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Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January 2003 Through March 2003

Document Details

Information about this document as published in the Federal Register.

Published Document

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




This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2003 through March 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, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe.

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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 should be directed 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 Willingham, 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 Margie Teeters, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-13-18, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-4678.

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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 these 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, fiscal intermediaries and carriers 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, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the 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, substantive and interpretive regulations, national coverage determinations, and Food and Drug Administration-approved investigational device exemptions published during the timeframe 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 Coverage Issues Manual (CIM) may wish to review the August 21, 1989 publication (54 FR 34555). Those interested in the procedures used in making national coverage determinations under the Medicare program may review the April 27, 1999 publication (64 FR 22619).

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 instruction or many. Often, it is necessary to use information in a transmittal in conjunction with information currently in the manuals. Start Printed Page 38360
  • Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register during the quarters 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 national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the 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 Food and Drug Administration-approved investigational device exemption categorizations, using the investigational device exemption numbers the Food and Drug Administration 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 investigational device exemption 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 of the Code of Federal Regulations (CFR) and in title 45 CFR, subchapter C. These collections of information, which OMB has approved, are being included for the first time in this quarterly listing of program issuances.

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, P.O. 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:​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​nara/​index.html, by using local WAIS client software, or by telnet to, 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​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​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 FDL 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 Part 3—Claims Process, (CMS Pub. 13-3) transmittal entitled “Ambulance Services,” use the Superintendent of Documents No. HE 22.8/6 and the transmittal number 1877.

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(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance, Program No. 93.774, Medicare—Supplementary Medical Insurance Program, Start Printed Page 38361and Program No. 93.714, Medical Assistance Program)

Dated: June 19, 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.

August 11, 1998 (63 FR 42857)

September 16, 1998 (63 FR 49598)

December 9, 1998 (63 FR 67899)

May 11, 1999 (64 FR 25351)

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)

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 Medicare Coverage Issues Manual (CIM) 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 (57 FR 47468).

Addendum III.—Medicare and Medicaid Manual Instructions

[January 2003 through March 2003]

