The following is the latest health policy news from the federal government for August 16-22.  Some of the language used below is taken directly from government documents.

The Courts
  • The federal government must include uninsured patients whom hospitals serve under state Medicaid waivers when calculating hospitals’ Medicare DSH payments, a federal court has ruled.  In the case of Baylor All Saints Medical Center, et al. v. Xavier Becerra, federal policymakers had invoked a 2023 regulation that excluded counting care provided to patients served by DSH-eligible hospitals providing care through state Medicaid waivers – generally, through uncompensated care pools.  A group of DSH-eligible hospitals in Texas sued over the regulation because its implementation reduced their Medicare DSH funding.  The court found the 2023 regulation to be unlawful.  Learn more about the Texas Medicare DSH case from the federal court ruling in the suit.
  • A federal court has rejected a Federal Trade Commission regulation that sought to ban non-compete agreements between employers and employees under most circumstances; such agreements are common among hospitals and other health care entities.  In a suit brought in Texas by the U.S. Chamber of Commerce, the Business Roundtable, the Texas Association of Business, and others, the court found that the FTC exceeded its authority in establishing the regulation and that the rule itself was “arbitrary and capricious,” based on limited evidence, and without either a rationale for such a sweeping approach nor any evidence that the agency considered a more limited approach to the challenges it identified as the basis for advancing the prohibition.  Learn more from the federal court decision in the case.  Other challenges to the ban have been filed and adjudicated, with a Pennsylvania court denying any relief from the regulation and a Florida court granting relief from the regulation only to the plaintiffs in the case.  The conflicting rulings suggest the final decision may be made by the U.S. Supreme Court.
Centers for Medicare & Medicaid Services
  • Starting July 1, 2024, hospitals must conform to a CMS template layout and data specifications for making public their standard charge information in a comprehensive machine-readable file.  Starting January 1, 2025, they also must encode additional data elements.  To help hospitals fulfill these requirements, CMS has posted the following resources:  a data dictionary GitHub repository; a tools web page; a resources web page; and a guide to hospital price transparency regulations.  In addition, CMS will hold a webinar on hospital price transparency and encoding price data in machine-readable files on Monday, October 21 at 1:00 (eastern).  Go here to register to participate.
  • CMS has published a brief report presenting data on complaints filed with the agency regarding enforcement of the No Surprises Act; these are separate from requests for adjudication of disagreements over fees filed under the act.  As of June 30, 2024, CMS received more than 16,000 such complaints alleging violations of No Surprises Act requirements.  The report includes data on the most common types of complaints filed against payers and providers.  Find the one-page data summary here.
  • Earlier this year CMS announced a new Cell and Gene Therapy Access Model, a multi-year voluntary program for states and manufacturers that seeks to improve the lives of people with Medicaid living with rare and severe diseases by increasing access to potentially transformative treatments; initially, the model will focus on access to gene therapy treatments for people living with sickle cell disease.  CMS released a request for applications to manufacturers in March and a request for applications to states in June.  Now, CMS has released a notice of funding opportunity to states.  States may begin participating at any time between January 2025 and January 2026.  Providers must pursue participation through state applications and not directly with CMS.  Learn more from the updated Cell and Gene Therapy Access Model web page.
  • CMS has sent an informational bulletin to state Medicaid programs to highlight federal Medicaid eligibility renewal requirements and available flexibilities to promote continuity of coverage for individuals eligible for home- and community-based services (HCBS) through Medicaid.  The reminder comes amid continuing challenges involving the review of Medicaid eligibility for enrollment in many states, noting that states must ensure that renewal practices and systems are accessible for individuals with disabilities, including by providing support, information, communication technology, and auxiliary aids and services at no cost to the individual.  In addition, states must take reasonable steps to provide meaningful access to individuals with limited English proficiency.  Learn more from this CMS notice to state Medicaid and CHIP programs.
  • CMS has updated its “Prescriber’s Guide to Medicare Prescription Drug (Part D) Opioid Policies,” adding information on the expansion of the exempted patient definition as of January 1, 2025.  Find the updated guide here.
