A U.S. Supreme Court decision in late June about the appointment of federal administrative patent judges (APJs) could influence the outcome of several ongoing lawsuits over the 340B program’s administrative dispute resolution (ADR) process.
On June 21, the high court
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Drug manufacturer Merck has begun informing 340B covered entities that, effective Sept. 1, it will stop providing 340B pricing to hospitals that partner with 340B contract pharmacies unless the hospitals share 340B claims data with its vendor 340B ESP.
Hospitals
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Federal officials relied “on sound statutory interpretation and sufficient evidence” when it concluded in May that United Therapeutics (UT) broke the law when it conditioned access to 340B pricing on its products, government lawyers told a federal district judge in
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Drug manufacturer AstraZeneca and the federal government each told a federal district court last Friday why it, and not the other, should prevail in Astra’s lawsuit over the government’s 340B contract pharmacy requirements.
The Aug. 6 filings were the latest
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President Biden has nominated current White House Office of Management and Budget (OMB) General Counsel Sam Bagenstos to be the U.S. Health and Human Services Department (HHS) General Counsel—a post that has had a growing role in defending the 340B
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President Biden this morning called on Congress to let Medicare negotiate drug prices and penalize drug companies that raise their prices faster than inflation.
Biden said lawmakers should establish a firm cap on the amount that Medicare beneficiaries have to
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The U.S. Senate on Tuesday voted 69-30 to pass a bipartisan infrastructure bill that includes two drug pricing provisions, neither directly 340B-related. The bill now moves to the U.S. House, which is on a seven-week summer break. The $1 trillion
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Regulations establishing a binding administrative dispute resolution (ADR) process for the 340B program were rushed into place last December to defeat lawsuits, are fatally flawed legally and constitutionally, and should be struck down, the main U.S. trade association for drug
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The Biden administration plans to rescind a published but unimplemented Trump-era regulation that would peg Medicare Part B drug reimbursement for 50 expensive, physician-administered drugs on the lowest price that drug manufacturers get in similar countries. The widely criticized regulation
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California’s twice-postponed shift of Medicaid (Medi-Cal) managed care prescription drug benefits to Medi-Cal fee for service (FFS) is back on for Jan. 1, 2022, one year later than originally planned.
A similar high-stakes battle over Medicaid reimbursement for 340B-purchased drugs
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