Health Care Week in Review: Biden Administration Announces $100 Million for ACA Marketplace Navigators and $81.3 Million for Mental Health, SUD Treatment, and Cancer Care

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 Biden Administration announced $100 million in funding for ACA Marketplace Navigators and $81.3 million in grant funding to advance mental health, substance use disorders (SUDs), and cancer care.

I. Regulations, Notices & Guidance

• On August 26, 2024, the Food and Drug Administration (FDA) released a notice entitled, Authorization of Emergency Use of a Freeze-Dried Plasma Product for Treatment of Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat; Availability. FDA announced the issuance of an Emergency Use Authorization (EUA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use of a freeze-dried plasma product, octaplasLG Powder, for emergent treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical.
• On August 26, 2024, FDA released a notice entitled, Determination That DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (Diltiazem Hydrochloride), 125 Milligrams/125 Milliliters (1 Milligram/Milliliter) and 250 Milligrams/250 Milliliters (1 Milligram/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. FDA has determined that Diltiazem Hydrochloride in Dextrose 5 percent (diltiazem hydrochloride (HCl)), 125 milligrams (mg)/125 milliliters (mL) (1 mg/mL) and 250 mg/250 mL (1 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for diltiazem HCl, 125 mg/125 mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL), if all other legal and regulatory requirements are met.
• On August 27, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on Medical Therapies for Locally Advanced Gastric Adenocarcinoma. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on medical therapies for locally advanced gastric adenocarcinoma, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
• On August 27, 2024,  the Centers for Disease Control and Prevention (CDC) released a notice entitled,  Single Source Cooperative Agreement: California Department of Public Health; Chicago Department of Public Health; Delaware Department of Health and Social Services; et al. CDC announced 23 separate awards to fund the California Department of Public Health; Chicago Department of Public Health; Delaware Department of Health and Social Services; Florida Department of Health; Georgia Department of Public Health; Houston Department of Health and Human Services; Illinois Department of Public Health; Indiana State Department of Health; Los Angeles County Department of Public Health; Michigan Department of Health and Human Services; Mississippi State Department of Health; New Jersey Department of Health and Senior Services; New York City Department of Health and Mental Hygiene; New York State Department of Health; North Carolina Department of Health and Human Services; Oregon Health Authority; Pennsylvania Department of Health; Philadelphia Department of Public Health; Puerto Rico Department of Health; San Francisco Department of Public Health; Texas Department of State Health Services; Virginia Department of Health; and Washington State Department of Health. The total amount of awards is approximately $16,305,555 in Federal Fiscal Year (FFY) 2025, with an expected total funding of approximately $81,527,775 for the five-year period of performance, subject to availability of funds. The awards will support implementation of the Medical Monitoring Project (MMP), an ongoing public health surveillance program funded since 2005 and designed to learn more about the experiences and needs of adults aged 18 or older living with HIV (PWH) in the U.S.
• On August 27, 2024, FDA released a notice entitled, Determination That FENTANYL CITRATE Injections, Equivalent to 2.5 Milligram Base/50 Milliliter and Equivalent to 5 Milligram Base/100 Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. FDA has determined that fentanyl citrate injections, equivalent to 2.5 milligram (mg) base/50 milliliter (mL) (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for fentanyl citrate injections, EQ 2.5 mg base/50 mL (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), if all other legal and regulatory requirements are met.
• On August 27, 2024, FDA released a notice entitled, Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LIVMARLI (maralixibat). FDA announced the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. 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 LIVMARLI (maralixibat), approved on September 29, 2021, manufactured by Mirum Pharmaceuticals, Inc., meets the criteria for a priority review voucher.
• On August 28, 2024, CDC released a notice entitled, Reporting of Pregnancy Success Rates from Assisted Reproductive Technology (ART) Programs; Proposed Modifications to Data Collection Fields and Data Validation Procedures; Final Notice. CDC announced revised plans for data collection fields for reporting of pregnancy success rates from assisted reproductive technology (ART) programs and for data validation procedures. This reporting is required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA). This notice also responds to public comments received in response to CDC’s 2023 request for comment in a Federal Register notice.
• On August 28, 2024, the Administration for Community Living (ACL) released a notice entitled, Announcing the Intent to Award a Single-Source Supplement for the Strengthening the Direct Care Workforce: A Technical Assistance and Capacity Building Initiative. ACL announced the intent to award a single-source supplement to the current cooperative agreement held by the National Council on Aging for the “Strengthening the Direct Care Workforce: A Technical Assistance and Capacity Building Initiative”. The administrative supplement for FY 2024 will be in the amount of $1,787,524 bringing the total award for FY 2024 to $3,087,207. The supplement will provide sufficient resources to enable the grantee and their partners to increase funding for technical assistance (TA) to state aging and disability partnerships to collaborate with workforce entities to strengthen the direct care workforce. The funding will enable the grantee to support additional states, including at more robust levels than originally planned.
