78428 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

requires only that a laboratory follow 

manufacturer’s instructions and does 

not require routine inspections of 

waived testing. Thus, the requirements 

of the AABB are more stringent than the 

requirements of the CLIA regulations. 

We have determined that the AABB 

has complied with the requirements 

under subpart E of part 493 and that the 

requirements of the AABB are equal to 

or more stringent than the conditionlevel requirements in subparts H, J, K, 

M, Q, and R of part 493. 

Subpart H—Participation in Proficiency 

Testing for Laboratories Performing 

Nonwaived Testing 

The AABB has revised its 

requirements to be equal to or more 

stringent than the CLIA requirements at 

§ 493.801 through § 493.865. 

Subpart J—Facility Administration for 

Nonwaived Testing 

The AABB has revised its 

requirements to be equal to or more 

stringent than the CLIA requirements at 

§ 493.1100 through § 493.1105. For 

example, the AABB requires 

laboratories to retain quality assessment 

records for five years, while the CLIA 

regulations require laboratories to retain 

these records for only two years. 

Subpart K—Quality System for 

Nonwaived Testing 

The quality control (QC) requirements 

of the AABB have been evaluated 

against the requirements of the CLIA 

regulations. The AABB has modified its 

survey process and made revisions to its 

standards encompassing general QC as 

well as specialty and subspecialty QC 

requirements in order to reflect the new 

QC requirements in the CLIA 

regulations. As such, we have 

determined that the AABB’s 

requirements are equal to or more 

stringent than the requirements in the 

CLIA regulations. The specific 

requirements that are more stringent 

than the requirements of the CLIA 

regulations are the following: 

• The requirement that laboratories 

meet the AABB’s QC requirements for 

all waived testing they perform. 

• The requirement for compliance 

with standards for parentage testing. 

• The AABB’s requirement that 

laboratories that perform providerperformed microscopy procedures must 

meet the same certification 

requirements as all other laboratories 

that perform moderate complexity 

testing.

Subpart M—Personnel for Nonwaived 

Testing 

The AABB has revised its 

requirements to equal the CLIA 

requirements at § 493.1403 through 

§ 493.1495 for laboratories that perform 

moderate and high complexity testing. 

The AABB personnel standards provide 

that the laboratory must meet CLIA 

requirements for personnel 

qualifications. The CLIA requirements 

for personnel responsibilities are 

encompassed in the revisions made to 

the AABB standards. 

Subpart Q—Inspections 

We have determined that the AABB’s 

requirements for inspections are equal 

to or more stringent than the 

requirements of § 493.1771 through 

§ 493.1780 of this subpart. 

Subpart R—Enforcement Procedures 

The AABB meets the requirements of 

subpart R to the extent it applies to 

accreditation organizations. The AABB 

policy sets forth the actions the 

organization takes when laboratories it 

accredits do not comply with its 

requirements and standards for 

accreditation. When appropriate, the 

AABB will deny, suspend, or revoke 

accreditation in a laboratory accredited 

by the AABB and report that action to 

CMS within 30 days. The AABB also 

provides an appeals process for 

laboratories that have had accreditation 

denied, suspended, or revoked. 

We have determined that the AABB’s 

laboratory enforcement and appeal 

policies are equal to or more stringent 

than the requirements of this part 493 

subpart R as they apply to accreditation 

organizations. 

IV. Federal Validation Inspection and 

Continuing Oversight 

The Federal validation inspections of 

AABB accredited laboratories may be 

conducted on a representative sample 

basis or in response to substantial 

allegations of noncompliance (that is, 

complaint inspections). The outcome of 

those validation inspections, performed 

by us or our agent, or the State survey 

agency, will be our principal means for 

verifying that the laboratories accredited 

by AABB remain in compliance with 

CLIA requirements. This Federal 

monitoring is an ongoing process. 

V. Removal of Approval as an 

Accrediting Organization 

Our regulations provide that CMS 

may rescind the approval of an 

accreditation organization, such as that 

of the AABB, for cause, before the end 

of the effective date of approval. If we 

determine that the AABB failed to adopt 

requirements that are equal to, or more 

stringent than, the CLIA requirements, 

or that systemic problems exist in its 

inspection process, we may give it a 

probationary period, not to exceed one 

year, to allow the AABB to adopt 

comparable requirements. 

Should circumstances result in our 

withdrawal of the AABB’s approval, we 

will publish a notice in the Federal 

Register explaining the basis for 

removing its approval. 

In accordance with the provisions of 

Executive Order 12866, the Office of 

Management and Budget did not review 

this notice because our publication of 

this notice is not a regulatory action 

under that Executive Order.

Authority: Section 353 of the Public Health 

Service Act (42 U.S.C.263a).

Dated: November 16, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 04–28152 Filed 12–29–04; 8:45 am] 

BILLING CODE 3410–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9024–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—July 2004 Through 

September 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 July 2004 through 

September 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 

Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 78429

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 

Timothy Jennings, Office of Strategic 

Operations and Regulatory Affairs, 

Centers for Medicare & Medicaid 

Services, C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850, 

or you can call (410) 786–2134. 

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—

Æ Date published; 

Æ Federal Register citation; 

Æ Parts of the Code of Federal 

Regulations (CFR) that have changed (if 

applicable); 

Æ Agency file code number; and 

Æ 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) 

78430 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

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 National Coverage 

Determinations publication titled ‘‘Islet 

Cell Transplantation,’’ use CMS–Pub. 

100–03, Transmittal No. 18.

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance, Program No. 93.774, Medicare—

Supplementary Medical Insurance Program, 

and Program No. 93.714, Medical Assistance 

Program)

Dated: December 13, 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.

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) 

September 24, 2004 (69 FR 57312) 

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.

Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 78431

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS JULY THROUGH SEPTEMBER 2004 

Transmittal No. Manual/Subject/Publication Number 

Medicare General Information (CMS-Pub. 100–01)

08 .......................... Standard Terminology for Claims Processing Systems Standard Terminology Chart. 

09 .......................... Transmittal rescinded and replaced with Transmittal 10. 

10 .......................... Update to Medicare Deductible, Coinsurance and Premium Rates for Calendar Year 2005. 

Basis for Determining the Part A Coinsurance Amounts. 

Part B Annual Deductible. 

Medicare Benefit Policy (CMS-Pub. 100–02)

18 .......................... This revision rescinded Transmittal 12. 

19 .......................... Hospital Services Covered Under Part B Outpatient Observation Services. 

20 .......................... This revision rescinded Transmittal 17. 

