The following is the latest health policy news from the federal government for September 13-29.  Some of the language used below is taken directly from government documents.

Congress
  • Energy and Commerce Committee. Yesterday the House Energy and Commerce Committee marked up 16 bills, including several that address health care.  These bills are unlikely to proceed to votes in the full House until after Congress returns following the November elections.
    • The committee passed a bill that would extend the current telehealth waivers, scheduled to expire on December 31, for two years and would extend the Medicare Hospital at Home program, also scheduled to expire December 31, for five years.  Though the bill does not address the pending rule from the Drug Enforcement Agency regarding tele-prescribing of controlled substances, committee members expressed opposition to the DEA’s plans.  This bill would offset the cost of those extensions with changes related to pharmacy benefit managers.
    • The committee also passed a resolution – without Democratic support – to overturn the Biden administration’s rule on minimum staffing standards for nursing homes.  The Biden administration would veto those efforts but a Trump administration, if Republicans are leading Congress, would be able to overturn the rule.
  • Funding the Federal Government. Congress is still attempting to pass a continuing resolution (CR) before the September 30 deadline to fund the federal government when the new federal fiscal year begins on October 1.  Congressional leaders hope to avoid a government shutdown but negotiations are expected to continue through next week.  While it appears a shutdown is unlikely, agencies are reviewing past contingency plans if authorization for funding ends.  HHS’s FY 2024 contingency plan states that CMS operations will continue in the event of a shutdown.  Find HHS’s FY 2024 contingency staffing plan here.
  • 340B. CMS and its Health Resources and Services Administration (HRSA) have written to Johnson & Johnson in response to the latter’s announced intention to change how it sells two of its prescription drugs, Xarelto and Stelara, to eligible DSH hospitals under the 340B prescription drug program.  Instead of selling the drugs at a discount, as is currently the practice under the 340B program, Johnson & Johnson has said it will sell those drugs to 340B DSH hospitals at regular cost and then may provide a rebate based on documentation submitted by the DSH hospitals.  In its letter, HRSA writes that “If J&J implements its rebate proposal without Secretarial approval, it will violate Section 340B(a)(1) of the Public Health Service (PHS) Act” and that “In correspondence with HRSA, J&J asserts that their proposed rebate model is similar to “replenishment” processes and that this authorizes J&J to unilaterally impose its proposed rebate model without violating the 340B statute. This is incorrect.”  The letter adds that “Because J&J’s rebate proposal, if implemented, violates J&J’s obligations under the 340B statute, it subjects J&J to potential consequences, such as termination of J&J’s Pharmaceutical Pricing Agreement (PPA)” and concludes that “HRSA expects J&J to cease implementation of its rebate proposal immediately and to inform HRSA no later than September 30, 2024, in order to provide adequate notice to covered entities.”  Find the full HRSA letter here.
Centers for Medicare & Medicaid Services
  • CMS has issued a request for information (RFI) through which it will gather information from interested parties, including health care companies, health care providers and payers, start-ups, and other developers, about existing Artificial Intelligence (AI) technologies that support health care outcomes and service delivery relevant to CMS programs and operations.  CMS will select organizations to provide demonstrations of their AI products and services to the agency during a series of “CMS AI Demo Days” to help the agency better understand AI uses in the health sector.  Demonstrations will be selected quarterly by a technical panel of CMS employees.  Through this RFI, CMS invites organizations to submit information about their products.  This RFI is for informational purposes only; CMS will award no contracts based on it and responses will be used solely for information and planning purposes and may be made available publicly.  Learn more about the RFI, how CMS intends to proceed, the nature of the information it seeks from respondents, and how to respond to the RFI from CMS’s RFI notice.
  • As of July 1, hospitals must use a CMS template layout and data specifications for making public their standard charge information in a comprehensive machine-readable file (MRF).  Starting January 1, 2025, they also must encode additional data elements.  To assist with such efforts, CMS has posted a series of hospital price transparency tools.  Find them here.
  • CMS has posted two documents to inform potential participants about its new Medicare Prescription Payment Plan:  the fact sheet “What’s the Medicare Prescription Payment Plan?” and a shorter version with fact sheet highlights.  Last week CMS launched a web page with information about the Medicare Prescription Payment Plan that offers information about the program and an interactive tool to help Medicare Part D enrollees determine if the program might help them.  Find that web page here.
Department of Health and Human Services
  • HHS and its Health Resources and Services Administration (HRSA) have awarded nearly $100 million in grants to grow, support, and strengthen the health workforce and improve access to quality care in high-need areas.  The grants focus on growing the nursing workforce for acute and long-term care; increasing the primary care physician workforce in high-need areas; responding to the opioid crisis; and integrating mental health care into pediatric care.  Learn more from this HHS news release, which includes a link to a list of grant recipients.
  • HHS and HRSA have awarded $240 million in grants to launch and expand mental health and substance use disorder services in more than 400 community health centers that together care for more than 10 million people.  These grants are intended to help expand access to needed care to help tackle the mental health and opioid crises.  Learn more about the grants here and their role in the broader approach to addressing mental health and substance use challenges here and find a list of the grant recipients here.
  • HHS has published a Notice of Proposed Rulemaking to amend current regulations by removing clinical research and institutional review board requirements for transplantation of kidneys and livers from donors with HIV to recipients with HIV.  If the proposed rule is finalized, HHS believes it will lead to a larger number of these kidney and liver transplants and help reduce the stigma and health disparities associated with HIV.  Learn more about the proposed rule from this HHS news release and from the Notice of Proposed Rulemaking.  The deadline for submitting comments is October 15.
  • HHS’s Office of the Inspector General (OIG) has issued an unfavorable advisory opinion regarding an entity’s proposal to share a percentage of its savings with certain groups to which it provides coverage through employer group waiver plans.  Find that advisory opinion here.
  • The OIG has published a Federal Register notice setting forth its guidance regarding the standards it will apply in assessing the performance of Medicaid Fraud Control Units.  Based on its experience overseeing Medicaid Fraud Control Units and after consultation with key stakeholders, OIG is revising and replacing the standards it introduced in 2012.  Learn more from this OIG notice.
  • The OIG has issued a report on CMS’s efforts to recover Medicare payments to providers under the COVID-19 Accelerated and Advance Payments Program.  Find that report here.
  • HHS and its Administration for Community Living have delivered to Congress a progress report on federal implementation of their national strategy to support family caregivers.  The 2022 strategy presents a vision, establishes goals, and provides recommendations for ensuring that family caregivers have the support and resources they need.  Learn more from this HHS news release, which includes a link to the progress report.
  • The OIG has updated its schedule of audits and reviews for September.  Find the updated work plan here.
  • The Provider Relief Fund reporting portal is now open for reporting period 7.  Providers that received Provider Relief Fund (general or targeted) and/or American Rescue Plan Rural payments exceeding $10,000 in the aggregate between January 1 and June 30, 2023 are required to report on their use of those funds during reporting period 7.  The deadline to submit a report is September 30.  Learn more on the Provider Relief Fund’s reporting and auditing web page.
HHS Newsletters
HHS Videos
Centers for Disease Control and Prevention