• On August 28, 2024, FDA released a notice entitled, Medical Devices and Device-led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers. FDA announced a minor, technical modification to an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. FDA refers to this alternative as the Voluntary Malfunction Summary Reporting Program.
• On August 28, 2024, FDA released a notice entitled, Voluntary Malfunction Summary Reporting Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability. This final guidance document is intended to help manufacturers better understand and use the VMSR Program. This guidance describes and clarifies several aspects of the VMSR Program, including the FDA’s approach to determining the eligibility of product codes for the program and the conditions for submitting MDRs for device malfunctions in summary format under the program.
• On August 29, 2024, FDA released a notice entitled, Prohibition of Sale of Tobacco Products to Persons Younger than 21 Years of Age. FDA is issuing a final rule to make conforming changes as required by the Further Consolidated Appropriations Act, 2020, which established a new federal minimum age of sale for tobacco products. These conforming changes include increasing the minimum age of sale for cigarettes, smokeless tobacco, and covered tobacco products from 18 to 21 years of age; increasing the minimum age for age verification by means of photographic identification for cigarettes, smokeless tobacco, and covered tobacco products from under the age of 27 to under the age of 30; increasing the minimum age of individuals who may be present or permitted to enter facilities that maintain vending machines to sell cigarettes, smokeless tobacco, or covered tobacco products from 18 to 21 years of age; and increasing the minimum age of individuals who may be present or permitted to enter facilities that maintain self-service displays that sell cigarettes or smokeless tobacco from 18 to 21 years of age.
• On August 29, 2024, the Indian Health Service (IHS) released a notice entitled, Catastrophic Health Emergency Fund. IHS administers the Catastrophic Health Emergency Fund (CHEF) pursuant to section 202 of the Indian Health Care Improvement Act (IHCIA). The purpose of the CHEF is to meet the extraordinary medical costs associated with the treatment of victims of disasters or catastrophic illnesses who are within the responsibility of the Service. This document finalizes the regulations governing the administration of the CHEF, with clarifying edits, and responds to comments received on the proposed rule.
• On August 29, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Secretarial Review and Publication of the Consensus Based Entity Report of 2023 Activities to Congress and the Secretary of the Department of Health and Human Services. This notice acknowledges receipt and review by the Secretary of the Department of Health and Human Services (HHS) of the 2023 Consensus Based Entity Annual Report to Congress as mandated by section 1890(b)(5) of the Social Security Act (the Act). The Secretary has reviewed and is publishing the report in the Federal Register together with the Secretary’s comments on the report.
• On August 30, 2024, FDA released a notice entitled, Medical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea. FDA is classifying the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices.
• On August 30, 2024, FDA released a notice entitled, Medical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder. FDA is classifying the digital therapy device for attention deficit hyperactivity disorder into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the digital therapy device for Attention Deficit Hyperactivity Disorder’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices.
• On August 30, 2024, FDA released a notice entitled, Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device. ) FDA is classifying the intervertebral body graft containment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intervertebral body graft containment device’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices.
• On August 30, 2024, FDA released a notice entitled, Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression. FDA is classifying the external compression device for internal jugular vein compression into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external compression device for internal jugular vein compression’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices.
• On August 30, 2024, FDA released a notice entitled, Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability. FDA announced the revocation of the EUA issued to Roche Molecular Systems, Inc, for the cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas Liat System, that includes the cobas SARS-CoV-2 & Influenza A/B Quality Control Kit. FDA revoked the EUA under the FD&C Act as requested by the EUA holder.
• On August 30, 2024, FDA released a notice entitled, Identifying Priority Focus Areas for Future Guidance Development and Engagement with Interested Parties in Model-Informed Drug Development; Request for Information. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) within FDA are announcing a request for information (RFI) for advancing model-informed drug development (MIDD). The purpose of this request is to obtain feedback on how to increase application of established MIDD approaches in regulatory decision making, to identify how emerging MIDD approaches are being incorporated within drug product development, and to identify opportunities to enhance interactions with FDA when discussing MIDD approaches. CDER and CBER intend to use the information submitted in response to this request to identify and prioritize potential focus areas for future policy or guidance development and enhance engagement with interested parties, including interactions as part of the MIDD Paired Meeting Program and other formal meetings with drug developers.
• On August 30, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Charter Renewal for the Advisory Committee on Organ Transplantation. In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the charter for the Advisory Committee on Organ Transplantation (ACOT) is renewed. The effective date of the renewed charter is August 31, 2024.
• On August 30, 2024, 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 notifies 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.

