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Notice

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April 2003 Through June 2003

Action

Notice.

Summary

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2003 through June 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.

 

Table of Contents Back to Top

Tables Back to Top

FOR FURTHER INFORMATION CONTACT: Back to Top

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

SUPPLEMENTARY INFORMATION: Back to Top

I. Program Issuances Back to Top

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 Back to Top

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 Coverage Issues Manual (CIM) may wish to review the August 21, 1989 publication (54 FR 34555). Those interested in the procedures used in making NCDs under the Medicare program may review the April 27, 1999 publication (64 FR 22619).

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

  • Addendum I lists the publication dates of the most recent quarterly listings of program issuances.
  • Addendum II identifies previous Federal Register documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda.
  • Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manuals.
  • Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register during the quarter covered by this notice. For each item, we list the—
  • Date published;
  • Federal Register citation;
  • Parts of the Code of Federal Regulations (CFR) that have changed (if applicable);
  • Agency file code number; and
  • Title of the regulation.
  • Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the 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 Back to Top

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: http://cms.hhs.gov/manuals/default.asp.

B. Regulations and Notices

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

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

C. Rulings

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

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

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

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

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

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

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

IV. How To Review Listed Material Back to Top

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

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

Superintendent of Documents numbers for each CMS publication are shown in Addendum III, along with the CMS publication and transmittal numbers. To help FDLs locate the materials, use the Superintendent of Documents number, plus the transmittal number. For example, to find the Carriers Manual, Part 3—Program Administration (CMS Pub. 14-3) transmittal entitled “Incident to Physician's Professional Services (Subsection A—Commonly Furnished in Physicians' Offices),” use the Superintendent of Documents No. HE 22.8/7 and the transmittal number 1793.

(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: September 8, 2003.

Jacquelyn Y. White,

Director, Office of Strategic Operations and Regulatory Affairs.

Addendum I Back to Top

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

May 11, 1999 (64 FR 25351)

November 2, 1999 (64 FR 59185)

December 7, 1999 (64 FR 68357)

January 10, 2000 (65 FR 1400)

May 30, 2000 (65 FR 34481)

June 28, 2002 (67 FR 43762)

September 27, 2002 (67 FR 61130)

December 27, 2002 (67 FR 79109)

March 28, 2003 (68 FR 15196)

June 27, 2003 (68 FR 38359)