Transmittal No.Manual/subject/publication No.
Intermediary Manual
Part 2—Audits, Reimbursement, Program
(CMS-Pub. 13-2)
(Superintendent of Documents No. HE 22.8/6-3)
421Provider Communications—Provider Education and Training
422Beneficiary Services
423Provider Services, Inquiries
Intermediary Manual
Part 3—Claims Process
(CMS-Pub. 13-3)
(Superintendent of Documents No. HE 22.8/6)
1872Prospective Payment for Outpatient Rehabilitation Services and the Financial Limitation
1873Pneumococcal Pneumonia, Influenza Virus and Hepatitis B Vaccines
1874Pneumococcal Pneumonia, Influenza Virus and Hepatitis B Vaccines
1875Review of Form HCFA-1450 for Inpatient and Outpatient Bills
1876Bill Review for Partial Hospitalization Services Provided in Community Mental Health Centers
Hospital Outpatient Partial Hospitalization Services
1877Ambulance Services
1878Intestinal and Multi-Visceral Transplants
Provider Education
Carriers Manual
Part 2—Program Administration
(Superintendent of Documents No. HE 22.8/7-3)
(CMS-Pub. 14-2)
146Provider/Supplier Communications—Provider/Supplier Education and Training
147Beneficiary Services
148Provider Services, Inquiries
Carriers Manual
Part 3—Claims Process
(CMS-Pub. 14-3)
(Superintendent of Documents No. HE 22.8/7)
1785Coding for Non-Covered Services and Services Not Reasonable and Necessary
1786Carrier Use of Undeliverable Notices for Utilization, Fraud, and Quality Control
1787Ordering Diagnostic Tests
Payment Conditions for Radiology Services
1788HCPCS Coding
1789Railroad Retirement Beneficiary Carrier
United Mine Workers of America
Title XIX Beneficiaries Residing in California
Disposition of Misdirected Claims
1790Zip Code File on the Direct Connect
1791Disposition of Misdirected Claims
Parenteral and Enteral Nutrition (PEN) Claims Jurisdiction
1792Claims Processing Procedures for Physician/Supplier Services to HMO Members
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Program Memorandum
Intermediaries (CMS-Pub. 60A)
(Superintendent of Documents No. HE 22.8/6-5)
A-02-128Revision to 42 CFR 405.371 Suspension, Offset and Recoupment of Medicare Payments to Providers and Suppliers of Services
A-02-1292003 Update of the Hospital Outpatient Prospective Payment System
A-03-001January Medicare Outpatient Code Editor Specifications Version 18.1 For Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System
A-03-002Installation of Version 28.0 Add-On of the Provider Statistical and Reimbursement Report
A-03-003January Outpatient Code Editor Specifications Version (V4.0)
A-03-004Calculating Provider-Specific Medicare Outpatient Cost-to-Charge Ratios and Instructions on Cost Report Treatment of Hospital Outpatient Services Paid on a Reasonable Cost Basis
A-03-005Health Insurance Portability and Accountability Act Transaction 835v4010 Companion Document Update for Intermediaries
A-03-006Update the Medicare Secondary Payment Module to Apportion Prospective Payment System (PPS) Outlier Amounts to all Service Lines With Medicare Reimbursement That Are PRICER Related and Potential Outlier Service Lines
A-03-007Payment to Hospitals and Units Excluded from the Acute Inpatient Prospective Payment System for Direct Graduate Medical Education and Nursing and Allied Health Education for Medicare+Choice Enrollees
A-03-008Clarification of 3-Day Payment Window vs. 1-Day Payment Window for Hospitals Excluded from Inpatient Prospective Payment System
A-03-009Medical Nutrition Therapy Services for Beneficiaries with Diabetes or Renal Disease
A-03-010Manual Medical Review Indicator for the Comprehensive Error Rate Testing Program
A-03-011Changes in Payment for Certain Services Provided by Outpatient Physical Therapy Providers Under the Medicare Physician Fee Schedule
A-03-012The Report of Benefit Savings
A-03-0133-Day Payment Window Refinements Under the Short-Term Hospital Inpatient Prospective Payment System
A-03-014Further Guidance Regarding Billing Under the Outpatient Prospective Payment System
A-03-015Electromagnetic Stimulation
A-03-016Continuous Home Care Under Medicare Hospice
A-03-017Payment for Services To Be Paid on a Fee Schedule But for Which There Is No Price
A-03-018Installation of Version 28.0 Second Add-On of the Provider Statistical and Reimbursement Report
A-03-019Reactivation of Outpatient Prospective Payment System Outpatient Code Editor Edit 15, “Service Unit Out Of Range” and Guidance on Editing for Low Osmolar Contrast Media Procedures
A-03-020April 2003 Update of the Hospital Outpatient Prospective Payment System
A-03-021Announcement of Medicare Rural Health Clinics and Federally Qualified Health Centers Payment Rate Increases, Clarification on Coverage and Payment of Diabetes Self-Management Training Services and Medical Nutrition Therapy Services
A-03-022Installation of Version 29.0 of the Provider Statistical and Reimbursement Reporting System—Modification
A-03-023Implementation of the Temporary Equalization of Urban and Rural Standardized Payment Amounts Under the Medicare Inpatient Hospital Prospective Payment System as Required by Section 402(b) of Public Law 108-7