21 .......................... Medicare Comprehensive Outpatient Rehabilitation Facility Coverage. 

Comprehensive Outpatient Rehabilitation Facility Services Provided by Medicare. 

Required Services. 

Optional Comprehensive Outpatient Rehabilitation Facility Services. 

Rules for Provision of Services. 

Physician’s Services. 

Physical Therapy Services. 

Occupational Therapy Services. 

Speech-Language Pathology Services. 

Respiratory Therapy Services. 

Prosthetic and Orthotic Devices and Supplies. 

Social Services. 

Psychological Services. 

Nursing Services. 

Drugs and Biologicals. 

Home Environment Evaluation. 

Outpatient Mental Health Treatment Limitation. 

22 .......................... This revision rescinded transmittal 15. 

Medicare National Coverage Determinations (CMS-Pub. 100–03)

17 .......................... Manualization of the Negotiated Clinical Diagnostic Laboratory National Coverage Determinations. 

Urine Culture, Bacterial. 

Human Immunodeficiency Virus Testing (Prognosis Including Monitoring). 

Human Immunodeficiency Virus Testing (Diagnosis). 

Blood Counts. 

Partial Thromboplastin Time. 

Prothrombin Time. 

Serum Iron Studies. 

Collagen Crosslinks, Any Method. 

Blood Glucose Testing. 

Glycated Hemoglobin/Glycated Protein. 

Thyroid Testing. 

Lipid Testing. 

Digoxin Therapeutic Drug Assay. 

Alpha-fetoprotein. 

Carcinoembryonic Antigen. 

Human Chorionic Gonadotropin. 

Tumor Antigen by Immunoassay. 

Prostate Specific Antigen. 

Gamma Glutamyl Transferase. 

Hepatitis Panel/Acute Hepatitis Panel. 

Fecal Occult Blood Test. 

18 .......................... Islet Cell Transplantation. 

Pancreas Transplants (Effective July 1, 1999). 

Islet Cell Transplantation in the Context of a Clinical Trial (Effective October 1, 2004). 

19 .......................... Blood-Derived Products for Chronic Non-Healing Wounds. 

20 .......................... Issued to a specific audience, not posted to Internet/Intranet due to sensitivity of Instruction. 

21 .......................... Magnetic Resonance Spectroscopy for Diagnosing Brain Tumors. 

Magnetic Resonance Imaging. 

Magnetic Resonance Spectroscopy. 

Magnetic Resonance Angiography. 

Medicare Claims Processing (CMS-Pub. 100–04).

222 ........................ Skilled Nursing Facility Consolidated Billing Requirements for Durable Medical Equipment Prosthetic, Orthotics & Supplies. 

Skilled Nursing Facility Consolidated Billing and Durable Medical Equipment Provided by Durable Medical Equipment Prosthetic, Orthotics & Supplies Suppliers. 

General Information. 

78432 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS JULY THROUGH SEPTEMBER 2004—Continued

Transmittal No. Manual/Subject/Publication Number 

223 ........................ Positron Emissions Tomography Scans and Related Claims Processing. 

Positron Emission Tomography Scans—General Information. 

Billing Instructions. 

Use of Gamma Cameras and Full Ring and Partial Ring Positron Emissions Scanners. 

Positron Emission Tomography Scan Qualifying Conditions and Health. 

Common Procedure Coding System Code Chart. 

Positron Emissions Tomography Scans for Imaging of the Perfusion of the Heart Using Rubidium 82. 

Expanded Coverage of Positron Emission Tomography Scans for Solitary Pulmonary Nodules. 

Expanded Coverage of Positron Emissions Tomography Scans Effective for Services on or after July 1, 1999. 

Expanded Coverage of Positron Emissions Tomography Scans Effective for Services on or after July 1, 2001. 

Expanded Coverage of Positron Emissions Tomography Scans for Breast Cancer Effective for Dates on or after October 1, 

2002. 

Coverage of Positron Emissions Tomography Scans for Myocardial Viability. 

Coverage of Positron Emissions Tomography Scans for Thyroid Cancer. 

Coverage of Positron Emissions Tomography Scans for Perfusion of the Heart Using Ammonia N–13. 

224 ........................ October Quarterly Update to 2004 Annual Update of Health Common Procedure Coding System Codes Used For Skilled 

Nursing Facility. 

Consolidated Billing Enforcement. 

225 ........................ Changes to the Laboratory National Coverage Determination Edit Software for October 2004. 

226 ........................ Quarterly Update of Health Common Procedure Coding System Codes Used for Home Health Consolidated Billing Enforcement. 

Home Health Prospective Payment System Consolidated Billing and Primary Home Health Agency. 

227 ........................ Local Medical Review Policy/Local Coverage Determination Medicare. 

Summary Notice Message Revision. 

Medical Necessity. 

Necesidad Me ́dica. 

228 ........................ General Policy. 

Patient and Insured Information. 

229 ........................ Additional Clarification of Bill Type 22x and 23x Submitted by Skilled Nursing Facilities With Instructions for Involuntarily 

Moving A Beneficiary Out of the Skilled Nursing Facility and Ending a Benefit Period. 

Skilled Nursing Facility Prospective Payment System and Consolidated Billing Overview. 

Consolidated Billing Requirements for Skilled Nursing Facility. 

Other Excluded Services Beyond the Scope of a Skilled Nursing Facility Part A Benefit. 

Outpatient Surgery and Related Procedures ‘‘Inclusions. 

Emergency Services. 

Dialysis and Dialysis Related Services to a Beneficiary With End Stage Renal Disease. 

End Stage Renal Disease Services. 

Coding Applicable to Epoetin Services. 

Coding for Darbepoetin Alfa. 

Ambulance Services. 

Screening and Preventive Services. 

Therapy Services. 

Situations that Require a Discharge or Leave of Absence. 

Billing Procedures for Periodic Interim Payment Method of Payment Ending A Benefit Period. 

Other Billing Situations. 

Billing for Outpatient Skilled Nursing Facility Services 

230 ........................ Update to the Claims Status Codes. 

Health Care Claims Status Category Codes and Health Care Claims Status Codes for Use with Health Care Claims Status 

Request and Response. 

231 ........................ Indian Health Service or Tribal Critical Access Hospital Payment Methodology for Inpatient and Outpatient Services. 

Payment for Inpatient Services Furnished by an Indian Health Service or Tribal Critical Access Hospital. 

Payment for Outpatient Services Furnished by an Indian Health Service or Tribal Critical Access Hopsital. 

232 ........................ Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. 

