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 distributed $482 million in PRF payments and announced $1.5 billion for State Opioid Response (SOR) grants. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On May 16, 2022, the Department of Health and Human Services (HHS) issued a request for information entitled, 2022 HHS Environmental Justice Strategy and Implementation Plan Draft Outline; Comment Period Extended. HHS would like to identify priority actions and strategies to best address environmental injustices and health inequities for people of color, disadvantaged, vulnerable, low-income, marginalized, and indigenous populations. With the engagement of and input from the public, the 2022 Environmental Justice Strategy and Implementation Plan will serve as a guide to confront environmental and health disparities and implement a multifaceted approach that will serve vulnerable populations and communities disproportionately impacted by environmental burdens. To be assured consideration, comments must be received no later than midnight Eastern Time (ET) on June 18, 2022.
- On May 16, 2022, the Food and Drug Administration (FDA) issued final guidance entitled, Infant Formula Enforcement Discretion Policy: Guidance for Industry. FDA is issuing this guidance document to help increase the supply of infant formula in the United States. FDA intends to temporarily exercise enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain statutory and regulatory requirements and is seeking information from manufacturers regarding the safety and nutritional adequacy of their products. This guidance document is intended to explain factors that FDA intends to consider in making case-by-case determinations about whether to exercise enforcement discretion to allow the introduction into interstate commerce (including importation) of infant formula that is safe and nutritionally adequate, but that may not comply with all statutory and regulatory requirements. The guidance is also intended to advise infant formula manufacturers about the type of information to provide to FDA, if they would like FDA to consider whether to exercise enforcement discretion with regard to particular products.
- On May 17, 2022, FDA issued final guidance entitled, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors; Guidance for Industry; Availability. The guidance focuses on safety aspects of the container label and carton labeling design for human prescription drug and biological products. The guidance provides sponsors of new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and prescription drugs marketed without an approved NDA or ANDA with a set of principles and recommendations for ensuring that critical elements of product container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product.
- On May 17, 2022, FDA issued final guidance entitled, Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Guidance for Industry; Availability. This guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application. This guidance is finalizing FDA’s draft guidance for industry “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017,” published in November 2019.
- On May 18, 2022, the Health Resources and Services Administration (HRSA) issued a notice entitled, Criteria for Determining Maternity Care Health Professional Target Areas. HRSA is directed to identify Maternity Care Target Areas (MCTAs), or geographic areas within health professional shortage areas that have a shortage of maternity care health professionals, for the purpose of providing maternity health care assistance to such health professional shortage areas. HRSA solicited feedback on proposed criteria in September 2021. This notice summarizes and responds to the comments received during the 60-day comment period and presents the final criteria which will be used to identify and score MCTAs.
- On May 18, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Solicitation of Nominations for Appointment to CDC’s Advisory Committee to the Director (ACD) Data and Surveillance Workgroup (DSW); Re-opening of Solicitation Period. The establishment and formation of the DSW is to provide input to the ACD on agency-wide activities related to the scope and implementation of CDC’s data modernization strategy across the agency, ultimately playing a key role in the agency’s work with public health, healthcare, and academic and private sector partners and with the promotion of equity. DSW members will serve terms ranging from six months to one year and be required to attend DSW meetings approximately one to two times per month (virtually or in person), and contribute time between meetings for research, consultation, discussion, and writing assignments.
- On May 19, 2022, FDA issued a notice entitled, Medical Devices; 510(k) Sterility Change Master File Pilot Program. The 510(k) Sterility Pilot Program is voluntary and intends to give interested companies that terminally sterilize single-use devices using certain sterilization methods a pathway to submit a Master File for FDA’s review. FDA will accept a Master File into the 510(k) Sterility Pilot Program when it determines, among other things, that there is not a likelihood that switching from a fixed chamber ethylene oxide (EtO) sterilization method to the sterilization method described in the Master File could significantly affect the safety or effectiveness of a 510(k)-cleared device that meets the product definition in the Master File.
