# Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—April 2004 Through June 2004
**AGENCY:**
Centers for Medicare & Medicaid Services (CMS), HHS.
**ACTION:**
Notice.
**SUMMARY:**
This notice lists CMS manual instructions, substantive and interpretive regulations, and other *Federal Register* notices that were published from April 2004 through June 2004, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) 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.
**FOR FURTHER INFORMATION CONTACT:**
It is possible that an interested party may have a specific information need and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing information contact persons to answer general questions concerning these items. Copies are not available through the contact persons. (See Section III of this notice for how to obtain listed material.)
Questions concerning items in Addendum III may be addressed to Karen Bowman, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-5252.
Questions concerning Medicare NCDs 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 Margaret Teeters, Office of Strategic Operations and Regulatory Affairs, Regulations Development 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:**
**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, NCDs, and FDA-approved 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 NCD Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may wish to review the August 21, 1989, publication (54 FR 34555). Those interested in the revised process used in making NCDs under the Medicare program may review the September 26, 2003, publication (68 FR 55634).
To aid the reader, we have organized and divided this current listing into six addenda:
• Addendum I lists the publication dates of the most recent quarterly listings of program issuances.
• Addendum II identifies previous *Federal Register* documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda.
• Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manuals.
• Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the *Federal Register* during the quarter covered by this notice. For each item, we list the—
• Date published;
• *Federal Register* citation;
• Parts of the Code of Federal Regulations (CFR) that have changed (if applicable);
• Agency file code number; and
• Title of the regulation.
• Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCDM 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: *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' Compact Disk-Read Only Memory (CD-ROM)**
Our laws, regulations, and manuals are also available on CD-ROM and may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, and the stock number is 717-139-00000-3. The following material is on the CD-ROM disk:
• Titles XI, XVIII, and XIX of the Act.
• CMS-related regulations.
• CMS manuals and monthly revisions.
• CMS program memoranda.
The titles of the Compilation of the Social Security Laws are current as of January 1, 1999. (Updated titles of the Social Security Laws are available on the Internet at *http://www.ssa.gov/OP_Home/ssact/comp-toc.htm.* ) The remaining portions of CD-ROM are updated on a monthly basis.
Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CD-ROM. We intend to re-visit this issue in the near future and, with the aid of newer technology, we may again be able to include the appendices on CD-ROM.
Any cost report forms incorporated in the manuals are included on the CD-ROM disk as LOTUS files. LOTUS software is needed to view the reports once the files have been copied to a personal computer disk.
**IV. How To Review Listed Material**
Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the 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 publication titled “Arrangements for Physical, Occupational, and Speech Language Pathology Services,” use CMS-Pub. 100-02, Transmittal No. 09.
(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 7, 2004.
Jacquelyn Y. White,
Director, Office of Strategic Operations and Regulatory Affairs.
**Addendum I**
This addendum lists the publication dates of the most recent quarterly listings of program issuances.
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 (68 FR 55618)
December 24, 2003 (68 FR 74590)
March 26, 2004 (69 FR 15837)
June 25, 2004 (69 FR 35634)