Program Memorandum
B-03-001Emergency Update to the 2003 Medicare Physician Fee Schedule Database
B-03-002DMERCs-VIPS Medicare System Implementation To Process ICD-9 CM Codes Using Date of Service and Not Date of Receipt
B-03-003Processing Initial Denials, of the DMEPOS Refund Requirements Implementation of Limits on Beneficiary Liability for Medical Equipment and Supplies—Change
B-03-004CWF Change for Billing for Glucose Test Strips and Supplies—Follow-up to Change Request 2156
B-03-005Reporting of Accident Date and Ambulance Certification Information on the X12N 837 (version 4010) Coordination of Benefits Transaction
B-03-006Program Integrity Management Reporting System for Part B—Correction of Multiple Reports of Savings by VIPS Standard Systems (i.e., VIPS Medicare System and Durable Medical Equipment Regional Contractor System)
B-03-007Minimum Number of Pricing Files That Must Be Maintained Online for Medicare Physician Fee Schedule Services
B-03-008Medical Review Progressive Corrective Action Continuation of Work Begun in Compliance with Change Request 2433
B-03-009Durable Medical Equipment Regional Carriers—New Modifier Needed To Invoke Advanced Beneficiary Notice Logic for Hard Copy and Electronic Claims
B-03-010Program Integrity Management Reporting System for Part B—Implementation of an Automated Edit Description Module
B-03-011Correct Payment of January and February 2003 Physician Services
B-03-012Use of the National Drug Code for Drug Claims at the Durable Medical Equipment Regional Carriers
B-03-013Continuation of April 2003 Change Request 2424: Create Import/Export Functionality Between the Unique Provider Identification Number System and the Provider Enrollment Chain Ownership System
B-03-014Continuation of April 2003 Change Request 2425: Create Import/Export Functionality Between the Medicare Claims System (MCS) and the Provider Enrollment Chain Ownership System
B-03-015Continuation of April 2003 Change Request 2426: Process all Medicare Part B Provider Enrollments in the Provider Enrollment Chain Ownership System; Modify the Medicare Claims System To Incorporate All Claim Payment and Provider Correspondence Functionality That Is Included in the Provider Enrollment System But Will Not Be a Part of Provider Enrollment Chain Ownership System
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B-03-016Continuation of April 2003 Change Request 2427: Process all Medicare Part B Provider Enrollments in the Provider Enrollment Chain Ownership System; Create Import/Export Functionality Between the Viable Medicare System and the Provider Enrollment Chain Ownership System
B-03-017Add-On-Codes for Anesthesia
B-03-018Changes to Correct Coding Edits, Version 9.2, Effective July 1, 2003
B-03-019Durable Medical Equipment Regional Carriers and Part B Carriers on the VMS Standard System—Short Descriptions of National Modifiers on the Healthcare Common Procedure Coding System Tape
B-03-0202003 DMEPOS Jurisdiction List
B-03-021Provider Education Regarding Home Health Consolidated Billing and Provider Liability
B-03-022Use of Statistical Sampling for Overpayment Estimation When Performing Administrative Reviews of Part B Claims
Program Memorandum
AB-03-001Medicare Coverage of Non-Invasive Vascular Studies for End-Stage Renal Disease Patients
AB-03-002Quarterly Update of HCPCS Codes Used for Home Health Consolidated Billing Enforcement
B-03-003Noncoverage of Multiple Electroconvulsive Therapy
B-03-004Installation of a Security Firewall for Deceased Beneficiary Files (Options B & C)
AB-03-005FY 2003 Systems Security Activities and Due Dates
AB-03-006April Quarterly Update for 2003 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule
AB-03-007Second Clarification of Medicare Policy Regarding the Implementation of the Ambulance Fee Schedule
AB-03-008Clarification of Physician Certification Requirements for Medicare Hospice
AB-03-009The Medicare Exclusion Database Replaces Publication 69
AB-03-010Shared System Maintainer Hours for Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing
AB-03-011Identifying the Primary Payer Amounts To Send to the Medicare Secondary Payer Pay Module and the Shared Systems When There Are Multiple Primary Payers on Electronic and Hardcopy Claims
AB-03-012Remittance Advice Remark and Reason Code Update
AB-03-013New Waived Tests—December 17, 2002
AB-03-014÷Single Drug Pricer
AB-03-015Shared Systems Changes for Name Change from HCFA to CMS (MCS and CWF External Changes Only)
AB-03-016CR 2240 Question and Answer Document
AB-03-017Scheduled Release for April Updates to Software Programs and Pricing/Coding Files
AB-03-018Implementation of the Financial Limitation for Outpatient Rehabilitation Services
AB-03-019Notice of Interest Rate for Medicare Overpayments and Underpayments
AB-03-020Clarification of Transmittal AB-00-107, Change Request 1163, and Transmittal AB-00-129, Change Request 1460, Regarding the Coordination of Benefits
Contractor and MSP Prepay Work Activities for Customer Service, MSP and Standard Systems Contractor Staff
