Alston & Bird Health Care Week in Review - March 2021 #2

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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:

On Thursday, President Biden signed the American Rescue Plan Act of 2021 into law. Read more about this legislation and other news below.


I. Regulations, Notices & Guidance

  • On March 9, 2021, the Department of Health and Human Services (HHS) issued a notice that it is extending the comment period for the proposed rule entitled, Proposed Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement. This rule would modify the Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). These modifications address standards that may impede the transition to value-based health care by limiting or discouraging care coordination and case management communications among individuals and covered entities (including hospitals, physicians, and other health care providers, payors, and insurers) or posing other unnecessary burdens. The comment period for the proposed rule, which would end March 22, 2021, is extended to May 6, 2021.
  • On March 9, 2021, HHS, through the Health Resources and Services Administration (HRSA), issued a notice delaying the effective date of the final rule entitled, Implementation of Executive Order on Access to Affordable Life-saving Medications. This final rule implements an Executive Order requiring entities funded under section 330(e) of the Public Health Service Act (PHS Act or the Act), whether by receiving a federal award or a subaward, and that also participate in the 340B Drug Pricing Program (340B Program) must establish practices to provide access to insulin and injectable epinephrine to low-income health center patients at the price the health center purchased these two drugs through the 340B Program. The Executive Order supports the improved access to these life-saving medications by low-income individuals who do not have access to affordable insulin and injectable epinephrine due to either lack of insurance or high cost sharing requirements. The effective date for the final rule is proposed to be further delayed until July 20, 2021.
  • On March 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a notice delaying the effective date of the final rule entitled, Coverage of Innovative Technology and Definition of Reasonable and Necessary. This final rule establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). The Medicare Coverage of Innovative Technology (MCIT) pathway will result in four years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within two years thereafter. This rule also implements regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B. The effective date for the final rule is delayed until May 15, 2021.

Event Notices 

  • March 18, 2021: The Agency for Healthcare Research and Quality (AHRQ) announced a public meeting entitled, Meeting of the National Advisory Council for Healthcare Research and Quality. The meeting will begin with an update on AHRQ’s recent accomplishments in Health Systems Research, Practice Improvement, Data and Analytics, and achieving organizational excellence. The agenda will also include a discussion of communication and value of health systems research, an update on PCOR Trust Funds, and a discussion of how AHRQ may advance health equity.
  • March 24-25, 2021: FDA announced a public meeting entitled, Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss biologics license application (BLA) 761130, tanezumab subcutaneous injection, submitted by Pfizer Inc., for the proposed indication of relief of signs and symptoms of moderate to severe osteoarthritis in adult patients for whom use of other analgesics is ineffective or not appropriate.
  • March 26, 2021: The Department of Health and Human Services (HHS) announced a public meeting entitled, Meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to discuss equitable vaccine access and acceptance.
  • March 31, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Center for Substance Abuse Treatment. The agenda will include consideration of minutes from the SAMHSA CSAT NAC meeting of September 22, 2020; an update on CSAT activities; a discussion with SAMHSA leadership; a discussion about the use of technology in prevention and treatment of substance use disorders; and a discussion on rural and frontier communities.
  • April 6, 2021: FDA announced a public meeting entitled, Meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the TransMedics Organ Care System (OCS) Heart, by TransMedics, Inc.
  • April 15, 2021: FDA announced a public meeting entitled, Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. The committee will discuss biologics license application (BLA) 125734 for donislecel (purified allogeneic deceased donor pancreas derived islets of Langerhans). The applicant, CellTrans, Inc., has requested an indication for the “treatment of brittle Type 1 diabetes mellitus (T1D).”
  • May 5, 2021: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on dengue vaccine and rabies vaccines. No recommendation votes are scheduled.

II. Congressional Hearings

U.S. Senate

  • On March 9, 2021, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, Examining Our COVID-19 Response: An Update from the Frontlines. Witnesses present included: Dr. Jerry P. Abraham, MD, MPH, CMQ, Director, Kedren Health Vaccines; Dr. Umair A. Shah, MD, MPH, Secretary of Health, Washington State; Dr. Ashish K. Jha, MD, MPH, Dean, Brown University School of Public Health; and Mary Ann Fuchs, DNP, RN, NEA-BC, FAAN, Vice President of Patient Care and System Chief Nurse Executive, Duke University Health System.

