[Federal Register Volume 68, Number 247 (Wednesday, December 24, 2003)]
[Notices]
[Pages 74590-74607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9019-N]


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

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

ACTION: Notice.

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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.

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.

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,

[[Page 74591]]

substantive 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:
    [sbull] Addendum I lists the publication dates of the most recent 
quarterly listings of program issuances.
    [sbull] Addendum II identifies previous Federal Register documents 
that contain a description of all previously published CMS Medicare and 
Medicaid manuals and memoranda.
    [sbull] 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.
    [sbull] 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--

    [sbull] Date published;
    [sbull] Federal Register citation;
    [sbull] Parts of the Code of Federal Regulations (CFR) that have 
changed (if applicable);
    [sbull] Agency file code number; and
    [sbull] Title of the regulation.

    [sbull] 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.
    [sbull] 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.
    [sbull] 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:
    [sbull] Titles XI, XVIII, and XIX of the Act.
    [sbull] CMS-related regulations.
    [sbull] CMS manuals and monthly revisions.
    [sbull] 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

[[Page 74592]]

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 
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)

    Dated: December 2, 2003.
Jacquelyn Y. White,
Director, Office of Strategic Operations and Regulatory Affairs.

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)
1892                 [sbull  Frequency of Billing
                         ]
                     ......  Provider Education
1893                 [sbull  Release Software
                         ]
1894                 [sbull  Review of Form CMS-1450 (previously Form
                         ]    HCFA-1450) for Inpatient and
                     ......  Outpatient Bills
1895                 [sbull  Diabetes Outpatient Self-Management
                         ]    Training Services
1896                 [sbull  Mammography 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
1897                 [sbull  Limitation 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

[[Page 74593]]

 
                     ......  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
1898                 [sbull  Payment 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)
1808                 [sbull  Mandatory Assignment and Participation
                         ]    Program
                     ......  Participation Program
                     ......  Limiting Charge
1809                 [sbull  Durable 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
1810                 [sbull  Payment for Physician Services Furnished to
                         ]    Dialysis Inpatients
                     ......  Dialysis Services (Codes 90935-90999)
1811                 [sbull  Release Software
                         ]
                     ......  Contractor Testing Requirements
1812                 [sbull  Definitions of Lines 1 through 115
                         ]
                     ......  Checking Reports
                     ......  Exhibits
1813                 [sbull  Data 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
1814                 [sbull  Screening Mammography Examinations
                         ]
                     ......  Identifying a Screening Mammography Claim
                              and a Diagnostic Mammography Claim
                     ......  Adjudicating the Claim
                     ......  Diagnostic and Screening Mammograms
                              Performed With New Technologies
1815                 [sbull  Repairs, Maintenance, Replacement, and
                         ]    Delivery
1816                 [sbull  Correct Coding Initiative
                         ]
1817                 [sbull  Medicare 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)
1818                 [sbull  Filing the Request for Payment
                         ]
1819                 [sbull  Special Requirements for Claims for Durable
                         ]    Medical Equipment, Prosthetics, Orthotics,
                              and Supplies

[[Page 74594]]

 
1820                 [sbull  Medicare 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)
------------------------------------------------------------------------
28                   [sbull  Provider of Services or Supplier
                         ]    Information
------------------------------------------------------------------------
                    Program Memorandum Intermediaries
                             (CMS Pub. 60A)
              (Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
A-03-057             [sbull  Medicare Program-Update to the Hospice
                         ]    Payment Rates, Hospice Cap, Hospice Wage
                              Index and the Hospice for Fiscal Year 2004
A-03-058             [sbull  Change in Methodology for Determining
                         ]    Payment for Outliers Under the Acute Care
                              Hospital Inpatient and Long-Term Care
                              Hospital Prospective Payment System
A-03-059             [sbull  Addition of Patient Status Code 43,
                         ]    Deletion of Patient Status Codes 71 and
                              72, and Information on New Patient Status
                              Code 65
A-03-060             [sbull  Medicare Program--Update to the Prospective
                         ]    Payment System for Home Health Agencies
                              for Fiscal Year 2004
A-03-061             [sbull  Tentative Settlement Requirements for Cost
                         ]    Reports from Home Health Agencies and
                              Skilled Nursing Facilities That Have No
                              Reimbursement Impact
A-03-062             [sbull  Department of Veterans Affairs Claims
                         ]    Adjudication Services Project System
                              Changes Needed
A-03-063             [sbull  Installation of Version 30 of the Provider
                         ]    Statistical and Reimbursement Reporting
                              System
A-03-064             [sbull  X12N 837 Institutional Health Care Claim
                         ]    Companion Document
A-03-065             [sbull  New Common Working File Edits to Ensure
                         ]    Accurate Coding and Payments for Discharge
                              and/or Transfer Policies Under the
                              Inpatient Prospective Payment System
A-03-066             [sbull  Hospital Outpatient Prospective Payment
                         ]    System Implementation Instructions
A-03-067             [sbull  The Supplemental Security Income Medicare
                         ]    Beneficiary Data for Fiscal Year 2002 for
                              Inpatient Prospective Payment System
                              Hospitals
A-03-068             [sbull  Informing Beneficiaries About Which Local
                         ]    Medical Review Policy and/or National
                              Coverage Determination Is Associated With
                              Their Claim Denial
A-03-069             [sbull  October Outpatient Code Editor
                         ]    Specification Version (V4.3)
A-03-070             [sbull  Inclusion 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-03-071             [sbull  Retroactive Correction of Provider
                         ]    Statistical and Reimbursement System
                              Report Data Related to Mammography and
                              Outpatient Therapy Services
A-03-072             [sbull  Instructions for Provider Credit Balance
                         ]    Reporting Related Activities
A-03-073             [sbull  Fiscal Year 2004 Inpatient Prospective
                         ]    Payment System, Long Term Care Hospital,
                              and Other Billing Changes
A-03-074             [sbull  Inpatient Rehabilitation Facility Annual
                         ]    Update: Prospective Payment System Pricer
                              Changes for Fiscal Year 2004
A-03-075             [sbull  Medicare Part A Skilled Nursing Facility
                         ]    Prospective Payment System Update
A-03-076             [sbull  October 2003 Update of the Hospital
                         ]    Outpatient Prospective Payment System
A-03-077             [sbull  October Medicare Outpatient Code Editor
                         ]    Specification Version 19.0 for Bills From
                              Hospitals That Are Not Paid Under the
                              Outpatient Prospective Payment System
A-03-078             [sbull  Reimbursement for Automated Multi-Channel
                         ]    Chemistry Tests for End-Stage Renal
                              Disease Beneficiaries
A-03-079             [sbull  Installation of Version 31 of the Provider
                         ]    Statistical and Reimbursement Reporting
                              System
A-03-080             [sbull  End-Stage Renal Disease Reimbursement for
                         ]    Automated Multi-Channel Chemistry Test
A-03-081             [sbull  Conflicting Policies With Provider
                         ]    Reimbursement Manual 15-1, Section 2771
A-03-082             [sbull  Clarification 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-03-050             [sbull  Multiple Primary Payers on Part B Claims-
                         ]    Revision to Change Request 2050
B-03-051             [sbull  Therapy Modifier Bypass for Ambulance
                         ]    Claims
B-03-052             [sbull  Addition of Temporary ``Q'' Codes for Drugs
                         ]    Used in Infusion Pumps
B-03-053             [sbull  Healthcare Provider Taxonomy Codes
                         ]    Crosswalk
B-03-054             [sbull  Establishing 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-03-055             [sbull  Common Working File crossover Editing for
                         ]    Durable Medical Equipment, Prosthetics,
                              Orthotics, and Supplies Claims During an
                              Inpatient Stay
B-03-056             [sbull  Durable 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-03-057             [sbull  Additional Guidelines for Implementing the
                         ]    National Council for Prescription Drug
                              Program Format
B-03-058             [sbull  Procedures 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

