The following is the latest health policy news from the federal government for October 20-26.  Some of the language used below is taken directly from government documents.

Congress

More than three weeks after House Republicans voted Rep. Kevin McCarthy (CA) out of the speaker’s office, the House has elected Rep. Mike Johnson (LA) to the position.  Speaker Johnson is a social conservative and has pushed for cuts to Medicare and Medicaid, including plans to roll back Medicaid expansion in 2019.

The Speaker has said he intends for the House to take up as many FY 2024 spending bills as possible before the end of the current continuing resolution (CR) on November 17 but, understanding that time is limited, he has floated the possibility of another CR through either January or even April if House Republicans will support it.  Many on Capitol Hill expect another CR would include the same health care extenders that are in the current CR, including delaying cuts to Medicaid DSH, but that is not certain at this time.  Learn more about the new Speaker’s priorities and immediate plans in this letter that he sent to his Republican colleagues in the House earlier this week.

340B

HHS’s Health Resources and Services Administration (HRSA) has published a notice informing and reminding stakeholders of the registration requirements for off-site, outpatient hospital facilities to participate in the 340B prescription drug discount program.  The notice specifies that to continue purchasing 340B drugs, covered entities’ off-site, outpatient hospital facilities must (1) be listed on the hospital’s most recently filed Medicare Cost Report and registered in HRSA’s 340B Office of Pharmacy Affairs Information System (OPAIS) by the next 340B program quarterly registration period or (2) the covered entity must notify HRSA within 90 days of the publication of the notice that it has initiated the process of listing the offsite, outpatient facility on the hospital’s Medicare Cost Report and registering it in the OPAIS.  HRSA is providing a 90-day grace period before non-compliant entities may be subject to audit and compliance action.  Learn more from this HRSA announcement and this pre-publication version of the formal Federal Register notice.

Centers for Medicare & Medicaid Services

Department of Health and Human Services

  • HRSA has updated the Provider Relief Fund web page to reflect that reporting period 5 has now passed and to offer guidance to providers that seek to submit a request to report late for reporting period 5 due to extenuating circumstances.  The deadline for submitting requests to report late for reporting period 5 is October 27.
  • States face a continuing challenge meeting third-party liability requirements for ensuring that Medicaid functions as the payer of last resort for some patients, HHS’s Office of the Inspector General (OIG) has concluded.  Learn more about why the OIG conducted this audit and what it found from this report and a summary of the report.
  • HHS and the Cybersecurity and Infrastructure Security Agency have released a cybersecurity toolkit that includes resources tailored for the health care and public health sectors.  Find the toolkit here.
  • HHS’s Agency for Healthcare Research and Quality is developing a research project through which it seeks to summarize definitions of Long COVID and describe what is known about Long COVID models of care, including models currently in use, promising approaches, advantages and disadvantages of models in different populations and settings, barriers and facilitators to implementation, access and equity issues, and needed research.  As part of this project it seeks stakeholder input into the research it should undertake.  Learn more from this summary of the research project and go here to submit comments and suggestions.  The deadline for submissions is November 7.

HHS Newsletters

Centers for Disease Control and Prevention

  • The CDC has issued a health advisory providing options for clinicians to protect infants from respiratory syncytial virus (RSV) in the wake of a limited supply of a vaccine for preventing RSV-associated lower respiratory tract disease in infants.  Find the advisory here.
  • Health care workers reported harassment, symptoms of poor mental health, and difficult working conditions at twice the rate in 2022 than they did in 2018, according to a new CDC report.  The conditions they report include threats, bullying, verbal abuse, or other actions from patients and co-workers that create a hostile work environment.  Learn more about the problems and how to address them from this CDC news release and the full CDC report.

Food and Drug Administration

The FDA has extended to 30 months the shelf life of certain supplies of Gohibic (vilobelimab), an emergency treatment for some hospitalized COVID-19 patients.  Learn more by going here, scrolling down to “COVID-19 Therapeutics,” and clicking on “Table 1:  Extended Expiry Dating for InflaRx Gohibic Authorized under EUA 118.”

