The following is the latest health policy news from the federal government for July 6-12.  Some of the language used below is taken directly from government documents.

The Courts

A federal court has blocked implementation of the FTC’s rule banning non-compete clauses in most employment contracts, a regulatory development with potentially significant implications for the health care industry.  The temporary ban affects only the five plaintiffs in the case and it is not yet clear whether the ruling will have broader implications in the wake of the recent reversal of the Chevron decision that could potentially curtail the rulemaking authority of federal agencies.  Learn more from the federal court ruling on the non-compete clause ban in the decision in the case of Ryan v. Federal Trade Commission.

Congress

The House Appropriations Committee has passed its FY 2025 HHS spending bill along party lines.  Selected highlights include:

  • Cutting Health Resources and Services Administration (HRSA) spending from $9 billion to $8.5 billion but increasing spending on provider training and loan repayment programs.
  • Providing $608 million for the maternal health block grant program, an increase of $5 million, and increasing funding for screening pregnant and postpartum people for mental health problems and substance abuse disorders.
  • Cutting Ryan White HIV/AIDs funding by $190 million and asking HRSA to review how it funds Ryan White-funded centers to prevent over-representing and under-representing some geographic areas.
  • Providing an additional $2 million to support the federal government’s revamp of the organ transplantation network.
  • Raising funding for rural health programs from the current $364 million to $400 million, with some of that money to be used to help small and critical access hospitals.
  • Explaining that the purpose of the reduction of NIH centers from 27 to 15 is driven by a desire to eliminate demographic and disease-specific centers to ensure that each remaining center addresses whole individuals across their lifespans.
  • Increasing funding for the Substance Abuse and Mental Health Services Administration (SAMHSA), encouraging the agency to focus more on the health of teenaged girls, and cutting funding for programs that employ harm-reduction strategies that the proposal’s supporters believe support the use of illegal drugs.
  • Eliminating HHS’s Office of Climate Change and Health Equity.

This bill can now proceed to a vote by the full House, but it is highly unlikely to win support from the Democratic majority in the Senate.

CMS – Medicare Payment Proposed Regulations
Proposed 2025 Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Regulation  

CMS has published its proposed 2025 outpatient prospective payment and ambulatory surgical center payment systems regulation.  The highlights of this proposed regulation include:

  • A 2.6 percent payment rate increase for outpatient and ambulatory surgical center services.
  • Proposed changes in the conditions of participation for hospitals for obstetrical services.
  • Changes in the list of ambulatory surgical center-covered surgical procedures and the inpatient-only procedures list.
  • Updated per diem rates for intensive outpatient program services.
  • Temporary additional payments for certain non-opioid treatments for pain relief in hospital outpatient departments and ambulatory surgical centers.
  • Changes in the review time frames of the hospital outpatient department prior authorization process.
  • Changes in the Medicare inpatient, Medicare outpatient, rural emergency hospital, and ambulatory surgical center quality reporting programs.
  • The updating of Medicaid and CHIP regulations to require 12 months of continuous eligibility for children under the age of 19 enrolled in Medicaid and CHIP.
  • Changes in the Medicaid clinic services regulation to authorize federal reimbursement, at state option, for services furnished outside the four walls of freestanding clinics in rural areas.

The deadline for stakeholders to submit comments about the proposed 2025 outpatient prospective payment and ambulatory surgical center payment systems rule is September 9.  Learn more about CMS’s proposed 2025 physician fee schedule rule from the following sources:

Proposed 2025 Medicare Physician Fee Schedule Regulation

CMS has published its proposed calendar year 2025 Medicare physician fee schedule regulation.  The highlights of this proposed regulation include:

  • A 2.93 percent reduction of physician and other provider payment rates.
  • A proposal to develop a potential ambulatory specialty care model.
  • New coding and payment processes for the delivery of current and expanded behavioral health care and opioid use disorder treatment.
  • Changes in payment and coding for office/outpatient evaluation and management visits.
  • Changes in allowable telehealth services and the supervision of such services.
  • A new set of advanced primary care management services for the delivery of care by physicians and non-physician practitioners.
  • New coding and payments for caregiver training for direct care services and supports.
  • Changes in payments for selected drugs and biological products covered by Medicare Part B.
  • Numerous changes for rural health clinics and FQHCs.

