Alston & Bird Health Care Week in Review, September 24, 2021

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, the Food and Drug Administration (FDA) authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine for certain populations. Read more about this authorization and other news below.

I. Regulations, Notices & Guidance

• On September 20, 2021, the Department of Health and Human Services (HHS) and the Department of the Treasury issued a final rule entitled, Patient Protection and Affordable Care Act; Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond. This final rule sets forth revised 2022 user fee rates for issuers offering qualified health plans (QHPs) through federally-facilitated Exchanges and State-based Exchanges on the Federal platform; repeals separate billing requirements related to the collection of separate payments for the portion of QHP premiums attributable to coverage for certain abortion services; expands the annual open enrollment period and Navigator duties; implements a new monthly special enrollment period for qualified individuals or enrollees, or the dependents of a qualified individual or enrollee, who are eligible for advance payments of the premium tax credit (APTC) and whose household income does not exceed 150 percent of the Federal poverty level, available during periods of time during which APTC benefits are available such that certain applicable taxpayers’ applicable percentage is set at zero, such as during tax years 2021 and 2022 under the section 9661 of the American Rescue Plan Act of 2021; repeals the recent establishment of a Direct Enrollment option for Exchanges; and modifies regulations and policies related to section 1332 waivers.
• On September 20, 2021, the Food and Drug Administration (FDA) issued a notice of availability entitled, Final Administrative Orders for Over-the-Counter Monographs. FDA is announcing certain final administrative orders, including for over-the-counter (OTC) drug monographs, that were deemed to be final orders by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which added a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is also announcing the process for making these final orders available. Finally, FDA is announcing its plan for withdrawing regulations that established final OTC drug monographs prior to the passage of the CARES act, and withdrawing or making technical changes to the procedures governing the OTC drug review.
• On September 22, 2021, FDA issued draft guidance entitled, Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products. This guidance is for sponsors, firms, individuals, and establishments that participate in the manufacture of, or perform any aspect of, the donor eligibility determination for animal cells, tissues, and cell- and tissue-based products (ACTPs).
• On September 22, 2021, FDA issued draft guidance entitled, Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products. This guidance provides establishments that manufacture animal cells, tissues, and cell- and tissue-based products (ACTPs) meeting the definition of new animal drugs with recommendations for meeting requirements for current good manufacturing practices (CGMPs).
• On September 23, 2021, FDA issued a notice of availability entitled, Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19. This notice announces the revocation of the Emergency Use Authorizations (EUAs) issued to Gravity Diagnostics, LLC for the Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation of America (DBA MatmaCorp, Inc.) for the MatMaCorp COVID-19 2SF Test, and Guardant Health Inc. for the Guardant-19.
• On September 24, 2021, FDA issued a notice of availability entitled, Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over The Counter Monograph Proposed Order. FDA is issuing this proposed order to amend and revise the deemed final administrative order concerning nonprescription sunscreen drug products established by the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). This proposed order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also sets forth certain characteristics that would establish that a sunscreen drug product is not GRASE.
• On September 24, 2021, the Health Resources and Services Administration (HRSA) issued a notice entitled, Criteria for Determining Maternity Care Health Professional Target Areas. HRSA is authorized by the HHS Secretary to establish the criteria which will be used to determine maternity care health professional target areas (MCTAs) in existing primary care Health Professional Shortage Areas (HPSAs). This notice sets forth the proposed criteria which will be used to identify and score MCTAs.

