Health Care Week in Review: FDA Issued a Final Rule to Make Hearing Aids Available Over-the-Counter

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, FDA issued a final rule to make hearing aids available over-the-counter and the Biden Administration launched a strategy to prepare for future pandemics and biological threats. Read more about this action and other news below.

I. Regulations, Notices & Guidance

• On October 17, 2022, the Food and Drug Administration (FDA) issued final guidance entitled, Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment; Guidance for Industry; Availability. This guidance is intended to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML). This guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs for the development of drugs and biological products to support an indication of treatment of AML, including indications limited to an individual phase of treatment (for example, maintenance, transplantation preparative regimen, etc.). The guidance also addresses the topics of general drug development, efficacy endpoints, and exploratory and confirmatory trial considerations for AML drug development. In addition, the guidance addresses investigational new drug applications (INDAs), new drug applications (NDAs), and biologics licensing applications for AML drugs.
• On October 17, 2022, FDA issued draft guidance entitled, Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials; Draft Guidance for Industry; Availability. This guidance is intended for sponsors of cancer immunotherapeutic drugs that modulate the endogenous immune system and may break immunologic tolerance to normal organs and tissues; it provides recommendations regarding the data that should be collected and evaluated to assess whether adverse events are immune-mediated adverse reactions (imARs) and the data on imARs that should be included in a NDA or biologics license application (BLA) for a cancer immunotherapeutic drug.
• On October 17, 2022, FDA issued draft guidance entitled, Tissue Agnostic Drug Development in Oncology; Draft Guidance for Industry; Availability. For the purpose of this guidance, the term “tissue agnostic oncology drug” refers to a drug that targets a specific molecular alteration(s) (a kind of biomarker) across multiple cancer types as defined, for example by organ, tissue, or tumor type. This draft guidance describes the development of tissue agnostic drugs, scientific considerations in determining when tissue agnostic oncology drug development may be appropriate, and, if appropriate, issues to be addressed during such development. Tissue agnostic drug development may expedite or enable the development of new therapies for patients with rare cancer types.
• On October 17, 2022, FDA issued a final rule entitled Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. FDA is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, FDA defines OTC hearing aids and establish applicable requirements; amends existing rules for consistency with the new OTC category; repeal the conditions for sale applicable to hearing aids; amends the existing labeling requirements for hearing aids; and updates regulations relating to decisions on applications for exemption from federal preemption that will become obsolete as a result of changes to the hearing aid requirements. In creating a regulatory category for OTC hearing aids and amending existing rules, FDA intends to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health. With this rule, adults with mild-to-moderate hearing loss can buy hearing aids at a store or online without a prescription, exam, or audiologist fitting.
• On October 17, 2022, the National Institutes of Health (NIH) issued a notice entitled, Request for Information on Research Opportunities Related to the National Institutes of Health Scientific Workshop on Gender-Affirming Care for Transgender and Gender-Diverse Populations. Through this Request for Information (RFI), the Sexual & Gender Minority Research Office (SGMRO) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), invites feedback from stakeholders throughout the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal NIH stakeholders, and other interested constituents on research opportunities related to the upcoming NIH Scientific Workshop on Gender-Affirming Care for Transgender and Gender-Diverse Populations. Comments are due by November 18, 2022.
• On October 19, 2022, FDA issued a notice entitled, Advancing Real-World Evidence (RWE) Program. The Advancing RWE Program aims to fulfill FDA’s commitment under the seventh iteration of the Prescription Drug User Fee Amendments (PDUFA VII), incorporated as part of the FDA User Fee Reauthorization Act of 2022. This program seeks to identify approaches for generating RWE that meet regulatory requirements in support of labeling for effectiveness (e.g., new indications, populations, dosing information) or for meeting post-approval study requirements. The Advancing RWE Program provides sponsors who are selected into the Program the opportunity to meet with Agency staff--before protocol development or study initiation--to discuss the use of RWE in medical product development. The program will proceed through September 30, 2027.
