Alston & Bird Health Care Week in Review - January 2021 #3

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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:

This week, President Biden issued a flurry of executive orders and unveiled a national strategy to combat COVID-19. Read more about these actions and other news below.


I. Regulations, Notices & Guidance

  • On January 19, 2021, the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking (NPRM) entitled, Proposed Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement. HHS is issuing this NPRM to 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 proposals in this NPRM address these burdens while continuing to protect the privacy and security of individuals’ protected health information.
  • On January 19, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency. This guidance is intended to alert pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. FDA is aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizers that were manufactured with methanol or methanol-contaminated ethanol. FDA has also received numerous reports of dermal toxicity associated with such products.
  • On January 19, 2021, FDA issued guidance entitled, Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency. FDA is issuing this guidance to provide manufacturers of licensed and investigational cellular therapy and gene therapy (CGT) products with risk-based recommendations to minimize potential transmission of the novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  This guidance is intended to supplement the recommendations to drug and biological product manufacturers provided in FDA’s “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing; Guidance for Industry” issued in June 2020.  The recommendations in this guidance specifically consider the source material (cells and/or tissues) recovered from donors and how the CGT product will be manufactured (e.g., cell expansion in culture, viral reduction steps, formulation).
  • On January 21, 2021, HHS delayed implementation of a final rule entitled, Implementation of Executive Order on Access to Affordable Life-Saving Medications. In accordance with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” this action temporarily delays for 60 days from the date of the memorandum the effective date of the final rule titled “Implementation of Executive Order on Access to Affordable Life-saving Medications,” published in the December 23, 2020, Federal Register. This document announces that the effective date is delayed until March 22, 2021, the first business day after 60 days from the date of the memorandum.

Event Notices

  • January 25, 2021: HHS announced a public meeting entitled, Meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. The Advisory Council will hear presentations on the impact of COVID-19 on people with dementia, health disparities in dementia research, and the implications of new technologies to identify Alzheimer’s disease through a blood tests.
  • January 27, 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 COVID-19 vaccines.
  • February 2, 2021: FDA announced a public meeting entitled, Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.
  • February 2, 2021: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the National Advisory Child Health and Human Development Council. The agenda will include opening remarks, administrative matters, Director’s Report, Division of Extramural Research Report, and other business of the Council.
  • February 4, 2021: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). NVAC will hear presentations on vaccine safety, communication activities for COVID-19 vaccines, and immunization equity.
  • February 10-11, 2021: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria (PACCARB). The February 10-11 public meeting will be dedicated to presentations from two new working groups of the PACCARB, one on Inter-Professional Education and another on Antibiotics Access and Use, which were formed in response to a task letter from the Assistant Secretary for Health. The two-day virtual public meeting will also include an update on the impact of COVID-19 on antimicrobial resistance.
  • February 11, 2021: NIH announced a public meeting entitled, Meeting of the National Cancer Institute President’s Cancer Panel. The purpose of the meeting is to discuss innovation to increase cancer screening.
  • February 11-12, 2021: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. During the meeting, the Advisory Committee will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include a presentation on potential processes for reviewing conditions on the RUSP; potential revisions to the condition nomination form; continuity of operations planning; innovations in long-term follow-up for conditions identified through newborn screening; and workgroup dates.

II. Congressional Hearings

There were no health-related Congressional events this week.

