The Regulator

The Centers for Medicare and Medicaid Services published draft guidance today spelling out how drug manufacturers must actually hand over Medicare’s negotiated “maximum fair price” starting in 2028, the first time that mechanic has ever had to work for drugs doctors administer in their offices instead of ones patients pick up at a pharmacy. The Centers for Medicare and Medicaid Services published the draft guidance in the Federal Register July 20, 2026, docket CMS-4219-N, covering manufacturer effectuation of the maximum fair price under the Inflation Reduction Act of 2022’s Medicare Drug Price Negotiation Program; comments are due September 18, 2026. The guidance governs the program’s third negotiation cycle, which for the first time includes five Medicare Part B drugs administered by physicians, among them Botox, Cimzia, Orencia and Entyvio, alongside 10 Medicare Part D drugs and the program’s first renegotiation, of the diabetes drug Tradjenta. Roughly 1.8 million Medicare beneficiaries used the 15 newly selected drugs between November 2024 and October 2025, accounting for about 27 billion dollars in combined Part B and Part D spending, about 6 percent of total spending in both programs; the negotiated prices take effect January 1, 2028. Confidence: High on the guidance’s existence, docket number and comment deadline, since the Federal Register notice itself confirms them; Low on how CMS will resolve Part B effectuation specifically, since the program has never had to pay a negotiated price through a physician’s office before and that is the open question the guidance seeks comment on. Sources: Medicare Program; IRA Medicare Drug Price Negotiation Program Draft Guidance, Federal Register, Medicare Drug Price Negotiation Program Guidance and Policy Documents, Centers for Medicare and Medicaid Services.

The Justice Department told the country today 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, without changing the underlying law. The Department of Justice published a notice in the Federal Register July 20, 2026, dated July 13, 2026, clarifying that its 2011 “Statement of the Department of Justice on Enforcement of the Integration Mandate of Title II of the Americans with Disabilities Act and Olmstead v. L.C.” is no longer enforceable guidance. Assistant Attorney General for Civil Rights Harmeet Dhillon’s notice says the department will revisit the underlying Olmstead guidance in light of the Supreme Court’s decision in Loper Bright Enterprises v. Raimondo to determine whether it reflects the best reading of the Americans with Disabilities Act; the 2011 statement had been the government’s primary enforcement roadmap for Title II’s integration mandate, covering nursing homes, intermediate care facilities and state Medicaid home and community based services programs. The underlying Olmstead v. L.C. Supreme Court decision itself remains binding precedent regardless of this notice, but disability rights advocates argue the guidance’s removal strips DOJ’s enforcement program of its practical roadmap. Confidence: High on the notice’s existence and date, since the Federal Register and the Department of Justice’s own ADA.gov page confirm it; Medium on the real-world enforcement impact, since the underlying Supreme Court precedent is unchanged and this notice governs only DOJ’s own guidance reliance. Sources: Clarification on Department of Justice Guidance on the Integration Mandate of Title II of the ADA and Olmstead v. L.C., Federal Register, Statement of the Department of Justice on Enforcement of the Integration Mandate of Title II of the ADA and Olmstead v. L.C., ADA.gov.

More than 20 Democratic state attorneys general told a federal court that immigration officials shared Medicaid recipients’ data with the contractor Palantir, and that when the states asked whether the data had been deleted, the government first said yes and then found six people still had copies. The attorneys general, led by California, made the allegation in a motion filed July 16, 2026 in California v. HHS, an ongoing case before the U.S. District Court for the Northern District of California over a 2025 data sharing agreement between the Centers for Medicare and Medicaid Services and Immigration and Customs Enforcement that a court has partially blocked. According to the motion, immigration officials shared Medicaid data obtained from the Centers for Medicare and Medicaid Services with Palantir, whose ELITE software helps enforcement officers locate people for deportation, then told the states the shared data had been purged from a Microsoft Teams channel, only for a broader search a day later to turn up six users who still had copies. Confidence: dropped, since this account is based on reporting that cites the court filing rather than the filing itself, which was not independently reviewed for this issue. Source: ICE shared Medicaid data it wasn’t supposed to have with Palantir, NPR.

