The following is the latest health policy news from the federal government for May 12-18.  Some of the language used below is taken directly from government documents.

Congress

The House Energy and Commerce Health Subcommittee has approved and advanced five bipartisan health care bills.

  • H.R. 3281 combined a number of proposals into a larger package and includes provisions that would:
    • delay for two years Medicaid disproportionate share (Medicaid DSH) cuts currently scheduled to take effect on October 1;
    • require health providers to use a unique identifier for each off-campus or remote outpatient department beginning in 2026;
    • change how Medicare pays off-campus hospital outpatient departments that are currently paid the site-neutral rate under the outpatient prospective payment system.  Those departments would submit a professional bill instead of a hospital bill and would be paid the physician fee schedule rate.  The bill does not expand site-neutral payment policy to off-campus hospital outpatient departments that are currently excepted; and
    • reauthorize and increase funding for teaching health centers, community health centers, and the National Health Services Corps.
  • H.R. 2666 would enable states to strike outcomes-based contracts for prescription drugs, which the committee believes would help improve access and reduce costs for expensive gene and cell therapies.
  • H.R. 3285 would limit consumer cost-sharing for drugs for which manufacturers pay large rebates to pharmacy benefit managers.
  • H.R. 3284 would require HHS to weigh the impact of proposed regulations on hospital industry consolidation.
  • H.R. 3290 would impose reporting requirements for hospitals that participate in the 340B prescription drug discount program.
  • H.R. 2544 would authorize HHS to award grants or contracts to public or private entities to manage the Organ Procurement and Transplantation Network.

The full committee is expected to take up these bills in the coming weeks.

End of the COVID-19 Public Health Emergency

  • DeBrunner & Associates has prepared a summary of the status of selected government health care waivers and flexibilities following expiration of the COVID-19 public health emergency. The DeBrunner summary covers telehealth, COVID-19 treatment and coverage, flexible hospital operations, long-term-care hospitals, inpatient rehabilitation facilities and units, patient cost-sharing, and state Medicaid waivers.  Find the summary here.
  • CMS has posted an FAQ that addresses its waivers and flexibilities upon the end of the COVID-19 public health emergency, including hospital billing for originating site services and telehealth provided by their employed therapists.  Find it here.
  • HHS has posted a fact sheet summarizing the telehealth-related flexibilities that were adopted to support the response to COVID-19 that expired at the end of the public health emergency on May 11 and those that remain in effect for now.  Find that fact sheet here.
  • Even though the formal COVID-19 public health emergency has ended, HHS has extended through 2024 certain liability protections introduced through the Public Readiness and Emergency Preparedness Act (PREP Act) in response to that emergency.  These extensions apply to selected countermeasures, including but not limited to the manufacture, distribution, and administration of vaccines that will still be employed in response to the continuing threat that COVID-19 poses to the public health.  Learn more about the specific protections that have been extended from this HHS announcement, which includes a link to a Federal Register notice.
  • CMS has posted a new FAQ on the end of continuous Medicaid eligibility now that the COVID-19 public health emergency has ended.  The primary audience for this FAQ is state Medicaid and CHIP agencies.

Centers for Medicare & Medicaid Services

  • To help schools provide health care and especially mental health services, CMS has issued a guide for Medicaid school-based services to make it easier for schools to deliver and receive payment for health care services.  The guide seeks to clarify, consolidate, and expand on past CMS guidance on how schools can receive payment for providing care for Medicaid- and CHIP-enrolled students and how states can ease the administrative burden on school-based health providers to promote their participation in Medicaid and CHIP while meeting federal statutory and regulatory requirements.  Learn more about these initiatives from this HHS news release; a CMS fact sheet on Medicaid services and administrative claiming for those services when delivered in school-based settings; a White House announcement; and a CMS memo to the states on coverage, billing, reimbursement, and documentation for the delivery of school-based mental health services.
  • CMS has published a quarterly notice listing its manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March of this year that address Medicare, Medicaid, and other CMS programs.  Go here to find the notice, which includes the names and contact information for individuals who can answer questions about the individual items.
  • The Health Affairs blog has posted an item by Dora Hughes, MD, MPH, chief medical officer of CMS’s Center for Medicare and Medicaid Innovation, outlining the center’s health equity strategy, progress made over the last year, and additional areas of focus in the future.  Find it here.

