Agency Information Collection Activities: Proposed Collection: Comment Request; Information Request Title: 340B Drug Pricing Program Reporting Requirements, OMB Number 0915-0176-Extension

Citation84 FR 46959
Record Number2019-19244
Published date06 September 2019
SectionNotices
CourtHealth Resources And Services Administration
Federal Register, Volume 84 Issue 173 (Friday, September 6, 2019)
[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
                [Notices]
                [Pages 46959-46960]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-19244]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Health Resources and Services Administration
                Agency Information Collection Activities: Proposed Collection:
                Comment Request; Information Request Title: 340B Drug Pricing Program
                Reporting Requirements, OMB Number 0915-0176--Extension
                AGENCY: Health Resources and Services Administration (HRSA), Department
                of Health and Human Services (HHS).
                ACTION: Notice.
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                SUMMARY: In compliance with the requirement for opportunity for public
                comment on proposed data collection, the Paperwork Reduction Act of
                1995, HRSA has submitted an Information Collection Request (ICR) to the
                Office of Management and Budget (OMB) for review and approval. Comments
                submitted during the first public review of this ICR will be provided
                to OMB. OMB will accept further comments from the public during the
                review and approval period.
                DATES: Comments on this ICR must be received no later than October 7,
                2019.
                ADDRESSES: Submit your comments, including the ICR title, to the desk
                officer for HRSA, either by email to [email protected] or by
                fax to (202) 395-5806.
                FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
                requests submitted to OMB for review, email Lisa Wright-Solomon, the
                HRSA Information Collection Clearance Officer at [email protected] or
                call (301) 443-1984.
                SUPPLEMENTARY INFORMATION: When submitting comments or requesting
                information, please include the ICR title for reference.
                 Information Collection Request Title: Drug Pricing Program
                Reporting Requirements (OMB No. 0915-0176)--[Extension].
                 Abstract: 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''), which instructs HHS to enter into a Pharmaceutical Pricing
                Agreement (PPA) with manufacturers of covered outpatient drugs.
                Manufacturers are required by section 1927(a)(5)(A) of the Social
                Security Act to enter into agreements with the Secretary of HHS that
                comply with section 340B of the PHS Act if they participate in the
                Medicaid Drug Rebate Program. When a drug manufacturer signs a PPA, it
                is opting into the 340B Drug Pricing Program (340B Program) and it
                agrees to the statutory requirement that prices charged for covered
                outpatient drugs to covered entities will not exceed defined 340B
                ceiling prices, which are based on quarterly pricing data reported by
                manufacturers to the Centers for Medicare & Medicaid Services. When an
                eligible covered entity voluntarily decides to enroll and participate
                in the 340B Program, it accepts responsibility for ensuring compliance
                with all provisions of the 340B Program, including all associated
                costs. Covered entities that choose to participate in the 340B 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 covered entity.
                 Section 340B(a)(5)(C) of the PHS Act permits the Secretary of HHS
                and manufacturers of a covered outpatient drug to conduct audits of
                covered entities in accordance with by procedures established the
                Secretary related to the number, duration, and scope of the audits.
                Manufacturers are 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 notifies the covered entity in writing
                when it believes the covered entity has violated these provisions of
                the 340B Program. If the problem cannot be resolved, the manufacturer
                will then submit an audit work plan describing the audit and evidence
                in support of the reasonable cause standard to HRSA, Healthcare Systems
                Bureau, Office of Pharmacy Affairs (OPA) for review. OPA will review
                the documentation to determine if reasonable cause exists. Once the
                audit is completed, the manufacturer will submit copies of the audit
                report to OPA 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 (OIG).
