Alston & Bird Health Care Week in Review, October 8, 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, HHS issued a rule to strengthen the Title X family planning program while CMS released 2022 Star Ratings for Medicare Advantage and Medicare Part D prescription drug plans. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On October 4, 2021, the Food and Drug Administration (FDA) issued a final rule entitled, Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports. FDA is issuing this final rule to provide additional information on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (SE Reports). The final rule also establishes the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report. The final rule will provide applicants with more certainty and clarity related to preparing and submitting SE Reports.
• On October 4, 2021, FDA issued a final rule entitled, Medical Device De Novo Classification Process. This final rule establishes procedures and criteria related to requests for De Novo classification (“De Novo request”) and provides a pathway to obtain marketing authorization as a class I or class II device and for certain combination products. The final rule implements the De Novo classification process under the FD&C Act, as enacted by the FDA Modernization Act of 1997 (FDAMA) and modified by the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act).
• On October 4, 2021, FDA issued a final rule entitled, Premarket Tobacco Product Applications and Recordkeeping Requirements. The final rule sets forth requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule codifies the general procedures FDA will follow when evaluating PMTAs and creates postmarket reporting requirements for applicants that receive marketing granted orders. The rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.
• October 4, 2021, FDA issued draft guidance entitled, S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonisation. The draft guidance expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline. The draft guidance is intended to offer an integrative approach that provides specific weight of evidence (WoE) criteria that inform whether or not a 2- year rat study adds value in completing a human carcinogenicity risk assessment. The Addendum also adds a plasma exposure ratio-based approach for setting the high dose in the rasH2-Tg mouse model, while all other aspects of the recommendations for high dose selection in S1C(R2) Guideline would still apply.
• On October 5, 2021, the Department of Health and Human Services (HHS) issued a final rule entitled, Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services. The effect of this 2021 final rule is to revoke the requirements of the 2019 regulations, including removing restrictions on nondirective options counseling and referrals for abortion services and eliminating requirements for strict physical and financial separation between abortion-related activities and Title X project activities, thereby reversing the negative public health consequences of the 2019 regulations. OPA also makes several revisions to the 2000 regulations to increase access to equitable, affordable, client-centered, quality family planning services.
• On October 5, 2021, HHS issued a noticed entitled, Request for Comments on the Draft Department Strategic Plan for FY 2022 – 2026. This document articulates how the Department will achieve its mission through five strategic goals. These five strategic goals are (1) Protect and Strengthen Equitable Access to High Quality and Affordable Health Care, (2) Safeguard and Improve National and Global Health Conditions and Outcomes, (3) Strengthen Social Well-being, Equity, and Economic Resilience, (4) Restore Trust and Accelerate Advancements in Science and Research for All, and (5) Advance Strategic Management to Build Trust, Transparency, and Accountability.
• On October 5, 2021, the Administration for Children and Families (ACF) issued a final rule entitled, Flexibility for Head Start Designation Renewals in Certain Emergencies. This rule adopts as final the provision to the Head Start Program Performance Standards (HSPPS) to establish parameters by which ACF may make designation renewal determinations during a federally declared major disaster, emergency, or public health emergency (PHE) and in the absence of all normally required data.
• On October 6, 2021, FDA issued revised draft guidance entitled, Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act. This revised draft guidance, when finalized, will describe how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to human drug products compounded by State-licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system.
• On October 7, 2021, FDA issued final guidance entitled, Surgical Staplers and Staples for Internal Use--Labeling Recommendations. FDA is issuing this guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths.
• On October 7, 2021, FDA issued a final rule entitled, General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers. The order will reclassify surgical staplers for internal use (formerly regulated under the classification for “manual surgical instrument for general use” and assigned the product code GAG) from class I (general controls) into class II (special controls) and subject to premarket review. As part of this reclassification, FDA is also amending the existing classification for “manual surgical instrument for general use” to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use.

