Health Care Watch: December 2, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 24 – November 28. 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 27, Energy & Commerce Committee member Rep. Mariannette Miller-Meeks (R-IA) wonreelection in Iowa's 1st Congressional District resulting in a current majority of 220 seats for House Republicans.
On December 2, the House will consider H.R. 9598, Office of National Drug Control Policy Reauthorization Act of 2024.
The House returns from recess on December 3. The GOP Steering Committee is expected to hear presentations from members who are seeking to become committee chairmen in the 119th Congress, including from Brett Guthrie (R-KY) and Bob Latta (R-OH) who are seeking the Energy & Commerce Committee gavel.
Senate
On November 22, Sen. Bernie Sanders (I-VT) announced that he will remain on the Health, Education, Labor & Pensions (HELP) Committee as Ranking Member during the 119th Congress.
On November 22, current HELP Committee Ranking Member Bill Cassidy (R-LA) and Sens. Mark Warner (D-VA), John Cornyn (R-TX), and Maggie Hassan (D-NH) introduced the Health Care Cybersecurity and Resiliency Act of 2024. The legislation aims to strengthen cybersecurity in the health care sector and protect Americans’ health data by providing grants to health entities to improve cyberattack prevention and response, providing best practices to rural health clinics and other providers, improving coordination between the Department of Health and Human Services (HHS) and Cybersecurity and Infrastructure Security Agency (CISA), and modernizing current regulations.
The Senate returns from recess on December 2.
REGULATORY UPDATE
On November 26, CMS released the Contract Year (CY) 2026 Medicare Advantage (MA) and Part D Policy and Technical Changes proposed rule. The rule includes policies to limit plans’ use of prior authorization tools by clarifying requirements for plan use of internal coverage criteria and proposing guardrails for the use of artificial intelligence (AI). Additionally, the proposed rule promotes access to behavioral health care providers and improves the administration of MA supplemental benefits. Finally, the proposed rule expands access to anti-obesity medications (AOMs) under the Medicare Part D and Medicaid programs. Specifically, the rule proposes to reinterpret the statute to recognize obesity as a disease, permitting coverage of AOMs for the treatment of obesity when such drugs are indicated to reduce excess body weight and maintain weight reduction long-term for individuals with obesity. A fact sheet detailing the proposed rule can be foundhere. Comments are due on January 27, 2025, by 5:00 PM ET.
On November 26, HHS released the Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model final rule. The final rule establishes a six-year mandatory model that will begin on July 1, 2025, and end on June 30, 2031. The model aims to increase access to kidney transplants, improve quality of care for people seeking kidney transplants, and reduce disparities among individuals undergoing the process to receive a kidney transplant. CMS is selecting half of the donation service areas (DSAs) in the country and all eligible kidney transplant hospitals within those DSAs to participate in the model, for a total of 103 kidney transplant hospitals. A fact sheet detailing the IOTA model can be found here.
On November 26, HHS released a final rule that aims to expand access to kidney and liver transplants for people with HIV. The final rule, which further implements the HIV Organ Policy Equity (HOPE) Act, removes the clinical research and institutional review board (IRB) approval requirements for kidney and liver transplants between donors with HIV and recipients with HIV. In tandem with the final rule, the National Institutes of Health (NIH) published a notice seeking public comment on a proposed revision to its research criteria for HOPE Act transplants of other organs, such as heart, lung, and pancreas.
On November 26, CMS released the 2024 Measures Under Consideration (MUC) ist. The list includes a total of 41 unique measures for consideration, of which 14 are currently implemented in Medicare programs and have been added to the MUC list due to significant revisions to their specifications. The full MUC list can be found here.
On November 27, the Administration for Strategic Preparedness and Response’s (ASPR) Center for the Biomedical Advanced Research and Development Authority (BARDA) announced awards of $27 million through the Rapid Response Partnership Vehicle (RRPV) Consortium to facilitate rapid development and manufacturing capabilities for diagnostics to address future biothreats.
WHITE HOUSE
On November 26, President-elect Donald Trump nominated Dr. Jay Bhattacharya, a Stanford University physician and economist, to serve as Director of NIH. President-elect Trump also nominated Jim O’Neill to serve as Deputy Secretary of HHS. Mr. O’Neill previously served as the Principal Associate Deputy Secretary of HHS during the first Trump Administration.
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
Advance Notice of Methodological Changes for CY 2026 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies + Draft CY 2026 Part D Redesign Program Instructions; Notice; 11/26/24
FDA
Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Final Rule; 9/24/24
Considerations for Including Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Notice; 9/27/24
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
ASTP ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Final Rule; 11/22/24
HEARINGS
Senate
HELP Committee
December 5; 10:00 AM; 562 Dirksen
What Is the FDA Doing to Reduce the Diabetes and Obesity Epidemics in America and Take on the Greed of the Food and Beverage Industry?
REPORTS
Office of Inspector General (OIG)
On November 25, OIG released a report examining the Health Insurance Portability and Accountability Act of 1996 (HIPAA) audit program. OIG found that the Office for Civil Rights (OCR) fulfilled its requirement under the Health Information Technology for Economic and Clinical Health (HITECH) Act to perform periodic HIPAA audits. However, OCR’s HIPAA audit implementation was too narrowly scoped to effectively assess electronic protected health information (ePHI) protections and demonstrate a reduction of risks within the health care sector. Specifically: 1) OCR’s audits consisted of assessing only 8 of 180 HIPAA Rules requirements; and 2) only 2 of those 8 requirements were related to Security Rule administrative safeguards and none were related to physical and technical security safeguards. OIG made a series of recommendations to OCR to enhance its HIPAA audit program, including that it: 1) expand the scope of its HIPAA audits to assess compliance with physical and technical safeguards from the HIPAA Security Rule; 2) document and implement standards and guidance for ensuring that deficiencies identified during the HIPAA audits are corrected in a timely manner; and 3) define metrics for monitoring the effectiveness of OCR’s HIPAA audits at improving audited covered entities and business associates’ protections over ePHI and periodically review whether these metrics should be refined.
On November 26, OIG released a report examining the Centers for Disease Control and Prevention’s (CDC) and the Substance Abuse and Mental Health Services Administration’s (SAMHSA) processes for and challenges with compiling data for the national drug control assessment. OIG found that CDC and SAMHSA used an iterative process to collect and report performance summary measurement data related to the reduction of overdose deaths. Additionally, OIG found that CDC and SAMHSA faced challenges including: 1) timely reporting of data in their evaluations of progress to ONDCP; and 2) issues with the availability of final data to meet the ONDCP reporting deadline.
OTHER HEALTH POLICY NEWS
On November 23, a Texas judge ruled in favor of UnitedHealth Group, stating that the federal government unlawfully factored in a disputed phone call to lower UnitedHealth’s MA star ratings. The judge ordered CMS to revise UnitedHealth’s 2025 MA star ratings by removing the call center metric and immediately publish the recalculated star ratings in the Medicare Plan Finder.