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Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October 2003 Through December 2003

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




This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2003 through December 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 (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. Finally, this notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations.

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

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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 FDA-approved Category B IDE numbers listed in Addendum VI may be addressed to Eileen Davidson, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, S3-26-10, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6874.

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 Group, Centers for Medicare & Medicaid Services, C5-12-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6954.

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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, 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:

  • Addendum I lists the publication dates of the most recent quarterly listings of program issuances.
  • Addendum II identifies previous Federal Register documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda.
  • Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in Start Printed Page 15838conjunction with information currently in the manuals.
  • Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register during the quarter covered by this notice. For each item, we list the—
  • Date published;
  • Federal Register citation;
  • Parts of the Code of Federal Regulations (CFR) that have changed (if applicable);
  • Agency file code number; and
  • Title of the regulation.
  • Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCDM (or CIM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision.
  • Addendum VI includes listings of the FDA-approved IDE categorizations, using the IDE numbers the FDA assigns. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B), and identified by the IDE number.
  • Addendum VII includes listings of all approval numbers from the Office of Management and Budget (OMB) for collections of information in CMS regulations in title 42; title 45, subchapter C; and title 20 of the CFR.

III. How To Obtain Listed Material

A. Manuals

Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses: Superintendent of Documents, Government Printing Office, ATTN: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-1800, Fax number (202) 512-2250 (for credit card orders); or National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.

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

B. Regulations and Notices

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

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

C. Rulings

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

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

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

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

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

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

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

IV. How To Review Listed Material

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

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

For each CMS publication listed in Addendum III, CMS publication and transmittal numbers are shown. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the Medicare Benefit Policy Manual, Inpatient Hospital Services publication, use CMS-Pub. 100-02, Transmittal No. 01.

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

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Dated: March 9, 2004.

Jacquelyn Y. White,

Director, Office of Strategic Operations and Regulatory Affairs.

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Addendum I

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

November 2, 1999 (64 FR 59185)

December 7, 1999 (64 FR 68357) Start Printed Page 15839

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

[October 2003 through December 2003]

