Health Care Watch: October 21, 2024

The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 13 – October 19. 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 October 16, Reps. Paul Tonko (D-NY) and Mike Turner (R-OH) announced that they have sent letters to dozens of hospitals, insurance plans, pharmacies, pharmacists, and providers aimed at gathering information on their existing actions and plans to eliminate barriers for accessing medications for opioid use disorder (MOUD). Theletters are intended to gain insight into the successes and barriers that have arisen following the implementation of the Mainstreaming Addiction Treatment (MAT) Act.

Senate

• On October 15, Finance Committee Chairman Ron Wyden (D-OR) sent a letter to UnitedHealth Group CEO Andrew Witty requesting answers to questions for the record following Mr. Witty’s testimony before the Finance Committee in June 2024. The letter states that some questions for the record have not been satisfactorily answered.

• On October 17, Democratic members of the Homeland Security and Governmental Affairs Subcommittee on Investigations, led by Subcommittee Chairman Richard Blumenthal (D-CT), released a report entitled Refusals of Recovery: How Medicare Advantage (MA) Insurers Have Denied Patients Access to Post-Acute Care. The report examines the three largest MA insurers – United Healthcare, Humana, and CVS – and their prior authorization practices. The report states that insurers are intentionally using prior authorization to boost profits by targeting costly yet critical stays in post-acute care facilities. Additionally, the report found that United Healthcare more than doubled the rate at which it denied care following hospital stays for its patients between 2020 and 2022 and that Humana’s denial rate for a similar type of care grew 54% during the same period.

REGULATORY UPDATE

• On October 11, a federal judge in Texas granted a Food & Drug Administration (FDA) request to stay the Outsourcing Facilities Association’s (OFA) lawsuit challenging its decision to pull Eli Lily’s GLP-1 drug tirzepatide from its shortage list while it reconsiders. OFA argued that FDA should have conducted a notice-and-comment rulemaking when pulling tirzepatide from its shortage list on October 2. While FDA reconsiders, the agency will not enforce the law holding large-scale compounders to a 60-day window to wind down operations once a drug comes off the list. FDA and OFA must file a joint status report by November 21, 2024.

• On October 15, FDA launched a webpage detailing how the Center for Drug Evaluation and Research (CDER) manages drug shortages. The webpage states that the Drug Shortage Staff (DSS) serves as CDER’s focal point for the evaluation and management of drug shortages and provides evaluation characteristics that DSS considers when declaring a shortage.

• On October 15, FDA released its annual report on the Accelerating Rare disease Cures (ARC) Program. ARC aims to increase the number of safe and effective rare disease drugs by promoting innovative scientific design, providing a deeper understanding of regulatory policies, and engaging in dialogue with rare disease patients and patient advocacy groups. The report highlights ARC’s achievements over the past year. Achievements include: 29 new rare disease drug approvals, 15 patent listening sessions on rare diseases, and more than 40 public speaking engagements featuring the ARC program.

• On October 16, the Centers for Medicare & Medicaid Services (CMS) approved section 1115 demonstration amendments that allow Medicaid and Children’s Health Insurance Program (CHIP) coverage of traditional health care practices provided by Indian Health Service (IHS) facilities, Tribal facilities, and urban Indian organizations (UIO). The actions are expected to improve access to culturally appropriate health care and improve the quality of care and health outcomes for tribal communities in Arizona, California, New Mexico, and Oregon, and will support IHS, Tribal, and UIO facilities in serving their patients.

• On October 17, CMS provided updates on its actions to prevent unauthorized agent and broker marketplace activity. CMS stated that it continues to exercise its full statutory and regulatory authority to protect the integrity of the Federally-facilitated Marketplaces (FFMs). Actions taken include: timely reviewing and addressing consumer complaints, updating Marketplace systems to prevent unauthorized changes with as little disruption to consumer access to FFM enrollment as possible, arming consumers with resources and information to help them avoid and report unauthorized plan changes by agents and brokers, and suspending and terminating the Marketplace Agreements of agents or brokers who have engaged in fraud or abusive conduct.

• On October 17, FDA published final guidance that provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.

• On October 17, FDA published final guidance that provides recommendations to sponsors for collection of a core set of patient reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design.

• On October 18, the Department of Health & Human Services (HHS) released a fact sheet detailing actions taken by the Agency to increase access and supply of IV fluids following Hurricane Helene. HHS stated that the Administration for Strategic Preparedness and Response (ASPR) is supporting Baxter International in efforts to airlift their product into the U.S. starting on October 19. Other actions taken by HHS include supporting the domestic supply, instating conservation efforts, and engaging stakeholders in open communication.

WHITE HOUSE

• On October 11, the Biden administration invoked the Defense Production Act to expedite repairs at Baxter International’s Marion, NC, hospital, a major IV fluid manufacturing plant that was shut down due to damage from Hurricane Helene.

• On October 15, the Harris-Walz campaign released a plan for improving rural health care. The plan recommends adding 10,000 health workers and bolstering hospitals, pharmacies and emergency medical services in rural areas. It also discusses increasing funding for telehealth equipment and use and broadly reducing health care costs.

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

• CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1807); Final Rule; 9/25/24

• CY 2025 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1809); Final Rule; 9/25/24

• CY 2025 Home Health Prospective Payment System Rate Update and Home Infusion Therapy and Home IVIG Services Payment Update (CMS-1803); Final Rule; 10/1/24

• CY 2025 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1805); Final Rule; 10/3/24

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

• Temporary Policies for Compounding Certain Large Volume Parenteral Drug Products for Hospitals (2024-742); Notice; 10/10/24

ADDITIONAL POLICY NEWS

• On October 15, drugmaker GlaxoSmithKline filed a lawsuit against Moderna in U.S. federal court, accusing Moderna of violating GSK patent rights in messenger RNA technology with its COVID-19 vaccine Spikevax and RSV shot mResvia.

• On October 15, the National Community Pharmacists Association (NCPA) released findings from a national survey, sharing that more than 90% of independent pharmacists may not sell drugs for which the Medicare Part D program is trying to negotiate lower prices. NCPA estimates pharmacies that dispense drugs in the program will have to invest $27,000 of their own money every month to stock the drugs and then wait one month or longer for manufacturer refunds to make the pharmacy whole. NCPA stated that for many pharmacies, this will be too much for them to absorb in an already difficult payment environment.

• On October 16, Novavax announced that FDA placed a clinical hold on the company’s Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The clinical hold is due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 trial participant outside of the U.S. who received the vaccine in January 2023. The trial was completed in July 2023 and the participant reported the SAE in September 2024.