Addendum II.—Description of Manuals, Memoranda, and CMS Rulings Back to Top

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

Addendum III.—Medicare and Medicaid Manual Instructions Back to Top
Transmittal No. Manual/Subject/Publication No.
[April 2003 Through June 2003]
Intermediary Manual    
Part 3—Audits, Reimbursement Program Administration    
(CMS Pub. 13-3)    
(Superintendent of Documents No. HE 22.8/6)    
1879 Clinical Diagnostic Laboratory Services Other Than To Inpatients Screening Pap Smears and Pelvic Examinations
1880 Autologous Stem Cell Transplantation
1881 Review of Form HCFA-1450 for Inpatient and Outpatient Bills
1882 Frequency of Billing
1883 Magnetic Resonance Angiography
1884 Telehealth Services
1885 Medicare Payment for Telehealth Services
1886 Payment Without Common Working File Approval
1887 Filing a Request for Payment
Request for Payment
Filing Claims for Payment
Time Limits for Requests and Claims for Payment for Services Reimbursed
Effects on Beneficiary and Provider of Beneficiary's Refusal to File a Request for Payment
Filing Claims Where Usual Time Limit Has Expired
Claims for Payment for Emergency Hospital Services and Services Outside the United States
Appeals
Time Limits for Filing Part B Reasonable Charge Claims
Claims Processing Timeliness
Time Limitations for Filing Provider Claims
Incomplete or Invalid Claims
Addendum L Paper and Electronic Data Element Requirements
Bill Type Codes and Allowable Provider Numbers
1888 Screening Pap Smears and Screening Pelvic Examinations
1889 Billing of the Diagnosis and Treatment of Peripheral Neuropathy With Loss of Protective Sensation in People With Diabetes
1890 Coverage and Billing of Sacral Nerve Stimulation
Deep Brain Stimulation for Essential Tremor and Parkinson's Disease
1891 International Classification of Diseases 9th Edition
Clinical Modification Coding for Diagnostic Tests
Carriers Manual    
Part 3—Program Administration    
(CMS Pub. 14-3)    
(Superintendent of Documents No. HE 22.8/7)    
1793 Incident to Physician's Professional Services (Subsection A—Commonly Furnished in Physicians' Offices)
1794 The “Do Not Forward” Initiative (Subsection C—Internal Revenue Services—1099 Reporting)
1795 Magnetic Resonance Angiography Coverage Summary Coding Requirements
1796 Skilled Nursing Facility Consolidated Billing
Determining the End of a Skilled Nursing Facility Stay
Types of Facilities Included in and Excluded From Consolidated Billing
Types of Services Included in and Excluded From Consolidated Billing
Risk-Based Health Maintenance Organization Beneficiaries
Clarification of Ambulance Services
Information on a Skilled Nursing Facility Contracting With Outside Entities for Services
Carrier Claims Processing
Special Requirements for Claims for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
Revisions to Common Working File Edits To Permit Payment for Certain Diagnostic Services Furnished To Beneficiaries Receiving Treatment for End-Stage Renal Disease at an Independent or Provider-Based Dialysis Facility
1797 Telehealth Claims
1798 Medicare Payment for Telehealth Services
1799 Payment Limit for Certain Drugs and Biologicals
Procedures for Determining Payment Limit
Injection Services
Mandatory Assignment for Drugs and Biologicals
1800 Drugs and Biologicals
Definition of Drug or Biological
Determining Self-Administration of Drugs or Biologicals Incident-To Requirements
1801 Healthcare Common Procedure Coding System Coding
Common Working File Edits for Flu and Pneumonia Claims
Administrative Bulletin Crossover Edit
Payment Requirements
No Legal Obligation To Pay
Roster Billing
Health Maintenance Organization Processing
Specialty Code/Place of Service Processing
1802 Foot Care and Supportive Devices for Feet Foot Care
Peripheral Neuropathy With Loss of Protective Sensation in People With Diabetes
Coverage
Applicable Codes
Payment Requirements
Standard System Edits
Common Working File Edits
1803 End-Stage Renal Disease Bill Procedures 1804
1804 Durable Medical Equipment Regional Carriers—Pre-Discharge Delivery of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies for Fitting and Training
1805 Necessity for Treatment
1806 Intestinal and Multi-Visceral Transplantation
Approved Transplant Facilities
Payment Procedures for Intestinal and Multi-Visceral Transplants
1807 International Classification of Diseases 9th Edition Clinical Modification
Coding for Diagnostic Tests
Program Memorandum Intermediaries    
(CMS Pub. 60A)    
(Superintendent of Documents No. HE 22.8/6-5)    
A-03-020 April 2003 Update of the Hospital Outpatient Prospective Payment System
A-03-021 Announcement of Medicare Rural Health Clinics and Federally Qualified
Health Centers Payment Rate Increases, Clarification on Coverage and Payment of Diabetes Self-Management Training Services and Medical Nutrition Therapy Services
A-03-022 Installation of Version 29.0 of the Provider Statistical and Reimbursement Reporting System—Modification A-03-023
A-03-023 Implementation of the Temporary Equalization of Urban and Rural Standardized Payment Amounts Under the Medicare Inpatient Hospital Prospective Payment System as Required By Section 402(b) of Public Law 108-7
A-03-024 Advance Beneficiary Notices Must Be Given To Beneficiaries and Demands Bills Must Be Submitted By Home Health Agencies
A-03-025 Advance Beneficiary Notices Must Be Given To Beneficiaries and Demands Bills Must Be Submitted By Home Health Agencies
A-03-026 April Outpatient Code Editor Specifications Version (V4.1)
A-03-027 Updated Outpatient Prospective Payment System: Requirements for Provider Education and Training
A-03-028 January Medicare Outpatient Code Editor Specifications Version 18.1R1 for Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System
A-03-029 Corrections to: Changes to the Hospital Inpatient Prospective Payment Systems and Rates and Costs of Graduate Medical Education, etc., as Published in the Federal Register, Fiscal Year 2003 (67 FR 49982, August 1, 2002)
A-03-030 Provider-Based Status On or After October 1, 2002
A-03-031 Medicare Secondary Payer Information Collection Policies Changed for Hospitals
A-03-032 Addition of Patient Status Code 43, Deletion of Patient Status Codes 71 and 72, and Information on New Patient Status Code 65
A-03-033 End-Stage Renal Disease Reimbursement for Automated Multi-Channel Chemistry Tests
A-03-034 Modification to Medicare Timely Filing Edit for Claims Paid Under Certain Prospective Payment Systems
A-03-035 Reporting of Revenue Codes Under the Outpatient Prospective Payment System
A-03-036 Installation of Version 30.0 of the Provider Statistical and Reimbursement Reporting System—Modification
A-03-037 Contractor Reporting of Operational and Workload Data for Electronic Data Interchange and Manual Transactions
A-03-038 Program Integrity Management Reporting System for Part A Phase 2
