Alston & Bird Health Care Week in Review, October 29, 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 White House released the framework for President Joe Biden’s proposed $1.75 trillion tax and spending bill, known as the Build Back Better Act. Read more about this legislation and other news below.

I. Regulations, Notices & Guidance

• On October 26, 2021, the Food and Drug Administration (FDA) issued a proposed order entitled, Exemption of Certain Categories of Biological Products from Certain Reporting Requirements under the Federal Food, Drug, and Cosmetic Act. FDA is proposing to exempt the two categories of biological products from these reporting requirements because the Agency has determined that applying such requirements is not necessary to protect the public health.
• On October 26, 2021, FDA issued a notice of guidance development entitled, Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2022 Proposed Guidance Development. FDA announced the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in fiscal year (FY) 2022.
• On October 27, 2021, the Health Resources and Services Administration (HRSA) issued a notice of guidance entitled, Updated HRSA-supported Women’s Preventive Services Guidelines: Contraception and Screening for HIV Infection. The notice seeks comments on two updated draft recommendations for (1) providing contraception and (2) screening for human immunodeficiency virus (HIV) infection, as part of the HRSA-supported Women’s Preventive Services Guidelines (Guidelines).
• On October 27, 2021, FDA issued a notice entitled, Authorization of Emergency Use of Certain Medical Devices During COVID-19. The notice announces the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products.
• On October 28, 2021, the Department of Health and Human Services (HHS), through FDA, Public Health Service (PHS), Centers for Medicare & Medicaid Services (CMS), Office of the Inspector General (OIG), Office of the Secretary, and Administration for Children and Families (ACF), issued a proposed rule entitled, Securing Updated and Necessary Statutory Evaluations Timely; Proposal to Withdraw or Repeal. The Department of Health and Human Services (HHS or Department) is proposing to withdraw or repeal a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET final rule) and published in the Federal Register of January 19, 2021.
• On October 29, 2021, FDA issued draft guidance entitled, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. This draft guidance addresses the process through which registrants of drug establishments should submit to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• On October 29, 2021, CMS issued a final rule entitled, Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model. This final rule updates the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2022. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rule updates requirements for the ESRD Quality Incentive Program (QIP), including a measure suppression policy for the duration of the coronavirus disease 2019 (COVID-19) public health emergency (PHE) as well as suppression of individual ESRD QIP measures for Payment Year (PY) 2022 under the measure suppression policy. This rule also finalizes that CMS will not score facilities or reduce payment to any facility under the ESRD QIP in PY 2022. Further, this rule finalizes changes to the ESRD Treatment Choices (ETC) Model, which is a mandatory payment model that is focused on encouraging greater use of home dialysis and kidney transplants, to reduce Medicare expenditures while preserving or enhancing the quality of care furnished to Medicare beneficiaries.

Event Notices

• November 16, 2021: FDA announced a virtual public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2023 through 2027. GDUFA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to assess and collect fees to support human generic drug activities. The current legislative authority for GDUFA expires at the end of September 2022.
• November 18, 2021: The Centers for Disease Control and Prevention (CDC) announced a public meeting for 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 (List), and research regarding certain health conditions related to the September 11, 2001, terrorist attacks.
• November 29, 2021: The National Institutes of Health (NIH) announced a public meeting of the National Advisory Environmental Health Sciences Council. The agenda will focus on the Climate Change and Health Initiative.
• November 30, 2021: FDA announced a public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
• December 10, 2021: FDA announced a public advisory committee meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.