III. Reports, Studies & Analyses

  • On January 20, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Claims Denials and Appeals in ACA Marketplace Plans. This report analyzes transparency data released or updated in 2020 by the Centers for Medicare and Medicaid Services (CMS) to examine claims denials and appeals among issuers offering individual market coverage on HealthCare.gov; data are from plan years 2018 and 2019.  The Affordable Care Act (ACA) requires transparency data reporting by non-grandfathered group health plans and by individual market plans offered on and off the Marketplace.
  • On January 21, 2021, KFF published an issue brief entitled, Analysis of Recent National Trends in Medicaid and CHIP Enrollment. This data note looks at national and state-by-state Medicaid and CHIP preliminary enrollment data through September 2020, as states were still in the early stages of experiencing the health and economic effects of the coronavirus pandemic.
  • On January 21, 2021, the Government Accountability Office (GAO) published a report entitled, Health Care Funding: Federal Obligations to and Funds Received by Certain Organizations Involved in Health-Related Services, 2016 through 2018. GAO reviewed federal funding provided to various organizations, including Federally Qualified Health Centers, Planned Parenthood Federation of America, and International Planned Parenthood Federation. The organizations included in our review provide health-related services, including services related to family planning and sexual and reproductive health. They found that in total, these organizations received almost $16 billion through the HHS or U.S. Agency for International Development grants or cooperative agreements from 2016 through 2018. Federally Qualified Health Centers received nearly all of the funds.
  • On January 21, 2021, GAO published a report entitled, Rural Hospital Closures: Affected Residents Had Reduced Access to Health Care Services. GAO was asked to examine the effects of rural hospital closures on residents living in the areas of the hospitals that closed. This report examines, among other objectives, how closures affected the distance for residents to access health care services, as well as changes in the availability of health care providers in counties with and without closures.
  • On January 22, 2021, RAND Corporation published a report entitled, What Role Will Telehealth Play After COVID-19? The growth of telehealth services during the COVID-19 pandemic—spurred by temporary changes that are intended to help prioritize and maintain both access to care and adherence to social distancing guidelines—has policymakers, payers, and advocates rethinking the role that they would like telehealth to play in a post-pandemic health care system. The authors of this report present considerations for how telehealth could benefit (or detract) from several policy goals. They also offer recommendations for how policymakers might use the tools at their disposal to achieve their post-pandemic goals.

IV. Other Health Policy News

  • On January 19, 2021, HHS announced a series of investments to help increase data sharing between health information exchanges (HIEs) and immunization information systems. The Office of the National Coordinator for Health Information Technology (ONC) will award nearly $20 million in funds from the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to support the nation’s vaccination efforts to fight the COVID-19 pandemic. More information about this funding can be found here.
  • On January 19, 2021, HHS awarded nearly $90 million in funding to 496 health centers across 48 states, the District of Columbia, Federated States of Micronesia, Puerto Rico, Palau, and the U.S. Virgin Islands to support HRSA-funded health centers address hypertension among racial and ethnic minorities. More information about this funding can be found here.
  • On January 20, 2021, White House Chief of Staff Ron Klain released a memo directing the heads of executive agencies to withdraw or delay Trump administration regulatory actions pending review. A regulatory pause is a common tradition among incoming presidents to ensure that the unfinished policies from the prior administration align with the new one. More information about the freeze can be found here.
  • On January 21, 2021, President Joe Biden signed a series of executive orders and a memorandum aimed at responding to the COVID-19 pandemic. These actions comprise President Biden’s National Strategy for the COVID-19 Response and Pandemic Preparedness, a comprehensive plan for addressing the pandemic. The executive orders contained within the National Strategy include the following:
    • Executive Order on Establishing the COVID-19 Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce for COVID-19 and Other Biological Threats
    • Executive Order on Protecting Worker Health and Safety
    • Executive Order on Supporting the Reopening and Continuing Operation of Schools and Early Childhood Education Providers
    • Executive Order on Ensuring an Equitable Pandemic Response and Recovery
    • Executive Order on a Sustainable Public Health Supply Chain
    • Executive Order on Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats
    • Executive Order on Improving and Expanding Access to Care and Treatments for COVID-19
    • Executive Order on Promoting COVID-19 Safety in Domestic and International Travel
    • Memorandum to Extend Federal Support to Governors’ Use of the National Guard to Respond to COVID-19 and to Increase Reimbursement and Other Assistance Provided to States
    • National Security Directive on United States Global Leadership to Strengthen the International COVID-19 Response and to Advance Global Health Security and Biological Preparedness

[View source.]

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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