HRSA further delays effective date of final rule on 340B drug ceiling prices

Mar 17, 2017 - 03:08 PM

The Health Resources and Services Administration today delayed to May 22 the effective date of its final rule on 340B drug ceiling prices and civil monetary penalties for manufacturers, and invited comments on whether a delay to Oct. 1 would be more appropriate. The rule was set to take effect March 21 following an earlier two-week delay. “[The Department of Health and Human Services] believes that the delay of the effective date is necessary to consider questions of fact, law and policy raised in the rule, consistent with the ‘Regulatory Freeze Pending Review’ memorandum,” the notice states. “In addition, HHS believes that the delay of the effective date is necessary to provide regulated entities sufficient time to implement the requirements of the rule.” HRSA will accept comments through April 17.

Related News Articles

Headline
HHS announces revised 340B Rebate Model Pilot Program; see AHA’s statement shared with media 
The Department of Health and Human Services today issued a notice announcing a revised 340B Rebate Model Pilot Program, allowing qualifying drug manufacturers…
Headline
CMS issues hospital inpatient payment final rule for FY 2027
The Centers for Medicare & Medicaid Services today issued a final rule that would increase Medicare rates by a net 2.3% in fiscal year 2027, compared with…
Headline
CMS releases 2025 report on program audits, enforcement for Medicare Advantage, Part D 
The Centers for Medicare & Medicaid Services July 27 released its Contract Year 2025 Part C and Part D Program Audit and Enforcement Report, outlining key…
Headline
Court rules that companies may not impose 340B rebate model without HHS approval
The U.S. District Court for the District of Columbia July 21 upheld a lower court’s decision that Section 340B of the Public Health Service Act does not …
Headline
CMS posts updated FAQ on PAMA clinical laboratory private payer data reporting 
The Centers for Medicare & Medicaid Services has released an updated FAQ on Protecting Access to Medicare Act private payer data reporting. The deadline is…
Headline
Draft guidance released for 2028 cycle of Medicare drug price negotiations 
The Centers for Medicare & Medicaid Services July 16 released draft guidance for the 2028 cycle of negotiations under the Medicare Drug Price Negotiation…