implementatyion on National Drug Codes and the National Council of Prescription Drug Programs
B-03-057Additional Guidelines for Implementing the National Council for Prescription Drug Program Format
B-03-058Procedures for the Reconciliation of Total Funds Expended for Multi-Carriers Systems Medicare Contractors Used in the Preparation of Form CMS-1522, Monthly Contractor Financial Report
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B-03-059Minimum Number of Pricing Files That Must Be Maintained Online for Medicare Single Drug Pricer
B-03-060Expansion of Beneficiary History and Claims in Process Files in the Voucher Insurance Plan Viable Medicare System. Phase 2—Adjudication Claims in Process File Expansion
B-03-061Durable Medical Equipment Regional Carriers National Council of Prescription of Drug Programs Crosswalk Requirements
B-03-062Procedures for Non-Medicare Secondary Payer Overpayments With Original Balance Less than $10
B-03-063Healthcare Provider Taxonomy Codes Crosswalk
B-03-064Clarification—ICD-9 Coding
B-03-065Changes to Code List for Therapy Services
B-03-066Durable Medical Equipment Regional Carriers—Eliminate Combined Working File Edit for Cancer Diagnosis for National Drug Codes
B-03-067National Council for Prescription Drug Programs Batch Transmittal Standard 1.1 Billing Request Companion Document
B-03-0682004 Annual Update for Skilled Nursing Facility Consolidated Billing for the Common Working File and Medicare Carriers
B-03-069Schedule for Completing the Calendar Year 2004 Fee Schedule Updates and the Participating Physician Enrollment Procedures
Program Memorandum
Intermediaries/Carriers
(CMS Pub. 60A/B)
(Superintendent of Documents No. HE 22.8/6-5)
AB-03-094October 2003 Quarterly Updates for Skilled Nursing Facility Consolidated Billing
AB-03-095Remittance Advice Remark and Reason Code Update
AB-03-096Quarterly Update of Healthcare Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement
AB-03-097Delay in Implementation of Outpatient Therapy Caps to September 1, 2003
AB-03-098Medicare Summary Notice Implementation for Contractors Using Arkansas Part A Standard System and HCFA Part B Standard System
AB-03-099Instructions for Fiscal Intermediary Standard System and Multi-Carriers System Healthcare Integrated General Ledger Accounting System Changes
AB-03-100October Quarterly Update for 2003 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule
AB-03-101Clarification for CR 2562: Collection of Fee-for-Service Payments Made During Periods of Managed Care Enrollment
AB-03-102Clarifications Regarding Coverage of Hyperbaric Oxygen Therapy for the Treatment of Diabetic Wounds of the Lower Extremities
AB-03-103Medicare Secondary Payer Debt Referral and Write-Off Closed Instructions
AB-03-104Changes to the Laboratory National Coverage Determination Edit Software for October 1, 2003
AB-03-105Harkin Grantees: Complaint Tracking System and Aggregate Reports
AB-03-106Third Clarification of Medicare Policy Regarding the Implementation of the Ambulance Fee Schedule
AB-03-107Federal Bankruptcy/State Insurer Liquidation Actions and Medicare Secondary Payer Debt
AB-03-108Medicare Secondary Payer—(1) Use of Inter-Contractor Notices and the Common Working File for the Development of the Medicare Secondary Payer Conditional Payment Amount for Liability, No-Fault, Worker's Compensation, and Federal Tort Claims Act Cases; (2) Reminder Regarding Termination Updates to the Common Working File; (3) Reminder Regarding Savings Information to Non-Lead Contractors
AB-03-109Discontinue Use of the Healthcare Integrity and Protection Data Bank for Provider Enrollment Only
AB-03-110Adjustment to the Rural Mileage Payment Rate for Ground Ambulance Services
AB-03-111Shared System Maintainer Hours for Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing
AB-03-112Transmittal AB-03-112 Has Been Rescinded
AB-03-113Update of Codes in the Program Integrity Management Reporting System and the Contractor Administrative Cost and Financial Management System
AB-03-114Claims Processing and Payment of Incomplete Screening Colonoscopies
AB-03-115Payment Denial for Medicare Services Furnished to Alien Beneficiaries Who Are Not Lawfully Present in the United States
AB-03-116Update of Rates and Wage Index for Ambulatory Surgical Center Payment Effective October 1, 2003
AB-03-117Contractor Guidance for Connection to the Medicare Data Communication Network for Real-time Eligibility Inquiries (270/271) Via a Route Other Than Insurance Value-Added Network Services
AB-03-118Cease Further Work on the Eligibility File-Based Standard Trading Partner Agreement for the Purpose of Coordination of Benefits
AB-03-119Final Update to the 2003 Medicare Physician Fee Schedule Database
AB-03-120Medicare Secondary Payer—(1) Copy of Recovery Demand Packages Resulting From a Data Match or Non-Data Match Group Health Plan Recovery Action to Insurers/Third Party Administrators of Employers; (2) Documentation Required When an Insurer/Third Party Administrator Wishes to Resolve a Debt on Behalf of Its Client, an Employer Debtor