**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.
| Transmittal No. | Manual/subject/publication No. |
| --- | --- |
| | |
| 04 | Scheduled Release for April Updates to Software and Pricing/Codes Files. |
| 05 | Release of Software. |
| 06 | Shared System Maintainer and Medicare Contractor Responsibilities for System Release. |
| | Testing Standards Applicable to All Beta Testers. |
| 07 | The Health Insurance Portability and Accountability Act Privacy Rule. |
| | |
| 09 | Arrangements for Physical, Occupational, and Speech Language Pathology Services. |
| 10 | Chapter 6. |
| 11 | Nurse Practitioner as Attending Physician in Hospice. |
| | Nursing Care. |
| 12 | New Requirements for Chiropractic Billing of Active/Corrective Treatment and Maintenance Therapy. |
| 13 | Diabetes Self-Management Training Services. |
| | Incident-To Provision. |
| 14 | Changes in the Medicare Benefit Policy Manual—Chapter 10. |
| 15 | Chapter 9. |
| | Nursing Care. |
| 16 | Confidential. |
| 17 | Incident-To Services on Form CMS-1500. |
| | |
| 09 | NCD—Ocular Photodynamic Therapy with Verteporfin for Age-Related Macular Degeneration. |
| 10 | Chapter 1—NCD Manual. |
| 11 | Reconsideration of NCD for Acupuncture. |
| 11 | Acupuncture for Fibromyalgia. |
| 13 | Removal of Coding From NCD on Stem Cell Transplantation. |
| 14 | NCD—Arthroscopic Lavage and Arthroscopic Debridement for the Osteoarthritic Knee. |
| 15 | Reconsideration of NCD for Sensory Nerve Conduction Threshold Test (Note that Change Request CR 3339 constitutes a technical correction to previously issued CR 2988 dated 03/19/04. CR 2988 should be discarded and replaced with 3339). |
| | Sensory Nerve Conduction Threshold Test. |
| 16 | Internal Reconsideration of NCD for Cardiac Pacemakers. |
| | |
| 212 | Confidential. |
| 213 | Payment To Be Sent to the Bank Similar Financial Institution in the Name of a Provider. |
| 214 | MSN Message. |
| 215 | Implementation of Skilled Nursing Facility Consolidated Billing Common. |
| 216 | Chapter 32. |
| | Intermediary Payment Requirements. |
| | Healthcare Common Procedure Coding System for Intermediaries. |
| 217 | CR 3318, Full Replacement of CR3223, Implementation of the Analysis and Design Phases of the Physician Scarcity Bonus. CR 3318 rescinds CR 3223. |
| | Claims Coding Requirements. |
| 218 | Implementation of the Analysis and Design Phases of the Revision to the Health Professional Shortage Area Bonus Payment. |
| | Remittance Messages. |
| 219 | This CR fully replaces CR 3215, Implementation of the Analysis and Design Phases of the Revision to the Health Professional Shortage Area Bonus Payment. |
| 220 | Implementation of Section 414 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. |
| | General. |
| 221 | Medicare Inpatient Rehabilitation Facilities Classification Requirements. |
| | Verification Process To Be Used To Determine if the Inpatient Rehabilitation Facility Met the Classification Criteria. |
| | Retroactive Adjustments for Provisionally Excluded Inpatient Rehabilitation Facilities or Beds. |
| | |
| 14 | MSP Manual Update CR 2074. |
| 15 | Change in Interest Calculation for Medicare Overpayment and Underpayments. |
| 16 | Update Medicare Secondary Payer Group Health Recovery Demand Letters to Employers and Insurers for Data Match and Non-Data Match Debts. |
| | |
| 38 | Consolidation of Claims Crossover—Small Scale Initial Implementation. |
| 39 | Installation of Version 34.0 of the Provider Statistical and Reimbursement (PS&R) Reporting System. |
| 40 | Modification of Contractor Reporting of Operational and Workload Data Form 5. |
| 41 | Change in Interest Calculation for Medicare Overpayments and Underpayments and Medicare Secondary Payer Recoveries. |
| 42 | Unsolicited/Voluntary Refunds. |
| | Handling Checks or Associated Correspondence With Conditional Endorsements. |
| 43 | Expanded Identification and Workload Reporting for CMS Medicare System. |
| | General Information. |
