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, President Biden signed into law the Consolidated Appropriations Act, 2022 and the Senate HELP Committee advanced the PREVENT Pandemics Act. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On March 14, 2022, the Food and Drug Administration (FDA) issued a notice entitled, Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2022. FDA is announcing the fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA) for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. This notice publishes the OMUFA fee rates for FY 2022.
- On March 14, 2022, the Federal Communications Commission (FCC) issued a proposed rule entitled, Promoting Telehealth in Rural America. FCC seeks comment on revisions to the Rural Health Care Telecommunications (Telecom) Program rules to ensure that rural healthcare providers receive funding necessary to access the broadband and telecommunications services necessary to provide vital healthcare services; proposes to modify the applicability of the internal funding cap on upfront costs and multi-year commitments in the Rural Health Care Healthcare Connect Fund Program, proposes to streamline the invoice process in the Telecom Program, and seeks comment on ways to further increase the speed of funding commitments.
- On March 15, 2022, FDA issued a draft guidance entitled, Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Draft Guidance for Industry. The draft guidance document is intended to assist sponsors, including industry and academic sponsors, developing Chimeric Antigen Receptor (CAR) T cell products. The draft guidance includes CAR T cell-specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design.
- On March 15, 2022, FDA issued a draft guidance entitled, Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry. The draft guidance document provides recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. Specifically, the guidance provides recommendations regarding information that should be provided in an investigational new drug (IND) application in order to assess the safety and quality of the investigational GE product, including information on product design, product manufacturing, product testing, preclinical safety assessment, and clinical trial design.
- On March 15, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicaid Program; Final FY 2018, Final FY 2019, Preliminary FY 2020, and Preliminary FY 2021 Disproportionate Share Hospital Allotments, and Final FY 2018, Final FY 2019, Preliminary FY 2020, and Preliminary FY 2021 Institutions for Mental Diseases Disproportionate Share Hospital Limits. This notice announces the final Federal share (FS) disproportionate share hospital (DSH) allotments for FY 2018 and FY 2019, and the preliminary FS DSH allotments for FY 2020 and FY 2021. This notice also announces the final FY 2018 and FY 2019 and the preliminary FY 2020 and FY 2021 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FY DSH allotments.
- On March 16, 2022, the Department of Health and Human Services (HHS) issued a final rule entitled, Annual Civil Monetary Penalties Inflation Adjustment. HHS is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalty amounts in its regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015; adding references to new penalty authorities; and making technical changes to correct errors in the regulation.
- On March 16, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Public Health Reassessment and Immediate Termination of Order Suspending the Right to Introduce Certain Persons from Countries Where a Quarantinable Communicable Disease Exists with Respect to Unaccompanied Noncitizen Children. CDC is hereby terminating the Order Suspending the Right to Introduce Certain Persons from Countries Where a Quarantinable Communicable Disease Exists, issued on August 2, 2021, and all related prior orders issued pursuant to the authorities in sections 362 and 365 of the Public Health Service (PHS) Act and the implementing regulation, to the extent they apply to Unaccompanied Noncitizen Children (UC).
- On March 17, 2022, FDA issued a request for comments entitled, Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange; Request for Comments. FDA is requesting comment on the draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange for the electronic submission of PQ/CMC data. This document provides draft design of Health Level 7 (HL7) Fast Health Interoperability Resources (FHIR) profiles that contain the data elements and terminologies associated with PQ/CMC subject areas and scoped to some of what is currently submitted in Module 3 of the electronic Common Technical Document (eCTD) submission. Specifically, FDA is seeking comment on the mapping of the PQ/CMC data elements to the various FHIR Resources.
- On March 17, 2022, the Administration for Community Living (ACL) issued a proposed rule entitled, National Institute on Disability, Independent Living, and Rehabilitation Research. ACL is proposing to amend its regulations for the National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR). These minor amendments to NIDILRR's peer review criteria will allow NIDILRR to better evaluate the extent to which grant applicants conduct outreach to and hire people with disabilities and people from other groups that traditionally have been underserved and underrepresented, and emphasize the need for engineering research and development activities within NIDILRR's Rehabilitation Engineering Research Centers (RERC) program.
