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, Congress successfully passed a new temporary funding bill for FY2024 appropriations to avert a government shutdown, and the Biden Administration released the final part one guidance for the new Medicare Prescription Payment Plan.

I. Regulations, Notices & Guidance

• On February 27, 2024, the National Institutes of Health (NIH) released a notice entitled, Government-Owned Inventions; Availability for Licensing. The notice describes an invention that is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. The technology is a device and system for expediting the thawing frozen specimens contained in cryo-vials, offering a breakthrough solution for researchers seeking efficiency and precision in their workflows.
• On February 27, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, National Vaccine Injury Compensation Program: List of Petitions Received. HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services (HHS) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
• On February 29, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Notice of Award of a Sole Source Cooperative Agreement to Fund Ministry of Health (MOH)– AIDS Control Program. CDC is announcing the award of approximately $15,000,000, for Year 1 funding to MOH – AIDS Control Program. The award will support achievement of HIV epidemic control in Uganda by supporting the MOH to develop and disseminate key national policies and guidelines, increase technical capacity, ensure quality of health services, improve data quality and utilization, and provide leadership and direction to all partners engaged in the epidemic response. Funding amounts for years 2-5 will be set at continuation.
• On February 29, 2024, the Food and Drug Administration (FDA) released a notice entitled, Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability. This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by HHS and identical provisions in FDA’s proposed rule entitled “Protection of Human Subjects and Institutional Review Boards.” FDA’s proposed rule, if finalized, would harmonize certain sections of FDA’s regulations on human subject protections and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule, in accordance with the 21st Century Cures Act (Cures Act). The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA’s proposed rule.
• On February 29, 2024, FDA released a notice entitled, Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 061. FDA is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews. This publication will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
• On February 29, 2024, FDA released a notice entitled, Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Guidance for Industry; Availability. FDA is announcing the availability of a final guidance for industry entitled “Clinical Pharmacology Considerations for Antibody-Drug Conjugates,” which provides recommendations for the development of antibody drug conjugates (ADCs). Specifically, this guidance addresses the FDA’s current thinking regarding clinical pharmacology considerations and recommendations for ADC development programs, including bioanalytical methods, dose selection and adjustment, dose-and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions (DDIs) for ADCs with a cytotoxic small-molecule drug or payload. Currently, there are no final FDA guidances outlining the clinical pharmacology considerations for ADCs. This guidance finalizes the draft guidance of the same title issued on February 8, 2022.
• On February 29, 2024, HHS issued a final rule entitled, Improving Child Care Access, Affordability, and Stability in the Child Care and Development Fund (CCDF). This final rule makes regulatory changes to the CCDF. These changes lower child care costs for families participating in CCDF, improve the program’s child care provider payment rates and practices, and simplify enrollment in the child care subsidy program. The final rule also includes technical and other changes to improve clarity and program implementation.
• On February 29, 2024, NIH released a notice entitled, Government Owned Inventions Available for Licensing. The invention entitled, T Cell Receptors oTargeting EGFR L858R mutation on HLA-A*11:01+ Tumors, is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
• On February 29, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards to Engage in Urine and Oral Fluid Drug Testing for Federal Agencies. HHS notified Federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.
• On March 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, National Plan and Provider Enumeration System (NPPES) Data Changes. This notice provides information on changes to data elements that providers are required to submit to the National Plan and Provider Enumeration System (NPPES) to obtain and maintain a National Provider Identifier (NPI). The changes to the required data elements affect the data that is made available to the public from NPPES in downloadable files and in a query-only database on the internet.
• On March 1, 2024, HHS released a notice entitled, Partnerships With Faith-Based and Neighborhood Organizations. This final rule amends the regulations of the agency to clarify protections for beneficiaries and prospective beneficiaries of federally funded social services and the rights and obligations of organizations providing such services. In accordance with the Executive Order of February 14, 2021 entitled, Establishment of the White House Office of Faith-Based and Neighborhood Partnerships, this clarification should promote maximum participation by beneficiaries and providers in the Agencies’ covered programs and activities and ensure consistency in the implementation of those programs and activities.
• On March 1, 2024, CDC released a notice entitled, Requests for Nominations: Communications and Public Engagement Workgroup of the Advisory Committee to the Director. CDC is seeking nominations for membership to the Communications and Public Engagement Workgroup (CPEW) of the Advisory Committee to the CDC Director. The CPEW workgroup consists of approximately 15 members who are experts in the fields associated with communications, including public relations, health communication, risk communication, communication research, and marketing; community and partner engagement; public health science and practice, including implementation; and behavioral science/behavior change campaigns.

Event Notices

March 5, 2024: HHS announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.

March 6, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Center for Health Statistics. This meeting is open to the public.