[[Page 74595]]

 
B-03-059             [sbull  Minimum Number of Pricing Files That Must
                         ]    Be Maintained Online for Medicare Single
                              Drug Pricer
B-03-060             [sbull  Expansion 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-03-061             [sbull  Durable Medical Equipment Regional Carriers
                         ]    National Council of Prescription of Drug
                              Programs Crosswalk Requirements
B-03-062             [sbull  Procedures for Non-Medicare Secondary Payer
                         ]    Overpayments With Original Balance Less
                              than $10
B-03-063             [sbull  Healthcare Provider Taxonomy Codes
                         ]    Crosswalk
B-03-064             [sbull  Clarification--ICD-9 Coding
                         ]
B-03-065             [sbull  Changes to Code List for Therapy Services
                         ]
B-03-066             [sbull  Durable Medical Equipment Regional
                         ]    Carriers--Eliminate Combined Working File
                              Edit for Cancer Diagnosis for National
                              Drug Codes
B-03-067             [sbull  National Council for Prescription Drug
                         ]    Programs Batch Transmittal Standard 1.1
                              Billing Request Companion Document
B-03-068             [sbull  2004 Annual Update for Skilled Nursing
                         ]    Facility Consolidated Billing for the
                              Common Working File and Medicare Carriers
B-03-069             [sbull  Schedule 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-03-094            [sbull  October 2003 Quarterly Updates for Skilled
                         ]    Nursing Facility Consolidated Billing
AB-03-095            [sbull  Remittance Advice Remark and Reason Code
                         ]    Update
AB-03-096            [sbull  Quarterly Update of Healthcare Common
                         ]    Procedure Coding System Codes Used for
                              Home Health Consolidated Billing
                              Enforcement
AB-03-097            [sbull  Delay in Implementation of Outpatient
                         ]    Therapy Caps to September 1, 2003
AB-03-098            [sbull  Medicare Summary Notice Implementation for
                         ]    Contractors Using Arkansas Part A Standard
                              System and HCFA Part B Standard System
AB-03-099            [sbull  Instructions for Fiscal Intermediary
                         ]    Standard System and Multi-Carriers System
                              Healthcare Integrated General Ledger
                              Accounting System Changes
AB-03-100            [sbull  October Quarterly Update for 2003 Durable
                         ]    Medical Equipment, Prosthetics, Orthotics,
                              and Supplies Fee Schedule
AB-03-101            [sbull  Clarification for CR 2562: Collection of
                         ]    Fee-for-Service Payments Made During
                              Periods of Managed Care Enrollment
AB-03-102            [sbull  Clarifications Regarding Coverage of
                         ]    Hyperbaric Oxygen Therapy for the
                              Treatment of Diabetic Wounds of the Lower
                              Extremities
AB-03-103            [sbull  Medicare Secondary Payer Debt Referral and
                         ]    Write-Off Closed Instructions
AB-03-104            [sbull  Changes to the Laboratory National Coverage
                         ]    Determination Edit Software for October 1,
                              2003
AB-03-105            [sbull  Harkin Grantees: Complaint Tracking System
                         ]    and Aggregate Reports
AB-03-106            [sbull  Third Clarification of Medicare Policy
                         ]    Regarding the Implementation of the
                              Ambulance Fee Schedule
AB-03-107            [sbull  Federal Bankruptcy/State Insurer
                         ]    Liquidation Actions and Medicare Secondary
                              Payer Debt
AB-03-108            [sbull  Medicare 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-03-109            [sbull  Discontinue Use of the Healthcare Integrity
                         ]    and Protection Data Bank for Provider
                              Enrollment Only
AB-03-110            [sbull  Adjustment to the Rural Mileage Payment
                         ]    Rate for Ground Ambulance Services
AB-03-111            [sbull  Shared System Maintainer Hours for
                         ]    Resolution of Problems Detected During
                              Health Insurance Portability and
                              Accountability Act Transaction Release
                              Testing
AB-03-112            [sbull  Transmittal AB-03-112 Has Been Rescinded
                         ]
AB-03-113            [sbull  Update of Codes in the Program Integrity
                         ]    Management Reporting System and the
                              Contractor Administrative Cost and
                              Financial Management System
AB-03-114            [sbull  Claims Processing and Payment of Incomplete
                         ]    Screening Colonoscopies
AB-03-115            [sbull  Payment Denial for Medicare Services
                         ]    Furnished to Alien Beneficiaries Who Are
                              Not Lawfully Present in the United States
AB-03-116            [sbull  Update of Rates and Wage Index for
                         ]    Ambulatory Surgical Center Payment
                              Effective October 1, 2003
AB-03-117            [sbull  Contractor 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-03-118            [sbull  Cease Further Work on the Eligibility File-
                         ]    Based Standard Trading Partner Agreement
                              for the Purpose of Coordination of
                              Benefits
AB-03-119            [sbull  Final Update to the 2003 Medicare Physician
                         ]    Fee Schedule Database
AB-03-120            [sbull  Medicare 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-03-121            [sbull  Requirement to Cross Claims Over to
                         ]    Multiple Supplemental Insurers
AB-03-122            [sbull  Notice of Interest Rate for Medicare
                         ]    Overpayments and Underpayments
AB-03-123            [sbull  Scheduled Release for October Updates to
                         ]    Software Programs and Pricing/Coding Files
AB-03-124            [sbull  Standard System Automation of the Notice of
                         ]    Change to Medicare Secondary Payer
                              Auxiliary File Process
AB-03-125            [sbull  Consolidation of Claims Cross-Over Process
                         ]
AB-03-126            [sbull  Change in Type of Service for L04080
                         ]
AB-03-127            [sbull  Payment for Fecal Leukocyte Examination
                         ]    Under Clinical Laboratory Improvement
                              Amendments of 1988 Certificate for
                              Provider-Performed Microscopy Procedures
                              During Calendar Year 2003

