Health Care Watch: November 11, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 3 – November 9. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On November 6, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA) sent letters to five independent federal agencies asking Biden-Harris administration appointees to abandon partisan efforts and instead focus remaining efforts on bipartisan, consensus items. The letters state that the agency should immediately stop work on any partisan or controversial item under consideration, consistent with applicable law and regulation.
As of November 9, control of the House of Representatives remains in limbo. Thus far, according to CNN, Republicans have secured 213 of the 218 seats needed to retain control of the House, while Democrats have won 204 seats. Ballots in 18 contests are still being counted, primarily in California. Majority Leader Steve Scalise (R-LA) is on record as saying he expects the GOP to end up with 221-223 seats when all races have been called.
The House returns from recess on November 12. The GOP is planning to hold their leadership elections for next Congress on November 13 and the Democrats on November 19.
Senate
On November 6, Republicans won control of the Senate next Congress by flipping four seats (MT, OH, PA, and WV) and are currently sitting at a 53-46 majority, according to the Associated Press. The Democrats will likely win the Arizona race, bringing the final margin to 53-47. Expected committee leadership changes include Sen. Bill Cassidy (R-LA) rising to Chairman of the Health, Education, Labor & Pensions (HELP) Committee and Sen. Mike Crapo (R-ID) becoming Chairman of the Finance Committee.
The Finance Committee will see significant turnover next Congress with five Democrats leaving the Committee (Sens. Brown and Casey via election losses and Sens. Cardin, Carper, and Stabenow via retirement). The Democrats could lose two or three seats on the committee while the Republicans could gain two or three seats, based on party composition ratios in the Senate.
The Senate returns from recess on November 12. Republicans are planning to hold their leadership elections on November 13.
REGULATORY UPDATE
On November 4, the Food & Drug Administration (FDA) authorized marketing of LumiThera, Inc.’s Valeda Light Delivery System to help improve vision in certain dry age-related macular degeneration (AMD) patients.
On November 4, the Centers for Disease Control and Prevention (CDC) expanded its testing guidance after new data suggested that a significant number of H5N1 bird flu cases are not being reported. CDC now recommends testing for workers who were exposed but did not show signs of an infection. Officials also recommend Tamiflu for workers with known exposure and who did not wear protective equipment, even if they do not show signs of an H5N1 infection.
On November 5, the Department of Health & Human Services (HHS) announced that, following the one-year anniversary of the Task Force on Maternal Mental Health launch, it is expanding efforts to advance maternal mental health and substance use disorder care. HHS is asking interested non-federal organizations to submit pledges highlighting new initiatives that address challenges and barriers to maternal mental health and substance use disorder care. HHS will collect pledges through December 6, 2024, and announce them publicly in early 2025.
On November 7, HHS released the 2021–2023 Progress Report for the Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. The progress report includes the status of seven core indicators and seven disparities indicators. The most recently available data reveal that seven of the indicators have met or are moving toward annual targets and that seven have not met or are moving away from annual targets.
On November 7, FDA announced that it is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion after an agency review of the available data determined that oral phenylephrine is not effective for this use. For now, companies may continue to market OTC monograph drug products containing oral phenylephrine as a nasal decongestant, as only a final order will affect what products can be marketed.
WHITE HOUSE
On November 6, Donald Trump won the 2024 Presidential election, becoming the 47th President of the United States.
On November 7, President-elect Donald Trump announced that his campaign senior adviser Susie Wiles will serve as White House Chief of Staff.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056); Final Rule; 6/27/24
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Proposed Rule; 8/8/24
Contract Year 2026 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4208); Proposed Rule; 9/20/24
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Final Rule; 9/20/24
FDA
Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability; Notice; 7/9/24
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Notice; 8/26/24
Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Final Rule; 9/24/24
Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Notice; 9/26/24
Considerations for Including Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Notice; 9/27/24
Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices; Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 10/2/24
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry (2023-663); Notice; 10/23/24
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 10/29/24
HEARINGS
House
Oversight and Investigations Committee
Preparing for the Next Pandemic: Lessons Learned and The Path Forward
November 14; 11:30 AM; 2145 Rayburn
REPORTS
Office of Inspector General (OIG)
On November 7, OIG released a final assessment report of the National Background Check Program for long-term care providers. OIG found that the National Background Check Program successfully established a program to help States identify efficient, effective, and economical procedures for conducting background checks on prospective long-term care employees. Additionally, the National Background Check Program helped states successfully build systems to disqualify employees with concerning criminal convictions from working in long-term care settings. OIG noted that states reported two procedures that were appropriate, efficient, and effective for conducting background checks: 1) having an automated system for conducting background checks; and 2) having the ability to monitor status changes to a person’s background check after the initial background check has been completed. OIG did not provide any recommendations.
ADDITIONAL POLICY NEWS
On November 4, Kroger finalized a $1.4 billion settlement with states, local governments and Native American tribes to resolve allegations that it helped fuel the U.S. opioid epidemic. The company did not admit wrongdoing; however, Kroger did agree to require its pharmacies to monitor and report suspicious opioid prescription activity.
On November 5, the Supreme Court heard oral arguments in Christ Medical Center v. Becerra. The case challenges how the government calculates Disproportionate Share Hospital (DSH) payments, stating that the Centers for Medicare & Medicaid Services (CMS) should count all patients eligible for Social Security Supplemental Security Income, not just those who receive cash assistance through the program. HHS argues that in calculating DSH payments, it follows the statute as passed by Congress.
On November 6, CVS Health named Steve Nelson the president of its health insurance company, Aetna. Nelson is a former UnitedHealthcare leader who most recently served as Chief Executive Officer of ChenMed.