Transmittal No.Manual/Subject/Publication No.
Manual System (CMS-Pub. 100-00)
Medicare Benefit Policy (CMS-Pub. 100-02)
01Inpatient Hospital Services.
Inpatient Psychiatric Hospital Services.
Duration of Covered Inpatient Services.
Inpatient Psychiatric Benefit Days Reduction and Lifetime Limitation.
Lifetime Reserve Days.
Hospital Services Covered Under Part B.
Home Health Services.
Coverage of Extended Care Skilled Nursing Facility Services Under Hospital Coverage of Hospice Services Under Hospital Insurance.
Ambulance Services.
End-Stage Renal Disease.
Comprehensive Outpatient Rehabilitation Facility Coverage.
Rural Health Clinic and Federally Qualified Health Center Services.
Medical Devices.
Covered Medical and Other Health Services.
General Exclusions from Coverage.
02Provider Education Article Stopping Abuse of the Power Wheelchair Benefit.
03Fecal-Occult Blood Tests.
Medicare National Coverage Determinations (CMS-Pub. 100-03)
02Artificial Hearts and Related Devices.
03Lung Volume Reduction Surgery (Reduction Pneumoplasty).
04Provider Education Article Ventricular Assist Devices for Destination Therapy.
05Colorectal Cancer Screening Test.
Medicare Claims Processing (CMS-Pub. 100-04)
01General Billing Requirements.
Admission and Registration Requirements.
Inpatient Part A Hospital.
Part B Hospital (Including Inpatient Hospital Part B and Outpatient Prospective Payment System).
Part B Outpatient Rehabilitation and Comprehensive Outpatient Rehabilitation Facility Services.
Skilled Nursing Facility Inpatient Part A Billing.
Skilled Nursing Facility Part B (Including Inpatient Part B and Outpatient Fee Schedule).
Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims.
Rural Health Clinics and Federal Qualified Health Centers.
Home Health Agency Billing.
Physician/Practitioner Billing.
Radiology Services.
Ambulatory Surgical Centers.
Laboratory Services from Independent Labs, Physicians, and Providers.
Drugs and Biologicals.
Preventive and Screening Services.
Indian Health Services (not yet available).
Durable Medical Equipment, Prosthetics, Orthotics and Supplies Parenteral and Enteral.
Medicare Summary Notices.
Remittance Notices to Providers.
Fee Schedule Administration and Coding Requirements.
EDI Support Requirements.
Completing and Processing UB-92 (CMS-1450) Data Set.
Completing and Processing Form CMS-1500 Data Set.
Contractor Instructions for Common Working File.
Coordination With Medigap, Medicaid, and Other Complementary Insurers.
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Appeals of Claims Decisions.
Financial Liability Protections.
02File Descriptions for Retrieving the 2004 Pricing and Health Common Coding Data Files through Centers for Medicare & Medicaid Services.
Mainframe Telecommunications System.
03New Effective Data for CR2112 (Revisions to the Outpatient Prospective Payment System Pricer Software and Outpatient Code Editor).
04October 2003 Update to the Health Care Provider Taxonomy Code.
05Type of Service.
06Implementation of the Coding, Testing, and Implementation Phase and Provider Education for Change Request 2631, Revisions to the Medicare.
Carrier Manual for Jurisdiction and Unprocessable Claims.
07Correction of Duplicate Editing in Common Working File for Immunosuppressive Drug Claims at the Durable Medical Equipment Regional Carrier.
08Annual Update of Healthcare Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement.
09Reasonable Charge Update for 2004 for Splints, Casts, Dialysis Supplies, Dialysis Equipment, Therapeutic Shoes, and Certain Intraocular Lenses.
10Billing Instructions for Claims for Ventricular Assist Devices for Beneficiaries in a Medicare+Choice Plan.
11Use of GY Modifier to Identify Clinical Diagnostic Laboratory Services That Are Not Covered by Medicare.
12Certificate for Physician-Performed Microscopy Procedures.
13Confirming Outcome & Assessment Information Set Assessment Items.
Therapy Threshold.
Hospitalization Within 14 Days of Start Care.
14Modifier for Transportation of Portable X-rays.
15Implementation Guide Edits.
16Payment Limit for Purchased Service.
17Billing and Payment Procedures Regarding Ownership and Provider Numbers.
Payment Procedures for Terminated Home Health Agency.
18Expansion of Beneficiary History and Claims In Process Files in the Viable Information Processing System Medicare System.
19Annual Update of Healthcare Common Procedure Coding System Codes Used For Skilled Nursing Facility Consolidated Billing Enforcement.
20Updated Skilled Nursing Facility to Pay File Available for Download.
