CMS draft guidance on manufacturer effectuation of negotiated drug prices, first cycle to include Part B
Plus: DOJ says it will stop relying on 2011 Olmstead integration-mandate enforcement guidance. The day's rules, money, and enforcement, sourced and tiered below.
Plus: DOJ says it will stop relying on 2011 Olmstead integration-mandate enforcement guidance. The day's rules, money, and enforcement, sourced and tiered below.
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American Health Intel
Rules · Money · Medicine · Decoded daily
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| The Regulator |
Monday, July 20, 2026 |
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CMS draft guidance on manufacturer effectuation of negotiated drug prices, first cycle to include Part B
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Plus: DOJ says it will stop relying on 2011 Olmstead integration-mandate enforcement guidance. The day's rules, money, and enforcement, sourced and tiered below.
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Rule Confidence: High
CMS just published guidance on the hardest problem in Medicare drug price negotiation, the program that sets discounted prices for costly drugs: how manufacturers pay out the discount when a doctor administers the drug in-office.
The guidance covers 15 drugs including Botox, Cimzia, Orencia and Entyvio, the first cycle to include physician-administered drugs. 1.8M beneficiaries, $27B in spending. Prices effective Jan 1, 2028. Comments due Sept 18, 2026.
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Why it matters
This is the first test of Medicare's drug price negotiation program on drugs your doctor administers in office rather than ones you pick up at a pharmacy, and the mechanics are still being worked out.
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Rule Confidence: High
The Justice Department just said it will stop relying on the 15-year-old guidance that has directed states to move people with disabilities out of institutions and into community care whenever possible.
The underlying Supreme Court ruling in Olmstead v. L.C. still stands, but disability rights advocates say DOJ just pulled the practical roadmap it has used to enforce it. Notice dated July 13, published July 20, 2026.
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Why it matters
The Supreme Court ruling that people with disabilities have a right to community based care instead of institutionalization is unchanged, but the government just pulled the practical guidance it used to enforce it.
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