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, a federal district judge in Texas blocked a Federal Trade Commission (FTC) final rule banning noncompete agreements, and the Biden Administration announced $1.4 billion in funding for HIV medications and services for low-income individuals.

I. Regulations, Notices & Guidance

• On August 19, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Updates to the Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure. The Ryan White HIV/AIDS Program (RWHAP) statute of the Public Health Service (PHS) Act requires that RWHAP Parts A, B, and C recipients expend 75 percent of Parts A, B, and C grant funds on core medical services for individuals who are identified with HIV/AIDS and eligible for RWHAP services under the statute, after reserving statutorily permissible amounts for administrative and clinical quality management costs. The statute also grants the Secretary of the Department of Health and Human Services (HHS) authority to waive this requirement if certain factors are met. HRSA is proposing to update Policy Notice 21-01, “Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement,” pertaining to the associated data collection form to clarify applicants’ proposed allocation of resources between core medical and support services.
• On August 19, 2024, the Food and Drug Administration (FDA) released guidance entitled, Product-Specific Guidance Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under the Generic Drug User Fee Amendments; Guidance for Industry; Availability. This guidance provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA, or an applicant that has submitted to FDA, an abbreviated new drug application (ANDA) under the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, this guidance provides information on requesting and conducting PSG meetings with FDA (i.e., pre-submission PSG teleconferences, post-submission PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings), as contemplated in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). This guidance provides procedures that will promote well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA III commitment letter. This guidance finalizes the draft guidance for industry of the same title issued on February 21, 2023.
• On August 20, 2024, 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 PHS Act, as amended. While the HHS Secretary 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 August 20, 2024, HRSA released a notice entitled, Notice of Supplemental Award; Pediatric Mental Health Care Access Program. HRSA is announcing supplemental funding to expand existing Pediatric Mental Health Care Access Program (PMHCA) activities. The recipients of the supplemental awards will enhance workforce capacity in pediatric primary care, school settings, and emergency departments to address growing behavioral health needs among children and adolescents.
• On August 20, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Fiscal Year (FY) 2024 Notice of Supplemental Funding Opportunity. SAMHSA is supporting administrative supplements in scope of the parent award for the 12 eligible grant recipients funded in FY 2022 under the Tribal Behavioral Health Grant Program (Short Title: Native Connections), Notice of Funding Opportunity (NOFO) SM-21-011. Recipients may receive up to $77,500 each for a total of $930,000 across the grant cohort. These recipients have a project end date for these supplemental funds of September 29, 2025. The supplemental funding will be used to fund a comprehensive Training of Trainers (ToT) model to enhance and expand workforce development and capacity in the areas of focus of the TBH program: preventing and reducing substance use, overdose, suicidal behavior, suicide, and addressing the impact of trauma among American Indian/Alaska Native (AI/AN) youth, up to and including age 24.
• On August 21, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Notice of Award of a Sole Source Cooperative Agreement to Fund the CDC Foundation. CDC is announcing an award of approximately $17,000,000, with an expected total funding of approximately $68,000,000 over a four-year period, to the National Foundation for the Centers for Disease Control & Prevention, Inc (CDCF). The award will use a national public health organization to strengthen the capacity of state, local, and territorial public health departments to implement overdose surveillance and prevention strategies through increased staffing support and strengthen efforts to build and maintain public health/public safety partnerships.
• On August 21, 2024, FDA issued a final rule technical amendment entitled, Food Additives Permitted in Feed and Drinking Water of Animals; Fermented Ammoniated Condensed Whey. FDA is amending the food additive regulations to update the production organism Lactobacillus bulgaricus that has been scientifically reclassified to Lactobacillus delbrueckii. This action is being taken to improve the accuracy and clarity of the regulations.
• On August 21, 2024, FDA released guidance entitled, Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. FDA is announcing the availability of the draft guidance entitled, Predetermined Change Control Plans for Medical Devices. A predetermined change control plan (PCCP) is the documentation describing what modifications will be made to a device and how the modifications will be assessed. This draft guidance provides FDA’s current thinking on a policy for PCCPs and recommendations on the information to include in a PCCP in a marketing submission for a device. This draft guidance is not final nor is it for implementation at this time.
