Regulation
24 items from the daily postsRegulators, payers and courts: FDA, CMS and Medicare, HHS, Congress, the states, and who gets sued. Each item links to the day it ran and to its original source.
- Regulation Sept 23, 2026STAT reported that UnitedHealth Group, CVS Health and Kaiser Permanente each sent CMS letters opposing the proposed 2027 fee schedule provision that would allow remote physiologic monitoring only when the clinical staff are employed by the billing practice, a change that would end the vendor-run model most small practices use. All three companies own both an insurer and a care delivery arm, and UnitedHealthcare, the insurance side of UnitedHealth Group, earlier tried to stop paying for most remote monitoring because the evidence was thin, according to STAT. The companies asked for "focused guardrails on RPM instead of a ban on vendors." Physician in the Loop reported Sept. 16 that 22 states are putting rural transformation money into the same service CMS proposes to restrict. The final rule is expected around Nov. 1.From the Sept 24, 2026 post · Source: STAT
- Regulation Sept 18, 2026In a Sept. 18 letter to Dr. Mehmet Oz that Fierce Healthcare reported Tuesday, Dr. John Whyte, the AMA's chief executive, asked CMS to "stay the course" on the electronic prior authorization (ePA) requirements of the 2024 interoperability rule, whose API deadline is Jan. 1, 2027, and not to grant payers or vendors broad enforcement discretion through 2027. Whyte called the insurers' position that physicians are unwilling to use ePA a "manufactured problem," said practices are not getting implementation timelines or testing from their EHR vendors and plans, and asked CMS to require vendors to publish both. In the AMA's own December survey, 33% of 1,000 physicians said they believed the payers' 2025 pledges would make a difference, and the projected savings are about $15 billion over 10 years. Holland & Knight's summary of the more than 40,000 comments on the 2027 fee schedule lists widespread opposition to mandatory ePA "before the underlying technology is broadly available and proven effective," alongside opposition to the conversion factor cut, the same-day E/M reduction and the remote monitoring restrictions; the final rule is due around Nov. 1.
- Regulation Sept 22, 2026The Senate HELP Committee hears the nomination of Dr. Heidi Overton, who also holds a Ph.D., to be commissioner of food and drugs on Thursday, Sept. 24, at 10:30 a.m. Eastern time in 430 Dirksen, a hearing announced Sept. 17. Overton is a deputy director of the White House Domestic Policy Council, according to BioSpace, which reported in August that the FDA planned a deputy commissioner for "the intersection between health and AI"; The Cancer Letter reported Sept. 11 that Jared Seehafer, a former regulatory-software founder and FDA policy adviser, now holds that job as the inaugural deputy commissioner for technology and AI. The nominee would inherit an Aug. 18 discussion paper that proposes testing generative models the way a clinician is tested, with comments due Oct. 19; formal guidance promised by the agency's digital health center; a Sept. 17 final order that kept radiology AI under 510(k) review; and an agency that STAT reported lost about 5,000 people last year and cannot rehire fast enough. The FDA's AI-enabled device page, refreshed Tuesday, now says "over 1,600," up from the 1,500 in this site's long read.From the Sept 23, 2026 post · Sources: Senate HELP Committee (hearing page), Senate HELP Committee (announcement), FDA (AI-enabled medical devices), The Cancer Letter, BioSpace, FDA (generative-AI discussion paper), STAT (guidance coming), Federal Register (radiology AI final order), STAT (FDA hiring)
- Regulation Sept 21, 2026The summit's site lists the sponsors and partners of the one-day event at the Waldorf Astoria in Washington: GRAIL, ResMed, Advocate Health, Anthropic, Candid Health, Compass Pathways, Hims & Hers, Noom, OpenAI, Sutter Health, Centene, Prenuvo, Sword Health, Tempus, Walmart and a dozen smaller names. The event is run by MAHA Center, a nonprofit built around the movement of Robert F. Kennedy Jr., the secretary of the Department of Health and Human Services (HHS), and its speakers include Anthropic's Syed Mohiuddin, OpenAI's Felipe Millon and Dr. Jay Bhattacharya, the director of the National Institutes of Health. Sponsorship buys a private dinner with the summit's speakers, HHS officials among them, and executives from UnitedHealth, Elevance and the insurers' trade group are taking part, Becker's Hospital Review reported. The top package was pitched at $300,000 for a speaking slot, a say in panel topics and a dinner for 30 with Kennedy and Dr. Mehmet Oz, according to a report relaying Bloomberg's account; an HHS spokesperson said the department had no part in the sponsorship planning, and the price has not been independently verified. The sponsor list includes two AI model developers with clinical products, a direct-to-consumer telehealth company, two ACCESS participants, Noom and Sword Health, which now owns Headspace, a full-body MRI seller and a company that won Advanced Research Projects Agency for Health (ARPA-H) funding for autonomous cardiology; no physician society appears on it. The sponsorships come a week before comments close on the FDA's generative-AI paper and as Medicare officials discuss a payment category for AI physicians.