The deadline for stakeholders to submit comments is September 9.  Learn more about CMS’s proposed 2025 physician fee schedule rule from the following sources:

Department of Health and Human Services
  • HHS and its Office of the National Coordinator for Health Information Technology (ONC) have published a proposed rule titled “Health Data, Technology, and Interoperability:  Patient Engagement, Information Sharing, and Public Health Interoperability,” which they are referring to as “HTI-2.”  The purpose of the proposed rule is to advance interoperability and improve information sharing among patients, providers, payers, and public health authorities.

Significantly for providers, ONC proposes to adopt “Prior authorization API – provider” and “Prior authorization API – payer” certification criteria that specify requirements for health IT that can be used by providers and payers to conduct electronic prior authorization.

HTI-2 proposes two sets of new certification criteria designed to enable health IT for public health and health IT for payers to be certified by ONC.  These new certification criteria focus heavily on standards-based application programming interfaces to improve end-to-end interoperability between data exchange partners.  Technology certified to criteria ONC proposes has the potential to reduce administrative burden associated with the largely manual prior authorization process which exists today.  The proposed rule also includes several proposed technology and standards updates that build on the “Health Data, Technology, and Interoperability:  Certification Program Updates, Algorithm Transparency, and Information Sharing” (HTI-1) final rule, published in January 2024, and it proposes requiring adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028.  The proposed rule also includes a new, real-time prescription benefit tool certification criterion that would empower providers and their patients to make more informed decisions.  Also included is a proposal to establish certain Trusted Exchange Framework and Common AgreementTM (TEFCATM) governance rules. 

Learn more about the proposed rule from this HHS news release; this ONC summary; this ONC fact sheet; and this preview version of the proposed rule.  The deadline for stakeholders to submit comments will be 60 days after the proposed rule’s official publication, which is not yet scheduled.

  • HHS and its Substance Abuse and Mental Health Services Administration (SAMHSA) have posted notices of funding opportunities aimed at improving women’s behavioral health across the country.  Grants of $27.5 million will be awarded to support women’s behavioral health by expanding access to services and enhancing the capacity of providers to identify and address mental health conditions, substance use, and gender-based violence.  The funding includes $15 million for a Community-Based Maternal Behavioral Health Services Program and $12.5 million to establish a Women’s Behavioral Health Technical Assistance Center.  Learn more about the funding and the grant programs and find links to the notices of funding opportunities in this HHS news release.  The deadline for submitting applications for funding under the Maternal Behavioral Health Services Program is August 26 and for the Women’s Behavioral Health Technical Assistance Center program is August 20.
  • In its FAQ on general questions regarding certain fraud and abuse authorities for hospitals, HHS’s Office of the Inspector General has added four questions about hospital financial assistance policies, the practice of waiving patient cost-sharing, and civil monetary penalties for violations of federal anti-kickback statutes.  Find the four new questions and answers in this updated portion of the FAQ.
  • The administration has updated its anticipated agenda of regulatory and deregulatory actions for the coming months.  Go here to see the HHS agenda, which includes agenda items for CMS, the Office of Inspector General, the CDC, and other HHS agencies.
Centers for Medicare & Medicaid Services
  • CMS’s Center for Medicare and Medicaid Innovation has published a list of the providers that will participate in its Guiding an Improved Dementia Experience (GUIDE) Model, a voluntary, nationwide program to test ways to support people with dementia and their unpaid caregivers.  The model began on July 1, 2024 and will run for eight years.  Learn more about GUIDE from the program’s web page and click on GUIDE Participant List (XLSX) for a downloadable file of the nearly 400 program participants.  In addition, CMS describes the program, its underlying rationale and objectives, and how it will operate in this entry on the CMS blog.
  • CMS has updated its information for clinicians on the national patient registry for Alzheimer’s disease drugs.  Find the new information through this direct download file:  CMS National Patient Registry for Alzheimer’s Drugs.
HHS Newsletters
Stakeholder Events

HHS/Health Resources and Services Administration – National Telehealth Conference – July 16

HHS’s Health Resources and Services Administration (HRSA) will hold a virtual national telehealth conference on Tuesday, July 16 from 9:30-5:00 (eastern).  Conference topics will include licensing across state lines to increase access to behavioral health care; implications of health policy to inform telehealth’s future; expanding access to services for underserved and low-income communities; exploring health care innovations and future telehealth technologies; and improving health equity through expansion of broadband connectivity and adoption of telehealth.  Go here to learn more about the conference and to register to participate.