The CDC has posted a rural public health strategic plan for FY 2024 through FY 2029.  The stated purpose of the plan is to improve the health of rural communities by advancing the best rural public health science and practices through a coordinated, transparent, and strategic approach.  The document outlines key priorities, objectives, and outcomes for the next five years for collaborating with both internal and external partners, including federal agencies.  It includes background on the CDC’s rural public health efforts, the science and practice of rural public health, the structure and role of the agency’s Office of Rural Health, and the strategic plan’s development.  This plan will guide the CDC’s programs and research to ensure that rural needs are part of public health programs at the outset.  Learn more from the CDC’s “Rural Public Health Strategic Plan: FY 2024-2029.”

Government Accountability Office (GAO)

HHS gathers selected information needed for public health emergencies, such as pandemics; this includes data on critical response resources and medical care capacity, among other things.  As part of a review of HHS’s performance during the COVID-19 emergency, the GAO examined HHS’s efforts to reduce unnecessary duplication, overlap, or fragmentation in the systems it uses to collect this kind of data and its efforts to protect personal information.  The GAO review found that HHS does not have a comprehensive list of these systems, has not identified or reduced unnecessary duplication, and did not fully implement key privacy safeguards for the nine systems it reviewed.  Learn more from the GAO report “COVID-19:  HHS Needs to Identify Duplicative Pandemic IT Systems and Implement Key Privacy Requirements.”

Stakeholder Events

MACPAC – Commissioners Meeting – September 19-20

MACPAC commissioners are holding their latest public meeting on Thursday, September 19 and Friday, September 20.  Go here to find the presentations to be delivered during the meeting and a link to register to participate remotely.

CMS – TCET Pathway Education Session – September 23

Last month CMS issued a final procedural notice outlining a Medicare coverage pathway to achieve more timely and predictable access to certain new medical technologies for people with Medicare.  This new Transitional Coverage for Emerging Technologies (TCET) pathway for certain FDA-designated breakthrough devices is expected to increase the number of national coverage determinations (NCDs) that CMS will conduct every year and seeks to support improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining appropriate safeguards for the Medicare population.  Now, CMS will hold an education session on Monday, September 23 at 2:30 (eastern) to share information about the TCET pathway and answer questions.   CMS notes that this session is intended for all Medicare and health care partners.  Go here to register to participate and to find an email address to which to submit questions.

