The Administration

Public Communication

The new administration has directed HHS to pause all external communications, including announcements, advisories, regular publications, and web site updates.  According to a published report,

“HHS has issued a pause on mass communications and public appearances that are not directly related to emergencies or critical to preserving health,” a spokesperson wrote in an email.  “This is a short pause to allow the new team to set up a process for review and prioritization.  There are exceptions for announcements that HHS divisions believe are mission critical, but they will be made on a case-by-case basis.”  The directive also applies to HHS’s agencies, such as CMS, the CDC, the FDA, and the NIH.  The pause is reportedly in effect until February 1.

Regulatory Freeze

The President issued an executive order directing a regulatory freeze.  The order directs that agencies:

  • may not propose or issue any rule until it has been reviewed and approved by a Trump administration department or agency head
  • immediately withdraw rules that have been sent to the Office of the Federal Register but have not been published
  • consider postponing for 60 days the effective day of any rules published in the Federal Register or issued but that have not yet taken effect
  • consider reopening comment periods and potentially delaying the rules beyond 60 days

Some of the orders and actions issued before the end of the Biden administration that are described below may be subject to reconsideration by the Trump administration pursuant to the regulatory freeze.

Rescinded Executive Orders and Actions

In an executive order titled “Initial Recissions of Harmful Executive Orders and Actions,” the President revoked 78 published executive orders, actions, and presidential memorandum issued by the Biden administration.

Artificial Intelligence

  • Executive Order 14110 of October 30, 2023 (Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence).  This executive order announced the Biden administration’s policy to advance and govern the development and use of AI in accordance with eight guiding principles and priorities and directed federal departments and agencies to adhere to those principles in their AI-related endeavors.

Rescinded Biden Administration Executive Orders Addressing Health Care-Related Issues

  • Executive Order 14009 of January 28, 2021 (Strengthening Medicaid and the Affordable Care Act).  This Biden administration order called on federal agencies to protect and strengthen Medicaid and the Affordable Care Act and to make high-quality care accessible and affordable for every American by identifying and addressing practices, demonstrations, and waivers that limit access to care through pre-existing condition requirements, barriers to Medicaid and health insurance enrollment, or the lack of affordability of care.
  • Executive Order 14070 of April 5, 2022 (Continuing To Strengthen Americans’ Access to Affordable, Quality Health Coverage).  Like the 2021 order, this 2022 Biden administration executive order called for strengthening Medicaid and the Affordable Care Act and called on executive branch agencies review existing regulations, orders, guidance documents, policies, and any other similar agency actions to determine whether their actions were consistent with this policy, promoted affordable coverage, and reduced barriers to enrollment.
  • Executive Order 14087 of October 14, 2022 (Lowering Prescription Drug Costs for Americans).  This executive order directed HHS to develop the means, as authorized by the Inflation Reduction Act, to establish a $35 monthly cap per prescription for insulin covered by a Medicare prescription drug plan and insulin delivered through traditional pumps; to require drug companies to pay Medicare rebates if they increase the prices of drugs used by Medicare beneficiaries faster than the rate of inflation; and to establish a process for negotiating prices for selected high-cost prescription drugs for Medicare beneficiaries.

Rescinded Biden Administration Executive Orders Addressing COVID-19

  • Executive Order 13987 of January 20, 2021 (Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security).
  • Executive Order 13996 of January 21, 2021 (Establishing the COVID-19 Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce for COVID-19 and Other Biological Threats).
  • Executive Order 13997 of January 21, 2021 (Improving and Expanding Access to Care and Treatments for COVID-19).
  • Executive Order 13999 of January 21, 2021 (Protecting Worker Health and Safety).
  • Executive Order 14002 of January 22, 2021 (Economic Relief Related to the COVID-19 Pandemic).
  • Executive Order 14099 of May 9, 2023 (Moving Beyond COVID-19 Vaccination Requirements for Federal Workers).

Other Executive Orders

  • A separate executive order withdraws the U.S. from the World Health Organization.
  • An executive order titled “Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government” states that “It is the policy of the United States to recognize two sexes, male and female.  These sexes are not changeable and are grounded in fundamental and incontrovertible reality.  Under my direction, the Executive Branch will enforce all sex-protective laws to promote this reality.”  It also defines what constitutes “male” and “female;” notes that “‘Sex’ is not a synonym for and does not include the concept of ‘gender identity;’” and explains that “When administering or enforcing sex-based distinctions, every agency and all Federal employees acting in an official capacity on behalf of their agency shall use the term ‘sex’ and not ‘gender’ in all applicable Federal policies and documents.”

Other Day-One Actions  

  • The administration announced that Dr. Dorothy Fink, currently director of HHS’s Office on Women’s Health, will serve as interim HHS Secretary pending Senate confirmation of nominee Robert F. Kennedy, Jr. and that Dr. Mehmet Oz will serve as acting Administrator of CMS following the resignation of the current Administrator, Chiquita Brooks-LaSure.