| 44 | Notices of New Interest Rate for Medicare Overpayments and Underpayments CR 2830. |
| 45 | Addition of Instructions for Form CMS-2591 to Chapter 6. |
| | A—Intermediary Appeal Request. |
| 46 | Installation of Version 33.0 of the Provider Statistical and Reimbursement Reporting System-Modification of CR 3131. |
| 47 | Expanded Identification and Workload Reporting for CMS Medicare Systems. |
| | Structure of the Workload Identifier. |
| 48 | This transmittal is rescinded and Replaced With Transmittal 50, dated July 30, 2004. |
| | |
| 1 | Release of Basic Manual. |
| | |
| 770 | New Requirements for Self-Administered Drug Exclusion List Articles in the Medicare Coverage Database Articles. |
| 71 | Program Integrity Manual Revisions 72 Automated Prepayment Review. |
| 73 | Program Integrity Management Reporting System Section 7.2 of the Program Integrity Manual. |
| 74 | Skilled Nursing Facility Certification and Recertification. |
| 75 | Informing Beneficiaries About Which Local Medical Review Policy and /or Local Coverage Determination and /or National Coverage Determination Is Associated with Their Claim Denial. |
| 76 | Clarification of Complex Medical Review. |
| 77 | Instructions for Carriers, DMERCs, FIs, and Full PSCs When Interacting With the Comprehensive Error Rate Testing (CERT) Contractor (
Handling Appeals of CERT-Initiated Denials, Contracting Non-Responders, Tracking Over/Underpayments). |
| | Affiliated Contractor Full PSC Communication With the CERT Contractor. |
| | Tracking Overpayments. |
| | LMRP/NCD. |
| | Types of Referral of Non-Responding Providers. |
| 78 | Medical Review Progressive Corrective Action for Part A. |
| | |
| 05 | Manual Instruction for Updated Beneficiary Services Sections 5104 and 2958, and Beneficiary Services Section 20 of the Internet-Only Manual. |
| | Customer Service Assessment and Management System Reporting Requirements. |
| | Second Level Screening of Provider Inquiries (Miscellaneous Code 13201/01). |
| | Local Medical Review Policy Local Coverage Determination Requests. |
| 06 | Provider/Supplier Communications—Revisions and Additions to Existing Contractor Requirements. |
| | Call Handling Requirements. |
| | Next Generation Desktop. |
| | |
| 48 | Grievances, Organization Determinations, and Appeals. |
| 49 | Chapter 4—Benefits and Beneficiary Protections. |
| 50 | Chapter 20—Plan Communications Guide. |
| 51 | Revisions to Chapter 2—Medicare+Choice Enrollment and Disenrollment. |
| 52 | Chapter 17a and 17b. |
| 53 | Chapter 11—Revisions. |
| 54 | Chapter 19—Revisions. |
| 55 | Chapter 10, Organization Compliance With State Law and Preemption by Federal Law. |
| | |
| 67 | Transmittal 67, Dated April 2, 2004, Was Rescinded and Replaced With Transmittal 81 dated May 14, 2004. |
| 68 | Transmittal 49 Implementation Data Extension. |
| 69 | Carrier Only Shared System Maintainer Hours for Resolution of Problems Detected as a Result of Implementation of CR 2525 and CR 2527. |
| 70 | How Fiscal Intermediaries Are To Record Coinsurance Amounts From the Provider. |
| 71 | Update to the Healthcare Provider Taxonomy Codes Version 4.0. |
| 72 | Pub. 100-20, Transmittal 72, dated April 16, 2004, Is Rescinded and Replaced With Pub. 100-20, Transmittal 82 Dated May 14, 2004. |
| 73 | Revised American National Standards Institute X12N 837 Professional Health Care Claims Companion Document. |
| 74 | Emergency Correction Regarding Correction to Healthcare Common Procedure. |
| 75 | One Time Instructions for Audit Intermediary Cost Reporting Processes To Accommodate Claims Processing Error That Prevented Some Supply Charges From Being Reported on Home Health Prospective Payment System Claim. |
| 76 | Shared System Maintainer Hours for Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing. |
| 77 | Instructions Related to Redistribution of Unused Resident Positions, Section 422 of the Modernization Act of 2003 (MMA), P.L. 108-173, for Purposes of Graduate Medical Education Payment. |