21Update to Medicare Deductible, Coinsurance, and Premium Rates for Calendar Year 2004.
22Schedule Release for January Updates to Software Programs and Pricing/Coding Files.
23Claims Information and Claims Forms and Formats.
Paper Claim Submission to Carriers.
Electronic Claim Submission to Carriers.
24Billing Non-Covered Charges to Fiscal Intermediaries “ Summary and New Instructions.
25Billing Non-Covered Charges to Fiscal Intermediaries.
26Lung Volume Reduction Surgery.
27CPT Code for Lung Volume Reduction Surgery and Instructions for Processing Claims for Beneficiaries in a Risk Medicare+Choice Plan.
28Consolidation of the Claims Crossover Process & the Adding of Common Working File.
Crossover Disposition Indicators.
29Consolidation of Claims Crossover.
30The Financial Limitation.
Discipline Specific Outpatient Rehabilitation Modifiers—All Claims.
31Dialysis Provider Number Series.
32Remittance Advice Remark Code and Claim Adjustment Reason Code Update.
33Mammography Quality Standards Act of 1992 File.
34ANSIX12 Transaction 835 Companion Document and Flat File Change for.
Durable Medical Equipment Regional Carriers, and Correction in the Companion Document for Fiscal Intermediaries.
35Minimum Number of Pricing Files that Must be Maintained Online for Single Drug Pricer.
36Revenue Code 068X.
37Medicare Physician Fee Schedule Data Base.
38Revised Skilled Nursing Facility No Pay/File—Effective January 1, 2004.
39The Supplemental Security Income Medicare Beneficiary Data for Fiscal Year 2002 for Inpatient Rehabilitation Facility Paid Under the Prospective Payment System.
40Healthcare Common Procedure Coding System and Diagnosis Codes.
Roster Claims Submitted to Carriers for Mass Immunization.
Claims Submitted to Fiscal Intermediaries for Mass Immunizations of Influenza and Pneumococcal Pneumonia Vaccine.
41Payment for Anesthesia in a Critical Access Hospital.
42Financial Limitation on Therapy Services.
43Displaying Material With CDT-4 Code.
American Dental Association's Copyright Notice.
Point and Click License, and Shrink Wrap License.
44Mandatory Electronic Submission of Claims.
Small Providers and Full-Time Equivalent Employee Assessments Exceptions.
Electronic and Paper Claims Implications Of Mandatory Electronic Submission.
45Outpatient Provider Specific File.
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46Outpatient Prospective Payment System Outpatient Code Editors.
47Carriers Specific Requirements for Certain Specialties/Services.
48National Council for Prescription Drug Programs.
49Fiscal Intermediaries Health Insurance Portability and Accountability Act.
Claim Level Edits.
50Description of Healthcare Common Procedure Coding System.
51January Medicare Outpatient Code Editor (OCE) Specifications Version 19.1 For Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System.
52Colorectal Cancer Screening.
53January Outpatient Code Editor Specifications Version 5.0.
54Payment Allowance Limit for Drugs and Biologicals Not Paid on a Cost or Prospective Payment Basis.
55Calculation of the Payment Allowance Limit for Durable Medical Equipment Regional Carrier Drugs.
56Ambulance Inflation Factor.
Medicare Secondary Payer (CMS-Pub. 100-05)
01Background and Overview.
Medicare Secondary Payer Provisions.
Medicare Secondary Providers Billing Requirements.
Coordination of Benefits Contractor Requirements.
Contractor Prepayment Processing Requirements.
Medicare Secondary Payer Common Working File Process.
Contractor MSP.
Recovery Rules.
02Individuals Not Subject to the Limitation on Payment.
03Non-Employer Group Health Plan “Send to Common Working File”.
Switch Error.
04Data Center Testing Production.
05Data Center Testing Production.
06Auto Notice of Change to Medicare Secondary Payer.
Medicare Financial Management.
Medicare Financial Management. (CMS-Pub. 100-06)
23Clarification of Existing Instructions to Chapters 1 and 2 of the Medicare Financial Management.
24Installation of Version 32.0 of the Provider Statistical and Reimbursement Reporting Stem.
25Initial Interest Rate Manual Instruction and Business Requirement.
26Incremental Cost Budgeting and Reporting for Productivity Investment Projects.
27Revision to Chapters 8, 9 and 10 of the Medicare Financial Management Manual.
28Uncollectible Accounts Forms.
29Revisions to Chapters 3 and 4.
Medicare Program Integrity (CMS-Pub. 100-08)
52The Report of Benefit Saving.
53Informing Beneficiaries About Which Local Medical Review Policy and/or National Determination Is Associated With Their Claims Denial.
