[Federal Register Volume 62, Number 168 (Friday, August 29, 1997)]
[Notices]
[Pages 45823-45824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23019]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice Regarding Section 602 of the Veterans Health Care Act of
1992 Rebate Option
AGENCY: Health Resources and Services Administration.
ACTION: Notice.
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SUMMARY: Section 602 of Pub. L. 102-585, the ``Veterans Health Care Act
of 1992,'' enacted section 340B of the Public Health Service (PHS) Act,
``Limitation on Prices of Drugs Purchased by Covered Entities.''
Section 340B provides that a manufacturer who sells covered outpatient
drugs to eligible 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 request comments on the proposal
of a rebate option for State AIDS Drug Assistance Programs (ADAPs)
receiving funds under Title XXVI of the PHS Act.
DATES: The public is invited to submit comments on the proposed rebate
[[Page 45824]]
process by September 29, 1997. After consideration of comments
submitted, the Secretary will issue the final guideline.
ADDRESSES: Comments should be submitted to: Annette Byrne, R. Ph.,
M.S., Director, Office of Drug Pricing, Bureau of Primary Health Care,
Health Resources and Services Administration, 4350 East-West Highway,
Bethesda, MD 20814, Phone (301) 594-4353; FAX (301) 594-4982.
FOR FURTHER INFORMATION CONTACT: Robert Staley, R. Ph., Senior Program
Manager, Office of Drug Pricing, Bureau of Primary Health Care, Health
Resources and Services Administration, 4350 East-West Highway,
Bethesda, MD 20814, Phone (301) 594-4353; Fax (301) 594-4982.
SUPPLEMENTARY INFORMATION: Section 340B requires manufacturers, as a
condition for the receipt of Medicaid matching funds with respect to
their covered outpatient drugs, to charge participating entities no
more than a ceiling price for such drugs. This price is determined by
reducing the average manufacturer price of the drug by a rebate
percentage. Entities eligible to access section 340B pricing (covered
entities) include certain PHS grantees (e.g., federally-qualified
health centers, certain family planning projects, AIDS assistance
programs, black lung clinics, hemophilia treatment centers, Native
Hawaiian health centers, and centers that treat sexually-transmitted
disease and/or tuberculosis) and certain disproportionate share
hospitals.
Section 340B has no explicit language as to whether the required
reduction in price should be obtained by an initial reduction in the
purchase price (i.e., a discount mechanism) or received as a required
reduction in cost rebated after purchase, dispensing, and payment are
completed (i.e., a rebate option). Section 340B(a)(1) of the PHS Act
provides that the amount to be paid to the manufacturers for covered
drugs takes ``into account any rebate or discount, as provided by the
Secretary. * * *'' Further, section 340B does not specify whether
entities should receive the section 340B pricing ``through a point of
purchase discount, through a manufacturer rebate, or through some other
mechanism. A mechanism that is appropriate to one type of ``covered
entity,'' such as community health centers, may not be appropriate to
another type, such as State AIDS drug assistance programs * * * [T]he
Secretary of HHS * * * will use the mechanism that is the most
effective and most efficient. * * *'' H.R. Rep. No 102-384, 102d Cong.,
2d Sess., pt. 2, at 16 (1992).
Initially, HRSA guidance for the section 340B program described
only a discount process. Covered entities generally preferred a
discount system, because they could negotiate lower prices and needed
less initial outlay of drug purchasing money.
Although the discount system is functioning successfully for most
covered entities, most ADAPs have drug purchasing systems that have
prevented their participation in the section 340B discount program. The
use of a rebate option (in addition to the discount mechanism) should
allow these groups to access section 340B pricing.
The HRSA recognizes rebates obtained by the State ADAPs that equal
or exceed the discount provided by the statutory ceiling price as a
method of accessing the 340B program. State ADAPs wishing technical
assistance in developing a rebate program should contact HRSA's Office
of Drug Pricing at (301) 594-4353 or (800) 628-6297.
Section 340B(a)(5)(A) of the PHS Act reflects Congressional
recognition that there is a potential for drugs purchased by a covered
entity at the 340B discount price to be subject to a Medicaid rebate,
if the drug is reimbursed by the Medicaid program. State ADAPs need to
be aware that regardless of whether a discount mechanism or a rebate
option is chosen to access 340B pricing, the standards preventing
duplicate discounts on drugs still apply. Guidance regarding billing
State Medicaid Agencies at actual acquisition cost plus a dispensing
fee established by the State Medicaid agency, and the prevention of
duplicate discounts, was first published in the Federal Register on May
7, 1993 (58 FR 27293) entitled ``Duplicate Discounts and Rebates on
Drug Purchases.'' Further guidance was published in the Federal
Register on December 29, 1993 (58 FR 68922). State ADAPs may find it
necessary to work with State Medicaid Agencies to adapt these
guidelines to meet the unique circumstances of each individual State,
such as provisions permitting retroactive reimbursement of drug
purchases while Medicaid eligibility was pending. This will assure that
the discount to the covered entity will be passed on to the State
Medicaid Agency.
The HRSA is sensitive to concerns about diversion of covered drugs
to individuals who are not patients of the covered entities. Guidelines
have been issued to minimize this potential, and manufacturers have
available to them specified remedies if they believe diversion has
occurred. The HRSA believes that these guidelines and remedies will
apply fully to drugs purchased under a rebate option and that
instituting rebates will not increase the potential for diversion.
Dated: August 22, 1997.
Claude Earl Fox,
Acting Administrator.
[FR Doc. 97-23019 Filed 8-28-97; 8:45 am]
BILLING CODE 4160-15-P