AB-03-021Additional Documentation Requests Requirements for Ordering Providers of Laboratory Services
AB-03-022Use of the American Medical Association's Physicians' Current Procedural Terminology, Fourth Edition Codes on Contractors' Web Sites
AB-03-023Deep Brain Stimulation for Essential Tremor and Parkinson's Disease
AB-03-024Clarification of the Allocation of Initial Claim Entry Activities Where the Claim Is Paid Secondary by Medicare
AB-03-025System Networking Electronic Correspondence Referral System 1.3 User and Installation Guides for Testing and Production
AB-03-026Implementation of the Modifications (4010A1) to Transactions and Code Set Standards for Electronic Transactions Adopted Under the Health Insurance Portability and Accountability Act
AB-03-027Payment Change for the 2003 Medicare Physician Fee Schedule and Further Extension of the 2003 Participation Enrollment Process
AB-03-028Coverage and Billing of Sacral Nerve Stimulation
AB-03-029Health Care Claims Status Category Codes and Health Care Claim Status Codes for Use With the Health Care Claim Status Request and Response ASC X12N 276/277
AB-03-030Changes to the Laboratory National Coverage Determination Edit Software for April 1, 2003
AB-03-031Addition or Modification of Temporary “K” Codes and Change in Status for Code A4232
AB-03-032File Names, Descriptions and Instructions for Retrieving the 2003 Ambulatory Surgical Center HCPCS Additions, Deletions, and Master Listing
AB-03-033Promoting Colorectal Cancer Screening As a Part of National Colorectal Cancer Awareness Month
AB-03-034Medicare Fee for Service Contractor Guidance on the HIPAA Privacy Rule
AB-03-035Emergency Changes to the 2003 Medicare Physician Fee Schedule Database
AB-03-036270/271 Implementation and Direct Date Entry Eligibility
AB-03-037Provider Education Article: Medicare Payments for Part B Mental Health Services
AB-03-038Reporting Benefit Integrity Workload in CROWD
AB-03-039Procedure for Granting Extension to File Requests for Appeal Under the New 120-day Timeframe Created by section 521 of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000
AB-03-040Provider Education Article: “Hospice Care Enhances Dignity and Peace As Life Nears Its End”
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Hospital Manual
(Superintendent of Documents No. HE 22.8/2)
796Pneumococcal Pneumonia, Influenza Virus, and Hepatitis B Vaccines
797Pneumococcal Pneumonia, Influenza Virus, and Hepatitis B Vaccines
798Billing for Hospital Outpatient Partial Hospitalization Services
799Identifying Other Primary Players During the Admission Process
Hospice Manual
(CMS-Pub. 21)
(Superintendent of Documents No.)
66Special Coverage Requirements
Coverage Issues Manual
(CMS-Pub. 6)
(Superintendent of Documents No. HE 22.8/14)
166Multiple-Seizure Electroconvulsive Therapy
167Treatment of Motor Function Disorders with Electric Nerve Stimulation—Not Covered
167Deep Brain Stimulation for Essential Tremor and Parkinson's Disease
168Ambulatory Blood Pressure Monitoring
Outpatient Physical Therapy
(CMS Pub. 9)
(Superintendent of Documents No. HE 2.8/9)
17Billing Instructions for Partial Hospitalization Services Provided in Community Mental Health Centers
Provider Reimbursement Manual—Part 2
Provider Cost Reporting Forms and Instructions
Chapter 35/Form CMS-2540-96
(CMS-Pub. 15-2-35)
12Skilled Nursing Facility Cost Report Form CMS-2540-96, and Is Effective for Cost Reporting Periods Ending on and After December 31, 2002
Financial Management
(CMS-Pub. 100-06)
13Intermediary Claims Accounts Receivable
Physician/Supplier Overpayment Reporting System Summary Entry Debts Financial Reporting for Intermediary Claims Accounts Receivable
15FMFIA and the CMS Medicare Contractor
Risk Assessment
Fiscal Year 2003 Medicare Control Objectives
Documentation and Work Papers
Certification Statement
Executive Summary
CPIC—Report of Material Weaknesses
CPIC—Report of Reportable
Definitions and Examples of Reportable Conditions and Material Weaknesses
Corrective Action Plans
Submission, Review, and Approval of Corrective Action Plans
Universal Corrective Action Plan Report
CMS Finding Numbers
Program Integrity Manual
(CMS-Pub. 100-08)
37Written Orders
Written Orders Prior to Delivery
39Overview of Prepayment and Postpayment Review for MR Purposes
Determinations Made During Prepayment and Postpayment MR
Documentation Specifications for Areas Selected for Prepayment or Postpayment MR
Additional Documentation Requests During Prepayment of Postpayment MR
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Handling Late Documentation
Documenting That a Claim Should Be Denied
Spreading Workload Evenly
Review That Involves Utilization Parameters
Prepayment Review of Claims for MR Purposes
Documentation Specifications for Areas Selected for MR
Laboratory Claims
Documentation for Non-Physician Claims
Development of Claims for Additional Documentation
Postpayment Review Case Selection
Location of Postpayment Reviews
Re-adjudication of Claims
Calculation of the Correct Payment Amount and Subsequent
Provider(s) Rebuttal(s) of Findings

