The Regulator

Medicare’s drug price negotiation program now has a permanent rulebook that takes effect December 5, and CMS will pick up to 20 more drugs by February 1, 2027. The Centers for Medicare & Medicaid Services (CMS) final rule, CMS-4215-F, issued November 5, writes the program’s rules for prices that take effect in 2029 and later, because the authority to run it through guidance covered only 2026 through 2028. Who it hits: drugmakers with Part D or Part B drugs, and Part D plans, which must now carry any selected drug with a negotiated price on their formularies and pay pharmacies no more than that price plus dispensing fees. So what: CMS finalized, unchanged from its proposal, a policy that groups a new formulation with an existing drug when both come from the same manufacturer and the new version adds a component and a new route of administration, closing a route to avoid negotiated prices. It also sets a temporary floor for small biotech drugs for 2029 and 2030 that bars CMS from offering or accepting a price below it. CMS gives no dollar savings figure, and the pages do not state the floor’s value. Confidence: High on dates and provisions, which come from CMS; Low on the savings, which CMS does not estimate in its release. Sources: CMS fact sheet on the final rule, CMS-4215-F, CMS press release.

CMS proposes to drop hospital obstetric training and quality rules that were due January 1, and says the package would save $320 million. The proposed rule, CMS-3484-P, is called Cutting Administrative Requirements for Excellence in Patient Care (CARE). It would revise the Conditions of Participation, the standards providers must meet to bill Medicare and Medicaid, across all 21 provider and supplier types. Who it hits: hospitals and critical access hospitals, which would no longer have to train staff on obstetric care or meet obstetric-specific quality improvement requirements starting in 2027, plus nursing homes, which would shed most COVID-19 vaccine education and routine respiratory illness reporting. So what: CMS estimates 3.26 million hours of staff time returned, and would rescind Medicaid reporting on how much nursing home payments go to direct care workers. It would add patient rights on birth tissue collection. The fact sheet gives no comment deadline and no per-provider breakdown, and the Federal Register text was only on public inspection. Confidence: High that these are the proposals; Med on the $320 million, a CMS estimate. Sources: CMS fact sheet, CMS-3484-P, Federal Register public inspection copy, 2026-22812.

A Washington judge ordered Albertsons to pay $900 million for failing to guard against opioid diversion, the state attorney general says. King County Superior Court Judge Janet Helson ruled that Albertsons violated state law between 2006 and 2022, when its pharmacies dispensed more than 641 million opioid pills in Washington and filled red-flagged prescriptions more than 6.5 million times without documenting checks. The judgment is $900 million plus fees and costs. Who it hits: Albertsons, which runs more than 200 Washington pharmacies under the Albertsons, Safeway and Haggen names. So what: the attorney general says the money will fund treatment and prevention, and counts $2.17 billion in opioid recoveries to date. The release states no appeal deadline, and we have not seen the court order itself. Confidence: Med; the figures come from the attorney general’s release, not the opinion. Sources: Washington Attorney General press release.

Washington, Minnesota, New Mexico and Oregon sued HHS over Medicaid work-requirement rules, with Washington estimating 120,000 people could lose coverage. The suit, called Oregon v Oz, was filed in federal court in Eugene, Oregon, and challenges how the Department of Health and Human Services plans to implement work, school or volunteering documentation under H.R. 1, the 2025 budget law. Who it hits: more than 600,000 Washington adults covered through the Affordable Care Act Medicaid expansion, of about 1.9 million on Apple Health, the state’s Medicaid program. So what: Washington’s Health Care Authority estimates at least 20% of those members, about 120,000 people, may lose coverage; implementation does not begin until 2027. This is a separate case from the medically frail test ruling we covered November 1. Confidence: Med; figures are the state’s estimates and we have not read the complaint. Sources: Washington Attorney General press release.

An Orlando clinic CEO got 13 months and a VA employee 6 months for a kickback scheme that billed the Veterans Affairs community care program over $14 million. The Department of Justice says Heriberto Rivera, chief executive of Family Integrative Medicine of Orlando, paid bribes to Laurent Cassagnol, a VA community care assistant, who steered veterans to the clinic for acupuncture, chiropractic and other holistic services. Who it hits: community care vendors, which depend on referrals the VA staff member controls. So what: more than $11 million was paid out; Rivera must forfeit $515,542 and Cassagnol $175,172. The release does not name the court. Confidence: High; the figures come from the DOJ release. Sources: DOJ press release 26-1327.

FDA granted accelerated approval to Rybrevant Faspro for recurrent head and neck cancer, the first new drug approval of its kind in 10 years. The Food and Drug Administration (FDA) approved the amivantamab and hyaluronidase-lpuj injection, from Janssen Biotech, for adults whose head and neck squamous cell carcinoma progressed after platinum chemotherapy and immunotherapy. Who it hits: patients with that disease, excluding HPV-associated oropharyngeal cancer, and payers that will price a new oncology drug. So what: in a 102-patient trial the response rate was 42%, and 56% of responders held it six months or longer, versus about 20% or less for current therapies, per FDA. Approval rests on response, so confirmatory trials are required; no price was given. Confidence: High on trial figures, which come from FDA. Sources: FDA press announcement.

Federal Register note: the 2027 hospital outpatient final rule is formally published today, and the Drug Enforcement Administration (DEA) gives 3-CMC its own Schedule I listing. The outpatient rule (2026-22739) is a final rule with comment period that, per its summary, adds prior authorization for more botulinum toxin injections and lets accrediting organizations assess certain emergency-treatment (EMTALA) administrative requirements; we covered its payment figures November 5. DEA is listing 3-chloromethcathinone separately, though it was already Schedule I as an isomer of a controlled drug, so this is a clarification. FDA also classified an external mechanical stimulator for nasal congestion into class II. Comment and effective dates were not available this run. Confidence: High on the summaries; Low on dates. Sources: Federal Register CMS final rule 2026-22739, Federal Register DEA rule 2026-22717, Federal Register FDA rule 2026-22657.