[Federal Register: July 30, 2004 (Volume 69, Number 146)]
[Notices]
[Page 45822-45823]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jy04-112]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-4068-N]
Medicare Program; Open Public Meeting Regarding the Development
of the Model Guidelines for Categories and Classes of Drugs
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
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SUMMARY: This notice announces a public meeting to provide
pharmaceutical benefit managers and other interested parties, an
opportunity to provide individual comments on the Model Guidelines for
Classes and Categories of Drugs (Model Guidelines) developed by the
United States Pharmacopeia (USP). Interested parties include
beneficiaries, advocacy groups, managed care organizations, trade and
professional associations, prescription drug plans, healthcare
practitioners, providers, pharmaceutical manufacturers, and others. USP
is a nongovernmental organization, as set forth under the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).
The MMA provides for the development of Model Guidelines by USP in
consultation with pharmaceutical benefit managers and other interested
parties.
DATES: The meeting is scheduled for August 27, 2004, from 9 a.m. until
4 p.m. e.d.t. This meeting is open to the public.
ADDRESSES: The meeting will be held in Baltimore, MD at the Wyndham
Baltimore-Inner Harbor, 101 West Fayette Street. Phone: 410-752-1100.
The meeting will be organized by the United States Pharmacopeia with
support from its meeting coordinator, Conferon Inc.
FOR FURTHER INFORMATION CONTACT: Kelly Coates, United States
Pharmacopeia at 12601 Twinbrook Parkway, Rockville, MD 20852,
conferences@usp.org, (301) 816-8130.
SUPPLEMENTARY INFORMATION:
I. Background
The Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003)
establishes a new prescription drug benefit under Part D of the
Medicare Program through competing prescription drug plans. The
Secretary will approve or disapprove prescription drug plans based on
various requirements in the statute, including the requirements
specified in section 1860D-11(e)(2)(D)(i) and (ii) of the MMA. One of
the requirements is that the Secretary does not find that the design of
the plan and its benefits are likely to discourage enrollment by
certain Part D eligible individuals. The Secretary may not find that
the design of categories and classes within a formulary discourages
enrollment if the categories and classes are consistent with Model
Guidelines established by United States Pharmacopeia (USP).
In an effort to establish these guidelines, MMA requires the
Secretary to request USP to develop, in consultation with
pharmaceutical benefit managers and other interested parties, a list of
categories and classes (Model Guidelines) that may be used by
prescription drug plans and to revise the classification from time to
time to reflect changes in therapeutic uses of covered Part D drugs and
additions of new covered Part D drugs. At the request of the Secretary
and as specified in section 1860D-4(b)(3)(C)(ii) of the MMA, USP is in
the process of developing the Model Guidelines that may be used by
prescription drug plans and is seeking comments on the draft Model
Guidelines.
II. Provisions of the Notice
The purpose of this meeting is to provide information on the draft
of the Model Guidelines for Classes and Categories of Drugs to be used
in Part D plan formularies and to allow for public comment.
Meeting Format: USP Staff and the USP Medicare Model Guideline
Expert Committee (Expert Committee) will present a draft of the Model
Guidelines and the approach and methodology of establishing the Model
Guidelines. Interested persons may present data, information, or views
orally or in writing, on issues directly related to the Model
Guidelines.
[[Page 45823]]
Public Presentations: USP and the Expert Committee Members will
hear oral presentations from the public. The Expert Committee may limit
the number and duration of oral presentations to the time available. If
you wish to make a formal oral presentation, you must contact the
individual named in the FOR FURTHER INFORMATION CONTACT section of this
notice and submit the following by August 20, 2004: a brief statement
of the general nature of the comment, the name and address of proposed
individual to present, and approximate time needed for the
presentation. All presenters must submit written documentation of their
oral presentation. USP will determine the time allotments for oral
presentations based upon the number of presenters. If additional time
is available, USP and the Expert Committee will open the floor to
additional comments by attendees. An agenda for the meeting will be
posted on USP's website approximately two weeks prior to the meeting.
Public Written Comment: Comments on the draft Model Guidelines and
associated documents must be mailed to Lynn Lang, United States
Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Maryland 20852-1790,
lfl@usp.org, by September 10, 2004. Comments must clearly identify the
individual or organization submitting the comment and must be clearly
marked as ``Comments to the Draft Model Guidelines.'' Comments may be
submitted either in paper or in electronic format. USP will post all
comments on its Web page for public viewing.
Registration: Registration for this public meeting is required and
will be on a first-come, first-served basis up to the 500 person
capacity of the meeting room. There is no charge for registration. The
registration deadline will be August 20, 2004. Registration may be
accomplished by visiting http://www.usp.org/conferences or you may call United
States Pharmacopeia's meeting coordinator, Conferon Inc. at (330) 425-
9330. A confirmation notice will be sent to attendees upon finalization
of registration. Individuals who are not registered in advance will not
be guaranteed attendance due to space limitations.
Written Requests Concerning the Public Meeting: USP will accept
written questions about meeting logistics or requests for the Draft
Model Guidelines before the meeting. Written submissions must be sent
to: Kelly Coates, United States Pharmacopeia, at e-mail ktc@usp.org.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program;
and No. 93.774, Medicare--Supplementary Medical Insurance Program)
Dated: July 21, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-17237 Filed 7-29-04; 8:45 am]
BILLING CODE 4120-01-P