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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. 

 
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 
EO 13771 Designation: uncollected 
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:
Action Source Description Date
Other  Statutory  ANPRM met deadline for Civil Monetary Penalties for Manufacturers.  09/20/2010 

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.

 

 

 

Summary of the Legal Basis:

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

Alternatives:

None.  This rule implements a statutory requirement.

Anticipated Costs and Benefits:

None.

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.

Timetable:
Action Date FR Cite
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 
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