• On October 19, 2022, FDA issued a notice entitled Complex Innovative Design Paired Meeting Program. PDUFA VII highlights the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. FDA is announcing the continuation of the paired meeting program established under the sixth iteration of PDUFA that affords sponsors, who are selected, the opportunity to meet with Agency staff to discuss the use of complex innovative trial design (CID) approaches in medical product development. Meetings under the program will be conducted by FDA’s Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) during fiscal years 2023 to 2027. For each sponsor whose meeting request is granted, two meetings will be held between the sponsor and CDER or CBER that will provide an opportunity for medical product developers to discuss their CID proposals. To promote innovation in this area, trial designs developed through the paired meeting program may be presented by FDA (e.g., in a guidance or public workshop) as case studies, including trial designs for drugs that have not yet been approved by FDA.
• On October 20, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request on Strategies for Integrating Behavioral Health and Primary Care. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform the agency’s review on Strategies for Integrating Behavioral Health and Primary Care, 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. Submissions are due on or before November 20, 2022.
• On October 20, 2022, FDA issued final guidance entitled, Multiple Endpoints in Clinical Trials; Guidance for Industry; Availability. This final guidance provides sponsors and review staff with the agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. This guidance finalizes the draft guidance of the same title issued on January 13, 2017.
• On October 20, 2022, FDA issued draft guidance entitled, Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. FDA has developed this draft guidance to propose select updates to the guidance that clarifies how the program may be applicable to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or healthcare disparities.
• On October 20, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, Opportunity to Co-Sponsor Office of Research Integrity Events. The Office of Research Integrity (ORI) announces the opportunity for non-federal public and private sector entities to co-sponsor ORI conferences, workshops, symposia, meetings, roundtables, or other such events (collectively, “Events”). ORI co-sponsors a limited number of events with non-federal entities each year. Potential co-sponsors must have demonstrated interest and experience in the responsible conduct of research or handling allegations of research misconduct. Potential co-sponsors must be willing to participate substantively in the co-sponsored event. Expressions of interest for co-sponsorship of an ORI Event may be submitted on an ongoing basis throughout the fiscal year (October 1, 2022 – September 30, 2023) or beyond.
• On October 20, 2022, FDA issued a proposed rule entitled, Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Extension of Comment Period. FDA is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers. FDA is extending the comment period on the proposed rule published on June 28, 2022 until November 25, 2022.
• On October 21, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Solicitation of Nominations for Appointment to the Advisory Committee on Breast Cancer in Young Women (ACBCYW). The ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women. Nominations for membership on the ACBCYW must be received no later than December 29, 2022.
• On October 21, 2022, FDA issued final guidance entitled, Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry; Availability. Neurodegenerative diseases are a heterogeneous group of disorders characterized by progressive degeneration of the structure and function of the central nervous system or peripheral nervous system. The guidance document provides recommendations to sponsors developing human gene therapy (GT) products for neurodegenerative diseases affecting adult and pediatric patients. The guidance focuses on considerations for product development, preclinical testing, and clinical trial design.
• On October 21, 2022, HHS issued a notice entitled, Announcement of Solicitation of Written Comments on Proposed Healthy People 2030. HHS solicits written comments on an additional objective proposed to be added to Healthy People 2030, and written comments from the public proposing additional new core, developmental, or research objectives to be included in Healthy People 2030. HHS will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2030 reflects current public health priorities and public input. The updated set of Healthy People 2030 objectives will be incorporated on https://health.gov/healthypeople. This updated set will reflect further review and deliberation by federal Healthy People topic area workgroups, the Federal Interagency Workgroup on Healthy People 2030, and other federal subject matter experts. Written comments will be accepted through December 2, 2022.

