Health Care Watch: November 25, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 17 – November 23. 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
The House returns from recess on December 3. This week, the GOP Steering Committee is expected to hear presentations from members who are seeking to become committee chairman 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 21, the Judiciary Committee advanced S. 2220, the PREVAIL Act, in an 11-10 vote. The legislation amends the Patent and Trademark Office Appropriation Act to authorize the Director of the Patent Trial and Appeal Board (PTCB) to: 1) collect fees authorized in this Act or any other Act to be charged or established by the Director; and 2) make such fees available to the Director until expended to carry out the activities of the PTCB.
The Senate returns from recess on December 2.
REGULATORY UPDATE
On November 15, the Drug Enforcement Administration (DEA) and the Department of Health & Human Services (HHS) released a final rule entitled Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. The final rule extends current telemedicine flexibilities that allow clinicians to remotely prescribe controlled substances, such as Adderall and buprenorphine, through December 31, 2025.
On November 18, the Food & Drug Administration (FDA) published draft guidance aimed at providing drugmakers with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The guidance is intended to help facilitate the development of safe, effective, and high-quality CGT products.
On November 18, HHS launched the Behavioral Health Workforce Career Navigator. The navigator is designed to help current and aspiring behavioral health professionals identify state requirements for a range of behavioral health careers.
On November 21, the HHS Office of Inspector General (OIG) released nursing facility industry segment-specific compliance program guidance. The guidance serves as OIG’s updated and centralized source of voluntary compliance program guidance for nursing facilities. The guidance aims to help nursing facilities identify their own risks and implement an effective compliance and quality program to reduce those risks.
On November 21, FDA issued final guidance outlining its 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. The guidance outlines FDA's current thinking on key aspects of the programs by describing FDA's expectations for the review of 510(k) submissions and EUA requests by third party review organizations.
On November 22, the Centers for Medicare & Medicaid Services (CMS) released a snapshot of the 2025 health care marketplace open enrollment. CMS reported that nearly 496,000 consumers who do not currently have health care coverage through the individual-market Marketplace plans have signed up for coverage in 2025, since the start of the Marketplace Open Enrollment Period (OEP) on November 1. Additionally, CMS stated that over 2.5 million existing consumers have already returned to the Marketplace to select a plan for 2025.
WHITE HOUSE
On November 19, President-elect Donald Trump announced his intent to nominate Dr. Mehmet Oz, a celebrity physician and TV personality, to serve as Administrator of CMS. Dr. Oz previously ran for a Senate seat in Pennsylvania and lost to Sen. John Fetterman (D-PA).
On November 21, President Biden signed H.R. 7189, the Congenital Heart Futures Reauthorization, into law. The legislation reauthorizes the National Congenital Heart Disease Research, Surveillance, and Awareness Program.
On November 23, President-elect Donald Trump announced his nominations to lead three major health agencies. President-elect Trump selected Dr. Marty Makary to lead the FDA. Makary is the chief of islet transplant surgery at Johns Hopkins and has written books about surprise billing practices at hospitals and the benefits of minimally invasive surgery. Trump selected former congressman Dr. Dave Weldon to lead the CDC. Weldon served in the House representing Florida's 15th district from 1995-2009. Finally, he selected Dr. Janette Nesheiwat as Surgeon General. Nesheiwat is a family medicine doctor and Fox News contributor.
On November 23, President-elect Trump selected Russ Vought, a co-author of Project 2025, to again lead the White House’s Office of Management and Budget.
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
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
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
Office of Inspector General (OIG)
On November 18, OIG released a report examining Medicare improper payments to acute care hospitals. OIG found that Medicare improperly paid acute care hospitals an estimated $190 million over 5 years for outpatient services provided to hospice enrollees. OIG found that for 70 of the 100 sample items, payments to acute care hospitals for outpatient services provided to hospice enrollees did not comply with the requirements. Specifically, OIG found that Medicare paid acute-care hospitals for outpatient services that palliated or managed hospice enrollees’ terminal illnesses and related conditions. Medicare improperly paid the acute-care hospitals because, among other causes: 1) the prepayment edit process was not properly designed; 2) most acute-care hospitals reviewed only whether outpatient services palliated or managed terminal illnesses, not related conditions; 3) Medicare guidance lacks details; and 4) Medicare contractors did not conduct prepayment or post payment reviews. OIG made six recommendations to CMS. CMS concurred with five of the six recommendations.
On November 19, OIG released a report examining HHS’ compliance with the Federal Information Security Modernization Act (FISMA) of 2014 for the fiscal year (FY) 2024. OIG found that overall, through the evaluation of FISMA metrics, HHS’s information security program was rated “not effective” for FY 2024, which is the same as the “not effective” program rating from FY 2023. The determination that HHS’s information security program was “not effective” was made based on HHS’s inability to meet the “managed and measurable” maturity level for the Core and Supplemental Inspector General metrics in the function areas of Identify, Protect, Detect, Respond, and Recover. OIG made a series of six recommendations to HHS to strengthen its information security program through improved oversight and information security controls implementation. HHS concurred with five of the recommendations but did not concur with the recommendation to complete implementation of a cybersecurity risk management strategy, because it believes its current strategy is sufficient.
Center for Disease Control and Prevention (CDC)
On November 21, CDC’s National Center for Health Statistics released a report examining chronic pain and high-impact chronic pain in U.S. adults. The report found that in 2023, 24.3% of U.S. adults experienced chronic pain, with 8.5% reporting that it frequently limited their life or work activities in the past three months. Additionally, the report found that chronic pain and high-impact chronic pain both increased with age and the percentage of adults with chronic pain and high-impact chronic pain increased with decreasing urbanization level.
ADDITIONAL POLICY NEWS
On November 14, Lilly filed a lawsuit against the Health Resources and Service Administration (HRSA) following HRSA’s rejection of Lilly’s plan to change the way it offers reduced prices on its medicines in the 340B program using a “cash replenishment model.” A few days earlier, on November 12, Johnson & Johnson filed a similar lawsuit against HRSA over the agency blocking its new 340B rebate plan. Both Eli Lilly and Johnson & Johnson’s proposed plans would swap upfront 340B discounts for after-the-fact rebates under the federal drug discount program.
On November 19, CVS Health Corp., Cigna Group and UnitedHealth Group filed a lawsuit against the Federal Trade Commission (FTC), following FTC’s administrative complaint against the companies accusing them of leveraging their role as pharmacy benefit managers (PBMs) to exclude cheaper insulin products from the list of medications they make available to patients through insurance. The lawsuit argues that FTC’s use of in-house tribunals to pursue enforcement actions violates their due process rights under the U.S. Constitution. The companies argue that the administrative process allows the agency to act as both a prosecutor and a judge, depriving the PBMs of a fair and impartial hearing.