[[Page 74596]]

 
AB-03-128            [sbull  Clarification to Transmittal AB-03-044 (CR
                         ]    2611), Addition of New Temporary ``K''
                              Codes
AB-03-129            [sbull  Addition 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-03-130            [sbull  Levocarnitine for Use in the Treatment of
                         ]    Carnitine Deficiency in End-Stage Renal
                              Disease Patients
AB-03-131            [sbull  Update 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-03-132            [sbull  Provider Education Article: Guidelines for
                         ]    Medicare Part B Laboratory Testing
AB-03-133            [sbull  Managing Medicare Appeals Workloads in
                         ]    Fiscal Year 2004
AB-03-134            [sbull  Modifier and Condition Code for Providers
                         ]    to Use When Billing for Implantable
                              Automatic Defibrillators for Beneficiaries
                              in Medicare+Choice Plan
AB-03-135            [sbull  Darbepoetin Alfa (Trade Name Aranesp) and
                         ]    Epoetin Alfa (Trade Name Epogen) for
                              Treatment of Anemia in End-Stage Renal
                              Disease Patients on Dialysis
AB-03-136            [sbull  Correction to Quarterly Update of Health
                         ]    Care Common Procedure Coding System Codes
                              Used for Home Health Consolidated Billing
                              Enforcement
AB-03-137            [sbull  Update 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-03-138            [sbull  Modification of Medicare Policy for
                         ]    Erythropoietin
AB-03-139            [sbull  Appeals Quality Improvement and Data
                         ]    Analysis Activities
AB-03-140            [sbull  2004 Healthcare Common Procedure Coding
                         ]    System Annual Update Reminder
AB-03-141            [sbull  CMS Companion Document for the Accredited
                         ]    Standards Committee X12N276/277 Health
                              Care Claim Status Request and Response
AB-03-142            [sbull  The 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-03-143            [sbull  Implementation 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-03-144            [sbull  Establishing 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-03-145            [sbull  Instructions for Contractors Other Than the
                         ]    Religious Nonmedical Health Care
                              Institution Specialty Intermediary
                              Regarding Claims For Beneficiaries With
                              Religious Nonmedical Health Care
                              Institution Elections
AB-03-146            [sbull  Reminder Notice of the Implementation of
                         ]    the Ambulance Transition Schedule
AB-03-147            [sbull  Core Elements and Required Statements for a
                         ]    Valid Privacy Authorization
------------------------------------------------------------------------
                         State Operations Manual
                              (CMS Pub. 7)
              (Superintendent of Documents No. HE 22.8/12)
------------------------------------------------------------------------
31                   [sbull  Regional Offices Assignment of Provider and
                         ]    Supplier Identification Number
------------------------------------------------------------------------
                             Hospice Manual
                              (CMS Pub. 10)
               (Superintendent of Documents No. HE 22.8/2)
------------------------------------------------------------------------
806                  [sbull  Hospital Manual, Credit Balance Reporting
                         ]    Requirements--General Provisions
                     ......  Payment of Amounts Owed Medicare
                     ......  Medicare Credit Balance Reporting
                              Certification Page
807                  [sbull  Payment for Services Furnished by a
                         ]    Critical Access Hospital
------------------------------------------------------------------------
                        Home Health Agency Manual
                              (CMS Pub. 11)
               (Superintendent of Documents No. HE 33.8/5)
------------------------------------------------------------------------
305                  [sbull  Diabetes Outpatient Self-Management
                         ]    Training
306                  [sbull  Home 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)
------------------------------------------------------------------------
377                  [sbull  Credit Balance Reporting Requirements--
                         ]    General Provisions
                     ......  Payment of Amounts Owed Medicare
                     ......  Medicare Credit Balance Report
                              Certification Page
------------------------------------------------------------------------