March 7, 2024: The Agency for Healthcare Research and Quality (AHRQ) announced a meeting for Software Developers on the Common Formats for Patient Safety Data Collection. This is a virtual meeting open to the public.

March 13, 2024: NIH announced a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. This is a virtual meeting open to the public.

March 13, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health. This is a virtual meeting open to the public.

March 13, 2024: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a virtual meeting open to the public.

March 14, 2024: CDC announced a meeting of the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health. This is a virtual meeting open to the public.

March 14, 2024: HRSA announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is a virtual meeting open to the public.

March 18, 2024: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee. This is a virtual meeting open to the public.

March 19, 2024: CDC announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.

March 20, 2024: NIH announced a meeting of the National Cancer Institute Board of Scientific Advisors. This is a virtual meeting open to the public.

March 20, 2024: HHS announced a meeting of the Secretary’s Advisory Committee on Human Research Protections. This is a virtual meeting open to the public.

March 21, 2024: The Administration for Community Living (ACL) announced a meeting of the President’s Committee for People with Intellectual Disabilities. This is a virtual meeting open to the public.

March 21, 2024: FDA announced a meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.

March 22, 2024: NIH announced a meeting of the National Advisory Child Health and Human Development Council Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) Implementation Working Group. This is a hybrid meeting open to the public.

March 25, 2024: NIH announced a meeting of the Center for Scientific Review Advisory Council. This is a hybrid meeting open to the public.

March 25-26, 2024: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.

March 27, 2024: SAMHSA announced a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee. This is a hybrid meeting open to the public.

April 4-5, 2024: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a hybrid meeting open to the public.

April 5, 2024: HHS announced a meeting of the Office of Global Affairs on Public Health Emergencies Preparedness and Response Negotiations. This is a virtual meeting open to the public.

April 9, 2024: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a hybrid meeting open to the public.

April 10, 2024: CDC announced a meeting of the Clinical Laboratory Improvement Advisory Committee. This is a virtual meeting open to the public.

April 9-11, 2024: HRSA announced a meeting of the National Advisory Committee on Rural Health and Human Services. This is a hybrid meeting open to the public.

April 17, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health. This is a hybrid meeting open to the public.

II. HEARINGS & MARKUPS

House of Representatives

• On February 29, 2024, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Legislative Proposals to Support Patients with Rare Diseases. Legislation discussed included: H.R. 1092, Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act; H.R. 3433, Give Kids a Chance Act; H.R. 4758, Accelerating Kids Access to Care Act; H.R. 5539, Optimizing Research Progress Hope And New (ORPHAN) Cures Act;  H.R. 5547, Maintaining Investments in New Innovation (MINI) Act; H.R. 5663, ALS Better Care Act; H.R. 6020, Honor Our Living Donors Act; H.R. 6094, Providing Realistic Opportunity To Equal and Comparable Treatment for (PROTECT) Rare Act; H.R. 6465, Preserving Life-saving Access to Specialty Medicines in America (PLASMA) Act; H.R. 6664, Innovation in Pediatric Drugs Act; H.R. 6705, Effective Screening and Testing for Tuberculosis Act; H.R. 7188, Shandra Eisenga Human Cell and Tissue Product Safety Act; H.R. 7248, FDA Modernization Act 3.0; H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act; H.R. 7384, Creating Hope Reauthorization Act of 2024; H.R. ____, Antimicrobial Resistance Research Assessment Act; H.R. ____, Patient Access Act; and,  H.R. ____, Sickle Cell Disease Comprehensive Care Act.

III. Reports, Studies, & Analyses

• On February 28, 2024, the RAND Corporation released a report entitled, Barriers Primary Care Clinic Leaders Face to Improving Value in a Consumer Choice Health Plan Design. This paper explores the challenges faced by primary care clinics in reducing costs within a tiered total cost of care (TCOC) commercial health insurance benefit design. Through semi-structured interviews with clinic leaders, six barriers to improving value in primary care were identified: insufficient information on cost drivers, limited control over spending, patient preference for higher-cost specialists, administrative challenges, resource constraints, and misaligned incentives. Despite these challenges, tiered TCOC networks offer promise in aligning incentives with value, benefiting both consumers and clinics in improving efficiency and reducing costs. Researchers proposed potential actions to address these barriers including: 1) providing actionable data on cost drivers; 2) improving referral options; 3) enhancing patient education; and 4) developing new clinical processes to incentivize cost-conscious decisions.
• On February 29, 2024, the HHS Office of Inspector General (OIG) released a report entitled, Lessons Learned During the Pandemic Can Help Improve Care in Nursing Homes. This is the last of three reports OIG published on the impacts COVID-19 had on nursing homes. The report finds that nursing homes faced significant challenges during the pandemic that continue today, including difficulties in hiring, training, and retaining staff. Nursing homes continue to have long-term struggles related to costs, testing protocols, and vaccination rates that began during the pandemic. To improve care and strengthen nursing homes’ preparedness for future pandemics, OIG recommended the following to CMS:

1. Implement and expand policies to strengthen the nursing home workforce;
2. Reevaluate nurse aid training programs and requirements;
3. Update infection control requirements for nursing homes so that it incorporates lessons from the COVID-19 pandemic;
4. Release guidance on how to comply with these updated infection control requirements; and
5. Facilitate information exchange between nursing homes to share strategies on overcoming challenges and improving care.

