Alston & Bird Health Care Week in Review, February 19, 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.

Week in Review Highlight of the Week:

This week, HHS announced new actions to expand COVID-19 testing capacity across the country. Read more about the announcement and other news below.

I. Regulations, Notices & Guidance

• On February 18, 2021, the Food and Drug Administration (FDA) issued a notice entitled, Guidance Documents Related to Coronavirus Disease 2019; Availability. The FDA is announcing the availability of FDA guidance documents related to the COVID-19 public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency’s good guidance practices.
• On February 18, 2021, the Department of Health and Human Services (HHS) delayed implementation of a final rule entitled, Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. As required by an order issued by the U.S. District Court for the District of Columbia, this action provides notice of the delay of the effective date of certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in this final rule published on November 30, 2020. The new effective date for these certain amendments is January 1, 2023.

Event Notices    

• February 24-25, 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 cholera vaccine, hepatitis B vaccine, influenza vaccines, zoster vaccine, orthopoxvirus vaccine, pneumococcal vaccine, rabies vaccine, and tickborne encephalitis vaccine. A recommendation vote on the rabies vaccine is scheduled.
• February 26, 2021: HHS announced a public meeting entitled, Meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to introduce Task Force members and to outline the charges as directed by Executive Order 13995, Ensuring an Equitable Pandemic Response and Recovery.
• March 5, 2021: FDA announced a public meeting entitled, Meeting of the Vaccines and Related Biological Products Advisory Committee. The Committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 influenza season.
• 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 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 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).”

II. Congressional Hearings

U.S. House of Representatives

• On February 19, 2021, the House Committee on Oversight and Reform Select Subcommittee on the Coronavirus Crisis held a briefing entitled, Ensuring Equity In Coronavirus Vaccinations. Witnesses present included: Dr. Helene D. Gayle, President and CEO, The Chicago Community Trust; Abigail Echo-Hawk, Chief Research Officer, Seattle Indian Health Board, Director, Urban Indian Health Institute; Frankie Miranda, President and CEO, Hispanic Federation; and Lathran Woodard, CEO, South Carolina Primary Health Care Association.

III. Reports, Studies & Analyses

• On February 16, 2021, Kaiser Family Foundation (KFF) published an issue brief entitled, Racial and Ethnic Health Inequities and Medicare. This chart collection draws on primary and secondary data analyses by KFF and other sources to examine the characteristics, experiences, and outcomes of the Medicare population by race and ethnicity (see Methods for details on data and analysis). It includes data from a variety of sources to describe demographics, health status and disease prevalence, health coverage, access to care and service utilization, and health outcomes, including the most current data available pertaining to disparities related to COVID-19 within the Medicare population. It also documents disparities in income and wealth among people on Medicare.
• On February 16, 2021, RAND Corporation published a report entitled, Increasing Price Transparency in Health Care: Key Themes and Policy Options from a Technical Expert Panel. Price transparency is one strategy that policymakers have proposed to help consumers identify and select lower-priced health care providers and services, but use of price transparency websites remains low. This report examines current price transparency efforts and their features, describes barriers to more widespread availability and use of price information, and discusses possible ways to overcome those barriers.
• On February 18, 2021, RAND Corporation published a report entitled, Impact of Policy Options for Reducing Hospital Prices Paid by Private Health Plans. Hospital spending—the largest health spending category in the United States—accounts for one-third of national health expenditures; in 2018, U.S. hospital spending totaled $1.2 trillion. In response to high health care spending and concerns about affordability, policymakers have proposed a variety of reforms to increase health insurance coverage and modify how providers are paid. In this report, the authors analyze the spending impacts of policy options to reduce hospital prices paid by private health plans. The authors estimate the potential impact on hospital prices and spending for a range of policy designs and assumptions for each option.
• On February 18, 2021, the Congressional Budget Office (CBO) published a report entitled, A Comparison of Brand-Name Drug Prices Among Selected Federal Programs. The federal government is a major purchaser of prescription drugs, both directly through federal agencies, such as the Department of Defense (DOD), and indirectly through federal health insurance programs, such as Medicare Part D. In this report, the CBO describes how the prices of brand-name prescription drugs are determined in different federal programs and compares drug prices among those programs in 2017.
• On February 18, 2021, KFF published an issue brief entitled, Impact of Key Provisions of the House COVID-19 Relief Proposal on Marketplace Premiums. This issue brief examines the impact of provisions in the reconciliation COVID-19 relief package that would, for two years, temporarily expand Marketplace subsidies above 400% of poverty and also increase subsidies for those making between 100% and 400% of the poverty level.

IV. Other Health Policy News

• On February 16, 2021, HHS announced Biden-Harris Administration appointments. The appointments represent both an experienced and diverse team committed to President Biden’s mission to end the COVID-19 pandemic, expand affordable health care and reduce costs, and advance equity. The new appointees and their roles can be found here.
• On February 17, 2021, HHS announced new actions to expand COVID-19 testing capacity across the country. These actions will improve the availability of tests, including for schools and underserved populations; increase domestic manufacturing of tests and testing supplies; and better prepare the nation for the threat of variants by rapidly increasing virus genome sequencing. More information about the plan to expand COVID-19 testing capacity can be found here.

Click here to view the members of our Health Care Legislative & Public Policy team.