Event Notices

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 17, 2024: The SAMHSA announced a joint meeting of the Tribal Technical Advisory Committee (TTAC) and IHS National Tribal Advisory Committee on Behavioral Health (NTAC). 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 23, 2024: CDC announced a meeting of the World Trade Center Health Program Scientific/Technical Advisory Committee. This is a virtual 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, 2024: CDC announced a meeting of the Advisory Committee to the Director (ACD). 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.

October 30, 2024: FDA announced a meeting of the Patient Engagement Advisory Committee. This is a virtual 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 26, 2024, the Kaiser Family Foundation (KFF) released a report entitled, how narrow or broad are ACA marketplace physician networks. The report analyzes the provider networks of Affordable Care Act (ACA) Marketplace plans, including across plan metal tiers. The report finds that on average, ACA Marketplace enrollees had access to 40 percent of nearby doctors through their plan’s network, though there is significant variation across plans and locations. In large metro areas, networks tended to be narrower, and enrollees had access to 34 percent of doctors through their network on average. Conversely, rural areas had broader networks but fewer doctors overall. Overall, roughly 27 percent of active physicians were not in any Marketplace network. When analyzing metal tiers, higher-cost Silver plans generally offered broader networks. Around 37 percent of enrollees lived in countries where the two cheapest Silver plans included less than half of their local doctors. To access a more comprehensive network that included more than 50 percent of local providers, enrollees would have had to pay an additional $88 per month towards their health insurance expenses.

