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, HHS released a final rule entitled, Safeguarding the Rights of Conscience as Protected by Federal Statutes and the Biden Administration announced a program through ARPA-H to invest in primary care.

I. Regulations, Notices & Guidance

• On January 8, 2024, the Food and Drug Administration (FDA) released a notice entitled, Issuance of Priority Review Voucher; Rare Pediatric Disease Product. FDA is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that CASGEVY (exagamglogene autotemcel), manufactured by Vertex Pharmaceuticals, Inc., meets the criteria for a priority review voucher.
• On January 8, 2024, the National Institutes of Health (NIH) released a notice entitled, Prospective Grant of an Exclusive Patent License: Development and Commercialization of Thermally Responsive T Cell Therapies for the Treatment of HPV-Positive Cancer(s). The National Cancer Institute, an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Port Therapeutics, Inc. (Port). Port incorporated in Delaware and is presently headquartered in Los Angeles, California.
• On January 8, 2024, the Substance Abuse and Mental Health Service Agency (SAMHSA) released a notice entitled, Questions from the Task Force on Maternal Mental Health. The Task Force on Maternal Mental Health (Task Force) solicits public comments on a set of questions concerning the context, policies, effectiveness, promising practices, and limitations and gaps related to prevention and treatment of maternal mental health conditions and substance use disorders (inclusive of alcohol use/misuse) and its complications. The Task Force is required to solicit public comments, as appropriate, from stakeholders for the purposes of developing a report that analyzes and evaluates the state of maternal mental health programs at the Federal level and identifies best practices with respect to maternal mental health and substance use disorders as well as a national strategy for improving maternal mental health. The taskforce will be highlighting recommendations that fall within the pregnancy and postpartum (up to one year after birth) periods for individuals with or at risk for mental health and substance use conditions.
• On January 9, 2024, HHS released a rule entitled, Safeguarding the Rights of Conscience as Protected by Federal Statutes. HHS is issuing this final rule to partially rescind the May 21, 2019, final rule entitled, Protecting Statutory Conscience Rights in Health Care; Delegations of Authority (2019 Final Rule), while leaving in effect the framework created by the February 23, 2011, final rule entitled, Regulation for the Enforcement of Federal Health Care Provider Conscience Protection Laws (2011 Final Rule), which has been in effect continuously since March 25, 2011. Though the 2019 Final Rule never took effect, HHS also retains certain provisions of the 2019 Final Rule regarding federal conscience protections, but eliminates others that are redundant or confusing, that undermine the clarity of the statutes Congress enacted to both safeguard conscience rights and protect access to health care, or because significant questions have been raised as to their legality.
• On January 10, 2024, FDA released a notice entitled, Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin; International Council for Harmonisation; Guidance for Industry; Availability. The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application. The guidance also finalizes the updates based on advances in scientific knowledge and regulatory expectations to the first version of the ICH guidance for industry, Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, issued in September 1998. Lastly, the guidance replaces the draft guidance, Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, issued on November 14, 2022.
• On January 10, 2024, FDA released a notice entitled, Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request. This draft guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. This draft guidance revises the draft guidance of the same title issued in October 2017. This revision is being issued to reflect the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA) and to clarify what matters are appropriate for requests for reconsideration.
• On January 10, 2024, FDA released a notice entitled, Issuance of Priority Review Voucher; Rare Pediatric Disease Product. 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 FILSUVEZ (birch triterpenes), manufactured by Amryt Pharmaceuticals, meets the criteria for a priority review voucher.
• On January 12, 2024, FDA released a notice entitled, Notice of Approval of Product under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; FABHALTA. FDA is announcing the approval of a product redeeming a material threat medical countermeasure (MCM) priority review voucher. The FD&C Act authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the issuance of material threat MCM priority review vouchers as well as the approval of products redeeming a voucher. FDA has determined that FABHALTA (iptacopan) capsules, approved December 5, 2023, meets the redemption criteria.

Event Notices

January 19, 2024: HHS announced a meeting of the 2025 Dietary Guidelines Advisory Committee. This is a virtual meeting open to the public.

January 19, 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). This is a virtual meeting open to the public.

January 22, 2024: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.

January 24, 2024: NIH announced the Interagency Autism Coordinating Committee will hold a meeting to discuss committee business, updates, and issues related to autism research and services activities. This is a hybrid meeting open to the public.

January 24, 2024: NIH announced the National Advisory Child Health and Human Development Council Stillbirth Working Group Meeting. This is a virtual meeting open to the public.