AB-03-121Requirement to Cross Claims Over to Multiple Supplemental Insurers
AB-03-122Notice of Interest Rate for Medicare Overpayments and Underpayments
AB-03-123Scheduled Release for October Updates to Software Programs and Pricing/Coding Files
AB-03-124Standard System Automation of the Notice of Change to Medicare Secondary Payer Auxiliary File Process
AB-03-125Consolidation of Claims Cross-Over Process
AB-03-126Change in Type of Service for L04080
AB-03-127Payment for Fecal Leukocyte Examination Under Clinical Laboratory Improvement Amendments of 1988 Certificate for Provider-Performed Microscopy Procedures During Calendar Year 2003
Start Printed Page 74596
AB-03-128Clarification to Transmittal AB-03-044 (CR 2611), Addition of New Temporary “K” Codes
AB-03-129Addition of Three New International Classifications of Diseases, Ninth Revision, Clinical Modification Diagnosis Codes To Be Effective as Part of the October 1, 2003, International Classification of Diseases, Clinical Update
AB-03-130Levocarnitine for Use in the Treatment of Carnitine Deficiency in End-Stage Renal Disease Patients
AB-03-131Update to Health Care Claims Status Category Codes and Health Care Claim Status Codes for Use With the Health Care Claim Status Request and Response ASCX12N 276/277
AB-03-132Provider Education Article: Guidelines for Medicare Part B Laboratory Testing
AB-03-133Managing Medicare Appeals Workloads in Fiscal Year 2004
AB-03-134Modifier and Condition Code for Providers to Use When Billing for Implantable Automatic Defibrillators for Beneficiaries in Medicare+Choice Plan
AB-03-135Darbepoetin Alfa (Trade Name Aranesp) and Epoetin Alfa (Trade Name Epogen) for Treatment of Anemia in End-Stage Renal Disease Patients on Dialysis
AB-03-136Correction to Quarterly Update of Health Care Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement
AB-03-137Update of Home Care Common Procedure Coding System Codes and Payment for Ambulatory Surgical Centers and File Names, Descriptions and Instructions for Retrieving the 2004 Ambulatory Surgical Center Home Health Care Common Procedure Coding System Additions, Deletions, and Master Listing
AB-03-138Modification of Medicare Policy for Erythropoietin
AB-03-139Appeals Quality Improvement and Data Analysis Activities
AB-03-1402004 Healthcare Common Procedure Coding System Annual Update Reminder
AB-03-141CMS Companion Document for the Accredited Standards Committee X12N276/277 Health Care Claim Status Request and Response
AB-03-142The Coordination of Benefits Contractor Will Post the Lead Medicare Contractor in the Group Name Field on the Common Working File and Expansion of Lead Contractor Viewing in the Electronic Correspondence Referral System
AB-03-143Implementation of Certain Initial Determination and Appeal Provisions Within Section 521 of the Medicare, Medicaid and State Child Health Insurance Program Benefits Improvement and Protection Act of 2000
AB-03-144Establishing a Uniform Process for the Preparation and Mailing of Case Files From the Contractor to the Office of Hearings and Appeals of the Social Security Administration
AB-03-145Instructions for Contractors Other Than the Religious Nonmedical Health Care Institution Specialty Intermediary Regarding Claims For Beneficiaries With Religious Nonmedical Health Care Institution Elections
AB-03-146Reminder Notice of the Implementation of the Ambulance Transition Schedule
AB-03-147Core Elements and Required Statements for a Valid Privacy Authorization
State Operations Manual
(CMS Pub. 7)
(Superintendent of Documents No. HE 22.8/12)
31Regional Offices Assignment of Provider and Supplier Identification Number
Hospice Manual
(CMS Pub. 10)
(Superintendent of Documents No. HE 22.8/2)
806Hospital Manual, Credit Balance Reporting Requirements—General Provisions
Payment of Amounts Owed Medicare
Medicare Credit Balance Reporting Certification Page
807Payment for Services Furnished by a Critical Access Hospital
Home Health Agency Manual
(CMS Pub. 11)
(Superintendent of Documents No. HE 33.8/5)
305Diabetes Outpatient Self-Management Training
306Home Health Agency Manual, Credit Balance Reporting Requirements—General Provisions
Completing the Centers for Medicare & Medicaid Services—838
Payment of Amounts Owed Medicare
Medicare Credit Balance Report Certification Page
Skilled Nursing Facility Manual
(CMS Pub. 12)
(Superintendent of Documents No. HE 22.8/3)
377Credit Balance Reporting Requirements—General Provisions
Payment of Amounts Owed Medicare
Medicare Credit Balance Report Certification Page
Start Printed Page 74597
Coverage Issues Manual
(CMS Pub. 6)
(Superintendent of Documents No. HE 22.8/14)
173Implantable Automatic Defibrillators
Peer Review Organization (CMS Pub. 19)
(Superintendent of Documents No. 22.8/8-15)
91Case Review and Health Care Quality Improvement Program—has been moved to Corresponding Internet-Only Manual chapter in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at http://www.cms.hhs.gov/​manuals.
