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 sent a letter to providers and hospitals reminding them of EMTALA requirements and the US Surgeon General released an advisory on social isolation and loneliness. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On May 1, 2023, the Food and Drug Administration (FDA) issued final guidance entitled, A Risk-Based Approach to Monitoring of Clinical Investigations--Questions and Answers; Guidance for Industry. This guidance provides information on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combination products. The guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry entitled “Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring” (August 2013) by providing additional information to facilitate sponsors’ implementation of risk-based monitoring. This guidance finalizes the draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers,” issued on March 15, 2019.
- On May 1, 2023, FDA issued a request for information (RFI) entitled, Methodological Challenges Related to Patient Experience Data; Request for Information and Comments. FDA is establishing a public docket to collect comments on methodological challenges related to patient experience data in the context of benefit-risk assessment and product labeling, and other areas of greatest interest or concern to public stakeholders. Public comments will help FDA plan two public workshops focused on methodological challenges and identify priorities for future work. Comments must be received by July 1, 2023.
- On May 2, 2023, FDA issued draft guidance entitled, Decentralized Clinical Trials for Drugs, Biological Products, and Devices. This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this draft guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. These trial-related activities may take place at the location of trial participants or in local healthcare facilities that are close to trial participants’ locations.
- On May 3, 2023, FDA issued final guidance entitled, Q9(R1) Quality Risk Management. 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 a targeted revision of the 2006 guidance for industry “Q9 Quality Risk Management” and addresses product availability risks due to manufacturing quality issues, lack of understanding as to what constitutes formality in Quality Risk Management (QRM) work, lack of clarity on risk-based decision-making, and high levels of subjectivity in risk assessments and QRM outputs. The revision is intended to provide guidance on quality risk management principles and tools that can be applied to different aspects of pharmaceutical quality. The guidance replaces the draft guidance “Q9(R1) Quality Risk Management” issued on June 15, 2022.
- On May 3, 2023, FDA issued an RFI entitled, Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products; Establishment of a Public Docket; Request for Comments. FDA is announcing the establishment of a docket to solicit public comments on the identification, assessment, and control of N-nitrosamine (nitrosamine) drug substance-related impurities (NDSRIs) that may be considered by the Agency in its regulation of these types of impurities in drug products. This notice identifies scientific and regulatory considerations regarding the identification, assessment, and control of NDSRIs, including areas that may benefit from collaborative efforts, and requests public comments on these topics. This notice is not intended to communicate FDA’s regulatory expectations on these issues but is instead intended to seek input from the public to inform scientific and/or regulatory approaches as appropriate. Comments must be received by July 3, 2023.
- On May 3, 2023, the National Institutes of Health (NIH) issued a notice entitled, National Heart, Lung, and Blood Institute; Notice of Proposed Reorganization. The National Heart, Lung, and Blood Institute (NHLBI) will host a public hearing on June 6-7, 2023 to enable discussion of the Institute’s proposal to reorganize the Division of Lung Disease (DLD). The proposed reorganization aims to ensure effective oversight, alignment of expertise, and translation of knowledge within and across research areas in the lung disease field. It establishes a new branch structure that will strategically position leadership over DLD programs, balance workload, and enhance depth/succession planning for ingrained operational sustainability. There will be no impact on the National Center on Sleep Disorders Research (NCSDR) as a result of the restructuring. The online forums will allow members of the public to review the reorganization proposals and submit comments.
- On May 4, 2023, 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. CDC is seeking nominations for membership on the Advisory Committee to the Director (ACD). The ACD consists of up to 15 experts knowledgeable in areas pertinent to the CDC mission, such as public health, global health, health disparities, biomedical research, and other fields, as applicable. Nominees will be selected for four-year terms based on their expertise in the fields of public health, global health, health disparities, biomedical research, and public health disciplines. Federal employees will not be considered for membership. Nominations must be received by June 4, 2023.
