Health Care Watch: December 16, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from December 8 – December 14. 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 December 9, the House GOP Steering Committee chose Rep. Brett Guthrie (R-KY) to serve as the next chairman of the Energy & Commerce Committee. Rep. Guthrie currently serves as the Chairman of the Energy & Commerce Subcommittee on Health. The Steering Committee also announced that Rep. Jason Smith (R-MO) will remain Chairman of the Ways & Means Committee. On December 11, the Democratic Caucus elected Rep. Frank Pallone (NJ) to again serve as the Ranking Member of the Energy & Commerce Committee and Rep. Richard Neal (MA) to again serve as the Ranking Member of the Ways & Means Committee next Congress. These committees will each add an additional Republican and Democrat seat next Congress.
On December 13, Ways & Means Committee Chairman Smith announced GOP Reps. Aaron Bean (FL), Max Miller (OH), Nathanial Moran (TX), and Rudy Yakym (IN) will join the Committee in the 119th Congress.
On December 13, incoming Chairman of the Energy & Commerce Committee Guthrieannounced 10 new Republicans will join the committee next Congress:
Cliff Bentz (OR)
Erin Houchin (IN)
Russell Fry (SC)
Laurel Lee (FL)
Nick Langworthy (NY)
Tom Kean (NJ)
Mike Rulli (OH)
Gabe Evans (CO)
Craig Goldman (TX)
Julie Fedorchak (ND)
As of December 14, House and Senate negotiators continue to move closer to a health care package to be combined with legislation that would fund the federal government beyond December 20. The current negotiations are rumored to be centered around a $20-$25 billion package that could include:
Spending Policies
Extended Medicare, Medicaid, and public health extenders for one year;
Medicare physician payment increase in 2025 and an Alternative Payment Model (APM) bonus;
Medicare telehealth flexibilities extension for two years;
High Deductible Health Plan telehealth extension for one year;
Hospital at Home program extension for five years;
Funding for Community Health Centers;
SUPPORT Act reauthorization for five years;
Reauthorization of PAHPA for 1-2 years
Coverage of multi-cancer early deduction tests;
Offsets
Extension of Medicare payment sequester
Pharmaceutical patent reforms
Pharmacy Benefit Manager (PBM) reforms including delinking reimbursements from Part D drug costs, banning spread pricing in Medicaid, and transparency in the commercial market;
National Provider Identifiers;
Medicare improvement Fund;
Q1 and Q2 adjustments; and
Hospice cap reforms
On December 16, the House will consider:
S. Amdt. to H.R. 7213, AUTISM Cares Act of 2024
H.R. 7224, to amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program
H.R. 4534, Women and Lung Cancer Research and Preventive Services Act of 2024
H.R. 6020, Honor Our Living Donors Act
Senate
On December 10, Sens. Elizabeth Warren (D-MA), Dick Durbin (D-IL), and Ben Cardin (D-MD) sent a letter to Dr. Mehmet Oz, in the wake of his nomination as Administrator of the Centers for Medicare & Medicaid Services (CMS), expressing concerns about protecting Traditional Medicare and his alleged financial ties to private health insurers.
On December 10, the Senate unanimously passed S. 4776, the Older Americans Act Reauthorization Act of 2024. The legislation reauthorizes the Older Americans Act for five years and would increase funding from $2.3 billion to $2.76 billion in fiscal 2025.
On December 10, the Senate passed H.R. 3797, the Paperwork Burden Reduction Act and H.R. 3801, the Employer Reporting Improvement Act. Both pieces of legislation seek to ease compliance requirements for employers under the Affordable Care Act. H.R. 3797 would no longer require employers and insurers to send tax forms to covered individuals showing proof of minimum coverage unless requested. H.R. 3801 would provide more time for employers to respond to a penalty assessment and allow employers to file some documents related to coverage electronically. These bills will now go to President Biden for his signature.
On December 11, Sens. Warren and Josh Hawley (R-MO) introduced legislation that would prohibit the parent company of a PBM or health insurer from also owning a pharmacy business. The legislation would require these healthcare companies to sell pharmacy assets within three years. Reps. Jake Auchincloss (D-MA) and Diana Harshbarger (R-TN) introduceda companion bill in the House.
