From TekinHealthHealthcare Tech Field Notes

CMS announced that its ACCESS model will add tracks for heart failure, chronic obstructive pulmonary disease, substance use disorder and tobacco cessation starting in spring 2027. ACCESS is a voluntary 10-year Medicare model that pays participants for technology-enabled chronic care between visits. It launched on July 5, 2026, with tracks for hypertension, diabetes, chronic musculoskeletal pain and depression. Full payment depends on patients reaching defined outcomes, such as better blood pressure control. CMS says about 160 organizations joined at launch and that three in four Medicare beneficiaries qualify for at least one track.

Why it's notable: ACCESS is Medicare's main outcome-based payment route for virtual care, remote monitoring and connected-device programs. Adding common high-cost conditions like heart failure and COPD widens the pool of patients whose between-visit care clinics and digital health partners can be paid for.

CMS's proposed CY 2027 Medicare Physician Fee Schedule, released July 14, 2026, would pay for remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) only when the clinical staff doing the work are employed by the billing practice, not by a contracted vendor. It would also limit the services to established patients, require a separately billed initiating visit before monitoring starts, and revalue the device codes. CMS is also considering bundling the codes into four new G-codes. The same rule carries forward telehealth flexibilities through 2027 and proposes a roughly 1.7% cut to the main conversion factor. Comments were due September 14; if finalized, most provisions take effect January 1, 2027.

Why it's notable: Many practices run RPM through third-party vendors, so the proposal could force them to bring monitoring in-house or drop it. It follows an OIG finding that about 43% of 2022 Medicare RPM patients did not get all three required components.

Iowa Gov. Kim Reynolds signed House File 2635 on May 13, 2026, effective July 1, 2026. The law says insurers may not use artificial intelligence as the sole basis for denying, delaying or downgrading medically necessary care, and a human clinical reviewer must be involved. It also removes prior authorization for recommended cancer screenings, sets deadlines for insurers to tell hospitals the status of a claim, and requires clinical explanations when care is denied. The bill passed the Iowa House 87-0 and was opposed mainly by insurers.

Why it's notable: Iowa joined a growing list of states putting rules on insurers' use of AI in prior authorization, which gives clinics grounds to challenge denials that were never reviewed by a clinician.

On January 6, 2026, FDA Commissioner Marty Makary announced at the Consumer Electronics Show that the agency was relaxing oversight of some digital health products. The same day the FDA issued revised final guidance on clinical decision support (CDS) software, replacing its 2022 version, and on low-risk general wellness products. Under the CDS guidance, the FDA will generally not regulate software that gives clinicians a single recommendation, such as a specific drug to consider, if the software meets its other non-device criteria. The wellness guidance lets non-invasive wearables report readings such as blood pressure and blood glucose without FDA review, as long as they are marketed only for wellness and make no medical claims. The guidances were issued without a prior public comment period.

Why it's notable: More AI decision-support tools and consumer wearables can now reach clinicians and patients without FDA review, so validating them falls more on the health systems and clinics that adopt them.

On January 6, 2026, Utah's Office of Artificial Intelligence Policy and the startup Doctronic announced a 12-month pilot, set up through the state's regulatory sandbox, in which Doctronic's AI renews routine prescriptions for chronic conditions such as diabetes and hypertension. Reports put the list at about 192 drugs. Controlled substances, ADHD medications and injectables are excluded, and the first prescription must still come from a human clinician. The state agreed not to enforce its unprofessional-conduct rules against Doctronic as long as the company follows a contract with safety and privacy terms. Physicians review the AI's decisions at first, and uncertain cases are sent to clinicians. Doctronic told regulators its system matched physician treatment plans in 99.2% of 500 urgent care cases it reviewed.

Why it's notable: It is the first state-approved program in the US to let an AI system renew prescriptions on its own, which makes it a test case for how states may license autonomous clinical AI.

On December 22, 2025, HHS's Assistant Secretary for Technology Policy/Office of the National Coordinator (ASTP/ONC) proposed the HTI-5 rule. It would remove 34 of the 60 criteria in the ONC Health IT Certification Program and revise 7 others. One revision cuts back the Biden-era 'model card' transparency requirements for AI decision support tools in certified EHRs. The rule would also change the information blocking rules: it adds 'autonomous AI systems' to the definitions of access and use, drops the TEFCA manner exception, and narrows exceptions that let EHR developers limit third-party access. HHS estimates savings of $1.53 billion, and the rule was opened for 60 days of public comment.

Why it's notable: The certification program defines what every certified EHR must do, so this changes which features vendors are required to keep and how much they must disclose about the AI built into them. The information blocking changes are aimed at making it harder for EHR vendors to shut out AI tools and third-party apps that want patient data.

On December 1, 2025, the FDA said it had deployed agentic AI tools, which can plan and carry out multi-step tasks, to all of its employees. The agency listed uses including meeting management, premarket reviews, review validation, postmarket surveillance, inspections and compliance. Use is voluntary, and the models run in a secure GovCloud environment. The FDA says they do not train on staff inputs or on industry submissions. It also says all AI output is checked by staff before it goes into any regulatory action. The rollout builds on the Elsa generative AI tool launched in May 2025, which the agency says more than 70% of staff use.

Why it's notable: The regulator that clears drugs and devices is now putting AI agents into its own review work. That could affect how fast, and how consistently, applications from device makers and drug sponsors are handled.

When Congress failed to pass FY2026 funding and the federal government shut down on October 1, 2025, Medicare's pandemic-era telehealth flexibilities expired with it. Medicare telehealth coverage for most services was again limited to rural patients seen at approved originating sites instead of at home, audio-only coverage ended, and CMS's Acute Hospital Care at Home waiver, used by more than 400 facilities in 39 states, also lapsed. Behavioral health telehealth was largely protected by permanent law, and CMS said providers could hold telehealth claims while Congress acted. The spending bill that ended the shutdown in November restored the flexibilities through January 30, 2026, with retroactive payment for services delivered during the lapse.

Why it's notable: For six weeks, practices and hospital-at-home programs could not be sure Medicare would pay for virtual visits, which exposed how much U.S. telehealth still depends on short-term extensions.