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 AHA Aug. 17 provided comments to the Centers for Medicare & Medicaid Services on its proposed rule to codify in regulation the Medicare Drug Price…
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The Centers for Medicare & Medicaid Services Aug. 7 released a procedural notice on its new pathway to expedite access to certain Food and Drug…
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A bipartisan group of senators Aug. 5 introduced the Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future…
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The U.S. District Court for the Eastern District of Pennsylvania Aug. 5 granted a motion for the AHA and the Hospital and Healthsystem Association of…
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The Department of Health and Human Services today issued a notice announcing a revised 340B Rebate Model Pilot Program, allowing qualifying drug manufacturers…
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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…