Reps. Peter Welch (D-VT) and Gregg Harper (R-MS) yesterday introduced the Closing Loopholes for Orphan Drugs Act (H.R. 2889, legislation that would limit the “orphan drug” exclusion for 340B Drug Pricing Program rural and cancer hospitals. Specifically, the legislation would allow 340B critical access hospitals, sole community providers, rural referral centers and free-standing cancer hospitals to purchase orphan drugs at discounted rates through the 340B program as long as the orphan drug is used to treat illnesses or conditions other than the rare illnesses or conditions for which the orphan drug designation was originally given.

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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The Centers for Medicare & Medicaid Services July 16 released draft guidance for the 2028 cycle of negotiations under the Medicare Drug Price Negotiation…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…