III. Other Health Policy News

• On August 23, 2024, Johnson & Johnson (J&J) announced that starting on October 15, 2024, the company would make 340B drugs available through a new rebate approach, starting with the drugs XARELTO and STELARA. Both of these drugs were included in the first round of Medicare drug price negotiations requiring lower costs under Medicare Part D. Within hours last Friday, the American Hospital Association (AHA), reported that HRSA informed J&J that the rebate model is inconsistent with the 340B statute and that this model has not been approved by the HHS Secretary. AHA also stated that HRSA “will take appropriate action as warranted.” As proposed by J&J, 340B participating disproportionate share hospitals (DSH hospitals) would be required to purchase STELARA and XARELTO through wholesalers at a commercial price, such as the wholesale acquisition cost for each drug similar to non-340B customers, and then DSH hospitals would need to submit a rebate claim to a third party platform to acquire the rebate once a sufficient number of rebate claims have been validated.
• On Tuesday, August 27, 2024, in response to HRSA’s position, J&J stated that it was standing firm and proceeding with its transition from drug discounts to rebates for two of its 340B drugs. While J&J has provided some detail on the new rebate program via a notice to its 340B end customers, it appears this dispute may be headed to the courts. J&J may be hoping that the recent Supreme Court decisions – Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce – may strengthen its position. The Loper Bright and Relentless decision overturned the longstanding doctrine of “Chevron deference,” and thus, federal courts no longer have to defer to a federal agency’s permissible interpretation of a silent or ambiguous statute when promulgating regulations. J&J may be hoping that a federal judge will decide the issue to their benefit, claiming that HRSA’s interpretation of the 340B statute disallowing rebates is not the “best” reading of statute.
• On August 26, 2024, the Biden Administration announced an award of $100 million to Navigator organizations that assist underserved communities in accessing affordable health coverage through ACA Marketplace plans offered on HealthCare.gov. The funding is part of a $500 million commitment over five years, enabling longer grant periods for sustained outreach. Navigators help consumers review plans, complete enrollment forms, and utilize coverage. The initiative focuses on reaching key underserved groups, including racial minorities, rural communities, LGBTQIA+ individuals, and immigrants. Grantees will tailor services to the unique needs of these communities, ensuring broader access to health care. For example, a grantee, Rural Health Project, will focus on rural Oklahoma, targeting Marshallese populations with language support, while another grantee, Choose Healthy Life, will use a faith-based approach to reach Black communities in South Carolina. Also, another grantee, Foundation Communities, will employ data-driven outreach in Texas to assist low-income and minority residents. These efforts align with the Administration’s commitment to making health care more accessible, particularly in communities that have historically faced barriers to enrollment. A press release with more information is available here.
• On August 26, 2024, the Biden Administration announced over $65 million in grant awards through SAMHSA to address the mental health and substance abuse crises. The funding will be used to strengthen the nation’s prevention and treatment workforce, particularly in mental health and substance use disorder (SUD) care. This initiative aligns with the President’s Unity Agenda, which emphasizes tackling mental health challenges and the opioid crisis. The funding will support the expansion of Certified Community Behavioral Health Clinics, along with other programs focused on training and deploying a more diverse and culturally competent healthcare workforce, aiming to improve access to essential services in underserved communities. A press release with more information is available here.
• On August 27, 2024, the Biden Administration announced over $558 million in funding to enhance maternal health across the U.S., with a particular focus on reducing maternal mortality and addressing health disparities. The funding is distributed across 35 states and supports various initiatives, including the expansion of maternal care services, workforce training for healthcare providers, and improved data collection to better understand and tackle the root causes of maternal health inequities. These efforts are part of a broader strategy to ensure safer pregnancies and healthier outcomes for both mothers and babies nationwide. The funding allocations include $368 million for the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program, $90 million for the State Maternal Health Innovation and Data Capacity Program, $25 million for the Rural Maternity and Obstetrics Management Strategies (RMOMS) Program, and $50 million for the Maternal Health Pipeline Training Program. Additionally, the CDC is investing $118 million to support public health initiatives focused on maternal and infant health. A press release with more information is available here.
• On August 28, 2024, the U.S. Surgeon General issued an advisory highlighting the critical importance of addressing the mental health and well-being of parents. The advisory emphasizes that parental mental health directly impacts children’s health and development, urging healthcare providers to prioritize this issue. It outlines several strategies for healthcare professionals, including screening for parental mental health issues, integrating mental health services into pediatric care, and providing resources and support for parents. The advisory also calls for broader societal changes to support parents, such as improved access to mental health care and family-friendly policies. Healthcare providers are encouraged to take proactive steps in recognizing and addressing mental health challenges faced by parents. The advisory emphasizes the need for a coordinated approach that involves pediatricians, mental health professionals, and community resources to create a supportive environment for families. By focusing on parental mental health, healthcare providers can help mitigate the long-term effects on children’s well-being, promoting healthier families and communities. The advisory also highlights the importance of reducing stigma and increasing awareness about the challenges parents face, particularly in underserved populations. A press release with more information is available here. The advisory is available here.
• On August 29, 2024, the Biden Administration announced $81.3 million in grant funding to advance key health priorities under President Biden’s Unity Agenda, with specific focus on mental health, SUDs, and cancer care. Of this funding, $68.6 million has been allocated to SAMHSA to expand mental health services and enhance treatment for SUDs. An additional $12.7 million has been earmarked for cancer prevention and control, prioritizing underserved communities. These investments are part of a broader effort to improve health equity and access to care across the nation. The grants will support a range of initiatives, including increasing access to behavioral health care in schools and providing critical resources to address the growing mental health crisis. The cancer prevention funds will focus on early detection and intervention, particularly in communities that have historically faced barriers to accessing quality health care. By targeting these areas, the administration aims to address significant public health challenges and ensure that all Americans can benefit from the advancements in medical care and treatment.

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