Health Care Watch: October 28, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 20 – October 26. 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 23, Energy & Commerce Committee Republicans released a report examining the Department of Health & Human Services (HHS) public relations COVID-19 campaign entitled “We Can Do This.” The report states that the Centers for Disease Control and Prevention’s (CDC) guidance, which the Campaign relied on, went beyond the terms of the Food & Drug Administration’s (FDA) Emergency Use Authorization (EUA) to state that COVID vaccines were highly effective against transmission leading to an ultimately negative impact on vaccine confidence and CDC’s credibility when proven untrue. The report also states that CDC had inconsistent and flawed messaging about the effectiveness of masks. The report makes various recommendations including that Congress should consider formally authorizing CDC and clearly define the agency’s core mission.
The House returns from recess on November 12.
Senate
On October 18, Finance Committee Chairman Ron Wyden sent a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure asking that the Agency include opportunities to expand the addiction medicine physician workforce as part of forthcoming guidance on increasing access to behavioral health providers for Medicaid and Children’s Health Insurance Program (CHIP) enrollees, as required by the Consolidated Appropriations Act of 2024.
The Senate returns from recess on November 12.
REGULATORY UPDATE
On October 21, the Departments of HHS, Labor, and of the Treasury released proposed rules entitled Enhancing Coverage of Preventive Services Under the Affordable Care Act. These proposed rules would expand access to coverage of recommended preventive services without cost sharing in the commercial market, with a particular focus on reducing barriers to coverage of contraceptive services. Under the proposed rules, most group health plans and health insurance issuers would be required to cover over-the-counter (OTC) contraceptives without cost sharing or requiring a prescription, and provide consumers with more choices of covered contraceptives. The proposed rules also further reinforce plans’ and issuers’ responsibility to cover FDA-approved, -cleared, and -granted birth control methods without cost sharing. A fact sheet detailing the proposed rule can be found here. Comments are due December 27, 2024.
On October 22, HHS’ Office of Assistant Secretary for Planning and Evaluation (ASPE) released new data showing that 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Inflation Reduction Act. The reported data shows that if the $2,000 Part D out-of-pocket (OOP) drug costs cap had been in effect this year, 4.6 million enrollees would have hit the cap by June 30 and would not have had to pay any more OOP costs for the remainder of the year.
On October 22, HHS Secretary Xavier Becerra, California State University (CSU) Chancellor Mildred García, and HHS Assistant Secretary for Administration Cheryl Campbell signed a memorandum of understanding with CSU, the nation’s largest four-year public university system. The memorandum seeks ways to collaborate on channeling students to work in federal health roles and forms a national model for how universities and federal agencies can work together to meet critical workforce needs.
On October 22, FDA announced that it is extending the comment period for its draft guidance on chemical analysis for biocompatibility assessment of medical devices until December 19, 2024.
On October 22, CMS Administrator Chiquita Brooks-LaSure and National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo were elected as members of the National Academy of Medicine.
On October 22, FDA announced that Dr. Michelle Tarver is set to serve as the Permanent Director of the Center for Devices and Radiological Health. She previously served as Acting Director.
On October 23, CMS’ Innovation Center announced that it is continuing to work on the final rule for the Increasing Organ Transplant Access (IOTA) Model – and, as such, is “anticipating a later start date for the model than the proposed start date of January 1, 2025.”
On October 23, HHS, in collaboration with the U.S. Departments of State, Agriculture (USDA), and Homeland Security (DHS), and their respective counterparts in Mexico and Canada, released the North American Preparedness for Animal and Human Pandemics Initiative (NAPAHPI) to continue strengthening regional health security and pandemic preparedness through a One Health approach. NAPAHPI is a flexible, scalable, and cross-sectoral platform to strengthen regional capacities for prevention, preparedness, and response to a broad range of health security threats that builds on lessons learned from COVID-19 and other health security events in the last decade. The new initiative establishes a Senior Coordinating Body as a key decision-making forum and the North American Health Security Working Group as its technical arm with members from the human health, animal health/agriculture, homeland security, and foreign affairs sectors.