- March 28-29, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Cancer Institute Board of Scientific Advisors. The agenda will include the Director's Report; RFA, RFP, and PAR Concept Reviews; and Scientific Presentations.
- March 31, 2022: The Agency for Healthcare Research and Quality (AHRQ) announced a public meeting to discuss implementation of the Common Formats with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the Common Formats electronically.
- April 6, 2022: The Department of Veterans Affairs (VA) announced a public meeting of the Special Medical Advisory Group. The purpose of the Group is to advise the VA Secretary and the Under Secretary for Health on the care and treatment of Veterans, and other matters pertinent to the Veterans Health Administration. The agenda will include discussions on Center for Care and Payment Innovation, H.R. National Green Alert Act of 2021, reinventing training and research at VA facilities, and VA's quality of care priorities, national leadership role and the post-pandemic way ahead.
- April 11, 2022: CDC announced a public meeting of the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC). The agenda will include an update on the Traumatic Brain Injury (TBI) Research Priorities; Older Adult Falls Research Priorities; the Diversity, Equity, Belonging, Inclusion and Accessibility (DEBIA) Strategic Plan; and Health Equity.
- April 13, 2022: CDC announced a public meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, CMS, and FDA. In addition to the general updates, an update will be provided on the ongoing CLIAC workgroups. Presentations and CLIAC discussion will focus on the future of laboratory medicine, especially testing in nontraditional sites. There will be an extended public comment session focusing on anticipated changes in testing practices, personnel issues, and emerging technologies used in nontraditional testing sites.
- April 13-14, 2022: NIH announced a public meeting of the National Institute of Mental Health (NIMH) Interagency Autism Coordinating Committee. The purpose of the IACC meeting is to discuss business, agency updates, and issues related to autism spectrum disorder (ASD) research and services activities.
- April 20, 2022: CDC announced a public meeting of the Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee for Dose Reconstruction Reviews (SDRR), National Institute for Occupational Safety and Health (NIOSH). The agenda will include discussions on the following dose reconstruction program quality management and assurance activities: Dose reconstruction cases under review from Set 30, possibly including cases involving the Hanford site and discussion of changes in SDRR selection criteria based on SC&A document, Summary Dose Reconstruction Information, dated December 20, 2021.
- April 20, 2022: CDC announced a public meeting of the Board of Scientific Counselors (BSC), NIOSH. The agenda addresses the evolving national landscape for respiratory protection and occupational robotics research.
- April 27, 2022: CDC announced a public meeting of the Advisory Board on Radiation and Worker Health (ABRWH), NIOSH. The agenda will include discussions on the following: NIOSH Program Update; Department of Labor Program Update; Department of Energy Program Update; Special Exposure Cohort (SEC) Petitions Update; Procedures Review Finalization/Document Approvals; Update on Review of SEC-00253 Petition Evaluation Report for Reduction Pilot Plant; Update on Review of SEC-00188 Sandia Petition Addendum 2; Subcommittee on Dose Reconstruction Reviews Update; and a Board Work Session.
- April 27-28, 2022: CDC announced a public meeting of the CDC and Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). The agenda will include discussions on 1) Leveraging policy to advance HIV, STI, and viral hepatitis priorities; 2) Providing comprehensive STI services; 3) Syndemic approaches to HIV, viral hepatitis, and STI prevention; and 4) Self-testing and self-sample collection.
- May 12, 2022: CDC announced a public meeting of the Lead Exposure and Prevention Advisory Committee (LEPAC). The agenda will include updates on the Flint Lead Registry and lead-related activities from LEPAC Members; information on lead exposure in Clarksburg, West Virginia; and discussions on the following: infrastructure initiatives related to lead; lead in air, soil, and blood; navigating multiple funding streams at the local level; and policy approaches to improve childhood blood lead testing rates.
- May 18-19, 2022: NIH announced a public meeting of the National Institute of Neurological Disorders and Stroke (NINDS) National Advisory Neurological Disorders and Stroke Council. The agenda will include a Report by the Director, NINDS; Report by the Director, Division of Extramural Activities; Administrative and Program Developments; and Overview of the NINDS Intramural Program.