January 25, 2024: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). This is a hybrid meeting open to the public.

January 29, 2024: NIH announced the National Heart, Lung, and Blood Institute Sickle Cell Disease Advisory Committee will hold a virtual meeting open to the public.

January 29, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). This is a hybrid meeting open to the public.

February 1, 2024: The Centers for Medicare & Medicaid Services (CMS) announced a virtual meeting of the Advisory Panel on Outreach and Education (APOE). This meeting is open to the public.

February 2, 2024: FDA announced the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee will hold a meeting that is open to the public.

February 6, 2024: FDA announced the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee will hold a meeting that is open to the public.

February 13-14, 2024: HHS announced a meeting of the Office of Minority Health. The meeting is open to the public. Individuals who wish to attend must register by emailing OMH-ACMH@hhs.gov by 5:00 p.m. EST on January 30, 2024. Each registrant should provide their name, affiliation, phone number, email address, days attending, and if participation is in-person or via webcast.

February 14, 2024: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health. This meeting is open to the public, but without a public comment period. The public can join the meeting by teleconference.

February 27, 2024: SAMHSA announced a meeting of SAMHSA’s Tribal Technical Advisory Committee (TTAC). The meeting is open to the public and will be held in person.

February 28-29, 2024: CDC announced a meeting of the Advisory Committee on Immunization Practices. 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 that is 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 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.

II. Hearings & Markups

House of Representatives

• On January 11, 2024, the House Committee on Education & the Workforce, Subcommittee on Health, Employment, Labor, and Pensions hosted a hearing entitled, Lowering Costs and Increasing Access to Health Care with Employer-Driven Innovation. Witnesses present included Michele Beehler, Senior Director of Health and Wellbeing, Schweitzer Engineering Laboratories; Laura Josh, General Manager, California Schools VEBA; Andrea Ducas, Vice President, Health Policy, Center for American Progress; and Dr. Christopher Whaley, Health Economist, RAND Corporation.

III. Reports, Studies, & Analyses

• On January 9, 2024, the U.S. Government Accountability Office (GAO) issued a report entitled, VA Health Care: Office of Rural Health Efforts and Recommendations for Improvement. GAO examined the Veteran’s Affairs (VA's) Office of Rural Health efforts to enhance healthcare access for rural veterans, including identifying challenges like staffing shortages and limited internet access. The report found that the agency lacked formal communication channels for research funding opportunities, disadvantaging some researchers. GAO recommended a formal process for disseminating these opportunities, with the VA initiating steps to address this by May 2024. Additionally, GAO recommended the development of clear, measurable goals, a step VA started taking for its 2025-2029 strategic plan. This report highlights the need to improve VA support for rural veterans, given their unique challenges in accessing healthcare.
• On January 10, 2024, the Kaiser Family Foundation (KFF) issued a report entitled, Unwinding of Medicaid Continuous Enrollment: Key Themes from the Field. KFF conducted a variety of interviews with state Medicaid officials, insurers, primary care associations, advocacy organizations, and navigator organizations to understand their perspectives on the ongoing Medicaid unwinding process. Key findings centered around communication and engagement, the renewal process, and coverage transitions. The report found that all 50 states are utilizing new and innovative communication campaigns to reach enrollees about renewing their Medicaid coverage. Additionally, KKF reports that while state Medicaid agencies are struggling with the volume of renewals admits staff shortages, ex parte, or automated, renewals have assisted in streamlining the process. Finally, in relation to coverage transitions, the report found that some disenrolled beneficiaries are reenrolling in Medicaid coverage, states have mixed experiences in seamlessly transitions kids to the Children’s Health Insurance Program (CHIP), and cost is a barrier for Marketplace plan enrollment.
• On January 10, 2024, the Bipartisan Policy Center (BPC) issued a report entitled, The Future of Remote Patient Monitoring. Through a series of interviews and roundtables with public and private stakeholders, BPC developed federal policy recommendations to promote the appropriate use and coverage of remote patient monitoring (RPM) devices and services. BPCs recommendations center on ensuring appropriate service coverage, improving equity, and ensuring data security and privacy. The report notes that while RPM utilization increased sixfold among Medicare beneficiaries from 2018-2021, utilization remains relatively low with 2021 seeing an average of 594 monthly RPM claims per 100,000 Medicare enrollees. These recommendations aim to promote safe, equitable, and evidence-based access to RPM.
• On January 11, 2024, a report from the Medicare Payment Advisory Commission (MedPAC) revealed that the federal government is projected to overpay privately run Medicare Advantage (MA) plans by $88 billion in 2024. According to the report, the overpayment is attributed, in part, to private insurance companies adding unnecessary diagnostic codes to medical claims, influencing higher payments for treating patients with more complex medical needs. The report also highlights how, by restricting in-network doctors, MA plans discourage sicker patients from enrolling, leading to additional overpayments. The findings are significant as 52 percent of Medicare beneficiaries were enrolled in an MA plan in 2023.