On October 23, CDC’s Advisory Committee on Immunization Practices' (ACIP) voted 14-1 to recommend lowering the age for pneumococcal vaccination from 65 to 50 years old. CDC Director Mandy Cohen endorsed the recommendation shortly after the vote.
On October 23, CDC’s ACIP voted unanimously to recommend: 1) a second dose of the 2024-2025 COVID-19 vaccine for adults 65 years and older; 2) a second dose of the 2024-2025 COVID-19 vaccine for people ages 6 months to 64 years old who are moderately or severely immunocompromised; and 3) additional doses of the 2024-2025 COVID-19 vaccine for people ages 6 months and older who are moderately or severely immunocompromised under shared clinical decision making. CDC Director Cohen endorsed the recommendations.
On October 23, CDC’s ACIP voted unanimously to recommend GlaxoSmithKline’s meningococcal vaccine, Bexsero, as a two-dose shot for healthy adolescents and young adults ages 16 to 23 in consultation with a doctor. ACIP also recommended the product as a three-dose shot for ages 10 or under at increased risk for serogroup B meningococcal disease.
On October 24, HHS’ Office of the Assistant Secretary for Health (OASH) Office on Women’s Health (OWH), announced six winners for Phase 2 of the HHS Endocrine-Disrupting Chemicals (EDC) Innovator Award Competition. The competition identifies and awards programs that demonstrate effectiveness, sustainability, and the ability to replicate and/or expand interventions that address gaps in knowledge and provide solutions to reduce endocrine-disrupting chemical exposure risk for women. During Phase 1, HHS identified programs with innovative approaches to reducing the associated exposure risks of endocrine-disrupting chemicals. Phase 2 focuses on demonstrating the program's effectiveness by increasing knowledge and reducing the risk of exposure. The third phase will award programs that have successfully replicated and/or expanded.
On October 24, HHS and USDA released a fact sheet detailing new actions taken to stop the spread of avian flu. HHS and USDA stated that they are working closely with their state and local counterparts to respond to the outbreak and protect public health. They noted that while CDC’s assessment of the risk of avian flu to the general public remains low, USDA and HHS continue to take this outbreak seriously to protect human health, animal health, and food safety.
On October 24, FDA’s Acting Chief Scientist David Strauss announced that he is stepping down after 14 years with the agency. Steve Kozlowski, who most recently worked in the Office of Pharmaceutical Quality for the Center for Drug Evaluation and Research, will take over the position.
On October 25, CMS released a marketplace 2025 Open Enrollment Period fact sheet. The fact sheet details the open enrollment period as well as resources and information about lower prices, improvements in choice and management, and consumer and local call center supports. CMS also launched window-shopping for consumers to preview health coverage options available through the 2025 Open Enrollment Period for the HealthCare.gov marketplaces.
WHITE HOUSE
On October 23, First Lady Jill Biden, at the HLTH Conference, announced $110 million in awards from the Advanced Research Projects Agency for Health (ARPA-H) to accelerate transformative research and development in women’s health. The awards aim to spur innovation and advance high-impact, novel approaches to diseases and conditions that affect women uniquely, disproportionately, and differently. The awards will work across a range of women’s health issues including ways to prevent, detect, and treat cardiovascular conditions, ovarian cancer, endometriosis, neurological diseases, and pain in women to developing next generation approaches to menopause, migraines, obstetrics, and gynecological care.
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
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
REPORTS
Office of Inspector General (OIG)
On October 22, OIG released a report examining Part D payments for drugs available under the Part A skilled nursing facility (SNF) benefit. OIG found that for all 215 sample items, Part D improperly allowed prescription drug events (PDEs) for drugs that were dispensed to or on behalf of Part D enrollees during their Part A SNF stays. For 89 of the 215 sample items, SNFs’ medical records confirmed that the drugs were administered to the Part D enrollees during their Part A SNF stays. Additionally, OIG found that for 136 of the 215 sample items, there was no documentation to determine whether drugs from the pharmacies listed on the PDEs were administered during Part D enrollees’ Part A SNF stays. Based on OIG’s sample results, for 2018 through 2020, OIG estimated that up to the entire Part D total cost of $465.1 million was improperly paid for drugs for which payment was available under Part A. Of that amount, OIG estimated that approximately $245.4 million was for drugs that the medical records showed were administered to Part D enrollees during their Part A SNF stays. OIG made five recommendations, including that CMS work with its plan sponsors to adjust or delete PDEs, as necessary, and determine the impact to the Federal Government related to the Part D total costs of $953,370.