• On August 22, 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) for certain medical devices related to COVID-19. FDA has issued the EUAs listed in this document under the FD&C Act. These EUAs contain, among other things, conditions on the emergency use of the authorized products. The authorization follows the February 4, 2020, determination by the HHS Secretary, 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 August 22, 2024, FDA released guidance entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability. FDA is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support ANDAs. In the June 11, 2010 Federal Register, 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 guidances identified in this notice were developed using the process described in that guidance.
• On August 22, 2024, FDA released guidance entitled, Electronic Submission Template for Medical Device De Novo Requests; Guidance for Industry and Food and Drug Administration Staff; Availability. FDA is issuing this guidance to introduce submitters of De Novo requests to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support De Novo electronic submissions to FDA. This guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.
• On August 22, 2024, FDA released a notice entitled, Final Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650. FDA is issuing an order under the FD&C Act refusing to approve a new drug application (NDA) submitted by Intarcia Therapeutics, Inc., an i2o Therapeutics Business Unit, (Intarcia) for ITCA 650 (exenatide in DUROS device). FDA has determined that the approval criteria in the FD&C Act have not been met because Intarcia has failed to demonstrate that ITCA 650 is safe for its intended conditions of use.
• On August 23, 2024, CDC released a notice entitled, Reorganization of the National Center for Injury Prevention and Control. CDC has modified its structure. This notice announces the National Center for Injury Prevention and Control (NCIPC) reorganization. NCIPC established the Behavioral Integration Branch.
• On August 23, 2024, the Administration for Community Living (ACL) released a notice entitled, Announcing the Intent to Award a Single-Source Supplement for the Eldercare Locator. ACL announces its intent to award a single-source supplement to the current cooperative agreement held by USAging for the Eldercare Locator. The purpose of this funding is to continue operation of the Disability Information and Access Line (DIAL). Originally funded in FY 2021 to connect people with disabilities to information about COVID-19 and assistance with accessing the COVID-19 vaccine, DIAL has become a critical resource for people with disabilities to get information and connect to state and local organization able to provide assistance serving over 100,000 since launching in June 2021.
• On August 23, 2024, FDA released guidance entitled, Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff; Availability. The Mammography Quality Standards Act of 1992 (MQSA) final rule amended FDA’s regulations to address, among other things, standards for accreditation bodies, certifying agencies, mammography equipment, quality assurance testing, and clinical image quality, as well as to require certain breast density information be provided by mammography facilities to patients and their health care providers. The small entity compliance guide (SECG) is intended to help small entities comply with the MQSA final rule.
• On August 23, 2024, SAMHSA released a notice entitled, Fiscal Year (FY) 2024 Notice of Supplemental Funding Opportunity. SAMHSA is supporting administrative supplements in scope of the parent award for the five eligible grant recipients funded in FY 2022 and FY 2023 under the Grants to Prevent Prescription Drug/Opioid Overdose Program (PDO), NOFO SP-21-002. Recipients may receive up to $279,266 each for a total of $1,396,330 across the program. These recipients have a project end date for use of these supplemental funds of September 29, 2025. The supplemental funding will be used to fund a comprehensive ToT model to enhance workforce development and capacity in the arena of preventing prescription drug/overdose related deaths and adverse events within existing projects funded under the PDO program.
• On August 23, 2024, SAMHSA released a notice entitled, Fiscal Year (FY) 2024 Notice of Supplemental Funding Opportunity. SAMHSA is supporting administrative supplements in scope of the parent award for the 26 eligible grant recipients funded in FY 2022 under the First Responders Comprehensive Addiction and Recovery Act (FR-CARA), NOFO TI-22-008. Recipients may receive up to $58,190 each, for a total of $1,512,940 across the program. These recipients have a project end date for use of these supplemental funds of September 29, 2025. The supplements will be used to fund a ToT model to rapidly expand workforce development and capacity in the arena of preventing overdose related deaths and adverse events within existing projects funded under the FR-CARA program.
• On August 23, 2024, SAMHSA released a notice entitled, Fiscal Year (FY) 2024 Notice of Supplemental Funding Opportunity. SAMHSA is supporting an administrative supplement in scope of the parent award for one eligible grant recipient funded under the FY 2023 Provider’s Clinical Support System – Medications for Opioid Use Disorder (PCSS-MOUD), NOFO TI-23-014. The recipient may receive up to $1,000,000. This supplement provides support to the recipient with a project end date of September 30, 2025. The supplemental funding will be used to support increased fees from the training platform service as a result of an increase in the number of practitioners accessing training from the program.