IV. Other Health Policy News

• On January 8, 2024, HHS Secretary Xavier Becerra appointed Ms. Stacy Sanders as Chief Competition Officer, a newly created role aimed at reducing healthcare and prescription drug costs by promoting competition. Ms. Sanders, previously a Counselor to the Secretary, will focus on implementing the Inflation Reduction Act, long-term care initiatives, and policies supporting healthcare competition and Medicare. Her responsibilities include identifying opportunities to enhance competition in healthcare markets, collaborating with the Federal Trade Commission (FTC) and Department of Justice (DOJ), and executing strategies outlined in the President’s Executive Order (EO) on Promoting Competition in the American Economy. A press release with more information is available here.
• On January 9, 2024, CMS announced the approval of an amendment to New York’s Medicaid section 1115 demonstration, aiming to improve access to primary care, behavioral health, and health equity. This initiative encompasses a range of actions including: 1) setting sustainable base rates for underserved safety net hospitals; 2) facilitating access to housing and nutritional support services; 3) enhancing treatment for substance use disorders; and 4) investing in the healthcare workforce. The amendment focuses on addressing social needs, integrating primary care with behavioral health services, and supporting vulnerable hospitals with high-risk populations. It aligns with broader federal efforts, such as the Making Care Primary and States Advancing All-Payer Health Equity Approaches and Development models, aimed at strengthening primary care infrastructure nationwide. CMS has emphasized rigorous evaluations to monitor outcomes, aiming to improve access and affordability in healthcare coverage under the Biden-Harris Administration’s healthcare initiatives. Similar efforts are underway in various other states to enhance coverage impact and healthcare accessibility. A press release with more information is available here.
• On January 9, 2024, the HHS Office for Civil Rights (OCR) issued a final rule entitled, Safeguarding the Rights of Conscience as Protected by Federal Statutes. This final rule partially rescinds the 2019 final rule entitled, Protecting Statutory Conscience Rights in Health Care; Delegations of Authority. The 2019 final rule was intended to increase enforcement of Federal conscience and anti-discrimination laws and increase protections for health care entities and workers exercising religious beliefs or moral convictions in the coverage or provision of health care services. The 2019 final rule has been held unlawful by three federal district courts. In addition to partially rescinding the 2019 final rule, the Safeguarding the Rights of Conscience as Protected by Federal Statutes final rule restores the previous process for handling conscience complaints and describes the authority and tools available to OCR to enforce the Federal health care conscience protection statutes. With regard to providers, HHS states that they have tried to balance provider and patient rights in this final rule. For example, HHS acknowledges that some doctors may object for religious or moral reasons to providing abortions or assisted suicide. HHS emphasizes that the final rule is intended to provide clarity to both providers and patients about where and how they may register their concerns regarding conscience rights. In addition, HHS underscores their intention to educate providers about their rights and obligations under the conscience statutes. The final rule is available here.
• On January 9, 2024, the Biden-Harris Administration, as part of its Unity Agenda, announced the launch of the Health care Rewards to Achieve Improved Outcomes (HEROES) program through the Advanced Research Projects Agency for Health (ARPA-H). HEROES aims to address preventable health challenges in underserved communities by incentivizing investment in community-level preventative care resources. The program seeks to align financial incentives for major healthcare stakeholders, including insurers, investors, providers, and patients, to accelerate and sustain the adoption of breakthroughs in medicine and healthcare. Recognizing that zip codes and income often define health outcomes, HEROES focuses on establishing a care system that incentivizes better preventative care to reduce preventable deaths, particularly in areas with worse health outcomes than the national average. ARPA-H will solicit proposals from “Health Accelerators” to address specific health challenges, offering incentive-based awards for quantifiable reductions in targeted health outcomes over a three-year period. The unique HEROES program aims to create a sustainable market that transforms the healthcare paradigm from a sick care system to one that genuinely rewards better health. Interested groups can engage with ARPA-H through the HEROES program page and Proposers’ Days on February 13-14, 2024, in Washington, D.C. A press release with more information is available here.

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