Alston & Bird Health Care Week in Review, September 3, 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 Centers for Medicare & Medicaid Services (CMS) issued Medicaid and CHIP guidance for coverage of COVID-19 vaccination and testing. Read more about this guidance and other news below. 

I. Regulations, Notices & Guidance

• On August 30, 2021, the Centers for Disease Control and Prevention (CDC) issued guidance entitled, Updating CDC’s Contraception Guidance Documents: U.S. Medical Eligibility Criteria for Contraceptive Use and U.S. Selected Practice Recommendations for Contraceptive Use. On August 19, 2021 CDC published a notice to obtain comment. Two guidance documents, S. Medical Eligibility Criteria for Contraceptive Use (US MEC) and U.S. Selected Practice Recommendations for Contraceptive Use (US SPR), provide evidence-based recommendations to assist health care providers when counseling patients on contraceptive choice and use. The notice did not include the mailing address to submit public comment. This notice provides the mailing address for the public.

• On August 30, 2021, the Food and Drug Administration (FDA) issued a notice entitled, Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19. FDA is announcing the revocation of the Emergency Use Authorization (EUA) issued to Curative Inc. for the Curative SARS-Cov-2 Assay. FDA revoked the EUA on July 15, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by Curative Inc. on June 16, 2021.

• On August 30, 2021, FDA issued a notice entitled, Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19. FDA is announcing the revocation of 15 EUAs, including 12 EUAs for decontamination systems for personal protective equipment, 1 EUA for a bioburden reduction system for personal protective equipment, and 2 umbrella EUAs for certain imported, non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators. FDA revoked the EUAs for the decontamination and bioburden reduction systems for personal protective equipment on June 30, 2021, under the FD&C Act as requested by each EUA holder. FDA revoked the umbrella EUAs issued to manufacturers and other stakeholders of imported nonNIOSH approved filtering facepiece respirators manufactured in China (China FFR Authorization), and to manufacturers and other stakeholders of imported non-NIOSH approved filtering facepiece respirators (Imports FFR Authorization) on June 30, 2021, under the FD&C Act.

• On September 1, 2021, the Drug Enforcement Administration (DEA) issued a proposed rule entitled, Schedules of Controlled Substances: Placement of Methiopropamine in Schedule I. DEA proposes placing N-methyl-1- (thiophen-2-yl)propan-2-amine (methiopropamine), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act.

• On September 2, 2021, the Office of Personnel Management (OPM) issued an interim final rule entitled, Access to Federal Employees Health Benefits (FEHB) for Employees of Certain Tribally Controlled Schools. The interim final rule expands eligibility for enrollment in the Federal Employees Health Benefits (FEHB) Program to additional tribal employees. The Consolidated Appropriations Act, 2021 (FY21 CAA) amended section 409 of the Indian Health Care Improvement Act and expanded entitlement to Indian tribes or tribal organizations carrying out programs under the Tribally Controlled Schools Act of 1988 (TCSA) to purchase coverage, rights, and benefits under the FEHB Program for their employees.

• On September 3, 2021, FDA issued a technical amendment to its final rule entitled, Revision to Restrictions on Shipment or Use for Human Blood and Blood Components Exceptions. FDA is amending the biologics regulation to improve clarity and revise an incorrect citation.

• On September 3, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare and Medicaid Programs; Adjustment of Civil Monetary Penalties for Inflation; Continuation of Effectiveness and Extension of Timeline for Publication of the Final Rule. This document announces the continuation of, effectiveness of, and the extension of the timeline for publication of a final rule. CMS issues this document in accordance with the Social Security Act, which allows an interim final rule to remain in effect after the expiration of the timeline specified in the Act if the Secretary publishes a notice of continuation explaining why CMS did not comply with the regular publication timeline.

