[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Notices]
[Pages 57325-57326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21197]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3141-N]


Procedure for Producing Guidance Documents Describing Medicare's 
Coverage Process

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

ACTION: Notice.

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SUMMARY: This notice implements part of section 731 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 by 
describing a method of developing, and making available to the public, 
guidance documents under the Medicare program. The guidance documents 
would explain the factors considered in making national coverage 
determinations of whether an item or service is reasonable and 
necessary.

FOR FURTHER INFORMATION CONTACT: Vadim Lubarsky, (410) 786-0840.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 731 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 
8, 2003), requires that the Secretary make available to the public the 
factors that are considered in making national coverage determinations 
of whether an item or service is reasonable and necessary. That section 
further specifies that the Secretary develop guidance documents to 
implement section 731 of the MMA in a manner similar to the development 
of guidance documents under section 701(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 371(h)). This notice describes the method 
we are adopting to develop and make public guidance documents 
consistent with these requirements.

II. CMS Guidance Documents

    For the purposes of this notice, the term ``guidance documents'' 
means documents prepared for our staff, potential requestors of 
National Coverage Determinations (NCDs), and other interested parties 
explaining the

[[Page 57326]]

NCD process and other issues involved in making coverage 
determinations. Those documents will be specifically labeled as 
guidance documents and do not include other CMS reports, documents, 
letters, or program instructions.
    Guidance documents give the public, particularly individuals or 
organizations that might request an NCD, detailed information on 
current interpretations of the statute, the NCD process, and related 
evaluation and decision-making factors. A more precise understanding of 
these factors assists product developers and others in making decisions 
by understanding:
     The implications of making an NCD request.
     What content is necessary in an NCD request.
     Relevant timelines and their relation to the overall NCD 
process.
     What types of scientific and other information are 
considered in the process.
     How various types of evidence are evaluated for reasonable 
and necessary determinations.
    In general, guidance documents reduce uncertainty about key aspects 
of the NCD process. Guidances may be useful in certain cases to help 
plan investment strategies, research and development efforts, and 
marketing and clinical diffusion strategies.
    CMS strives to achieve consistent and fair review of NCDs. 
Guidances are an additional tool that may be used in this effort.

III. Effect of Guidance Documents

    A guidance document represents the agency's current thinking on the 
relevant subject. It is not intended to be a comprehensive description 
or analysis of all issues and factors that might affect an individual 
NCD. A guidance document is not binding on the Agency or the public. 
For example, the guidance documents will describe how we will evaluate 
different types of study designs in determining whether an item or 
service is reasonable and necessary. This does not mean the absence of 
a particular type of research will necessarily result in a noncoverage 
decision nor does submitting data from a particular type of study 
ensure coverage. Every effort will be made to describe in general terms 
the factors that are most important in making a coverage determination. 
Nonetheless, each NCD involves unique factors that cannot be described 
explicitly in the guidance documents.

IV. Development of Guidance Documents

    For all guidance documents, the public will have an opportunity to 
comment upon issuance. Usually, guidance documents will not be 
considered in effect until CMS has analyzed public input received 
during a period for public comment. In cases of immediate need or for 
minor policy changes, however, guidance documents may be made effective 
upon issuance, prior to the public comment period. Each document will 
clearly denote the appropriate addresses for hard copy and electronic 
submission of comments. We will consider changes to the documents based 
on the comments as appropriate. Comments will be taken and reviewed on 
a continuous basis.

V. Public Notification of New Guidance Documents

    We will provide notice of new guidance documents and make them 
available on the Internet at http://www.cms.hhs.gov/coverage. At 
regular intervals, we will update a list of all guidance documents in 
the Federal Register. Individuals who need assistance accessing the 
guidance documents for any reason may send an e-mail to 
[email protected].

VI. Public Input

    We will provide a list of possible topics for guidance documents 
development related to section 731 of the MMA on our Web site. We 
invite public input regarding these and other possible topics for new 
guidance documents via the public comments function available at http://www.cms.hhs.gov/coverage. While these suggestions will be given 
serious consideration, we are not required to issue every document on 
the list and are not precluded from issuing other guidance documents 
not included on the list.
    We will review existing guidance documents on a regular basis. The 
public may submit proposals for review and revision of existing 
documents on the basis that they are no longer current. A statement 
explaining why the existing document needs updating and/or revision 
must accompany each request. We will review the statement and, when 
appropriate, develop the necessary revisions in accordance with the 
procedures specified in this notice.

VII. Dissemination/Availability to the Public

    A list of all guidance documents will be maintained on the CMS 
Coverage home page. The list will include the title of each document 
and issue and revision date.

VIII. List of Proposed Guidance Documents

    We will update this list as we continue to develop guidance 
documents. The first guidance document will be the ``Revised Process 
for Making Medicare National Coverage Determinations.''

    Authority: Section 731 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003.

(Catalog of Federal Domestic Assistance Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program)

    Dated: May 4, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-21197 Filed 9-23-04; 8:45 am]
BILLING CODE 4120-01-P