Alston & Bird Health Care Week in Review, November 12, 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.

This week, HHS announced new investments to remove barriers for eligible adults and children to access COVID-19 rapid diagnostic tests and vaccines. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On November 8, 2021, the Food and Drug Administration (FDA) issued draft and revised guidance entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). 

• On November 12, 2021, the Department of Health and Human Services (HHS), through the Office of the Secretary, the Centers for Medicare & Medicaid Services (CMS), the Office of the Inspector General (OIG), and the Administration for Children and Families (ACF) issued a final rule entitled, Adjustment of Civil Monetary Penalties for Inflation and the Annual Civil Monetary Penalties Inflation Adjustment for 2021. This final rule finalizes the provisions of the September 6, 2016 interim final rule that adjusts for inflation the maximum civil monetary penalty (CMP) amounts for all agencies within the Department of Health and Human Services (HHS) and updates certain agency-specific regulations. It also updates our required annual inflation-related increases to the CMP amounts in our regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015; adds references to new penalty authorities; and reflects technical changes to correct errors. 

• On November 12, 2021, CMS published a final rule entitled, Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary". This final rule repeals the “Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”” final rule, which was published on January 14, 2021, and was to be effective on December 15, 2021.

• November 23, 2021: The National Institutes of Health (NIH) announced a public meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council Special Meeting of NIDDK Advisory Council: Consideration of the NIDDK Strategic Plan. The meeting will feature consideration of the NIDDK Strategic Plan.
• December 5-7, 2021: NIH announced a public meeting of the Board of Scientific Counselors of the National Institute of Environmental Health Sciences (NIEHS). The meeting will feature a meeting overview; a question & answer session; and a poster session, among other sessions.
• December 7, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Prevention. The meeting will discuss the Mandatory Guidelines for Federal Workplace Drug Testing Programs with updates from the Department of Transportation, the Nuclear Regulatory Commission, and the Department of Defense. Other discussion topics include a presentation on tetrahydrocannabinol isomerism and an update on the federal electronic custody and control form (eCCF), and more.
• January 19, 2022: NIH announced a public meeting of the Interagency Autism Coordinating Committee (IACC). The purpose of the IACC meeting is to discuss business, agency updates, and issues related to autism spectrum disorder (ASD) research and services activities.
• January 26-27, 2022: NIH announced a public meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. The meeting will present the Director's Report and other scientific presentations, as well as evaluate grant applications.
• February 3, 2022: NIH announced a public meeting of the National Advisory General Medical Sciences Council. The meeting agenda will review and evaluate the discussion of program policies and issues and grant applications, as well as provide opening remarks; report of the Director, NIGMS; and other business of the Council.
• February 8, 2022: NIH announced a public meeting of the Board of Regents of the National Library of Medicine. The meeting agenda features a program discussion and evaluation of grant applications.
• April 7, 2022: NIH announced a public meeting of the National Library of Medicine Board of Scientific Counselors. The meeting agenda features a program discussion and investigator report, as well as a review and evaluation of personal qualifications, performance, and competence of individual investigators.

II. Congressional Hearings

No Congressional hearings were held this week.

III. Reports, Studies & Analyses

• On November 9, 2021, the Government Accountability Office (GAO) published a report entitled, Social Security Administration: Actions Needed by SSA to Ensure Disability Medical Consultants Are Properly Screened and Trained. The Social Security Administration (SSA) pays benefits to eligible people who are unable to work due to disability. State agencies review claims for disability benefits, and use "consultants" (physicians) to determine if claimants are medically eligible. SSA requires state agencies to ensure consultants meet its employment and training standards. While most states GAO surveyed reported meeting the requirements, several did not. GAO recommended that SSA take further steps, such as periodic reminders for states, to ensure states properly screen and train consultants. 

• On November 11, 2021, the Kaiser Family Foundation (KFF) published a report entitled, The U.S. Congress and Global Health: A Primer. To help shed light on Congress’ role in global health, this primer provides an overview of its engagement in this area, aiming to provide a basic framework with which congressional efforts may be understood. First, it examines the structure of Congress and its role and key activities in global health, which range from authorizing the creation of and providing funding for U.S. global health programs to engaging in program oversight and confirming presidential appointees to lead these efforts. It then illustrates these by examining selected legislative activities for two global health examples: the creation and evolution of PEPFAR and the 2014/2015 Ebola outbreak in West Africa. Finally, it discusses opportunities and challenges related to congressional engagement in global health going forward. 