- May 24-25, 2022: NIH announced a public meeting of the National Institute on Aging Board of Scientific Counselors. The agenda will include a Committee discussion, individual presentations, and laboratory overview.
II. Congressional Hearings
- On March 15, 2022, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held an execution session to markup S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act). Following member discussion, the Committee voted in favor of eight amendments to S. 3799. S. 3799, as amended, was ordered favorably reported to the Senate.
- On March 16, 2022, the Senate Committee on Finance held a hearing entitled, Prescription Drug Price Inflation: An Urgent Need to Lower Drug Prices in Medicare. Witnesses present included: Rena M. Conti, Ph.D., Associate Professor, Department Of Markets, Public Policy And Law, Questrom School Of Business, Boston University; Douglas Holtz-Eakin, Ph.D., President, American Action Forum; Stephen Ezell, Vice President, Global Innovation Policy, Information Technology and Innovation Foundation; and Steffany Stern, M.P.P., Vice President, Advocacy, National Multiple Sclerosis Society.
U.S. House of Representatives
- On March 17, 2022, the House Committee on Energy and Commerce held a hearing entitled, The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight. Legislation discussed during the hearing included: R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021; H.R. 3085, the Equity in Neuroscience and Alzheimer's Clinical Trials Act of 2021(ENACT Act of 2021); H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act (MADE in America Act); H.R. 4472, the Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021 (BENEFIT Act of 2021); H.R. 4511, the FDA Advancing Collection of Transformative Science Act (FACTS Act); H.R. 5030, the Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act (DIVERSE Trials Act); H.R. 5566, the Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2021 (FORWARD Act of 2021); H.R. 5585, the Advanced Research Project Agency–Health Act (ARPA-H Act); H.R. 6000, the Cures 2.0 Act; H.R. 6584, the Diverse and Equitable Participation in Clinical Trials Act (DEPICT Act); H.R. 6888, the Helping Experts Accelerate Rare Treatments Act of 2022; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6972, the Give Kids a Chance Act; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 6988, the Drug Manufacturing Innovation Act; H.R. 6996, the Accelerating Access for Patients Act; H.R. 7006, the Improving the Nation's Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act (INSPECTIONS Act); H.R. 7008, the Pre-Approval Information Exchange Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act; and H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. Witnesses present included: Jeff Allen, Ph.D., President and CEO, Friends of Cancer Research; Cartier Esham, Ph.D., Chief Scientific Officer and Executive Vice President, Emerging Companies, Biotechnology Innovation Organization; David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, Association for Accessible Medicines; Ruben Mesa, M.D., Executive Director, Mays Cancer Center, UT Health San Antonio MD Anderson; Reshma Ramachandran, M.D., Chair, Doctors for America FDA Task Force and Physician-Fellow, Yale National Clinician Scholars Program, Yale School of Medicine; and Lucy Vereshchagina, Ph.D., Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America.
III. Reports, Studies & Analyses
- On March 15, 2022, HHS Office of Inspector General (OIG) published a report entitled, At A Glance: Medicaid Fraud Control Units Fiscal Year 2021 Annual Report. Medicaid Fraud Control Units (MFCUs) investigate and prosecute Medicaid provider fraud and patient abuse or neglect. OIG is the designated Federal agency that oversees and annually approves Federal funding for MFCUs through a recertification process. For this report, OIG analyzed the annual statistical data on case outcomes—such as convictions, civil settlements and judgments, and recoveries—that the 53 MFCUs submitted for fiscal year 2021.
- On March 15, 2022, the Government Accountability Office (GAO) published a report entitled, Trends Affecting Government and Society. GAO publishes a strategic plan every 4 years to guide its work as GAO helps lawmakers oversee federal operations. The latest plan includes 12 papers on trends that will likely affect government and society in the next 5 to 15 years—including science and technology in an innovation economy, global supply chains, racial and ethnic disparities, and national security threats. The strategic plan also includes GAO's key efforts (near-term priorities for informing Congress on important issues).