- Regulation Sept 20, 2026Gov. Gavin Newsom's Sunday legislative update lists 83 bills signed and 24 vetoed. Among the vetoes is AB 539, by Assemblymember Pilar Schiavo, which would have required health plans to honor a prior authorization for at least a year, or for the full course of a shorter treatment; it cleared the Senate 31-0 and the Assembly 64-4, and the California Hospital Association supported it. AB 539 is not an AI bill. AB 1979, AB 2575, SB 903 and SB 503 appear on neither Sunday's list nor Monday's, when the governor signed seven data-center bills on water and power reporting and said nothing about health. All four AI bills passed with a handful of votes against them, and all four are opposed by hospitals, insurers or technology companies, or all three. Among the questions the four bills would settle is whether an AI can direct a medical assistant; the governor has eight days left to act.
- Regulation Sept 18, 2026Kinsey Fabrizio, the association's president and CEO, wrote in Fierce Healthcare on Sept. 18 that more than 240 health AI bills have been introduced across 43 states this year, that at least 20 state privacy laws now govern health data and that the patchwork will delay tools for the 77 million Americans in primary care shortage areas. The op-ed offers the association's own consensus standard for post-market AI monitoring, written with more than 75 organizations, as the model for a national rule, and it cites the association's own survey figures: 41% of consumers using AI for health information and 33% of users of web-based health assistants reporting satisfaction. The bill count and the survey figures are the trade group's own. The same day, Newsom's executive order directed California agencies to speed up SB 813 and AB 1405, the state's frontier-model oversight laws, and to convene experts within two months on an AI kill switch; the order does not mention health care or the four health bills on the governor's desk, which face a Sept. 30 deadline. The op-ed joins preemption arguments made this year by the Justice Department in Colorado and in the draft Great American AI Act.
- Regulation Sept 17, 2026Harrison.ai, a Sydney company with nine FDA clearances across 13 indications, petitioned in October 2025 for a partial exemption from premarket notification for computer-aided detection, diagnosis, triage and notification software and medical image analyzers, on the condition that the maker already held clearances and ran a post-market surveillance plan. The Sept. 17 order, docket FDA-2025-P-5560, said the petition "does not demonstrate that premarket notification is not necessary to assure the safety and effectiveness" of the devices under 21 CFR 892.2060, 892.2070, 892.2080 and 892.2090, and it took effect the day it was published. In the April denial letter, the agency said that holding a clearance "may not reflect that a manufacturer is proficient" in the processes needed for the next device, that a detection tool and a diagnosis tool are not the same thing, and that a radiologist cannot be counted on to catch a faulty algorithm because the truth about the image "may not be routinely available" before the output leads to a misdiagnosis. The docket drew more than 45 comments, most of them against the petition; Harrison.ai said AI touches about 1% of U.S. diagnostic radiology work against a far higher share abroad, the company's own figure, and said the remedy is for the agency to accept standalone performance studies instead of multi-reader trials. The order leaves the premarket review requirement for radiology triage and detection tools in place; the same agency in August proposed testing generative AI models the way clinicians are tested.
