[Federal Register: September 24, 2004 (Volume 69, Number 185)]
[Notices]
[Page 57325-57326]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se04-78]
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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
CAGInquiries@cms.hhs.gov.
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