  • CMS is responsible for developing the formula to calculate the amount of federal funding available for states’ Basic Health Programs (BHP) and for publishing revised BHP payment methodologies as needed.  Now, the agency explains in a memo to state governments that it does not need to update its methodology for 2025 and presents in that memo the final values for the factors needed to calculate federal BHP payment rates for 2025 using the 2023 methodology.  Find that memo here.
  • CMS has posted a bulletin describing changes in Medicare Part B coverage policy for pneumonia vaccines.  The bulletin updates coverage requirements for the vaccine and includes changes to align with Advisory Committee on Immunization Practices recommendations for pneumonia vaccination coverage.  Find the bulletin here.
  • CMS has posted a bulletin updating its national coverage determination (NCD) for allogeneic hematopoietic stem cell transplantation for myelodysplastic syndromes NCD 110.23.  The update adds two procedure codes and transmittal links.  Find the bulletin here.
  • CMS has announced that Medicare Administrative Contractors (MACs), after considering public comments, are not finalizing the proposed local coverage determination (LCD) issued in August of 2023 for testing for solid organ allograft rejection.  Instead, the MACs intend to issue a new LCD in the coming months.  Consequently, neither CMS nor the MACs have changed coverage for these blood tests that monitor for organ transplant rejection when prescribed under medically appropriate circumstances.  Patients with transplanted hearts, lungs, or kidneys or who meet Medicare’s existing local coverage criteria will continue to have access to these blood tests.  Learn more, including about the conditions for which access to these tests currently continues, from this CMS statement.
Department of Health and Human Services
  • HHS’s Health Resources and Services Administration (HRSA) has updated the Provider Relief Fund’s reporting and auditing web page to note that the Provider Relief Fund reporting portal is now open for reporting period 7.   Providers that received Provider Relief Fund general or targeted payments or American Rescue Plan Rural payments exceeding $10,000 in the aggregate between January 1 and June 30, 2023 must file a report on their use of funds during reporting period 7.  The deadline to submit this report is September 30, 2024.  Providers also must return unused funds to HRSA within 30 days of submitting this report.  Learn more from the Provider Relief Fund’s updated reporting and auditing web page.
  • HRSA’s Office for the Advancement of Telehealth has posted a series of documents about best practices for ensuring privacy and security in the delivery of telehealth services.  Find them here.
  • In a letter to the CEOs of health insurance companies, the secretaries of HHS and the Department of Labor outlined a series of steps they urge those companies to take to help improve Americans’ experience with their health care coverage and insurers, including simpler processes for filing claims; improved customer service; clearer information about benefits, provider networks, and prior authorization processes; and more.  Find that letter here.
  • HHS, its Office of the Assistant Secretary for Health, Office on Women’s Health, and Office of the Assistant Secretary for Planning and Evaluation (ASPE) have prepared a report that discusses activities and outcomes of HHS programs addressing the maternal health crisis.  The report describes trends in maternal health outcomes, the major drivers of maternal health outcomes, and how HHS is addressing these drivers.  The report also presents a measurement framework to assess progress in addressing the maternal health crisis.  Learn more from the HHS report “Addressing the Maternal Health Crisis in the United States.”
  • HRSA has awarded more than $1.4 billion in Ryan White HIV/AIDS Program funding for the HRSA AIDS Drug Assistance Program and related purposes.  This money pays for medication, HIV health care, and support services.  Learn more about the funding and its intended purposes and find a link to a list of the grant recipients in this HHS news release.
  • ASPE has published a report detailing progress, through FY 2022, toward the federal government fulfilling the National Action Plan for Combating Antibiotic-Resistant Bacteria.  Find the report here.
  • In a new blog post, HHS’s Office of the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health IT (until recently referred to as ONC but now seeking to go by ASTP) describes its efforts to support the adoption and implementation of health IT standards in general and its work with Health Level Seven International (HL7) and its HL7 Fast Healthcare Interoperability Resources (FHIR) standard and HL7 FHIR US Core Implementation Guide (IG) in particular.  Learn more about these efforts here, in the blog post.
  • HHS’s Office of the Inspector General has updated its plan of scheduled audits and reviews for the month of August.  Find the updated workplan here.
HHS Newsletters
HHS Videos
Medicaid and CHIP Payment and Access Commission (MACPAC)