233 ........................ Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. 

234 ........................ Standardized Responses to Provider Inquiries Regarding the Negotiated Laboratory National Coverage Determinations Edit 

Software. 

235 ........................ Instructions for Downloading the Medicare Zip Code File. 

236 ........................ 2005 Durable Medical Equipment Prosthetic, Orthotics & Supplies Pricing. 

File Record Layout Expansion and New Pricing Procedures for Certain Durable Medical Equipment Prosthetic, Orthotics & 

Supplies Items Based on Modifiers. 

Payment of Durable Medical Equipment Prosthetic, Orhtotics & Supplies Items based on Modifiers. 

Intermediary Format for Durable Medical Equipment, Prosthetic, Orthotic and Supply Fee Schedule. 

237 ........................ Implementation of Patient Status Code 65, Discharged/Transferred to a Psychiatric Hospital or Psychiatric Distinct Part 

Unit of a Hospital. 

238 ........................ Health Insurance Portability and Accountability Act Institutional Health Care Claim Implementation Guide Additional Updates. 

239 ........................ Transmittal 239 is Rescinded and replaced with Transmittal 270. 

240 ........................ Expansion of the Existing Interrupted Stay Policy Under Long Term Care. 

Hospital Prospective Payment System. 

241 ........................ Processing Part B Claims for Indian Health Services. 

General. 

Services That May Be Paid to Indian Health Service/Tribe/Tribal Organization Facilities. 

Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 78433

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS JULY THROUGH SEPTEMBER 2004—Continued

Transmittal No. Manual/Subject/Publication Number 

Services Paid Under the Physician Fee Schedule. 

Other Part B Services. 

Durable Medical Equipment. 

Prosthetics and Orthotics. 

Prosthetics Devices. 

Surgical Dressings and Splints and Casts. 

Therapeutic Shoes. 

Drugs. 

Clinical Laboratory Services. 

Ambulance Services. 

Claims Processing. 

Claims Processing Requirements for Benefits, Improvements & Protection Act of 2000 Services. 

Claims Processing Requirements for Medicare Modernization Act Enrollment and Billing for Durable Medical Equipment, 

Prosthetic, Orthotics & Supplies. 

Claims Processing for Durable Medical Equipment, Prosthetic, Orthotics & Supplies. 

Enrollment for Durable Medical Equipment, Prosthetic, Orthotics & Supplies. 

Claims Submission for Durable Medical Equipment, Prosthetic, Orthotics & Supplies. 

Enrollment and Billing for Clinical Laboratory and Ambulance Services Claims Submission and Processing for Clinical Laboratory and Ambulance Service. 

Enrollment for Clinical Laboratory and Ambulance Services and Part B drugs. 

242 ........................ Quarterly Update to Correct Coding Initiative edits, Version 10.3, Effective October 1, 2004. 

243 ........................ Patient Status Code and Reason for Patient Visit for the Hospital Outpatient Prospective Payment System. 

Patient Status Code and Reason for Patient Visit for the Hospital. 

244 ........................ Transmittal 244 is Rescinded and Replaced with Transmittal 269. 

245 ........................ Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. 

246 ........................ Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. 

247 ........................ Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. 

248 ........................ Durable Medical Equipment Regional Carrier/Local Carriers/Statistical Analysis Durable Medical Equipment Regional Carrier—Drug Pricing Limits as of January 1, 2005. 

Payment Rules for Drugs and Biologicals. 

Medicare Modernization Act Drug Pricing-Average Sales Price. 

Single Drug Pricer. 

Calculation of the Payment Allowance Limit for Durable Medical Equipment. 

Regional Carrier Drugs. 

Calculation of the Average Wholesale Price. 

Detailed Procedures for Determining Average Wholesale Price and the Drug. 

Payment Allowance Limits. 

Background. 

Review of Sources for Medicare Covered Drugs and Biologicals. 

Use of Generics. 

Find the Strength and Dosage. 

Restrictions. 

Inherent Reasonableness for Drugs and Biologicals. 

Injection Services. 

Injections Furnished to End Stage Renal Disease Beneficiaries. 

249 ........................ New Medicare Summary Notice Message 31.18. 

Adjustments. 

Ajustes. 

250 ........................ Coordination of Benefits Agreement Claims Selection Options. 

Consolidated Claims Crossover Process. 

Consolidation of the Claims Crossover Process. 

251 ........................ Editing Of Hospital And Skilled Nursing Facility Part B Inpatient Services. 

Inpatient Part B Hospital Services. 

Editing of Hospital Part B Inpatient Services. Billing for Inpatient Skilled Nursing Facility Services Paid Under Part B. 

Editing of Skilled Nursing Facilities Part B Inpatient Services. 

252 ........................ Paper Remittance Advice format change to accommodate the forced balancing Amount to balance at the claim level as 

well as the provider level, a flat file change, and a change in the companion document for fiscal intermediaries. 

253 ........................ Fiscal Intermediary Shared System Changes to Allow for Provider Liability Days on Skilled Nursing Facility and Swing Bed 

Facility Inpatient Bills. 

Billing Skilled Nursing Facility Prospective Payment System Services. 

254 ........................ October 2004 Outpatient Prospective Payment System Code Editor Specifications Version 5.3. 

255 ........................ October Update to the Medicare Outpatient Code Editor Version 20.0 for Bills From Hospitals That Are Not Paid Under the 

Outpatient Prospective Payment System. 

256 ........................ Use of Group Health Plan Payment System/Medicare Managed Care System To Pay Capitated Payments to Chronic Care 

Improvement Organizations Serving Medicare Fee-For-Service Beneficiaries Under Section 721 of the Medicare Modernization Act. 

257 ........................ Shared Systems Changes for Medicare Part B Drugs for End Stage Renal Disease Independent Dialysis Facilities. 

258 ........................ New Waived Tests—October 1, 2004. 

259 ........................ Scheduled Release for October Updates to Software Programs and Pricing/Coding Files. 

260 ........................ Cryosurgery of the Prostate. 

Cryosurgery of the Prostate Gland. 

Coverage Requirements. 

78434 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS JULY THROUGH SEPTEMBER 2004—Continued

Transmittal No. Manual/Subject/Publication Number 

Billing Requirements. 

Payment Requirements. 

261 ........................ Billing and Requirements for Islet Cell Transplantation for Beneficiaries in a National Institutes of Health Clinical Trial. 

Billing Requirements for Islet Cell Transplantation for Beneficiaries in a National Institutes of Health Clinical Trial. 

Healthcare Common Procedural Coding System Codes for Carriers. 