- On March 17, 2022, HHS OIG published a report entitled, Telehealth Was Critical for Providing Services to Medicare Beneficiaries During the First Year of the COVID-19 Pandemic. This data brief provides insight into the use of telehealth in both Medicare fee-for-service and Medicare Advantage during the first year of the COVID-19 pandemic, from March 2020 through February 2021. It is a companion to a report that examines the characteristics of beneficiaries who used telehealth during the pandemic. Another report in this series identifies program integrity concerns related to telehealth during the pandemic. Understanding the use of telehealth during the first year of the pandemic can shed light on how the temporary expansion of telehealth affected where and how beneficiaries accessed their health care. This information can help CMS, Congress, and other stakeholders make decisions about how telehealth can be best used to meet the needs of beneficiaries in the future.
- On March 17, 2022, GAO published a report entitled, Emergency Relief Funds: Significant Improvements Are Needed to Ensure Transparency and Accountability for COVID-19 and Beyond. When reviewing the federal government's response to the COVID-19 pandemic, GAO found that agencies had significant shortcomings in their application of fundamental internal controls and financial and fraud risk management practices. Such shortcomings—stemming in part from the need to distribute funds quickly—were exacerbated by existing financial management weaknesses. As a result, billions of dollars were at risk for improper payments, including those from fraud, providing limited assurance that programs effectively met their objectives. GAO identified actions Congress should take to improve monitoring of federal spending and ensure that, in future emergencies, agencies can act quickly with proper safeguards in place.
- On March 17, 2022, Alston & Bird published the latest edition of Healthy Byte entitled, Re-Imagining Health: Live from HIMSS22 in Orlando. In this edition, Alston & Bird's Jane Lucas, Elinor Hiller, and Sean Sullivan review the major topics of the Healthcare Information and Management Systems Society's 2022 conference, including interoperability, information blocking, telehealth reimbursement, and cybersecurity.
- On March 18, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, Nursing Facility Staffing Shortages During the COVID-19 Pandemic. KFF's analysis presents the most recent national and state-level data on nursing facility-reported staff shortages and describes the Biden Administration's new policy initiatives to address staffing and other quality issues in nursing facilities. National staff shortage trend data spans from May 2020, the first month when nursing facilities were required to report COVID-19 facility data to the CDC, through February 27, 2022.
IV. Other Health Policy News
- On March 14, 2022, HHS announced that a study published in the American Medical Association's journal JAMA Pediatrics exit disclaimer icon reports significant increases in the number of children diagnosed with mental health conditions. The study, conducted by HRSA, finds that between 2016 and 2020, the number of children ages 3-17 years diagnosed with anxiety grew by 29 percent and those with depression by 27 percent. The findings also suggest concerning changes in child and family well-being after the onset of the COVID-19 pandemic. More information on this study can be found here.
- On March 15, 2022, President Joe Biden signed into law H.R. 2471, the Consolidated Appropriations Act, 2022. This bill provides full-year funding through September 30, 2022 for projects and activities of the Federal Government. More information on this action can be found here.
- On March 15, 2022, HHS announced that the Substance Abuse and Mental Health Services Administration (SAMHSA) is announcing two grant programs totaling $25.6 million that will expand access to medication-assisted treatment for opioid use disorder and prevent the misuse of prescription drugs. By reducing barriers to accessing the most effective, evidenced-based treatments, this funding reflects the priorities of HHS' Overdose Prevention Strategy, as well as its new initiative to strengthen the nation's mental health and crisis care systems. More information on this funding can be found here.
- On March 17, 2022, the White House announced initial steps for the Biden Administration's reignited Cancer Moonshot. On February 2, 2022, President Biden reignited the Cancer Moonshot with renewed White House leadership and new ambitious goals: to reduce the death rate from cancer by at least 50 percent over the next 25 years, and improve the experience of people and their families living with and surviving cancer — and, by doing this and more, end cancer as people know it. On March 16, 2022, the President and First Lady Jill Biden joined a Cancer Cabinet meeting that included senior White House officials and leadership from across federal departments and agencies of the Biden-Harris Administration. The group further defined priorities for the Cancer Moonshot agenda for 2022 and beyond, with a focus on what the Cancer Cabinet agencies can accomplish through new programs and collaborations. More information on this announcement can be found here.
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