REGULATORY UPDATE
On December 6, the U.S. Department of Agriculture (USDA) issued a new Federal Order, as well as accompanying guidance, requiring that raw milk samples nationwide be collected and shared with USDA for testing. This new guidance from USDA will facilitate comprehensive H5N1 surveillance of the nation’s milk supply and dairy herds.
On December 10, the Department of Health & Human Services (HHS), Office for Civil Rights (OCR) announced a $250,000 settlement with Inmediata Health Group, LLC (Inmediata), a health care clearinghouse, concerning potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule, following OCR’s receipt of a complaint that HIPAA protected health information was accessible to search engines like Google, on the internet.
On December 11, the Center for Medicare and Medicaid Innovation (CMMI) released its 2024 Report to Congress that includes updates on 37 models and initiatives, 52 evaluations and other activities from October 2022 through September 2024. During the report period, CMMI noted that more than 192,000 providers and/or plans participated in CMMI’s models and initiatives, serving over 57 million beneficiaries.
On December 12, the Food & Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee met to consider respiratory syncytial virus (RSV) vaccine safety in children. The Committee also discussed whether additional safeguards should be implemented when evaluating these shots in infants and toddlers.
On December 12, the Center for Drug Evaluation and Research (CDER) announced that it is opening a Center for Real-World Evidence Innovation. The Center will coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making across CDER.
WHITE HOUSE
On December 10, President-elect Donald Trump nominated Andrew Ferguson to head the Federal Trade Commission (FTC).
On December 11, the Biden Administration released the final annual global health security report entitled U.S. Government Support for Global Health Security – Protecting Lives and Safeguarding Economies. The report highlights progress in global health security and identifies remaining challenges.
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
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
REPORTS
Congressional Budget Office (CBO)
On December 10, CBO released the monthly budget review for November 2024. The report states that the federal budget deficit in the first two months of the 2025 fiscal year, October and November 2024, was $242 billion more than in the same period last fiscal year, totaling $622 billion. Additionally, the report states that the highest increases in mandatory spending programs in the first two months of fiscal 2025 were in Medicaid costs and Social Security benefits. Overall, mandatory spending programs increased by $32 billion, or 7%, from last year, with a $9 billion increase in Medicaid payments. CBO stated that this is largely due to rising costs per enrollee.
On December 12, CBO released a report entitled Options for Reducing the Deficit: 2025 to 2034. The report presents 76 options for altering spending or revenues to reduce federal budget deficits over the next decade. The report presents options in three categories: 1) mandatory outlays; 2) discretionary outlays; and 3) revenues. Health related mandatory spending options proposed by CBO include establishing caps on federal spending for Medicaid, limiting state taxes on health care providers, reducing federal Medicaid matching rates, increasing the premiums paid for Medicare Part B, and reducing Medicare Advantage benchmarks, among other options.
ADDITIONAL POLICY NEWS
On December 10, the Ohio Supreme Court ruled that national pharmacy chains cannot be held liable for claims that they violated a state public nuisance law by oversupplying communities with addictive pain pills. The decision comes after U.S. District Judge Dan Polster had ordered the chains to pay $650.9 million in “equitable relief” to help the communities curb the ongoing addiction crisis. A federal appeals court then asked the Ohio Supreme Court to settle whether another Ohio law governing product liability trumped the public nuisance law.
On December 12 and 13, the Medicare Payment Advisory Commission (MedPAC) held its December public meetings to discuss payment adequacy. Updates included a reduction of base payments by 7% to inpatient rehabilitating facilities (IRFs) and home health agencies, a 3% base payment decrease for skilled nursing facilities, an elimination to the update to the 2025 Medicare base payment rates for hospice, and an update to the 2025 Medicare ESRD PPS base rate by the amount determined under current law.
On December 12 and 13, the Medicaid and CHIP Payment and Access Commission (MACPAC) also held its December public meetings and discussed ensuring accountability of Medicaid managed care organizations, potential areas for comment on CMS CY 2026 MA/Part D Proposed Rule; and self-directed services in Medicaid home- and community-based services (HCBS) – among other topics.