                 In response to the statutory mandate of section 340B(a)(5)(C) to
                permit the Secretary or manufacturers to conduct audits of covered
                entities and because of the potential for disputes involving covered
                entities and participating drug manufacturers, OPA developed an
                informal voluntary dispute resolution process for manufacturers and
                covered
                [[Page 46960]]
                entities. Prior to filing a request for resolution of a dispute with
                OPA, the parties involved should attempt in good faith to resolve the
                dispute. All parties involved in the dispute should maintain written
                documentation as evidence of a good faith attempt to resolve the
                dispute. To request voluntary dispute resolution of an unresolved
                dispute, a party submits a written request for a review of the dispute
                to OPA. 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.
                 HRSA published a notice in 1996 and a policy release in 2011 on
                manufacturer audit guidelines and the informal dispute resolution
                process (61 FR 65406 (December 12, 1996) and ``Clarification of
                Manufacturer Audits of 340B Covered Entities,'' Release No. 2011-3).
                 Need and Proposed Use of the Information: HRSA is proposing the
                collection of information related to the manufacturer audit guidelines.
                These guidelines contain the following reporting/notification elements:
                 1. Manufacturers should notify the covered entity in writing when
                it believes a violation has occurred;
                 2. manufacturers should submit documentation to OPA as evidence of
                good faith in attempts to resolve a dispute;
                 3. manufacturers must submit an audit work plan to OPA;
                 4. manufacturers should submit the audit report to the OPA and
                informational copies to the HHS OIG; and
                 5. the covered entity should provide a written response to the
                audit report.
                 This information is necessary to ensure the orderly conduct of
                manufacturer audits. Also, the informal dispute resolution process
                requires the participating manufacturer or covered entity requesting
                dispute resolution to provide OPA with a written request. The party
                alleged to have committed a 340B Program violation may provide a
                response or rebuttal to OPA. This information is necessary to ensure
                that the dispute will be resolved in a fair and equitable manner.
                 A 60-day notice was published in the Federal Register on June 18,
                2019, vol. 84, No. 117; pp. 28308-09. There was one public comment
                received. The comment received addressed a policy issue that is beyond
                the scope of this information collection request; therefore, HRSA will
                not be addressing the comment in this notice.
                 Likely Respondents: Drug manufacturers and 340B covered entities.
                 Burden Statement: Burden in this context means the time expended by
                persons to generate, maintain, retain, disclose, or provide the
                information requested during an audit. This includes the time needed to
                review instructions, to develop, acquire, install, and utilize
                technology and systems for the purpose of collecting, validating, and
                verifying information, processing and maintaining information, and
                disclosing and providing information, to train personnel and to be able
                to respond to a collection of information, to search data sources, to
                complete and review the collection of information, and to transmit or
                otherwise disclose the information for both covered entities and
                manufacturers. The total annual burden hours estimated for this ICR are
                summarized in the table below.
                 Total Estimated Annualized Burden Hours *
                ----------------------------------------------------------------------------------------------------------------
                 Number of Average burden
                 Form name Number of responses per Total per response Total burden
                 respondents respondent responses (in hours) hours
                ----------------------------------------------------------------------------------------------------------------
                Audits:
                 Good faith Resolution \1\... 10 1 10 60 600
                 Audit Notification to Entity 14 1 14 6 84
                 \1\........................
                 Audit Workplan \1\.......... 45 1 45 12 540
                 Audit Report \1\............ 14 1 14 12 168
                 Entity Response............. 14 1 14 12 168
                Dispute Resolution:
                 Mediation Request........... 10 4 40 15 600
                 Rebuttal.................... 10 1 10 28 280
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                 Total................... 117 .............. 147 .............. 2,440
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                \1\ Prepared by the manufacturer.
                * Since the first public review of the ICR, HRSA has received several audit work plans from manufacturers. HRSA
                 has decided to update its proposed burden hours to reflect the increase in submissions.
                 Recordkeeping Burden
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                 Number of Hours of
                 Recordkeeping requirement recordkeepers recordkeeping Total burden
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                Dispute Records.............................................. 50 1 50
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                Maria G. Button,
                Director, Division of the Executive Secretariat.
                [FR Doc. 2019-19244 Filed 9-5-19; 8:45 am]
                 BILLING CODE 4165-15-P
                

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