54Informing Beneficiaries About Which Lab Negotiated National Coverage.
55Quarterly Update To Correct Coding Initiative Edit, Version 10.0, Effective January 1, 2004.
56Update of Codes in the Program Integrity Management Reporting System and the Contractor Administrative Cost and Financial Management System.
57Quarterly Update to Correct Coding Initiative Edits, Version 10.0, Effective January 1, 2004.
58Provider Enrollment Manual Section 20.
59Documentation Specifications for Areas Selected for Prepayment or Postpayment.
Medicare Review.
60Provider Enrollment, Chain and Ownership System.
Medicare Contractor Beneficiary and Provider Communications (CMS Pub. 100-09)
1Contains General Instructions and Requirements for Medicare Carriers, Including Durable Medical Equipment Regional Carrier and Intermediaries, for Processing Correspondence.
2Revised Disclosure Desk Reference for Call Centers (Fourth Version).
3Corrections and Reorganization of Material.
Medicare Quality Improvement Organizations (CMS-Pub. 100-10)
11Medicare+Choice Organizations.
12Quality Improvement Organization.
13Hospital Self-Generated Data
Start Printed Page 15842
Medicare End-Stage Renal Disease Network Organizations (CMS Pub. 100-14)
4Confidentiality and Disclosure.
Medicare Managed Care (CMS Pub. 100-16)
32Contacts With Medicare+Choice Organizations.
33Contacts With Medicare+Choice Organizations.
34Medicare+Choice Beneficiary Grievances.
35Contacts With Medicare+Choice Organizations.
36Medicare+Choice Organizations.
37Revisions to Chapter 15.
38Medicare Cost Plan Enrollment and Disenrollment Instructions.
39Quality Assessment.
40Manualization of the Plan Communication Guide.
End-Stage Renal Disease (CMS-Pub. 100-14)
Purpose of the Network Manual.
Statutes and Regulations.
End-Stage Renal Disease Network Organizations 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.
Purpose of the Network Manual.
Statutes and Regulations.
Revision to the End-Stage Renal Disease Organizations Manual.
Purpose of End-Stage Renal Disease Network Organization.
Requirements for End-Stage Renal Disease Network Organizations.
Responsibilities of End-Stage Renal Disease Network Organizations Goals.
Network Organization's Role in Health Care Quality Improvement Program.
3Organizational Structure.
Establishing the Network Computer.
Board of Directors.
Other Committees.
Network Staff.
Required Administrative Reports/Activities.
Quarterly Progress and Status Reports.
Annual Report.
Semi Annual Report of Network Operating Costs.
New End Stage Renal Disease Patient Orientation Package Activities.
Internal Quality Control Program.
Internal Quality Control Program Requirements.
Managed Care Manual (CMS Pub. 100-16)
26Alternate Employer Group Enrollment Election.
Optional Employer Group Medicare+Choice Enrollment Election.
Request Submitted via Internet.
Request Signature and Data.
Effective Dates.
Notice Requirements.
Optional Employer Group Medicare+Choice Disenrollment Election.
Medigap-Guaranteed Issue Notification Requirements.
General Rule.
Effective Date.
Researching and Acting on a Change of Address.
Clarified the Notice Requirements for Out of Area Permanent.
27Noncontracted Provider Appeals.
Storage of Appeal Case Files by the Independent Review Entity.
Representative Filing on Behalf of the Enrollee.
Storage of Hearing Files.
28Streamlined Marketing Review Process.
Marketing Review Process.
Guidelines for Advertising Material.
Start Printed Page 15843
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.
Center 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.
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.
General Rule.
Obligations of Deemed Medicare & Medicaid Organizations.
Oversight of Accrediting Organizations.
Application Requirements.
Reporting Requirements.
Informal Hearing Procedures.
30Reasonable Cost-Based Payments—General.
Reasonable Cost Payments.
Bill Processing.
Principles of Payments.
Budget and Enrollment Forecast.
Interim Per Capita Rate.
Interim Payment for Health Care Prepayment Plans.
Electronic Transfer of Funds.
Payment Report.
Interim and Final Cost and Enrollment Report.
Adjustment of Payments.
Final Cost Report.
Final Settlement Process for Medicare Health Care Prepayment Plans.
Final Settlement Payment for Medicare Health Care Prepayment Plans.
Recovery of Overpayment.
Interest Charges for Medicare Overpayments/Underpayments.
The Basic Rules.
Definition of Final Determination.
Rate of Interest.
Accrual of Interest.
