Alston & Bird Health Care Week in Review - February 2022 #3

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare 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, CMS issued a RFI on Access to Care and Coverage in Medicaid and CHIP, and HRSA awarded $55 million to increase health care access through virtual care. Read more about these announcements and other news below.

I. Regulations, Notices & Guidance

• On February 14, 2022, the Food and Drug Administration (FDA) issued a notice entitled, International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Brorphine; Metonitazene; Eutylone; Request for Comments. FDA is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States’ position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2022.
• On February 15, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, 60-Day Report to Congress on Domestic Content Procurement Preferences Applicable to Federal Financial Assistance. The Infrastructure Investment and Jobs Act (IIJA) requires Federal awarding agencies to identify and report to Congress each Federal financial assistance program for infrastructure administered by the Federal awarding agency. The following report provides HHS’s initial analysis of its programs and the Build America, Buy America requirements.
• On February 16, 2022, HHS issued a final rule entitled, Privacy Act; Implementation. HHS is issuing this final rule to make effective the exemptions that were previously proposed for a subset of records covered in a new Privacy Act system of records, No. 09-25-0165, NIH Loan Repayment Records, which is maintained by the National Institutes of Health (NIH). The system of records covers records used to manage and evaluate the Loan Repayment Programs (LRPs) at NIH. The exemptions are necessary to maintain the integrity of the NIH peer review and award processes by enabling NIH to protect the identities of reviewers.
• On February 17, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a notice of request for information entitled, Request for Information: AHRQ’s Proposed Patient-Centered Outcomes Research Trust Fund Strategic Framework. AHRQ is seeking input from the public on its proposed strategic framework for AHRQ’s Patient-Centered Outcomes Research Trust Fund investments.
• On February 17, 2022, FDA issued a notice entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs).
• On February 17, 2022, FDA issued a final order entitled, Medical Devices; Ophthalmic Devices; Classification of the Electromechanical Tear Stimulator. FDA is classifying the electromechanical tear stimulator 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 electromechanical tear stimulator’s classification.
• On February 17, 2022, FDA issued a final order entitled, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Integrated Continuous Glucose Monitoring System. FDA is classifying the integrated continuous glucose monitoring 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 integrated continuous glucose monitoring system’s classification.
• On February 17, 2022, FDA issued a final order entitled, Medical Devices; Cardiovascular Devices; Classification of the Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access. FDA is classifying the percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access 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 percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access’ classification.

Event Notices

• February 24, 2022: The National Institutes of Health (NIH) issued an amended notice of meeting of the Frederick National Laboratory Advisory Committee to the National Cancer Institute. This notice is being amended to change the meeting end time.
• February 28, 2022: NIH announced a public meeting of the Office of the Director National Science Advisory Board for Biosecurity. The National Science Advisory Board for Biosecurity meeting will include a review of the charge to the committee and discussion of next steps for the committee.
• March 2, 2022: FDA announced a public advisory committee meeting of the Device Good Manufacturing Practice Advisory Committee. The committee reviews regulations proposed for promulgation regarding good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices, and makes recommendations to the Commissioner of Food and Drugs regarding the feasibility and reasonableness of those proposed regulations.
• March 9, 2022: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Prevention (CSAP) Drug Testing Advisory Board (DTAB). The board will meet to discuss the Mandatory Guidelines for Federal Workplace Drug Testing Programs with updates from the Department of Transportation, the Nuclear Regulatory Commission and the Food and Drug Administration. Other discussion topics include a presentation on the Drug-Free Workplace Program Summit meeting scheduled for May 2022, NLCP drug testing results, and synthetic urines and adulteration.
• March 10, 2022: FDA announced a public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.
• March 10-11, 2022: HHS announced a public meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on issues and topics pertaining to or associated with the protection of human research subjects.
• March 14-15, 2022: HHS announced a public meeting of the Presidential Advisory Council on HIV/AIDS. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective HIV diagnosis, treatment, prevention, and quality care services. There will be an interactive community engagement session during the first day of the meeting. Additionally, there will be a public comment session during the meeting; pre-registration is required to provide public comment.
• March 15, 2022: SAMHSA announced a public meeting of the Center for Substance Abuse Prevention National Advisory Council (CSAP NAC). The Council was established to advise the Secretary, HHS; the Assistant Secretary for Mental Health and Substance Use, SAMHSA; and Director, CSAP concerning matters relating to the activities carried out by and through the Center and the policies respecting such activities. The meeting will be open to the public and will consist of discussions of substance use prevention priorities, including the prevailing Institute of Medicine model, as well as agency practices regarding innovation and evaluation of programs. The meeting will also include updates on CSAP program developments.
• March 28, 2022: NIH announced a public meeting of the Center for Scientific Review (CSR) Advisory Council. The meeting agenda will include discussion to provide advice to the Director on matters related to planning, execution, conduct, support, review, evaluation, and receipt and referral of grant applications at CSR.
• March 30, 2022: FDA announced a public advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
• May 9-10, 2022: FDA announced a public workshop entitled, FY 2022 Generic Drug Science and Research Initiatives Workshop. The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.
• May 13, 2022: NIH announced a public meeting of the National Center for Complementary & Integrative Health (NCCIH) National Advisory Council for Complementary and Integrative Health. The meeting agenda will include remarks by the NCCIH Director and other staff presentations.
• Various Dates: The Federal Emergency Management Agency (FEMA) announced several public meetings to implement the Pandemic Response Voluntary Agreement under Section 708 of the Defense Production Act. FEMA is holding meetings under the Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Personal Protective Equipment (PPE) to Respond to COVID-19 and the Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Diagnostic Test Kits and other Testing Components to Respond to COVID-19, in order to implement the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic.