| 78 | Renovate Override Code Processing in Common Working File. |
| 79 | 18-Month Moratorium on Physician Self-Referrals to Specialty Hospitals; Processing of Form CMS-855A Applications To Become a Medicare Certified Hospital. |
| 80 | Medicare System Acceptance of New Provider Numbers for Home Health Agencies. |
| 81 | Requirement for Carriers, Durable Medical Equipment Regional Carriers, Fiscal Intermediaries, and Full Program Safeguard Contractors To Encourage Providers To Submit Medical Records to the Comprehensive Error Rate Testing Contractor for Use in the November 2004 Improper Medicare Fee-For-Service Payment Report. |
| 82 | This OTN Replaces Pub. 100-20, Transmittal 72, dated April 16, 2004. |
| 83 | Additional Health Insurance Health Insurance Portability and Accountability Act Coordination of Benefits Information for Trading Partners. |
| 84 | Reporting Medicare Secondary Payer Information on the Health Insurance Portability and Accountability Act of 1996 X12N 837 Created via Free Billing Software. |
| 85 | CD-ROM Initiative for Distribution of the Annual Disclosure, Dear Doctor Letter and Participation Enrollment Material. |
| 86 | Interface File From Recovery Management and Accounting System. |
| 87 | Instructions Related to Redistribution of Unused Resident Positions, Section 422 of the Medicare Modernization Act of 2003, P.L. 108-173, for Purpose of Graduate Medical Education Payments. |
| 88 | Clarification and Revision of Change Request 3084, Implementation of Section 508 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, (Public Law 108-173). |
| 89 | Shared System Maintainer Hours for Resolution of Problems Detected As a Result of Implementation of CR 2525 and CR 2527. |
| 90 | MMA Drug Pricing Update-Payment Limits for J7308 (Levulan Kerastick) and J9395 (Faslodex). |
| Publication | FR Vol. | CFR parts | File code | Title of regulation |
| --- | --- | --- | --- | --- |
| April 6, 2004 | 17935 | 42 CFR part 414 | CMS-1380-IFC | Medicare Program; Manufacturer Submission of Manufacturer's Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals. |
| April 6, 2004 | 17933 | 42 CFR parts 411 and 424 | CMS-1810-CN | Medicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase II); Correction. |
| April 23, 2004 | 22083 | | CMS-1363-N | Medicare Program; Meeting of the Practicing Physicians Advisory Council. |
| April 23, 2004 | 22081 | | CMS-4071-N2 | Medicare Program; Listening Sessions on Performance Measures for Public Reporting on the Quality of Hospital Care During April, May, and June 2004. |
| April 23, 2004 | 22080 | | CMS-4066-N | Medicare Program; Meeting of the Advisory Panel on Medicare Education—May 11, 2004, Friday, April 23, 2004. |
| April 23, 2004 | 22079 | | CMS-1273-N | Medicare Program; Public Meetings in Calendar Year 2004 for New Durable Medical Equipment Coding and Payment Determinations. |
| April 23, 2004 | 22065 | | CMS-5004-N | Medicare Program; Voluntary Chronic Care Improvement Under Traditional Fee-for-Service Medicare. |
| April 23, 2004 | 21963 | 42 CFR part 424 | CMS-1185-F | Medicare Program; Elimination of Statement of Intent Procedures for Filing Medicare Claims. |
| May 7, 2004 | 25752 | 42 CFR part 412 | CMS-1262-F | Medicare Program; Changes to the Criteria for Being Classified as an Inpatient Rehabilitation Facility. |
| May 7, 2004 | 25674 | 42 CFR part 412 | CMS-126-F | Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Annual Payment Rate Updates and Policy Changes, Part II. |
| May 18, 2004 | 28196 | 42 CFR parts 403, 412, 413, 418, 460, 480, 482, 483, 485, and 489 | CMS-1428-P | Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2005 Rates, Part II. |
| May 18, 2004 | 28133 | | CMS-2189-N | Medicaid Program; Real Choice Systems Change Grants. |
| May 28, 2004 | 30660 | | CMS-3130-N | Medicare Program; Meeting of the Medicare Coverage Advisory Committee—July 14, 2004. |