Waiver of Interest.
Rules Applicable to Partial Payments.
Exception to Applicability.
Nonallowable Interest Cost.
Centers for Medicare & Medicaid Services General Payment Principles.
Medicare Payments to Health Care Prepayment Plans.
Prudent Buyer Principle.
Allowable Costs.
Costs Not Reimbursable Directly to the Health Care Prepayment Plans.
Deductible and Coinsurance.
Hospice Care Costs.
Medicare as Secondary Payer.
31Overview of Enrollment and Payment Process.
Purpose of the Chapter.
Medicare+Choice Organization Data Processing Responsibilities.
Centers for Medicare & Medicaid Services Group Health Plan System.
Enrollment/Disenrollment Requirements and Effective Dates.
Start Printed Page 15844
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.
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 From Centers for Medicare & Medicaid Services.
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 Act.
Administration, and Customer Service Center Disenrollments.
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.
One Time Notification (CMS Pub. 100-20)
06Either Impact Multiple Manuals or Have No Manual Impact.
07Common Working File Edits for Inserts for Therapeutic Shoes.
08Revised X12N 4010A1 837 Professional Flat File.
09Shared System Maintainer Hours for Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing.
Start Printed Page 15845
10Changes to the Laboratory National Coverage Determination Edit Software for January 1, 2004.
11Calendar Year 2004 Participation Enrollment and Medicare Participating Physicians and Suppliers Directory Procedures.
12New Waived Tests—January 1, 2004.
13Program Integrity Management Reporting System for Part A—Phase 3.
14Comprehensive Error Rate Testing Program—Requirements Update for Medicare Part A Provider Address File and Sample Claims Resolution File.
15Changes in Transitional Outpatient Payment (TOP) for 2004.
16Implementation of Correction to: Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 2004 Rates; as Published in the October 6, 2003, Federal Register (68 FR 57732); and Extension of the Provision Equalizing the Urban and Rural Standardized Medicare Inpatient Hospital Payments as Required by Public Law 108-89.
17Fee Schedule Update for 2004 for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.
18Change in Coding on Medicare Claims for Darbepoetin Alfa (Trade Name Aranesp) and Epoetin Alfa (Trade Name Epogen) of Treatment of Anemia in End-Stage Renal Disease Patients on Dialysis.
19Change in Payment for Darbepoetin Alfa (Trade Name Aranesp) for Treatment of Anemia In End-Stage Renal Disease Patients on Dialysis.
202004 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services to Reasonable Charge Payment.
21Indian Health Service (IHS) Hospital Payment Rates for Calendar Year 2003.
22Clarification to Transmittal B-03-059 (CR 2755)—Minimum Number of Pricing Files That Must Be Maintained Online for Medicare Single Drug Pricer.
23Payment for Ambulance Services Furnished by New Suppliers.
24Instructions for Fiscal Intermediary Standard System (FISS) and Multi-Carrier System Healthcare Integrated General Ledger Accounting System Changes.
25Clarification of Mammography Annual Screening Examination.
26Coding and Billing Instructions for VelcadeTM (Bortezomib).
27Emergency Correction to the 2004 Healthcare Common Procedure Coding System File.
282004 Medicare Physician Fee Schedule Increase and Extension of the Annual Participation Enrollment Period.
29Revised American National Standards Institute X12N 837 Professional Health Care Claim Companion Document.
30Changes in Transitional Outpatient Payment (TOP) for 2004.
31Emergency Revised 2004 Update of the Durable Medical Equipment Provider of Services and Clinical Laboratory Fee Schedules.
32January 2004 Update of the Hospital Outpatient Prospective Payment System.
33Change of Medicare Part A Plan Under Contract With the Blue Cross/Blue Shield Association and Change of Part B Carrier in the State of Rhode Island From Blue Cross/Blue Shield of Rhode Island to Arkansas Blue Cross/Blue Shield.
342004 Medicare Physician Fee Schedule Annual Changes.
35Emergency Correction to the Fee Schedule Update for 2004 for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
36Additional Modification Regarding Change Request 2963: Change in Coding on Medicare Claims for Darbepoetin Alfa (Trade Name Aranesp) and Epoetin Alfa (Trade Name Epogen) for Treatment of Anemia In End-Stage Renal Disease Patient on Dialysis.
37Home Health Cost Reporting Processes.