II. Congressional Hearings

U.S. Senate

• On February 15, 2022, the Senate Committee on Health, Education, Labor & Pensions (HELP) held a hearing entitled, Supporting Quality Workforce Development Opportunities and Innovation to Address Barriers to Employment. Witnesses present included: Ms. Melinda Mack, Executive Director, New York Association of Training and Employment Professionals; Ms. Ashli Watts, President & CEO, Kentucky Chamber of Commerce; Mr. Peter Beard, Senior Vice President for Regional Workforce Development, Greater Houston Partnership; and Ms. Nicole Sherard-Freeman, Group Executive, Jobs, Economy & Detroit at Work.
• On February 15, 2022, the Senate Committee on Finance held a hearing entitled, Protecting Youth Mental Health: Part II - Identifying and Addressing Barriers to Care. Witnesses present included: Tami D. Benton, MD, FAACAP, FAAP, Psychiatrist-In-Chief, Executive Director and Chair, Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children’s Hospital of Philadelphia; Sharon Hoover, Ph.D., Professor, Division of Child and Adolescent Psychiatry; Co-Director of The National Center for School Mental Health, University of Maryland School of Medicine; Jodie L. Lubarsky, MA, LCMHC, Vice President of Clinical Operations, Youth and Family Services, Seacoast Mental Health Center; and Trace Terrell, Lead Intervention and Outreach Specialist, YouthLine.

U.S. House of Representatives

• On February 17, 2022, the House Committee on Energy & Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Americans in Need: Responding to the National Mental Health Crisis. Witnesses present included: Lisa Fortuna, M.D., M.P.H., American Psychiatric Association Member and Vice-Chair of Psychiatry, University of California San Francisco; Jacqueline Nesi, Ph.D., Assistant Professor of Psychiatry and Human Behavior, Brown University; Amit Paley, M.B.A., CEO and Executive Director, The Trevor Project; Christopher Thomas, Co-Founder, The Defensive Line; and the Hon. Elinore McCance-Katz, Ph.D., M.D., Former Assistant Secretary for Mental Health and Substance Abuse.
• On February 17, 2022, the House Committee on Education & Labor Subcommittee on Health, Employment, Labor, & Pensions (HELP) held a hearing entitled, Exploring Pathways to Affordable, Universal Health Coverage. Witnesses present included: The Honorable Robert B. Reich, Chancellors Professor of Public Policy, University of California at Berkeley; Georges C. Benjamin, MD, Executive Director, American Public Health Association; Brian Blase, Ph.D., President, Paragon Health Institute; and Katie Keith, JD, MPH, Visiting Professor and Director of the Health Policy and the Law Initiative, O'Neill Institute for National & Global Health Law, Georgetown University Law Center.