Event Notices

• October 13, 2021: The National Institutes of Health (NIH) announced a virtual public meeting of the 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.
• October 15, 2021: NIH announced a virtual public meeting of the Clinical Center Research Hospital Board. The meeting will include the CEO Update, Patient Safety and Clinical Quality Update, and discuss other business of the Board.
• October 20-21, 2021: The Centers for Disease Control and Prevention (CDC) announced a virtual public meeting of the Advisory Committee on Immunization Practices (ACIP). The committee is charged with advising the Director, CDC, on the use of immunizing agents. The agenda will include discussions on adult immunization schedule, child/adolescent immunization schedule, Ebola vaccine, hepatitis vaccines, herpes zoster vaccines, Orthopoxviruses vaccine, influenza vaccines, pneumococcal vaccine, cholera vaccine and tickborne encephalitis vaccine.
• October 22, 2021: NIH announced a virtual public meeting of the National Advisory Eye Council of the National Eye Institute. There will be a presentation of the NEI Director’s report and discussion of Data Sharing and Management as well as NEI programs. The meeting will also review and evaluate grant applications.
• October 26, 2021: NIH announced a virtual public meeting of the National Heart, Lung, and Blood Advisory Council. The meeting will discuss program policies and issues and review and evaluate grant applications.
• October 27, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a virtual public meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will address feedback from the ISMICC members regarding the final report to Congress and include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).
• November 2, 2021: FDA announced a virtual public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. The current legislative authority for BsUFA expires in September 2022.
• November 2, 2021: CDC announced a virtual public meeting of the Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR). The Board is charged with providing advice and guidance to the Secretary, Department of Health and Human Services (HHS), the Assistant Secretary for Health (ASH), the Director, Centers for Disease Control and Prevention (CDC), and the Director, Center for Preparedness and Response (CPR), concerning strategies and goals for the programs and research within CPR, monitoring the overall strategic direction and focus of the CPR Divisions and Offices, and administration and oversight of peer review for CPR scientific programs.
• November 3, 2021: The Health Resources and Services Administration (HRSA) announced a virtual public meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. The purpose of CHAC is to advise the Secretary of HHS, the Director of CDC, and the HRSA Administrator regarding objectives, strategies, policies, and priorities for HIV, viral hepatitis, and other STDs; prevention and treatment efforts, including surveillance of HIV infection, viral hepatitis, and other STDs, and related behaviors; epidemiologic, behavioral, health services, and laboratory research on HIV, viral hepatitis, and other STDs; identification of policy issues related to HIV/viral hepatitis/STD professional education, patient health care delivery, and prevention services; agency policies about prevention of HIV, viral hepatitis and other STDs; treatment, health care delivery, and research and training; strategic issues influencing the ability of CDC and HRSA to fulfill their missions of providing prevention and treatment services; programmatic efforts to prevent and treat HIV, viral hepatitis, and other STDs; and support to the CDC and HRSA in their development of responses to emerging health needs related to HIV, viral hepatitis, and other STDs.
• November 3, 2021: CDC announced a virtual public meeting of the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH) for the National Institute for Occupational Safety and Health (NIOSH). The Advisory Board is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) advise the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class.
• November 8, 2021: NIH announced a virtual public meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). The topic for this meeting will be “Evolving Concepts in the Assessment and Management of Hypoglycemia.”
• December 2, 2021: FDA announced a virtual public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
• December 8, 2021: FDA announced a virtual public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
• December 14-15, 2021: CMS announced a virtual public Town Hall Meeting to discuss fiscal year (FY) 2023 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS).

II. Congressional Hearings

U.S. Senate

• On September 22, 2021, the Senate Committee on Finance held a hearing entitled, Hearing to Consider the Nominations of Christi A. Grimm, of Colorado, to be Inspector General, Department of Health and Human Services and Neil Harvey MacBride, of Virginia, to be General Counsel for the Department of the Treasury. Witnesses present included Christi A. Grimm, United States Department of Health and Human Services; and Neil Harvey MacBride, United States Department of the Treasury.

