The following is the latest health policy news from the federal government for October 11-17.  Some of the language used below is taken directly from government documents.

Aftermath of Hurricanes Helene and Milton

  • CMS has updated its waivers and flexibilities to help health care providers respond to the damage caused by Hurricane Helene in South Carolina, Tennessee, Georgia, North Carolina, and Florida and by Hurricane Milton in Florida.  Find the updated waivers and flexibilities here.  Please note that these waivers are not dated and therefore require individual attention by affected providers.
  • HHS has initiated a series of steps to help restore the supply of IV solution that was greatly reduced by damage to a Baxter International facility in North Carolina during Hurricane Helene.  Among those steps are posting FDA guidance providing flexibility for compounding IV solution alternatives; extending the expiration dates of existing IV products; airlifting new supplies into and around the country; working with other manufacturers to increase production capacity; helping Baxter clean up and restore its North Carolina plant and invoking the Defense Production Act toward that end; and more.  Learn more from this HHS fact sheet.  That fact sheet also links to a Baxter web page that addresses its facilities, supply continuity, the status of supplies for peritoneal dialysis, clinical information about conservation strategies, resources for health professionals and Baxter customers, and more; find that web page here.
  • Addressing the same problem, the CDC issued a health alert to inform providers, facility administrators, and state, tribal, local, and territorial health departments about this supply disruption, warning that it could affect patient care and urging them to assess their supplies and develop plans and mitigation strategies to reduce any effect on patient care.  The CDC also offered resources to help providers address this challenge.  Learn more from this CDC health alert.

Centers for Medicare & Medicaid Services

  • CMS has issued a final rule that will enable selected Medicare patients who were admitted to hospitals as inpatients, but who later had their status reclassified as outpatient in observation status and whose care therefore was not covered by Medicare Part A and whose ability to receive Medicare-covered post-discharge post-acute care therefore was limited, to appeal the change in their status from inpatient to outpatient.  The rule, required by an appeals court decision, will be retroactive to 2009.  CMS will contract with a single entity to serve as the eligibility contractor to whom patients will submit appeal requests and this contractor will send eligible appeals to the relevant Medicare administrative contractor (MAC) for consideration.  In addition, the rule establishes an expedited review process for Part A participants who experience this same change in their classification in the future.  The regulation took effect on October 11 but CMS has not established an implementation date for filing appeal requests.  Learn more about the rule, including the processes hospitals will need to follow and a flow chart of those new processes, from this detailed CMS regulatory announcement.
  • CMS has posted an FAQ to help Medicare Part D plans and other interested parties prepare for the implementation of the Medicare Prescription Payment Plan on January 1, 2025.  Find the FAQ here.
  • CMS has updated its summary of Medicare-covered preventive services.  Find the revised list here.
  • CMS has updated its fact sheet on Medicare Part B coverage of pre-exposure prophylaxis (PrEP) for HIV treatment.  Find the updated fact sheet here.
  • CMS has published a bulletin about October 24 payment updates of its Medicare ambulatory surgical center payment system.  The changes described in the system took effect on October 1.  Find the bulletin here.
  • CMS has issued guidance for inpatient psychiatric facilities about all-inclusive cost reporting and a new cost-reporting methodology for reporting periods beginning on or after October 1, 2024.  Find that guidance here.
  • CMS has posted its 2025 star ratings for Medicare Part C and Part D programs.  In its news release, the agency presents data on the distribution of star ratings for each program; year-to-year changes in star ratings; offers a breakdown of plan ratings based on for-profit/non-profit status; details average star ratings for several dozen Part C and Part D measures; lists some of the highest- and lowest-rated performers in each plan type; and more.  Learn more from this CMS fact sheet the newly published star ratings and files with the underlying documentation and data (some of which are direct downloads and zip files).
  • CMS has approved section 1115 demonstration amendments that permit, for the first time ever, Medicaid CHIP coverage of traditional health care practices provided by Indian Health Service facilities, Tribal facilities, and urban Indian organizations.  CMS expects the waivers to improve access to culturally appropriate health care and improve the quality of care and health outcomes for tribal communities in Arizona, California, New Mexico, and Oregon.  Learn more from this CMS news release, which includes links to the waivers for the individual states.