Event Notices

• October 24-25, 2022: HHS announced a public meeting of the Tick-Borne Disease Working Group (TBDWG). The TBDWG will review and vote upon the third and final Report to Congress and the HHS Secretary. The 2022 report will address a wide range of topics related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify advances made in research, as well as overlap and gaps in tick-borne disease research; and provide recommendations regarding any appropriate changes or improvements to such activities and research.
• October 27-28, 2022: NIH announced a partially open meeting of the National Library of Medicine’s (NLM) Literature Selection Technical Review Committee. The agenda will include review and evaluation of journals as potential titles to be indexed by NLM.
• December 8, 2022: FDA announced a public advisory committee meeting of the Blood Products Advisory Committee (BPAC). The committee will meet in open session to hear an overview of the research programs of the Laboratory of Emerging Pathogens and the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER). After the open session, the meeting will be closed to the public for committee deliberations.

II. Reports, Studies & Analyses

• On October 17, 2022, HHS’ Office of Inspector General (OIG) released a report entitled, S. Department of Health and Human Services Met the Requirements of the Digital Accountability and Transparency Act of 2014, With Areas That Require Improvement. OIG assessed whether HHS complied with the reporting requirements under the Digital Accountability and Transparency Act of 2014 (DATA Act). The performance audit assessed the completeness, quality, accuracy, and timeliness of the data transmitted through the HHS submission. Overall, OIG determined that the agency’s data quality earned a rating of excellent and that its data was reliable. OIG also found that HHS established and implemented procedures and other controls to support the completeness and accuracy of the reporting requirements for the DATA Act. OIG recommends that HHS continue to review and update their procedures for data reporting and detect future accuracy issues.
• On October 17, 2022, the Government Accountability Office (GAO) published a report entitled, Public Health Preparedness: HHS Should Address Strategic National Stockpile (SNS) Requirements and Inventory Risks. GAO emphasized that the COVID-19 pandemic underscored the importance of the SNS, a multibillion-dollar inventory of medical countermeasures—medication, supplies, and more—that can be used in emergencies. GAO found that HHS suspended typical procedures for SNS reviews for inventory recommendations during FY 2020-2022 when the agency underwent reorganization. HHS resumed SNS reviews for FY 2023 and 2024, but GAO found that these reviews did not meet most statutory requirements because HHS had not updated their process since statutory changes were mandated in 2019. GAO also found that HHS typically did not include the recommended quantities of SNS materials, which HHS stated was due to budget constraints. Because of the COVID-19 pandemic, HHS also obligated $6.1 billion in COVID-19 relief funds for supplies for the SNS and now contains additional finished pharmaceutical products, such as sedatives for use with ventilators. GAO issued three recommendations for the Assistant Secretary for Preparedness and Response (ASPR) to update procedures for SNS reviews and manage risks associated with inventory gaps.
• On October 17, 2022, GAO released a report entitled, Routine Vaccinations: Adult Rates Vary by Vaccine Type and Other Factors. GAO was asked to review adult vaccination rates, as well as how the federal government and states address coverage of routine vaccines. GAO found vaccination rates among adults for flu, pneumococcal, shingles, and tetanus vaccines varied by vaccine type, state, race and ethnicity, the rate at which adults are screened for vaccination, adults' use of health care services, and the cost of vaccines for certain adults. GAO also found that HHS and states had various programs to help bolster vaccination rates among adults.
• On October 17, 2022, the Congressional Research Service (CRS) published a report entitled, Issues in Law Enforcement Reform: Responding to Mental Health Crises. This report follows policymakers’ interest in improving police response to individuals experiencing a mental health crisis. Policymakers have examined specialized responses employed by various local governments, including crisis intervention teams (CITs), co-responder teams (CRTs), and mobile crisis teams (MCTs). CRS found that employing such tactics improved some aspects of responses between police and people experiencing mental health crises such as officers’ perceptions and stigma. However, these tactics’ impacts on other aspects of interactions, such as fewer arrests, are still unknown. As such, CRS outlines several issues policymakers should consider to improve law enforcement’s response to people experiencing mental health crises, including: (1) helping local governments expand their capacity to provide mental health services, (2) providing funding for preventative interventions, (3) providing funding for law enforcement training, (4) collecting data on police interactions with people experiencing mental health crises, and (5) supporting research on CRTs and MCTs.
