[Federal Register Volume 62, Number 55 (Friday, March 21, 1997)]
[Notices]
[Pages 13659-13660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service


Notice Regarding Section 602 of the Veterans Health Care Act of 
1992--Withdrawal of Rebate Mechanism

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: Section 602 of Public Law 102-585, the ``Veterans Health Care 
Act of 1992,'' enacted section 340B of the Public Health Service Act, 
``Limitation on Prices of Drugs Purchased by Covered Entities.'' 
Section 340B

[[Page 13660]]

provides that a manufacturer who sells covered outpatient drugs to 
eligible (covered) entities must sign a pharmaceutical pricing 
agreement with the Secretary of HHS in which the manufacturer agrees to 
charge a price for covered outpatient drugs that will not exceed that 
amount determined under a statutory formula.
    The purpose of this notice is to withdraw the Federal Register 
notice entitled, ``Notice Regarding Section 602 of the Veterans Health 
Care Act of l992--Rebate Mechanism,'' published on March 14, l997. This 
notice requested comments on the proposal of a rebate process for State 
AIDS Drug Assistance Programs receiving funds under Title XXVI of the 
PHS Act.

FOR FURTHER INFORMATION CONTACT: Annette Byrne, R. Ph., Director, 
Office of Drug Pricing, Bureau of Primary Health Care, Health Resources 
and Services Administration, 4350 East West Highway, 10th Floor, 
Bethesda, MD 20814, Phone (301) 594-4353, Fax (301) 594-4982.

SUPPLEMENTARY INFORMATION: HRSA guidance for the section 340B drug 
program has described only a discount process for accessing 340B 
pricing. Although this discount system is functioning successfully for 
most covered entities, some State AIDS Drug Assistance Programs (ADAPs) 
have drug purchasing systems that have prevented their participation in 
the 340B drug program. The use of a rebate mechanism (in addition to 
the discount mechanism) should allow these groups to access 340B 
pricing.
    Because the rebate mechanism is only a part of a larger endeavor by 
HRSA to develop the 340B drug program in such a manner as to 
effectively reach all covered entities, the notice outlining the 
concept of a narrowly-focused rebate mechanism is withdrawn for further 
internal deliberation.

    Dated: March 14, 1997.
Ciro V. Sumaya,
Administrator.
[FR Doc. 97-7142 Filed 3-20-97; 8:45 am]
BILLING CODE 4160-15-P