• On November 11, 2021, KFF published an issue brief entitled, How Could the Build Back Better Act Affect Uninsured Children? This brief examines characteristics of uninsured children in 2020 and discusses how current policy proposals, including outreach efforts, continuous eligibility requirements, and closing the coverage gap, could affect children’s health coverage. Recent efforts to expand coverage for adults could benefit children’s coverage, especially for children in non-expansion states if the coverage gap is filled as proposed by the Build Back Better Act. 

• On November 12, 2021, the RAND Corporation published a report entitled, Temporary Safety-Net Policies and Pandemic-Related Insurance Loss in New York State. The coronavirus disease 2019 (COVID-19) pandemic–related recession and resulting job loss raised significant concerns that the U.S. uninsured population could increase, perhaps by millions. However, predictions about coverage loss have not materialized. To explore this issue, RAND researchers (1) assess the importance of temporary provisions relative to long-standing policies in stabilizing health insurance enrollment despite heavy job loss and (2) run simulations using New York state as a case study.

IV. Other Health Policy News

• On November 8, 2021, HHS’s Office on Women’s Health announced the 200+ hospitals that are participating in the HHS Perinatal Improvement Collaborative, a contract with Premier, Inc. This new network is focused on improving maternal and infant health outcomes by reducing disparities. Comprised of hospitals from all 50 states, the collaborative is the first to evaluate how pregnancy affects overall population health by linking inpatient data of newborns to their mothers. More information on this announcement can be found here. 

• On November 9, 2021, as a new phase of the COVID-19 vaccination campaign began for children ages 5 to 11 years old, U.S. Surgeon General Dr. Vivek Murthy released a Community Toolkit for Addressing Health Misinformation to help Americans navigate the serious threat of health misinformation, especially online. Earlier this year, Dr. Murthy issued the first Surgeon General’s Advisory of this administration warning people about the urgent threat of health misinformation and calling for a whole-of-society approach to address it. More information on this action can be found here. 

• On November 9, 2021, CMS issued a fact sheet entitled, Medicaid, CHIP and BHP COVID-19 Vaccine Administration Coverage, Cost-Sharing, and Reimbursement. The fact sheet outlines current Medicaid, Children’s Health Insurance Program (CHIP), and Basic Health Program (BHP) Requirements for COVID-19 Vaccine Administration for children aged 5 and older. More information on the fact sheet can be found here. 

• On November 9, 2021, the White House issued a memorandum for the Secretary of Homeland Security and the Administrator of the Federal Emergency Management Agency (FEMA) on maximizing assistance to respond to COVID-19. More information on the memorandum can be found here. 

• On November 10, 2021, HHS announced it will invest $650 million from the American Rescue Plan to strengthen manufacturing capacity for quick, high-quality diagnostic testing through rapid point-of-care molecular tests and increase Americans’ access to them. As at-home testing increases, the need for follow-up testing in health care settings will likely grow. This new investment will help ensure tests like these are readily available across the country and can provide results quickly. More information on this announcement can be found here. 

• On November 10, 2021, HHS, through the Health Resources and Services Administration (HRSA), announced $143.5 million in American Rescue Plan funding to expand community-based efforts to conduct tailored local outreach about vaccines, build vaccine confidence and address barriers to vaccination in their communities. The funding announced today supports two programs in which award recipients will develop regional and local partnerships to reach unvaccinated individuals, including pregnant women and people from underserved and high-risk communities, to help bolster COVID-19 vaccination efforts. More information on this announcement can be found here. 

• On November 10, 2021, CMS provided approximately $100 million in additional funding in 2022 to support MinnesotaCare, Minnesota’s Basic Health Program (BHP), and $750 million to support the Essential Plan, New York’s Basic Health Program (BHP). Both states will also receive added funds for 2020 and 2021. The additional funds, made available through the American Rescue Plan, will increase New York and Minnesota’s ability to provide affordable, quality health care coverage to approximately 1.1 million individuals. More information on this action can be found here. 

• On November 18, 2021, Alston & Bird will be holding a webinar entitled, IP 2021 Webinar: Pending Patent & Pharma Legislation Roundup. Pending legislation may significantly affect various aspects of patent litigation, especially in the pharmaceutical industry. Join Alston & Bird partners Shri Abhyankar, Christopher McArdle, and senior associate Emily Shaw as they provide an overview of the pending legislation and its potential impact, as well as the Restoring the America Invents Act, the Pride in Patent Ownership Act, and several important bills impacting generic pharmaceutical litigation. More information on the webinar and registration details can be found here.