WEDI MPA Event May 28 on CMS and ASTP/ONC Health Technology Ecosystem RFI. WEDI will hold a Member Position Advisory (MPA) event on Wednesday May 28 from 12:30 p.m. ET to 3:30 p.m. on the Centers for Medicare & Medicaid Services (CMS) and Assistant Secretary for Technology Policy (ASTP)/Office of the National Coordinator for Health Information Technology (ONC) Health Technology Ecosystem Request for Information (RFI). Questions in the RFI focus on digital health products for Medicare beneficiaries, the state of data interoperability, and the broader health technology infrastructure. Comments are due June 16. This is a members-only event. Register here for the program and download the list of RFI questions.
Feds Release Additional Health Care RFIs. The Departments of Labor, Health and Human Services (HHS), and Treasury are issuing a joint RFI that will soon be published. The intent of the RFI is to gather input on the implementation of the prescription drug machine-readable file disclosure requirements under the Transparency in Coverage final rules, including potential modifications to the disclosure requirements or additional technical implementation guidance to support the accurate and timely completion of the prescription drug file. The deadline for submitting comments will be 30 days from the date of the RFI’s publication in the Federal Register.
In addition, HHS published an RFI seeking input on opportunities to remove regulations, guidance, and other regulatory requirements that are unnecessary, burdensome, duplicative, or outdated. Questions in the RFI address what regulations could be modified, repealed, or reconsidered; what impact will result from the proposed changes; and what alternative approaches could be used that would impose less burden. Comments are due July 14.
Finally, HHS and the U.S. Food and Drug Administration (FDA) issued a call for public feedback through an RFI on eliminating outdated and unnecessary regulations with a deadline of July 14. Under the umbrella of HHS, the goal of these efforts is to decrease health care costs, remove barriers to the delivery of care, and increase innovation. Commenters have 60 days to respond and are encouraged to submit their ideas through the newly launched online portal at Regulations.gov/Deregulation.
MAHA Commission Report Released, Focuses on Children’s Health. The Make America Healthy Again (MAHA) Commission released a report focusing on the health and causes of chronic illness in today’s children. The report evaluates the role of nutrition, environmental factors, physical activity, and medications in children’s health. The MAHA Commission was created through Executive Order in February. Its next action, expected in August, is to develop a strategy to address the issues identified in the report.
Bipartisan Bill Introduced that Aims to Protect Kids Online. Sens. Marsha Blackburn (R-TN) and Richard Blumenthal (D-CT) re-introduced the Kids Online Privacy Act, which passed the Senate in July 2024 by a vote of 91-3. The bill, if enacted, would require social media platforms to enable stronger privacy settings by default, require platforms to take action to prevent and mitigate specific dangers to minors, give parents and educators new controls to help protect children, establish a mechanism to report harmful behaviors, and require independent audits and research on platforms’ impact on kids’ well-being.
Updates Coming to ACO REACH Model for Performance Year 2026. CMS outlined upcoming changes for the Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) model for Performance Year 2026 (PY 2026). The intent of the updates is to improve the sustainability of the model by adjusting the financial methodology. Updates include modification to risk score growth constraints, reduction of the regional component benchmark for all REACH ACOs, adjustment of the risk corridors, and revisions to the risk adjustment model. The complete list of changes is available here.
ONC Health IT Certification Developer Roundtable, May 28. Registration is open for the ASTP/ONC Developer Roundtable on Wednesday, May 28, at 12:00 pm ET. The agenda for the event includes condition and maintenance of certification, electronic prescribing testing tool, and general program updates. This event is open to all health IT developers, regardless of participation in the ONC Health IT Certification Program. Register for the webinar here.
ASTP/ONC Exercising Enforcement Discretion for Insights Condition. As part of its efforts to reduce regulatory burden, ASTP/ONC announced it is exercising enforcement discretion for Certified Health IT Developers for certain Insights Condition requirements. The Insights Condition and Maintenance of Certification requirements include seven measures that health IT developers under the ONC Health IT Certification Program must annually report on consistent with specified regulatory compliance timelines. The first required reporting begins in July 2027 and gradually increases to full reporting on all measures by July 2029. However, to meet these reporting requirements, health IT developers must begin annually collecting the data specified in each measure in the preceding year, starting in 2026. The Agency will focus enforcement only on the “use of FHIR in apps through certified health IT” measure. ASTP/ONC will continue to evaluate potential deregulatory actions for the Insights Condition and Maintenance of Certification requirements. More information on enforcement discretion is available here.
ONC Health IT Certification Program Provides New and Updated Inferno Test Kits. ONC recently updated its Inferno on Health IT.gov testing resources as follows:
New Test Kits:
- Central Cancer Registry Reporting Test Kit v0.9.1
- Cancer Pathology Data Sharing Test Kit v0.9.1
Updated Test Kits:
- ONC Certification (g)(10) Standardized API Test Kit v7.2.2
- SMART App Launch Test Kit v0.6.3
- Da Vinci PAS Test Kit v0.13.1
- UDAP Security Test Kit v0.11.4
- US Core Test Kit v0.11.2
- UDS+ Test Kit version 1.2.1
Inferno on HealthIT.gov is a public service for running select HL7® FHIR® conformance tests.