A-03-039 Clarification to Corrections to Updated Instruction on Receipt and Processing of Non-Covered Changes on Other Than Part A Inpatient Claims (Transmittals A-02-071, A-02-117)—Change In Effective and Implementation Date Only
A-03-040 Clarification of Bill Types 22x and 23x Submitted by Skilled Nursing Facilities
A-03-041 Health Insurance Portability and Accountability Act Version 4010A1
Institutional 837 Health Care Claim Additional Implementation Direction
A-03-042 Updated Revision to Change Request 2508, Suspension, Offset, and Recoupment of Medicare Payment to Providers and Suppliers of Services
A-03-043 Changes to Fiscal Year 2001 Nursing and Allied Health Education Payment Policies
A-03-044 Audit Guidance Pertaining To Write-Offs of Small Debit Balances in Patients' Accounts Receivable
A-03-045 Payment to Hospitals and Units Excluded From the Acute Inpatient Prospective Payment System for Direct Graduate Medical Education and Nursing and Allied Health Education for Medicare+Choice Enrollees
A-03-046 Demonstration—Settlement of Payment for Home Health Services to Beneficiaries Eligible for Both Medicare and Medicaid in Connecticut, and Massachusetts. Regional Home Health Intermediaries Only.
A-03-047 Medicare's Coordination of Benefits Contractor Shall Discontinue the Dissemination of the Right of Recovery Letter to Intermediaries
A-03-048 July Outpatient Code Editor Specifications Version (V4.2)
A-03-049 Fiscal Intermediaries Must Install and Use Super Op With the Fiscal Intermediary Standard System
A-03-050 July Medicare Outpatient Code Editor Specifications Version 18.2 for Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System
A-03-051 July 2003 Update of the Hospital Outpatient Prospective System
A-03-052 Revision to Billing for Swing-Bed Services Under the Skilled Nursing Facility Prospective Payment System
A-03-053 Nurse Practitioner Services Under Medicare Hospice
A-03-054 Revision to Change Request 2573, Transmittal A-03-013, dated February 14, 2003: 3-Day Payment Window Refinements Under the Short-Term Hospital Inpatient Prospective Payment System
A-03-055 Disclosure of Information Requirements Related to Hospice Claims
A-03-056 Payment Update for Long-Term Care Hospital Prospective Payment System Rate Year 2004
Program Memorandum Carriers    
(CMS Pub. 60B)    
(Superintendent of Documents No. HE 22.8/6-5)    
B-03-023 Correct Payment of January and February 2003 Physician Services
B-03-024 Follow-Up to Implementation of the National Council for Prescription Drug Programs Telecommunications Standard Version 5.1 and the Equivalents
Batch Standard Version 1.1 for Retail Pharmacy Drug Transactions
B-03-025 Durable Medical Equipment Regional Carriers—DeWall Posture Protector Orthotic Body Jacket (L0430)
B-03-026 Standard System Acceptance of Primary Payer Information at the Line Level
B-03-027 Implementation of Carriers Jurisdiction Manual Instructions Based on the Medicare Carriers Manual Part 3, Section 3101 for the Multi-Carrier System
Standard System and Associated Medicare Carriers
B-03-028 Durable Medical Equipment Regional Carriers—Internal Classification of Diseases—9—Classification of Diseases Coding
B-03-029 Manager Care Reasonable Charge Data Disclosure Requirements for Ambulance Services
B-03-030 Types of Services Corrections
B-03-031 Multi-Carriers System Reporting of 2003 Participating Data to the Contractor
Reporting of Operational and Workload Data System
B-03-032 Continuation of April and July 2003 Change Requests (2423 and 2524): Create Import/Export Functionality Between the Unique Provider Identification Number System and the Provider Enrollment Chain Ownership System
B-03-033 Continuation of April and July 2003 Change Requests (2425 and 2525): Create Import/Export Functionality Between the Medicare Claims System and the Provider Enrollment Chain Ownership System
B-03-034 Continuation of April and July 2003 Change Requests (2426 and 2526): Process All Medicare Part B Provider Enrollments in the Provider Enrollment Chain Ownership System. Modify the Medicare Claims System To Incorporate All Claim Payment and Provider Correspondence Functionality That Is Included in the Provider Enrollment System But Will Not Be a Part of Provider Enrollment Chain Ownership System
B-03-035 Continuation of April and July 2003 Change Requests (2427 and 2527): Process All Medicare Part B Provider Enrollments in the Provider Enrollment Chain Ownership System. Create Import/Export Functionality Between the Viable Information Processing Systems Medicare System and Provider Enrollment Chain Ownership System
B-03-036 Expansion of Beneficiary History and Claims In Process Files in the Viable Information Processing System Phase 1—Beneficiary History File Expansion
B-03-037 Excluding From Home Health Consolidated Billing Edits Claims for Therapy Services Rendered by Physicians
B-03-038 Oral Anti-Cancer Drugs
B-03-039 Common Working File Skilled Nursing Facility Consolidated Billing Bypass To Allow Separate Payment for Drugs
B-03-040 Update of the Place of Services Code Set
B-03-041 National Council for Prescription Drug Program Batch Transaction Standard 1.1 Billing Request Companion Document
B-03-042 Bi-Annual Updates to the Health Care Provider Taxonomy Code
B-03-043 Diabetes Outpatient Self-Management Training and the “Incident To” Provision
B-03-044 Correction to Business Requirements 2
B-03-045 International Classification of Diseases 9th Edition Clinical Modification Coding
Requirements for Claims Submitted to Medicare Carriers
B-03-046 Provider Education: Establishing New Requirements for ICD-9-CM Coding on Claims Submitted to Medicare Carriers—Increased Role for Physicians/Practitioners
B-03-047 Changes To Correct Coding Edits, Version 9.3, Effective October 1, 2003
B-03-048 Addition of Temporary Codes Q4052 and Q4053
B-03-049 Additional Instructions To Assist in the Implementation of Program Memorandum B-02-075—Carrier Review of Payment Amounts for Portable X-Ray Transportation Services Health Care Procedure Coding System
Program Memorandum    
Intermediaries/Carriers    
(CMS Pub. 60A/B)    
(Superintendent of Documents No. HE 22.8/6-5)    
AB-03-041 Common Working File Reject and Utilization Edits and Carriers Resolution for Consolidated Billing for Skilled Nursing Facility Residents
AB-03-042 Coverage and Billing for Percutaneous Image-Guided Breast Biopsy
AB-03-043 Addition of “K” Codes for Surgical Dressings
AB-03-044 Addition of Temporary “K” Codes
AB-03-045 Addition of Temporary “K” Codes
AB-03-046 Expanding the Number of Source Identifiers for Common Working File Medicare Secondary Payor
AB-03-047 Single Drug Pricer Clarifications
AB-03-048 End-Stage Renal Disease Coordination Period
AB-03-049 Clarification of Payment Responsibilities of Fee-for-Service Contractors as They Relate to Hospice Members Enrolled in Managed Care Organizations and Claims Processing Instructions for Processing Rejected Claims
AB-03-050 Data Center Testing and Production—Electronic Correspondence Referral System User Manual 5.1 and Quick Reference Guide Replacement
