The long-awaited guidance on drug discounts that was under White House review at the end of the Obama administration has been sent back to the HHS.
The 340B program covered by the guidance helps safety-net providers such as hospitals obtain discounted drugs. The proposed guidance released in 2015 defined who is considered a patient for purposes of the program and also covers drug company responsibilities, such as procedures for issuing credits and refunds.
The White House Office of Management and Budget Jan. 30 marked the final guidance document (RIN:0906-AB08) as withdrawn, sending it back to the Department of Health and Human Services. To move forward, the guidance would now have to be resubmitted to OMB.
The drug industry generally supports the guidance because it says more clarity is needed for the 340B program, particularly for the definition of patient. However, safety-net hospitals have concerns with the guidance because they say it could limit their ability to serve the poor by putting additional restrictions on drug discounts.
Attorney Donna Lee Yesner told me she’s not surprised that “pending regulatory guidance of this magnitude” would be re-examined by a new administration. Yesner, with Morgan, Lewis & Bockius in Washington, often counsels companies on government program reimbursement, drug price reporting and compliance requirements.
“Industry and covered entities [such as hospitals] need more clarity, but my hope is that the new administration will consider how expansive and burdensome industry subsidization of the 340B program has become, and return the program to its original purpose of reducing the cost of drugs provided by federally funded clinics to indigent and uninsured patients,” Yesner said.
My full article on this is here.
Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center.
Learn more about Bloomberg Law and sign up for a free trial.
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 firstname.lastname@example.org.
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 email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)