- On May 19, 2022, FDA issued draft guidance entitled, Risk Management Plans To Mitigate the Potential for Drug Shortages; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request. This draft guidance is intended to help stakeholders develop, maintain, and implement, as appropriate, risk management plans (RMPs) to proactively assist in the prevention of human drug product and biological product shortages. This draft guidance recommends a framework and factors to consider that stakeholders can use to develop RMPs. This draft guidance is relevant for all stakeholders, including those with oversight and control responsibilities for drug quality and contract establishments, and for manufacturers of active pharmaceutical ingredients (APIs), approved or licensed drug and biological products, and drug products marketed without an application.
- On May 19, 2022, FDA issued draft guidance entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs).
- On May 20, 2022, FDA issued a proposed rule entitled, Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases. FDA is proposing new regulations that would amend the requirements concerning current good manufacturing practice (CGMP) and post-marketing safety reporting that apply to certain medical gases. FDA further proposes to establish regulations regarding certification of designated medical gases and amend the labeling regulations that apply to certain medical gases. This action, if finalized, will clarify the regulatory obligations of entities that manufacture, process, pack, label, or distribute certain medical gases, as well as reduce regulatory burden in this area. This proposed rule is intended to establish requirements that are more specifically tailored to the medical gas industry.
- June 6, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Advisory Allergy and Infectious Diseases Council. The agenda will include reports from the Institute Director, the Division Director, and Division Staff.
- June 6, 2022: NIH announced a public meeting of the AIDS Research Advisory Committee. The agenda will include a report from the Division Director and Division Staff.
- June 7, 2022: NIH announced a public meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. The agenda will include a discussion of program policies and issues.
- June 14, 2022: FDA announced a public meeting of the Science Board to the Food and Drug Administration Advisory Committee. The Board will consider challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study. The Board will also hear about FDA’s enhanced efforts to spur the development, qualification, and adoption of new alternative methods for regulatory use that can replace, reduce, and refine animal testing and have the potential to provide both more timely and more predictive information to accelerate product development and enhance emergency preparedness. The Board will also hear about FDA’s efforts to ensure optimal organization, infrastructure, and expertise for data science efforts in alignment with its regulatory scope and evidence-based decision making, in support of FDA’s public health priorities.
- June 17, 2022: NIH announced a public meeting of the National Advisory Eye Council. The agenda will include the presentation of the National Eye Institute (NEI) Director’s report, discussion of NEI programs, and concept clearances.
- June 21-22, 2022: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Prevention’s (CSAP) Drug Testing Advisory Board (DTAB). The agenda will include a discussion of the Mandatory Guidelines for Federal Workplace Drug Testing Programs, updates on the Drug Free Workplace Program as well as updates from the Department of Transportation, the Nuclear Regulatory Commission, a presentation by Dr. Barry Sample on Workforce Drug Testing for Marijuana in 2021, and a presentation by Dr. Svante Vikingsson on Hydroxy Cocaine and Cocaine Ratios in Hair.
- September 12-13, 2022: HHS announced a public meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The agenda will be dedicated to a One Health anti-microbial resistance (AMR) and Pandemic Preparedness Policy Workshop with the goal of identifying key issues and critical policy gaps through a series of facilitated discussions examining a hypothetical large-scale disease outbreak scenario based on historic examples and estimates of future AMR outbreaks.
II. Congressional Hearings
U.S. House of Representatives
- On May 17, 2022, the House Committee on Oversight and Reform Select Subcommittee on the Coronavirus Crisis held a hearing entitled, Underpaid, Overworked, and Underappreciated: How the Pandemic Economy Disproportionately Harmed Low-Wage Women Workers. Witnesses present included: Ms. Mary Katharine Ham, CNN Commentator and Author; Dr. C. Nicole Mason, President & Chief Executive Officer, Institute for Women's Policy Research; Ms. Cynthia Murray, Fitting Department Associate, Walmart; Dr. Yana van der Meulen Rodgers, Professor of Labor Studies and Employment Relations, Faculty Director, Center for Women and Work, on behalf of Rutgers University; and Ms. Vicki Shabo, Senior Fellow - Paid Leave Policy and Strategy, Better Life Lab, New America.