III. Reports, Studies & Analyses

• On February 14, 2022, the Government Accountability Office (GAO) published a report entitled, Trafficking: Use of Online Marketplaces and Virtual Currencies in Drug and Human Trafficking. This report examines what is known about drug and human traffickers' use of online marketplaces and virtual currencies, efforts by federal and state agencies to counter such trafficking, and benefits and challenges virtual currencies pose for detecting and prosecuting drug and human trafficking, among other objectives.
• On February 16, 2022, the HHS Office of Inspector General (OIG) published a report entitled, Medicare Payments of $6.6 Billion to Nonhospice Providers Over 10 Years for Items and Services Provided to Hospice Beneficiaries Suggest the Need for Increased Oversight. In three prior reports, HHS OIG made several recommendations to the Centers for Medicare & Medicaid Services (CMS) to establish oversight and scrutiny of Medicare nonhospice payments. Implementing the recommendations from those reports and considering the information in this data brief may help CMS further evaluate the need to potentially restructure the hospice payment system to reduce duplicate payments for items and services that should be included in the hospice per diem payment. The information in this data brief may also help CMS determine whether the hospice benefit is operating consistent with its longstanding position that services unrelated to a hospice beneficiary's terminal illness and related conditions should be exceptional, unusual, and rare given the comprehensive nature of the services covered under the Medicare hospice benefit.
• On February 17, 2022, GAO published a report entitled, Biodefense: Opportunities to Address National Strategy and Programmatic Challenges. The 2018 National Biodefense Strategy outlines how the U.S. can prepare for and respond to biological threats, such as COVID-19. The pandemic highlighted shortcomings in federal response efforts. For example, federal agencies had problems managing information—like inconsistent federal guidance and lack of transparency about available supplies in the strategic national stockpile. GAO testified on its work evaluating federal agencies' biodefense efforts and preparedness, as well as challenges with acquiring biodetection technologies. Of the 29 recommendations that GAO made in prior reports to address these issues, 25 remain open.
• On February 17, 2022, the Kaiser Family Foundation (KFF) published a report entitled, Medicaid Coverage of Family Planning Benefits: Findings from a 2021 State Survey. To obtain information about state Medicaid family planning coverage policies for adults, KFF and Health Management Associates (HMA) conducted a survey of state Medicaid agencies regarding coverage of sexual and reproductive health care services. This report presents survey findings from the states that responded (41 states and District of Columbia) about coverage policies for fee-for-service Medicaid in place as of July 1, 2021, for the following categories of family planning benefits: prescription contraceptives, over-the-counter methods, STI and HIV services, well woman care, breast and cervical cancer services, and managed care services.
• On February 17, 2022, KFF published an issue brief entitled, Nursing Home Staff Vaccination Rates Vary Widely by State as Vaccination Mandates Take Effect. This data note presents completed vaccination and booster rates among nursing home staff, by state. This analysis does not categorize states or facilities by compliance since deadlines for all states have not passed and facility-level data is lagged. This analysis presents data on completed vaccinations at the state-level rather than at the facility-level, though this policy will be enforced at the facility-level. Future analyses will evaluate the share of facilities in each state in compliance with the rule once compliance deadlines for both doses have passed.

IV. Other Health Policy News

• On February 14, 2022, HHS, through the Health Resources and Services Administration (HRSA), awarded nearly $55 million to 29 HRSA-funded health centers to increase health care access and quality for underserved populations through virtual care such as telehealth, remote patient monitoring, digital patient tools, and health information technology platforms. This funding builds on over $7.3 billion in American Rescue Plan funding invested in community health centers over the past year to help mitigate the impact of COVID-19. More information on this funding can be found here.
• On February 17, 2022, as part of the Biden-Harris Administration’s work to advance health equity and reduce health disparities, CMS is seeking feedback on topics related to health care access, such as enrolling in and maintaining coverage, accessing health care services and supports, and ensuring adequate provider payment rates to encourage provider availability and quality. This Request for Information (RFI) is one of many actions CMS is taking to develop a more comprehensive access strategy in its Medicaid and CHIP programs. Feedback obtained from the RFI will aid in CMS’ understanding of enrollees’ barriers to enrolling in and maintaining coverage and accessing needed health care services and support through Medicaid and CHIP. This information will help inform future polices, monitoring, and regulatory actions and CMS’ work to ensure timely access to critical services, such as behavioral health care and home and community-based services. More information on this RFI can be found here.
• On February 17, 2022, HHS Secretary Xavier Becerra released a statement welcoming Dr. Robert M. Califf back to HHS as commissioner of the Food and Drug Administration. Dr. Califf is a prominent cardiologist with extensive clinical research experience who was confirmed on a bipartisan basis. He previously served as commissioner of the agency during the last year of the Obama-Biden Administration. Prior to that, he served as the agency’s deputy commissioner of medical products and tobacco. Dr. Califf began work right after he was sworn in. More information on this statement can be found here.

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