AB-03-051 Notice of Interest Rate for Medicare Overpayments and Underpayments
AB-03-052 Managing Medicare Appeals Workloads in Fiscal Year 2003
AB-03-053 Availability of Online Screens for the Laboratory National Coverage Determinations
AB-03-054 Diagnosis Code for Screening Pap Smear and Pelvic Examination Services
AB-03-055 Shared System Maintainer Hours for Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing
AB-03-056 New Waived Test—March 21, 2003
AB-03-057 Implementation of the Financial Limitation for Outpatient Rehabilitation Services
AB-03-058 Collection of Fee-for-Service Payments Made During Periods of Managed Care Enrollment
AB-03-059 Shared Systems Changes for Name Change From Health Care Financing Administration to Centers for Medicare Medicaid Services (Fiscal Intermediary Standard and VIPS Medicare System External Changes Only)
AB-03-060 Flat File Changes in the Health Care Claim Professional (837 Professional) Version 4010A1, Health Care Claim Payment/Advice (835) Version 4010 and 4010A1 and 3051.4A, and Health Care Claim Status Inquiry and Response (276/277) Version 4010A1 Transactions
AB-03-061 Program Memorandum on Written Statements of Intent To Claim Medicare Benefits
AB-03-062 New Common Working File Edits and Standard System Responses on Skilled Nursing Facility Claims
AB-03-063 New Common Working File Medicare Secondary Payer Edit to Reject Medicare Secondary Edit Records for Medicare Beneficiaries Who Are Only Entitled To Medicare Part B, and Are Covered by a Group Health Plan
AB-03-064 System Networking Electronic Correspondence Referral System User Guide
AB-03-065 Schedule Release for July Updates to Software Programs and Pricing/Coding Files
AB-03-066 Issuance of the Eligibility File-Based Standard Trading Partner Agreement for the Purpose of Coordination of Benefits
AB-03-067 Revision to Change Request 2170: Appeals Quality Improvement and Data Analysis Activities
AB-03-068 Common Working File Change for the 270/271 Eligibility Transaction
AB-03-069 Clarification of the Criteria for a Valid Written Statement of Intent To File a Medicare Claim
AB-03-070 Second Update to the 2003 Medicare Physician Fee Schedule Database
AB-03-071 July Quarterly Update for 2003 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule
AB-03-072 Mammography Computer-Aided Detection Equipment
AB-03-073 Provider Education Article: Financial Limitation of Claims for Outpatient Rehabilitation Services
AB-03-074 Instructions for Fiscal Intermediary Standard System and Multi-Carrier System Healthcare Integrated General Ledger Accounting System Changes
AB-03-075 Provider Education Article: Quarterly Provider Update
AB-03-076 Remittance Advice Message for Denial of Clinical Diagnostic Laboratory Services Denied Due to Frequency Edits
AB-03-077 Revised Disclosure Desk Reference for Call Centers
AB-03-078 Medicare Fee-for-Service Contractor Guidance of the Health Insurance Portability and Accountability Act Privacy Rule Business Associate Provisions
AB-03-079 Claims Processing Instructions for the Utah Graduate Medical Education Demonstration
AB-03-080 Single Drug Pricer Clarification for Code J7342
AB-03-081 Data Center Testing and Production—Electronic Correspondence Referral System User Manual 6.0
AB-03-082 Medicare Secondary Payer Prepayment and Postpayment Workload Reporting—Activity Code Definitions
AB-03-083 Screening of Complaints Alleging Fraud and Abuse
AB-03-084 Changes to the Laboratory National Coverage Determination Edit Software for July 1, 2003
AB-03-085 Beneficiary Notice of Implementation of Outpatient Therapy Service Limitations
AB-03-086 New Automatic Notice of Change to Medicare Secondary Payer Auxiliary File
AB-03-087 Common Working File Edits With Unsolicited Responses for Skilled Nursing Facility Consolidated Billing
AB-03-088 Prohibition on New Trading Partner Agreements With Certain Entities for the Purpose of Coordination of Benefits
AB-03-089 Coverage and Billing for Home Prothrombin Time International Normalized Ratio Monitoring for Anticoagulation Management
AB-03-090 Coverage of Compression Garments in the Treatment of Venous Stasis Ulcers
AB-03-091 Medicare Contractor Annual Update of the International Classification of Diseases, Ninth Revision, Clinical Modification
AB-03-092 Expanded Coverage of Positron Emission Tomography Scans and Related Claims Processing Requirements for Thyroid Cancer and Perfusion of the Heart Using Ammonia N-13
AB-03-093 Correction: Coverage and Billing Requirements for Electrical Stimulation for the Treatment of Wounds
Hospice Manual    
(CMS Pub. 10)    
(Superintendent of Documents No. HE 22.8/2)    
800 Screening Pap Smears and Screening Pelvic Examinations
801 Notice to Beneficiaries
Peer Review Organization Monitoring of Hospital Admission Notice to Beneficiaries
802 Frequency of Billing
803 Magnetic Resonance Angiography
804 Screening Pap Smears and Screening Pelvic Examinations
805 International Classification of Diseases 9th Edition Clinical Modification
Home Health Agency Manual    
(CMS Pub. 11)    
(Superintendent of Documents No. HE 22.8/5)    
304 Frequency of Billing
Coverage Issues Manual    
(CMS Pub. 6)    
(Superintendent of Documents No. HE 22.8/14)    
169 Stem Cell Transplantation
170 Magnetic Resonance Angiography
171 Positron Emission Tomography Scans
172 Intestinal and Multi-Visceral Transplantation
Peer Review Organization    
(CMS Pub. 19)    
(Superintendent of Documents No. 22.8/8-15)    
90 Eligibility—has been moved to the Pub. 100-10, Medicare Quality Improvement Organizations Manual, Chapter 2, which can be found at http://www.cms.hhs.gov/manuals.
Data Management—has been moved to the Pub. 100-10, Medicare Quality Improvement Organizations Manual, Chapter 8, which can be found at http://www.cms.hhs.gov/manuals.
Management—has been moved to the Pub. 100-10, Medicare Quality Improvement Organizations Manual, Chapter 13, which can be found at http://www.cms.hhs.gov/manuals.
Performance Evaluation—has been moved to the Pub. 100-10, Medicare Quality Improvement Organizations Manual, Chapter 15, which can be found at http://www.cms.hhs.gov/manuals.
Hospice Manual    
(CMS Pub. 21)    
(Superintendent of Documents No. HE 22. 8/18)    
67 Frequency of Billing
Rural Health Clinic Manual Federally Qualified Health Centers Manual    
(CMS Pub. 27)    
(Superintendent of Documents No. He 22. 8/19:985)    
38 Magnetic Resonance Angiography
Rural Dialysis Facility Manual (Non-Hospital Operated)    
(CMS Pub. 29)    
(Superintendent of Documents No. 22.8/13)    
95 Frequency of Billing
Provider Cost Reporting Forms and Instructions    
Provider Reimbursement Manual—Part 2    
Chapter 36/Form CMS-2552-96    
(CMS Pub. 15-2-36)    
(Superintendent of Documents No. HE 22.8/4)    
10 Hospital Healthcare Complex Cost Report
Program Integrity Manual    
(CMS Pub. 100-08)    
40 Local Provider Education and Training Program
41 Definitions Related To Enrollment