[[Page 74597]]

 
                         Coverage Issues Manual
                              (CMS Pub. 6)
              (Superintendent of Documents No. HE 22.8/14)
------------------------------------------------------------------------
173                  [sbull  Implantable Automatic Defibrillators
                         ]
------------------------------------------------------------------------
                 Peer Review Organization (CMS Pub. 19)
               (Superintendent of Documents No. 22.8/8-15)
------------------------------------------------------------------------
91                   [sbull  Case 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 manuals.
92                   [sbull  Denials, 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.
93                   [sbull  Agreements--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.
94                   [sbull  Confidentiality and Disclosure--has been
                         ]    moved to the Corresponding Internet-Only
                              Manual, which can be found at http://www.cms.hhs.gov/manuals.
95                   [sbull  Outreach 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 manuals.
96                   [sbull  Payment 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 manuals.
97                   [sbull  Beneficiary 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.
98                   [sbull  Data 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 manuals.
------------------------------------------------------------------------
                             Hospice Manual
                              (CMS Pub. 21)
              (Superintendent of Documents No. HE 22.8/18)
------------------------------------------------------------------------
69                   [sbull  Hospice 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)
------------------------------------------------------------------------
18                   [sbull  Outpatient 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)
------------------------------------------------------------------------
39                   [sbull  Rural 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)
96                   [sbull  Renal 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
------------------------------------------------------------------------

[[Page 74598]]

 
                      Provider Reimbursement Manual
------------------------------------------------------------------------
          Part 2 Provider Cost Reporting Forms and Instructions
                       Chapter 11/Form CMS 22.8/4
                           (CMS Pub. 15-2-11)
5                    [sbull  Reimbursement Information
                         ]
------------------------------------------------------------------------
                    ESRD Network Organizations Manual
------------------------------------------------------------------------
                             (CMS Pub. 81)
              (Superintendent of Documents No. HE 22.9/4)
15                   [sbull  Background 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)
3                    [sbull  New 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)
19                   [sbull  Intermediary Claims Accounts Receivable
                         ]
------------------------------------------------------------------------
                       Medicare Program Integrity
------------------------------------------------------------------------
                           (CMS Pub. 100-08)
44                   [sbull  When 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
45                   [sbull  Focused Medical Review Activity Report
                         ]
46                   [sbull  Prepayment Edits
                         ]
47                   [sbull  Data Analysis
                         ]
                     ......  Centers for Medicare & Medicaid Services
                              Mandated Edits
48                   [sbull  Written Orders Prior to Delivery
                         ]
49                   [sbull  Denial Notices
                         ]
50                   [sbull  Instructions for Processing Advance
                         ]    Determination of Medicare Coverage Request
51                   [sbull  Update 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)
2                    [sbull  Introduction
                         ]
                     ......  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
3                    [sbull  Introduction
                         ]
                     ......  Quality Improvement Project Process
                     ......  Developing and Conducting Interventions
                     ......  Documenting and Disseminating Results
                     ......  Centers for Medicare & Medicaid Services
                              Project Support and Guidance Activities

[[Page 74599]]

 
                     ......  Related Activities Through Quality
                              Improvement Organizations, Carrier,
                              Intermediary, and End-Stage Renal Diseases
                              Network Cooperation
4                    [sbull  Beneficiary Request for Review of Hospital-
                         ]    Issued Notice of Non-Coverage by a Quality
                              Improvement Organization
5                    [sbull  Intermediary/Carrier Memorandum of
                         ]    Agreement Specifications
                     ......  Introduction
                     ......  Memorandum of Agreement With State Agencies
                              Responsible for Licensing/Certification of
                              Providers/Practitioners
6                    [sbull  Statutory 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
7                    [sbull  Beneficiary 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
8                    [sbull  Introduction
                         ]
                     ......  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
9                    [sbull  Scope 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
10                   [sbull  Authority
                         ]
                     ......  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)
------------------------------------------------------------------------
1                    [sbull  Forward
                         ]
                     ......  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
2                    [sbull  Forward
                         ]
                     ......  Purpose of the Network Manual
                     ......  Statutes and Regulations

[[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
3                    [sbull  Organizational 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)
------------------------------------------------------------------------
26                   [sbull  Alternate 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
27                   [sbull  Noncontracted Provider Appeals
                         ]
                     ......  Storage of Appeal Case Files by the
                              Independent Review Entity
                     ......  Representative Filing on Behalf of the
                              Enrollee
                     ......  Storage of Hearing Files
28                   [sbull  Streamlined 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
29                   [sbull  Introduction
                         ]
                     ......  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

[[Page 74601]]

 
                     ......  Obligations of Deemed Medicare and Medicaid
                              Organizations
                     ......  Oversight of Accrediting Organizations
                     ......  Application Requirements
                     ......  Reporting Requirements
                     ......  Informal Hearing Procedures
30                   [sbull  Reasonable 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
31                   [sbull  Overview 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

[[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]