State Medicaid programs provide home- and community-based services (HCBS) to enrollees through state plan and waiver authorities.  A new MACPAC compendium of Medicaid eligibility policies addresses the timeliness of access to HCBS and describes how state Medicaid programs design their programs.  Included in the compendium is information on state use of presumptive eligibility and expedited eligibility flexibilities, components of level-of-care assessments, and person-centered service planning processes that contribute to timely Medicaid eligibility determinations for individuals who need HCBS.  Go here for an introduction to the compendium and go here for a direct download of the compendium itself.

Food and Drug Administration

The FDA has authorized marketing of the first over-the-counter home test to detect syphilis.  Learn more from this FDA news release.

Stakeholder Events

CMS – Advisory Panel on Hospital Outpatient Payment Meeting – August 26-27

CMS’s Advisory Panel on Hospital Outpatient Payment will meet virtually on Monday, August 26 and Tuesday, August 27. The purpose of the panel is to advise the Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare hospital outpatient prospective payment system, the ambulatory surgical center payment system, and the supervision of hospital outpatient therapeutic services.  The panel invites presentations and comment letters.  Learn more about the panel, submitting materials, and how to participate in the meeting from this CMS notice.

CMS – Rural Health Open Door Forum – August 29

CMS will hold an open-door forum for rural health providers on Thursday, August 29 at 2:00 (eastern).  Go here to register to participate.

CMS – 2024 “Rural Health Hackathon” – August 29

CMS and its Center for Medicare and Medicaid Innovation are holding 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.  The last of three Hackathon events will be held in person 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.

MedPAC – Commissioners Meeting – September 5-6

MedPAC commissioners will hold their next public meeting on Thursday, September 5 and Friday, September 6.  The meeting agenda and information about participating in the meetings in person or remotely are not yet available but when they are they will be posted here.

CMS – Hospital Open Door Forum – September 10

CMS will hold an open-door forum for hospital officials on Tuesday, September 10 at 2:00 (eastern).  Go here to register to participate.

HRSA – Council on Graduate Medical Education Meeting – September 12

HHS’s Health Resources and Services Administration will convene a virtual meeting of its Council on Graduate Medical Education on Thursday, September 12 at 10:00 (eastern).  Go here for information on the meeting agenda and materials and how to participate.

CMS – Maternal Health Webinar – September 17

CMS will hold a maternal health informational webinar offering an overview of maternal health affinity groups and the expression-of-interest process on Tuesday, September 17 at 2:00 (eastern).  Go here to register to participate.

CMS – Home Health, Hospice, and DME Open Door Forum – September 18

CMS will hold an open-door forum for home health, hospice, and DME providers on Wednesday, September 18 at 2:00 (eastern).  Go here to register to participate.

CDC – Outreach Webinar on Lyme Disease – September 19

As part of its clinician outreach and communication efforts, the CDC will hold a webinar on new clinical tools and resources to support patients with prolonged symptoms and   concerns about Lyme disease.  Presenters will offer a brief overview of Lyme disease, provide a diagnostic and management framework for patients with prolonged symptoms and concerns about Lyme disease, and review new clinical tools and resources to help support these patients.  Continuing education credits are available.  Learn more about the webinar and how to participate from this CDC notice.

MACPAC – Commissioners Meeting – September 19-20

MACPAC commissioners will hold their next public meeting on Thursday, September 19 and Friday, September 20.  The meeting agenda and information about participating in the meetings in person or remotely are not yet available but when they are they will be posted here.

CMS – Hospital Price Transparency Webinar – October 21

CMS will hold a webinar on hospital price transparency during which it will address encoding new January 25 price transparency requirements in a machine-readable file on Monday, October 21 at 1:00 (eastern).  Go here to register to participate.