Applicable Modifier for Islet Cell Transplant Claims for Carriers. 

Special Billing and Payment Requirements for Carriers. 

Special Billing and Payment Requirements for Intermediaries. 

Special Billing and Payment Requirements Medicare Advantage Beneficiaries. 

262 ........................ Confidential. 

263 ........................ Inpatient Rehabilitation Facility Annual Update: Prospective Payment System. 

Pricer Changes for Fiscal Year 2005. 

Outlier Payments: Cost-to-Charge Ratios. 

264 ........................ This Transmittal is Rescinded and Replaced with Transmittal 271. 

265 ........................ Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. 

266 ........................ Revision of Common Working File Editing for Same-Day, Same-Provider Acute Care Readmissions. 

Repeat Admissions. 

267 ........................ Crossover Patients in New Long Term Care Hospital. 

Billing Procedures for a Provider Assigned Multiple Provider Numbers or a Change in Provider Number. 

Crossover Patients in New Long Term Care Hospital. 

268 ........................ Medicare Part A Skilled Nursing Facility Prospective Payment. 

System Pricer Update Fiscal Year 2005. 

Skilled Nursing Facility Prospective Payment System Pricer Software. 

269 ........................ This Transmittal Replaces Transmittal 244. 

270 ........................ This Transmittal Replaces Transmittal 239. 

271 ........................ This Transmittal Replaces Transmittal 264. 

272 ........................ October Quarterly Update for 2004 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule. 

273 ........................ Modification of CMS’ Medicare Contingency Plan for Health Insurance Portability & Accountability Act Implementation. 

Receipt Date. 

Payment Ceiling Standards. 

Payment Floor Standards. 

Determining and Paying Interest. 

274 ........................ Good Cause Waiver of Late Claim Filing Payment Reduction Penalty. 

Extend Time for Good Cause. 

Conditions Which Establish Good Cause. 

Procedure to Establish Good Cause. 

Good Cause Is Not Found. 

Preparing Common Working File Claim Records for Services Subject to 10 Percent Payment Reduction. 

275 ........................ The Supplemental Security Income/Medicare Beneficiary Data for Fiscal Year 2003 for Inpatient Prospective Payment System Hospitals. 

276 ........................ Further Information Related to CR 3175, Distinct Part Units of Critical Access Hospitals. 

Requirements for Critical Access Hospital Services, Critical Access Hospital Skilled Nursing Care Services and Distinct 

Part Units. 

Inpatient Rehabilitation Facility Prospective Payment System. 

Billing Requirements Under Inpatient Rehabilitation Facility Prospective Payment System. 

277 ........................ Sensitive. 

278 ........................ This Transmittal is no longer sensitive and can be posted to Internet/Intranet. 

279 ........................ Issued to a specific audience, not posted to Internet/Intranet due to sensitivity of instruction. 

280 ........................ Issued to a specific audience, not posted to Internet/Intranet due to sensitivity of instruction. 

281 ........................ Issued to a specific audience, not posted to Internet/Intranet due to confidentiality of instruction. 

282 ........................ This Transmittal replaces Transmittal 274. 

283 ........................ 2005 Healthcare Common Procedure Coding System Annual Update Reminder. 

Health Care Common Procedure Coding System Annual Update Reminder. 

284 ........................ Durable Medical Equipment Regional Carriers Only—Appeals of Duplicate Claims. 

285 ........................ Addition of Physician Assistants, Nurse Practitioners and Clinical Nurse. 

Specialists as Emergency On-Call Providers for Critical Access Hospitals. 

Costs of Emergency Room On-Call Providers. 

286 ........................ Medicare Physician Fee Schedule Database 2005 File Layout. 

Addendum. 

287 ........................ Schedule for Completing the Calendar Year 2005 Fee Schedule Updates and the Participating Physician Enrollment Procedures. 

288 ........................ Fiscal Year 2005 Payment for Services Furnished in Ambulatory Surgical Centers. 

289 ........................ File Descriptions and Instructions for Retrieving the 2005 Pricing Files Through CMS’’ Mainframe Telecommunications System. 

Recurring Update Notification Containing New Pricing File Names and Retrieval Dates for 2005. 

290 ........................ October 2004 Update of the Hospital Outpatient Prospective Payment System. 

291 ........................ Use of Transmission Date in the Service Date/Assessment Date Field for Inpatient Rehabilitation Facility Prospective Payment System Claims. 

Payment Adjustment for Late Transmission of Patient Assessment Data. 

292 ........................ Confidential. 

293 ........................ Confidential. 

294 ........................ Sensitive/Controversial. 

Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 78435

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS JULY THROUGH SEPTEMBER 2004—Continued

Transmittal No. Manual/Subject/Publication Number 

295 ........................ Transmittal 214 is Rescinded and Replaced with Transmittal 295. 

296 ........................ This Transmittal replaces Transmittal 196. 

297 ........................ Reasonable Charge Update for 2005 for Splints, Casts, Dialysis Supplies, Dialysis Equipment, Therapeutic Shoes, and 

Certain Intraocular Lenses. 

298 ........................ This Transmittal replaces Transmittal 295. 

299 ........................ Use of Condition Code 44, ‘‘Inpatient Admission Changed to Outpatient’’. 

300 ........................ Payment For Outpatient End Stage Renal Disease-Related Services. 

301 ........................ Transmittal 301 Replaces Transmittal 251. 

302 ........................ Nursing Facility Visits (Codes 99301–99313). 

303 ........................ Instructions for Completion of Form CMS–1450. 

304 ........................ Transmittal 304 Replaces Transmittal 205. 

Medicare Secondary Payer (CMS-Pub. 100–05)

17 .......................... Clarification of CR 3064. 

General Policy. 

18 .......................... Application of the Medicare Secondary Payer for the Working Aged Provision and the Medicare Secondary for the Disabled Provision to Former Spouses and Certain Family Members With Coverage Under the Federal Employees Health 

Benefits Program. 

Individuals Not Subject to the Limitation on Payment. 

Individuals Not Subject to Medicare Secondary Payer Provision. 

19 .......................... Clarification of Medicare Secondary Payer Rules in Relation to a Temporary Leave of Absence. 

Rules Defining Employees Covered by Group Health Plans and Large Group Health Plans. 

Medicare Financial Management (CMS-Pub. 100–06)

49 .......................... Procedures For Re-Issuance and Stale Dating of Medicare Checks 

50 .......................... Unsolicited/Voluntary Refunds 

General Information. 

Office of Inspector General Initiatives. 