Event Notices

• October 14-15, 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.
• October 25-27, 2021: The Health Resources and Services Administration (HRSA) announced a virtual public meeting of the National Advisory Committee on Rural Health and Human Services (NACRHHS). NACRHHS provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning both rural health and rural human services. At this meeting, NACRHHS will discuss Behavioral Health and Primary Care Integration in Rural America and recommendations to the Secretary on designation of a new type of provider, the Rural Emergency Hospital.
• October 28, 2021: The Centers for Disease Control and Prevention (CDC) announced a virtual public meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). The Committee is charged with providing advice and guidance to the Director, Division of Healthcare Quality Promotion (DHQP), the Director, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), the Director, CDC, the Secretary, Health and Human Services regarding 1) the practice of healthcare infection prevention and control; 2) strategies for surveillance, prevention, and control of infections, antimicrobial resistance, and related events in settings where healthcare is provided; and 3) periodic updating of CDC guidelines and other policy statements regarding prevention of healthcare-associated infections and healthcare-related conditions.
• November 2, 2021: The Department of State announced a virtual public meeting of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) Scientific Advisory Board. SAB members will be discussing the COVID-19 pandemic and its impact on people living with or at risk of HIV infection; PEPFAR 2020 and 2021 strategies, plans, programs and performance; PEPFAR 2022 strategic updates and Minimum Program Requirements; and PEPFAR technical updates for 2022.
• November 9, 2021: HRSA announced a virtual public meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). ACHDNC provides advice and recommendations to the Secretary of Health and Human Services on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders.
• November 18, 2021: FDA announced a virtual public meeting entitled, Closer to Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages. The purpose of the public meeting is to discuss the scope of the Closer to Zero action plan as it relates to the impacts of toxic element exposure and nutrition at different crucial developmental stages, including discussion of the key nutrients in food for growth and development, foods commonly consumed by babies and young children, and exposure risks of toxic elements.
• November 19, 2021: FDA Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research, announced a public workshop entitled, “Best Practices for Development and Application of Disease Progression Models.” The purpose of this public workshop is to discuss the best practices for developing disease progression models and their application to support drug development decisions, share experiences and case studies that highlight the opportunities and limitations in the development and application of disease progression models including models for natural history of disease and clinical trial simulations, and discuss the knowledge gaps and research needed to advance the development and use of disease progression models.
• November 19, 2021: CDC announced a virtual public meeting of the Lead Exposure and Prevention Advisory Committee (LEPAC). The agenda will include updates on the blood lead reference value, lead-related activities from Federal LEPAC Members, the 1988 CLIA Amendment, and from Federal environmental justice efforts focused on lead, a discussion of best practices for increasing and enhancing screening in underserved populations, and presentations on mapping efforts to identify populations at higher risk of lead exposure and Lead Safe Cleveland.
• December 2, 2021: HHS/CDC’s Division of Select Agents and Toxins (DSAT) announced a virtual public webinar entitled, Informational Meeting: The Importation of Infectious Biological Agents, Infectious Substances and Vectors, to provide information about import permit regulations for infectious biological agents, infectious substances, and vectors.
• December 7, 2021: The National Institutes of Health (NIH) announced a virtual public meeting of the National Cancer (NCI) Advisory Board and Board of Scientific Advisors. The meeting will review intramural program site visit outcomes and discuss confidential personnel issues; and hear the NCI Director’s report and presentations, and the NCI Board of Scientific Advisors Concepts Review.

II. Congressional Hearings

U.S. Senate

• On October 7, 2021, the Senate Committee on Commerce, Science, and Transportation held a hearing entitled, State of Telehealth: Removing Barriers to Access and Improving Patient Outcomes. Witnesses present included: Sterling N. Ransone, Jr., MD, FAAFP, President, American Academy of Family Physicians; Sanjeev Arora, MD, MACP, FACG, Founder, Project ECHO, Distinguished Professor of Medicine, University of New Mexico; Deanna Larson, President, Avel eCARE; and the Honorable Brendan Carr, Commissioner, Federal Communications Commission.
• On October 7, 2021, the Senate Committee on the Judiciary held an executive business meeting on the nomination of Rahul Gupta, to be Director of National Drug Control Policy, among other business.