HHS – Maternal Health Stakeholder Briefing – September 25

HHS will hold a briefing on its recent maternal health activities on Wednesday, September 25 at 2:00 (eastern).  Among the issues to be addressed during the briefing are HHS’s recent releases of data, information, and funding to address and advance maternal health outcomes; there also will be an opportunity for participants to ask questions.  Go here to register to participate.

CMS – Medicare Open Enrollment Boot Camp – September 25 and 26

CMS will hold a two-day “boot camp” for those who help people with Medicare make informed decisions about their 2025 health and drug coverage.  The session on Wednesday, September 25 will address Medicare plan finder basics and user tips, 2024 plan finder updates, information about the Medicare Prescription Payment Plan, and a Q&A session while on Thursday, September 26 the focus will shift to an overview of the Medicare open enrollment period and general program updates, 1-800-MEDICARE overview and activities, open enrollment period media outreach campaigns, a State Health Insurance Assistance Program (SHIP) overview and virtual counseling toolkit, a Medicare account experience live demonstration, health and drug plan marketing updates, and more questions and answers.  Go here to register to participate; both sessions   will be held from 1:00 to 3:30 (eastern).

HHS/Agency for Healthcare Research and Quality – Technical Assistance Webinar for Grant Application – September 27

HHS’s Agency for Healthcare Research and Quality (AHRQ) will hold a pre-application technical assistance webinar for RFA-HS-24-004, its grant program for state-based health care extension cooperative program to accelerate the implementation of actionable knowledge into practice, on Friday, September 27 at 1:00 (eastern).  Go here to learn more about the funding opportunity and to register to participate in the webinar; registration is required to attend the webinar.

CMS – Medicare Promoting Interoperability Program Office Hours – October 4

In conjunction with the CDC and the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology, CMS will hold an office hour session on Friday, October 4 at 2:00 (eastern) to discuss and answer questions about the Antibiotic Use and Antibiotic Resistance Surveillance measure(s) of the Public Health and Clinical Data Exchange Objective for the Medicare Promoting Interoperability Program.  With participation limited, interested parties should email Elizabeth.Holland@cms.hhs.gov with their questions and will receive a response that includes dial-in information.

CMS – Hospital Open Door Forum – October 8

CMS will hold an open-door forum for hospital officials on Tuesday, October 8 at 2:00 (eastern).  Go here to register to participate.

CMS – Rural Health Open Door Forum – October 10

CMS will hold an open-door forum for rural health care providers on Thursday, October 10 at 2:00 (eastern).  Go here to register to participate.

MedPAC – Commissioners Meeting – October 10-11

MedPAC commissioners will hold their next public meeting on Thursday, October 10 and Friday, October 11.  When agenda and participation information are posted they will be here.

CMS – Skilled Nursing Facilities/Long-Term Care Open Door Forum – October 17

CMS will hold an open-door forum for skilled nursing and long-term-care facility officials on Thursday, October 17 at 2:00 (eastern).  Go here to register to participate.

CMS – Hospital Price Transparency Webinar – October 21

CMS will hold a webinar on hospital price transparency during which it will address encoding new January 2025 price transparency requirements data in machine-readable files on Monday, October 21 at 1:00 (eastern).  Go here to register to participate.

CMS – Long-Term Services and Supports Open Door Forum – October 29

CMS will hold an open-door forum for providers of long-term services and supports on Tuesday, October 29 at 2:00 (eastern).  Go here to register to participate.

CMS – Home Health, Hospice and DME – October 30

CMS will hold an open-door forum for home health, hospice, and DME operators on Wednesday, October 30 at 2:00 (eastern).  Go here to register to participate.

CMS – Healthcare Common Procedure Coding System (HCPCS) Public Meeting – November 6-8

CMS will hold a virtual Healthcare Common Procedure Coding System (HCPCS) public meeting to discuss its preliminary coding, Medicare benefit category, and payment determinations, if applicable, for new revisions to the HCPCS Level II code set for non-drug and non-biological items and services.  The meetings will be held on Wednesday, Thursday, and Friday, November 6-8, from 9:00 to 5:00 (eastern) each day.  Learn more about the purpose of the meeting, its agenda, how to submit questions and written comments, deadlines for submitting questions and materials or to request an opportunity to speak, and how to register to participate from this CMS notice.