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 Ways and Means Committee held a markup of telehealth legislation and CMS announced the Increasing Organ Transplant Access (IOTA) Model, an initiative designed to address the complexities and disparities in the kidney transplant process.

I. Regulations, Notices & Guidance

• On May 6, 2024, the Food and Drug Administration (FDA) released a notice entitled, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Pharmaceutical Development; Draft Guidance for Industry; Availability. This draft guidance was developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance describes the suggested contents for the Pharmaceutical Development section, which provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management to the development of a product and its manufacturing process.
• On May 6, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment Request. CMS is announcing an opportunity for the public to comment on CMS’ draft guidance for the second cycle of the Medicare Drug Price Negotiation Program and manufacturer effectuation of the maximum fair price for 2026 and 2027 for the implementation of the Inflation Reduction Act (IRA). This and other IRA-related guidance can be viewed on the dedicated IRA section of the CMS website at https://www.cms.gov/inflation-reduction-act-and-medicare/.
• On May 7, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to CDC’s Advisory Committee to the Director (ACD). In accordance with the Federal Advisory Committee Act, CDC is seeking nominations for membership on the ACD. The ACD consists of up to 15 experts knowledgeable in areas pertinent to the CDC mission, such as public health, global health, health disparities, biomedical research, and other fields, as applicable.
• On May 7, 2024, the Administration for Community Living (ACL) released a notice entitled, Adult Protective Services Functions and Grants Programs. ACL is issuing this final rule to modify the implementing regulations of the Older Americans Act of 1965 (OAA) to add a new subpart (Subpart D) related to Adult Protective Services (APS).
• On May 7, 2024, FDA released a notice entitled, Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments--Midomafetamine Capsules. FDA is announcing a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee. The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
• On May 7, 2024, the Department of Health and Human Services (HHS) released a notice entitled, Notice for Public Comments on Potential Viral Hepatitis Quality Measures in Medicaid. The HHS Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH) invites public comment on potential viral hepatitis quality measures for implementation at the state and territory level. In March 2024, OIDP hosted a technical consultation meeting to initiate the process of understanding the needs and developing national consensus on clinically meaningful and feasible viral hepatitis quality measures for proposal to the Medicaid Adult Core Set.
• On May 8, 2024, ACL released a notice entitled, Announcing the Intent to Award a Single-Source Supplement for the National Falls Prevention Resource Center. ACL is announcing its intent to award a single-source supplement to the current cooperative agreement held by the National Council on Aging (NCOA) for the National Falls Prevention Resource Center. The purpose of this program is to advance the development and expansion of technical assistance, education, and resources to increase public awareness about the risk of falls and how to prevent them; increase the number of older adults and adults with disabilities who participate in evidence-based community falls prevention programs; and support the integration and sustainability of evidence-based falls prevention programs within community integrated health networks.
• On May 8, 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. Through this Request for Information (RFI), the Sexual & Gender Minority Research Office (SGMRO) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), NIH, invites feedback from the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal NIH stakeholders, and other interested constituents on the development of the Fiscal Years (FYs) 2026 – 2030 NIH-Wide Strategic Plan for Sexual and Gender Minority Health Research. This plan will describe future directions in sexual and gender minority health and research to optimize NIH’s research investments.
• On May 8, 2024, NIH released a notice entitled, RFI: Inviting Input Regarding NIDCD’s Research Directions in Global Health. NIH invites input from all interested parties on the National Institute on Deafness and Other Communication Disorders (NIDCD’s) future research directions in global health, which is defined for this RFI as international collaboration among researchers in all countries to improve health. NIDCD requests input specifically focused on the NIDCD mission of advancing the science of communication to improve lives.
• On May 8, 2024, NIH released a notice entitled, Notice to Announce the Significant Changes to the NIH Grants Policy Statement for Fiscal Year 2024. NIH is announcing a publication of the updated significant changes that have already been made to the NIH Grants Policy Statement (GPS) in FY 2023 that will be reflected in the GPS for FY 2024. The NIH GPS provides both up-to-date policy guidance that serves as NIH’s standard terms and conditions of award for all NIH grants and cooperative agreements and extensive guidance to those who are interested in pursuing NIH grants. This update incorporates significant changes for FY 2024, such as new and modified requirements, the clarification of certain policies, and the implementation changes in statutes, regulations, and policies that have been implemented through appropriate legal and/or policy processes (e.g., Federal Register Notices, where appropriate) since the previous version of the NIHGPS was last released in December 2022.
• On May 9, 2024, CMS released a proposed rule entitled, Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model. This proposed rule describes a new mandatory Medicare payment model, the IOTA Model, that would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end-stage renal disease (ESRD) while preserving or enhancing the quality of care and reducing Medicare expenditures. This proposed rule also includes standard provisions that would apply to Innovation Center models whose first performance period begins on or after January 1, 2025, and also would apply, in whole or part, to any Innovation Center model whose first performance period begins prior to January 1, 2025, should such model’s governing documentation incorporate the provisions by reference in whole or in part. The proposed standard provisions relate to beneficiary protections; cooperation in model evaluation and monitoring; audits and records retention; rights in data and intellectual property; monitoring and compliance; remedial action; model termination by CMS; limitations on review; miscellaneous provisions on bankruptcy and other notifications; and the reconsideration review process.
• On May 9, 2024, FDA released a notice entitled, Remanufacturing of Medical Devices; Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff; Availability. This final guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.” This final guidance also clarifies existing regulatory requirements for remanufacturers and includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life.
• On May 9, 2024, CMS released a notice entitled, Medicare and Medicaid Programs: Application from The Compliance Team (TCT) for Continued Approval of its Rural Health Clinic (RHC) Accreditation Program. This final notice announces the agency’s decision to approve The Compliance Team for continued recognition as a national accrediting organization for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.
• On May 10, 2024, CMS released a notice entitled, Medicare Program; Updates to the Master List of Items Potentially Subject to Face-To-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face and Written Order Prior to Delivery List; and Updates to the Required Prior Authorization List. This document announces the updated Healthcare Common Procedure Coding System (HCPCS) codes on the Master List. It also announces updates to the HCPCS codes on the Required Face-to-Face and Written Order Prior to Delivery List and the Required Prior Authorization List.

