The following is the latest health policy news from the federal government for February 13-19.  Some of the language used below is taken directly from government documents.

Congress

Congress is not in session this week and will return on Monday, February 23.

The House Ways and Means Committee will hold a hearing titled “Next Generation of Health Care Workforce” on Tuesday, February 24.  View a livestream of the hearing here.

The Courts

A federal court has vacated the Federal Trade Commission’s (FTC) 2024 overhaul of the Hart-Scott-Rodino Premerger Notification Rule.  That rule expanded disclosure requirements, requiring filings for transactions valued at more than $133.9 million, subject to specific size-of-person tests.  The regulation required businesses, including hospitals and health systems, to provide more information to the FTC as they worked toward agreements for mergers and acquisitions.  The court found that the FTC had exceeded its authority with the expanded requirements.  Learn more from the court’s ruling in the case.

340B Request for Information

Only a week after a federal court rejected for a second time its attempt to introduce a new approach to administering the 340B Drug Pricing Program, the Health Resources and Services Administration (HRSA) began laying the groundwork for another attempt to institute the same rebate model for the program.  It did so by issuing a Request for Information (RFI) to gather input from interested parties on whether the agency should implement a rebate model under the 340B program and how best to implement such a model.  The RFI notes that in 2024, HRSA began receiving inquiries from drug companies seeking to implement different rebate models for the 340B program and that last August the agency published a notice inviting pharmaceutical companies to voluntarily participate in a proposed “340B Rebate Model Pilot Program.”  Until that time, the program did not employ rebates; instead, 340B-eligible providers received discounts for the prescription drugs they purchased for their patients.  Eligible providers filed suit to enjoin implementation of the rebate pilot, and after two setbacks in federal court, HRSA announced that it would cease pursuing implementation of its August proposal.

Now, only a week after this setback, HRSA is requesting comments from stakeholders to further evaluate the potential costs and benefits of a rebate model.  HRSA seeks comments on a range of issues, including:

  • administrative, operational, financial, and medication access concerns in connection with rebate models;
  • eligible providers’ desire to continue obtaining 340B ceiling prices through upfront discounts and whether that expectation is “reasonable” in light of the Secretary of Health and Human Services’ expressed statutory authority to provide for discounts via “rebate or discount;”
  • the potential impact on providers’ cash flow; and
  • proposed alternatives and scope-limiting measures to inform a rebate pilot design.

HRSA also seeks comments on costs for covered entities; payment timing and potential cash flow effects for covered entities; rebate denials; data collection by covered entities; manufacturer efforts to avoid duplicate discounts; required reporting; 340B program integrity; and other potential benefits of a rebate pilot.

Learn more about the events that led to the issuance of this RFI, the issues for which HRSA seeks stakeholder input through the RFI, and how to submit comments from this HRSA notice.  The deadline for stakeholders to submit comments is March 19.

Centers for Medicare & Medicaid Services
  • CMS has proposed a revision of a currently approved data collection titled “Information Collection:  CMS Electronic Data Interchange (EDI) Enrollment Registration, CMS EDI Enrollment Form, and CMS EDI Enrollment Attestation Form.”  This collection consists of three forms used by Medicare providers and suppliers to register for EDI services with Medicare contractors.  The updated collection includes the revised CMS EDI Registration Form (10164A) and CMS EDI Enrollment Agreement Form (10164B) and introduces the CMS EDI Enrollment Attestation Form (10164C), a new mandatory attestation form requiring formal compliance verification from all participating entities.  These forms collect essential information necessary to identify Medicare providers and suppliers during electronic transactions, authorize requested EDI functions, and establish appropriate access privileges for health care entities.  They ensure compliance with HIPAA transaction standards while implementing strengthened security requirements for billing vendors and clearinghouses that handle Medicare data.  The information collected in the forms will be uploaded into Medicare contractor computer systems and those contractors will store this information in a database used for provider connection to the Medicare Data Contractor Network.  Transactions are then initiated after successful authentication.  Learn more about the changes to this existing data collection tool from this CMS notice.  The deadline for stakeholders to submit comments is March 16.
  • CMS’s home health prospective payment system grouper software (V07.126) is now available.  Go here to learn more about the software update, which takes effect on April 1, and to download the software itself.
  • CMS has added the following item to its Quality Payment Program resource library.  (Note:  clicking this link will automatically download a zip file.)
Department of Health and Human Services

