Alston & Bird Health Care Week in Review, May 6, 2022

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 announced $3 million in funding for the launch of the Maternal Mental Health Hotline and $25 million for school-based health services. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On May 2, 2022, the Food and Drug Administration (FDA) issued draft guidance entitled, Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability. This draft guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage setting.
• On May 2, 2022, the Department of Health and Human Services (HHS) issued a final rule entitled, Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2023. This final rule includes payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs, as well as 2023 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also includes requirements related to guaranteed availability; the offering of QHP standardized plan options through Exchanges on the Federal platform; requirements for agents, brokers, and web-brokers; verification standards related to employer sponsored coverage; Exchange eligibility determinations during a benefit year; special enrollment period verification; cost-sharing requirements; Essential Health Benefits (EHBs); Actuarial Value (AV); QHP issuer quality improvement strategies; accounting for quality improvement activity (QIA) expenses and provider incentives for medical loss ratio (MLR) reporting and rebate calculation purposes; and re-enrollment.
• On May 3, 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 Data and Surveillance Workgroup. The Data and Surveillance Workgroup (DSW) will consist of approximately 15 members who are experts in fields associated with public health science and practice; policy development, analysis, and implementation; and surveillance and informatics.
• On May 3, 2022, CDC issued a notice entitled, Solicitation of Nominations for Appointment to CDC’s Advisory Committee to the Director (ACD) Laboratory Workgroup (LW). The LW will consist of up to 15 members who are experts in the fields of public health laboratory science and practice, laboratory quality management, diagnostic regulations, and laboratory testing and research.
• On May 3, 2022, HHS issued a notice entitled, Solicitation of Nominations for Membership on the National Vaccine Advisory Committee. The National Vaccine Advisory Committee (NVAC) serves an advisory role, providing recommendations to the Assistant Secretary for Health in her capacity as the Director of the National Vaccine Program. NVAC studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States, as well as research priorities and other measures to enhance the safety and efficacy of vaccines.
• On May 4, 2022, FDA issued draft guidance entitled, Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies; Draft Guidance for Industry; Availability. This draft guidance describes FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies, including deciding whether and when to conduct the study, designing the study, and reporting results.
• On May 5, 2022, FDA issued draft guidance entitled, Product-Specific Guidance for Testosterone; Revised Draft Guidance for Industry; Availability. The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for testosterone pellet.
• On May 5, 2022, FDA issued draft guidance entitled, Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary Improvement Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request. FDA is issuing this draft guidance to describe its policy regarding FDA’s participation in the Voluntary Improvement Program (VIP). The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals and is intended to guide improvement to enhance the quality of devices. The VIP builds on the framework piloted through FDA’s 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) and incorporates some of the successes and learnings from the pilot.
• On May 5, 2022, FDA issued final guidance entitled, Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus; Guidance for Industry and Food and Drug Administration Staff; Availability. This guidance provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus. These medical devices are intended to therapeutically reduce glycated hemoglobin in Type 2 Diabetes Mellitus patients independent of medication (e.g., insulin) delivery.
• On May 5, 2022, FDA issued a final rule entitled, Medical Devices; General and Plastic Surgery Devices; Classification of the Mountable Electromechanical Surgical System for Transluminal Approaches. FDA is classifying the mountable electromechanical surgical system for transluminal approaches into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the mountable electromechanical surgical system for transluminal approaches’ classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device.
• On May 5, 2022, FDA issued a final rule entitled, Medical Devices; Gastroenterology-Urology Devices; Classification of the Magnetically Maneuvered Capsule Endoscopy System. FDA is classifying the magnetically maneuvered capsule endoscopy system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the magnetically maneuvered capsule endoscopy system’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device.
• On May 5, 2022, FDA issued a final rule entitled, Medical Devices; Cardiovascular Devices; Classification of the Reverse Central Venous Recanalization System. FDA is classifying the reverse central venous recanalization system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the reverse central venous recanalization system’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device.
• On May 5, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, National Advisory Council for Healthcare Research and Quality: Request for Nominations for Members. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and works within HHS and with other partners to make sure that the evidence is understood and used. Seven new members will be appointed to replace seven current members whose terms will expire in November 2022.
• On May 6, 2022, AHRQ issued a notice entitled, Solicitation for Nominations for Membership to Serve on Initial Review Group for Scientific Peer Review. The Initial Review Group (IRG) conducts scientific and technical review for health services research grant applications and is comprised of five subcommittees or study sections, each with a particular research focus. AHRQ is seeking nominations for scientific reviewers in specific competency domains to evaluate grant applications.

Event Notices

• May 13, 2022: HHS announced a public meeting of the Office of Global Affairs in preparation for the 75^th World Health Assembly. The agenda includes a discussion of relevant topics that will be discussed at the World Health Assembly.
• May 19, 2022: CDC announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on the use of COVID-19 vaccines. A recommendation vote is scheduled.
• June 2, 2022: CDC announced a public meeting of the Healthcare Infection Control Practices Advisory Committee. The agenda will include updates from the following: the Healthcare Personnel Guideline Workgroup; Isolation Precautions Guideline Workgroup; and Neonatal Intensive Care Unit Workgroup.
• June 7-8, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Advisory Mental Health Council. The agenda includes a presentation of the National Institute of Mental Health (NIMH) Director's Report and discussion of NIMH programs.
• June 7-10, 2022: The Centers for Medicare & Medicaid Services (CMS) announced a series of public meetings for new revisions to the Healthcare Common Procedure Coding System (HCPCS) coding. The agenda will include discussions of CMS’ preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set. The June meetings will also include preliminary Medicare benefit category and payment determinations for codes effective January 1, 2020 to April 1, 2022, continuous glucose monitor and related supplies and accessories coding and payment determinations, and additional items added by CMS to address Medicare benefit category or payment determinations.
• June 8, 2022: FDA announced a public meeting of the Pharmacy Compounding Advisory Committee. The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: ammonium tetrathiomolybdate, enclomiphene citrate, ferric subsulfate, and glutathione.
• June 15, 2022: NIH announced a public meeting of the National Heart, Lung, and Blood Institute. The meeting agenda will include a discussion of program policies and issues.
• June 15-16, 2022: HHS announced a public meeting of the National Vaccine Advisory Committee. The agenda will include presentations on innovation for immunization, vaccine safety, and communication, and surveillance.
• June 17, 2022: FDA announced a public meeting of the Psychopharmacologic Drugs Advisory Committee. The committee will discuss supplemental new drug applications 210793-s008 and 207318-s011, efficacy supplement resubmission for NUPLAZID (pimavanserin) tablets, submitted by Acadia Pharmaceuticals Inc., for the proposed treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis.