On October 24, OIG released a report examining questionable use of health risk assessments (HRAs) in Medicare Advantage (MA). OIG stated that diagnoses reported only on enrollees’ HRAs and HRA-linked chart reviews, and not on any other 2022 service records, resulted in an estimated $7.5 billion in MA risk-adjusted payments for 2023. The lack of any other follow up visits, procedures, tests, or supplies for these diagnoses in the MA encounter data for 1.7 million MA enrollees raises concerns that either: 1) the diagnoses are inaccurate and thus the payments are improper; or 2) enrollees did not receive needed care for serious conditions reported only on HRAs or HRA-linked chart reviews. OIG found that 20 MA companies drove 80% of the estimated $7.5 billion in payments. OIG recommends that CMS: 1) impose additional restrictions on the use of diagnoses reported only on in-home HRAs or chart reviews that are linked to in-home HRAs for risk-adjusted payments; 2) conduct audits to validate diagnoses reported only on in-home HRAs and HRA-linked chart reviews; and 3) determine whether select health conditions that drove payments from in-home HRAs and HRA-linked chart reviews may be more susceptible to misuse among MA companies.
Government Accountability Office (GAO)
On October 23, GAO released a report examining limb loss rehabilitation services and outcomes for Medicare beneficiaries. GAO found that of beneficiaries in traditional Medicare who lost a limb in 2016, nearly all received at least one selected rehabilitative service, and 30% received a prosthetic limb from 2016 through 2019. GAO also found that most beneficiaries in traditional Medicare with limb loss in 2016 experienced adverse health outcomes within 4 years. GAO interviewed 10 stakeholders who reported challenges beneficiaries with limb loss face that could affect their ability to access care, such as issues with care coordination among health care providers and affordability of prosthetic limbs. GAO made no recommendations.
UPCOMING HEARINGS
Senate
Judiciary Committee
October 29; 10:00 AM; Chief Judge’s Courtroom, Everett McKinley Dirksen United States Courthouse in Chicago, IL
Field Hearing: Reducing Prescription Drug Prices: How Competition Can Make Medications Affordable for Patients
ADDITIONAL POLICY NEWS
On October 18, Humana Inc. filed a lawsuit against CMS after a drop in the Star Ratings of one of Humana’s MA plans. The lawsuit seeks a federal court’s reversal of the Agency’s decision to reform the Star Ratings program.
On October 21, Lilly filed a lawsuit against three companies for selling products claiming to contain tirzepatide, the main ingredient in its popular weight-loss medicine Zepbound, including in the form of dissolvable tablets. The new lawsuits, which name Pivotal Peptides, MangoRx and Genesis Lifestyle Medicine of Nevada, are the first related to copycat tirzepatide filed since FDA took the drug off its list of medicines in short supply earlier this month.
On October 22, Novo Nordisk nominated semaglutide for inclusion on FDA’s Demonstrable Difficulties for Compounding list, a list which includes drugs that are complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly. Novo Nordisk also asked FDA to convene an advisory committee of outside experts to scrutinize the risks around the compounding of the medicines.
On October 22, law firms Pollock Cohen LLP and Walden Macht Haran & Williams filed a class action lawsuitagainst Anthem Blue Cross Blue Shield (BCBS) of New York claiming the insurer published an inaccurate directory of providers accepting BCBS coverage, focusing on mental health care. In this case, attorneys for the plaintiffs conducted a secret shopper study and found only seven of 100 doctors accepted BCBS insurance and were taking new patients.