HHS’s Office for Civil Rights has announced a new program to implement and enforce statutory and regulatory requirements that protect the confidentiality of substance use disorder patient records.  The new program executes the substance use disorder confidentiality provisions in the 2020 CARES Act, and beginning immediately, entities and persons subject to the regulation protecting the confidentiality of SUD patient records must comply with all applicable requirements.  Also beginning immediately, HHS’s Office of Civil Rights will accept complaints alleging violations of the regulation that protect the confidentiality of these patient records and notification of breaches of those records.  Learn more from this HHS news release.

HHS – Office of the Inspector General (OIG)

Learn more about the individual audits’ objectives and how the OIG envisions pursuing them by clicking the link on the individual review titles.

Medicaid State Plan Amendments

CMS has approved the following state plan amendments for Medicaid and CHIP programs.

  • To Delaware, providing for mandatory coverage in accordance with section 1902(a)(84) as well as 1905(a)(19) and 42 CFR 440.169, authorizing targeted case management for eligible juveniles who are incarcerated in a public institution post-adjudication of charges.
  • To Alaska, aligning the state’s alternative benefit plan with the Medicaid state plan by removing the September 30, 2025 sunset date for the medication-assisted treatment benefit and making that benefit permanent for the Medicaid expansion group.
  • To Oregon, expanding the Family Connects Oregon nurse home visiting program into Multnomah County.
  • To Wisconsin, removing the end date for the medication-assisted treatment benefit under the amendments made to statute as a result of the passage of the Consolidated Appropriations Act of 2024 and updating provider credentials for some providers to align with current federal and state requirements.
  • To Alabama, removing the expiration date for the medication-assisted treatment for opioid use disorder benefit.
  • To Kentucky, continuing coverage of over-the-counter COVID-19 test kits with limitations.
  • To Nevada, continuing the authority for the Indigent Accident Fund program, a supplemental payment program based on inpatient hospital utilization, to preserve access to inpatient hospital services through state fiscal year 2025.
  • To Montana, updating the alternative benefit plan templates to align Montana’s alternative benefit plan with Montana’s state plan.
State-Directed Medicaid Payments

CMS has approved the following state preprints for Medicaid state-directed payments.