Department of Health and Human Services

  • HHS’s Office of the Inspector General has posted the inflation updates to the annual cap on patient engagement tools and supports, the safe harbor for arrangements for patient engagement and support.  The cap will rise 2.4 percent, to $605.  Learn more here.
  • HHS’s Office of the Inspector General has updated its work schedule of audits and reviews for October.  Find the updated work plan here.
  • HHS has updated its guide to best telehealth practices for emergency preparedness.  Find the update here.
  • 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

Drug Enforcement Administration (DEA)

The DEA has submitted to the Office of Budget and Management (OMB) a proposed final rule titled “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.”  While efforts to persuade Congress to extend or make permanent these COVID-era flexibilities have yet to succeed, submission of this proposed rule to OMB suggests that these flexibilities, set to expire at the end of the year and highly sought by many providers, may be extended instead by regulation for an as-yet unknown period of time.  Find the OMB listing of the DEA request here.

Food and Drug Administration

The FDA has approved a new treatment for hemophilia A and B that is the first non-factor and once-weekly treatment for hemophilia B.  Learn more from this FDA announcement.

Federal Trade Commission (FTC)

The FTC has revised its rules that govern notifying the federal government of possible mergers to require more information from participants in prospective mergers so federal officials can evaluate whether the proposed transaction would reduce competition and violate antitrust guidelines.  The rule, which applies to hospitals, health systems, and other health care organizations, revises the forms on which participants inform regulators about possible mergers by requiring more extensive information, including about high-level business plans related to competition; a description of the business lines of each filer to show existing areas of competition between the merging firms and supply relationships; and disclosure of investors in the buyer, including those with management rights.  Learn more about the proposed changes and why they have been adopted from this FTC news release and this pre-publication version of the final rule, which will take effect 90 days after its official publication.

Medicare Payment Advisory Commission (MedPAC)

MedPAC’s commissioners held their latest public meetings on Thursday, October 10 and Friday, October 11.  The subjects on the meetings’ agenda were:

  • Medicare beneficiaries in nursing homes
  • findings from MedPAC’s annual beneficiary and provider focus groups
  • supplemental benefits in Medicare Advantage
  • work plan for a mandated final report on the impact of recent changes to the home health prospective payment system
  • initial estimates of home health care use among Medicare Advantage enrollees

Go here for summaries, key points, actions, and the presentations offered at the meetings about each agenda item and go here for a transcript of the meetings.

Stakeholder Events

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.

HHS – Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT – “Ask Us About Information Sharing” – October 24

HHS’s Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT will hold virtual office hours on Thursday, October 24 at 2:00 (eastern) to answer stakeholders’ question about HHS information blocking regulations.  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 – Physicians, Nurses, and Allied Health Professionals Open Door Forum – November 7

CMS will hold an open-door forum for physicians, nurses, and allied health professionals on Thursday, November 7 at 2:00 (eastern).  Go here to register to participate.

CMS – Hospital Open Door Forum – November 12

CMS will hold an open-door forum for hospital leaders on Tuesday, November 12 at 2:00 (eastern).  Go here to register to participate.

CMS – Rural Health Open Door Forum – November 21

CMS will hold an open-door forum for rural health leaders on Thursday, November 21 at 2:00 (eastern).  Go here to register to participate.

HHS – Office of the Assistant Secretary for Technology Policy – Annual Meeting – December 4-5

HHS’s Office of the Assistant Secretary for Technology Policy will hold its annual meeting in Washington, D.C. on Thursday, December 4 and Friday, December 5.  The agency describes this meeting as “… two days of conversation, learning, and networking.  You’ll hear about the key issues at the intersection of health care, public health, policymaking, and technology through a variety of keynote speakers and mainstage, breakout, and education sessions…”  Go here for additional information and to register to attend.

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.