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has shared its agenda for its 2023-2024 public meeting cycle, writing that in addition to its regular work of offering recommendations to Congress on the adequacy of Medicare payments to providers and, as needed, suggesting changes in those payments, it will fulfill two statutory requirements in the coming year:  to evaluate Medicare Advantage special needs plans for individuals eligible for both Medicare and Medicaid and to review the new “Rural Emergency Hospital” designation.  MedPAC is working on these and several other issues in the Medicare program.  Learn more about MedPAC’s plans for the coming year from its document “MedPAC’s analytic agenda for the 2023-2024 meeting cycle.”
  • MedPAC has released its updated Medicare Payment Basics documents, which are brief explanations, updated annually, on Medicare’s 20 payment systems: for accountable care organizations, ambulance services, ambulatory surgical center services, clinical laboratory services, critical access hospitals, durable medical equipment, Federally Qualified Health Centers (FQHCs) and Rural Health Clinics, home health care services, hospice services, hospital inpatient services, hospital outpatient services, inpatient rehabilitation facilities, inpatient psychiatric facility services, long-term-care hospital services, Medicare Advantage program services, outpatient dialysis services, Part B drugs, Part D drugs, physician and other health professional services, Rural Health Clinics, and skilled nursing facility services.  Find the papers here.

Stakeholder Events

CMS – Patient-Focused Listening Sessions on Medicare Drug Price Negotiations – October 30-November 15

CMS will host a series of patient-focused listening sessions this fall as part of the Medicare Drug Price Negotiation Program.  The virtual public listening sessions will provide an opportunity for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to drugs selected for the first round of negotiations.  Learn more about the listening sessions, the schedule for these sessions, the individual drugs to be discussed at each, and how to participate from the CMS drug listening session web page.

FDA – Webinar on Laboratory-Developed Tests – October 31

The FDA will host a webinar on its proposed rule governing laboratory-developed tests, or LDTs, on Tuesday, October 31 at 1:00 (eastern).  Learn more about the webinar, what it will cover, and how to participate from this FDA announcement.

CMS – Provider Compliance Focus Group – November 2

The Provider Compliance Group within CMS’s Center for Program Integrity will hold a focus group to address medical review and prior authorization on Thursday, November 2 at 1:00 (eastern).  During the focus group CMS will seek provider input on what it can do better to communicate, improve its processes, and eliminate unnecessary requirements.  Learn more about the focus group and how to register to participate from this CMS announcement.  The deadline for registering is October 26.

MedPAC – Public Meetings – November 2 and 3

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on Thursday, November 2 and Friday, November 3.  An agenda and information about how to join the meeting are not yet available but when they are they will be posted here.

MACPAC – Public Meetings – November 2 and 3

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on Thursday, November 2 and Friday, November 3.  Go here to register to participate.

CMS – Burden Reduction Conference – November 15

CMS will convene leadership from the federal government, health provider organizations, and the patient advocacy community to focus on opportunities across the health care enterprise to reduce administrative burden, strengthen access to quality care, and make it easier for clinicians to provide that care during a day-long virtual conference it will hold on Wednesday, November 15 beginning at 9:00 (eastern).  Go here to learn more about the conference and find a link for registration.

CMS – Healthcare Common Procedure Coding System Public Meeting – November 28-30

CMS will hold virtual public meetings from November 28 through November 30 to discuss its preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set for non-drug and non-biological products.  Learn more about the meeting, why it is being held, its agenda, how it will be conducted, and how to register from this formal CMS notice.

CMS – Inpatient Rehabilitation Facility Prospective Payment System:  Coverage Requirements Webinar – November 29              

CMS will hold a webinar on inpatient rehabilitation facility prospective payment system coverage requirements on Wednesday, November 29 at 1:30 (eastern).  During the webinar CMS will review inpatient rehabilitation facility prospective payment system coverage requirements from pre-admission to discharge and provide a refresher on existing payment requirements and answer common payment system questions.  Go here to register to participate.

CMS – Medicaid and CHIP Renewals –December 6

HHS and CMS have been holding a series of monthly webinars on Medicaid and CHIP renewals to educate partners.  Topic covered vary each month.  The final webinar will be held on Wednesday, December 6 at noon (eastern)  Go here to register to participate and go here for recordings, transcripts, and slides from past webinars.

CMS – Town Hall Meeting on FY 2025 Applications for New Medical Services and Technologies Add-On Payments – December 13-14

CMS will hold a virtual town hall meeting on Wednesday, December 13 and Thursday, December 14 during which organizations representing hospitals, physicians, manufacturers, and other interested parties may present comments, recommendations, and data to CMS’s clinical staff about whether individual services or technologies represents a substantial clinical improvement.  The meeting will include a discussion of the substantial clinical improvement criteria for the FY 2025 applications for new technology add-on payments.  Learn more about the meeting, why it is being held, what it will address, and how to participate from this CMS notice.