Benefit Integrity/Payment Safeguard Contractor vs. Provider Enrollment Contractors
Forms Disposition
Processing the Application
Identification
Adverse Legal Actions
Practice Location
Ownership and Managing Control Information (Organizations)
Ownership and Managing Control Information (Individuals)
Delegated Official
Ambulance Services Suppliers
Certified Basic Life Support
Independent Diagnostic Testing Facilities—Attachment 1
Entities That Must Enroll as Independent Diagnostic Testing Facilities
Review of Attachment 2, Independent Diagnostic Testing Facility
Enrollment Checks
Special Consideration
Reassignment of Benefits—Form CMS-855R
Reassignment of Benefits Statement
Attestation Statement
Enrolling Certified Suppliers Who Enroll With Carrier
Managed Care Organization
Application Sectional Instructions for Intermediaries
Processing the Application
Provider Identification
Adverse Legal Actions
Practice Location
Ownership and Managing Control Information (Organizations)
Chain Home Office Information
Billing Agency
Staffing Company
Capitalization Requirements for Home Health Agencies
Contact Person
Certification Statement
Delegated Official
Special Processing Situation
Community Mental Health Centers
Benefit Improvement and Protection Act of 2000 Provisions
Community Mental Health Centers Enrollment and Change of Ownership
Site Visit
Process
Deactivation of Billing Numbers for Inactive Community Mental Health Centers
State Survey Regional Office Process
Changes of Information—New Form CMS-855 Data
Change Requirement
Procedures for Request for Additional Information, Approval, Denial or Transmission of Recommendations
Request for Additional Information
Approval and Recommendations for Approval
Denials
Failure to Sign and/or Date the Application
Revocations
Time Frame for Application Processing
Matrix
Verification and Validation of Information
Fraud Investigation Database
Healthcare Integrity and Protection Data Bank
Excluded Parties List System
Enrollment of Hospitals, Assignment of Billing Numbers
Provider-Based Processing and Changes in Status
Web Site
File Maintenance and Review
42 Effectuating Favorable Final Appellate Decisions That a Beneficiary Is Confined To Home
43 Medical Records Information Reported Electronically
Electronic Media Claim Flat File Record for End-Stage Renal Disease
Argus Filed Descriptions and Formats
Managed Care Manual    
(Pub. 100-16)    
23 Introduction
General Requirements
Basic Rule
Services of Noncontracting Providers and Suppliers
Types of Benefits
Availability and Structure of Plans
Terms of Medicare+Choice Plans
Multiple Plans in One Service Area
Centers for Medicare Medicaid Services Review and Approval of Medicare+Choice Benefits
Requirements Relating To Medicare Conditions of Participation
Provider Networks
Requirements Relating To Benefits
Basic Benefits
Additional Benefits
Supplemental Benefits—Mandatory Supplemental and Optional Supplemental
Basic Versus Supplemental Benefits
Medicare Covered Benefits
Medicare+Choice Medical Savings Account Plan Benefits
General Rule
Countable Expenses
Services After the Deductible
Balance Billing
The Annual Deductible
Special Rules on Supplemental Benefits for Medicare+Choice Medical Savings Account Plans
Point of Service Option
General Rule
Accessing Plan Contracting Providers
Financial Cap
Enrollee Information and Disclosure
Prompt Payment
Point of Services Related Data
Services Area
Definition
Factors That Influence Service Area Approvals
The “County Integrity Rule”
Coordination of Benefits With Employer Group Health Plans and Medicaid
General Rule
Requirements, Rights, and Beneficiary Protection
Medicare Secondary Payer Procedures
Basic Rule
Responsibilities of the Medicare+Choice Organization
Medicare Benefits Secondary to Group Health Plans and Large Group Health Plans
Collecting From Other Entities
Collecting From Other Insurers or the Enrollee
Collecting From Group Health Plans and Large Group Health Plans
Medicare Secondary Payor
National Coverage Determinations and Legislative Changes in Benefits
Definitions
General Rules
Sources for Obtaining Information
Discrimination Against Beneficiaries Prohibited
General Prohibition
Additional Requirements
A Medicare+Choice Organization's Responsibility
Disclosure Requirements
Introduction
Disclosure Requirements at Enrollment (and Annually Thereafter)
Disclosure Upon Request
Information Pertaining to a Medicare+Choice Organization Changing Its Rules or Provider Network
Other Information That Is Disclosable
Access to (and Availability of ) Service
Introduction
Access and Availability Rule for Coordinated Care Plans
Rules for All Medicare+Choice Organizations to Ensure Continuity of Care
Ambulance, Emergency, and Urgently Needed, and Post-Stabilization Care Services Ambulance
Emergency and Urgently Needed Services
Post-Stabilization Care Services
Confidentiality and Accuracy of Enrollee Records
General Rule
Private Fee-for-Service Plans
Information on Advance Directives
Definition Basic Rule State Law Primary Content of Enrollee Information and Other Medicare+Choice Obligations Incapacitated Enrollees Community Education Requirements Medicare+Choice Organization Rights Appeal and Anti-Discrimination Rights
24 Introduction Provider Involvement in Policy-Making Physician Consultation in Medical Policies Consultation in Development of Credentialing Policies Written Information on Physician Participation Interference With Health Care Professionals' Advice to Enrollees Prohibited Provider Anti-Discrimination Provider Participation Notice of Reason for Not Granting Participation Confirmation of Eligibility for Participation in Medicare Excluded and Outpatient Physical Therapy and Opt-Out Provider Checks Credentialing, Monitoring, and Recredentialing Suspension, Termination, or Nonrenewal of Physician Contract Institutional Provider and Supplier Certification Physician Incentive Plans Requirements and Limitations Disclosure of Physician Incentive Plans Provider Indemnification of Medicare+Choice Organization Prohibited Special Rules for Services Furnished by Non-Contract Provider
25 Introduction Terminology Rules Governing Premiums and Cost Sharing Monthly Premiums Uniformity of Premiums Segmented Services Area Option
