0906-AA89 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0906 Health Resources and Services Administration HRSA 0900 Department of Health and Human Services HHS 340(B) Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations

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. 

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No None sec 7102 of the Affordable Care Act Pub. L. 111-148, amending subsec(d) sec 340(B) of the PHS Act Statutory Other 09/20/2010 ANPRM met deadline for Civil Monetary Penalties for Manufacturers. Yes

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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Sections 340B(d)(1)(B)(vi) and 340B(d)(1)(B)(i)(I) of the Public Health Service Act.

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None.  This rule implements a statutory requirement.

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None.

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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.

]]> ANPRM 09/20/2010 75 FR 57230 ANPRM Comment Period End 11/19/2010 NPRM 06/17/2015 80 FR 34583 NPRM Comment Period End 08/17/2015 Final Rule 11/00/2016 Undetermined None No No No No 0906-AA92 Merged with Krista Pedley CAPT Director, Office of Pharmacy Affairs 0906 Health Resources and Services Administration HRSA 301 443-5294 krista.pedley@hrsa.hhs.gov Healthcare Systems Bureau, 5600 Fishers Lane, 10C-03, Rockville MD 20857