U.S. House of Representatives

• On September 22, 2021, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Putting Kids First: Addressing COVID-19’s Impacts on Children. Witnesses present included: Lee Savio Beers, M.D., F.A.A.P., President, American Academy of Pediatrics (AAP); Margaret G. Rush, M.D., President, Monroe Carell Jr. Children's Hospital at Vanderbilt; Arthur Evans, Jr., Ph.D., Chief Executive Officer, American Psychological Association (APA); Kelly Danielpour, Founder, VaxTeen; and Tracy Beth Hoeg, M.D., Ph.D., Epidemiologist and Public Health Expert, Physical Medicine and Rehabilitation Research Associate, University of California, Davis, and Private Practice Physician.
• On September 22, 2021, the House Select Subcommittee on the Coronavirus Crisis hearing entitled, Recognizing and Building on the Success of Pandemic Relief Programs. Witnesses present included: Indivar Dutta-Gupta, Co-Executive Director, Georgetown Center on Poverty & Inequality, on behalf of Georgetown University Law Center; Douglas Holtz-Eakin, President, American Action Forum; H. Luke Shaefer, Professor of Social Justice and Social Policy, Associate Dean for Research and Policy Engagement, Gerald R. Ford School of Public Policy, on behalf of University of Michigan; Diane Whitmore Schanzenbach, Professor of Human Development and Social Policy, Director, Institute for Policy Research, on behalf of Northwestern University; and Starsky Wilson President, Children's Defense Fund.

III. Reports, Studies & Analyses

• On September 20, 2021, the Government Accountability Office (GAO) published a report entitled, Electronic Health Records: DOD Has Made Progress in Implementing a New System, but Challenges Persist. GAO's objectives were to (1) determine what progress the Department of Defense (DOD) has made toward implementing a new electronic health record system, and (2) identify the challenges and key risks to MHS GENESIS implementation and what steps DOD is taking to address them.
• On September 20, 2021, the HHS Office of Inspector General (OIG) published a report entitled, Opportunities Exist To Strengthen Evaluation and Oversight of Telehealth for Behavioral Health in Medicaid. This data brief provides insight into State evaluations and oversight of telehealth for behavioral health services as of January and February 2020, before the expansion of telehealth due to the COVID-19 pandemic. As States consider making telehealth expansions permanent, States can use information in this data brief to help determine which services best support enrollees. This data brief is a companion report to a data brief that describes the challenges States reported with using telehealth to provide behavioral health services to Medicaid enrollees.
• On September 21, 2021, GAO published a report entitled, Supplemental Security Income: SSA Faces Ongoing Challenges with Work Incentives and Improper Payments. Prior and ongoing GAO work has identified issues with the Social Security Administration’s (SSA) efforts to reduce improper payments, including overpayments, to Supplemental Security Income (SSI) beneficiaries in general and beneficiaries who are working in particular. This testimony describes SSA's challenges with (1) incentivizing employment for SSI recipients who wish to work, and (2) preventing improper payments to SSI recipients, including overpayments.
• On September 21, 2021, the Kaiser Family Foundation (KFF) published a report entitled, Dental, Hearing, and Vision Costs and Coverage Among Medicare Beneficiaries in Traditional Medicare and Medicare Advantage. KFF previously analyzed dental coverage, use, and out-of-pocket spending among Medicare beneficiaries and provided an in-depth look at coverage of dental services in Medicare Advantage plans. This brief builds on that prior work by analyzing hearing and vision use, out-of-pocket spending and cost-related barriers to care among beneficiaries in traditional Medicare and Medicare Advantage, incorporating top-level findings from our analysis of dental services to provide a comprehensive profile of dental, hearing, and vision benefits in Medicare Advantage plans.
• On September 23, 2021, GAO published a report entitled, Health Care Capsule: Racial and Ethnic Health Disparities. The "capsule" draws from several GAO reports to provide examples of these health disparities, such as COVID-19, maternal mortality, chronic health conditions, as well as disparities among veterans. GAO also offers policy considerations to help the federal government better understand health disparities and promote health equity.