CDC – Update for Clinicians on Highly Pathogenic Avian Influenza A – July 16

The CDC will present an update for clinicians and health centers on the highly pathogenic avian influenza A (H5N1) virus on Tuesday, July 16 at 2:00 (eastern).  The session will offer an update on the current outbreak in the U.S. and CDC surveillance and monitoring efforts and provide information for clinicians and others on testing, using antivirals, and infection prevention and control recommendations.  Learn more about the session, how to participate, and continuing education credits available for physicians, nurses, pharmacists, and others from this CDC notice.

NIH – Interdisciplinary Approaches to Understanding and Addressing Structural Racism and Health – July 18-19

The NIH will hold a two-day workshop on Thursday, July 18 and Friday, July 19 from 10:30 to 4:30 (eastern) each day to share interdisciplinary approaches to understanding and addressing structural racism and health.  The workshop will bring together researchers, clinicians, and community partners with expertise in fields such as the social and natural sciences, law and criminal justice, education, public policy, social work, biomedicine, behavioral health, and public health.  Workshop objectives include reviewing historical data and perspectives surrounding structural racism; showcasing research on new methodologies, advancements in understanding the drivers of structural racism, and strategies for cultivating meaningful partnership; and sharing best practices and lessons learned from interventions aimed at addressing structural racism.  Go here to register to participate and to learn more about the event.

CMS – Rural Health Open Door Forum – July 18

CMS will hold an open-door forum for rural health care providers on Thursday, July 18 at 2:00 (eastern).  Go here to register to participate.

CMS – Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests – July 25-26

CMS’s Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests will hold public meetings on Thursday, July 25 and Friday, July 26.  The panel advises the Secretary of the Department of Health and Human Services and the CMS Administrator on issues involving clinical diagnostic laboratory tests.  Learn more about the meetings and how to participate from this CMS notice.

CMS – Skilled Nursing Facility/Long-Term Care Open Door Forum – July 25

CMS will hold an open-door forum for skilled nursing facility and long-term care facility operators on Thursday, July 25 at 2:00 (eastern).  Go here to register to participate.

CMS – Long-Term Services and Supports Open Door Forum – July 30

CMS will hold an open-door forum for long-term services and supports providers on Tuesday, July 30 at 2:00 (eastern).  Go here to register to participate.

CMS – Post-Acute Care Health Equity Confidential Feedback Report Listening Session – July 31

CMS will hold a listening session on Wednesday July 31 at 2:00 (eastern) to discuss the 2023 Health Equity Confidential Feedback Reports, which were released to post-acute-care providers in home health, inpatient rehabilitation facility, long-term-care hospital, and skilled nursing facility settings.  The goal of the listening session is to gather feedback from providers and stakeholders on the post-acute care health equity confidential feedback to guide the development of this report in the future.  Go here to learn more about the listening session and to register to participate.

CMS – 2024 “Rural Health Hackathon” – August 14, 22, and 29

In August CMS and its Center for Medicare and Medicaid Innovation will hold a series of collaborative sessions, to be held in person, designed to generate and develop creative and actionable ideas to address rural health challenges.  The event seeks to build on CMS’s outreach to rural communities through site visits and listening sessions to better understand rural health care issues.  At these sessions CMS will bring together rural health community care providers, community organizations, industry and tech entrepreneurs, funders, policy experts, and beneficiaries to attempt to take advantage of the collective experience and expertise of participants to generate new ideas to address some of the top challenges affecting health care in rural health settings and drive action to improve clinical outcomes, increase access, and foster a better care experience for patients and providers in rural communities.  Hackathon events will be held in person on August 14 in Bozeman, Montana; on August 22 in Dallas; and on August 29 in Wilson, North Carolina.  Learn more about the event, including how to participate in person or submit ideas virtually, from this CMS announcement.

CMS – National Provider Compliance Conference – August 7-8

CMS will hold its National Provider Compliance Conference on Wednesday, August 7 and Thursday, August 8.  The conference will bring together Medicare Administrative Contractors (MACs) and program integrity experts to provide compliance professionals with the information and tools they need to efficiently and effectively submit Medicare Part A, Part B, home health, hospice, and durable medical equipment claims.  The target audience is anyone who processes Medicare Part A and Part B, home health, hospice, or DME claims, including physicians, non-physician practitioners, billing specialists, suppliers, associations, coders, and medical review contractors.  Go here to learn more about the conference and to register to participate in the virtual event.  The deadline for registering is July 31.