Event Notices

• May 15-16, 2024: The Health Resources and Services Administration (HRSA) announced a meeting of the National Advisory Council on Migrant Health. This is a hybrid meeting open to the public.
• 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: 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 8, 2024, the House Ways and Means Committee held a markup entitled, Markup of H.R. 8261, H.R. 7931, H.R. 8245, H.R. 8244, H.R. 8235, and H.R. 8246. The Committee considered the following legislation:
  • R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act;
  • R. 7931, the PEAKS Act;
  • R. 8245, the Rural Hospital Stabilization Act;
  • R. 8244, the Ensuring Seniors’ Access to Quality Care Act;
  • R. 8235, the Rural Physician Workforce Preservation Act; and
  • R. 8246, the Second Chances for Rural Hospitals Act.
• All six bills under consideration were voted to be reported favorably to the full U.S. House of Representatives.
• On May 8, 2024, the Senate Budget Committee held a hearing entitled, Reducing Paperwork, Cutting Costs: Alleviating Administrative Burdens in Health Care. Witnesses included: Dr. David Cutler, Professor of Applied Economics, Harvard University; Mr. Noah Benedict, President & CEO, Rhode Island Primary Care Physicians Corporation; and, Dr. Anthony DiGiorgio, Assistant Professor, University of California, San Francisco.

III. Reports, Studies, & Analyses

• On May 10, 2024, the HHS Office of the Inspector General (OIG) released a report entitled, Potential Vulnerabilities in CMS Oversight of Medicare Add-on Payments for COVID-19 Tests Show That Oversight of Incentive Payments Could Be Improved. CMS implemented an add-on payment system to encourage laboratories to promptly conduct COVID-19 tests within a two-day timeframe. However, an analysis of $339.4 million in Medicare add-on payments to 9,380 laboratories revealed potential vulnerabilities in CMS’ oversight. Over two-thirds of laboratories billed Medicare for the add-on payment for all their COVID-19 tests during the audit period from January 1, 2021, through June 30, 2022. The audit identified issues with vague CMS requirements for supporting documentation and inadequate reviews of claims by CMS and Medicare Administrative Contractors (MACs). The report emphasized the importance of effective oversight to prevent fraud, waste, and abuse in the Medicare program. CMS did not provide a comment in response to the report.
• On May 10, 2024, HHS OIG released a report entitled, State Agencies Could Be Obtaining Hundreds of Millions in Additional Medicaid Rebates Associated With Physician-Administered Drugs. OIG conducted this audit to summarize the findings from previous audits of Medicaid state agencies regarding their compliance with federal requirements for invoicing manufacturers for rebates associated with physician-administered drugs. The review encompassed 57 previous audits covering the period from April 1, 2008, to December 31, 2020. OIG found that state agencies generally did not comply with these requirements, potentially missing out on significant rebate collections. Specifically, state agencies could have invoiced an additional $225.7 million (federal share) for fee-for-service physician-administered drugs and should have collected additional rebates associated with $236.2 million (federal share) for drugs administered to Medicaid managed-care organization enrollees. Furthermore, some state agencies missed opportunities to obtain additional rebates beyond those required by Federal law due to the lack of internal controls and policies. OIG recommended that CMS collaborate with state agencies to implement internal controls and policies to facilitate the collection of all rebates for eligible physician-administered drugs, issue clarified guidance on rebate collection requirements, and encourage state agencies to maximize rebate collection whenever possible. CMS agreed with the first and third recommendations and outlined corrective actions, noting that States had already implemented about 70 percent of the previous audit recommendations.