| May 28, 2004 | 30659 | | CMS-4069-N | Medicare Program; Open Public Meeting To Discuss Definitions of Regions for Regional Medicare Preferred Provider Organizations and Prescription Drug Plans Under the Medicare Modernization Act—July 21, 2004. |
| May 28, 2004 | 30658 | | CMS-1266-N | Medicare Program; Public Meeting in Calendar Year 2004 for New Clinical Laboratory Tests Payment Determinations. |
| May 28, 2004 | 30656 | | CMS-2195-N | Medicaid Program; Demonstration To Improve the Direct Service Community Workforce. |
| May 28, 2004 | 30654 | | CMS-1269-N | Medicare Program; Establishment of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG) and Request for Nominations for Members. |
| May 28, 2004 | 30580 | 42 CFR part 440 | CMS-2132-F | Medicaid Program; Provider Qualifications for Audiologists. |
| June 2, 2004 | 31248 | 42 CFR part 484 | CMS-1265-P | Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2005, Part IV. |
| June 2, 2004 | 31125 | | CMS-1279-N | Medicare Program; Request for Nominations for the Program Advisory Oversight Committee for the Competitive Acquisition of Durable Medical Equipment and Other Items. |
| June 2, 2004 | 31123 | | CMS-5033-N | Medicare Program; Establishment of the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End Stage Renal Disease Services and Request for Nominations for Members. |
| June 18, 2004 | 34169 | | CMS-2200-N3 | Medicare Program; Meeting of the State Pharmaceutical Assistance Transition Commission—July 7, 2004. |
| June 22, 2004 | 34585 | 42 CFR part 412 | OFR-generated correction | Prospective Payment Systems for Inpatient Hospital Services—OFR Correction. |
| June 25, 2004 | 35920 | 42 CFR parts 403, 412, 413, 418, 460, 480, 482, 483, 485, and 489 | CMS-1428-CN | Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2005 Rates; Correction, Part V. |
| June 25, 2004 | 35716 | 42 CFR parts 405, 413, and 417 | CMS-1727-P | Medicare Program; Provider Reimbursement Determinations and Appeals, Part II. |
| June 25, 2004 | 35650 | | CMS-3134-N | Medicare Program; Town Hall Meeting on Potential Facility Qualifications for Expanded Coverage of Percutaneous Transluminal Angioplasty for Carotid Stenting Procedures |
| June 25, 2004 | 35634 | | CMS-9022-N | Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January 2004 Through March 2004. |
| June 25, 2004 | 35634 | | CMS-2189-CN | Medicaid Program; Real Choice Systems Change Grants; Correction Notice. |
| June 25, 2004 | 35529 | 42 CFR part 411 | CMS-1809-F5 | Medicare and Medicaid Programs; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Extension of Partial Delay of Effective Date. |
| June 25, 2004 | 35529 | 42 CFR part 409 | CMS-1469-F2 | Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Correcting Amendment. |
| June 25, 20043 | 35527 | 42 CFR parts 405 and 414 | CMS-1372-CN2 | Medicare Program; Changes to Medicare Payment for Drugs and Physician Fee Schedule Payments for Calendar Year 2004: Correction. |
| June 29, 2004 | 38898 | | CMS-5025-N | Medicare Program; Medicare Replacement Drug Demonstration. |
**Addendum V—National Coverage Determinations**
**[April 2004 Through June 2004]**
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 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* .
| Pub. 100-03 NCDM | Title | Issue Date | Effective Date |
| --- | --- | --- | --- |
| 80.2 | Ocular Photodynamic Therapy With Verteporfin for Age-Related Macular Degeneration | 4/01/04 | 4/01/04 |
| 30.3 | Acupuncture for Fibromyalgia | 4/16/04 | 4/16/04 |
| 30.3 | Acupuncture for Osteoarthritis | 4/16/04 | 4/16/04 |
| 110.8.1 | Stem Cell Transplantation | 5/28/04 | 7/06/04 |
| 150.9 | Arthroscopic Lavage and Arthroscopic Debridement for the Osteoarthritic Knee | 6/10/04 | 7/11/04 |
| 160.23 | Sensory Nerve Conduction Threshold Tests | 6/18/04 | 4/01/04 |
| 20.8 | Cardiac Pacemakers | 6/25/04 | 4/30/04 |
**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 non-experimental 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 2nd quarter, April 2004 through June 2004.
