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7103 - GAO Study to Make Recommendations on Improving the 340B Program

 
Implementation Status 
Statutory Text 

Summary

Requires the GAO report to Congress within 18 months on whether individuals served by 340B covered entities are receiving “optimal healthcare services,” including providing recommendations on whether the program should be expanded, whether mandatory sales of certain products by the 340B program could hinder patients’ access to those therapies through any provider, and whether income from the 340B program is being used by the covered entities under the program to further the program objectives.

#340B, #Hospitals

Implementation Status

 
Summary 
Statutory Text 

Complying with the statutory deadline, GAO issued a September 23, 2011 report – “Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement.” Several of GAO’s recommendations have been implemented, according to the GAO website (see status under “Recommendations for Executive Action”). HRSA referenced the GAO report in a February 10, 2012 stakeholder letter regarding steps it is taking to strengthen 340B program oversight.

On July 23, 2014, HRSA issued an interpretive rule in which the agency affirms its previously finalized policy (June 23, 2013) whereby orphan drugs are excluded from the 340B Drug Pricing Program only when used for the orphan-designated indication but not when used for broader uses.

On August 4, 2014, HRSA highlighted some of the most frequently asked technical assistance questions and the answers for 340B Program from hospitals and clinics. Additionally HRSA reminded hospitals of requirements for recertification and issued passwords for hospitals on August 6, 2014.

On a related note, on August 7, 2014 HRSA updated its list of entities that agreed to the HRSA Final Report audit. The list is here and information on Corrective Action Plans and Sanctions will be updated once approved by HRSA.

Additionally, on August 20, 2014, four health clinics and centers were terminated from the 340B Drug Pricing Program (340B Program) and indicated to HRSA that they made purchases when they were not eligible to do so.  Entities are encouraged by HRSA to work with affected manufacturers regarding possible repayment.

Statutory Text

 
Implementation Status 
Summary 

SEC. 7103. GAO STUDY TO MAKE RECOMMENDATIONS ON IMPROVING THE 340B PROGRAM. (a) REPORT.

—Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report that examines whether those individuals served by the covered entities under the program under section 340B of the Public Health Service Act (42 U.S.C. 256b) (referred to in this section as the ‘‘340B program’’) are receiving optimal health care services. (b) RECOMMENDATIONS.—The report under subsection (a) shall include recommendations on the following: (1) Whether the 340B program should be expanded since it is anticipated that the 47,000,000 individuals who are uninsured as of the date of enactment of this Act will have health care coverage once this Act is implemented. (2) Whether mandatory sales of certain products by the 340B program could hinder patients access to those therapies through any provider. (3) Whether income from the 340B program is being used by the covered entities under the program to further the program objectives.

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