Addendum IV.—Regulation Documents Published in the Federal Register

[October 2003 through December 2003]

Publication dateFR Vol. 68 page no.CFR parts affectedFile codeTitle of regulation
October 6, 20035773242 CFR Parts 412 and 413CMS-1470-CNMedicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates; Correction.
October 10, 20035875642 CFR Parts 409, 411, 413, 440, 483, 488, and 489CMS-1469-CNMedicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Correction.
October 24, 200361005CMS-1253-NMedicare Program; November 17, 2003, Meeting of the Practicing Physicians Advisory Council.
October 24, 200361004CMS-4061-NMedicare Program: Meeting of the Advisory Panel on Medicare Education-November 20, 2003.
October 24, 200361002CMS-8018-NMedicare Program; Part A Premium for 2004 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement.
October 24, 200360997CMS-8017-NMedicare Program; Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Beginning January 1, 2004.
October 24, 200360995CMS-8016-NMedicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for 2004.
November 7, 20036339842 CFR Parts 410 and 4419CMS-1471-FCMedicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004 Payment Rates.
Start Printed Page 15846
November 7, 20036369242 CFR Parts 400, 405, and 426CMS-3063-FMedicare Program: Review of National Coverage Determinations and Local Coverage Determinations.
November 7, 20036319642 CFR Parts 410, and 414CMS-1476-FCMedicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004.
November 19, 20036534642 CFR Part 426OFR CorrectionMedicare Program; Review of National Coverage Determinations and Local Coverage Determinations.
November 28, 20036692042 CFR Parts 412, 413, and 424CMS-1213-PMedicare Program; Prospective Payment System for Inpatient Psychiatric Facilities.
November 28, 20036672142 CFR Part 408CMS-6016-FMedicare Program; Reduction in Medicare Part B Premiums as Additional Benefits Under Medicare+Choice Plans.
November 28, 20036671042 CFR Parts 403, 489, and 498CMS-1909-FMedicare Program; Religious Nonmedical Health Care Institutions and Advance Directives.
December 5, 20036796042 CFR Part 414CMS-1232-FCMedicare Program; Coverage and Payment of Ambulance Services; Inflation Update for CY 2004.
December 5, 20036795542 CFR Parts 412, 413, 476, and 484CMS-3055-FMedicare Program; Photocopying Reimbursement Methodology.
December 15, 200369928CMS-4063-NMedicare Program; Medicare Prescription Drug Discount Card.
December 15, 20036984042 CFR Parts 403 and 408.CMS-4063-IFCMedicare Program, Prescription Drug Discount Card.
December 15, 200369707CMS 1370-NMedicare Program; The Practicing Physicians Advisory Council's Request for Nominations.
December 24, 20037479242 CFR Parts 405 and 491.CMS-1910-FMedicare Program; Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions; and Establishment of a Quality Assessment and Performance Improvement Program.
December 24, 200374622CMS-1247-NMedicare Program; Town Hall Meeting in Calendar Year 2004 for Ambulance Condition Codes.
December 24, 200374621CMS-1254-NMedicare Program, Meeting of the Advisory Panel on Ambulatory Payment Classification Groups—February 18, 19, and 20, 2004.
December 24, 200374613CMS-1226-GNCMedicare Program; Criteria and Standards for Evaluating Intermediary, Carrier, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Regional Carrier Performance During Fiscal Year 2004.
December 24, 200374607CMS-3119-PNMedicare Program; Procedures for Maintaining Code Lists in the Negotiated National Coverage Determinations for Clinical Diagnostic Laboratory Services.
December 24, 200374590CMS-9019-NMedicare and Medicaid Programs; Quarterly Listing of Program Issuances—July 2003 Through September 2003.
December 24, 20037449142 CFR Part 411.CMS-18089-F4Medicare and Medicaid Programs; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Extension of Partial Delay of Effective Date.
December 31, 20037544242 CFR Parts 410 and 419.CMS-1471-CNMedicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004 Payment Rates; Final Rule; Correction.

