End of Year Flurry of Regulatory Action Brought to You by HHS, ASTP/ONC, and CMS
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), Assistant Secretary for Technology Policy (ASTP)/Office of the National Coordinator for Health Information Technology (ONC), and the Centers for Medicare & Medicaid (CMS) released proposed rules, requests for information, and new models. The following is a cheat sheet of the late 2025 HHS, ASTP/ONC, and CMS regulatory activity.
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) Proposed Rule 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 are 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.
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 a Request for Information (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 CMS Innovation Center announced the launch of the Long-term Enhanced ACO Design (LEAD) Model, which 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
The CMS Innovation Center announced two new models 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.
For tracking purposes, deadlines for submitting comments are February 23, 26, and 27. February will be a busy month.