U.S. House of Representatives

  • On March 9, 2021, the House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing entitled, FDA'S Foreign Drug Inspections Program. The Subcommittee heard testimony from Dr. Mary Denigan-Macauley, Director of Health Care, Public Health and Private Markets, at the Government Accountability Office (GAO), regarding improvements that should be made to FDA’s foreign drug inspections.
  • On March 11, 2021, the House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, COVID-19 and the Mental Health and Substance Use Crises. Witnesses present included: Dr. Arthur Evans Jr., CEO and Executive Vice President, American Psychological Association (APA); Mark Stringer, Director, Missouri Department of Mental Health; Dr. Lisa Amaya-Jackson, Co-Director, UCLA-Duke University National Center for Child Traumatic Stress; and Verna Foust, CEO, Red Rock Behavioral Health Sciences.
  • On March 11, 2021, the House Committee on Education and Labor Subcommittee on Workforce Protections held a hearing entitled, Clearing the Air: Science-Based Strategies to Protect Workers from COVID-19 Infections. Witnesses present included: Dr. Linsey Marr, Professor of Civil and Environmental Engineering, Virginia Polytechnic Institute and State University; Ms. Pascaline Muhindura, RN, COVID Progressive Care Unit, Research Medical Center, on behalf of National Nurses United; Mr. Manesh Rath, Partner, Keller and Heckman LLP; and Dr. David Michaels, Professor of Occupational and Environmental Medicine, The George Washington University.

III. Reports, Studies & Analyses

  • On March 9, 2021, the Kaiser Family Foundation (KFF) published a report entitled, Preventive Services Tracker. This tracker presents up-to-date information on the adult preventive services nongrandfathered private plans must cover, by condition, including a summary of the recommendation, the target population, the effective date of coverage, and related federal coverage clarifications.
  • On March 10, 2021, KFF published an issue brief entitled, How are States Addressing Racial Equity in COVID-19 Vaccine Efforts? This brief reviews information available through state websites and publicly available vaccine distribution plans as of February 2021 to provide greater insight into how states are addressing equity through vaccine allocation and distribution strategies, outreach and communications efforts, and data collection and reporting.
  • On March 10, 2021, KFF published an issue brief entitled, Are Health Centers Facilitating Equitable Access to COVID-19 Vaccinations? Community health centers are a national network of safety net primary care providers and are a primary source of care for many low-income populations and people of color. This analysis examines the extent to which early vaccination efforts through community health centers are reaching people of color using data from the federal government’s weekly Health Center COVID-19 Survey. Additionally, this analysis may shed light on the Biden Administration’s recent partnership with health centers to advance equitable access to COVID-19 vaccinations by directly supplying health centers with vaccines.

IV. Other Health Policy News

  • On March 8, 2021, the Biden Administration announced it is investing $250 million to encourage COVID-19 safety and vaccination among underserved populations. The HHS Office of Minority Health (OMH) will offer the funding as health literacy grants to localities, who will partner with community-based organizations, to reach racial and ethnic minority, rural and other vulnerable populations. More information about the announcement can be found here.
  • On March 10, 2021, CMS announced revised guidance to expand indoor visitation in nursing homes, in response to significant reductions in COVID-19 infections and transmission resulting from ongoing infection control practices, and high vaccination rates in the nursing home population following the authorization of COVID-19 vaccines by the FDA’s authorization of COVID-19 vaccines for emergency use. Additional details on the updated guidance can be found here.
  • On March 11, 2021, HHS announced that an additional 700 HRSA-supported health centers will be invited to join the Health Center COVID-19 Vaccine Program. These health centers will have the opportunity to join the program over the next six weeks, increasing the total number of invited health center participants to 950.  More information about the program and this announcement can be found here.
  • On March 11, 2021, President Biden signed the $1.9 trillion American Rescue Plan Act of 2021 into law. The bill provides additional relief to address the continued impact of the COVID-19 pandemic on the economy, public health, State and local governments, individuals, and businesses. The bill’s provisions are heavily focused on additional dollars for state and local pandemic aid, funding for vaccines, testing, contact tracing, sequencing, and public health workforce development. The package also provides premium subsidies for COBRA, the Affordable Care Act (ACA) exchange, and clarifies Medicaid’s coverage for the vaccine. In bill also provides $8.5 billion in rural provider relief and $3.5 billion in funding for mental health and substance use disorder assistance. A section-by-section summary of the bill can be found here. An overview of key health provisions can be found here.
  • On March 12, 2021, HHS announced that it has used its authority under the Public Readiness and Emergency Preparedness Act (PREP Act) to add additional categories of qualified people authorized to prescribe, dispense, and administer COVID-19 vaccines authorized by the FDA, including dentists, EMTs, midwives, optometrists, paramedics, physician assistants, podiatrists, respiratory therapists, and veterinarians. This action also authorizes medical students, nursing students, and other health care students in the professions listed under the PREP Act with proper training and professional supervision to serve as vaccinators. More information about this action can be found here.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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