| IDE | Category |
| --- | --- |
| G010048 | B |
| G030067 | B |
| G030123 | B |
| G030163 | B |
| G030242 | B |
| G030251 | B |
| G040003 | B |
| G040004 | B |
| G040011 | B |
| G040036 | B |
| G040038 | B |
| G040050 | B |
| G040053 | B |
| G040054 | B |
| G040055 | B |
| G040056 | B |
| G040058 | B |
| G040059 | B |
| G040060 | B |
| G040061 | B |
| G040062 | B |
| G040066 | B |
| G040067 | B |
| G040068 | B |
| G040069 | B |
| G040075 | B |
| G040076 | B |
| G040077 | B |
| G040078 | B |
| G040079 | B |
| G040080 | B |
| G040083 | B |
| G040085 | B |
| G040087 | B |
| G040089 | B |
| G040093 | B |
| G040106 | B |
**Addendum VII.—Approval Numbers for Collections of Information**
Below we list all approval numbers for collections of information in the referenced sections of CMS regulations in title 42; title 45, subchapter C; and title 20 of the Code of Federal Regulations, which have been approved by the Office of Management and Budget:
| OMB No. | Approved CFR sections |
| --- | --- |
| 0938-0008 | 414.40, 424.32, 424.44. |
| 0938-0022 | 413.20, 413.24, 413.106. |
| 0938-0023 | 424.103. |
| 0938-0025 | 406.28, 407.27. |
| 0938-0027 | 486.100-486.110. |
| 0938-0033 | 405.807. |
| 0938-0035 | 407.40. |
| 0938-0037 | 413.20, 413.24. |
| 0938-0041 | 408.6, 408.22. |
| 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, 455.100-455.106. |
| 0938-0101 | 430.30. |
| 0938-0102 | 413.20, 413.24. |
| 0938-0107 | 413.20, 413.24. |
| 0938-0146 | 431.800-431.865. |
| 0938-0147 | 431.800-431.865. |
| 0938-0151 | 493.1405, 493.1411, 493.1417, 493.1423, 493.1443, 493.1449, 493.1455, 493.1461, 493.1469, 493.1483, 493.1489. |
| 0938-0155 | 405.2470. |
| 0938-0170 | 493.1269-493.1285. |
| 0938-0193 | 430.10-430.20, 440.167. |
| 0938-0202 | 413.17, 413.20. |
| 0938-0214 | 411.25, 489.2, 489.20. |
| 0938-0236 | 413.20, 413.24. |
| 0938-0242 | 488.26, 442.30. |
| 0938-0245 | 407.10, 407.11. |
| 0938-0246 | 431.800-431.865. |
| 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 | 413.170, 413.184. |
| 0938-0300 | 431.800. |
| 0938-0301 | 413.20, 413.24. |
| 0938-0302 | 418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.74, 418.83, 418.96, 418.100. |
| 0938-0313 | 418.1-418.405. |
| 0938-0328 | 482.12, 482.13, 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. |
| 0938-0334 | 491.9, 491.10. |
| 0938-0338 | 486.104, 486.106, 486.110. |
| 0938-0354 | 441.60. |
| 0938-0355 | 488.26, 442.30. |
| 0938-0357 | 409.40-409.50, 410.36, 410.170, 411.4-411.15, 421.100, 424.22, 484.18, 489.21. |
| 0938-0358 | 412.20-412.30. |
| 0938-0359 | 412.40-412.52. |
| 0938-0360 | 488.60. |
| 0938-0365 | 484.10, 484.11, 484.12, 484.14, 484.16, 484.18, 484.20, 484.36, 484.48, 484.52. |
| 0938-0372 | 414.330. |
| 0938-0378 | 482.60-482.62. |
| 0938-0379 | 488.26, 442.30. |
| 0938-0382 | 488.26, 442.30. |
| 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. |
| 0938-0448 | 405.2133, 45 CFR 5, 5b; 20 CFR part 401 and part 422, subpart E. |
| 0938-0449 | 440.180, 441.300-441.310. |
| 0938-0454 | 424.20. |
| 0938-0456 | 412.105. |
| 0938-0463 | 413.20, 413.24, 413.106. |
| 0938-0467 | 431.17, 431.306, 435.910, 435.920, 435.940-435.960. |
| 0938-0469 | 417.107, 417.478. |
| 0938-0470 | 417.143, 422.6, 417.800-417.840. |
| 0938-0477 | 412.92. |
| 0938-0484 | 424.123. |
| 0938-0501 | 406.15. |
| 0938-0502 | 433.138. |