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        FR Vol. 68
           Publication date              page No.             CFR parts affected                         File code                  Title of regulation
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 2, 2003.........................        39764  .....................................  CMS-1473-NC..........................  Medicare Program; Home
                                                                                                                                   Health Prospective
                                                                                                                                   Payment System Rate
                                                                                                                                   Update for FY 2004.
July 15, 2003........................        41861  .....................................  OFR Correction.......................  Medicare Program;
                                                                                                                                   Prospective Payment
                                                                                                                                   System for Long-Term
                                                                                                                                   Care Hospitals:
                                                                                                                                   Annual Payment Rate
                                                                                                                                   Updates and Policy
                                                                                                                                   Changes.
July 25, 2003........................        44091  .....................................  CMS-3117-N...........................  Medicare Program;
                                                                                                                                   Meeting of the
                                                                                                                                   Medicare Coverage
                                                                                                                                   Advisory Committee
                                                                                                                                   September 9, 2003.
July 25, 2003........................        44089  .....................................  CMS-1260-N...........................  Medicare Program;
                                                                                                                                   Meeting of the
                                                                                                                                   Advisory Panel on
                                                                                                                                   Ambulatory Payment
                                                                                                                                   Classification
                                                                                                                                   Groups--August 22,
                                                                                                                                   2003.
July 25, 2003........................        44088  .....................................  CMS-3124-WN..........................  Medicare Program;
                                                                                                                                   Withdrawal of
                                                                                                                                   Medicare Coverage of
                                                                                                                                   Multiple-Seizure
                                                                                                                                   Electroconvulsive
                                                                                                                                   Therapy,
                                                                                                                                   Electrodiagnostic
                                                                                                                                   Sensory Nerve
                                                                                                                                   Conduction Threshold
                                                                                                                                   Testing, and
                                                                                                                                   Noncontact
                                                                                                                                   Normothermic Wound
                                                                                                                                   Therapy.
July 25, 2003........................        44000  42 CFR Part 424......................  CMS-1185-P...........................  Medicare Program;
                                                                                                                                   Elimination of
                                                                                                                                   Statement of Intent
                                                                                                                                   Procedures for Filing
                                                                                                                                   Medicare Claims.
July 25, 2003........................        43998  42 CFR Part 406......................  CMS-4018-P...........................  Medicare Program;
                                                                                                                                   Continuation of
                                                                                                                                   Medicare Entitlement
                                                                                                                                   When Disability
                                                                                                                                   Benefit Entitlement
                                                                                                                                   Ends Because of
                                                                                                                                   Substantial Gainful
                                                                                                                                   Activity.

[[Page 74603]]