The Senate committee that oversees federal health agencies has two votes this week: one on a bill capping insulin at 35 dollars a month, the other on who runs the CDC. The Senate Health, Education, Labor and Pensions Committee will hold an executive session Wednesday, July 22, 2026 on 13 bills, including the INSULIN Act of 2026, which would cap monthly insulin costs at 35 dollars for privately insured patients and pilot a similar benefit for the uninsured, and the Patients Deserve Price Tags Act, which would expand federal price disclosure requirements for hospitals, providers and insurers. The same committee will then vote Thursday, July 23, 2026 on three nominations: Dr. Erica Schwartz to lead the Centers for Disease Control and Prevention, Sean Kaufman to be HHS assistant secretary for preparedness and response, and Keith Sonderling to be secretary of labor; both health nominees faced questions at their July 15 confirmation hearing about their independence from HHS Secretary Robert F. Kennedy Jr. on vaccine policy. Confidence: High on the schedule, bill list and nominees, since the committee’s own announcements confirm them; Low on whether any bill or nominee clears the committee, since the votes have not yet occurred. Sources: Senate HELP Committee to Vote on Bills Improving Families’ Access to Quality, Affordable Health Care, Senate HELP Committee to Vote on Health, Labor Nominations.

The House Ways and Means Committee advanced a bill that would force Medicare Advantage insurers to show their work on how they spend premium dollars, on a week when hospital and insurer price transparency split the committee along party lines. The committee approved seven Medicare bills July 15, 2026, including the Medicare Advantage Medical Loss Ratio Transparency Act, which would require Medicare Advantage insurers to publicly disclose how they allocate premium revenue between patient care and administration starting January 1, 2029, and the Health Care Price Certainty for All Americans Act, which would require hospitals, imaging centers, surgical centers and labs to disclose prices to employers and patients and require insurers to publish negotiated in-network and out-of-network rates. Six of the seven bills passed unanimously or near unanimously; the price certainty bill passed 25 to 15 on a party line vote, a split that signals it faces a harder path to the House floor than its companions. Confidence: High on the vote counts and bill content, since the committee’s own release confirms them; Low on floor or Senate prospects, since neither chamber has scheduled further action. Source: Ways and Means Committee Approves Legislation to Expand Access to Care for Rural Patients and Seniors, Improve Health Care Price Transparency, and Hold Health Care Empires Accountable, House Committee on Ways and Means.

HHS and the Department of Veterans Affairs signed a five year agreement to get ready for psychedelic drugs that do not exist yet, in case the FDA approves one for the more than 1 million veterans the agencies say could be affected. The Department of Health and Human Services and the Department of Veterans Affairs signed a memorandum of understanding July 13, 2026 to coordinate clinical trial research, train therapists, nurses and physicians to administer future rapid acting psychiatric drug products including psychedelic assisted therapies if the Food and Drug Administration approves them, and collect real world data on safety, effectiveness and cost for veterans with serious mental health conditions. The Department of Veterans Affairs currently runs 20 active clinical trials in the space backed by more than 23 million dollars in external funding, and HHS’s Health Resources and Services Administration opened a public request for information July 14, 2026 on how the health care workforce should prepare for any future approved psychedelic drug product. Confidence: High on the agreement’s existence, date and scope, since HHS’s own press release confirms them; Low on any near term change in what veterans can actually be prescribed, since no psychedelic drug product currently has FDA approval for these uses. Sources: HHS and VA Announce Partnership to Advance Rapid-Acting Mental Health Treatments for Veterans, U.S. Department of Health and Human Services, VA, HHS Sign MOU to Improve Cooperation on Psychedelic Drug Trials, U.S. Department of Veterans Affairs.