• On October 18, 2022, HHS OIG released a report entitled, Home Health Agencies Used Multiple Strategies To Respond to the COVID-19 Pandemic, Although Some Challenges Persist. This report identifies key strategies home health agencies (HHAs) developed to respond to the challenges during the COVID-19 pandemic to help stakeholders prepare for future emergencies. HHAs experienced multiple challenges over the pandemic, including staffing shortages, a lack of personal protective equipment (PPE), and infection control and prevention practices challenges. Strategies HHAs utilized to alleviate challenges included offering benefits to staff (e.g., paid leave), soliciting PPE from nontraditional sources (e.g., nail salons), and regulatory flexibilities (e.g., telehealth). However, OIG notes that HHAs’ challenges with telehealth, including funding and limited reporting, raise questions about the future role of telehealth in HHAs. Finally, OIG also found emergency preparedness plans required by HHS guided HHAs’ response to the pandemic, but the plans fell short of fully addressing a global emergency such as COVID-19.
• On October 19, 2022, GAO published a report entitled, Maternal Health: Availability of Hospital-Based Obstetric Care in Rural Areas. GAO conducted this report to address concerns of recent hospital closures’ effect on access to obstetric care. This report describes: (1) the availability of hospital-based obstetric services in rural areas, (2) stakeholder perspectives on factors that affect such availability, and (3) stakeholder perspectives on efforts federal agencies, states, and others could take to increase such availability. GAO found that more than half of rural counties studied did not have obstetric services in 2018 and that most hospital closures were in rural counties that were sparsely populated, had a majority of Black or African American residents, and were considered low income. Stakeholders GAO interviewed identified low Medicaid reimbursement rates and staffing challenges as the two biggest barriers affecting the availability of obstetric care in rural areas. The stakeholders noted that addressing these two challenges as well as implementing other solutions such as remote telehealth consultations, establishing regional partnerships, financially incentivizing and training providers to practice in rural areas, and reducing the costs of medical liability insurance costs for rural obstetric physicians would also help expand access to rural obstetric care.
• On October 19, 2022, GAO released a report entitled, Maternal Health: Outcomes Worsened and Disparities Persisted During the Pandemic. To understand the effects of COVID-19 on maternal health, GAO examined data from CDC and reviewed documents and interviewed officials at various HHS agencies. GAO’s analysis of CDC data showed that maternal deaths, low birth weights, and rates of self-reported maternal mental illness increased during the COVID-19 pandemic. Specifically, GAO found that COVID-19 was a factor in 25 percent of all maternal deaths in 2020 and 2021. Although White women accounted for the highest number of maternal deaths in 2020 and 2021, the rate of maternal deaths was significantly higher for Black women. Specifically, CDC data also showed the maternal death rate for Black or African American women increased to 68.9 per 100,000 live births in 2020 as compared to 26.1 per 100,000 for White women. GAO noted that the pandemic exacerbated the effects of social determinants of health—such as access to care, transportation, or employment—on maternal health disparities. GAO also identified various efforts from HHS agencies to address maternal health outcomes and disparities during the COVID-19 pandemic.
• On October 19, 2022, Teus Health published a report commissioned by the Alliance for Connected Care entitled, Medicare Telehealth Analysis. The analysis examined Medicare fee-for-service (FFS) claims data from 2019-2021 to understand telehealth utilization as a result of COVID-19 policies and the potential financial impact of long-term telehealth expansion. Specifically, the researchers explored if telehealth utilization increased total volume of Medicare services and if patients who used telehealth visits had more follow-up visits as compared to patients who had in-person visits. The analysis found that: (1) telehealth did not add to the total volume of Medicare services and (2) there is no evidence that patients who initiated care via telehealth rather than in-person visits required more follow-up visits. The analysis also identified provider types who most heavily relied on telehealth (e.g., mental health providers and primary care clinicians) and recommended further exploration of potential variation in revisits by diagnosis category. In conclusion, these findings suggest that telehealth expansion policies over the pandemic have not increased the volume of patient services paid for by Medicare.

