Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
June 16 — 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 reginfo.gov website. The proposal from the Department of Health and Human Services, which administers the program, is required under the Affordable Care Act.
The HHS proposal would establish a binding administrative dispute resolution process for claims raised by covered entities such as hospitals that say they were overcharged for drugs under the 340B program. This process also would be available to drug manufacturers, according to the OMB's explanation of the rule. The 340B program requires drug manufacturers to provide outpatient drugs to eligible health-care organizations at significantly reduced prices.
Bloomberg Intelligence analyst Brian Rye told Bloomberg BNA in a June 16 e-mail that “both drugmakers and eligible 340B providers have expressed a number of concerns about the program's oversight, resulting in a heightened importance for regulations governing the dispute resolution process.”
The proposed rule has been delayed several times. The HHS spring regulatory agenda said the proposal would be published in September. However, the fall 2015 regulatory agenda said it would be published in May. And in the spring 2015 regulatory agenda, it was scheduled to be published in December 2015.
Randy Barrett, vice president of communications at 340B Health, a group that represents health-care providers receiving discounts in the program, told Bloomberg BNA in a June 16 e-mail that “we are very pleased to see movement on this process.”
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.”
He noted that the HHS initially opened the issue up for comments in an advance notice of proposed rulemaking in 2010, as opposed to starting the process with a proposed rule, “so it may be some time before stakeholders see a final rule on this particular issue.”
“Stakeholders should be prepared to issue comments to the proposed rule in the coming months pending OMB’s official signoff on the draft proposed rule,” Vasquez added.
To contact the reporter on this story: Bronwyn Mixter in Washington at email@example.com
To contact the editor responsible for this story: Brian Broderick at firstname.lastname@example.org
The OMB's posting on the rule is at http://www.reginfo.gov/public/do/eoDetails?rrid=126464.
More information on the 340B program is at http://www.hrsa.gov/opa/programintegrity/.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)