II. Congressional Hearings

U.S. House of Representatives

• On October 26, 2021, the House Committee on Energy & Commerce Committee Subcommittee on Health held a legislative hearing entitled, Caring for America: Legislation to Support Patients, Caregivers, and Providers. The following legislation was discussed during the hearing: H.R. 1474, the Alzheimer's Caregiver Support Act; H.R. 1667, the Lorna Breen Health Care Provider Protection Act; H.R. 3297, the Public Health Workforce Loan Repayment Act of 2021; H.R. 3320, the Allied Health Workforce Diversity Act of 2021; H.R. 5583, the Helping Enable Access to Lifesaving Services Act (HEALS Act); H.R. 5594, the Enhancing Community Health Workforce Act; and H.R. 5602, the Bolstering Infectious Outbreaks Preparedness Workforce Act of 2021 (BIO Preparedness Workforce Act of 2021). Witnesses present included: Corey Feist, Founder, Dr. Lorna Breen Foundation; Lisa Macon Harrison, M.P.H., President, National Association of County and City Health Officials (NACCHO); Brooks A. Keel, Ph.D., President, Augusta University; Alan Levine; Executive Chairman, President, and CEO, Ballad Health; Jeanne Marrazzo, M.D., Board Member, Infectious Disease Society of America (IDSA), Infectious Disease Division Chief, University of Alabama at Birmingham; Stephanie Monroe, J.D., Director, Equity and Access, UsAgainstAlzheimer's, Executive Director, AfricanAmericansAgainstAlzheimer's; and Victoria Garcia Wilburn, D.H.Sc., O.T.R., F.A.O.T.A., Assistant Professor, Occupational Therapy, IUPUI School of Health & Human Sciences.
• On October 26, 2021, the House Education & Labor Committee Joint Subcommittee held a hearing entitled, Protecting Lives and Livelihoods: Vaccine Requirements and Employee Accommodations. Witnesses present included: Dr. Sidney Shapiro, Frank U. Fletcher Chair in Administrative Law & Professor of Law, Wake Forest University School of Law; Ms. Richelle Luther, Senior Vice President, Corporate Affairs and Chief Human Resources Officer, Columbia Sportswear Company; Mr. Scott Hecker, Senior Counsel, Seyfarth Shaw LLP; and Dr. Doron Dorfman, Associate Professor of Law, Syracuse University College of Law.

III. Reports, Studies & Analyses

• On October 25, 2021, the Government Accountability Office (GAO) published a report entitled, COVID-19: Federal Agencies' Initial Reentry and Workplace Safety Planning. GAO reviewed federal agencies' plans for workers to reenter the workplace safely. This report (1) examines agencies' approaches to initial reentry planning, (2) assesses the extent to which agencies' workplace safety plans are consistent with federal guidance, and (3) examines the coordination and oversight of federal reentry and workplace safety planning across the government.
• On October 26, 2021, Alston & Bird published the latest edition of Healthy Byte: FTC’s New Policy Statement for Its Health Breach Notification Rule. The Federal Trade Commission (FTC) published a key policy statement in September that announced a broad interpretation of its Health Breach Notification Rule, what constitutes a “breach of security,” and its intentions to enforce the Rule. Sean Sullivan and Andrew Liebler from Alston & Bird discuss what triggers reporting obligations, how the FTC will start enforcing the rule, and who it may affect.
• On October 26, 2021, the Bipartisan Policy Center published a report entitled, Streamlining and Simplifying State HCBS Authorities. This report focuses on streamlining and simplifying states’ Medicaid home and community-based services (HCBS) waiver and state plan authorities into a single state plan amendment (SPA), with the goal of reducing complexity for states administering the programs and for beneficiaries navigating the system. Streamlining and simplifying the program would make services more uniform from state to state and across populations within a state. Ultimately, this change should improve access to services.
• On October 27, 2021, the HHS Office of Inspector General (OIG) published a report entitled, OIG’s Top Unimplemented Recommendations: Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs. This report is an annual publication of the Department of Health and Human Services (HHS), Office of Inspector General (OIG). In this edition, OIG focuses on the top 25 unimplemented recommendations that, in OIG’s view, would most positively affect HHS programs in terms of cost savings, public health and safety, and program effectiveness and efficiency, if implemented.
• On October 27, 2021, GAO published a report entitled, COVID-19:Additional Actions Needed to Improve Accountability and Program Effectiveness of Federal Response. This report found more ways to help the federal government address the pandemic and prepare for future emergencies. Specifically, GAO made 16 new recommendations, including on ways to ensure proper use of relief funds, oversee worker safety and health, and reduce fraud risks.

