Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, the House Energy and Commerce Health Subcommittee held a markup of 23 bills and Senators Bill Cassidy (R-LA) and Sheldon Whitehouse (D-RI) announced the Pay PCPS Act of 2024, a proposal on primary care payment reform.

I. Regulations, Notices & Guidance

• On May 14, 2024, the Food and Drug Administration (FDA) released a notice entitled, Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Ojemda (tovorafenib). The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that Ojemda (tovorafenib), approved on April 23, 2024 and manufactured by Day One Biopharmaceuticals, Inc., meets the criteria for a priority review voucher.
• On May 14, 2024, the National Institutes of Health (NIH) released a notice entitled, Request for Information on the Development of the Fiscal Years 2026 – 2030 NIH-Wide Strategic Plan for Sexual & Gender Minority Health Research; Correction. The Department of Health and Human Services (HHS), NIH published a Notice in the Federal Register on May 9, 2024. That notice requires a correction in the “DATES” section.
• On May 15, 2024, FDA released a notice entitled, Issuance of Priority Review Voucher; Rare Pediatric Disease Product; XOLREMDI (mavorixafor). The FD&C Act authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that XOLREMDI (mavorixafor), approved on April 26, 2024 and manufactured by X4 Pharmaceuticals, Inc., meets the criteria for a priority review voucher.
• On May 15, 2024, FDA released a notice entitled, Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability. FDA is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to COVID-19. FDA has issued the Authorizations listed in this document under the FD&C Act. These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorization follows the February 4, 2020, determination by the Secretary of HHS, as amended on March 15, 2023, that there is a public health emergency (PHE), or a significant potential for a PHE, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA’s website from the links indicated.
• On May 16, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Advisory Committee on Immunization Practices (ACIP); Notice of Charter Renewal. This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Committee on Immunization Practices (ACIP), CDC, HHS, has been renewed for a two-year period through April 1, 2026.
• On May 16, 2024, the Administration for Children and Families (ACF) released a notice entitled, Administration for Children and Families Privacy Act of 1974; System of Records. In accordance with the requirements of the Privacy Act of 1974, as amended, HHS is modifying an existing system of records maintained by ACF, Office of Child Support Services (OCSS): System No. 09–80–0389, “OCSE Data Center General Support System” being renamed “OCSS Data Exchange Platform”.
• On May 16, 2924, FDA released a notice entitled, Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability. FDA is announcing the revocation of the EUAs (the Authorizations) issued to Bio-Rad Laboratories Inc., for the Bio-Rad SARS-CoV-2 ddPCR Kit, and Fast Track Diagnostics Luxembourg S.á.r.l. (A Siemens Healthineers Company), for the FTD SARS-CoV-2. FDA revoked the Authorizations under the FD&C Act as requested by the Authorization holders.
• On May 16, 2024, FDA released draft guidances entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability. The draft guidance provides product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The draft guidance identified in this notice were developed using the process described in that guidance.
• On May 17, 2024, CDC released a notice entitled, Notice of Award of a Single Source Cooperative Agreement to Fund Emory University/International Association of National Public Health. CDC is announcing the award of approximately $5,000,000 with an expected total funding of approximately $25,000,000 over a 5-year period, to Emory University/ International Association of National Public Health. This award will help countries increase surveillance, laboratory, and outbreak response capacity to improve recognition of and respond to health threats.
• On May 17, 2024, CDC released a notice entitled, Notice of Award of a Single Source Cooperative Agreement to Fund National Emergency Management Association. CDC is announcing the award of approximately $165,000, with an expected total funding of approximately $825,000 over a five-year period, to National Emergency Management Association. The award will identify promising practices and opportunities that build upon existing CDC public health partnership efforts to advance the public health and healthcare system overall capacity to prevent, protect, mitigate, respond to, and recover from all-hazards emergency incidents to include, but not limited to, interrelated efforts to align the Federal Emergency Management (FEMA) Thread and Hazard Identification and Risk Assessment (THIRA) and ongoing alignment of National Preparedness Goal Core Capabilities with the CDC PHEP capabilities and the Assistant Secretary for Preparedness and Response (ASPR) Hospital Preparedness Program (HPP) capabilities.
• On May 17, 2024, NIH released a notice entitled, Prospective Grant of an Exclusive Patent License: T Cell Receptor Fusion Proteins for the Treatment of Cancer. NIH is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to INTcRON LLC (“INTcRON”) located in Memphis, Tennessee.