 
July 25, 2003........................        43995  42 CFR Parts 405 and 411.............  CMS-6014-P...........................  Medicare Program;
                                                                                                                                   Interest Calculation.
July 25, 2003........................        43940  42 CFR Parts 411 and 489.............  CMS-1475-FC..........................  Medicare Program;
                                                                                                                                   Third Party Liability
                                                                                                                                   Insurance
                                                                                                                                   Regulations.
August 1, 2003.......................        45674  42 CFR Part 412......................  CMS-1474-F...........................  Medicare Program;
                                                                                                                                   Changes to the
                                                                                                                                   Inpatient
                                                                                                                                   Rehabilitation
                                                                                                                                   Facility Prospective
                                                                                                                                   Payment System and
                                                                                                                                   Fiscal Year 2004
                                                                                                                                   Rates.
August 1, 2003.......................        45346  42 CFR Parts 412 and 413.............  CMS-1470-F...........................  Medicare Program;
                                                                                                                                   Changes to the
                                                                                                                                   Hospital Inpatient
                                                                                                                                   Prospective Payment
                                                                                                                                   Systems and Fiscal
                                                                                                                                   Year 2004 Rates.
August 4, 2003.......................        46036  42 CFR Parts 409, 411, 413, 440, 483,  CMS-1469-F...........................  Medicare Program;
                                                     488, and 489.                                                                 Prospective Payment
                                                                                                                                   System and
                                                                                                                                   Consolidated Billing
                                                                                                                                   for Skilled Nursing
                                                                                                                                   Facilities--Update.
August 11, 2003......................        47637  42 CFR Part 412......................  CMS-1470-F...........................  Medicare Program;
                                                                                                                                   Changes to the
                                                                                                                                   Hospital Inpatient
                                                                                                                                   Prospective Payment
                                                                                                                                   Systems and Fiscal
                                                                                                                                   Year 2004 Rates.
August 12, 2003......................        47966  42 CFR Parts 410 and 419.............  CMS-1471-P...........................  Medicare Program;
                                                                                                                                   Changes to the
                                                                                                                                   Hospital Outpatient
                                                                                                                                   Prospective Payment
                                                                                                                                   System and Calendar
                                                                                                                                   Year 2004 Payment
                                                                                                                                   Rates.
August 15, 2003......................        49030  42 CFR Parts 410 and 414.............  CMS-1476-P...........................  Medicare Program;
                                                                                                                                   Revisions to Payment
                                                                                                                                   Policies Under the
                                                                                                                                   Physician Fee
                                                                                                                                   Schedule for Calendar
                                                                                                                                   Year 2004.
August 15, 2003......................        48805  42 CFR Part 424......................  CMS-0008-IFC.........................  Medicare Program;
                                                                                                                                   Electronic Submission
                                                                                                                                   of Medicare Claims.
August 20, 2003......................        50428  42 CFR Part 405......................  CMS-1229-P...........................  Medicare Program;
                                                                                                                                   Payment Reform for
                                                                                                                                   Part B Drugs.
August 22, 2003......................        50840  42 CFR Parts 409, 417, and 422.......  CMS-4041-F...........................  Medicare Program;
                                                                                                                                   Modifications to
                                                                                                                                   Managed Care Rules.
August 22, 2003......................        50794  .....................................  CMS-1236-N...........................  Medicare Program;
                                                                                                                                   September 15 and 16,
                                                                                                                                   2003, Meeting of the
                                                                                                                                   Practicing Physicians
                                                                                                                                   Advisory Council and
                                                                                                                                   Request for
                                                                                                                                   Nominations.
August 22, 2003......................        50793  .....................................  CMS-4053-N...........................  Medicare Program:
                                                                                                                                   Meeting of the
                                                                                                                                   Advisory Panel on
                                                                                                                                   Medicare Education--
                                                                                                                                   September 18, 2003.
August 22, 2003......................        50790  .....................................  CMS-2136-FN..........................  Medicaid Program;
                                                                                                                                   State Allotments for
                                                                                                                                   Payment of Medicare
                                                                                                                                   Part B Premiums for
                                                                                                                                   Qualifying
                                                                                                                                   Individuals: Federal
                                                                                                                                   Fiscal Year 2002.
August 22, 2003......................        50784  .....................................  CMS-2166-N...........................  State 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, 2003......................        50735  42 CFR Part 414......................  CMS-1167-P...........................  Medicare Program;
                                                                                                                                   Payment for
                                                                                                                                   Respiratory Assist
                                                                                                                                   Devices With Bi-level
                                                                                                                                   Capability and a Back-
                                                                                                                                   up Rate.
August 22, 2003......................        50722  .....................................  CMS-2226-CN..........................  Medicare, Medicaid,
                                                                                                                                   and CLIA Programs;
                                                                                                                                   Laboratory
                                                                                                                                   Requirements Relating
                                                                                                                                   to Quality Systems
                                                                                                                                   and Certain Personnel
                                                                                                                                   Qualifications;
                                                                                                                                   Correction.
August 22, 2003......................        50717  42 CFR Part 413......................  CMS-1199-F...........................  Medicare Program;
                                                                                                                                   Electronic Submission
                                                                                                                                   of Cost Reports.
August 29, 2003......................        51912  42 CFR Part 447......................  CMS-2175-FC..........................  Medicaid Program; Time
                                                                                                                                   Limitation on Price
                                                                                                                                   Recalculations and
                                                                                                                                   Recordkeeping
                                                                                                                                   Requirements Under
                                                                                                                                   the Drug Rebate
                                                                                                                                   Program.
September 9, 2003....................        53266  42 CFR Part 412......................  CMS-1262-P...........................  Medicare Program;
                                                                                                                                   Changes to the
                                                                                                                                   Criteria for Being
                                                                                                                                   Classified as an
                                                                                                                                   Inpatient
                                                                                                                                   Rehabilitation
                                                                                                                                   Facility.
September 9, 2003....................        53222  42 CFR Parts 413, 482, and 489.......  CMS-1063-F...........................  Medicare Program;
                                                                                                                                   Clarifying Policies
                                                                                                                                   Related to the
                                                                                                                                   Responsibilities of
                                                                                                                                   Medicare-
                                                                                                                                   Participating
                                                                                                                                   Hospitals in Treating
                                                                                                                                   Individuals With
                                                                                                                                   Emergency Medical
                                                                                                                                   Conditions.
September 26, 2003...................        55634  .....................................  CMS-3062-N...........................  Medicare Program;
                                                                                                                                   Revised Process for
                                                                                                                                   Making Medicare
                                                                                                                                   National Coverage
                                                                                                                                   Determinations.
September 26, 2003...................        55618  .....................................  CMS-9018-N...........................  Medicare and Medicaid
                                                                                                                                   Programs; Quarterly
                                                                                                                                   Listing of Program
                                                                                                                                   Issuances--April 2003
                                                                                                                                   Through June 2003.
September 26, 2003...................        55616  .....................................  CMS-2182-FN..........................  Medicare and Medicaid
                                                                                                                                   Programs; Reapproval
                                                                                                                                   of the Community
                                                                                                                                   Health Accreditation
                                                                                                                                   Program (CHAP) for
                                                                                                                                   Deeming Authority for
                                                                                                                                   Hospices.

[[Page 74604]]

 
September 26, 2003...................        55566  42 CFR Parts 410 and 414.............  CMS-1476-CN..........................  Medicare Program;
                                                                                                                                   Revisions to Payment
                                                                                                                                   Policies Under the
                                                                                                                                   Physician Fee
                                                                                                                                   Schedule for Calendar
                                                                                                                                   Year 2004;
                                                                                                                                   Correction.
September 26, 2003...................        55528  42 CFR Parts 483 and 488.............  CMS-2131-F...........................  Medicare and Medicaid
                                                                                                                                   Programs;
                                                                                                                                   Requirements for Paid
                                                                                                                                   Feeding Assistants in
                                                                                                                                   Long Term Care
                                                                                                                                   Facilities.
September 26, 2003...................        55527  42 CFR Part 447......................  CMS-2175-CN..........................  Medicaid Program; Time
                                                                                                                                   Limitation on Price
                                                                                                                                   Recalculations and
                                                                                                                                   Recordkeeping
                                                                                                                                   Requirements Under
                                                                                                                                   the Drug Rebate
                                                                                                                                   Program; Correction
September 29, 2003...................        55882  42 CFR Parts 409, 411, 413, 440, 483,  CMS-1469-CN..........................  Medicare Program;
                                                     488, and 489.                                                                 Prospective Payment
                                                                                                                                   System and
                                                                                                                                   Consolidated Billing
                                                                                                                                   for Skilled Nursing
                                                                                                                                   Facilities;
                                                                                                                                   Correction.
September 30, 2003...................        56478  .....................................  CMS-1233-N...........................  Medicare Program;
                                                                                                                                   Hospice Wage Index
                                                                                                                                   for Fiscal Year 2004.
September 30, 2003...................        56383  .....................................  CMS-1473-NC OFR Correction...........  Medicare 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 section                           Title                    Issue date          Effective date
----------------------------------------------------------------------------------------------------------------
35-85.1.................................  Implantable Automatic.....  08/22/03..................        10/01/03
                                          Defibrillators............  09/22/03 (correction).....        10/01/03
----------------------------------------------------------------------------------------------------------------