  • To Colorado, to establish a uniform increase for professional medical services at an academic medical center for rating periods covering July 1, 2025 through June 30, 2026, to be incorporated into capitation rates through a separate payment term amount of up to $11.3 million.
  • To Pennsylvania, renewing a minimum fee schedule for behavioral health inpatient services and behavioral health outpatient services for the rating period covering January 1, 2026 through December 31, 2026, to be incorporated into capitation rates through an alternative fee schedule of up to $633.6 million.
  • To Pennsylvania, renewing a uniform percentage increase for dental services for the rating period covering January 1, 2026 through December 31, 2026, which is being incorporated into capitation rates through a risk-based rate adjustment of up to $63.4 million.
  • To Pennsylvania, renewing a minimum fee schedule for integrated community wellness centers for the rating period covering January 1, 2026 through December 31, 2026, which is being incorporated into capitation rates through a risk-based rate adjustment of up to $49.9 million.
  • To Arizona, renewing a uniform increase by the state for primary care, behavioral health outpatient, and justice-involved clinic services for the rating period from October 1, 2025 through September 30, 2026, which has been incorporated into capitation rates through a separate payment term up to $50 million.
  • To Florida, introducing a uniform percentage increase for inpatient and outpatient hospital services for rating periods covering October 1, 2023 through September 30, 2024, which was incorporated into capitation rates through a separate payment term amount of up to $452.8 million.
  • To Georgia, implementing a uniform percentage increase for inpatient hospital services and outpatient hospital services for the rating period covering July 1, 2025 through June 30, 2026, which is being incorporated into capitation rates through a risk-based rate adjustment of up to $155.7 million.
  • To Ohio, renewing a uniform percentage increase for inpatient and outpatient hospital services provided by non-profit adult hospitals located in Hamilton County that are affiliated with a public medical school and that maintain a Level 1 trauma designation for the rating period covering January 1, 2025 through December 31, 2025, which was incorporated into capitation rates through a separate payment term of up to $ 205.8 million.
  • To Ohio, renewing uniform increases established by the state for inpatient and outpatient services provided by all in-state hospitals for the rating period covering January 1, 2025 through December 31, 2025, which was incorporated into capitation rates through a separate payment term up to $3.9 billion.
  • To New Mexico, renewing a uniform increase for primary care services for the rating period covering January 1, 2026 through December 31, 2026, which is being incorporated into capitation rates through a separate payment term of up to $26 million.
  • To New Mexico, amending a value-based purchasing and uniform percent increase arrangement established by the state to increase nursing facility per diem rates by the market basket index factor and to provide quality incentive payments for nursing facilities that meet performance requirements on specified quality metrics for the rating period covering January 1, 2023 through December 31, 2023, which was incorporated into capitation rates through a risk-based adjustment.
  • To Massachusetts, renewing a primary care sub-capitated arrangement established by the state for the rating period from January 1, 2025 through December 31, 2027, which is being incorporated into capitation rates through a risk-based adjustment.
  • To Massachusetts, renewing an integrated care incentive program for non-state, public hospitals for the rating periods covering January 2, 2025 to December 31, 2027, which is being incorporated into capitation rates through a separate payment term of up to $148.8 million for January 1, 2025 through December 31, 2025; for $148.8 million for January 1, 2026 through December 31, 2026; and for $148.8 million for January 1, 2027 through December 31, 2027.
  • To Massachusetts, renewing a hospital quality incentive program for the rating period covering January 1, 2025 through December 31, 2027, which is being incorporated into capitation rates through a separate payment term of up to $160.8 million for January 1, 2025 through December 31, 2025; $160.8 million for January 1, 2026 through December 31, 2026; and $160.8 million for January 1, 2027 through December 31, 2027.
  • To Massachusetts, renewing the performance improvement initiative for professional services program for the rating period covering January 1, 2025 through December 31, 2027, which is being incorporated into capitation rates through a separate payment term of up to $75 million for January 1, 2025 through December 31, 2025; $75 million for January 1, 2026 through December 31, 2026; and $75 million for January 1, 2027 through December 31, 2027.
  • To Massachusetts, renewing the minimum fee schedule for behavioral health outpatient services, including 24-hour diversionary substance use disorder services and behavioral health diversionary services, for the rating period covering January 1, 2025 through December 31, 2025, which was incorporated into capitation rates through a risk-based rate adjustment of up to $156.2 million.
  • To Iowa, renewing a uniform percentage increase for inpatient and outpatient hospital services provided at qualifying Iowa state-owned or operated teaching hospitals as defined in the Medicaid state plan for the rating period covering July 1, 2025 through June 30, 2026, which is incorporated into capitation rates through a separate payment term amount of up to $704.7 million.
  • To Iowa, renewing a uniform percentage increase for physician and professional services provided at qualifying Iowa state-owned or operated professional services practices as defined in the Medicaid state plan for rating periods covering July 1, 2025 through June 30, 2026, which is being incorporated into capitation rates through a separate payment term amount of up to $136.8 million.
  • To Iowa, renewing a uniform percentage increase for inpatient and outpatient hospital services provided at qualifying non-state owned or operated hospitals as defined in the Medicaid state plan for rating periods covering July 1, 2025 through June 30, 2026, which is being incorporated into capitation rates through a separate payment term amount of up to $1.5 billion.
  • To New Jersey, introducing a uniform dollar increase for primary care services to meet Healthy Steps model fidelity for the rating period covering July 1, 2025 through June 30, 2026, which has been incorporated into capitation rates through a risk-based rate adjustment of up to $98,385.
  • To North Carolina, amending a uniform dollar increase and minimum fee schedule for home- and community-based services and behavioral health outpatient services established by the state for the rating period covering July 1, 2025 through June 30, 2026, which is being incorporated into capitation rates through a risk-based rate adjustment of up to $374.7 million.
  • To North Carolina, revising the minimum fee schedule established by the state for eligible non-state government-owned nursing facilities for actual utilization of services for the rating period covering July 1, 2025 through June 30, 2026, which has been incorporated into capitation rates through a risk-based rate adjustment of up to $5.7 million.
  • To Nevada, renewing a quality payment/pay for performance (Category 2 APM, or similar) for Certified Community Behavior Health Center services for rating periods covering January 1, 2026 through December 31, 2026, which is being incorporated into capitation rates through a separate payment term amount of up to $3.7 million.
  • To Texas, revising Texas incentive physicians and professional services, which has components consisting of both uniform increases and pay for performance for eligible providers, for the rating period covering September 1, 2025 through August 31, 2026, which has been incorporated into capitation rates through a risk-based rate adjustment of up to $645.4 million.
  • To Vermont, renewing a value-based payment arrangement for the Vermont Medicaid Next Generation ACO program for the rating period covering January 1, 2025 through December 31, 2025, which was incorporated into capitation rates through a risk-based adjustment.
HHS Newsletters, Reports, and Videos
Centers for Disease Control and Prevention (CDC)