- On May 4, 2023, the Health Resources and Services Administration (HRSA) issued a notice entitled, Solicitation of Nominations for Membership to Serve on the Advisory Committee on Interdisciplinary, Community-Based Linkages. HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) for three-year terms. ACICBL provides advice and recommendations to the Secretary of the Department of Health and Human Services (HHS) concerning policy and program development, and other significant matters related to activities under the Public Health Service (PHS) Act, which includes Area Health Education Centers, Geriatrics, Mental and Behavioral Health, Social Work, Graduate Psychology, Rural Health, and Pharmacy. Nominations for membership on ACICBL must be received on or before June 30, 2023.
- June 5, 2023: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The meeting will include information on the progress of the ISUDCC Working Groups, discussion of the ISUDCC Reauthorization, and sections 1262 and 1263 of the Consolidated Appropriations Act, 2023 (CAA, 2023), commonly known as the Mainstreaming Addiction Treatment (MAT) Act and Medication Access and Training Expansion (MATE) Act.
- June 5-6, 2023: NIH announced a public meeting of the Fogarty International Center (FIC) Advisory Board. The meeting agenda will include an update and discussion on current and planned FIC activities.
- June 8, 2023: FDA, in co-sponsorship with the Duke-Margolis Center for Health Policy, announced a public workshop entitled, Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches. This workshop will address innovative manufacturing technologies for drug and biological products and will include a discussion of potential best practices, case studies from previous submissions, potential barriers to adoption, corresponding regulatory strategies, and the Advanced Manufacturing Technologies Designation Program.
- June 8, 2023: FDA announced a public meeting of the Antimicrobial Drugs Advisory Committee (AMDAC). The committee will discuss biologics license application (BLA) 761328, for nirsevimab, a long-acting respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody for intramuscular use, submitted by AstraZeneca AB. The proposed indication is prevention of RSV lower respiratory tract disease in infants and young children in their first or second RSV season.
- June 15, 2023: FDA announced a public meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. This discussion will include consideration of the vaccine composition for fall to winter, 2023-2024.
- June 20, 2023: CDC announced a public meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). The agenda will include discussions on: (1) strengthening tuberculosis (TB) public health infrastructure through data modernization; (2) equitable access to TB diagnostics; (3) revisions to the Tuberculosis Technical Instructions for Panel Physicians and Civil Surgeons; and (4) provider education and access to TB diagnostics.
- June 21-23, 2023: CDC announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on Mpox vaccines, influenza vaccines, pneumococcal vaccines, meningococcal vaccines, Polio vaccine, respiratory syncytial virus vaccine pediatric/maternal, respiratory syncytial virus vaccine in older adults, dengue vaccines, Chikungunya vaccine, informational session by CDC Immunization Safety Office, and COVID-19 vaccines. Recommendation votes on influenza vaccines, pneumococcal vaccines, Polio vaccines, and respiratory syncytial virus vaccine in older adults are scheduled. A Vaccines for Children Program (VFC) vote on pneumococcal vaccines is scheduled.
II. Hearings & Markups
- On May 3, 2023, the Senate Committee on Finance held a hearing entitled, Barriers to Mental Health Care: Improving Provider Directory Accuracy to Reduce the Prevalence of Ghost Networks. Witnesses present included: Keris Jän Myrick, Inseparable; Dr. Jack Resneck Jr., MD, American Medical Association (AMA); Dr. Robert L. Trestman, PhD, MD, Carilion Clinic and Virginia Tech Carilion School of Medicine; Mary Giliberti, Mental Health America; and Dr. Jeff Rideout, MD, Integrated Healthcare Association.
- On May 4, 2023, 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 2024 Funding Request and Budget Justification for the National Institutes of Health. Witnesses present included: Dr. Lawrence Tabak, Acting Director, NIH; Dr. Monica Bertagnolli, Director, National Cancer Institute (NCI); Dr. Joshua Gordon, Director, National Institutes of Mental Health (NIMH); Dr. Richard Hodes, Director, National Institute on Aging (NIA); and Dr. Nora Volkow, Director, National Institute on Drug Abuse (NIDA).
