[Federal Register Volume 62, Number 45 (Friday, March 7, 1997)]
[Notices]
[Pages 10574-10575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5560]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Health Resources and Services
Administration (HRSA) will publish periodic summaries of proposed
projects being developed for submission to OMB under the Paperwork
Reduction Act of 1995. To request more information on the proposed
project or to obtain a copy of the data collection plans, call the HRSA
Reports Clearance Officer on (301) 443-1129.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
[[Page 10575]]
Proposed Project
Drug Pricing Program Reporting Requirements (OMB No. 0915-0176)--
Extension, No Change--Section 602 of Public Law 102-585, the Veterans
Health Care Act of 1992, enacted section 340B of the Public Health
Service Act (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 Health and Human
Services in which the manufacturer agrees to charge a price for covered
outpatient drugs that will not exceed an amount determined under a
statutory formula.
Covered entities which choose to participate in the section 340B
drug discount program must comply with the requirements of section
340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered
entity from accepting a discount for a drug that would also generate a
Medicaid rebate. Further, section 340B(a)(5)(B) prohibits a covered
entity from reselling or otherwise transferring a discounted drug to a
person who is not a patient of the entity.
Because of the potential for disputes and/or audits involving
covered entities and participating drug manufacturers; the HRSA Office
of Drug Pricing Program has developed an informal dispute resolution
process for manufacturers and covered entities as well as manufacturer
guidelines for audit of covered entities.
Audit guidelines: A manufacturer will be permitted to conduct an
audit only when there is reasonable cause to believe a violation of
section 340B(a)(5) (A) or (B) has occurred. The manufacturer must
submit a request for an audit of a covered entity to the HRSA Office of
Drug Pricing Program. The manufacturer must then submit an audit work
plan describing the audit to the HRSA Office of Drug Pricing Program
for review. The manufacturer will submit copies of the audit report to
the HRSA Office of Drug Pricing Program for review and resolution of
the findings, as appropriate. The manufacturer will also submit an
informational copy of the audit report to the HHS Office of Inspector
General.
Dispute resolution guidelines: Because of the potential for audit
and other disputes involving covered entities and participating drug
manufacturers, the HRSA Office of Drug Pricing Program has developed an
informal dispute resolution process, which can be used if an entity or
manufacturer is believed to be in violation of section 340B. Prior to
filing a request for resolution of a dispute with the HRSA Office of
Drug Pricing Program, the parties must attempt, in good faith, to
resolve the dispute. All parties involved in the dispute must maintain
written documentation as evidence of a good faith attempt to resolve
the dispute. If the dispute is not resolved and dispute resolution is
desired, a party must submit a written request for a review of the
dispute to the HRSA Office of Drug Pricing Program. A committee
appointed to review the documentation will send a letter to the party
alleged to have committed a violation. The party will be asked to
provide a response to or a rebuttal of the allegations.
To date, there have been no requests for audits, and no disputes
have reached the level where a committee review was needed. As a
result, the estimates of annualized hour burden for audits and disputes
have been reduced to the level shown in the table below.
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Number of Responses per Total Total burden
Reporting requirement respondents respondent responses Hours/response hours
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Audits:
Audit request \1\........... 2 1 2 4 8
Audit workplan \1\.......... 1 1 1 8 8
Audit report \1\............ 1 1 1 1 1
Entity response............. 1 1 1 16 16
Dispute resolution:
Mediation request........... 5 1 5 8 40
Rebuttal.................... 2 1 2 16 32
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Total................... 10 1.2 12 8.75 105
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\1\ Prepared by the manufacturer.
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Number of Hours of
Recordkeeping requirement recordkeepers recordkeeping Total burden
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Dispute records............................... 8 .5 4
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Send comments to Patricia Royston, HRSA Reports Clearance Officer,
Room 14-36, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.
Written comments should be received within 60 days of this notice.
Dated: February 26, 1997.
J. Henry Montes,
Director, Office of Policy and Information Coordination.
[FR Doc. 97-5560 Filed 3-6-97; 8:45 am]
BILLING CODE 4160-15-P