Congress

  • The current continuing resolution funding the federal government expires on March 14 and health care extenders expire March 31.   It is not yet clear how Congress intends to proceed on addressing them.
  • The debt ceiling suspension lapsed on January 1 and the Treasury Department is employing various measures to extend the federal government’s borrowing ability.  It is not yet clear when those measures will no longer be possible and there has been no action to date on lifting the debt ceiling.
  • With President Trump in office, House Republicans are eager to pass legislation advancing his agenda.  It is not yet clear how they will proceed but committees are compiling lists of possible cuts to mandatory spending – including around $2-3 billion in cuts to health care programs.
  • The Senate Finance Committee will hold its confirmation hearing for HHS Secretary nominee Robert F. Kennedy, Jr. on Wednesday, January 29; go here to view the hearing.  The Senate HELP Committee may hold its hearing as soon as Thursday, January 30.
  • The House Ways and Means Committee has released a document that details possible federal policy changes it may consider, primarily (but not entirely) as ways to reduce federal spending.  Among the health care issues addressed in the document are the elimination of Medicare bad debt reimbursement, the introduction of site-neutral Medicare outpatient payments, changes in graduate medical education payment policy, changes in the Medicare area wage index system, reform of Medicare payments to physicians, elimination of non-profit status for hospitals and tax deductions for charitable contributions to health organizations, reductions of federal Medicaid matching fund rates, limits on Medicaid provider taxes, introducing Medicaid work requirements, instituting Medicaid per capita payment caps, reinstating the public charge rule, and more.  Find the Ways and Means document here.

MedPAC Rate Recommendations

The Medicare Payment Advisory Commission has made its annual recommendations for Medicare rate changes for the next fiscal and calendar years.  Those recommendations are:

  • inpatient and outpatient rates – update the 2025 Medicare inpatient prospective payment system and outpatient prospective payment system rates for general acute-care hospitals by the amount specified in current law plus one percent, which is anticipated to result in a 4.3 percent increase.  MedPAC also recommends that Congress redistribute existing Medicare disproportionate share hospital payments (Medicare DSH) and uncompensated care payments through its own Medicare Safety-Net Index (MSNI) and add $4 billion to the Medicare Safety-Net Index pool.
  • physician payments – recommends changing the calculation of physician payments to be updated by the Medicare Economic Index minus one percentage point and establishing safety-net add-on payments for services provided to low-income Medicare beneficiaries.   This is anticipated to net a 1.3 percent increase in base rates plus an additional 1.7 percent increase related to the safety-net add-on
  • outpatient dialysis – a 1.8 percent increase
  • hospice services – no update
  • skilled nursing facilities – a three percent cut
  • home health services – a seven percent cut
  • inpatient rehabilitation facilities – a five percent cut

Centers for Medicare & Medicaid Services

  • CMS is inviting applications for two graduate medical education (GME) residency slot award programs hospitals seeking to add or expand existing residency programs beginning July 1, 2026.  Section 4122 of the Consolidated Appropriations Act of 2023 directed CMS to add 200 residency slots to the Section 126 program for FY 2026 and to distribute at least 100 of those positions to psychiatry (or subspecialty) programs.  While these programs use the same criteria for hospital eligibility and scoring, they each have their own application.  To be eligible to apply, a hospital must meet at least one of the following criteria:
  1. Location in rural areas or that are treated as being located in a rural area (pursuant to sections 1886(d)(2)(D) and 1886(d)(8)(E) of the Social Security Act).
  2. A reference resident level greater than the otherwise applicable resident limit.
  3. Location in a state with new medical schools or additional locations and branches of existing medical schools.
  4. Service areas designated as Health Professional Shortage Areas (HPSAs).

For both programs, applicant hospitals will be ranked based on the HPSA that would be served by the new or expanding residency program.  In previous rounds of the Section 126 awards, successful hospitals have been those with HPSA scores at or above 12.  For further information about the Section 126 program, see FAQs about the program; HPSA scores for application (this link downloads a zip file); and the MEARIS application portal.  For further information about the Section 4122 program, see FAQs about the program; HPSA scores for application (downloads a zip file); and the MEARIS application portal.  The deadline for applying is March 31.