92Denials, Reconsiderations and Appeals—has been moved to corresponding Internet-Only Manual chapters in Pub. 100-10, Medicare Quality Improvement Organization Manual, which can be found at http://www.cms.hhs.gov/​manuals.
93Agreements—has been moved to Corresponding Internet-Only Manual chapter in Pub. 100-10, Medicare Quality Improvement Organization Manual, which can be found at http://www.cms.hhs.gov/​manuals.
94Confidentiality and Disclosure—has been moved to the Corresponding Internet-Only Manual, which can be found at http://www.cms.hhs.gov/​manuals.
95Outreach Activities—has been moved to corresponding Internet-Only Manual chapters in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at http://www.cms.hhs.gov/​manuals.
96Payment Error Prevention Program—has been moved to corresponding Internet-Only Manual chapter in Pub.100-10, Medicare Improvement Organizations Manual, which can be found at http://www.cms.hhs.gov/​manuals.
97Beneficiary Complaint Review—has been moved to corresponding Internet-Only Manual chapter in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at http://www.cms.hhs.gov/​manuals.
98Data Management—has been moved to corresponding Internet-Only Manual chapter in Pub. 100-10, Medicare Quality Improvement Organizations Manual, which can be found at http://www.cms.hhs.gov/​manuals.
Hospice Manual
(CMS Pub. 21)
(Superintendent of Documents No. HE 22.8/18)
69Hospice Manual, Credit Balance Reporting Requirements—General Provisions
Completing the Centers for Medicare & Medicaid Services—838
Payment of Amounts Owed Medicare
Medicare Credit Balance Report Certification Page
Outpatient Physical Therapy and Comprehensive
Outpatient Rehabilitation Facility Manual
(CMS Pub. 9)
(Superintendent of Documents No. HE 22. 8/9)
18Outpatient Physical Therapy/Comprehensive Outpatient Rehabilitation
Facility/Community Mental Health/Clinic Manual, Credit Balance Reporting Requirements
General Provisions
Completing the Centers for Medicare & Medicaid Services—838
Payment of Amounts Owed Medicare
Medicare Credit Balance Reporting Certification Page
Rural Health Clinic Manual & Federally Qualified
Health Centers Manual
(CMS Pub. 27)
(Superintendent of Documents No. He 22.8/19:985)
39Rural Health Clinic and Federally Qualified Health Center Manual, Credit Balance Reporting—General Provisions
Completing the CMS-838
Payment of Amounts Owed Medicare
Medicare Credit Balance Reporting Certification Page
Rural Dialysis Facility Manual
(Non-Hospital Operated)
CMS Pub. 29)
(Superintendent of Documents No. 22.8/13)
96Renal Health Clinic Manual, Credit Balance Reporting Requirement—General Provisions
Completing the Centers for Medicare & Medicaid Services-838
Payment of Amounts Owed Medicare
Medicare Credit Balance Report Certification Page
Start Printed Page 74598
Provider Reimbursement Manual
Part 2 Provider Cost Reporting Forms and Instructions
(CMS Pub. 15-2-11)
5Reimbursement Information
ESRD Network Organizations Manual
(CMS Pub. 81)
(Superintendent of Documents No. HE 22.9/4)
15Background and Responsibilities
Administration
Confidentiality and Disclosure
Information Management
Quality Improvement
Community Information and Resource
Sanctions and End-Stage Renal Disease Grievances
Publication Policy
Information Collection
Medicare Claims Processing Manual
(CMS Pub. 100-04)
3New Effective Data for CR2112 (Revisions to the Outpatient Prospective Payment System Pricer Software and Outpatient Code Editor for Blood Deductible and Technician)
Financial Management
(CMS Pub. 100-06)
19Intermediary Claims Accounts Receivable
Medicare Program Integrity
(CMS Pub. 100-08)
44When to Develop New/Revised Local Medical Review Policy
Coverage Provisions in Local Medical Review Policy
Contractor Medical Director
Local Medical Review Policy Development Process
Final Local Medical Review Policy Web Site Requirements
45Focused Medical Review Activity Report
46Prepayment Edits
47Data Analysis
Centers for Medicare & Medicaid Services Mandated Edits
48Written Orders Prior to Delivery
49Denial Notices
50Instructions for Processing Advance Determination of Medicare Coverage Request
51Update of Codes in the Program Integrity Management Reporting System and the Contractor Administrative Cost and Financial Management System
Quality Improvement Organization
(CMS Pub. 100-10)
2Introduction
Referrals
Quality Review
Diagnostic Related Group
Limitation on Liability Determinations
Third-Level Physician Review
Use of the Physician Reviewer Assessment Format
Review Setting
Requesting Medical Records/Reviewing Documentation
Providing Opportunity for Discussion
Adhering to Review Timeframes
Monitoring Hospitals' Physician Acknowledgement Statements
3Introduction
Quality Improvement Project Process
Developing and Conducting Interventions
Documenting and Disseminating Results
Centers for Medicare & Medicaid Services Project Support and Guidance Activities