IV. Other Health Policy News

• On October 22, 2021, CMS issued guidance to states about the statutory requirement for states to cover COVID-19-related treatment without cost-sharing in Medicaid and Children’s Health Insurance Program (CHIP) for many seniors, low-income adults, pregnant women, children, and people with disabilities who receive health coverage through these programs. This life-saving health care coverage, supported through the American Rescue Plan (ARP), includes care for conditions that could complicate the treatment of COVID-19 in patients who are presumed positive for the virus or have been diagnosed with COVID-19. More information about this announcement can be found here.
• On October 25, 2021, HHS announced it is taking several new actions to help reduce costs, make tests more available, and support bringing more tests to market in the U.S. to increase access to COVID-19 testing. The National Institutes of Health (NIH) is investing $70 million from the American Rescue Plan to help bring more high-quality, at-home tests onto the market in the U.S. in coordination with the Food and Drug Administration (FDA). NIH’s new Independent Test Assessment Program (ITAP) will establish an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing. The program is an extension of the NIH Rapid Acceleration of Diagnostics (RADx) initiative. More information about this announcement can be found here.
• On October 25, 2021, HHS announced that consumers can preview 2022 health insurance plans and prices on HealthCare.gov ahead of Marketplace Open Enrollment, which begins on November 1 and runs through January 15. This year, consumers will have more plan choices, and continue to benefit from lower costs thanks to President Biden’s American Rescue Plan (ARP), making it easier to find quality, affordable health care coverage.  In fact, four out of five consumers will be able to find health care coverage for $10 or less per month with the extra savings made available under the ARP. To help consumers take advantage of historically low subsidized premiums, the Biden-Harris Administration is launching one of the largest Open Enrollment outreach campaigns to date. Increased consumer assistance will be available at no cost and consumers will have an additional month to shop with Open Enrollment extended through January 15. More information about this announcement can be found here.
• On October 25, 2021, CMS released a Marketplace 2022 Open Enrollment Fact Sheet to accompany the Marketplace Open Enrollment Period on HealthCare.gov that runs from November 1, 2021 to January 15, 2022. More information about this fact sheet can be found here.
• On October 27, 2021, HHS announced the availability of up to $256 million in grant funding to support equitable, affordable, client-centered, and high-quality family planning services through the Title X family planning program. Title X is the only federal grant program dedicated solely to providing individuals with comprehensive family planning and related preventive health services in communities across the United States. This announcement supplements the recent effort by HHS to restore and strengthen the Title X program through updated rulemaking, effective November 8. Both steps represent the Biden-Harris Administration’s commitment to family planning care nationwide. More information on this announcement can be found here.
• On October 27, 2021, HHS Secretary Xavier Becerra announced the release of the new HHS Overdose Prevention Strategy, designed to increase access to the full range of care and services for individuals who use substances that cause overdose, and their families. This new strategy focuses on the multiple substances involved in overdose and the diverse treatment approaches for substance use disorder. More information about this announcement can be found here.
• On October 28, 2021, after weeks of negotiating with moderate Congressional Democrats, the White House released the framework for President Joe Biden’s tax and spending bill, the Build Back Better Act. According to the framework and associated fact sheet, the White House has settled on a topline spending amount of $1.75 trillion—a significant reduction from the original $3 trillion proposal. Shortly after the framework was announced, the House Committee on Rules released a modified version of the Build Back Better Act legislative text. A complete list of included health provisions can be found in the Rules Committee section-by-section summary of the modified bill.
• On October 29, 2021, FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms). More information about this action can be found here.

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