Happenings on the Hill
Congress is back in session this week following the holiday recess and faces a packed agenda with several high-stakes issues. Top of mind is the impending government funding deadline, which also governs the status of Medicare telehealth flexibilities and the Acute Hospital Care at Home program, both of which are set to expire on January 30, 2026, unless Congress acts again. While another extension is widely expected, the length remains unclear, and advocacy for long-term solutions is ongoing. Lawmakers are also dealing with pending appropriations votes, a potential war powers resolution related to Venezuela, and debates over Affordable Care Act subsidies.
Although a partial government shutdown is technically possible, leaders in both parties have publicly stated they want to avoid a repeat of last year’s shutdown and are prioritizing keeping the government open. ATA Action has a full slate of meetings scheduled over the coming weeks to gather intelligence, engage with lawmakers and staff, and advocate for stability and long-term telehealth solutions. Prior to the break, there were early discussions about a potential two-year extension of key telehealth policies, but there has been no recent confirmation, and earlier timing suggested action closer to spring or summer. We will continue to closely monitor developments and keep members informed as more clarity emerges from Capitol Hill.
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NYE Win for Telehealth, Just Hours Before the Remote Prescribing Deadline
On December 31, 2025, the Drug Enforcement Administration (DEA) granted a clean, one year extension of the remote prescribing of controlled substances flexibilities just hours before the midnight deadline. This one-year extension – the fourth since these waivers were put in place during the pandemic – is a major relief for patients and healthcare providers, restoring certainty and avoiding treatment gaps for millions of Americans, especially individuals with mental and behavioral health needs.
Importantly, this extension (through December 31, 2026) also gives ATA Action and other key stakeholders time to continue working with the Trump Administration, the DEA, the U.S. Department of Health and Human Services (HHS), and our bipartisan champions in Congress to establish a permanent and workable framework that guarantees appropriate and necessary access to care.
We continue to support a permanent Special Registration framework that enables responsible patient care and equips the DEA with appropriate tools to prevent misuse. We also encourage the DEA to seek provider feedback when developing safeguards to reduce diversion, improve access to essential prescriptions for mental health, substance use disorder, and other chronic conditions, and prioritize patient safety. ATA Action believes clinical decisions should remain the judgment of qualified medical professionals, supported by regulatory frameworks that protect patients and promote responsible care.
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FDA Announces Sweeping Changes to Oversight of Wearables, AI-enabled Devices
Earlier this week, the Food and Drug Administration (FDA) announced relaxed regulations for digital health products, including AI-based clinical decision support software which include AI-enabled products that help doctors navigate diagnoses and treatment options. Previously, products that delivered a single recommendation were regulated as medical devices, but such products can now enter the market without FDA review if they meet certain criteria. This change could allow generative AI tools to be used unregulated for tasks like summarizing radiology findings.
ELEVATE AND ACCESS Programs
The Centers for Medicare and Medicaid Services (CMS) announced two new initiatives, the CMS Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model and the Make America Health Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence (MAHA ELEVATE) Model.
- The CMMI ACCESS Model is a 10-year national test of a voluntary “outcome aligned” payment approach under Fee-for-Service Medicare designed to expand access to technology-supported care for people with certain chronic conditions.
- The MAHA ELEVATE Model will provide approximately $100 million to fund three-year cooperative agreements for up to 30 organizations that either provide “whole person” functional or lifestyle medicine services that are not covered by Medicare.
We want to hear from you! Please reach out to Alexis Apple at aapple@ataaction.org with your questions and recommendations for making these programs successful and watch for upcoming meetings soliciting member feedback.
FDA TEMPO Pilot Process Begins
Aligned with CMMI ACCESS initiative, the FDA recently launched its new pilot program, Technology-Enabled Meaningful Patient Outcomes (TEMPO), aimed at accelerating access to digital health technologies targeting the conditions managed under the new CMMI model. Under TEMPO, FDA may allow companies participating in ACCESS to seek temporary enforcement discretion while collecting real-world data to support future FDA authorization. FDA is currently accepting statements of interest by email for participation in the program, which are expected to be followed by requests for more information from the agency in early March.
HHS and ASTP/ONC RFI on AI in Clinical Care
HHS, through the Office of the Deputy Secretary and ASTP/ONC, is seeking public input on accelerating the adoption of artificial intelligence in clinical care, including feedback on regulation, reimbursement, research, and implementation challenges. The agencies have posed 10 questions to inform HHS-wide approaches across regulation, reimbursement, and R&D. Comments are due February 23, 2026, and ATA Action is preparing a response based on member input. Please contact Alexis Apple (aapple@ataaction.org) with feedback.
New Pilot in Utah Allows Artificial Intelligence to Prescribe Medications
Last month, Utah launched a new pilot program that allows an AI system to handle routine prescription renewals for patients with chronic conditions. Patients will visit a webpage that verifies they are physically in the state, the system will pull the patient’s prescription history and then offer a list of medications eligible for renewal. The patient must then answer the same clinical questions a physician would ask to determine whether a refill is appropriate. If the system clears the renewal, the prescription is sent directly to a pharmacy. This pilot program is limited to 190 commonly prescribed medications.