Start Printed Page 74599
Related Activities Through Quality Improvement Organizations, Carrier, Intermediary, and End-Stage Renal Diseases Network Cooperation
4Beneficiary Request for Review of Hospital-Issued Notice of Non-Coverage by a Quality Improvement Organization
5Intermediary/Carrier Memorandum of Agreement Specifications
Introduction
Memorandum of Agreement With State Agencies Responsible for Licensing/Certification of Providers/Practitioners
6Statutory and Regulatory Requirements
General Requirements
Confidential Information
Disclosure of Confidential Quality Improvement Organization Information to Officials and Agencies
Disclosure of Quality Improvement Organization Information for Research Purposes
Disclosure of Quality Improvement Organization Sanction Information
Re-disclosure of Quality Improvement Organization Information
7Beneficiary Helpline Language
Beneficiary Complaints
Physician/Provider Meeting Activities
Quality Improvement Organization/Intermediary/Carriers Coordination Activities
Background
Confidentiality Requirements
Report Requirements
Distribution Requirements
Publications Policy
Definition
Requirements
Disagreements
Information Collection Policy
Centers for Medicare & Medicaid Services Office of Clinical Standards and Quality Requirement
Statutory and Regulatory Requirements—Office of Management & Budget
Centers for Medicare & Medicaid Services, Information Collection
Approval Process
Additional Consideration
8Introduction
Review Responsibilities
Monitoring Hospital Payment Patterns and Developing
Collaborating With Provider and Practitioner Groups
Collaborating Efforts With Federal and State Agencies and Other Medicare Contractors
9Scope of Review
Complaints That Do Not Meet Statutory Requirements
Referral
Review Process
Notice of Disclosure
Final Response to Complaints
Disclosure of Quality Review Information to Complaints
Corrective Actions
Coordination With Other Entities
Data Analysis and Reporting Requirements
10Authority
Purpose of Quality Improvement Organization Review
Quality Improvement Organization Responsibilities
Centers for Medicare & Medicaid Services' Role
Health Care Quality Improvement Program
Hospital Payment Monitoring Program
End Stage Renal Disease
(CMS Pub. 100-14)
1Forward
Purpose of the Network Manual
Statutes and Regulations
End-Stage Renal Disease Network Organization's Manual Revisions
Acronyms and Glossary
Purpose of End-Stage Renal Disease Network Organization
Requirements for End-Stage Renal Disease Network Organization
Responsibilities of End-Stage Renal Disease Network Organization
Health Care Quality Improvement Program
 Goals
Network Organization's Role in Health Care Quality Improvement Program
2Forward
Purpose of the Network Manual
Statutes and Regulations
Start Printed Page 74600
Revision to the End-Stage Renal Disease Organizations Manual
Purpose of End-Stage Renal Disease Network Organization
Requirements for End-Stage Renal Disease Network Organizations
Responsibilities of End-Stage Renal Disease Network Organizations
Goals
Network Organization's Role in Health Care Quality Improvement Program
3Organizational Structure
Establishing the Network Computer
Board of Directors
Other Committees
Network Staff
Required Administrative Reports/Activities
Quarterly Progress and Status Reports
Annual Report
Semi-Annual Report of Network Operating Costs
New End-Stage Renal Disease Patient Orientation Package Activities
Internal Quality Control Program
Internal Quality Control Program Requirements
Managed Care Manual (CMS Pub. 100-16)
26Alternate Employer Group Enrollment Election
Optional Employer Group Medicare+Choice Enrollment Election
Request Submitted via Internet
Request Signature and Data
Effective Dates
Notice Requirements
Optional Employer Group Medicare+Choice Disenrollment Election
Medigap Guaranteed Issue Notification Requirements
General Rule
Effective Date
Researching and Acting on a Change of Address
Clarified the Notice Requirements for Out of Area Permanent
27Noncontracted Provider Appeals
Storage of Appeal Case Files by the Independent Review Entity
Representative Filing on Behalf of the Enrollee
Storage of Hearing Files
28Streamlined Marketing Review Process
Introduction
Marketing Review Process
Guidelines for Advertising Material
Guidelines for Advertising (Pre-Enrollment) Material
Guidelines for Beneficiary Notification Materials
Model Annual Notice of Change
General Guidance on Dual Eligibility
Guideline for Outreach Program
Submission Requirements
Centers for Medicare & Medicaid Services' Review/Approval Process
Model Direct Mail Letter
Summary of Benefits for Medicare+Choice Organizations
Referral Programs
Allowable Actions for Medicare+Choice Organizations
Specific Guidance About the Use of Independent Insurance Agents
Answers to Frequently Asked Questions About Promotional Marketing of Multiple Lines of Business
29Introduction
Quality Assessment and Performance Improvement Program
Administration of the Quality Assessment and Performance Improvement Program