- On May 4, 2023, the Senate HELP Committee held a hearing entitled, Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act. Witnesses in panel one included: Dawn O’Connell, Assistant Secretary for Preparedness and Response, Administration for Strategic Preparedness and Response (ASPR), HHS; Dr. Rochelle Walensky, MD, MPH, Director, CDC; and Dr. Robert Califf, MD, Commissioner, FDA. Witnesses in panel two included: Dr. Reshma Ramachandran, MD, MPP, MHS, Assistant Professor of Medicine, Yale School of Medicine; Robert Weissman, President, Public Citizen; and Dr. Martin Makary, MD, MPH, Professor, Johns Hopkins University.
III. Reports, Studies & Analyses
- On May 1, 2023, the Kaiser Family Foundation (KFF) published a blog post entitled, Half of All Eligible Medicare Beneficiaries Are Now Enrolled in Private Medicare Advantage Plans. The authors state that data from the Centers for Medicare & Medicaid Services (CMS) highlights that over 30 million of the nearly 60 million people with both Medicare Part A and Part B were enrolled in a private Medicare Advantage (MA) plan. They note that enrollment has increased dramatically in recent years due to a number of reasons, including: (1) MA plans offer extra benefits such as vision and dental services that traditional Medicare Parts A and B do not; (2) MA plans also provide a “one-stop-shop” for enrollees to receive all of their benefits unlike traditional Medicare where beneficiaries have to enroll separately in Part D for prescription drug coverage or other supplemental benefits. However, the authors note that MA plans also typically use utilization and cost management tools, such as prior authorization, which may affect access to care, value, and equity. They conclude by stating that assessing how well MA serves its beneficiaries will be a growing area of interest for many stakeholders.
- On May 2, 2023, the Government Accountability Office (GAO) published a report entitled, Grants Management: Observations on Challenges with Access, Use, and Oversight. GAO conducted this study to assess the federal grant management system, particularly in light of grants becoming a key tool in funding national priorities and responding to the health and economic crisis resulting from the COVID-19 pandemic. GAO identified four areas of persistent challenges over several decades related to federal grants management: (1) capacity, (2) streamlining, (3) transparency, and (4) internal controls and oversight. Specifically related to capacity, financial and resource issues make it difficult for federal programs and agencies to implement and award grant recipients. Related to streamlining, grant management requirements are often duplicative and burdensome, resulting in programs becoming more expensive to administer. Related to transparency, GAO notes that better public reporting of how grants are spent and ensuring more complete and accurate data would improve government accountability. Finally, GAO noted that federal agencies must improve oversight of programs to ensure grants are being provided, funded, and utilized appropriately.
- On May 2, 2023, authors from the RAND Corporation published a study in the American Journal of Managed Care entitled, Financial Impact of Telehealth: Rural Chief Financial Officer Perspectives. The authors conducted semi-structured interviews with 20 chief financial officers (CFOs) and other hospital administrators from rural hospitals to explore their perceptions of telehealth services on hospital finances. Overall, the interviewees believed that although telehealth had some financial advantages (e.g., reducing patient transfers), it did not improve overall hospital finances. The interviewees noted that despite the lack of financial incentives, the recognition of telehealth’s ability to improve quality of care and access to care drove rural hospitals’ decisions to adopt telehealth. The interviewees reported that limited reimbursement, low patient volume due to preference for in-person care, and insufficient broadband access made it challenging to expand telehealth and ensure telehealth financial viability for their hospitals. The authors conclude that understanding how hospitals consider return on investment and cost-effective implementation strategies can help develop policy solutions to improve the financial attractiveness and sustainability of telehealth.