- Regulation Sept 17, 2026ATA Action, the American Telemedicine Association's advocacy arm, announced the Cross-State Care Coalition on Sept. 17 with Johns Hopkins Medicine as co-chair and Access TeleCare, AdventHealth, Clara, MedStar Health, Ohio State's Wexner Medical Center, Sanford Health, Talkiatry and Teladoc Health as founding members. The coalition is seeking federal legislation creating "narrow, clearly defined" pathways for a physician licensed in one state to treat a patient in another in named situations: follow-up with an established clinician, specialty and rare-disease care, second opinions, federally regulated trials, and what the release calls technology-enabled services, with states keeping standards of care, discipline and malpractice. "This is not about federalizing medical licensure," Kyle Zebley, who runs ATA Action, said; no bill carrying the proposal has been drafted. AI-first care companies that operate across state lines hold a license in each state where they treat patients, and the number of licensed physicians such a company needs is set by those state requirements; a federal pathway for technology-enabled services would reduce that number. The Federation of State Medical Boards said in August that AI is not ready for a license of its own; the coalition is not asking for one.
- Regulation Sept 18, 2026SB 503, by state Sen. Akilah Weber Pierson, passed the Senate 39-0 and the Assembly 70-1 and was presented to the governor on Aug. 30, making it the fourth health-AI bill awaiting action by the Sept. 30 deadline. The enrolled text requires developers of AI clinical decision support to identify known or reasonably foreseeable risks of biased impact, attempt to mitigate them and provide deployers a statement of intended uses and documentation on training data, performance evaluation and bias mitigation; deployers, defined to include health facilities, clinics, physician offices and group practices, must "regularly monitor" the system for biased impact and take reasonable and proportionate steps when they find it. The text sets no deadline and names no enforcer. The Transparency Coalition's Sept. 18 tally lists the bill beside AB 1979, AB 2575 and SB 903, all awaiting action by Sept. 30, and the governor on Friday issued an executive order on frontier-model oversight that does not mention any of the four. The monitoring duty would fall on a solo practice with a risk-score tool in its electronic health record as well as on a hospital.
- Regulation Sept 18, 2026The bill, by state Sen. Steve Padilla, cleared both chambers with four votes against it, passing the Senate 39-0 and the Assembly 71-4, and was presented to the governor Sept. 9. On Friday the Senate Democratic caucus released a campaign by licensed mental health professionals urging the governor to sign it. The enrolled text bars any person or company from providing or advertising therapy or psychotherapy unless a licensed professional conducts it, bars licensed clinicians from letting an AI make independent therapeutic decisions or communicate therapeutically with a client, requires consent before AI touches session recordings and sets civil penalties of up to $10,000 per violation. The caucus release describes the bill as a response to the Trump administration's push to put AI therapy agents into Medicare, which the ACCESS model does for depression and anxiety. Gov. Gavin Newsom has until Sept. 30 to act on bills from the end of the session, the same deadline that applies to AB 1979 and AB 2575.
- Regulation Sept 10, 2026In Raphael v. Mantei, a Clark County Superior Court judge held Aug. 7 that the recording a DAX ambient scribe makes to draft the note is an administrative document exempt from patient disclosure under the state's Uniform Health Care Information Act, the American Medical Association (AMA) reported Sept. 10. The AMA Litigation Center, the Washington State Medical Association and the Washington State Hospital Association filed together for the clinic, arguing that only the physician's final note is the record of care. Separately, Confluence Health said its primary care physicians cut daily EHR time by 34 minutes, and Ohio State told Becker's Hospital Review that AI visit summaries save 15 to 20 minutes per encounter. How long the audio exists depends on the vendor's retention policy.
- Regulation Sept 16, 2026Murray's office posted the exchange from the Sept. 16 hearing. Murray said the Washington state contractor denied more requests than it approved in the first three months, that the vendors "are paid based on the number of claims they deny," and that a CMS Office of the Actuary memo warned participants would have an incentive to deny as many claims as possible. Klomp first said his understanding was that the contractors are "not" paid on denial volume; he then acknowledged financial penalties for inappropriate denials, said the Innovation Center monitors performance and agreed the program must be done appropriately or should not expand. Murray called the program one that "is really hurting patients" and said she would fight the planned expansion to oncology, which matches a June 2025 Innovation Center plan, contained in the records EFF reported on, that contemplated cancer treatment, MRI and air ambulance. Klomp, as deputy secretary, would oversee the program.