Addendum V—National Coverage Determinations [October 2003 Through December 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​coverage. Start Printed Page 15847

National Coverage Determinations

[October 2003 Through December 2003]

100-03TitleIssue dateEffective date
20.9Ventricular Assist Devices (VADs)10/17/0310/01/03
240.1Lung Volume Reduction Surgery (LVRS)11/04/0310/01/03
210.3Fecal Occult Blood Tests (FOBT)12/19/0301/01/04

Medicare Claims Processing Manual

100-04TitleIssue dateEffective date
AB03-104Changes to the Laboratory NCD Edit Software for 01/01/0410/24/0301/01/04

One-Time Notification

100-20TitleIssue dateEffective date
AB03-1272004 Annual Update for Clinical Lab Fee Schedule11/07/0301/01/04

Addendum VI—FDA-Approved Category B IDEs

Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved IDE. Category A refers to experimental IDEs, and Category B refers to nonexperimental IDEs. 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 list includes all Category B IDEs approved by FDA during the 4th quarter, October through December 2003.






















































Addendum VII Approval Numbers for Collections of Information

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

OMB Control No.Approved CFR Sections in Title 42, Title 45, and Title 20 (Note: Sections in Title 45 are preceded by “45 CFR,” and sections in Title 20 are preceded by “20 CFR”)
0938-0008414.40, 424.32, 424.44
0938-0022413.20, 413.24, 413.106
0938-0025406.28, 407.27
0938-0037413.20, 413.24
0938-0041408.6, 408.22
0938-0042410.40, 424.124
0938-0050413.20, 413.24
0938-0062431.151, 435.1009, 440.220, 440.250, 442.1, 442.10-442.16, 442.30, 442.40, 442.42, 442.100-442.119, 483.400-483.480, 488.332, 488.400, 498.3-498.5
0938-0080406.7, 406.13
0938-0086420.200-420.206, 455.100-455.106
Start Printed Page 15848
0938-0102413.20, 413.24
0938-0107413.20, 413.24
0938-0151493.1405, 493.1411, 493.1417, 493.1423, 493.1443, 493.1449, 493.1455, 493.1461, 493.1469, 493.1483, 493.1489
0938-0193430.10-430.20, 440.167
0938-0202413.17, 413.20
0938-0214411.25, 489.2, 489.20
0938-0236413.20, 413.24
0938-0242416.44, 418.100, 482.41, 483.270, 483.470
0938-0245407.10, 407.11
0938-0266416.41, 416.47, 416.48, 416.83
0938-0267410.65, 485.56, 485.58, 485.60, 485.64, 485.66
0938-0269412.116, 412.632, 413.64, 413.350, 484.245
0938-0272440.180, 441.300-441.305
0938-0296413.170, 413.184
0938-0301413.20, 413.24
0938-0302418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.74, 418.83, 418.96, 418.100
0938-0328482.12,482.13, 482.21, 482.22, 482.27, 482.30, 482.41, 482.43, 482.45, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, 482.66, 485.618, 485.631
0938-0338486.104, 486.106, 486.110
0938-0357409.40-409.50, 410.36, 410.170, 411.4-411.15, 421.100, 424.22, 484.18, 489.21
0938-0365484.10, 484.11, 484.12, 484.14, 484.16, 484.18, 484.20, 484.36, 484.48, 484.52
0938-0379442.30, 488.26
0938-0391488.18, 488.26, 488.28
