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 more than $560 million in PRF Phase 4 General Distribution payments and CMS announced the ACO Realizing Equity, Access, and Community Health (REACH) Model. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

  • On February 22, 2022, the Food and Drug Administration (FDA) issued a proposed rule entitled, Medical Devices; Quality System Regulation Amendments. FDA is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). FDA proposes to do so through incorporating by reference an international standard specific for device quality management systems set by the International Organization for Standardization (ISO). Through this rulemaking, FDA also proposes additional requirements to align with existing requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, and make conforming edits to the Code of Federal Regulations (CFR) to clarify the device CGMP requirements for combination products.
  • On February 22, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice with comment entitled, Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Rabies Section.  CDC announces the opening of a docket to obtain comment on the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Rabies Section (Draft Guideline: Rabies Section). The Draft Guideline: Rabies Section updates the Rabies section of the Guideline for infection control in health care personnel, 1998 (1998 Guideline), Part E: Epidemiology and Control of Selected Infections Transmitted Among Health Care Personnel and Patients and its corresponding recommendations in Part II of the 1998 Guideline: "14. Rabies." These updated recommendations will help facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) who have been exposed or infected and may be contagious to others in the workplace.
  • On February 23, 2022, FDA issued a notice entitled, Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic; Guidance for Industry. This guidance provides FDA's recommendations to industry to help mitigate the nonhuman primate NHP) supply issue by reducing the demand for NHPs during the COVID-19 pandemic.
  • On February 25, 2022, FDA issued a notice entitled, New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor.  FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and a conditionally approved new animal drug application (cNADA) during July, August, and September 2021. The animal drug regulations are also being amended to improve the accuracy of the regulations.
  • On February 25, 2022, FDA issued final guidance entitled, Patient-Focused Drug Development: Methods To Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. This guidance is the second in a series of four methodological guidance documents that FDA committed to develop to describe how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision making. This guidance finalizes the draft guidance of the same title issued on October 1, 2019.

Event Notices

  • March 22, 2022:  NIH announced a public meeting entitled, Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act. The public meeting will also have an opportunity for public comment. The topics to be discussed are the final assessment and public stakeholder views of the Program.
  • March 24, 2022: CDC announced a public meeting of the Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR). The agenda will include: 1) BSC CPR Polio Containment Workgroup (PCWG) Update; and 2) Strategic Capacity Building and Innovation Program Review Working Group Update.
  • April 6, 2022:  NIH announced a public meeting of the Office of the Director Advisory Committee on Research on Women's Health. The meeting agenda includes the Director's report; a presentation from the Director of the National Heart, Lung, and Blood Institute (NHLBI); a panel discussing health disparities and COVID-19; and concept clearances for various programs.
  • May 16-17, 2022:  NIH announced a public meeting of the National Human Genome Research Institute National Advisory Council for Human Genome Research. The meeting will include a report from the Institute Director and Institute Staff.
  • Various Dates:  The Health Resources and Services Administration (HRSA) announced a meeting cancellation for a public meeting of the Advisory Commission on Childhood Vaccines (ACCV). The notice states that the March 3, 2022, meeting of the Advisory Commission on Childhood Vaccines (ACCV) is canceled and will be rescheduled. Future meetings will occur in June, September, and December of 2022.

II. Congressional Hearings

No Congressional hearings were scheduled for this week.

III. Reports, Studies & Analyses

  • On February 23, 2022, the Congressional Budget Office (CBO) published a working paper entitled, Economic Effects of Five Illustrative Single-Payer Health Care Systems: Working Paper 2022-02. This paper builds on previous studies published by CBO about single-payer health care systems. It uses a general-equilibrium, overlapping-generations model to analyze the economic and distributional implications of five illustrative single-payer health care systems.
  • On February 23, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, 10 Things to Know About Medicaid Managed Care.  The brief describes 10 themes related to the use of comprehensive, risk-based managed care in the Medicaid program and highlights significant data and trends. It states that understanding these trends provides important context for the role managed care organizations (MCOs) play in the Medicaid program overall as well as during the ongoing COVID-19 public health emergency (PHE) and in its expected unwinding.
  • On February 25, 2022, KFF published an issue brief entitled, Prices Increased Faster Than Inflation for Half of all Drugs Covered by Medicare in 2020.  KFF's analysis compares price changes for drugs covered by Medicare Part B (administered by physicians) and Part D (retail prescription drugs) between 2019 and 2020 to the inflation rate over the same period (1 percent) (prior to the recent surge in the annual inflation rate, which is currently 7.5 percent). KFF found that among the 25 drugs covered by Medicare Part D with the highest total gross spending (not accounting for rebates), 23 had price increases greater than inflation in 2020.

IV. Other Health Policy News

  • On February 18, 2022, President Joseph Biden issued a notice on the continuation of the national emergency concerning the COVID-19 pandemic. In this notice, President Biden stated that the COVID-19 pandemic continues to cause significant risk to the public health and safety of the Nation. For this reason, the national emergency declared on March 13, 2020, and beginning March 1, 2020, must continue in effect beyond March 1, 2022. More information on this notice can be found here.
  • On February 23, 2022, HHS released a new report that shows historic gains in health care coverage access and affordability among Black Americans. The report, which was produced by researchers in HHS's Office of the Assistant Secretary for Planning and Evaluation (ASPE), shows that since the implementation of the Affordable Care Act's (ACA) coverage provisions beginning in 2010, the uninsured rate among Black Americans under age 65 decreased from 20 percent in 2011 (approximately 7.1 million people) to 12 percent in 2019 (approximately 4.4 million people), a decline of 40 percent. The report also highlights the Biden-Harris Administration's legislative and administrative actions over the past year to expand affordable coverage options through American Rescue Plan subsidies, a Marketplace Special Enrollment Period (SEP), and enhanced outreach to Black Americans. More information on this report can be found here.
  • On February 24, 2022, HHS Secretary Xavier Becerra issued a new report highlighting the progress that has been made over the past year to strengthen the U.S. public health and medical supply chain and industrial base. The report highlights the U.S. government's accomplishments in addressing public health and medical supply chain challenges since the beginning of the COVID-19 pandemic, describes how HHS is implementing the recommendations and goals in the National Strategy for a Resilient Public Health Supply Chain, and outlines additional actions the U.S. government can take to build on its progress. More information on this report can be found here.
  • On February 24, 2022, HHS, through HRSA, announced that it is making more than $560 million in Provider Relief Fund (PRF) Phase 4 General Distribution payments to more than 4,100 providers across the country. With this announcement, nearly $11.5 billion in PRF Phase 4 payments has now been distributed to more than 78,000 providers in all 50 states, Washington D.C., and five territories. This is in addition to HRSA's distribution of American Rescue Plan (ARP) Rural payments totaling nearly $7.5 billion in funding to more than 44,000 providers since November 2021. More information on these payments can be found here.
  • On February 24, 2022, the Centers for Medicare & Medicaid Services (CMS) announced a redesigned Accountable Care Organization (ACO) model. The ACO Realizing Equity, Access, and Community Health (REACH) Model, a redesign of the Global and Professional Direct Contracting (GPDC) Model, addresses stakeholder feedback, participant experience, and Administration priorities, including CMS' commitment to advancing health equity. The first performance year of the redesigned ACO REACH Model will start on January 1, 2023, and the model performance period will run through 2026. CMS is releasing a Request for Applications for provider-led organizations interested in joining the ACO REACH Model. More information on this announcement can be found here.

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