| 0938-0512 | 486.304, 486.306, 486.307. |
| 0938-0526 | 475.102, 475.103, 475.104, 475.105, 475.106. |
| 0938-0534 | 410.38, 424.5. |
| 0938-0544 | 493.1-493.2001. |
| 0938-0564 | 411.32. |
| 0938-0565 | 411.20-411.206. |
| 0938-0566 | 411.404, 411.406, 411.408. |
| 0938-0573 | 412.256, 412.230. |
| 0938-0578 | 447.534. |
| 0938-0581 | 493.1-493.2001. |
| 0938-0599 | 493.1-493.2001. |
| 0938-0600 | 405.371, 405.378, 413.20. |
| 0938-0610 | 417.436, 417.801, 422.128, 430.12, 431.20, 431.107, 434.28, 483.10, 484.10, 489.102. |
| 0938-0612 | 493.801, 493.803, 493.1232, 493.1233, 493.1234, 493.1235, 493.1236, 493.1239, 493.1241, 493.1242, 493.1249, 493.1251, 493.1252, 493.1253, 493.1254, 493.1255, 493.1256, 493.1261, 493.1262, 493.1263, 493.1269, 493.1273, 493.1274, 493.1278, 493.1283, 493.1289, 493.1291, 493.1299. |
| 0938-0618 | 433.68, 433.74, 447.272. |
| 0938-0653 | 493.1771, 493.1773, 493.1777. |
| 0938-0657 | 405.2110, 405.2112. |
| 0938-0658 | 405.2110, 405.2112. |
| 0938-0659 | 456.700, 456.705, 456.709, 456.711, 456.712. |
| 0938-0667 | 482.12, 488.18, 489.20, 489.24. |
| 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 | 486.304, 486.306, 486.307, 486.310, 486.316, 486.318, 486.325. |
| 0938-0690 | 488.4-488.9, 488.201. |
| 0938-0691 | 412.106. |
| 0938-0692 | 466.78, 489.20, 489.27. |
| 0938-0701 | 422.152. |
| 0938-0702 | 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, 146.180. |
| 0938-0703 | 148.120, 148.124, 148.126, 148.128. |
| 0938-0713 | 441.16, 489.66, 489.67. |
| 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 | 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 | 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, 422.560-422.622. |
| 0938-0770 | 410.2. |
| 0938-0778 | 422.111, 422.64. |
| 0938-0779 | 417.470, 417.126, 422.210, 422.64. |
| 0938-0781 | 411.404-411.406, 484.10. |
| 0938-0783 | 422.66, 422.562, 422.564, 422.568, 422.570, 422.572, 422.582, 422.584, 422.586, 422.590, 422.594, 422.602, 422.612, 422.618, 422.619, 422.620, 422.622. |
| 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 | 491.8, 491.11. |
| 0938-0798 | 413.24, 413.65, 419.42. |
| 0938-0802 | 419.43. |
| 0938-0818 | 410.141, 410.142, 410.143, 410.144, 410.145, 410.146, 414.63. |
| 0938-0829 | 422.568. |
| 0938-0832 | 489. |
| 0938-0833 | 483.350-483.376. |
| 0938-0841 | 431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560, 457.570, 457.740, 457.750, 457.810, 457.940, 457.945, 457.965, 457.985, 457.1005, 457.1015, 457.1180. |
| 0938-0842 | 412.23, 412.604, 412.606, 412.608, 412.610, 412.614, 412.618, 412.626, 413.64. |
| 0938-0846 | 411.1, 411.350-411.357, 424.22. |
| 0938-0857 | 419. |
| 0938-0860 | 419. |
| 0938-0866 | part 162. |
| 0938-0872 | 483.20, 413.337. |
| 0938-0873 | 422.152. |
| 0938-0874 | parts 160 and 162. |
| 0938-0878 | Part 422 subparts F and G. |
| 0938-0883 | parts 160 and 164. |
| 0938-0884 | 405.940. |
| 0938-0887 | 148.316, 148.318, 148.320. |
| 0938-0897 | 412.22, 412.533. |
| 0938-0907 | 412.230, 412.304, 413.65. |
| 0938-0910 | 422.624, 422.626, 422.620. |
| 0938-0911 | 426.400, 426.500. |
| 0938-0916 | 483.16. |
| 0938-0920 | 438.6, 438.8, 438.10, 438.12, 438.50, 438.56, 438.102, 438.114, 438.202, 438.206, 438.207, 438.240, 438.242, 438.402, 438.404, 438.406, 438.408, 438.410, 438.414, 438.416, 438.710, 438.722, 438.724, 438.810. |