June 16, 2016
From BNA Health Care Daily Report

by Bronwyn Mixter

A proposal on handling disputes arising from a safety-net drug discount program is moving closer to public release.

The White House Office of Management and Budget started its review June 15 of the proposed rule (RIN: 0906-AA90 ) under the 340B discount program, according to the OMB's website. The proposal from the Department of Health and Human Services, which administers the program, is required under the Affordable Care Act.

Kyle Vasquez, an attorney with Polsinelli in Chicago, told Bloomberg BNA that, at a time when audit and repayment activity continues to rise in the 340B program, it's “important that stakeholders have a formal dispute resolution process available, but one that balances the interests of both covered entities and [drug] manufacturers.”

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