• On February 29, 2024, the Government Accountability Office (GAO) released a report entitled, Biomedical Research: Actions Needed to Adopt Collaboration Practices to Address Research Duplication. This is the first report in a new series where GAO will analyze the potential duplication of research across four HHS agencies: NIH, FDA, the Advanced Research Projects Agency for Health (ARPA-H), and the Biomedical Advanced Research and Development Authority (BARDA). In 2022, Congress directed the ARPA-H Director to establish the Interagency Advisory Committee comprised of representatives from eight federal agencies to ensure that ARPA-H’s research is not unnecessarily duplicating biomedical research. This report focuses on the practices used by the agencies to avoid unnecessary research duplication and analyzes ARPA-H’s efforts to create an interagency advisory committee to prevent unnecessary research duplication. GAO found that the four agencies do currently employ strategies to prevent research duplications, such as cross-agency communication and scanning research databases. GAO recommended that ARPA-H finalize its Interagency Advisory Committee charter to define how the participating agencies should share information to avoid unnecessary research duplication.

IV. Other Health Policy News

• On February 27, 2024, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) unveiled the Health Industry Cybersecurity Five Year Strategic Plan (HIC-SP) at the ViVE 2024 Conference. The plan emphasizes the critical need for robust cybersecurity measures across the healthcare ecosystem to safeguard patient safety, data privacy, and care operations. Developed over eighteen months with input from various stakeholders, the HIC-SP outlines key cybersecurity goals to be achieved by 2029. These goals include promoting a culture of cybersecurity responsibility among all stakeholders, enhancing workforce cybersecurity education, and establishing a proactive “911 Cyber Civil Defense” capability for early warning and incident response. The HSCC calls upon healthcare organizations and government agencies to collaborate in implementing the plan to ensure a resilient and secure healthcare cybersecurity landscape. The next phase involves developing measurable outcomes and metrics for assessing success, with plans to release them by the end of 2024. A press release with more information is available here.
• On February 27, 2024, HHS introduced initiatives from the Direct Care Workforce (DCW) Strategies Center to tackle the shortage of professionals aiding older adults and people with disabilities. These include technical assistance for states, a national hub for resources, and a webinar series. HHS Secretary Xavier Becerra highlighted the administration’s focus on caregiving infrastructure and access to services. The technical assistance programs aim to enhance workforce recruitment and retention, while the website serves as a resource hub. A webinar series will be launched to educate stakeholders on workforce support. The shortage of direct care workers, driven by low wages and limited opportunities, poses challenges to home and community-based services. A press release with more information is available here.
• On February 29, 2024, Congress voted to pass another stop-gap measure for fiscal year (FY) 2024, averting a partial government shutdown that would have gone into effect March 1, 2024. The continuing resolution (CR), H.R. 7463, passed in the House with a vote of 320-99. The bill then went to the Senate, where it passed with a vote of 77-13. The CR effectively extends the previous funding deadlines of March 1 and March 8 to March 8 and March 22, respectively. Congress intends to pass six appropriations bills by March 8, and the remaining six, which includes funding HHS, by March 22. It appears that Congress intends to include several health extenders, such as community health center funding, and a continuation of the delay of the scheduled Medicaid Disproportionate Share Hospital (DSH) payment cuts as part of the March 8 package. Other health policy proposals under discussion this year, including adjustments to the Medicare Physician Fee Schedule (PFS), are still being considered. Text of the CR is available here.
• On February 29, 2024, the Biden-Harris Administration released final guidance to assist individuals with Medicare prescription drug coverage in managing their prescription drug costs through the new Medicare Prescription Payment Plan. This guidance ensures that Medicare Part D plan sponsors can effectively implement the program, offering participants the option to spread out-of-pocket costs over the year rather than paying in full at the pharmacy counter. Additionally, the guidance focuses on operational requirements for Part D plan sponsors, addressing topics such as program eligibility, opt-in processes, participant protections, and data collection for evaluation. Key provisions include the requirement for Part D sponsors to notify pharmacies to provide information on the program for individuals meeting a $600 out-of-pocket threshold per prescription. This notification supplements ongoing communications to ensure eligible beneficiaries are informed about the program. A press release with more information is available here. A fact sheet for the final part one guidance is available here.

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