  • CMS has posted a bulletin on payments for Medicare Part B preventive vaccines and their administration for rural health clinics and FQHC.  Find that bulletin here.  The policy changes it describes take effect on July 1.
  • CMS has posted its April 2025 quarterly update on HCPCS codes used for skilled nursing facility consolidated billing enforcement.  Find that bulletin here.  The updated codes the bulletin describes take effect on April 1.
  • CMS has posted a bulletin on updates in payments for ambulatory surgical centers.  Find that bulletin here.  The update took effect on January 1.
  • CMS has announced that an additional 15 drugs covered under Medicare Part D will be subject to price negotiations with their manufacturers in the coming months.  In accordance with the Inflation Reduction Act, the negotiations with participating drug companies for these 15 drugs will occur in 2025 and any negotiated prices will take effect in 2027.  Learn more about the drugs chosen for these negotiations and the next steps in the price negotiation process from this HHS news release, which includes a list of the selected drugs, and this CMS fact sheet on the selected drugs and the negotiation process that will follow.
  • CMS has hired contractors to support the development of interoperability measures for use in its post-acute care quality reporting programs (QRPs).  As part of their measure development process, the consultants will convene groups of interested parties and experts to contribute direction and input during measure development and maintenance.  Panel meetings will be conducted virtually and will focus on providing guidance on concepts involving the development of an interoperability measure for the post-acute care QRPs.  Learn more about the panel’s work, the background sought among potential participants, the time commitment involved, and how to apply to participate by going here and scrolling down to the link for “Development of Post-Acute Care (PAC) Quality Reporting (QRP) Interoperability Measure.”  The deadline for submitting applications is February 18.
  • CMS has written to state governments with its annual update of poverty guidelines, as required by law.  This update will be applied to eligibility criteria for programs such as Medicaid and CHIP.   This year’s guideline reflects the 2.9 percent price increase between calendar years 2023 and 2024.  Learn more from this CMS memo to state governments.
  • CMS has sent a memo to state survey agencies providing guidance on special procedures for laboratories.  The update includes revisions to survey and enforcement timelines and budget responsibilities; incorporation of current procedures and practices for federal monitoring surveys, state agency performance reviews, and revisit surveys; removal of past forms; the incorporation of several previous memos and regulatory updates; and notice that certain past guidance memos have expired.  Learn more from this CMS memo to state survey agencies.

Department of Health and Human Services

  • HHS has published its semi-annual regulatory agenda.  Find the preview version here; official publication is scheduled for February 12.
  • HHS’s Health Resources and Services Administration (HRSA) will award three grants of up to $1 million to support the development of collaborative improvement and innovation networks to improve access to and delivery of maternity and obstetrics care in rural areas.  Learn more about the program, the grants, eligibility, and how to apply from this HRSA grant opportunity notice.  The deadline for applying is April 22.

HHS Newsletters and Reports

HHS Office of Information Security and Health Sector Cybersecurity Coordination Center – monthly cybersecurity vulnerability bulletin for December

Centers for Disease Control and Prevention

In response to concerns about the possible spread of avian (bird) flu, the CDC has issued a health alert

to clinicians and laboratories recommending a shortened timeline for subtyping all influenza A specimens among hospitalized patients and increasing efforts at clinical laboratories to identify non-seasonal influenza.  Learn more about what the CDC is recommending and why and find links to additional information from this CDC health alert.

Cybersecurity and Infrastructure Security Agency (CISA)

CISA, in cooperation with HHS’s Office of Information Security and Health Sector Cybersecurity Coordination Center, the FBI, the National Security Agency, and government cybersecurity agencies in several other countries, has issued a guide presenting priority considerations for operational technology owners and operators when selecting digital products.  Find that guide here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

MACPAC has written to CMS in response to CMS’s proposed rule on policy and technical changes to Medicare Advantage for contract year 2026.  In its letter, MACPAC points out that in proposing to make mandatory coverage of certain weight-loss drugs for obesity through Medicaid, the new rule could create the risk that costs could temporarily shift from Medicare to Medicaid for dually eligible individuals.  In its letter, MACPAC explains how this would occur, how CMS can avoid this problem, and how CMS can better integrate Medicaid and Medicare services for the dually eligible.  Learn more from MACPAC’s letter to CMS.

Stakeholder Events

MACPAC – Commissioners Meeting – January 24

MACPAC’s commissioners will hold the second day of their latest two-day public meeting virtually on Friday, January 24.  Go here to find the meeting’s agenda and for information about how to participate.

CMS – Skilled Nursing Facilities/Long-Term Care Open Door Forum – February 6

CMS will hold an open-door forum for skilled nursing facilities and long-term-care facilities on Thursday, February 6 at 2:00 (eastern).  Go here to register to participate.

CMS – Home Health, Hospice, and Durable Medical Equipment Open Door Forum – February 26

CMS will hold an open-door forum for home health, hospice, and durable medical equipment providers on Wednesday, February 26 at 2:00 (eastern).  Go here to register to participate.

MedPAC – Commissioners Meeting – March 6-7

MedPAC’s commissioners will hold their next public meeting virtually on Thursday, March 6 and Friday, March.  An agenda and registration information are not yet available but when they are they will be posted here.