0938-0426476.104, 476.105, 476.116, 476.134
0938-0443473.18, 473.34, 473.36, 473.42
0938-04441004.40, 1004.50, 1004.60, 1004.70
0938-0445412.44, 412.46, 431.630, 456.654, 466.71, 466.73, 466.74, 466.78
0938-0449440.180, 441.300-441.310
0938-0463413.20, 413.24
0938-0465411.404, 411.406, 411.408
0938-0467431.17, 431.306, 435.910, 435.920, 435.940-435.960
0938-0469417.107, 417.478
0938-0470417.143, 417.408, 417.800-417.840, 422.6
0938-0526462.102, 462.103, 475.100, 475.106, 475.107
0938-0534410.38, 424.5
0938-0566411.404, 411.406, 411.408
0938-0567Part 498 Subparts D and E, and 20 CFR 404.933
0938-0573412.230, 412.256
Start Printed Page 15849
0938-0600405.371, 405.378, 413.20
0938-0610417.436, 417.801, 422.128, 430.12, 431.20, 431.107, 434.28, 483.10, 484.10, 489.102
0938-0618433.68, 433.74, 447.272
0938-0653493.1771, 493.1773, 493.1777
0938-0657405.2110, 405.2112
0938-0658405.2110, 405.2112
0938-0667482.12, 488.18, 489.20, 489.24
0938-0685410.32, 410.71, 413.17, 424.57, 424.73, 424.80, 440.30, 484.12
0938-0690488.4-488.9, 488.201
0938-0692466.78, 489.20, 489.27
0938-0700417.479, 417.500; 422.208, 422.210; 434.44, 434.67, 434.70; 1003.100, 1003.101, 1003.103, 1003.106
0938-070245 CFR 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, 146.180
0938-070345 CFR 148.120, 148.124, 148.126, and 148.128
0938-0730405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, 424.24
0938-0732417.126, 417.470
0938-073445 CFR 5b
0938-0739413.337, 413.343, 424.32, 483.20
0938-0758413.20, 413.24
0938-0760Part 484 Subpart E, 484.55
0938-0761484.11, 484.20
0938-0763422.1-422.10, 422.50-422.80, 422.100-422.132, 422.300-422.312, 422.400-422.404, 422.560-422.622
0938-0778422.64, 422.111, 422.560-422.622
0938-0779417.126, 417.470, 422.64, 422.210
0938-0781411.404-411.406, 484.10
0938-0786438.352, 438.360, 438.362, 438.364
0938-0787406.28, 407.27
0938-0790460.12, 460.22, 460.26, 460.30, 460.32, 460.52, 460.60, 460.70, 460.71, 460.72, 460.74, 460.80, 460.82, 460.98, 460.100, 460.102, 460.104, 460.106, 460.110, 460.112, 460.116, 460.118, 460.120, 460.122, 460.124, 460.132, 460.152, 460.154, 460.156, 460.160, 460.164, 460.168, 460.172, 460.190, 460.196, 460.200, 460.202, 460.204, 460.208, 460.210
0938-0792491.3, 491.8, 491.11
0938-0798413.24, 413.65, 419.42
0938-081945 CFR 146.121
0938-0824440.10, 482.13
0938-082745 CFR 146.141
0938-0832Part 489
0938-0841431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560, 457.570, 457.740, 457.750, 457.810, 457.940, 457.945, 457.965, 457.985, 457.1005, 457.1015, 457.1180
0938-0842412, 413
0938-0846411.1, 411.350-411.357, 424.22
0938-0857Part 419
0938-0860Part 419
0938-086645 CFR Part 162
0938-0872413.337, 483.20
0938-087445 CFR Parts 160 and 162
0938-0878Part 422 Subparts F and G
Start Printed Page 15850
0938-088345 CFR Parts 160 and 164
0938-088745 CFR 148.316, 148.318, 148.320
0938-0897412.22, 412.533
0938-0907412.30, 412.304, 413.65
End Supplemental Information

[FR Doc. 04-6350 Filed 3-25-04; 8:45 am]