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HHS/HRSA | RIN: 0906-AA89 | Publication ID: Fall 2016 |
Title: 340(B) Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations | |
Abstract:
This final rule is required under the Affordable Care Act. It amends section 340(B) of the Public Health Service Act to impose monetary sanctions (not to exceed $5,000 per instance) on drug manufacturers who intentionally charge a covered entity a price above the ceiling price established under the procedures of the 340(B) Program and also define standards and methodology for the calculation of ceiling prices for purposes of the 340(B) Program. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: sec 7102 of the Affordable Care Act Pub. L. 111-148, amending subsec(d) sec 340(B) of the PHS Act |
Legal Deadline:
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Statement of Need: The final rule provides a critical enforcement mechanism for the Department when drug manufacturers intentionally charge a covered entity a price above the ceiling price established under the procedures of the 340B Program. The rule also defines the standards and methodology for the calculation of ceiling prices for purposes of the 340B Program.
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Summary of the Legal Basis: Sections 340B(d)(1)(B)(vi) and 340B(d)(1)(B)(i)(I) of the Public Health Service Act. |
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Alternatives: None. This rule implements a statutory requirement. |
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Anticipated Costs and Benefits: None. |
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Risks: This final rule enables the Department to meet its statutory obligation under the Affordable Care Act to finalize regulations in these areas, which is expected to enhance the integrity of the 340B Program. |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: Yes | |
RIN Data Printed in the FR: No | |
Related RINs: Merged with 0906-AA92 | |
Agency Contact: CAPT Krista Pedley Director, Office of Pharmacy Affairs Department of Health and Human Services Health Resources and Services Administration Healthcare Systems Bureau, 5600 Fishers Lane, 10C-03, Rockville, MD 20857 Phone:301 443-5294 Email: krista.pedley@hrsa.hhs.gov |