Event Notices

• May 20, 2024: HHS announced a meeting of the National Advisory Committee on Seniors and Disasters. This is a hybrid meeting open to the public.
• May 21, 2024: The Centers for Medicare & Medicaid Services (CMS) announced a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). This is a virtual meeting open to the public.
• May 21-22, 2024: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a hybrid meeting open to the public.
• May 23, 2024: CDC announced a meeting entitled, National Public Health Strategy for the Prevention and Control of Vector-Borne Diseases in People. This is a virtual meeting open to the public.
• May 24, 2024: FDA announced a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This is a virtual meeting open to the public.
• May 30, 2024: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a virtual meeting open to the public.
• June 3, 2024: FDA announced a meeting of the AIDS Research Advisory Committee. This is a hybrid meeting open to the public.
• June 3, 2024: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting open to the public.
• June 4, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health, Subcommittee for Dose Reconstruction Review. This meeting is open to the public.
• June 4, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Center for Substance Abuse Prevention’s (CSAP) Drug Testing Advisory Board (DTAB). This is a hybrid meeting open to the public.
• June 5, 2024: HHS announced a meeting of the National Committee on Vital and Health Statistics. This meeting is open to the public.
• June 6, 2024: CDC announced a meeting of the Advisory Committee to the Director, CDC. This is a virtual meeting open to the public.
• June 6, 2024: CDC announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting open to the public.
• June 6, 2024: FDA announced a meeting entitled, Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments. This is a virtual meeting open to the public.
• June 7, 2024: FDA announced a meeting of the National Advisory Eye Council. This is a virtual meeting open to the public.
• June 26, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
• June 26, 2024: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid meeting open to the public.

II. Hearings & Markups

• On May 15, 2024, the House Energy and Commerce Health Subcommittee held a markup entitled, Full Committee Markup of 23 Bills. The Subcommittee considered the below legislation:
  • H.R. 3433, Give Kids a Chance Act (Reps. McCaul and Eshoo)
  • H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act (Reps. Matsui and Bilirakis)
  • H.R. 7384, Creating Hope Reauthorization Act of 2024 (Reps. McCaul and Eshoo)
  • H.R. 7188, Shandra Eisenga Human Cell and Tissue Product Safety Act (Reps. Moolenaar and Dingell)
  • H.R. 6033, Supporting Patient Education And Knowledge (SPEAK) Act of 2023 (Reps. Steel and Gomez)
  • H.R. 7858, Telehealth Enhancement for Mental Health Act of 2024 (Reps. James and D.G. Davis)
  • H.R. 7623, Telehealth Modernization Act of 2024 (Reps. Carter and Blunt Rochester)
  • H.R. 1406, Sustainable Cardiopulmonary Rehabilitation Services in the Home Act (Reps. Joyce and Peters)
  • H.R. 7856, PREVENT Diabetes Act (Reps. DeGette and Bilirakis)
  • H.R. 5394, Expanding Remote Monitoring Access Act (Reps. Balderson and Porter)
  • H.R. 1199, Facilitating Innovative Nuclear Diagnostics Act of 2023 (Reps. Dunn and Peters)
  • H.R. 6020, Honor Our Living Donors Act (Reps. Obernolte and DelBene)
  • H.R. 455, To amend the Controlled Substances Act to fix a technical error in the definitions (Reps. Burchett and Cohen)
  • H.R. 7213, Autism Collaboration, Accountability, Research, Education, and Support (CARES) Act of 2024 (Reps. C. Smith and Cuellar)
  • H.R. 4534, Women and Lung Cancer Research and Preventive Services Act of 2023 (Reps. Boyle and Fitzpatrick)
  • H.R. 670, Think Differently Database Act (Reps. Molinaro and Sherrill)
  • H.R. 8084, LIVE Beneficiaries Act (Reps. Bilirakis and Craig)
  • H.R. 8089, Medicare and Medicaid Fraud Prevention Act of 2024 (Reps. Garcia and Peters)
  • H.R. 8111, To amend title XIX of the Social Security Act to ensure the reliability of address information provided under the Medicaid program (Reps. Miller-Meeks and Cartwright)
  • H.R. 8112, To amend title XIX of the Social Security Act to further require certain additional provider screening under the Medicaid program (Rep. D’Esposito)
  • H.R. 4758, Accelerating Kids’ Access to Care Act (Reps. Trahan and Miller-Meeks)
  • H.R. 3227, Ensuring Seniors’ Access to Quality Care Act (Reps. Estes and Connolly)
  • H.R. 468, Building America’s Health Care Workforce Act (Reps. Guthrie and Dean)
• Outcome: All bills considered were ordered reported favorably, as amended, to the House Full Committee on Energy and Commerce. Note that H.R. 7383, the Retaining Access and Restoring Exclusivity (RARE) Act, and H.R. 7384, the Creating Hope Reauthorization Act of 2024, were included in the Amendment in the Nature of a Substitute (AINS) offered by Gus Bilirakis (R-FL-12) for H.R. 3433, the Give Kids a Chance Act, which meant a total of 21 bills were reported.
• On May 16, 2024, the Senate Finance Committee held a hearing entitled, Rural Health Care: Supporting Lives and Improving Communities. Witnesses present included: Keith J. Mueller, Ph.D., Gerhard Hartman Professor of Health Management and Policy and Director, Rural Policy Research Institute; Lori Rodefeld, MS, Director of Graduate Medical Education Development, Wisconsin Collaborative for Rural Graduate Medical Education; Michael Topchik, Executive Director, Chartis Center for Rural Health; and Jeremy P. Davis, MHA, President and Chief Executive Officer, Grande Ronde Hospital.
• On May 16, 2024, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, Examining the Dental Care Crisis in America: How Can We Make Dental Care More Affordable and More Available? Witnesses included: Lisa Simon, MD, DMD, Associate Physician, Brigham and Women’s Hospital, Member of the Faculty, Harvard Medical School; Myechia Minter-Jordan, MD, MBA, President and CEO, CareQuest Institute for Oral Health; Brian Jeffrey Swann, DMD, MPH, Board of Directors, Remote Area Medical (RAM), Co-Chair, Global Oral Health Outreach, National Dental Association; and Gordon Roswell Isbell, III, DMD, MAGD, Past Trustee, Academy of General Dentistry.