Event Notices

• September 13-14, 2021: The National Institutes of Health (NIH) announced a virtual public meeting of the National Human Genome Research Institute’s National Advisory Council for Human Genome Research. The meeting will include a report from the Institute Director and program staff, and a review and evaluation of grant applications.
• September 14-15, 2021: The Department of Health and Human Services (HHS) announced a virtual public meeting of the National Vaccine Advisory Committee (NVAC). During this NVAC meeting, NVAC will hear presentations on vaccine safety, vaccine development, and communication activities.
• September 17, 2021: FDA announced a virtual public meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.
• September 17, 2021: FDA issued a meeting correction for the notice of the meeting of the Pediatric Advisory Committee. The document was published with the incorrect docket number and end time of the meeting. This document corrects those errors.
• September 17, 2021: FDA announced a virtual public meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.
• September 20-22, 2021: The Department of Veterans Affairs (VA) announced a virtual public meeting of the Veterans’ Rural Health Advisory Committee. The purpose of the Committee is to advise the Secretary of Veterans Affairs on rural health care issues affecting Veterans. The agenda will include updates from Department leadership, the Executive Director Office of the VA Office of Rural Health, and the Committee Chair; as well as presentations by subject-matter experts on general rural health care access.
• September 23, 2021: HHS announced a virtual public meeting of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). The committee will discuss and vote on recommendations to improve the supply chain and data infrastructure that supports the blood industry, especially during public health emergencies. This meeting will build upon the presentations and discussions held during the 53rd ACBTSA meeting from August 17 – 18, 2021.
• September 23-24, 2021: NIH announced a virtual public meeting of the National Center for Advancing Translational Sciences Advisory Council. The Council will review and evaluate grant applications; hear a report from the Institute Director and other staff; and view and discuss Clearance of Concepts.
• September 28, 2021: CDC announced a virtual public meeting of the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC). The purpose of the WTCHP STAC is to review scientific and medical evidence and to make recommendations to the Administrator of the World Trade Center (WTC) Health Program regarding additional WTC Health Program eligibility criteria, potential additions to the List of WTC-Related Health Conditions, and research regarding certain health conditions related to the September 11, 2001, terrorist attacks.
• September 30, 2021: HHS announced a virtual public meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to present and vote on the final recommendations for mitigating inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future.
• October 19-21, 2021: FDA announced a virtual public meeting entitled, “FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers.” The purpose of the public meeting is to engage with stakeholders and invite input on various topics pertaining to the implementation of Core Element 3.1 of the New Era of Smarter Food Safety Blueprint.
• October 28, 2021: FDA announced a virtual public meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
• November 4, 2021: FDA announced a virtual public meeting of the Psychopharmacologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
• Various Dates: HHS announced two virtual public meetings of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The October 6, 2021 public meeting will be held virtually and is dedicated to deliberation and vote of the letter with recommendations from the Immediate Action Subcommittee of the Advisory Council. The November 31, 2021 and December 1, 2021 public meeting will be held virtually and will be dedicated to addressing the current situation regarding antimicrobial resistance as well as to a presentation from the National Academies of Sciences, Engineering, and Medicine on their report, Examining the Long-term Health and Economic Effects of Antimicrobial Resistance in the United States.

II. Congressional Hearings

U.S. Senate

• On August 30, 2021, the Senate Special Committee on Aging field hearing entitled, Eyes, Ears and Teeth: Expanding Medicare to Cover Whole Person Care. Witnesses present included: Joanne Grossi, President, AARP Pennsylvania; Joseph Hollander, CEO, Scranton Primary Health Care Center; Robin Stelly, Statewide Organizer, Pennsylvania Health Access Network (PHAN); and Kelly Ranieli, Executive Director, Volunteers in Medicine (VIM).

III. Reports, Studies & Analyses

• On September 2, 2021, Alston & Bird published a new edition of Healthy Byte, discussing the proposed 2022 Physician Fee Schedule, enacted through the Consolidated Appropriations Act of 2021, which creates opportunities and some new challenges for telehealth.
• On September 3, 2021, the Bipartisan Policy Center (BPC) published a report entitled, Streamlining and Simplifying Medicaid HCBS Part I. In this report, part I of a two-part series, BPC: 1) outlines policy options to streamline and simplify the current system of HCBS waivers and state plan options; and 2) solicits feedback from stakeholders to help inform part II, which will be released in September. Part II will include final recommendations to policymakers on streamlining and simplifying Medicaid HCBS. This report includes a brief overview of existing HCBS waivers and state plan options, followed by draft policy options. The report also includes a set of questions to help guide BPC in the development of final recommendations.

IV. Other Health Policy News

• On August 30, 2021, the Biden-Harris Administration issued Medicaid and Children's Health Insurance Program (CHIP) guidance that provides essential information to states as they navigate the options available to advance COVID-19 vaccination and testing, and the Medicaid program's broader aim of providing much-needed health coverage for millions of eligible individuals. To help states support families and communities and to continue to address health disparities, CMS will provide guidance to states about additional ARP funding for states to promote the importance of COVID-19 vaccination for eligible children and adults enrolled in Medicaid. More information about this guidance can be found here.
• On August 30, 2021, HHS announced it is establishing the Office of Climate Change and Health Equity (OCCHE) in response to President Joe Biden’s Executive Order Tackling the Climate Crisis at Home and Abroad. This is the first office of its kind at the national level to address climate change and health equity. The Office’s mission is to protect vulnerable communities who disproportionately bear the brunt of pollution and climate-driven disasters, such as drought and wildfires, at the expense of public health. More information about this announcement can be found here.
• On August 30, 2021, CMS announced Dr. Ellen Montz as Deputy Administrator and Director of the Center for Consumer Information and Insurance Oversight (CCIIO); Dr. Natalia Chalmers as its first-ever Chief Dental Officer in the Office of the Administrator; and Dara Corrigan as Deputy Administrator and Director of the Center for Program Integrity (CPI). More information about this announcement can be found here.
• On September 1, 2021, Moderna announced it has initiated its submission to FDA for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level. On September 3, 2021, Moderna announced it completed its submission to FDA. More information about the submission can be found here.
• On September 1, 2021, Texas S.B. 8, entitled Relating to abortion, including abortions after detection of an unborn child's heartbeat; authorizing a private civil right of action, became effective. The broad scope of this law has the potential to impact insurers and health plans, nonprofit organizations, health care providers, financial institutions, transportation providers, and more. The law’s full legislative text can be found here.
• On September 3, 2021, the Biden administration unveiled a $65 billion plan to prepare for future pandemics threats. The proposal focuses on protecting the U.S. against potentially catastrophic biological threats, including those that are naturally occurring, accidental, or deliberately set in motion by bad actors. More information about the proposal can be found here.

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