The following is the latest health policy news from the federal government for October 4-10.  Some of the language used below is taken directly from government documents.

Hurricane-Related Notices
  • HHS Secretary Becerra has posted a letter to health care leaders and stakeholders outlining his department’s response to Hurricane Helene and the shortage of IV solutions exacerbated by that storm and how providers can modify some of their practices in response to the shortage.  Learn more from Secretary Becerra’s letter, which includes links to other HHS and external resources.  In addition, the FDA has established a web page that addresses specific drug shortages and possible responses and alternatives.  Find that web page here.
  • Supporting Secretary Becerra’s message, CMS has issued a series of emergency waivers and flexibilities for areas in Florida affected by Hurricane Milton.  These waivers address a wide range of facilities, practitioners, and requirements, including requirements for acute-care hospitals, critical access hospitals, long-term acute-care facilities (LTCHs), inpatient rehabilitation facilities (IRFs), skilled nursing facilities (SNFs), and others; conditions of participation and certification requirements for selected health care professionals; compliance with prevailing guidelines for EMTALA, HIPAA, and physician self-referral limits; various facility reporting requirements; and others.  Learn more from the “Hurricane Milton – Florida (2024)” section on CMS’s “Current Emergencies” web page; the individual waivers and waiver-related links in that section; and in particular, the CMS document “2024 Hurricane Milton Available Waivers for Affected Counties in the State of Florida Health Care Providers.”  These waivers and flexibilities also are described in this CMS news release.
  • At the same time, CMS also has updated its waivers and flexibilities to help health care providers respond to the damages caused by Hurricane Helene in South Carolina, Tennessee, Georgia, and Florida.  Find the updated waivers and flexibilities here.  Please note that these waivers are not dated and therefore require individual attention by affected providers.
  Centers for Medicare & Medicaid Services
  • CMS has issued its proposed “Notice of Benefit and Payment Parameters” for the 2026 plan year that proposes standards for the health insurance marketplaces and for health insurance issuers, brokers, and agents who connect consumers to ACA coverage.  The notice would prevent unauthorized marketplace activity among agents and brokers and support that effort by strengthening reviews and enforcement actions.  CMS seeks to advance health equity and mitigate health disparities by creating incentives for plans that enroll underserved consumers with high health needs and by introducing reviews to ensure that plans include enough essential community providers in their provider networks.  In addition, it includes measures to make it easier to enroll in and maintain health care coverage, simplifies plan choice, updates plan options, and improves public reporting on marketplaces and quality performance.  The notice includes updates to the HHS risk adjustment program; 2026 user fee rates for issuers; changes to calculations for the Basic Health Program; and annual public reporting of aggregated, summary-level information from the ACA Quality Improvement Strategy.  Learn more about the Notice of Benefit and Payment Parameters from this CMS news release and this CMS regulatory announcement.  The deadline for submitting comments is November 10.
  • As part of its Medicare $2 Drug List Model, a voluntary model under development that would test whether a simplified approach to offering low-cost, clinically important generic drugs can improve medication adherence, lead to better health outcomes, and improve satisfaction with the Part D prescription drug benefit for people with Medicare and prescribers, CMS has issued a Request for Information (RFI) seeking input on the sample list of drugs and other features of the model.  Learn more from this CMS news release and go here to see the RFI and the list of sample drugs for potential inclusion in the model.  The deadline for submitting comments is December 9.
  • As part of the Continuing Appropriations and Extensions Act of 2025, Congress has delayed data reporting requirements for clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests and also delayed the phase-in of payment reductions under the clinical laboratory fee schedule from private payer rate implementation.  Learn more from CMS’s Clinical Laboratory Fee Schedule web page.
  • Late last month CMS held a two-day virtual “bootcamp” to help prepare providers for the 2024 Medicare open enrollment period.  Now, the agency has posted the materials it shared during that bootcamp and videos of both days.  Find them all here.
Department of Health and Human Services
  • HHS and its Health Resources and Services Administration (HRSA) have awarded $19 million in grants to 15 states to identify and implement innovative strategies to address the maternal health crisis.  State maternal health innovation programs identify the key drivers of maternal mortality in their state, develop strategies, and implement new interventions to address these issues tailored to their state’s needs.  Learn more from this HHS news release, which includes a link to a list of the award recipients.
  • HHS is seeking written comments on 12 proposed new objectives for Healthy People 2030.  The new objectives address immunizations and infectious diseases; maternal, infant, and child health; chronic kidney disease; educational and community-based programs; environmental health; and hearing and other sensory or communication disorders.  Learn more about Healthy People 2030 and the proposed new objectives from this HHS announcement.
  • HHS’s Office of the Assistant Secretary for Technology Policy (ASTP) has posted a blog article about information blocking and application programming interfaces (APIs).  The article describes the challenges that have arisen during the push toward interoperability, the consequences of non-compliance, federal enforcement efforts, and the agency’s plans moving forward.  Find that article here.
  • HHS’s Office of Infectious Disease and HIV/AIDS Policy has issued an RFI inviting feedback on strategic plans to inform the development of its 2026-2030 national HIV/AIDS strategy and the national strategic plans for sexually transmitted infections, vaccines, and viral hepatitis.  Learn more about the RFI and find links to the individual strategies from this HHS notice.  The deadline for submitting comments is December 6.
  • HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) has published a study in which it estimates how the anticipated effects of climate change on the prevalence of a sample of four chronic conditions will affect demand for drugs needed to treat those conditions.  Find the ASPE report here.
  • HHS’s Office of Information Security and its Health Sector Cybersecurity Coordination Center are warning the health care sector and others about Trinity ransomware, a relatively new threat that employs a double extortion strategy that infiltrates systems through several attack vectors, including phishing emails, malicious websites, and exploitation of software vulnerabilities and then exfiltrates sensitive data before encrypting files, thereby increasing pressure on victims to pay a ransom.  Learn more from this Trinity ransomware threat profile.
  • With the closing of HHS’s Provider Relief Fund reporting portal for reporting period 7 on September 30, providers that missed this deadline have until November 1 to submit a request to report late due to extenuating circumstances.  Learn more from the Provider Relief Fund’s reporting and auditing web page.
HHS Newsletters
HHS Videos
Food and Drug Administration

