End of Year Flurry of Regulatory Action Released by HHS
Nancy Spector, MSC, WEDI Senior Director, Federal Affairs
As people were rushing around with final shopping, baking, and parties, the Department of Health and Human Services (HHS) and its agencies released proposed rules, requests for information, and new models. The following is a cheat sheet of the late 2025 regulatory activity from the Department, Assistant Secretary for Technology Policy (ASTP)/Office of the National Coordinator for Health Information Technology (ONC), and the Centers for Medicare & Medicaid (CMS).
Deregulatory Actions to Unleash Prosperity (HTI-5) NPRM
ASTP/ONC released the Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Notice of Proposed Rulemaking (NPRM) for a 60-day comment period. The proposed rule includes deregulatory actions to update the ONC Health IT Certification Program by removing redundant requirements, revising definitions to improve health information access, exchange, and use, and advancing artificial intelligence (AI)-enabled interoperability solutions. Resources available on the NPRM from ASTP/ONC include: HTI-5 Proposed Rule Overview Fact Sheet, HTI-5 Proposed Rule Chart of Proposed Changes to Certification Criteria, and HTI-5 Proposed Rule Information Session and slides. The deadline to submit comments is February 27.
Withdrawal of Non-Finalized HTI-2 Provisions
ASTP/ONC published a notice of withdrawal of the remaining non-finalized provisions of the Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (HTI-2) Proposed Rule, effective the December 29, 2025, notice date of publication. This action comes following review by ASTP/ONC of the HTI-2 Proposed Rule, comments received, and proposals not yet finalized, in addition to comments received from the several deregulatory requests for information (RFIs) during 2025. The intent of withdrawing the non-finalized provisions is to focus on deregulation, changes in applicable technologies, and emerging AI technologies. Proposals that have been withdrawn include adoption of certain U.S. Core Data for Interoperability data classes, adoption of updated encryption and decryption standards, revisions to minimum standards code sets, and revisions to certain definitions.
Price Transparency NPRM with 60-Day Comment Period
CMS, in partnership with the Departments of Labor and Treasury, published a Notice of Proposed Rulemaking (NPRM) updating the health care price transparency regulations. The intent of the proposed changes is to improve price transparency by reducing pricing data files’ complexity and size, making data clearer, and producing more usable information. Included in the NPRM are changes that:
- Require health plans and issuers to exclude certain data for services that providers would be unlikely to perform
- Reorganize In-network Rate Files by provider network rather than by plan
- Require Change-log and Utilization Files so users can easily identify what has changed in the files
- Reduce reporting burden for In-network Rate and Allowed Amount Files by requiring quarterly instead of monthly updates
- Increase the amount of out-of-network pricing information reported in the files
The proposed rule also would require group health plans and health insurance issuers to provide the same cost-sharing information online, in print, or via telephone. The deadline to submit comments is February 26. Additional information about the NPRM is available here.
RFI on the Adoption and Use of AI in Clinical Care
ASTP/ONC published an RFI seeking public comments on how HHS can accelerate the adoption and use of AI in clinical care. The RFI is specifically requesting feedback from those who are developing, evaluating, using, and receiving care from AI tools that are part of clinical care. Questions relate to regulation, reimbursement, and research and development and the impact of current HHS’ policies and actions on AI adoption. The deadline to submit comments is February 23.
New Proposed CMS Innovation Models
- LEAD Model to Expand Access to Accountable Care
The Long-term Enhanced ACO Design (LEAD) Model is designed for providers that have not yet joined accountable care organizations (ACOs). The model will address patients with high needs, such as dual eligibles and those who are homebound or home limited. It will begin on January 1, 2027, when the REACH Model ends, and extends for 10 years through December 31, 2036. Applications for the model will begin in March 2026.
- Proposed New Models to Lower Medicare Part B and Part D Drugs
Two new models are aimed at lowering costs of prescription drugs covered by Medicare Part B and Part D. The Global Benchmark for Efficient Drug Pricing (GLOBE) Model would help make Part B medications more accessible for Medicare patients, which would better enable them to follow their medication regimen. The deadline to submit comments on GLOBE is February 23. The Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model would lower costs of certain prescription drugs covered by Medicare Part D making it easier for Medicare patients to obtain their medications and follow their prescribed care. The deadline to submit comments on GUARD is February 23.
- ACCESS Model Focuses on New Technology to Improve Health
The Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model is an outcome-aligned payment approach for Medicare-enrolled care organizations and will expand access to new technology-supported care for improving health. Participating organizations will receive recurring payments for managing patients’ qualifying conditions, with full payment tied to achieving measurable health outcomes. The voluntary model will run for 10 years beginning July 5, 2026.
- MAHA ELEVATE Model to Promote Healthy Lifestyle
The Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence (MAHA ELEVATE) Model will provide approximately $100 million to fund three-year cooperative agreements for up to 30 proposals that promote health and prevention for Medicare beneficiaries. The model focuses on evidence-based, whole-person care including functional or lifestyle interventions and will gather and evaluate new data on cost and quality to inform future interventions promoting healthy lifestyle behaviors. CMS plans to release a Notice of Funding Opportunity in early 2026 for the first cohort, and the voluntary model will launch on September 1, 2026.
Funding Awards for Rural Health Transformation
CMS announced funding awards for all 50 states, part of the $50 billion Rural Health Transformation Program. In 2026, states will receive first-year awards from CMS averaging $200 million. The funding is part of the Rural Health Transformation Program’s effort to improve the health and well-being of rural communities. States are expected to address issues such as bringing more care within reach, strengthening and sustaining the rural clinical workforce, modernizing rural health infrastructure and technology, empowering community providers, and advancing innovative care models and payment reform. The Notice of Funding Opportunity provides additional information on the expected allocations to states.
WEDI will be thoroughly reviewing these NPRMs, RFI, notices, and announcements. We expect to hold Member Position Advisories (MPAs) on the HTI-5 proposed rule and AI RFI. An MPA is WEDI’s process to receive input and engage with our members to develop comments that are inclusive of the industry’s various stakeholders. Be on the lookout for announcements of these MPAs.
For WEDI members, be sure to join our Value-Based Care, Patient Experience, Privacy & Security Workgroups, Emerging Technology Subworkgroup, and No Surprises Task Group to hear more about these regulatory activities. Remember, all employees at a member company have access to WEDI’s workgroups and membership-only resources. Contact Ariana at apoole@wedi.org to get signed up. (And, contact Bill Allder at ballder@wedi.org about a WEDI membership if you are not a member.)
Set reminders on your calendar for February 23, 26, and 27, as these are the deadlines for submitting comments. February will be a busy month.