Medicare+Choice Organizations Using Physician Incentive Plans
Health Information System
Quality Assessment and Performance Improvement
Centers for Medicare & Medicaid Services' Directed Special Projects
Reporting Time Frames
Communication Process
Quality Assessment and Performance Improvement
Process for Centers for Medicare & Medicaid Services' Multi-Year Quality Assessment and Performance Improvement Program Project Approvals
Evaluation of Quality Assessment and Performance Improvement Program Projects
The Medicare+Choice Deeming Program
Terminology
General Rule
Start Printed Page 74601
Obligations of Deemed Medicare and Medicaid Organizations
Oversight of Accrediting Organizations
Application Requirements
Reporting Requirements
Informal Hearing Procedures
30Reasonable Cost-Based Payments—General
Reasonable Cost Payments
Bill Processing
Principles of Payments
Budget and Enrollment Forecast
Interim Per Capita Rate
Interim Payment for Health Care Prepayment Plans
Electronic Transfer of Funds
Payment Report
Interim and Final Cost and Enrollment Report
Adjustment of Payments
Final Cost Report
Final Settlement Process for Medicare Health Care Prepayment Plans
Final Settlement Payment for Medicare Health Care Prepayment Plans
Recovery of Overpayment
Interest Charges for Medicare Overpayments/Underpayments
The Basic Rules
Definition of Final Determination
Rate of Interest
Accrual of Interest
Waiver of Interest
Rules Applicable to Partial Payments
Exception to Applicability
Nonallowable Interest Cost
Centers for Medicare & Medicaid Services' General Payment Principles
Medicare Payments to Health Care Prepayment Plans
Prudent Buyer Principle
Allowable Costs
Costs Not Reimbursable Directly to the Health Care Prepayment Plans
Deductible and Coinsurance
Hospice Care Costs
Medicare as Secondary Payer
31Overview of Enrollment and Payment Process
Purpose of the Chapter
Medicare+Choice Organization Data Processing Responsibilities
Centers for Medicare & Medicaid Services' Group Health Plan System
Enrollment/Disenrollment Requirements and Effective Dates
General
Enrollments
Cost-Based Medicare+Choice Organizations Only
Medicare+Choice Organizations Only
Disenrollments
Cost-Based Medicare+Choice Organizations Only
Medicare+Choice Organizations Only
Cost-Based Medicare+Choice Organizations Only—Employer Group Health Plan
Retroactive Enrollment
Medicare Membership Information
The Centers for Medicare & Medicaid Services' Medicare+Choice
Organizations Only Interface Submitting Medicare Membership
Information to Centers for Medicare & Medicaid Services
Submission of Enrollment/Disenrollment Transaction Records
Submission of Correction Transaction Records
Health Insurance Claim Number
Transaction Type Code and the Prior Commercial Indicator
Transaction Type Codes
Prior Commercial Months Field
Special Status Beneficiaries—Medicare+Choice Organizations
Special Status Beneficiaries
Special Status—Hospice
Special Status—End-Stage Renal Disease
Special Status—Institutionalized
Special Status—Medicaid/Medical Assistance Only
Special Status—Working Aged
When to Submit “Special Status” Information (Medicare+Choice Organizations Only)
Other Medicare Membership Information
Start Printed Page 74602
Risk Adjustment Payment
Bonus Payment
Extra Payment in Recognition of Quality Congestive Heart Failure
Outpatient Care
Benefit Stabilization Fund
Electronic Submission of Membership Records to Centers for Medicare & Medicaid Services
Timeliness Requirements
Record Submission Schedule
Sending the Transaction File to Centers for Medicare & Medicaid Services
Electronic Data Transfer
Centers for Medicare & Medicaid Services' Data Center Access
Data Processing Vendor
Receiving Medicare Membership Information Form Centers for Medicare & Medicaid Services
General
Centers for Medicare & Medicaid Services' Transaction Reply/Monthly Activity Report
Transaction Reply Field Information
Plan Payment Report
Demographic Report—Medicare+Choice Organizations Only
Medicare Fee-For-Service Bill Itemization and Summary Report
Monthly Membership Report
Bonus Payment Report
Working Aged Transaction Status Report
Retroactive Payment Adjustment Policy
Standard Operating Procedures for State and County Code Adjustments
Standard Operating Procedures for Processing of Institutional Adjustments
Standard Operating Procedures for Medicaid Retroactive Adjustments
Standard Operating Procedures for End-Stage Renal Disease Retroactive Adjustments
Processing of Working Aged Retroactive Adjustments
Standard Operating Procedures for Retroactive Adjustment Plan Elections
Centers for Medicare & Medicaid Services, Social Security Administration, and Customer Service Center Disenrollments
General
Medicare Customer Service Center Disenrollments
Centers for Medicare & Medicaid Services' Disenrollments
Coordination With the Medicare Fee-For-Services Program
Pro-Rate Deductible
Duplicate Payment Prevention by Cost-Based Medicare+Choice Organizations