- On May 18, 2022, the House Committee on the Judiciary held a hearing entitled, Revoking Your Rights: The Ongoing Crisis in Abortion Care Access. Witnesses present included: Ms. Aimee Arrambide, Executive Director, Avow Texas; Ms. Catherine Glenn Foster, President & CEO, Americans United for Life; Ms. Michele Bratcher Goodwin, Chancellors Professor of Law, University of California, Irvine; and Dr. Yashica Robinson, At-Large Member, Board of Directors, Physicians for Reproductive Health.
- On May 18, 2022, the House Committee on Homeland Security Subcommittee on Border Security, Facilitation, and Operations held a hearing entitled, Examining the Department of Homeland Security’s (DHS) Efforts to Combat the Opioid Epidemic. Witnesses present included: Mr. Brian Sulc, Executive Director, Transnational Organized Crime Mission Center, Office of Intelligence & Analysis, U.S. Department of Homeland Security; Mr. Pete Flores, Executive Assistant Commissioner, Office of Field Operations, U.S. Customs & Border Protection, U.S. Department of Homeland Security; and Mr. Steve Cagan, Assistant Director for Countering Transnational Organized Crime, Homeland Security Investigations, U.S. Immigration & Customs Enforcement, U.S. Department of Homeland Security.
- On May 18, 2022, the House Committee on Energy & Commerce held a markup of six bills. Legislation discussed included: H.R. 7667, the Food and Drug Amendments of 2022, H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act of 2022, H.R. 7233, the Keeping Incarceration Discharges Streamlined for Child and Accommodating Resources in Education (KIDS CARES) Act, H.R. 623, the Gabriella Miller Kids First Research Act 2.0, H.R. 3771, the South Asian Heart Health Awareness Act of 2021, and H.R. 5585, the Advanced Research Project Agency-Health (ARPA-H) Act. All six bills, as amended, were ordered reported favorably to the House.
- On May 19, 2022, the House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing entitled, Fiscal Year 2023 Budget Request for the Food and Drug Administration. Witnesses present included: The Honorable Robert M. Califf, Commissioner of Food and Drugs, Food and Drug Administration.
- On May 17, 2022, the Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, A Review of the President’s FY 2023 Funding Request and Budget Justification for the National Institutes of Health. Witnesses present included, Dr. Lawrence Tabak, Acting Director, National Institutes of Health; Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases; Dr. Gary Gibbons, Director, National Heart, Lung, and Blood Institute; Dr. Joshua Gordon, Director, National Institute of Mental Health; Dr. Richard Hodes, Director, National Institute on Aging; and Dr. Nora Volkow, Director, National Institute on Drug Abuse.
- On May 18, 2022, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, Cybersecurity in the Health and Education Sectors. Witnesses present included: Ms. Denise Anderson, President and CEO, Health Information Sharing and Analysis Center; Mr. Joshua Corman, Founder, I Am The Cavalry; Ms. Amy McLaughlin, Cybersecurity Program Director, Consortium of School Networking; and Ms. Helen Norris, Vice President and Chief Information Officer, Chapman University.
- On May 19, 2022, the Senate Special Committee on Aging held a hearing entitled, Mental Health Care for Older Adults: Raising Awareness, Addressing Stigma, and Providing Support. Witnesses present included: Dr. Erin E. Emery-Tiburcio, Ph.D., ABPP, Co-Director, Rush Center for Excellence in Aging; Dr. Kenneth M. Rogers, M.D., MSPH, MMM, State Director, South Carolina Department of Mental Health; Ms. Kimberly Williams, President and CEO, Vibrant Emotional Health; and Mr. Jim Klasen, Certified Older Adult Peer Specialist (COAPS) Facilitator.