Unsolicited/Voluntary Refund Accounts. 

Receiving and Processing Unsolicited/Voluntary Refund Checks When Identifying Information Is Provided. 

51 .......................... This transmittal is rescinded and replaced with Transmittal 52. 

52 .......................... Notice of New Interest Rate for Medicare Overpayments and Underpayments. 

53 .......................... Change Request 3367, Debt Collection System, replaces Change Request 2952, Debt Collection System 

54 .......................... Notification to Providers of Intent to Complete a Post-Payment Audit. 

Contractor’s Responsibility Prior to Submission of Cost Reports. 

Medicare State Operations Manual (Pub. 100–07)

02 .......................... Provider Identification Number. 

Medicare Program Integrity (CMS-Pub. 100–08)

79 .......................... Local Medical Review Policy/Local Coverage Determination Medicare Summary. 

Notice Message Revision. 

Prepayment Edits. 

80 .......................... Program Integrity Management Fraud and Abuse Complaint Screening Revisions. Complaint Screening. 

81 .......................... Implementation of the Quarterly Strategy Analysis. 

The Quarterly Strategy Analysis. 

The Quarterly Strategy Analysis Format. 

Executive Summary. 

Problem Specific Activities. 

Problem Specific Activity Definitions. 

Narrative. 

82 .......................... Home Health Demand Bills. 

Home Health. 

Effectuating Favorable Final Appellate. 

Decisions That a Beneficiary Is ‘‘Confined to Home’’ . 

Medical Review of Home Health Demand Bills. 

83 .......................... Program Integrity Management Revisions for Chapter 4. 

Program Safeguard Contractor and Medicare Contractor Benefit Integrity Unit. 

Benefit Integrity Security Requirements. 

Medical Review for Benefit Integrity Purposes. 

Requests for Information from Outside Organizations. 

Conducting Investigations. 

Disposition of Cases. 

Types of Fraud Alerts. 

Background. 

Investigation, Case, and Suspension Entries. 

Initial Entry Requirements for Investigations. 

Referral of Cases to the Office of the Inspector General/Office of Investigations. 

78436 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS JULY THROUGH SEPTEMBER 2004—Continued

Transmittal No. Manual/Subject/Publication Number 

Suspension. 

Referral to Quality Improvement Organizations 

Exceptions. 

Medicare Contractor Beneficiary and Provider Communications (CMS-Pub. 100–09)

07 .......................... Confidential. 

Medicare Managed Care (CMS-Pub. 100–16)

56 .......................... Administrative Contracting Requirements. 

57 .......................... Coverage of Clinical Trials. 

Hospital Inpatient Data. 

Diagnostic Coding and Guidelines for Data Collection From Provider Network. 

58 .......................... Terminology. 

59 .......................... State and County Code Corrections. 

Completion of Enrollment Form. 

Passive Elections. 

Eligibility Requirements for Medicare Medical Savings Account Plans. 

Annual Elective Period. 

Open Enrollment Period. 

Open Enrollment Period Through 2005. 

Open Enrollment Period in 2006. 

Open Enrollment Period in 2007 and Beyond. 

Open Enrollment for Newly Eligible Individuals in 2006 and Beyond. 

Open Enrollment Period for Institutionalized Individuals in 2006 and Beyond. 

Special Enrollment Period for Beneficiaries Age 65. 

60 .......................... Streamlined Marketing Review Process. 

File and Use. 

Guidelines for Advertising and Pre-Enrollment Materials. 

Guidelines for Advertising Materials. 

Guidelines for Pre-Enrollment Materials. 

61 .......................... Emergency and Urgently Needed Services. 

62 .......................... Revisions to Chapter 13—Medicare+Choice Beneficiary Grievances, Organization Determinations and Appeals. 

Demonstrations (CMS-Pub. 100–19)

05 .......................... Use of Group Health Plan Payment System to Pay Capitated Payments to Non-Health Plan Demonstration/Program Sites 

Serving Medicare Fee For Service Beneficiaries—Updated List of Plan Numbers. 

06 .......................... Revision of CR 3269 for the Demonstration Project to Clarify the Definition of Homebound (Homebound Demonstration). 

One Time Notification (CMS-Pub. 100–20)

92 .......................... Additional Instructions Related to the ‘‘Redistribution of Unused Resident Positions,’’ Section 422 of the Medicare Modernization Act of 2003 P.L. 108–173, for Purposes of Graduate Medical Education Payments. 

93 .......................... Temporary Skilled Nursing Facility Extension. 

94 .......................... Shared System Maintainer Hours for Resolution of Problems Detected During Health Insurance Portability and Accountability Act. 

Transaction Release Testing. 

95 .......................... Modifications to Post-payment Adjustment Process for Home Health Prospective Payment System Claims Failing to Report 

Prior Inpatient Discharges. 

96 .......................... Annual Changes to the Amount in Controversy Thresholds For the Administrative Law Judge and Judicial Review. 

Levels of the Claim Appeals Process as Required by Section 940 of the Medicare Prescription Drug, Improvement, and 

Modernization Act of 2003. 

97 .......................... Implementation of the Business Segment Identifier in the Healthcare Integrated General Ledger Accounting System. 

98 .......................... Change to Previous Transmittal Regarding the Discounted Use of Revenue Code 0910. 

99 .......................... This One-Time Notification is a full replacement for Transmittal 86. 

100 ........................ This Transmittal is Rescinded and Replaced with Transmittal 103. 

101 ........................ Change of the Premera Blue Cross Medicare Part A Plan Under Contract to BCBSA to a Part A Fiscal Intermediary Contract with Noridian Mutual Insurance Company in the States of Washington and Alaska. 

102 ........................ Update to the Healthcare Provider Taxonomy Codes/Medicare Specialty Code Crosswalk. 

103 ........................ This Transmittal replaces Transmittal 100. 

104 ........................ Confidential. 

105 ........................ Confidential. 

106 ........................ Medicare Modernization Act Drug Pricing Update-Payment Limits for J9045 (Carboplatin Injection) and (Rituximab Cancer 

Treatment). 

107 ........................ Common Working File Analysis to Process Claims Per the Renovated Override Code Processing (re: CR3190) and Common Working File Analysis to Review System Edits for Additional 2-byte Modifiers Added in CR3190 (Phase 2). 

108 ........................ New Remark Code Message for Use With Claims for Parental Pumps-Durable Medical Equipment Regional Carrier Only. 

109 ........................ Billing Instructions for ADVATE rAHF-PFM on Medicare Claims. 