Addendum IV.—Regulation Documents Published in the Federal Register

[January 2003 through March 2003]

Publication dateFR Vol. 68 pageCFR Part(s)File code*Regulation title
01/10/2003137442 CFR 403, 416, 418, 460, 482, 483, 485CMS-3047-FMedicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities.
01/24/2003358642 CFR 433 and 438CMS-2015-FMedicaid Program; External Quality Review of Medicaid Managed Care Organizations.
01/24/20033534CMS-3113-NMedicare Program; Meeting of the Medicare Coverage Advisory Committee—March 12, 2003.
01/24/20033532CMS-2177-PNMedicare and Medicaid Programs; Application by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for Hospices.
01/24/2003348242 CFR Chapter IVCMS-6012-N4Medicare Program; Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for Prosthetics and Certain Custom-Fabricated Orthotics.
01/24/2003343542 CFR 482CMS-3050-FMedicare and Medicaid Programs; Hospital Conditions of Participation: Quality Assessment and Performance Improvement.
02/10/20036750CMS-4051-NMedicare Program; Renewal of the Advisory Panel on Medicare Education (APME) and Notice of Meeting of the Advisory Panel—February 27, 2003.
02/10/2003668242 CFR 413CMS-1126-PMedicare Program; Provider Bad Debt Payment.
02/10/2003663642 CFR 405 and 419CMS-1206-CN2Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2003 Payment Rates; and Changes to Payment Suspension for Unfiled Cost Reports; Correction.
02/20/2003833445 DCFR 160, 162, 164CMS-0049-FHealth Insurance Reform: Security Standards.
02/28/20039681CMS-1225-GNCMedicare Program; Criteria and Standards for Evaluating Intermediary, Carrier, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Regional Carrier Performance During Fiscal Year 2003.
02/28/20039680CMS-3099-NMedicaid Program; Annual Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs).
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02/28/20039673CMS-5002-NMedicare Program; Demonstration: Capitated Disease Management for Beneficiaries With Chronic Illnesses.
02/28/20039672CMS-2165-NMedicaid Program; Infrastructure Grant Program To Support the Competitive Employment of People With Disabilities.
02/28/20039671CMS-1245-NMedicare Program; Request for Nominations To the Advisory Panel on Ambulatory Payment Classifications Groups.
02/28/2003956742 CFR 410, 414, 485CMS-1204-F2Medicare Program; Physician Fee Schedule Update for Calendar Year 2003.
03/05/20031042042 CFR 412CMS-1243-PMedicare Program; Proposed Change in Methodology for Determining Payment for Extraordinarily High-Cost Cases (Cost Outliers) Under the Acute Care Hospital Inpatient Prospective Payment System.
03/07/20031123442 CFR 412CMS-1472-PMedicare Program; Prospective Payment System for Long-Term Care Hospitals: Proposed Annual Payment Rate Updates and Policy Changes.
03/07/20031098742 CFR 412CMS-1177-F2Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Implementation and FY 2003 Rates; Correcting Amendment.
03/28/20031526842 CFR 416CMS-1885-FCMedicare Program; Update of Ambulatory Surgical Center List of Covered Procedures Effective July 1, 2003.
03/28/200315207CMS-1230—NMedicare Program; Public Meetings in Calendar Year 2003 for New Durable Medical Equipment Coding and Payment Determinations.
03/28/200315206CMS-1474-NMedicare Program; Town Hall Meeting on the Inpatient Rehabilitation Facility Prospective Payment System.
03/28/200315196CMS-9016-NMedicare and Medicaid Programs; Quarterly Listing of Program Issuances—October 2002 Through December 2002.
03/28/20031513942 CFR Chapter IVCMS-6012-N5Medicare Program; Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for Prosthetics and Certain Custom-Fabricated Orthotics; Meeting Announcement

Addendum V—National Coverage Determinations [January 2003 Through March 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, 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 became effective 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 impending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by section of the 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 website at​coverage.