Addendum IV—Regulation Documents Published in the Federal Register [July 2003 Through September 2003]

Publication dateFR Vol. 68 page No.CFR parts affectedFile codeTitle of regulation
July 2, 200339764CMS-1473-NCMedicare Program; Home Health Prospective Payment System Rate Update for FY 2004.
July 15, 200341861OFR CorrectionMedicare Program; Prospective Payment System for Long-Term Care Hospitals: Annual Payment Rate Updates and Policy Changes.
July 25, 200344091CMS-3117-NMedicare Program; Meeting of the Medicare Coverage Advisory Committee September 9, 2003.
July 25, 200344089CMS-1260-NMedicare Program; Meeting of the Advisory Panel on Ambulatory Payment Classification Groups—August 22, 2003.
July 25, 200344088CMS-3124-WNMedicare Program; Withdrawal of Medicare Coverage of Multiple-Seizure Electroconvulsive Therapy, Electrodiagnostic Sensory Nerve Conduction Threshold Testing, and Noncontact Normothermic Wound Therapy.
July 25, 20034400042 CFR Part 424CMS-1185-PMedicare Program; Elimination of Statement of Intent Procedures for Filing Medicare Claims.
July 25, 20034399842 CFR Part 406CMS-4018-PMedicare Program; Continuation of Medicare Entitlement When Disability Benefit Entitlement Ends Because of Substantial Gainful Activity.
Start Printed Page 74603
July 25, 20034399542 CFR Parts 405 and 411CMS-6014-PMedicare Program; Interest Calculation.
July 25, 20034394042 CFR Parts 411 and 489CMS-1475-FCMedicare Program; Third Party Liability Insurance Regulations.
August 1, 20034567442 CFR Part 412CMS-1474-FMedicare Program; Changes to the Inpatient Rehabilitation Facility Prospective Payment System and Fiscal Year 2004 Rates.
August 1, 20034534642 CFR Parts 412 and 413CMS-1470-FMedicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates.
August 4, 20034603642 CFR Parts 409, 411, 413, 440, 483, 488, and 489CMS-1469-FMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update.
August 11, 20034763742 CFR Part 412CMS-1470-FMedicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates.
August 12, 20034796642 CFR Parts 410 and 419CMS-1471-PMedicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004 Payment Rates.
August 15, 20034903042 CFR Parts 410 and 414CMS-1476-PMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004.
August 15, 20034880542 CFR Part 424CMS-0008-IFCMedicare Program; Electronic Submission of Medicare Claims.
August 20, 20035042842 CFR Part 405CMS-1229-PMedicare Program; Payment Reform for Part B Drugs.
August 22, 20035084042 CFR Parts 409, 417, and 422CMS-4041-FMedicare Program; Modifications to Managed Care Rules.
August 22, 200350794CMS-1236-NMedicare Program; September 15 and 16, 2003, Meeting of the Practicing Physicians Advisory Council and Request for Nominations.
August 22, 200350793CMS-4053-NMedicare Program: Meeting of the Advisory Panel on Medicare Education—September 18, 2003.
August 22, 200350790CMS-2136-FNMedicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: Federal Fiscal Year 2002.
August 22, 200350784CMS-2166-NState Children's Health Insurance Program; Final Allotments to States, the District of Columbia, and U.S. Territories and Commonwealths for Fiscal Year 2004.
August 22, 20035073542 CFR Part 414CMS-1167-PMedicare Program; Payment for Respiratory Assist Devices With Bi-level Capability and a Back-up Rate.
August 22, 200350722CMS-2226-CNMedicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Correction.
August 22, 20035071742 CFR Part 413CMS-1199-FMedicare Program; Electronic Submission of Cost Reports.
August 29, 20035191242 CFR Part 447CMS-2175-FCMedicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program.
September 9, 20035326642 CFR Part 412CMS-1262-PMedicare Program; Changes to the Criteria for Being Classified as an Inpatient Rehabilitation Facility.
September 9, 20035322242 CFR Parts 413, 482, and 489CMS-1063-FMedicare Program; Clarifying Policies Related to the Responsibilities of Medicare-Participating Hospitals in Treating Individuals With Emergency Medical Conditions.
September 26, 200355634CMS-3062-NMedicare Program; Revised Process for Making Medicare National Coverage Determinations.
September 26, 200355618CMS-9018-NMedicare and Medicaid Programs; Quarterly Listing of Program Issuances—April 2003 Through June 2003.
September 26, 200355616CMS-2182-FNMedicare and Medicaid Programs; Reapproval of the Community Health Accreditation Program (CHAP) for Deeming Authority for Hospices.
Start Printed Page 74604
September 26, 20035556642 CFR Parts 410 and 414CMS-1476-CNMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004; Correction.
September 26, 20035552842 CFR Parts 483 and 488CMS-2131-FMedicare and Medicaid Programs; Requirements for Paid Feeding Assistants in Long Term Care Facilities.
September 26, 20035552742 CFR Part 447CMS-2175-CNMedicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program; Correction
September 29, 20035588242 CFR Parts 409, 411, 413, 440, 483, 488, and 489CMS-1469-CNMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Correction.
September 30, 200356478CMS-1233-NMedicare Program; Hospice Wage Index for Fiscal Year 2004.
September 30, 200356383CMS-1473-NC OFR CorrectionMedicare Program; Home Health Prospective Payment System Rate Update for FY 2004; Correction.