Event Notices

August 26-27, 2024: The Centers for Medicare & Medicaid Services (CMS) announced a meeting of the Advisory Panel on Hospital Outpatient Payment. This is a virtual meeting open to the public.

August 27, 2024: SAMHSA announced a meeting of the Center for Substance Abuse Prevention National Advisory Council. This is a hybrid meeting open to the public.

August 27, 2024: SAMHSA announced a meeting of the Advisory Committee for Women’s Services (ACWS). This is a virtual meeting open to the public.

August 28, 2024: SAMHSA announced a joint meeting of the SAMHSA National Advisory Council (NAC), the Center for Mental Health Services NAC, the Center for Substance Abuse Prevention NAC, the Center for Substance Abuse Treatment NAC; and the two SAMHSA advisory committees: ACWS and the Tribal Technical Advisory Committee (TTAC). This is a virtual meeting open to the public.

August 28-29, 2024: HHS announced a meeting of the Presidential Advisory Council on HIV/AIDS. This is a virtual meeting open to the public.

August 29, 2024: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a virtual meeting open to the public.

September 4-6, 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.

September 5, 2024: CMS announced a meeting of the Advisory Panel on Outreach and Education. This is a hybrid meeting open to the public.

September 6, 2024: FDA announced a workshop entitled, Enhancing Diversity in Therapeutics Development for Pediatric Patients. This is a hybrid meeting open to the public.

September 6, 2024: HHS announced a meeting of the President’s Council on Sports, Fitness & Nutrition. This is a hybrid meeting open to the public.

September 10-11, 2024: CDC announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.

September 11, 2024: The National Institutes of Health (NIH) announced a meeting of the National Institute on Drug Abuse. This is a hybrid meeting open to the public.

September 12, 2024: HRSA announced a meeting of the Council on Graduate Medical Education. This is a virtual meeting open to the public.

September 12-13, 2024: HHS announced a meeting of the National Vaccine Advisory Committee. This is a hybrid meeting open to the public.

September 13, 2024: CDC announced a meeting of the Advisory Committee on Breast Cancer in Young Women. This is a hybrid meeting open to the public.

September 17, 2024: NIH announced a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods. This is a hybrid meeting open to the public.

September 18, 2024: FDA announced a meeting of the Pediatric Advisory Committee (PAC). This is a virtual meeting open to the public.

September 20, 2024: FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.

September 23, 2024: NIH announced a meeting of the Center for Scientific Review. This is a hybrid meeting open to the public.

September 25-26, 2024: HHS announced a meeting of the 2025 Dietary Guidelines Advisory Committee. This is a virtual meeting open to the public.

September 26, 2024: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a hybrid meeting open to the public.

October 7, 2024: FDA announced a meeting of the Science Board to the FDA. This is a virtual meeting open to the public.

October 8, 2024: NIH announced a meeting of the NIH Office of the Director. This is a virtual meeting open to the public.