- On May 3, 2023, the Congressional Research Service (CRS) published a report entitled, Connecting Older Adults and Individuals with Disabilities to Health Services: Resources for Congressional Offices. CRS notes that navigating the U.S. health care and long-term services and supports (LTSS) systems can be particularly difficult for older adults and individuals with disabilities. To simplify access to information about the health care and LTSS systems, many states have developed No Wrong Door (NWD) systems, which are collaborations between the Administration for Community Living (ACL), CMS, and the Veterans Health Administration (VHA), to help families find LTSS options. In this report specifically, CRS details federally funded resources that provide information, outreach, and assistance for congressional offices helping their constituents to access health care and LTSS. For example, Local Aging and Disability Resource Centers (ADRCs), administered by ACL, can help provide counseling and assistance with accessing a wide range of LTSS and caregiver supports. Eldercare Locator is an information and referral service that connects older adults and caregivers with local resources, benefits, and services, including home- and community-based services (HCBS). CMS Care Compare provides information about quality measures for various provider types. These and other services provide a critical support system for older adults and individuals with disabilities to find appropriate and necessary care.
- On May 3, 2023, KFF published a report entitled, State Policy Choices Are Likely to Affect the Extent of Medicaid Enrollment Declines During the Unwinding Period. As of April 1, 2023, states have begun “unwinding” from the continuous Medicaid enrollment provision implemented during the pandemic to prohibit states from disenrolling people from Medicaid coverage during the COVID-19 public health emergency (PHE). Now that the PHE is coming to an end later this month, the authors note that the unwinding will play out differently across states based on policy choices they made and variation in their administrative infrastructures. To understand how states may differ, the authors assessed nine metrics that will support continued Medicaid coverage during the unwinding, such as if the state follows up on returned mail, if the state’s processing of renewals is mostly automated and completed on an ex parte basis, and if the state has adopted Medicaid expansion or 12-month coverage for postpartum women and children. They note that states fall along a spectrum on meeting the nine metrics. For example, Colorado meets all nine metrics, but six states meet fewer than four. Additionally, 42 states do not have fully automated systems that can complete a majority of renewals using ex parte Only 14 states have both expanded Medicaid and adopted 12-month continuous coverage for children and postpartum women. The authors conclude by reiterating that state policy choices and system capacity will play a role in how many people are able to maintain Medicaid or transition to other types of coverage following the end of the PHE.
- On May 4, 2023, the HHS Office of the Inspector General (OIG) published a report entitled, Medicare Improperly Paid Providers for Some Psychotherapy Services, Including Those Provided via Telehealth, During the First Year of the COVID-19 Public Health Emergency. OIG conducted this study to determine if providers met Medicare requirements and guidance when billing for psychotherapy services, including services provided via telehealth. OIG found that for 128 out of 216 sampled enrollee days, providers did not meet Medicare requirements and guidance when billing for psychotherapy services. OIG estimated that of the $1 billion that Medicare paid for psychotherapy services, providers received $580 million in improper payments for services that did not comply with Medicare requirements, consisting of $348 million for telehealth services and $232 million for non-telehealth services. OIG is recommending that CMS: (1) work with Medicare contractors to recoup improper payments; (2) implement system edits for psychotherapy services to prevent payments for incorrectly billed services; and (3) strengthen educational efforts to make providers more aware of requirements and guidance for psychotherapy services.
- On May 4, 2023, GAO published a report entitled, NIH: Better Data Will Improve Understanding of Federal Contributions to Drug Development. This report provides an assessment of: (1) NIH funding for basic research, clinical trials, and biomedical workforce training; (2) reporting of information about NIH-funded clinical trials at ClinicalTrials.gov; and (3) the extent to which NIH support is disclosed in patents arising from research funded by the Agency. GAO found that for FYs 2017 through 2021. NIH obligated $97 billion for basic research, $28 billion for clinical trials and related activities, and $9 billion for biomedical workforce training. The report also found that only about half of NIH-funded clinical trials submitted results on time to the ClinicalTrials.gov public database in calendar years 2019 and 2020 due to insufficient monitoring and enforcement by NIH. GAO also found that NIH awardees failed to consistently disclose NIH support in patents arising from research funded by the Agency. GAO recommended that NIH update its guidance to clarify that awardees should name NIH and include the NIH award number when disclosing the Agency’s support in patent applications.
