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, several Committees in the U.S. House of Representatives marked up the Build Back Better Act under budget reconciliation. Read more about this legislative update and other news below.

I. Regulations, Notices & Guidance

  • On September 13, 2021, the Department of Health and Human Services (HHS), the Office of Personnel Management (OPM), Department of the Treasury, and the Department of Labor, issued a proposed rule entitled, Requirements Related to Air Ambulance Services, Agent and Broker Disclosures, and Provider Enforcement. This proposed rule implements certain provisions of Title I (No Surprises Act) and Title II (Transparency) of Division BB of the Consolidated Appropriations Act, 2021 (CAA). It would amend and add provisions to existing rules under the Internal Revenue Code (Code), the Employee Retirement Income Security Act (ERISA), the Public Health Service Act (PHS Act), and the Federal Employees Health Benefits (FEHB) Act.
  • On September 13, 2021, the Executive Office of the President (EOP) issued an Executive Order entitled, Executive Order 14043: Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. The Executive Order states that to promote the health and safety of the Federal workforce and the efficiency of the civil service, it is necessary to require COVID-19 vaccination for all Federal employees, subject to such exceptions as required by law.
  • On September 13, 2021, the EOP issued an Executive Order entitled, Executive Order 14042: Ensuring Adequate COVID Safety Protocols for Federal Contractors. This Executive Order promotes economy and efficiency in Federal procurement by ensuring that the parties that contract with the Federal Government provide adequate COVID-19 safeguards to their workers performing on or in connection with a Federal Government contract or contract-like instrument as described in section 5(a) of this order.
  • On September 13, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary". This proposed rule would repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" final rule, which was published on January 14, 2021, and would be effective on December 15, 2021.
  • On September 16, 2021, the Food and Drug Administration (FDA) issued revised draft guidance entitled, Product-Specific Guidances for Ferric Oxyhydroxide. The revised draft guidances, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for ferric oxyhydroxide oral tablets (previously sucroferric oxyhydroxide) and ferric oxyhydroxide intravenous injectable (previously iron sucrose).
  • On September 17, 2021, the FDA issued revised final guidance entitled, Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009. This guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, and also describes FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled "Questions and Answers on Biosimilar Development and the BPCI Act" issued December 12, 2018.

Event Notices

  • September 22-23, 2021: The Centers for Disease Control and Prevention (CDC) announced a virtual public meeting of the Advisory Committee on Immunization Practices (ACIP). The committee is charged with advising the Director, CDC, on the use of immunizing agents. The agenda will include discussions on COVID-19 vaccine booster doses.
  • September 28, 2021: HHS announced a virtual public meeting of the National Biodefense Science Board (NBSB). The NBSB provides expert advice and guidance on scientific, technical, and other matters of special interest to the Department regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. The NBSB will discuss high priority issues related to national public health emergency preparedness and response.
  • September 29, 2021: The National Institutes of Health (NIH) announced a virtual public meeting of the National Cancer Institute Council of Research Advocates. The meeting will include Chairwoman's Remarks, NCI Updates, Legislative Update, and Director's Update.
  • October 20, 2021: CDC announced a virtual public meeting of the Advisory Board on Radiation and Worker Health (ABRWH) of the National Institute for Occupational Safety and Health (NIOSH). This meeting will include discussions on the following: Work Group and Subcommittee Reports; Update on the Status of SEC Petitions; and plans for the December 2021 Advisory Board Meeting.
  • October 28, 2021: NIH announced a virtual public meeting of the Office of AIDS Research Advisory Council of the Office of the Director. The meeting will include the OAR Director's Report; updates from the HIV Clinical Guidelines Working Groups of OARAC; updates from NIH HIV-related advisory councils; special invited presentations and discussions on interagency collaboration and strategic planning; and public comment.
  • November 2-5, 2021: The Health Resources and Services Administration (HRSA) announced a virtual public meeting of the National Advisory Council on Migrant Health (NACMH). NACMH is a non-discretionary advisory body to advise, consult with, and make recommendations to the Secretary of the Department of Health and Human Services and the Administrator of HRSA regarding the organization, operation, selection, and funding of migrant health centers and other entities.
  • November 3, 2021: CDC announced a virtual public meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). This Committee is charged with providing scientific and technical advice and guidance to the Secretary, HHS; the Assistant Secretary for Health; the Director, CDC; the Commissioner, Food and Drug Administration (FDA); and the Administrator, Centers for Medicare and Medicaid Services (CMS).