                         Program Memorandum (PM)
------------------------------------------------------------------------
        PM No.                Title         Issue date    Effective date
------------------------------------------------------------------------
AB-03-104.............  Changes to the          07/25/03        10/01/03
                         Laboratory NCD
                         Edit Software
                         For 10/03.
------------------------------------------------------------------------


                      Federal Register Publications
------------------------------------------------------------------------
                                            Publication
                  Title                        date       Effective date
------------------------------------------------------------------------
CMS-3062-N--Revised Process for Making          09/26/03             N/A
 National Coverage Determinations.......
------------------------------------------------------------------------

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
------------------------------------------------------------------------
                    IDE                                Category
------------------------------------------------------------------------
G020202....................................  B
G020312....................................  B
G020316....................................  B
G030027....................................  B
G030031....................................  B
G030040....................................  B
G030059....................................  B
G030066....................................  B
G030100....................................  B
G030121....................................  B
G030131....................................  B
G030133....................................  B
G030134....................................  B
G030135....................................  B
G030136....................................  B

[[Page 74605]]

 
G030137....................................  B
G030138....................................  B
G030141....................................  B
G030143....................................  B
G030144....................................  B
G030145....................................  B
G030146....................................  B
G030147....................................  B
G030151....................................  B
G030159....................................  B
G030162....................................  B
G030165....................................  B
G030167....................................  B
G030169....................................  B
G030170....................................  B
G030172....................................  B
G030173....................................  B
G030174....................................  B
G030177....................................  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; Title 45, Subchapter C; and Title 20 of the Code of Federal 
Regulations, which have been approved by the Office of Management 
and Budget:

------------------------------------------------------------------------
                               Approved CFR sections in Title 42, Title
                               45, and Title 20 (Note: sections in Title
      OMB control Nos.            45 are preceded by ``45 CFR,'' and
                               sections in Title 20 are preceded by ``20
                                                CFR'')
------------------------------------------------------------------------
0938-0008...................  414.40, 424.32, 424.44
0938-0022...................  413.20, 413.24, 413.106
0938-0023...................  424.103
0938-0025...................  406.28, 407.27
0938-0027...................  486.100-486.110
0938-0033...................  405.807
0938-0034...................  405.821
0938-0035...................  407.40
0938-0037...................  413.20, 413.24
0938-0041...................  408.6
0938-0042...................  410.40, 424.124
0938-0045...................  405.711
0938-0046...................  405.2133
0938-0050...................  413.20, 413.24
0938-0062...................  431.151, 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
0938-0065...................  485.701-485.729
0938-0074...................  491.1-491.11
0938-0080...................  406.7, 406.13
0938-0086...................  420.200-420.206, 455.100-455.106
0938-0101...................  430.30
0938-0102...................  413.20, 413.24
0938-0107...................  413.20, 413.24
0938-0146...................  431.800-431.865
0938-0147...................  431.800-431.865
0938-0151...................  493.1405, 493.1411, 493.1417, 493.1423,
                               493.1443, 493.1449, 493.1455, 493.1461,
                               493.1469, 493.1483, 493.1489
0938-0155...................  405.2470
0938-0170...................  493.1269-493.1285
0938-0193...................  430.10-430.20, 440.167
0938-0202...................  413.17, 413.20
0938-0214...................  411.25, 489.2, 489.20
0938-0236...................  413.20, 413.24
0938-0242...................  416.44, 418.100, 482.41, 483.270, 483.470
0938-0245...................  407.10, 407.11
0938-0246...................  431.800-431.865
0938-0251...................  406.7
0938-0266...................  416.41, 416.47, 416.48, 416.83
0938-0267...................  410.65, 485.56, 485.58, 485.60, 485.64,
                               485.66
0938-0269...................  412.116, 412.632, 413.64, 413.350, 484.245
0938-0270...................  405.376
0938-0272...................  440.180, 441.300-441.305
0938-0273...................  485.701-485.729
0938-0279...................  424.5
0938-0287...................  447.31
0938-0296...................  413.170
0938-0300...................  431.800
0938-0301...................  413.20, 413.24
0938-0302...................  418.22, 418.24, 418.28, 418.56, 418.58,
                               418.70, 418.74, 418.83, 418.96, 418.100
0938-0313...................  418.1-418.405
0938-0328...................  482.12, 482.22, 482.27, 482.30, 482.41,
                               482.43, 482.53, 482.56, 482.57, 482.60,
                               482.61, 482.62, 482.66
0938-0334...................  491.9
0938-0338...................  486.104, 486.106, 486.110
0938-0354...................  441.60
0938-0355...................  484.10-484.52
0938-0357...................  409.40-409.50, 410.36, 410.170, 411.4-
                               411.15, 421.100, 424.22, 484.18, 489.21
0938-0358...................  412.20-412.30

[[Page 74606]]