Department of Health and Human Services

HHS has launched Project NextGen, a $5 billion program that will seek to accelerate and streamline the development of the next generation of vaccines and treatments through public-private collaborations.  Based at HHS and led by the Administration for Strategic Preparedness and Response’s Biomedical Advanced Research and Development Authority (BARDA) and the NIH’s National Institute of Allergy and Infectious Diseases, Project NextGen will coordinate across the federal government and the private sector to advance the pipeline of new, innovative vaccines and therapeutics.  For more information about the program and its priorities, the types of vaccines on which it will focus, and research funding opportunities, see this HHS fact sheet.

HHS Newsletters

Provider Relief Fund

  • HHS has posted the following deadlines for certain Provider Relief Fund-related activities.
  • June 2 – the reporting portal closes for request to report late-approved providers.
  • June 30 – deadline to apply Provider Relief Fund and/or American Rescue Plan rural funds to lost revenues.
  • July 1 – reporting period 5 begins

Centers for Disease Control and Prevention

The CDC has issued a health alert advising that while the number of mpox cases has declined since peaking in August of last year, the outbreak is not over and spring and summer could see a resurgence of cases as people gather for festivals and other events.  The purpose of this alert is to inform clinicians and public health agencies about the potential for new clusters or outbreaks of mpox cases and to provide resources on clinical evaluation, treatment, vaccination, and testing.  It also notes a recent cluster of new cases in the Chicago area.  Find the alert here.

Food and Drug Administration

  • The FDA and HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) have issued a joint letter to health care providers intended to clarify buprenorphine prescribing recommendations.  Find that letter here.
  • The FDA has updated its FAQ on medical device shortages.  Find it here.

Government Accountability Office (GAO)

The GAO has issued a brief report on the challenges of gaining access to health care in rural areas.  Find the report here.

Stakeholder Events

CMS – Skilled Nursing Facility Prospective Payment System – Proposed Value-Based Purchasing Changes for FY 2024 – May 24

On April 10, CMS issued a proposed rule that would update Medicare payment policies and rates for skilled nursing facilities under its FY 2024 skilled nursing facility prospective payment system, including proposals for the SNF quality reporting and value-based purchasing program.  CMS will hold a webinar offering an overview of these skilled nursing facility proposals on Wednesday, May 24 at 2:00 (eastern).  Go here to register to participate.

CMS – BPCI Application Process Webinar – May 25

CMS’s Center for Medicare and Medicaid Innovation will hold a webinar on Thursday, May 25 at 2:00 (eastern) to help guide interested parties through the process of applying to participate in year seven of its Bundled Payments for Care Improvement Advanced (BPCI Advanced) Model program.  Go here to learn more about the webinar and for a link through which to register to participate.

 CMS – Health Equity Conference – June 7-8

CMS will hold a health equity conference in Washington, D.C. on Wednesday, June 7 and Thursday, June 8; the conference also will be streamed for virtual participation.  Learn more about the conference agenda, speakers, and how to register to participate and find an FAQ in this CMS notice.

 CDC – Healthcare Infection Control Practices Advisory Committee Meeting – June 8-9

The CDC’s Healthcare Infection Control Practices Advisory Committee will hold public meetings on Thursday, June 8 and Friday, June 9 at 9:00 (eastern) on both days.  The agenda includes updates on CDC activities for the prevention of health care-associated infections and reports from various subcommittees.  Individuals may participate in person or virtually and registration is required.  Learn more about the meeting and how to register and participate from this CDC announcement.

CMS – Skilled Nursing Facility MDS 3.0 RAI v1.18.11 Guidance Training Program – June 21

CMS is offering a virtual training program that provides instruction on its updated guidance for the Skilled Nursing Facility Minimum Data Set 3.0 Resident Assessment Instrument (RAI) v1.18.11 Manual and Item Set.  The program includes recorded training webinars and live, virtual workshop sessions that provide practice coding scenarios on selected data elements.  The live component will be held on Wednesday, June 21 at 12:30 (eastern).  Learn more about the program from this CMS announcement and go here to register to participate.

HHS – Agency for Healthcare Research and Quality – Meeting of the National Advisory Council for Healthcare Research and Quality – July 12

The Agency for Healthcare Research and Quality’s National Advisory Council for Healthcare and Research and Quality will meet virtually on Wednesday, July 12 at 11:15 (eastern).  For information about the council, the meeting’s agenda, and how to participate, see this agency notice.