IV. Other Health Policy News

• On May 8, 2024, the Biden Administration announced $46.8 million in notices of funding through SAMHSA to promote youth mental health, bolster the behavioral health workforce, and address substance use treatment and recovery. The funding will be available through programs including the Minority Fellowship Program, which is intended to reduce health disparities and improve behavioral health outcomes for racial and ethnic populations and the Addiction Technology Transfer Centers Cooperative Agreements, which accelerates the adoption and implementation of evidence-based substance use disorder (SUD) treatment and recovery practices and services across the behavioral health and primary care workforce. The funding also will be available through programs such as the Cooperative Agreements for the Garrett Lee Smith State/Tribal Youth Suicide Prevention and Early Intervention Program and the National Center for Mental Health Dissemination, Implementation and Sustainment Cooperative Agreement to address youth suicide prevention efforts and build capacity to provide mental health services for grant recipients. A press release with more information is available here.
• On May 8, 2024, CMS announced the Increasing Organ Transplant Access (IOTA) Model, a comprehensive initiative designed to address the complexities and disparities in the kidney transplant process. The primary goal of the IOTA Model is to increase access to kidney transplants for individuals with end-stage renal disease (ESRD) while improving the quality of care and reducing disparities in the transplant process. If finalized, the model would be implemented by the CMS Innovation Center and would require participation from eligible transplant hospitals. These hospitals must be non-pediatric facilities that perform a minimum of 11 transplants each during a three-year baseline period, with an estimated 90 hospitals nationwide required to participate starting January 1, 2025, for a proposed six-year model duration. Participating transplant hospitals would be measured based on increases in the number of transplants, improved organ acceptance rates, and post-transplant outcomes. Additionally, the model includes provisions to incentivize hospitals to improve equity in the transplant process by establishing health equity plans aimed at addressing access gaps among underserved populations in their communities. A press release with more information is available here.
• On May 8, 2024, Senator Bill Cassidy (R-LA) published a white paper detailing proposals to improve the NIH. Last year, Senator Cassidy published an RFI that requested feedback from stakeholders on policies Congress could consider to modernize NIH. The report found that NIH is increasingly utilizing funding for applied projects, which represent a growing portion of the agency’s extramural portfolio, given that “applied research often has a more immediate, tangible impact on Americans’ daily lives.” However, some RFI responses expressed concern that this reprioritization could negatively impact investigator-initiated, basic science research. The white paper noted that “waning federal focus on basic research could lead to a decline in treatments and cures eventually developed through private funding.” The white paper also called for NIH to focus more on reducing redundancies within research programs and utilizing untapped data that NIH and its extramural partners possess on applications for funding and outcomes. Additionally, the report focused on proposing actions to ensure the U.S. remains a global leader in biomedical research, including recommendations such as incentivizing innovation, public-private collaborations, improving staffing and supporting the research workforce, and updating the Intramural Research Program. Finally, the report touched on improving transparency and trust in NIH operations and preventing research misconduct. This includes addressing ongoing deficiencies in how NIH conducts post-award monitoring. The white paper is available here.
• On May 9, 2024, CMS announced it is extending temporary unwinding-related flexibilities. CMS is extending the following flexibilities through June 30, 2025, including unwinding-related waivers approved under section 1902(e)(14)(A) of the Social Security Act; temporary changes to verification policies and procedures submitted through a Verification Plan Addendum; and the use of the exception to delay procedural disenrollments if the state continues to meet the conditions described in § 435.912(e). The Center for Medicaid & CHIP Services (CMCS) Informational Bulletin (CIB): Extension of Temporary Unwinding-Related Flexibilities is available here.

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