The CDC reported a drug-resistant Salmonella outbreak in seven states linked to Rosabella brand moringa powder capsules.  Three individuals have been hospitalized but no deaths have been reported.  Learn more from this CDC news release.

Government Accountability Office (GAO)

The GAO has published a report on private insurance and provider participation and payments for selected services before and after implementation of the No Surprises Act.  Find that report here.

Stakeholder Events

CMS – 2026 CMS Burden Reduction Conference – February 25

CMS will hold its 2026 Burden Reduction Conference on Wednesday, February 25.  The conference will be held in Washington, D.C., with options for individuals to attend in person or participate virtually.  Learn more from this CMS notice.  Registration information is not available at this time.

CMS – eCQI Resource Center – Expert-to-Expert Webinars on eCQM Annual Updates for 2026 – February 26, March 5, March 12, March 19

CMS’s eCQI Resource Center will hold expert-to-expert webinars offered in collaboration by the Joint Commission, CMS, and eCQM stewards.  The webinars will address the eCQM annual updates for 2026 implementation and offer continuing education credits for the live broadcast.  The webinar will address frequently asked questions and participants can submit questions for response.  The sessions, all to be held at 1:00 (eastern), are as follows:

  • February 26 – Annual Updates for PC-02 and PC-07 for 2026 Reporting Year – for more information and to register, go here.
  • March 5 – Annual Updates for STK and VTE eCQMs for 2026 Reporting Year – for more information and to register, go here.
  • March 12 – Annual Updates for Opioid Related Adverse Events eCQM for 2026 Reporting Year – for more information and to register, go here.
  • March 19 – Annual Updates for Hospital Harm-Pressure Injury eCQM for 2026 Reporting Year – for more information and to register, go here.

MedPAC – Commissioners Meeting – March 2-3

MedPAC’s commissioners will hold their next public meeting virtually on Monday, March 2 and Tuesday, March 3.  An agenda and registration information are not yet available but when they are they will be posted here.

MACPAC – Commissioners Meeting – March 5-6

MACPAC’s commissioners will hold their next public meeting virtually on Thursday, March 5 and Friday, March 6.  Go here to register to participate.

CMS – 2026 CMS Quality Conference – March 16-18

CMS will hold its 2026 Quality Conference on Monday, March 16 through Wednesday, March 18 in Baltimore.  The theme of the conference will be “Make America Healthy Again:  Innovating Together for Better Health.”  Interested parties can participate in person or virtually.  Learn more about the conference and how to register to participate from this CMS announcement.

HHS Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology/Health Information Technology Advisory Committee – May 7

The Health Information Technology Advisory Committee of HHS’s Office of the Assistant Secretary for Technology Policy will hold its next meeting on Monday, February 19 at 10:00 (eastern).  This committee’s role is to identify priorities for standards adoption and make recommendations to the Assistant Secretary for Technology Policy.  Learn more about the committee, its structure, and its purpose from this HHS notice, which also outlines the meeting’s agenda.  Information about how to participate in the meeting is not yet available but when it is it will be posted here.  Other 2026 meetings will be held on September 24 and November 5.