Addendum V—National Coverage Determinations [July 2003 Through September 2003]

A national coverage determination (NCD) is a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act, but does not include a determination of what code, if any, is assigned to a particular item or service covered under this title, or determination with respect to the amount of payment made for a particular item or service so covered. We include below all of the NCDs that were issued during the quarter covered by this notice. The entries below include information concerning completed decisions as well as sections on program and decision memoranda, which also announce pending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by the section of the NCDM (or CIM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. Information on completed decisions as well as pending decisions has also been posted on the CMS Web site at http://cms.hhs.gov/​coverage.

National Coverage Decisions [July 2003 Through September 2003]

Coverage Issues Manual (CIM) (CMS Pub. 06)

CIM sectionTitleIssue dateEffective date
35-85.1Implantable Automatic08/22/0310/01/03
Defibrillators09/22/03 (correction)10/01/03

Program Memorandum (PM)

PM No.TitleIssue dateEffective date
AB-03-104Changes to the Laboratory NCD Edit Software For 10/0307/25/0310/01/03

Federal Register Publications

TitlePublication dateEffective date
CMS-3062-N—Revised Process for Making National Coverage Determinations09/26/03N/A

Addendum VI—Categorization of Food and Drug Administration-Allowed Investigational Device Exemptions

Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices fall into one of three classes. Also, under the new categorization process to assist CMS, the Food and Drug Administration (FDA) assigns each device with an FDA-approved investigational device exemption (IDE) to one of two categories. Category A refers to experimental/investigational device exemptions, and Category B refers to nonexperimental/investigational device exemptions. To obtain more information about the classes or categories, please refer to the Federal Register notice published on April 21, 1997 (62 FR 19328).

The following information presents the device number and category (A or B) for the second quarter, July through September 2003.

Investigational Device Exemption Numbers, 3rd Quarter 2003

IDECategory
G020202B
G020312B
G020316B
G030027B
G030031B
G030040B
G030059B
G030066B
G030100B
G030121B
G030131B
G030133B
G030134B
G030135B
G030136B
Start Printed Page 74605
G030137B
G030138B
G030141B
G030143B
G030144B
G030145B
G030146B
G030147B
G030151B
G030159B
G030162B
G030165B
G030167B
G030169B
G030170B
G030172B
G030173B
G030174B
G030177B

Addendum VII—Approval Numbers for Collections of Information

Below we list all approval numbers for collections of information in the referenced sections of CMS regulations in Title 42; Title 45, Subchapter C; and Title 20 of the Code of Federal Regulations, which have been approved by the Office of Management and Budget:

OMB control Nos.Approved CFR sections in Title 42, Title 45, and Title 20 (Note: sections in Title 45 are preceded by “45 CFR,” and sections in Title 20 are preceded by “20 CFR”)
0938-0008414.40, 424.32, 424.44
0938-0022413.20, 413.24, 413.106
0938-0023424.103
0938-0025406.28, 407.27
0938-0027486.100-486.110
0938-0033405.807
0938-0034405.821
0938-0035407.40
0938-0037413.20, 413.24
0938-0041408.6
0938-0042410.40, 424.124
0938-0045405.711
0938-0046405.2133
0938-0050413.20, 413.24
0938-0062431.151, 435.1009, 440.220, 440.250, 442.1, 442.10-442.16, 442.30, 442.40, 442.42, 442.100-442.119, 483.400-483.480, 488.332, 488.400, 498.3-498.5
0938-0065485.701-485.729
0938-0074491.1-491.11
0938-0080406.7, 406.13
0938-0086420.200-420.206, 455.100-455.106
0938-0101430.30
0938-0102413.20, 413.24
0938-0107413.20, 413.24
0938-0146431.800-431.865
0938-0147431.800-431.865
0938-0151493.1405, 493.1411, 493.1417, 493.1423, 493.1443, 493.1449, 493.1455, 493.1461, 493.1469, 493.1483, 493.1489
0938-0155405.2470
0938-0170493.1269-493.1285
0938-0193430.10-430.20, 440.167
0938-0202413.17, 413.20
0938-0214411.25, 489.2, 489.20
0938-0236413.20, 413.24
0938-0242416.44, 418.100, 482.41, 483.270, 483.470
0938-0245407.10, 407.11
0938-0246431.800-431.865
0938-0251406.7
0938-0266416.41, 416.47, 416.48, 416.83
0938-0267410.65, 485.56, 485.58, 485.60, 485.64, 485.66
0938-0269412.116, 412.632, 413.64, 413.350, 484.245
0938-0270405.376
0938-0272440.180, 441.300-441.305
0938-0273485.701-485.729
0938-0279424.5
0938-0287447.31
0938-0296413.170
0938-0300431.800
0938-0301413.20, 413.24
0938-0302418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.74, 418.83, 418.96, 418.100
0938-0313418.1-418.405
0938-0328482.12, 482.22, 482.27, 482.30, 482.41, 482.43, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, 482.66
0938-0334491.9
0938-0338486.104, 486.106, 486.110
0938-0354441.60
0938-0355484.10-484.52
0938-0357409.40-409.50, 410.36, 410.170, 411.4-411.15, 421.100, 424.22, 484.18, 489.21
0938-0358412.20-412.30
Start Printed Page 74606
0938-0359412.40-412.52
0938-0360405.2100-405.2184
0938-0365484.10, 484.11, 484.12, 484.14, 484.16, 484.18, 484.20, 484.36, 484.48, 484.52
0938-0372414.330
0938-0378482.60-482.62
0938-0379442.30, 488.26
0938-0386405.2100-405.2171
0938-0391488.18, 488.26, 488.28
0938-0426476.104, 476.105, 476.116, 476.134
0938-0429447.53
0938-0443473.18, 473.34, 473.36, 473.42
0938-04441004.40, 1004.50, 1004.60, 1004.70
0938-0445412.44, 412.46, 431.630, 456.654, 466.71, 466.73, 466.74, 466.78
0938-0447405.2133
0938-0449440.180, 441.300-441.310
0938-0454424.20
0938-0456412.105
0938-0463413.20, 413.24
0938-0465411.404, 411.406, 411.408
0938-0467431.17, 431.306, 435.910, 435.920, 435.940-435.960
0938-0469417.107, 417.478
0938-0470417.143, 417.408
0938-0477412.92
0938-0484424.123
0938-0486498.40-498.95
0938-0501406.15
0938-0502433.138
0938-0512486.301-486.325
0938-0526462.102, 462.103. 475.100, 475.106, 475.107
0938-0534410.38, 424.5
0938-0544493.1-493.2001
0938-0565411.20-411.206
0938-0566411.404, 411.406, 411.408
0938-0567Part 498 Subparts D and E, and 20 CFR 404.933
0938-0573412.230, 412.256
0938-0581493.1-493.2001
0938-0599493.1-493.2001
0938-0600405.371, 405.378, 413.20
0938-0610417.436, 417.801, 422.128, 430.12, 431.20, 431.107, 434.28, 483.10, 484.10, 489.102
0938-0612493.1-493.2001
0938-0618433.68, 433.74, 447.272
0938-0653493.1771, 493.1773, 493.1777
0938-0655493.1840
0938-0657405.2110, 405.2112
0938-0658405.2110, 405.2112
0938-0667482.12, 488.18, 489.20, 489.24
0938-0673430.10
0938-0679410.38
0938-0685410.32, 410.71, 413.17, 424.57, 424.73, 424.80, 440.30, 484.12
0938-0686493.551-493.557
0938-0688486.301-486.325
0938-0690488.4-488.9, 488.201
0938-0691412.106
0938-0692466.78, 489.20, 489.27
0938-0700417.479, 417.500; 422.208, 422.210; 434.44, 434.67, 434.70; 1003.100, 1003.101, 1003.103, 1003.106
0938-0701422.152
0938-070245 CFR 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, 146.180
0938-070345 CFR 148.120, 148.124, 148.126, and 148.128
0938-0714411.370-411.389
0938-0717424.57
0938-0721410.33
0938-0722422.370-422.378
0938-0723421.300-421.318
0938-0730405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, 424.24
0938-0732417.126, 417.470
0938-073445 CFR 5b
0938-0739413.337, 413.343, 424.32, 483.20
0938-0742422.300-422.312
0938-0749424.57
0938-0753422.000-422.700
0938-0754441.152
0938-0758413.20, 413.24
0938-0760Part 484 Subpart E, 484.55
Start Printed Page 74607
0938-0761484.11, 484.20
0938-0763422.1-422.10, 422.50-422.80, 422.100-422.132, 422.300-422.312, 422.400-422.404, 422.560-422.622
0938-0768417.800-417.840
0938-0770410.2
0938-0778422.64, 422.111, 422.560-422.622
0938-0779417.126, 417.470, 422.64, 422.210
0938-0781411.404-411.406, 484.10
0938-0786438.352, 438.360, 438.362, 438.364
0938-0787406.28, 407.27
0938-0790460.12, 460.22, 460.26, 460.30, 460.32, 460.52, 460.60, 460.70, 460.71, 460.72, 460.74, 460.80, 460.82, 460.98, 460.100, 460.102, 460.104, 460.106, 460.110, 460.112, 460.116, 460.118, 460.120, 460.122, 460.124, 460.132, 460.152, 460.154, 460.156, 460.160, 460.164, 460.168, 460.172, 460.190, 460.196, 460.200, 460.202, 460.204, 460.208, 460.210
0938-0792491.3, 491.8, 491.11
0938-0798413.24, 413.65, 419.42
0938-0802419.43
0938-0810482.45
0938-081945 CFR 146.121
0938-0823420.410
0938-0824440.10, 482.13
0938-082745 CFR 146.141
0938-0829422.568
0938-0832Part 489
0938-0833483.350-483.376
0938-0841431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560, 457.570, 457.740, 457.750, 457.810, 457.940, 457.945, 457.965, 457.985, 457.1005, 457.1015, 457.1180
0938-0842412, 413
0938-0846411.1, 411.350-411.357, 424.22
0938-0857Part 419
0938-0860Part 419
0938-086645 CFR Part 162
0938-0872413.337, 483.20
0938-0873422.152
0938-087445 CFR Parts 160 and 162
0938-0878Part 422 Subparts F and G
0938-088345 CFR Parts 160 and 164
0938-088745 CFR 148.316, 148.318, 148.320
0938-0897412.22, 412.533
End Supplemental Information

[FR Doc. 03-30756 Filed 12-23-03; 8:45 am]

BILLING CODE 4120-01-P