National Coverage Decisions for Quarterly Notices

Coverage Issues Manual (CIM) HCFA Pub. 06

CIM sectionTitleIssue dateEffective date
50-42Ambulatory Blood Pressure Monitoring03/28/0307/01/03
35-103Multiple Monitored Electroconvulsive Therapy01/10/0304/01/03
65-19Deep Brain Stimulation for Parkinson's02/14/0304/01/03
35-102Electrical Stimulation for Wounds01/15/0304/01/03+
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Program Memorandum (PM)

PM No.TitleIssue dateEffective date
AB-03-030Clinical Laboratory Edit Update02/28/0304/01/03

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 assigns each device with a Food and Drug Administration-approved investigational device exemption 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 first quarter, January through March 2003.

Investigational Device Exemption Numbers, 1st Quarter 2003


G000247 B

G003004 B

G010216 B

G020225 B

G020231 B

G020240 A

G020244 B

G020247 B

G020248 B

G020262 B

G020279 B

G020299 B

G020301 B

G020308 B

G020310 B

G020311 B

G020314 B

G020315 B

G020317 B

G020318 B

G020319 B

G020320 B

G020324 B

G030003 A

G030004 B

G030006 B

G030012 B

G030013 B

G030014 B

G030016 B

G030018 B

G030019 B

G030020 B

G030021 B

G030023 B

G030024 B

G030025 B

G030028 B

G030030 B

G030033 B

G030035 B

G030036 B

G030037 B

G030041 B

G030043 A

G030048 B

G030049 B

G030052 B

G030053 B

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 and title 45, subchapter C, 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 and title 45
0938-0008414.40, 424.32, 424.44
0938-0022413.20, 413.24, 413.106
0938-0025406.28, 407.27
0938-0037413.20, 413.24
0938-0042410.40, 424.124
0938-0050413.20, 413.24
0938-0062431.151, 435.1009, 440.250, 440.220, 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
0938-0086420.200-420.206, 455.100-455.106
0938-0102413.20, 413.24
0938-0107413.20, 413.24
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
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0938-0266416.41, 416.83, 416.47, 416.48
0938-0267485.56, 485.58, 485.60, 485.64, 485.66, 410.65
0938-0269412.116, 412.632, 413.64, 413.350, 484.245
0938-0272440.180, 441.300-441.305
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
0938-0328482.12, 482.22, 482.27, 482.30, 482.41, 482.43, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, 482.66
0938-0338486.104, 486.106, 486.110
0938-0357409.40-409.50, 410.36, 410.170, 411.4-411.15, 421.100, 424.22, 484.18, 489.21
0938-0365484.10, 484.11, 484.12, 484.14, 484.16, 484.18, 484.20, 484.36, 484.48, 484.52
0938-0391488.18, 488.26, 488.28
0938-0426476.104, 476.105, 476.116, 476.134
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
0938-0449440.180, 441.300-441.310
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
0938-0526475.100 Subpart C, 475.106, 475.107, 462.102, 462.103
0938-0534410.38, 424.5
0938-0566411.404, 411.406, 411.408
0938-0567498 Subpart D, E, and H and 20 CFR 404.933
0938-0573412.256, 412.230
0938-0600405.371, 405.378, 413.20
0938-0610417.436, 417.801, 417.436, 422.128, 430.12, 431.20, 431.107, 434.28, 483.10, 484.10, 489.102
0938-0618433.68, 433.74, 447.272
0938-0657405.2110, 405.2112
0938-0658405.2110, 405.2112
0938-0667482.12, 488.18, 489.20, 489.24
0938-0685410.32, 410.71, 413.17, 424.57, 424.73, 424.80, 440.30, 484.12
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0938-0690488.4-488.9, 488.201
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
0938-070245 CFR 146
0938-070345 CFR 148
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
0938-0758413.20, 413.24
0938-0760484 Subpart E, 484.55
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
0938-0778422.64, 422.111, 422.560-422.622
0938-0779417.470, 417.126, 422.210, 422.64
0938-0781411.404-411.406, 484.10
0938-0786438.360, 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
0938-079745 CFR 148
0938-0798413.24, 413.65, 419.42
0938-0818410.141-410.145, 414.63
0938-081945 CFR 146.121
0938-0824482.13, 440.10
0938-082745 CFR 146.141
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
0938-086645 CFR Part 162
0938-0872483.20, 413.337
0938-087445 CFR Parts 160 and 162
0938-0878422 Subpart F & G
0938-088345 CFR parts 160 and 164
0938-0885403.804, 403.806, 403.808, 403.810, 403.811, 403.820
Note: Sections in title 45 are preceded by “45 CFR.”
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[FR Doc. 03-16058 Filed 6-26-03; 8:45 am]