110 ........................ Medicare Modernization Act Drug Pricing Update-Payment Limits for J100 (Depo-estradiol cypionate inj). 

111 ........................ Creation of Common Working File Auxilliary File and Associated Logic to Property. 

Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 78437

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS JULY THROUGH SEPTEMBER 2004—Continued

Transmittal No. Manual/Subject/Publication Number 

Calculate Medicare-Equivalent Deductibles for Department of Veteran Affairs Claims. 

112 ........................ This Transmittal replaces Transmittal 109. 

113 ........................ Implementation of § 921 of the Medicare Modernization Act Provider Customer Program. 

114 ........................ Sensitive. 

115 ........................ Instructions for Fiscal Intermediary Standard System and Multi-Carrier System Healthcare Integrated General Ledger Accounting System Changes. 

116 ........................ Notification of Medlearn Matters Article for Confidential Change Request (CR) 3301. 

ADDENDUM IV.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER

[July 2004 Through September 2004] 

Publication date FR Vol. 69 

page No. CFR parts affected File code Title of regulation 

July 1, 2004 ............... 40288 42 CFR Part 414 ................ CMS–1492–

IFC 

Medicare Program; Medicare Ambulance MMA Temporary 

Rate Increases Beginning July 1, 2004. 

July 23, 2004 ............. 44036 ............................................. CMS–1334–

N 

Medicare Program; Public Meeting in Calendar Year 2004 

for Coding and Payment Determinations for Power 

Wheelchairs. 

July 23, 2004 ............. 44035 ............................................. CMS–1364–

N 

Medicare Program; August 30, 2004, Meeting of the Practicing Physicians Advisory Council and Request for 

Nominations. 

July 23, 2004 ............. 44034 ............................................. CMS–4074–

N 

Medicare Program; Meeting of the Advisory Panel on 

Medicare Education—September 9, 2004. 

July 23, 2004 ............. 44031 ............................................. CMS–3142–

NC 

Medicare Program; Evaluation Criteria and Standards for 

Quality Improvement Program Contracts. 

July 23, 2004 ............. 44029 ............................................. CMS–3112–

NC2

Medicare Program; Adjustment in Payment Amounts for 

New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers. 

July 23, 2004 ............. 44027 ............................................. CMS–2202–

PN 

Medicare and Medicaid Programs; Application by the 

American Association for Accreditation of Ambulatory 

Surgery Facilities, Inc., for Continued Deeming Authority 

for Ambulatory Surgical Centers. 

July 23, 2004 ............. 44013 ............................................. CMS–2187–

N 

State Children’s Health Insurance Program (SCHIP); Extended Availability of Unexpended SCHIP Funds From 

the Appropriation for Fiscal Years 1998 Through 2001; 

and Provision of Authority for Qualifying States To Use a 

Portion of SCHIP Funds for Medicaid Expenditures. 

July 23, 2004 ............. 43956 42 CFR Part 402 ................ CMS–6146–

P 

Medicare Program; Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures. 

July 23, 2004 ............. 43926 45 CFR Part 146 ................ CMS–2033–

F 

Requirements for the Group Health Insurance Market; 

Non-Federal Governmental Plans Exempt From HIPAA 

Title I Requirements. 

July 23, 2004 ............. 43924 45 CFR Part 146 ................ CMS–2152–

F2 

Amendment to the Interim Final Regulation for Mental 

Health Parity. 

July 30, 2004 ............. 45822 ............................................. CMS–4068–

N 

Medicare Program; Open Public Meeting Regarding the 

Development of the Model Guidelines for Categories and 

Classes of Drugs. 

July 30, 2004 ............. 45775 ............................................. CMS–1249–

N 

Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update. 

July 30, 2004 ............. 45721 ............................................. CMS–1360–

N 

Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Fiscal Year 2005. 

July 30, 2004 ............. 45640 42 CFR Part 484 ................ CMS–1265–

CN 

Medicare Program; Home Health Prospective Payment 

System Rate Update for Calendar Year 2005; Correction 

Notice. 

July 30, 2004 ............. 45604 42 CFR Parts 405 and 411 CMS–6014–

F 

Medicare Program; Interest Calculation. 

August 3, 2004 ........... 46866 42 CFR Parts 417 and 422 CMS–4069–

P 

Medicare Program; Establishment of the Medicare Advantage Program. 

August 3, 2004 ........... 46632 42 CFR Parts 403, 411, 

417, and 423.

CMS–4068–

P 

Medicare Program; Medicare Prescription Drug Benefit. 

August 5, 2004 ........... 47488 42 CFR Parts 405, 410, 

411, 414, 418, 424, 484, 

and 486.

CMS–1429–

P 

Medicare Program; Revisions to Payment Policies Under 

the Physician Fee Schedule for Calendar Year 2005. 

August 5, 2004 ........... 47446 ............................................. CMS–1275–

N 

Medicare Program; Meeting of the Advisory Panel on Ambulatory Payment Classification Groups—September 1, 

2, and 3, 2004. 

78438 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

ADDENDUM IV.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER—Continued

[July 2004 Through September 2004] 

Publication date FR Vol. 69 

page No. CFR parts affected File code Title of regulation 

August 11, 2004 ......... 48916 42 CFR Parts 403, 412, 

413, 418, 460, 480, 482, 

483, 485, and 489.

CMS–1428–

F 

Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2005 Rates. 

August 16, 2004 ......... 50448 42 CFR Parts 410, 411, 

419.

CMS–1427–

P 

Medicare Program; Proposed Changes to the Hospital 

Outpatient and Prospective Payment System and Calendar Year 2005 Payment Rates. 

August 27, 2004 ......... 52723 ............................................. CMS–1279–

N2 

Medicare Program; Public Meeting of the Program Advisory and Oversight Committee (PAOC) for Quality 

Standards and Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). 

August 27, 2004 ......... 52722 ............................................. CMS–3136–

N 

Medicare Program; Meeting of the Medicare Coverage Advisory Committee—September 28, 2004. 

August 27, 2004 ......... 52721 ............................................. CMS–5025–

CN 

Medicare Program; Medicare Replacement Drug Demonstration; Correction. 

August 27, 2004 ......... 52710 ............................................. CMS–1264–

N 

Medicare Program; Hospice Wage Index for Fiscal Year 

2005. 

August 27, 2004 ......... 52706 ............................................. CMS–4067–

PN 

Medicare and Medicaid Programs; Application by the Utilization Review Accreditation Commission (URAC) for 

Deeming Authority for Medicare Advantage. 