III. Reports, Studies & Analyses

• On October 1, 2021, the HHS Office of Inspector General (OIG) published a report entitled, Medicare: Provider Performance and Experiences Under the Merit-Based Incentive Payment System. Under Medicare’s Merit-based Incentive Payment System, doctors and other providers may receive increases or decreases to their Medicare payments based on factors like the cost and quality of care they provide. OIG found that, from 2017-2019, over 90 percent of providers earned a small increase (less than 2 percent) to their Medicare payments.
• On October 5, 2021, HHS OIG published a report entitled, SAMHSA's Oversight Generally Ensured That the Commission on Accreditation of Rehabilitation Facilities Verified That Opioid Treatment Programs Met Federal Opioid Treatment Standards. OIG’s objective was to determine whether the Substance Abuse and Mental Health Services Administration’s (SAMHSA) oversight ensured that: (1) the Commission on Accreditation of Rehabilitation Facilities (CARF) verified that opioid treatment programs (OTPs) met Federal opioid treatment standards and (2) CARF's survey teams met Federal requirements. OIG found that SAMHSA's oversight generally ensured that CARF verified that OTPs met Federal opioid treatment standards.
• On October 8, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, COVID-19 Cases and Deaths by Race/Ethnicity: Current Data and Changes Over Time. Over the course of the COVID-19 pandemic, analyses of federal, state, and local data have shown that people of color have experienced a disproportionate burden of cases and deaths. They have shown particularly large disparities in cases and deaths for Black and American Indian and Alaska Native (AIAN) people and in cases among Hispanic people compared to their White counterparts. However, some of these disparities have narrowed as the pandemic spread throughout the country and social distancing measures have eased. This analysis examines racial disparities in COVID-19 cases and deaths and how they have changed over time.

IV. Other Health Policy News

• On October 5, 2021, HHS issued a report finding that COVID-19 vaccinations may have helped prevent hundreds of thousands of new COVID-19 infections and tens of thousands of deaths among seniors. The study, which was conducted by researchers with HHS's Office of the Assistant Secretary for Planning and Evaluation (ASPE), found that vaccinations were linked to a reduction of approximately 265,000 COVID-19 infections, 107,000 hospitalizations, and 39,000 deaths among Medicare beneficiaries between January and May 2021. More information on this report can be found here.
• On October 5, 2021, HHS announced approximately $2.21 billion in Ryan White HIV/AIDS Program funding for cities, counties, states, and local community-based organizations in fiscal year (FY) 2021. This funding, through HRSA, supports a comprehensive system of HIV primary medical care, medication, and essential support services critical to improving the health outcomes of nearly 560,000 people with HIV in the United States. More information about this funding can be found here.
• On October 7, 2021, HHS released its Climate Adaptation and Resilience Plan to bolster resilience of its operations and assets from the accelerating impacts of climate change. The HHS plan provides a road map for assuring that all parts of the Department address the threats to health and well-being related to climate change for all people in the United States, especially those most vulnerable. The plan also ensures continuity of operations of HHS facilities in the face of extreme weather events and fosters healthy greenhouse gas reduction and resilience efforts in the public health sector and community. More information about this plan can be found here.
• On October 8, 2021, CMS released the 2022 Star Ratings for Medicare Advantage (Medicare Part C) and Medicare Part D prescription drug plans to help people with Medicare compare plans ahead of Medicare Open Enrollment, which kicks off on October 15. Plans are rated on a one-to-five scale, with one star representing poor performance and five stars representing excellent performance. Star Ratings are released annually and reflect the experiences of people enrolled in Medicare Advantage and Part D prescription drug plans. More information about this announcement can be found here.

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