III. Reports, Studies & Analyses
- On May 16, 2022, KFF published an issue brief entitled, State Actions to Address Nursing Home Staffing During COVID-19. This issue brief summarizes federal and state standards related to nursing home staffing prior to COVID-19 and builds on existing information by identifying changes to state minimum staffing requirements adopted since the onset of the COVID-19 pandemic. KFF also examined state legislative and regulatory actions since the onset of the pandemic that directly affect worker wages and training requirements.
- On May 16, 2022, the Congressional Budget Office published a report entitled, Budgetary Effects of a Policy That Would Lower the Age of Eligibility for Medicare to 60. In this report, CBO discusses an estimate of the federal budgetary costs of a policy that would lower the age of eligibility for Medicare, largely reflecting current program rules for people who would be newly eligible. The estimate was prepared in conjunction with the staff of the Joint Committee on Taxation (JCT). This report also describes the resulting changes in the number of people with health insurance coverage and the sources of that coverage.On May 17, 2022, the RAND Corporation published a report entitled, Prices Paid to Hospitals by Private Health Plans. This report uses medical claims data from a large population of privately insured individuals, including hospitals and other facilities from across the United States, and allows an easy comparison of hospital prices using a single metric. The report found that in 2020, across all hospital inpatient and outpatient services (including both facility and related professional charges), employers and private insurers paid 224 percent of what Medicare would have paid for the same services at the same facilities.
- On May 17, 2022, the RAND Corporation published a report entitled, Prices Paid to Hospitals by Private Health Plans. This report uses medical claims data from a large population of privately insured individuals, including hospitals and other facilities from across the United States, and allows an easy comparison of hospital prices using a single metric. The report found that in 2020, across all hospital inpatient and outpatient services (including both facility and related professional charges), employers and private insurers paid 224 percent of what Medicare would have paid for the same services at the same facilities.
- On May 19, 2022, KFF published a report entitled, Medicaid Coverage of Pregnancy-Related Services: Findings from a 2021 State Survey. The survey asked states about the specific maternity services they cover. The range of pregnancy-related services that states cover is shaped by many factors, and states have significant latitude to set income eligibility levels, define specific maternity care services, and apply utilization controls such as prior authorization and preferred drug lists (PDL). This report presents detailed survey findings from 41 states and DC on fee-for-service coverage and utilization limits for Prenatal care and Delivery, Fertility Services, Counseling and Support Services, Substance Use Disorder Services, and Breastfeeding Supports and Postpartum Care.
IV. Other Health Policy News
- On May 16, 2022, HHS announced a funding opportunity of nearly $15 million for a three-year federal grant to establish a SAMHSA program that will strengthen the delivery of behavioral health care to residents of nursing homes and other long-term care facilities. Funded by the Centers for Medicare & Medicaid Services (CMS), this program will establish a Center of Excellence for Building Capacity in Nursing Facilities to Care for Residents with Behavioral Health Conditions (Center for Excellence). The Center of Excellence is expected to improve overall health care in nursing homes and other long-term care facilities by providing direct consultation to staff to increase understanding, improve awareness, reduce stigmatization, and build knowledge and skills for effective resident care. The program will be funded with CMS’ Civil Money Penalty (CMP) funds, which come from collected CMPs that are imposed against nursing homes and other long-term care facilities when they are not in substantial compliance with one or more Medicare and Medicaid program participation requirements for long-term care facilities. More information on this funding can be found here.
- On May 17, 2022, HHS announced a nearly $3.5 million five-year grant opportunity to develop a Center of Excellence, advancing behavioral health care for Asian American, Native Hawaiian, and Pacific Islander (AANHPI) communities while reducing behavioral health-related disparities. The AANHPI Behavioral Health Center of Excellence will promote culturally and linguistically appropriate behavioral health information and practices; establish a steering committee to identify emerging issues; and provide training, technical assistance, and consultation to practitioners, educators, and community organizations. Training topics include addressing mental health impacts caused by unconscious bias and hate against AANHPI communities. The Center of Excellence will also develop accessible, public-facing infographics and other materials that address behavioral health, including those that provide data disaggregated by race and ethnicity, as well as best practices for improving engagement and retention of AANHPI behavioral health professionals. More information on this funding can be found here.