Timing of Payments Monetary Inducements Prohibited Submission of Proposed Premiums and Related Information General Rule Information Required for Coordinated Care Plans and Private Fee-For-Service Plans Average Payment Rate Centers for Medicare Medicaid Services Review Limits on Premiums and Cost-Sharing Amounts Rules for Coordinated Care Plans Rules for Medicare+Choice Private Fee-for-Service Plans Special Rules for Mid-Year (Benefit) Enhancement General Rule Incorrect Collections of Premiums and Cost Sharing Definitions Refund Methods Reduction by Centers for Medicare Medicaid Services Adjusted Community Rate Process General Information Standard Method Initial Rate Calculation Initial Rate Adjustment by Medicare+Choice Organization Initial Rate Adjustment by Centers for Medicare Medicaid Services Other Methods for Computing Adjusted Community Rate Special Rule for Centers for Medicare Medicaid Services Average Payment Rate or Adjusted Community Rate Calculation Centers for Medicare and Medicaid Services Review Sufficiency of Documentation and Periodic Audits Requirement for Additional Benefits—42 Code of Federal Regulations 422.312 Definitions General Information Stabilization Fund Establishment of a Stabilization Fund Limit Per Contract Period Exception to the Limit Per Contract Period Cumulative Limit Interest on and Accounting of Reserved Funds Withdrawal From a Stabilization Fund Criteria for Centers for Medicare Medicaid Services Approval
Basis for Denial
Form of Payment
Additional Benefits
Part B Premium Reduction As an Additional Benefit
Additional Health Care Benefits
Reduction of Charges to Enrollees for Basic Benefits
Additional Supplemental Health Care Benefits and Related Premiums
Detailed Instructions
Enrollees Who Elect Hospice While Remaining Enrolled in a Medicare+Choice Plan
Hospice Benefits
Medicare+Choice Non-Medicare-Covered Benefits
Medicare+Choice Medicare-Covered Benefits (Except Hospice)
Medicare+Choice Non-Medicare-Covered Benefits
Enrollees with End-Stage Renal Stage Disease User Fees
End-Stage Renal Disease Network Fee
Information Campaign User Fee
Waivers for Medicare+Choice Organization Contracts With Employer or Union Groups
Background
Section 617 Waiver Categories Approved
Service Areas
Adjusted Community Rate Filings
Coordination of Benefits
Effect on Medicare+Choice Plan Cash Flow
Effect on Adjusted Community Rate Calculations
Addendum IV.—Regulation Documents Published in the Federal Register Back to Top
Publication date FR vol. 68 page No. CFR parts affected File code Title of regulation
[April 2003 Through June 2003]
April 2, 2003 15973 42 CFR Part 440 CMS-2132-P Medicaid Program; Provider Qualifications for Audiologists.
April 4, 2003 16652 42 CFR Parts 422 and 489 CMS-4024-FC Medicare Program; Improvements to the Medicare+Choice Appeal and Grievance Procedures.
April 16, 2003 18654 CMS-1256-N Medicare Program; Notice of Ambulance Fee Schedule in Accordance With Federal District Court Order.
April 17, 2003 18895 45 CFR Part 160 CMS-0010-IFC Civil Money Penalties: Procedures for Investigations, Imposition of Penalties, and Hearings.
April 25, 2003 22268 42 CFR Parts 405, 412, 413, and 485 CMS-1203-CN Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2003 Rates; Correction.
April 25, 2003 22064 42 CFR Parts 420, 424, 489, and 498 CMS-6002-P Medicare Program; Requirements for Establishing and Maintaining Medicare Billing Privileges.
April 25, 2003 20394 CMS-1251-N Medicare Program; Meeting of the Practicing Physicians Advisory Council—May 19, 2003.
April 25, 2003 20393 CMS-4052-N Medicare Program: Meeting of the Advisory Panel on Medicare Education—May 21, 2003.
April 25, 2003 20391 CMS-2182-PN Medicare and Medicaid Programs; Application by the Community Health Accreditation Program (CHAP) for Continued Approval of Deeming Authority for Hospices.
April 25, 2003 20349 42 CFR Parts 422 and 489 CMS-4024-CN Medicare Program; Improvements to the Medicare+Choice Appeal and Grievance Procedures; Correction.
April 25, 2003 20347 42 CFR Part 411 CMS-1809-F3 Medicare and Medicaid Programs; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Extension of Partial Delay of Effective Date.
April 28, 2003 22453 45 CFR Part 160 CMS-0010-IFC (OFR) Correction) Civil Money Penalties: Procedures for Investigations, Imposition of Penalties, and Hearings; Correction.
May 2, 2003 23410 45 CFR Part 148 CMS-2179-FC Grants to States for Operation of Qualified High Risk Pools.
May 16, 2003 26786 42 CFR Part 412 CMS-1474-P Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for FY 2004.
May 16, 2003 26758 42 CFR Parts 409, 413, 440, and 483 CMS-1469-P Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update.
May 16, 2003 26621 CMS-4060-N Medicare Program; Town Hall Meeting on the Refinement of the Minimum Data Set (MDS), Version 3.0.
May 19, 2003 27154 42 CFR Parts 412 and 413 CMS-1470-P Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates.
May 29, 2003 32053 CMS-2185-N Fiscal Year 2003 Program Announcement; Availability of Funds and Notice Regarding Applications.
May 30, 2003 32528 CMS-2177-FN Medicare and Medicaid Programs; Approval of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for Deeming Authority for Hospices.
May 30, 2003 32527 CMS-3116-N Medicare Program; Request for Nominations for Members for the Medicare Coverage Advisory Committee.
May 30, 2003 32406 42 CFR Part 416 CMS-1885-CN Medicare Program; Update of Ambulatory Surgical Center List of Covered Procedures Effective July 1, 2003.
May 30, 2003 32400 42 CFR Parts 410, 414, and 485 CMS-1204-CN Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2003 and Inclusion of Registered Nurses in the Personnel Provision of the Critical Access Hospital Emergency Services Requirement for Frontier Areas and Remote Locations.
June 4, 2003 33579 42 CFR Parts 412 and 413 CMS-1470-P (OFR Correction) Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates.
June 4, 2003 33495 CMS-5003-N Medicare Program; Demonstration: End-Stage Renal Disease—Disease Management.
June 6, 2003 34122 42 CFR Part 412 CMS-1472-F Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Annual Payment Rate Updates and Policy Changes.
June 9, 2003 34494 42 CFR Part 412 CMS-1243-F Medicare Program; Change in Methodology for Determining Payment for Extraordinarily High-Cost Cases (Cost Outliers) Under the Acute Care Hospital Inpatient and Long-Term Care Hospital Prospective Payment Systems.
June 9, 2003 34492 42 CFR Parts 412 and 413 CMS-1470-P (OFR Correction) Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2004 Rates; Correction.
June 10, 2003 34768 42 CFR Part 413 CMS-1469-P2 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update.
June 27, 2003 38370 CMS-1259-N Medicare Program; Public Meeting in Calendar Year 2003 for New Clinical Laboratory Tests Payment Determinations.
June 27, 2003 38370 CMS-5003-N2 Medicare Program; Extension of Date of Submissions and Informational Meeting on the Application Process for the End-Stage Renal Disease—Disease Management Demonstration.
June 27, 2003 38359 CMS-9017-N Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January 2003 Through March 2003.
June 27, 2003 38346 CMS-4062-N Medicare and Medicaid Programs; Solicitation for Information on the Hospital CAHPS.
June 27, 2003 38345 CMS-1257-N Medicare Program: Notice of the Practicing Physicians Advisory Council Rechartering.
June 27, 2003 38269 CMS-6012-N6 Medicare Program; Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for Prosthetics and Certain Custom-Fabricated Orthotics; Meeting Announcement.
June 27, 2003 38206 45 CFR Part 146 CMS-2152-F Amendment to the Interim Final Regulation for Mental Health Parity.