October 21-22, 2024: HHS announced a meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis, and Sexually Transmitted Disease (STD) Prevention and Treatment. This is a hybrid meeting open to the public.

October 22-23, 2024: HRSA announced a meeting of the National Advisory Council on Migrant Health. This is a hybrid meeting open to the public.

November 15, 2024: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a virtual meeting open to the public.

II. Reports, Studies, & Analyses

• On August 21, 2024, the U.S. Government Accountability Office (GAO) released a report entitled, Veterans Community Care Program: VA Needs to Strengthen Contract Oversight. The report evaluated the Department of Veterans Affairs (VA) efforts to improve its health care system, focusing on critical areas such as workforce management, infrastructure, and quality assurance. Specific recommendations included addressing staffing shortages and ensuring adequate training for employees, improving the infrastructure of VA facilities to better meet the needs of veterans, and ensuring the quality of care by strengthening oversight mechanisms. Additionally, GAO urged the VA to fully implement previous recommendations to address persistent issues and ensure more effective service delivery to veterans. These recommendations focused on improving data collection and analysis to better monitor the quality of care, enhancing the management of electronic health records, and strengthening the process for assessing veterans’ eligibility for care. The report highlighted that the VA has faced ongoing challenges in fully implementing recommended improvements, which are crucial for enhancing care delivery to veterans. It underscored the need for the VA to address these issues to ensure the effectiveness and efficiency of its health care services, particularly in areas vital to meeting veterans' needs.
• On August 22, 2024, the Kaiser Family Foundation (KFF) released a report entitled, Beyond cost, what barriers to health care do consumers face. KFF analyzed 2022 National Health Interview Survey to understand the impact of financial and non-financial barriers that individuals face when accessing health care. The report finds that 28 percent of adults reported delaying or forgoing various types of health care due to cost concerns, and 17 percent of adults under 65 experienced at least one non-financial access barriers. These non-financial obstacles include difficulties finding available appointments, locating providers who accept their insurance, and managing travel times to health care facilities. Younger adults and those with Medicaid coverage are more likely to encounter non-financial barriers to care. While Medicaid enrollees face more non-financial barriers, they also face fewer cost-related issues compared to people with private insurance. People over age 65 experienced less non-financial these barriers compared to younger adults, likely due to widespread Medicare coverage.

III. Other Health Policy News

• On August 20, 2024, a federal district court judge in Texas struck down the Federal Trade Commission’s (FTC’s) FTC’s rule banning noncompete clauses in employment agreements. The ruling was released 15 days before the final rule was expected to take effect on September 4, 2024. U.S. District Judge Ada Brown ruled that the FTC does not have the authority to issue substantive rules regarding unfair methods of competition. In her order, Judge Brown stated, “The Court concludes that the FTC lacks statutory authority to promulgate the Non-Compete Rule, and that the Rule is arbitrary and capricious. Thus, the FTC’s promulgation of the Rule is an unlawful agency action”. The FTC final rule is available here. The district court opinion is available here.
• On August 20, 2024, the Biden Administration announced during the 2024 National Ryan White Conference on HIV Care & Treatment the availability of over $1.4 billion in funding through the Ryan White HIV/AIDS Program to provide HIV medications and healthcare services to low-income individuals with HIV. Managed by HRSA, this funding will support the AIDS Drug Assistance Program (ADAP), which covers the costs of lifesaving HIV medications, including antiretroviral therapies, for low-income individuals. Additionally, the funding will assist in paying for co-pays, insurance premiums, and other essential health care services. Beyond medication costs, the funds will also be allocated to addressing social determinants of health (SDOH), such as housing, transportation, and food access, which are critical in helping patients remain in care and adhere to treatment plans. The Administration emphasized that the goal of this financial commitment is to reduce health disparities, improve health outcomes for people with HIV, and support the Administration’s efforts to end the HIV epidemic in the U.S. A press release with more information is available here.

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