II. Congressional Hearings

U.S. House of Representatives

  • On September 13-15, 2021, the House Committee on Energy & Commerce held a markup of the Build Back Better Act. The Committee marked up the following Budget Reconciliation Legislative Recommendations: Subtitle A: Air Pollution; Subtitle B: Hazardous Materials; Subtitle C: Drinking Water; Subtitle D: Energy; Subtitle E: Drug Pricing; Subtitle F: Affordable Care Act; Subtitle G: Medicaid; Subtitle H: CHIP; Subtitle I: Medicare; Subtitle J: Public Health; Subtitle K: Next Generation 9-1-1; Subtitle L: Wireless Connectivity; Subtitle M: Distance Learning; Subtitle N: Manufacturing Supply Chain; Subtitle O: FTC Privacy Enforcement; and Subtitle P: Department of Commerce Inspector General. All subtitles, as amended, were favorably reported to the House Committee on Budget, except Subtitle E, which failed to advance by a 29-29 vote.
  • On September 14-15, 2021, the House Ways & Means Committee held a markup of the Build Back Better Act. The Committee marked up Subtitles F, G, H, and J: Budget Reconciliation Legislative Recommendations Relating to Infrastructure Financing, Green Energy, Social Safety Net, and Prescription Drugs; and Amendment in the nature of a substitute to add Subtitle I: Legislative Recommendations Relating to Funding Our Priorities. All subtitles, as amended, were favorably reported to the House Committee on Budget.

III. Reports, Studies & Analyses

  • On September 13, 2021, the RAND Corporation published a research brief entitled, New Patient-Centered Quality Measures for Office-Based Palliative Care. In 2017, the American Academy of Hospice and Palliative Medicine (AAHPM) and the RAND Corporation embarked on a multiyear project funded by CMS to engage palliative care stakeholders in the development of two patient-centered quality measures of symptom management and communication. This research brief describes how these measures were developed and tested and provides considerations for providers that plan to use them.
  • On September 14, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Unvaccinated COVID patients cost the U.S. health system billions of dollars. The brief analyzes HHS and CDC data and finds there were 32,000 preventable COVID-19 hospitalizations in June, 68,000 preventable COVID-19 hospitalizations in July, and another 187,000 preventable COVID-19 hospitalizations among unvaccinated adults in the U.S. in August, for a total of 287,000 across the three months.
  • On September 14, 2021, the Bipartisan Policy Center published a report entitled, Bipartisan Solutions to Improve the Availability of Long-term Care. This report outlines policy recommendations, including new proposals to expand the availability of home and community-based services for low- and middle-income individuals. It also includes previous recommendations that BPC has developed to improve private-sector options for those with more financial resources.
  • On September 16, 2021, the Government Accountability Office (GAO) issued a report entitled, Chronic Health Conditions: Federal Strategy Needed to Coordinate Diet-Related Efforts. This report examines (1) federal data on prevalence, mortality, and costs of selected diet-related chronic health conditions; (2) federal diet-related efforts to reduce Americans' risk of chronic health conditions; and (3) the extent to which federal agencies have coordinated their efforts.

IV. Other Health Policy News

  • On September 10, 2021, the Biden-Harris Administration awarded $20 million in American Rescue Plan (ARP) grant funding to State-based Marketplaces (SBMs) to increase consumer access to affordable, comprehensive health insurance coverage. The grants will be used by 21 SBMs to modernize IT systems and/or conduct targeted consumer outreach activities to help make health care coverage enrollment smoother. More information about this funding can be found here.
  • On September 13, 2021, the Substance Abuse and Mental Health Services Administration (SAMHSA) awarded more than $123 million in funding through six grant programs to provide multifaceted support to communities and health care providers as the Nation continues to combat the overdose epidemic. More information about this funding can be found here.
  • On September 15, 2021, the Biden-Harris Administration announced that more than 2.8 million people newly gained access to affordable health care under the Biden-Harris Administration through the 2021 Special Enrollment Period (SEP) on HealthCare.gov and State-based Marketplaces. There are now 12.2 million people enrolled in the federal and state marketplaces. Additionally, there are now over 82.3 million people relaying on the Medicaid and the Children's Health Insurance Program (CHIP) as of April 2021. More information about this announcement can be found here.
  • On September 16, 2021, HHS, through HRSA, awarded over $48 million to 271 HRSA-supported health centers across 26 states, Puerto Rico, and the District of Columbia to expand HIV prevention and treatment, including pre-exposure prophylaxis (PrEP) related services, outreach, and care coordination. More information about this funding can be found here.
  • On September 17, 2021, an FDA advisory panel voted 16-3 recommending against FDA approval of a booster dose of the Pfizer-BioNTech COVID-19 vaccine for people aged 16 years and older. The recommendation is non-binding on FDA's decision on Pfizer's application.

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