IV. Other Health Policy News
- On May 1, 2023, CMS announced two investigations of hospitals that were alleged to have not offered necessary stabilizing care to an individual experiencing an emergency medical condition and requiring abortion services, in violation of the Emergency Medical Treatment and Labor Act (EMTALA). In response, HHS Secretary Xavier Becerra released a statement reminding hospitals and providers of their professional and legal requirements to provide care for patients who need emergency care, including abortion care, under EMTALA. Secretary Becerra also sent a letter to hospital and provider associations reminding them of their obligations under EMTALA. More information on this announcement can be found here.
- On May 2, 2023, HHS, through the Office of the Assistant Secretary for Health (OASH) Office on Women’s Health (OWH), announced 15 winners for Phase 1 of the HHS Endocrine-Disrupting Chemicals (EDC) Innovator Award Competition, a competition to identify gaps in knowledge and solutions to improve Black women’s health by reducing their exposure to EDCs (which can be found in food, environment, everyday consumer products, cosmetics, plastics, and more). EDCs are chemicals that may mimic or interfere with the body’s hormones and lead to adverse health complications. HHS recognizes that there are disparities among women affected by EDCs. As such, Phase 1 of the competition awarded programs that provide innovative solutions to addressing gaps in knowledge and to reducing EDC exposure risk for Black women. During Phases 2 and 3 of the competition, HHS will monitor program effectiveness and demonstrate that programs have been successfully replicated or expanded. More information on this announcement can be found here.
- On May 3, 2023, U.S. Surgeon General Dr. Vivek Murthy released a Surgeon General Advisory to bring attention to the public health crisis of loneliness, isolation, and lack of connection among U.S. adults. Loneliness and isolation affect people’s mental, physical, and societal health. Social isolation has been correlated with a 29 percent increased risk of heart disease, a 50 percent increased risk of developing dementia, and a 60 percent increased risk of premature death. People experiencing loneliness are also twice as likely to develop depression than those not. Recognizing the critical need to improve social connection amidst the mental health crisis in the U.S., the Surgeon General released the advisory to announce a framework for a National Strategy to Advance Social Connection. The national strategy is based on six foundational pillars: (1) strengthen social infrastructure (e.g., design parks and libraries); (2) enact pro-connection public policies (e.g., expand accessible public transportation); (3) mobilize the health sector (e.g., educate providers on the importance of screening for risk of loneliness); (4) reform digital environments (e.g., ensure technology does not detract from meaningful connections); (5) deepen knowledge (e.g., outline a robust research agenda to understand and address social isolation); and (6) cultivate a culture of connection (e.g., promote everyday practices to develop relationships). More information on this announcement can be found here.
- On May 5, 2023, HHS announced two new initiatives at the HHS Mental Health Summit aimed at increasing access to mental health resources and support. The two initiatives – FindSupport.gov and the HHS Children and Youth Resilience Challenge – are designed to help connect individuals to the mental health resources they need. The launch of FindSupport.gov is aimed at helping Americans identify available resources, explore information about various treatment options, and learn how to reach out to get the support they need for issues related to mental health, drugs or alcohol. The HHS Children and Youth Resilience Challenge will provide $1 million in funding for innovative community-led solutions to promote resilience in children and adolescents affected by the COVID-19 pandemic and other disasters, and promote positive strategies to help children and adolescents thrive. The Resilience Challenge will include a proposal phase and a pilot phase for selected finalists. Proposals are due Friday, July 7, 2023.More information on this announcement can be found here.
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