IV. Other Health Policy News

• On September 17, 2021, HHS announced that beginning this year, consumers will have an extra 30 days to review and choose health plans through Open Enrollment, which will run from November 1, 2021 through January 15, 2022, on HealthCare.gov. The Centers for Medicare & Medicaid Services (CMS) is also expanding services provided by Federally-facilitated Marketplace (FFM) Navigators and will re-launch its “Champions for Coverage” program. The program currently includes more than 1,000 local organizations that are active in providing outreach and education about the Health Insurance Marketplace and how consumers can enroll in coverage through HealthCare.gov, Medicaid, or the Children’s Health Insurance Program (CHIP). More information on this announcement can be found here.
• On September 17, 2021, HHS announced nearly $350 million in awards to every state across the nation to support safe pregnancies and healthy babies. Funding will expand home visiting services to families most in need, increase access to doulas, address health disparities in infant deaths, and improve data reporting on maternal mortality. The Health Resources and Services Administration (HRSA) awarded these funds. More information on this announcement can be found here.
• On September 17, 2021, HHS Secretary Xavier Becerra announced new resources and actions to protect reproductive health care for Texans, in response to President Joe Biden’s directive. Following the passage of SB 8, President Biden launched a whole-of-government response and directed HHS to explore options to bolster access to safe and legal abortions in Texas. Secretary Becerra is announcing measures HHS will take, including grant support for clinics, and resources that outline protections for health care personnel, and reinforcement of legal protections for pregnant individuals or persons experiencing pregnancy loss in Texas. More information on this announcement can be found here.
• On September 21, 2021, CMS awarded $15 million in planning grants to 20 states to support expanding community-based mobile crisis intervention services for Medicaid beneficiaries. The planning grants—funded by the ARP—provide financial resources for state Medicaid agencies to assess community needs and develop programs to bring crisis intervention services directly to individuals who are experiencing a substance use-related or mental health crisis outside a hospital or facility setting. These grants will help states integrate community-based mobile crisis intervention services into their Medicaid programs, a critical component of establishing a sustainable and public health-focused crisis support network. More information on this announcement can be found here.
• On September 21, 2021, CMS made it easier to check COVID-19 vaccination rates for nursing home staff and residents with a new feature on Medicare.gov. It made vaccination data available in a user-friendly format to help people make informed decisions when choosing a nursing home for themselves or a loved one. CMS and CDC are also continuing to use this data to monitor vaccine uptake among residents and staff and to identify facilities that may need additional resources or assistance to respond to the pandemic. More information about this announcement can be found here.
• On September 22, 2021, FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in: individuals 65 years of age and older; individuals 18 through 64 years of age at high risk of severe COVID-19; and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. More information on this announcement can be found here.
• On September 22, 2021, HHS Office of the National Coordinator for Health Information Technology (ONC) awarded $73 million in cooperative agreements as part of its Public Health Informatics & Technology Workforce Development Program (PHIT Workforce Program). Announced earlier this year and funded through the American Rescue Plan, the program aims to strengthen U.S. public health information technology (IT) efforts, improve COVID-19 data collection, and increase representation of underrepresented communities within the public health IT workforce. ONC will support the overall administration of the program. More information about this announcement can be found here.
• On September 24, 2021, CMS announced that following FDA’s recent action that authorized a booster dose of the Pfizer COVID-19 vaccine for certain high-risk populations and a recommendation from CDC, CMS will continue to provide coverage for this critical protection from the virus, including booster doses, without cost sharing. Beneficiaries with Medicare pay nothing for COVID-19 vaccines or their administration, and there is no applicable copayment, coinsurance or deductible. In addition, thanks to the American Rescue Plan Act of 2021 (ARP), nearly all Medicaid and CHIP beneficiaries must receive coverage of COVID-19 vaccines and their administration, without cost-sharing. COVID-19 vaccines and their administration, including boosters, will also be covered without cost-sharing for eligible consumers of most issuers of health insurance in the commercial market. More information about this announcement can be found here.

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