Addendum V.—National Coverage Determinations, April 2003 Through June 2003 Back to Top

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 became effective during the quarter covered by this notice. The entries below include information concerning completed decisions as well as sections on program and decision memoranda, which also announce impending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by section of the Coverage Issues Manual (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 Back to Top
CIM section Title Issue date Effective date
[April 2003 Through June 2003]
Coverage Issues Manual (CIM) (CMS Pub. 06)      
50-14 Magnetic Resonance Angiography of the Abdomen and Pelvis 05/09/03 07/01/03
35.85.1 Implantable Automatic Defibrillators 06/06/03 10/01/03
50-36 PET for Thyroid Cancer 06/20/03 10/01/03
50-36 PET for Soft Tissue Sarcoma 06/20/03 10/01/03
50-36 PET for Alzheimer's Disease/Dementia 06/20/03 10/01/03
50-36 PET for Myocardial Perfusion of the Heart Using Ammonia N-13 06/20/03 10/01/03
PM No. Title Issue date Effective date
Program Memorandum (PM)      
AB-03-084 Changes to the Laboratory NCD Edit Software For 07/03 (Blood Counts, Blood Glucose Testing, HIV Testing) 06/06/03 07/01/03

Addendum VI.—Categorization of Food and Drug Administration-AllowedInvestigational Device Exemptions Back to Top