August 27, 2004 ......... 52700 ............................................. CMS–2201–

N 

State Children’s Health Insurance Program; Final Allotments to States, the District of Columbia, and U.S. Territories and Commonwealths for Fiscal Year 2005. 

August 27, 2004 ......... 52699 ............................................. CMS–1269–

N2 

Medicare Program; Second Request for Nominations for 

Two Specific Categories of Members of the Emergency 

Medical Treatment and Labor Act (EMTALA) Technical 

Advisory Group (TAG). 

August 27, 2004 ......... 52620 42 CFR Parts 431 and 457 CMS–6026–

P 

Medicaid Program and State Children’s Health Insurance 

Program (SCHIP): Payment Error Rate Measurement. 

August 27, 2004 ......... 52620 42 CFR Part 402 ................ CMS–6146–

CN 

Medicare Program; Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures. 

September 9, 2004 .... 54674 ............................................. CMS–8020–

N 

Medicare Program; Medicare Part B Monthly Actuarial 

Rates, Premium Rate, and Annual Deductible Beginning 

January 1, 2005. 

September 9, 2004 .... 54673 ............................................. CMS–8022–

N 

Medicare Program; Part A Premium for 2005 for the Uninsured Aged and for Certain Disabled Individuals Who 

Have Exhausted Other Entitlement, Thursday, September 9, 2004. 

September 9, 2004 .... 54671 ............................................. CMS–8021–

N 

Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts 

for 2005, Thursday, September 9, 2004. 

September 14, 2004 .. 55440 ............................................. CMS–6027–

N 

Medicare Program; September 30, 2004 Open Door 

Forum: Requirements for Coordination Between Plans 

Primary or Secondary to Medicare Part D Under the 

Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). 

September 16, 2004 .. 55763 42 CFR Part 414 ................ CMS–1380–

F 

Medicare Program; Manufacturer Submission of Manufacturer’s Average Sales Price (ASP) Data for Medicare 

Part B Drugs and Biologicals. 

September 24, 2004 .. 57325 ............................................. CMS–3141–

N 

Procedure for Producing Guidance Documents Describing 

Medicare’s Coverage Process. 

September 24, 2004 .. 57325 ............................................. CMS–3137–

N 

Medicare Program; Meeting of the Medicare Coverage Advisory Committee—November 4, 2004. 

September 24, 2004 .. 57324 ............................................. CMS–2200–

N4 

Medicare Program; Meeting of the State Pharmaceutical 

Assistance Transition Commission—October 14, 2004. 

September 24, 2004 .. 57312 ............................................. CMS–9023–

N 

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—April 2004 Through June 2004. 

September 24, 2004 .. 57310 ............................................. CMS–4077–

PN 

Medicare and Medicaid Programs; Application by the National Committee for Quality Assurance Preferred Provider Organization for Deeming Authority for Medicare 

Advantage. 

September 24, 2004 .. 57308 ............................................. CMS–2208–

PN 

Medicare and Medicaid Programs; Application by the 

American Osteopathic Association for Continued Approval of Deeming Authority for Hospitals. 

September 24, 2004 .. 57307 ............................................. CMS–2256–

PN 

Medicare and Medicaid Programs; Application by the Community Health Accreditation Program (CHAP) for Home 

Health Agencies. 

Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 78439

ADDENDUM IV.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER—Continued

[July 2004 Through September 2004] 

Publication date FR Vol. 69 

page No. CFR parts affected File code Title of regulation 

September 24, 2004 .. 57305 ............................................. CMS–2204–

PN 

Medicare and Medicaid Programs; Application by the Joint 

Commission on Accreditation of Healthcare Organizations (JCAHO) for Home Health Agencies. 

September 24, 2004 .. 57304 ............................................. CMS–3154–

N 

Medicare Program; Request for Nominations for Members 

for the Medicare Coverage Advisory Committee. 

September 24, 2004 .. 57244 42 CFR Parts 431 and 457 CMS–6026–

CN 

Medicaid Program and State Children’s Health Insurance 

Program (SCHIP); Payment Error Rate Measurement; 

Correction. 

September 24, 2004 .. 57226 42 CFR Part 411 ................ CMS–1810–

IFC2 

Medicare Program; Physicians’ Referrals to Health Care 

Entities With Which They Have Financial Relationships 

(Phase II); Correcting Amendment. 

September 24, 2004 .. 57224 42 CFR Part 406 ................ CMS–4018–

F 

Medicare Program; Continuation of Medicare Entitlement 

When Disability Benefit Entitlement Ends Because of 

Substantial Gainful Activity. 

September 24, 2004 .. 57859 42 CFR Part 493 ................ Laboratory Requirements; OFR Correction. 

September 30, 2004 .. 58596 42 CFR Parts 431 and 457 CMS–6026–

CN 

Medicaid Program and State Children’s Health Insurance 

Program (SCHIP); Payment Error Rate Measurement; 

OFR Correction. 

Addendum V—National Coverage 

Determinations [July 2004 Through 

September 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 website at http://

cms.hhs.gov/coverage.

NATIONAL COVERAGE DETERMINATIONS

[July 2004 Through September 2004] 

Title NCDM 

section TN# Issue date Effective date 

Manualization of Negotiated Clinical Diagnostic Laboratory NCDs ............................ N/A ........... R17NCD .. 07/02/2004 07/02/2004 

Changes to the Laboratory NCD Edit Software for October 2004 .............................. N/A ........... R225CP ... 04/09/2004 10/04/2004 

Blood-Derived Products for Chronic Non-Healing Wounds ........................................ 270.3 ....... R19NCD .. 07/30/2004 07/23/2004 

Islet Cell Transplantation ............................................................................................. 260.3.1 .... R18NCD .. 07/30/2004 10/04/2004 

MRS for Diagnosing Brain Tumors .............................................................................. 220.2.1 ..... R21NCD .. 09/10/2004 09/10/2004 

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, July 2004 

Through September 2004. 

