Drugmakers are getting another delay in a final rule imposing penalties on them for overcharging safety-net hospitals and other providers.
The Department of Health and Human Services is delaying the rule’s effective date until Oct. 1, the agency said in a notice published May 19 in the Federal Register. This follows an earlier postponement until May 22, and an even earlier postponement until March 21.
The rule (RIN:0906-AA89) on ceiling prices and civil monetary penalties for the 340B program originally was published near the end of the Obama administration after a heated public debate over drug costs. Under the 340B program, drug manufacturers provide outpatient drugs to covered entities, such as safety-net hospitals, at significantly reduced prices. The rule requires drug manufacturers to pay a penalty if they intentionally charge above what is known as the ceiling price.
Attorney Donna Lee Yesner told me she’s “relieved that the new rule’s effective date has been extended to October” and that HHS’s Human Resources and Services Administration has acknowledged in extending the date that it imposes significant compliance burdens. Yesner, with Morgan, Lewis & Bockius in Washington, counsels companies on government program reimbursement, drug price reporting and compliance requirements.
Yesner said it’s “unclear whether HRSA intends to re-evaluate the rule’s provisions per the president’s order and possibly amend it. It’s also unclear whether the absence of a new director of HRSA is affecting the rulemaking process.” In February, President Donald Trump signed an executive order that calls for a reduction in “unnecessary regulatory burdens placed on the American people.” Yesner is a Bloomberg BNA advisory board member.
Meanwhile, 340B Health, an association of hospitals and health systems that participate in the 340B program, said in a May 18 statement that it is disappointed the rule was delayed. However, the group said it takes comfort that, in announcing the delay, the HHS declined to withdraw the rule and issue a new proposal, as urged by the drug industry. The group also said it is pleased that the HHS didn’t suggest that another delay might be necessary.
Read my full article 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 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)