[Federal Register Volume 69, Number 146 (Friday, July 30, 2004)]
[Notices]
[Pages 45822-45823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17237]


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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, 
[email protected], (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, 
[email protected], 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 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 [email protected].

(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