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, April through June 2003.

Investigational Device Exemption Numbers, 2nd Quarter 2003 Back to Top
IDE Category
G010175 B
G010354 B
G020083 B
G020115 A
G020230 B
G020231 B
G020244 B
G020273 B
G020307 B
G020319 B
G020323 B
G030001 B
G030007 B
G030034 B
G030044 B
G030045 B
G030051 B
G030054 B
G030055 B
G030056 B
G030058 B
G030061 B
G030062 B
G030063 B
G030064 B
G030065 B
G030073 B
G030074 B
G030075 B
G030078 B
G030080 B
G030082 B
G030088 B
G030089 B
G030090 B
G030091 B
G030095 B
G030096 B
G030097 B
G030101 B
G030103 B
G030104 B
G030105 A
G030106 B
G030108 B
G030109 B
G030110 B
G030113 B
G030114 B
G030115 B
G030117 B
G030118 B
G030120 B
G030122 B
G030124 B
G030126 B
G030128 B

Addendum VII.—Approval Numbers for Collections of Information Back to Top

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

OMB control Nos. Approved CFR sections in title 42, title 45, and title 20 (note: sections in title 45 are preceded by “45 CFR,” and sections in title 20 are preceded by “20 CFR”)
0938-0008 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.
0938-0034 405.821.
0938-0035 407.4.
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, 440.250, 440.220, 442.1, 442.10-442.16, 442.30, 442.40, 442.42, 442.100-442.119, 483.400-483.480, 488.332, 488.400, 498.3-498.5.
0938-0065 485.701-485.729.
0938-0074 491.1-491.11.
0938-0080 406.7, 406.13.
0938-0086 420.200-420.206 and 455.100-455.106.
0938-0101 430.3.
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 405.247.
0938-0170 493.1269-493.1285.
0938-0193 430.10-430.20 and 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.
0938-0251 406.7.
0938-0266 416.41, 416.83, 416.47, 416.48.
0938-0267 485.56, 485.58, 485.60, 485.64, 485.66, 410.65.
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 413.17.
0938-0300 431.8.
0938-0301 413.20, 413.24.
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 Subpart A.
0938-0338 486.104, 486.106, 486.110.
0938-0354 441.6.
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 and 489.21.
0938-0358 412.20-412.30.
0938-0359 412.40-412.52.
0938-0360 405.2100-405.2184.
0938-0365 484.10, .11, .12, .14, .16, .18, .20, .36, .48, .52.
0938-0372 414.33.
0938-0378 482.60-482.62.
0938-0379 418.1-418.405.
0938-0380 482.1-482.66.
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 424.2.
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 and 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 475.100 Subpart C, 475.106 and 475.107, 462.102, 462.103.
0938-0534 410.38, 424.5.
0938-0544 493.1-493.2001.
0938-0565 411.20-411.206.
0938-0566 411.404(b)(c), 411.406(d), 411.408(d)(2) and (f).
0938-0567 Part 498 Subpart H, Part 498 Subparts D and E, and 20 CFR 404.933.
0938-0573 412.256 and 412.230.
0938-0581 493.1-493.2001.
0938-0599 493.1-493.2001.
0938-0600 405.371, 405.378 and 413.20.
0938-0610 417.436, 417.801, 417.436(d), 422.128, 430.12(c)(1)(ii), 431.20, 31.107, 434.28, 483.10, 484.10(c)(ii), 489.102.
0938-0612 493.1-493.2001.
0938-0618 433.68, 433.74, 447.272.
0938-0653 493.
0938-0655 493.184.
0938-0657 405.2110, 405.2112.
0938-0658 405.2110, 405.2112.
0938-0667 482.12, 488.18, 489.20 and 489.24.
0938-0673 430.1.
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, and 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.
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, and 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 417.470, 417.126(a), 422.210(h), 422.64(10).
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 413.65, 419.42.
0938-0802 419.43.
0938-0810 482.45.
0938-0819 45 CFR 146.121.
0938-0823 420.41.
0938-0824 482.13(f)(7), 440.10(1)(3)(iii).
0938-0827 45 CFR 146.141.
0938-0829 422.568.
0938-0832 489.
0938-0833 483.350-483.376.
0938-0840 422.152(b)(2).
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, and 457.1180.
0938-0842 412 and 413.
0938-0846 411.1, 411.350-411.357 and 424.22.
0938-0857 419.
0938-0860 419.
0938-0866 45 CFR Part 162.
0938-0872 483.20, 413.337.
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. 03-24069 Filed 9-25-03; 8:45 am]

BILLING CODE 4120-03-P

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