 
0938-0359...................  412.40-412.52
0938-0360...................  405.2100-405.2184
0938-0365...................  484.10, 484.11, 484.12, 484.14, 484.16,
                               484.18, 484.20, 484.36, 484.48, 484.52
0938-0372...................  414.330
0938-0378...................  482.60-482.62
0938-0379...................  442.30, 488.26
0938-0386...................  405.2100-405.2171
0938-0391...................  488.18, 488.26, 488.28
0938-0426...................  476.104, 476.105, 476.116, 476.134
0938-0429...................  447.53
0938-0443...................  473.18, 473.34, 473.36, 473.42
0938-0444...................  1004.40, 1004.50, 1004.60, 1004.70
0938-0445...................  412.44, 412.46, 431.630, 456.654, 466.71,
                               466.73, 466.74, 466.78
0938-0447...................  405.2133
0938-0449...................  440.180, 441.300-441.310
0938-0454...................  424.20
0938-0456...................  412.105
0938-0463...................  413.20, 413.24
0938-0465...................  411.404, 411.406, 411.408
0938-0467...................  431.17, 431.306, 435.910, 435.920, 435.940-
                               435.960
0938-0469...................  417.107, 417.478
0938-0470...................  417.143, 417.408
0938-0477...................  412.92
0938-0484...................  424.123
0938-0486...................  498.40-498.95
0938-0501...................  406.15
0938-0502...................  433.138
0938-0512...................  486.301-486.325
0938-0526...................  462.102, 462.103. 475.100, 475.106,
                               475.107
0938-0534...................  410.38, 424.5
0938-0544...................  493.1-493.2001
0938-0565...................  411.20-411.206
0938-0566...................  411.404, 411.406, 411.408
0938-0567...................  Part 498 Subparts D and E, and 20 CFR
                               404.933
0938-0573...................  412.230, 412.256
0938-0581...................  493.1-493.2001
0938-0599...................  493.1-493.2001
0938-0600...................  405.371, 405.378, 413.20
0938-0610...................  417.436, 417.801, 422.128, 430.12, 431.20,
                               431.107, 434.28, 483.10, 484.10, 489.102
0938-0612...................  493.1-493.2001
0938-0618...................  433.68, 433.74, 447.272
0938-0653...................  493.1771, 493.1773, 493.1777
0938-0655...................  493.1840
0938-0657...................  405.2110, 405.2112
0938-0658...................  405.2110, 405.2112
0938-0667...................  482.12, 488.18, 489.20, 489.24
0938-0673...................  430.10
0938-0679...................  410.38
0938-0685...................  410.32, 410.71, 413.17, 424.57, 424.73,
                               424.80, 440.30, 484.12
0938-0686...................  493.551-493.557
0938-0688...................  486.301-486.325
0938-0690...................  488.4-488.9, 488.201
0938-0691...................  412.106
0938-0692...................  466.78, 489.20, 489.27
0938-0700...................  417.479, 417.500; 422.208, 422.210;
                               434.44, 434.67, 434.70; 1003.100,
                               1003.101, 1003.103, 1003.106
0938-0701...................  422.152
0938-0702...................  45 CFR 146.111, 146.115, 146.117, 146.150,
                               146.152, 146.160, 146.180
0938-0703...................  45 CFR 148.120, 148.124, 148.126, and
                               148.128
0938-0714...................  411.370-411.389
0938-0717...................  424.57
0938-0721...................  410.33
0938-0722...................  422.370-422.378
0938-0723...................  421.300-421.318
0938-0730...................  405.410, 405.430, 405.435, 405.440,
                               405.445, 405.455, 410.61, 415.110, 424.24
0938-0732...................  417.126, 417.470
0938-0734...................  45 CFR 5b
0938-0739...................  413.337, 413.343, 424.32, 483.20
0938-0742...................  422.300-422.312
0938-0749...................  424.57
0938-0753...................  422.000-422.700
0938-0754...................  441.152
0938-0758...................  413.20, 413.24
0938-0760...................  Part 484 Subpart E, 484.55

[[Page 74607]]

 
0938-0761...................  484.11, 484.20
0938-0763...................  422.1-422.10, 422.50-422.80, 422.100-
                               422.132, 422.300-422.312, 422.400-
                               422.404, 422.560-422.622
0938-0768...................  417.800-417.840
0938-0770...................  410.2
0938-0778...................  422.64, 422.111, 422.560-422.622
0938-0779...................  417.126, 417.470, 422.64, 422.210
0938-0781...................  411.404-411.406, 484.10
0938-0786...................  438.352, 438.360, 438.362, 438.364
0938-0787...................  406.28, 407.27
0938-0790...................  460.12, 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
0938-0792...................  491.3, 491.8, 491.11
0938-0798...................  413.24, 413.65, 419.42
0938-0802...................  419.43
0938-0810...................  482.45
0938-0819...................  45 CFR 146.121
0938-0823...................  420.410
0938-0824...................  440.10, 482.13
0938-0827...................  45 CFR 146.141
0938-0829...................  422.568
0938-0832...................  Part 489
0938-0833...................  483.350-483.376
0938-0841...................  431.636, 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
0938-0842...................  412, 413
0938-0846...................  411.1, 411.350-411.357, 424.22
0938-0857...................  Part 419
0938-0860...................  Part 419
0938-0866...................  45 CFR Part 162
0938-0872...................  413.337, 483.20
0938-0873...................  422.152
0938-0874...................  45 CFR Parts 160 and 162
0938-0878...................  Part 422 Subparts F and G
0938-0883...................  45 CFR Parts 160 and 164
0938-0887...................  45 CFR 148.316, 148.318, 148.320
0938-0897...................  412.22, 412.533
------------------------------------------------------------------------

[FR Doc. 03-30756 Filed 12-23-03; 8:45 am]
BILLING CODE 4120-01-P