II. Congressional Hearings

U.S. Senate

• On May 4, 2022, the Senate Committee on Appropriations Subcommittee on Labor, Health and Humans Services, Education, and Related Agencies held a hearing entitled, A Review of the President’s FY 2023 Funding Request and Budget Justification for the Department of Health and Human. Witnesses present included: The Honorable Xavier Becerra, Secretary, HHS.
• On May 5, 2022, the Senate Committee on Commerce, Science, & Transportation Subcommittee on Consumer Protection, Product Safety, and Data Security held a hearing entitled, Ensuring Fairness and Transparency in the Market for Prescription Drugs. Witnesses present included: David Balto, Antitrust Attorney, David A. Balto Law Offices; Robin Feldman, Professor and Researcher, UC Hastings College of Law; Craig Garthwaite, Professor and Director of the Program on Healthcare, Kellogg School of Management, Northwestern University; and JC Scott, President and CEO, Pharmaceutical Care Management Association.

III. Reports, Studies & Analyses

• On May 3, 2022, the Kaiser Family Foundation (KFF) published a report entitled, An Overview of Medicaid Work Requirements: What Happened Under the Trump and Biden Administrations? KFF’s report details a recent history of Medicaid work requirements, which illustrates the tensions between states, changing presidential administrations, and the courts. This issue brief answers key questions about the history of Medicaid and work requirements, the impacts of Medicaid work requirements, and the current status and future of Medicaid work requirements.
• On May 3, 2022, KFF published a report entitled, PrEP Access in the United States: The Role of Telehealth. This brief provides an overview of the tele-pre-exposure prophylaxis (PrEP) landscape, including how PrEP services (e.g., initial consults, lab work, prescribing, and ongoing monitoring) are provided and factors that facilitate its provision as well as barriers that remain. It is based on in-depth interviews conducted at the end of 2021 with representatives from the major national telehealth companies (those serving all or large portions of the U.S.) providing tele-PrEP and other select tele-PrEP programs. KFF also highlights two-state run programs – California and Iowa – and four community-based clinics that offer tele-PrEP programs. Collectively, the organizations included in this analysis are estimated to provide tele-PrEP services to over ten thousand clients.
• On May 4, 2022, the Bipartisan Policy Center (BPC) published a report entitled, The Impact of COVID-19 on the Rural Health Care Landscape. BPC conducted a series of interviews over the last year with rural hospital leaders from eight states—Iowa, Minnesota, Montana, Nebraska, Nevada, North Dakota, South Dakota, and Wyoming—as well as with health policy experts from federal and state government, national organizations, provider organizations, and academia. The goal was to gain on-the-ground insights into today’s rural health care landscape, where the population is older, sicker, and less likely to be insured or seek preventive services than in urban areas.

IV. Other Health Policy New

• On May 3, 2022, HHS announced nearly $25 million to improve and strengthen access to school-based health services in communities across the country. Awards will support local partnerships between schools and health centers to provide children and youth the comprehensive physical and mental health care they need. Health centers will use this funding to reduce disparities and improve access to care by increasing the number of young people receiving essential health care, including mental health services. Health centers will also use these funds for activities such as community and patient outreach, health education, and translation support. More information on this funding can be found here.
• On May 4, 2022, HHS announced $55 million in funding for its Tribal Opioid Response (TOR) grant program. This program reflects HHS’ commitment to evidence-based programs addressing opioid and stimulant misuse in tribal communities, as well as the Biden-Harris Administration’s Unity Agenda item of combatting addiction. The TOR grant program addresses the overdose crisis in tribal communities by increasing access to FDA-approved medications for the treatment of opioid misuse, and supporting prevention, harm reduction, treatment, and recovery support services for opioid and stimulant misuse and co-occurring mental and substance use conditions. Funding will be provided each year for up to 150 grantees over a two-year project period, beginning late FY 2022. More information about this funding can be found here.
• On May 6, 2022, the Health Resources and Services Administration (HRSA) announced the launch of the Maternal Mental Health Hotline, a new, confidential, toll-free hotline for expecting and new moms experiencing mental health challenges. With an initial $3 million investment, the hotline will launch on Mother’s Day, May 8, 2022, with counselors available to provide mental health support. President Biden’s Fiscal Year 2023 Budget would more than double this initial investment, allowing HRSA to expand the Maternal Mental Health Hotline’s expert staffing and build additional capacity in its future phases. Those who contact the hotline can receive a range of support, including brief interventions from trained counselors who are culturally and trauma-informed, as well as referrals to both community-based and telehealth providers as needed. Callers also will receive evidence-based information and referrals to support groups and other community resources. More information on this action can be found here.

Click here to view the members of our Health Care Legislative & Public Policy team.