- On May 18, 2022, HHS announced its first-ever behavioral health Recovery Innovation Challenge. The goal of this challenge is to identify innovations developed by peer-run or community-based organizations, and entities that may partner with them—such as local or state governments, health systems, hospitals, or health plans—that advance recovery. As part of this challenge, participants are encouraged to share details about the practices they are using to advance recovery and demonstrate how these practices have: 1) expanded upon SAMHSA’s definition of recovery, or 2) helped them overcome challenges in incorporating recovery into their behavioral health services or systems. SAMHSA is using the challenge to directly engage with a larger and more diverse number of organizations, including groups providing recovery services and supports at all levels in the continuum of care for behavioral health. More information on this opportunity can be found here.
- On May 18, 2022, HHS announced $2 million in funding to establish a national center of excellence on social media and mental wellness. The purpose of the CoE will be to develop and disseminate information, guidance, and training on the impact—including benefits and risks—that social media use has on children and youth, especially the risks to their mental health. This center of excellence will also examine clinical and social interventions that can be used to mitigate the risks. The center of excellence on Social Media and Mental Wellness will focus on three priorities: 1) education and resources around the risks and benefits of social media use for children and youth; 2) culturally and linguistically appropriate technical assistance focusing on active learning, consultation, and support on how to best assist children and youth when interfacing with the digital world in a way that enhances their mental health while reducing harm; and 3) best practices and research updates. More information on this funding can be found here.
- On May 18, 2022, HRSA announced the distribution of more than $482 million from previously-appropriated funding for the Provider Relief Fund (PRF) in Phase 4 General Distribution payments. These payments are being issued to nearly 2,300 providers across the U.S. HRSA will continue to distribute additional PRF Phase 4 General Distribution payments as it processes remaining applications from providers. Including these payments, HRSA has distributed a total of nearly $14 billion in PRF Phase 4 payments to approximately 88,000 providers across the U.S. In addition to these PRF payments, HRSA also has distributed a total of $7.9 billion from funding appropriated for American Rescue Plan (ARP) Rural payments to more than 46,000 providers since November 2021. More information on this funding can be found here.
- On May 18, 2022, the Centers for Medicare & Medicaid Services (CMS) announced a series of monthly calls for health care stakeholders related to the unwinding of the Public Health Emergency (PHE) that was declared in response to the COVID-19 pandemic. The first call will be held on May 25, 2022. Registration information for the CMS monthly calls can be found here. Previously, in December 2021, HHS Secretary Xavier Becerra pledged to provide a 60-day notice before any termination or expiration of the declaration of a PHE. Notably, HHS would have been expected to announce the 60-day notice of termination of the PHE by May 16, 2022 in advance of the expiration of the current PHE on July 15, 2022. However, to date, HHS has not announced a date for ending the PHE, indicating that HHS expects to extend the PHE beyond July 15, 2022.
- On May 19, 2022, HHS announced a State Opioid Response (SOR) grant funding opportunity that will provide nearly $1.5 billion to states and territories to help address the nation’s opioid addiction and overdose epidemic. The SOR grant program provides formula funding to states and territories for increasing access to FDA-approved medications for the treatment of Opioid Use Disorder (OUD), and for supporting prevention, harm reduction, treatment, and recovery support services for OUD and other concurrent substance use disorders (SUD). The SOR program also supports care for stimulant misuse and use disorders, including for cocaine and methamphetamine. The SOR program helps reduce overdose deaths and close the gap in treatment needs across America by giving states and territories flexibility in funding evidence-based practices and supports across different settings to meet local community needs. More information on this funding can be found here.
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