IDE Category 

G030093 

G030237 

G040049 

G040052 

G040057 

G040091 

G040092 

G040094 

G040096 

G040098 

G040099 

G040100 

G040102 

G040103 

G040104 

G040105 

G040109 

G040111 

G040112 

G040113 

G040119 

G040122 

G040124 

G040126 

G040128 

G040129 

G040130 

G040134 

G040137 

G040142 

G040143 

G040144 

G040145 

G040146 

G040147 

G040148 

G040149 

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78440 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

G040153 

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Addendum VII–Approval Numbers for 

Collections of Information 

Below we list all approval numbers 

for collections of information in the 

referenced sections of CMS regulations 

in Title 42; Title 45, Subchapter C; and 

Title 20 of the Code of Federal 

Regulations, which have been approved 

by the Office of Management and 

Budget:

OMB control 

numbers 

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 

0938–0033 ........ 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, 440.220, 440.250, 442.1, 442.10–442.16, 442.30, 442.40, 442.42, 442.100–442.119, 483.400–483.480, 

488.332, 488.400, 498.3–498.5 

0938–0065 ........ 485.701–485.729 

0938–0074 ........ 491.1–491.11 

0938–0080 ........ 406.7, 406.13 

0938–0086 ........ 420.200–420.206, 455.100–455.106 

0938–0101 ........ 430.30 

0938–0102 ........ 413.20, 413.24 

0938–0107 ........ 413.20, 413.24 

0938–0146 ........ 431.800–431.865 

0938–0147 ........ 431.800–431.865 

0938–0151 ........ 493.1405, 493.1411, 493.1417, 493.1423, 493.1443, 493.1449, 493.1455, 493.1461, 493.1469, 493.1483, 493.1489 

0938–0155 ........ 405.2470 

0938–0170 ........ 493.1269–493.1285 

0938–0193 ........ 430.10–430.20, 440.167 

0938–0202 ........ 413.17, 413.20 

0938–0214 ........ 411.25, 489.2, 489.20 

0938–0236 ........ 413.20, 413.24 

0938–0242 ........ 488.26, 442.30 

0938–0245 ........ 407.10, 407.11 

0938–0246 ........ 431.800–431.865 

0938–0251 ........ 406.7 

0938–0266 ........ 416.41, 416.47, 416.48, 416.83 

0938–0267 ........ 410.65, 485.56, 485.58, 485.60, 485.64, 485.66 

0938–0269 ........ 412.116, 412.632, 413.64, 413.350, 484.245 

0938–0270 ........ 405.376 

0938–0272 ........ 440.180, 441.300–441.305 

0938–0273 ........ 485.701–485.729 

0938–0279 ........ 424.5 

0938–0287 ........ 447.31 

0938–0296 ........ 413.170, 413.184 

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 ........ 489.11, 489.20 

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 

0938–0358 ........ 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 

Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 78441

OMB control 

numbers 

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’’) 

0938–0444 ........ 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 Parts 401, 422E 

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 ........ 417.126, 422.502, 422.516 

0938–0470 ........ 417.143, 417.800–417.840, 422.6 

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 ........ 412.230, 412.256 

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 

0938–0667 ........ 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 ........ 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, 148.128 

0938–0714 ........ 411.370–411.389 

0938–0717 ........ 424.57 

0938–0721 ........ 410.33 

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 ........ 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 

0938–0786 ........ 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 

78442 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

OMB control 

numbers 

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’’) 

0938–0802 ........ 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 and 491 

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 ........ 411.352–411.361 

0938–0857 ........ 419 

0938–0860 ........ 419 

0938–0866 ........ 45 CFR Part 162 

0938–0872 ........ 413.337, 483.20 

0938–0873 ........ 422.152 

0938–0874 ........ 45 CFR Parts 160 and 162 

0938–0878 ........ 422 Subpart F & G 

0938–0883 ........ 45 CFR Parts 160 and 164 

0938–0884 ........ 405.940 

0938–0887 ........ 45 CFR 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 

0938–0921 ........ 414.804 

[FR Doc. 04–28156 Filed 12–29–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9026–N] 

RIN 0938–AN112 

Medicare Program; Timeline for 

Publication of Medicare Final 

Regulations After Proposed or Interim 

Final Regulations

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Notice.

SUMMARY: This notice implements 

section 902 of the Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003, which establishes a general 

3-year timeline for publishing a 

Medicare final regulation after a 

proposed regulation or an interim final 

regulation has been published. In 

accordance with the statute, this notice 

permits an extension of a published 

timeline under exceptional 

circumstances. The notice also 

establishes a transition period for 

publishing Medicare final regulations 

for previously published interim final 

regulations.

EFFECTIVE DATE: This notice is effective 

on December 30, 2004.

FOR FURTHER INFORMATION CONTACT:

Renee Swann, (410) 786–4492.

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

The general statutory authority for the 

Department to issue Medicare 

regulations is found in section 1871 of 

the Social Security Act (the Act). 

Specifically, section 1871(a)(1) of the 

Act authorizes us to publish regulations 

to administer the Medicare program. 

Section 1871(a)(2) of the Act states that, 

with the exception of national coverage 

determinations, we must publish a 

regulation ‘‘that establishes or changes a 

substantive legal standard governing the 

scope of benefits, the payment for 

services, or the eligibility of individuals, 

entities, or organizations to furnish or 

receive services or benefits* * *’’

Before issuing a final regulation, 

section 1871(b)(1) of the Act generally 

requires us to publish a proposed 

regulation that solicits comments (for at 

least 60 days) from the public. There 

are, however, several exceptions that 

permit the Secretary to issue final 

regulations or interim final regulations 

without first obtaining advance public 

comments. 

Executive Order 12866 (issued on 

September 20, 1993) requires that all 

Federal agencies prepare an agenda of 

all regulations under development or 

review, at a time and in a manner 

specified by the Administrator of the 

Office of Information and Regulatory 

Affairs, of the Office of Management and 

Budget. 

We announce in the Semi-Annual 

Unified Regulations Agenda the 

regulations we plan to publish during 

the 12-month period following 

publication of the Agenda in the 

Federal Register. The Agenda is 

generally published in April and 

October each year. 

In October 2001, to better serve all of 

our constituencies, including our health 

care providers, we began publishing 

regulations on the fourth Friday of every 

month (except when a statutory 

deadline demands otherwise), and we 

began issuing a quarterly publication 

called the Quarterly Provider Update

(QPU). The QPU is publicly available on 

the Internet and lists all of the 

regulations that we plan to publish in 

the coming quarter, as well as the 

publication date and page reference to 

all regulations published in the previous 

quarter. The QPU is published on the 

CMS web site at http://qa.cms.hhs.gov/

providerupdate/main.asp.

On December 8, 2003, the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA, Pub. 

L. 108–173) was enacted. Section 902 of 

the MMA added a new paragraph (a)(3) 

to section 1871 of the Act. New section 

1871(a)(3)(A) of the Act requires the 

Secretary, in consultation with the 

Director of the Office of Management 

and Budget, to establish a standardized 

timeline for the publication of a 

Medicare final regulation after the