- Regulation Sept 16, 2026The Sept. 16 policy applies to the State Employee Health Plan and the Partnership Plan for municipal workers, with Anthem on medical, Cigna on dental, Aetna on retiree Medicare Advantage and Caremark on pharmacy, according to CT Mirror, which reported a Jan. 1, 2027, effective date. Under the five rules, no adverse determination may be "made solely by an AI system" and each must be reviewed by a human; carriers may not use AI as the sole basis to "downcode claims, reduce provider payments, or alter billing codes without human review"; disclosure is required when AI is materially assisting with or recommending a benefit or service; member data may not be used to train or develop other models; and AI systems must be validated for accuracy, consistency and fairness, with governance procedures disclosed to the comptroller. Scanlon said that "you and your doctor should make your health care decisions, not artificial intelligence," and that he plans to recommend the legislature extend the protections next session to all state-regulated plans, which CT Mirror said cover about 220,000 residents. Alabama, Georgia and Minnesota require human review of payer utilization decisions by statute; Connecticut's requirement comes through the plans' own rules for their carriers.
- Regulation Sept 16, 2026In her Sept. 16 State of the Union address, the European Commission president, who trained as a physician, said she wants her doctor to have instant AI access to the data needed for the best diagnostic or treatment choice and does not want her doctor to be a robot, and she cited AI-supported mammography as the example of what Europe should scale. She named health as one of five sectors for industrial AI initiatives the Commission will announce in November, with no money or rules attached yet. Health Commissioner Olivér Várhelyi wants to use Europe's data and research infrastructure to speed adoption, Euronews reported. In Washington, officials have discussed paying company-run AI physicians 60% to 80% of the human rate, and the CMS administrator has promoted AI avatars for rural care.
- Regulation Sept 16, 2026In its ACCESS announcement Tuesday, CMS said three out of four people with Medicare now qualify for at least one track, that 18 clinical and patient societies back the model and that "major health payers representing 165 million Americans with Medicare Advantage, Medicaid, and private health insurance plans" have pledged to adopt an outcomes-based payment structure aligned to it. Fierce Healthcare counted 17 payers and reported that CMS is publishing sample provider agreements, standardized billing codes and reporting infrastructure so Medicaid programs can adopt the model, quoting Jacob Shiff, the Innovation Center's chief AI officer, as saying it was designed "from day one" for impact beyond Original Medicare. Heart failure, chronic obstructive pulmonary disease (COPD), substance use and nicotine dependence join the model in spring 2027. The structure that lets Headspace, Noom and WeightWatchers bill Medicare for chronic-condition management would extend to commercial and Medicaid contracts under the pledges, with payment tied to outcomes such as blood pressure and A1c.
- Regulation Sept 15, 2026The Energy and Commerce Health Subcommittee took testimony Sept. 15 on 17 bills, including H.R. 9693, the Patients First Act, sponsored by three physician members of the House, John Joyce, Kim Schrier and Greg Murphy. The bill would tie the fee schedule to the Medicare Economic Index minus one point (minus half a point for alternative payment model participants), raise the budget-neutrality trigger from $20 million to $57.64 million in 2028 and replace the Merit-based Incentive Payment System (MIPS) over five years; the Provider Reimbursement Stability Act, H.R. 8163, addresses only the budget-neutrality change. Medicare physician payment has fallen about 33% against practice-cost inflation since 2001, according to the American Medical Association (AMA). A legislative hearing is not a markup, and no vote is scheduled. The conversion factor is set to drop another 1.19% on Jan. 1.