III. Reports, Studies, & Analyses

• On May 14, 2024, the U.S. Office of the Inspector General (OIG) released a report entitled, New Mexico Should Refund Almost $120 Million to the Federal Government for Medicaid Nursing Facility Level-of-Care Managed Care Capitated Payments. This audit evaluated New Mexico's oversight of capitated payments for Community Benefit (CB) services and nursing facility level-of-care (NFLOC) services managed by its organizations (MCOs). Despite performing reconciliations of capitated payments for CB services, New Mexico failed to recoup identified overpayments or refund the corresponding federal share. Moreover, the state couldn't provide sufficient evidence to verify the eligibility of enrollees receiving NFLOC services, leading to overpayments and inappropriate receipt of federal funds. Although New Mexico disagreed with the necessity to recoup overpayments and suggested an alternative method, the OIG maintained the validity of its findings and recommendations.
• On May 14, 2024, OIG released a report entitled, Colorado Did Not Report and Refund the Correct Federal Share of Medicaid-Related Overpayments for Some Cases Identified by the State’s Program Integrity Section. OIG undertook this audit as part of a series focusing on whether states appropriately recovered and refunded the federal share of Medicaid overpayments. Specifically examining Colorado's actions from October 1, 2014, through December 31, 2020, the audit aimed to ascertain if the state accurately reported and refunded Medicaid overpayments identified by its Program Integrity Section. Despite reviewing 403 cases totaling $28.4 million in Medicaid overpayments, the OIG found discrepancies in Colorado's reporting and refunding processes. The state failed to report $385,180 ($637,686 federal share) in overpayments for 80 cases and neglected to timely report $12.7 million ($8.5 million federal share) to CMS. Moreover, Colorado's policies and procedures for overpayment reporting were deemed inadequate. OIG recommended corrective measures, including reporting and refunding unreported overpayments, determining owed interest, and strengthening reporting protocols. Colorado concurred with the recommendations, outlining plans for corrective action, including enhanced tracking of overpayments and policy revisions.

IV. Other Health Policy News

• On May 15, 2024, Senators Bill Cassidy (R-LA) and Sheldon Whitehouse (D-RI) introduced legislation to reform Medicare payment for primary care providers. The bill, called the Pay PCPs Act of 2024, would encourage CMS to accelerate existing value-based primary care programs and increase the adequacy of Medicare primary care payment. The new hybrid payment would combine prospective, per member per month payments with fee-for-service (FFS) payments. The hybrid payment model aims to reduce administrative burdens, particularly related to billing practices. Additionally, the bill would establish a new technical advisory committee on relative value updates and revisions to provide the Secretary of HHS with technical input regarding the determination of relative value units. Through a request for information, the bill sponsors have invited stakeholders to react and respond to the proposal. The text of the bill is available here. The request for information (RFI) is available here.
• On May 15, 2024, Senators Roger Marshall (R-KS), Kyrsten Sinema (I-AZ), John Thune (R-SD), and Sherrod Brown (D-OH) and Representatives Mike Kelly (R-PA), Suzan DelBene (D-WA), Ami Bera, M.D., (D-CA), and Larry Bucshon M.D. (R-IN) announced they would be introducing a revised bill to reform Medicare Advantage prior authorization process following the release of the CMS final rule on Medicare Advantage. The Improving Seniors’ Timely Access to Care Act would codify some of the provisions included in the March CMS final rule which included provisions to improve real-time electronic decision-making for routine services, and bring greater transparency to the process. In an email to stakeholder groups, the legislative group shared a draft copy of their bill and noted that they would introduce the legislation on June 5. They stated that the CMS final rule was an important first step but they are proposing provisions to increase real-time decision, improve transparency, and strengthen enforcement. The text of the bill is available here.
• On May 15, 2024, Senators Tom Carper (D-DE) and Tim Scott (R-SC) introduced the Hospital Inpatient Services Modernization Act of 2024 (S. 4350) to extend the CMS Acute Hospital Care at Home waiver program for five years. The program, set to expire on December 31, 2025, is currently active in 37 states. This legislation is a companion to legislation in the House, H.R. 8260, introduced earlier this month. The text of the bill is available here.

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