As announced by the FDA last month, U.S.  households may now order four free COVID-19 tests.  Individuals can order tests here.

Congressional Budget Office (CBO)
  • The CBO has published a report that reviews the factors underlying prescription drug prices and examines a set of potential policy approaches that might help reduce those prices.  The agency assesses how each approach, if implemented in 2025, would affect average drug prices for purchasers in 2031.  Learn more from the CBO report “Alternative Approaches to Reducing Prescription Drug Prices.”
  • The CBO has published the findings of its analysis on how authorizing Medicare to cover anti-obesity medications might affect the federal budget.  Find that CBO report here.
Government Accountability Office (GAO)

The GAO has published a brief report describing its work on the effects of drug misuse on certain populations, treatment availability, and related barriers to treatment.  The report also cites areas for improvement for expanding access to drug misuse treatment.  Find the GAO report here.

Stakeholder Events

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.

MACPAC – Commissioners Meeting – October 31-November 1

MACPAC commissioners will hold their next public meeting on Thursday, October 31 and Friday, November 1.  When agenda and participation information are posted they will be here.

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.

CMS – 2024 CMS Optimizing Health Care Delivery to Improve Patient Lives Conference – December 12

CMS will hold a virtual conference that will convene change-makers from the health care community and federal government to share innovative ideas, lessons learned, and best practices that strengthen patient health care delivery and access to high-quality care by reducing the administrative burdens that affect patients and the health care workforce.  The conference will be held on Thursday, December 12 at 11:00 (eastern).  Go here for further information and to register to participate.