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.

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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 …
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The Centers for Medicare & Medicaid Services has released an updated FAQ on Protecting Access to Medicare Act private payer data reporting. The deadline is…
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The Centers for Medicare & Medicaid Services July 16 released draft guidance for the 2028 cycle of negotiations under the Medicare Drug Price Negotiation…
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The AHA July 14 urged the Health Resources and Services Administration to revise its estimate of the administrative burden associated with the agency’s…
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The AHA today filed a friend-of-the-court brief supporting the Department of Health and Human Services’ motion to dismiss AbbVie’s lawsuit …
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The Health Resources and Services Administration announced that 340B covered entities purchased $100 billion in outpatient drugs under the federal 340B Drug…