III. Other Health Policy News

• On October 18, 2022, the Biden-Harris Administration launched the National Biodefense Strategy and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (the Strategy). The strategy outlines the Biden Administration’s efforts across several federal agencies to prepare for future pandemics and biological threats. Actions include investing in establishing a new fund for pandemic prevention and response at the World Bank; strengthening domestic and global laboratory capacity; investing in technologies to detect and respond to biological weapon use; recruiting and training a critical health infrastructure workforce; supporting vaccine development within 100 days and testing within 12 hours; and directing agencies to prioritize and implement the Strategy in their budgets and practice. The Biden Administration emphasizes the importance of preparing Americans for future disease outbreaks, pandemics, and biological weapon use. More information on the Strategy can be found here.
• On October 18, 2022, HHS, through SAMHSA, announced a new funding opportunity of $15 million authorized under the Bipartisan Safer Communities Act (BSCA), for states to develop and implement Certified Community Behavioral Health Clinics (CCBHCs) to provide crisis services that are available 24/7 to patients regardless of their insurance status. States must first receive a planning grant in 2023 to be eligible to apply for the CCBHC demonstration program in 2024. The purpose of CCBHC Planning Grants is to support states to develop and implement certification systems for CCBHCs, establish Prospective Payment Systems (PPS) for Medicaid reimbursable services, and prepare an application to participate in a four-year CCBHC Demonstration program. 10 states (MI, MO, KY, MN, NV, NJ, NY, OK, OR, and PA) have already been selected to receive one-year planning grants in 2023 from HHS. The other 40 states are eligible to apply for up to 15 awards of up to $1 million each for? the one-year planning, and of the states that submit a successful demonstration application, 10 will be initially selected to be in the actual CCBHC demonstration. More information on this announcement can be found here.
• On October 20, 2022, the U.S. Surgeon General, Dr. Vivek Murthy, released a new framework entitled, Surgeon General’s Framework for Mental Health & Well-Being in the Workplace, to outline the role of workplaces in promoting health and wellbeing of their employees and communities. The COVID-19 pandemic highlighted the important relationships between work and well-being of workers. For example, recent surveys found that 81 percent of workers reported that they will look for workplaces that support their mental health in the future and 84 percent of respondents reported at least one workplace factor had negatively affected their mental health. Dr. Murthy outlined the following five essentials for organizations to develop and implement effective policies and procedures to support their employees’ mental health: (1) protection from harm, (2) connection and community, (3) work-life harmony, (4) mattering at work, and (5) opportunities for growth. More information on this framework can be found here.
• On October 21, 2022, HHS more than $100 million this week in funding from the Bipartisan Safer Communities Act (BSCA) to states and territories for mental health emergency preparedness, crisis response, and the expansion of 988 Suicide & Crisis Lifeline services. The $100 million includes $54 distributed to states and territories through the Community Mental Health Services Block Grant (MHBG) program for mental health emergency preparedness and response and $50 million in supplemental funding to states and territories to expand 988 services. This funding, along with several other efforts of the Biden Administration, aim to address the growing mental health crisis in the U.S. More information on this announcement can be found here.
• On October 21, 2022, CMS announced revisions to the Special Focus Facility (SFF) Program to improve oversight over the poorest-performing nursing facilities. The SFF program identifies the poorest-performing nursing homes and increases their scrutiny to improve the quality of care they deliver. Specifically, CMS will (1) make the requirements to “graduate from the SFF more stringent, (2) terminate participation in federal funding programs for facilities that do not improve, (3) increase the severity of enforcement remedies, (4) extend the monitoring period of enforcement actions to encourage sustainability of facility improvements, and (5) encourage state survey agencies to assess staffing when conducting quality inspections. The enhancements to the program aim to increase accountability of poor-performing nursing homes and improve quality of care and life for all residents. More information on this announcement can be found here.

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