- Regulation Sept 14, 2026The Alliance for Connected Care counts 22 states with roughly $240 million in remote patient monitoring (RPM) funding and 35 states with more than $2.4 billion in broader remote-care technology money, all drawn from the $50 billion Rural Health Transformation Program, Fierce Healthcare reported. The proposed 2027 fee schedule would limit remote physiologic and therapeutic monitoring to clinical staff employed by the billing practice, a change the American Telemedicine Association said would make the service unworkable for small practices; CMS received nearly 40,000 comments. Medicare RPM payments rose 31% to $536 million in 2024 and reached about 1 million beneficiaries. The final rule is expected around Nov. 1. Practices that bill the RPM codes 99454 and 99457 through a vendor would fall under the proposed staffing limit.From the Sept 16, 2026 post · Source: Fierce Healthcare
- Regulation Sept 14, 2026The New York Times reported Sept. 14 that federal officials have discussed a new Medicare payment category for AI clinical software, with rates for AI physicians operated by technology companies at 60% to 80% of the human fee. Nothing has been proposed. Dr. John Whyte, chief executive of the American Medical Association (AMA), said autonomous models are not ready.
- Regulation Aug 18, 2026The Food and Drug Administration (FDA) issued a discussion paper Aug. 18 proposing a two-axis risk framework and "competency-based" premarket evaluation for generative-AI devices, with postmarket monitoring. The agency's digital health chief said formal guidance is coming. The docket is open until Oct. 19.From the Sept 16, 2026 post · Source: FDA
- Regulation Sept 15, 2026Medicare's ACCESS model, which launched in July and pays for technology-enabled care of hypertension, diabetes, musculoskeletal pain, depression and anxiety, now has about 160 participating organizations and adds heart failure, COPD, substance use and tobacco next spring, the Centers for Medicare & Medicaid Services (CMS) said. Paired with the FDA's TEMPO pilot, tools that have never been cleared, including a voice-AI therapy program, are treating beneficiaries under enforcement discretion in exchange for data. The CMS administrator described the program as access to "AI-enabled technologies."
- Regulation Sept 15, 2026About 1,000 pages of records obtained by the Electronic Frontier Foundation (EFF) show that one vendor in Medicare's WISeR prior-authorization pilot told CMS before launch it would auto-affirm requests because it was not ready, two vendors denied more than 20,000 requests in three months, vendors are paid per denial and one request sat for 83 days. A Senate vote to end the program failed 46-50 in July.
- Regulation Aug 12, 2026Manatt Health's tracker counts 33 health-AI laws in 22 states through July. The laws typically require AI disclosure to patients, licensed accountability for clinical use, human review of payer denials and a bar on chatbots posing as therapists. Colorado's HB 1177 took effect Aug. 12 and requires licensed oversight of any clinical AI. California's AB 1979, which would bar AI from performing licensed work or directing unlicensed staff, sits on the governor's desk until Sept. 30. No state has authorized an AI to practice medicine, and of 20 liability bills introduced, none passed.From the Sept 16, 2026 post · Source: Manatt Health
- Regulation Sept 10, 2026AB 1979 (Bonta) would prohibit health facilities, clinics and physician offices from allowing AI to independently perform clinical functions that require a licensed professional or to direct unlicensed personnel to carry out licensed duties; AI could inform a decision if a licensed professional keeps final authority, and documentation, routine communications and supervised education are exempt. It would also make direct-to-consumer health chatbots that handle medical records subject to California's medical confidentiality law. AB 2575 (Ortega) would protect clinicians who override unsafe AI output and bar developers from shifting blame for AI-caused harm onto the workers using it. Both bills cleared the Legislature by Aug. 31 with the California Nurses Association as sponsor and hospitals, insurers and technology firms opposed; enforcement would run through the licensing boards, effective Jan. 1, 2027, if signed.
- Regulation Sept 15, 2026Roughly 1,000 pages of WISeR records, won by EFF in a Freedom of Information Act suit, show Virtix denied more requests than it approved in its first three months and was required to submit a corrective action plan, Fierce Healthcare reported, adding detail to earlier STAT coverage. The records also show that Innovaccer told CMS before launch it needed more time and was still working backlogs in early April, that vendors and Medicare contractors miscommunicated and mis-categorized requests, and that low quality scores cut vendor pay by 5% to 10%. EFF's write-up said the Innovation Center's June 2025 investment plan considered adding services that need urgent authorization, including air ambulance, cancer treatment, MRI and medications without public coverage criteria. The CMS WISeR page, updated Sept. 10, lists the original service categories and no expansion. CMS has not responded to the records.