Health Policy Report (4/19)

Both chambers of Congress will return to action today to begin the second week of the April legislative session. In the House, floor activity for the week includes a pair of immigration-related measures pertaining to the Trump administration’s travel ban on individuals from predominantly Muslim countries, as well as access to legal counsel for immigrants (H.R. 1333; H.R. 1573). Additionally, House lawmakers will also take up a bill that would make Washington, D.C. the 51st state, providing equal representation in Congress for its residents.

On the Senate floor this week, Majority Leader Chuck Schumer (D-NY) has queued up a bill that seeks to facilitate an expedited review of pandemic-related hate crimes by the Department of Justice. Senators are also expected to take up a $35 billion water infrastructure package out of the Environment and Public Works Committee — marking the first floor consideration of an infrastructure-related bill since President Joe Biden unveiled his “American Jobs Plan” late last month. In addition to the aforementioned bills, the upper chamber will vote on Gary Gensler’s nomination to lead the Securities and Exchange Commission (SEC), serving the remainder of former SEC Chair Jay Clayton’s tenure through June 5, 2026.

Administration Asks SCOTUS Not to Hear CSR Case

The Biden administration recently asked the Supreme Court not to consider a request from two insurers to review a lower court decision on the Affordable Care Act’s (ACA) cost sharing reduction (CSR) payments. In late February, Maine Community Health Options and Community Health Choice asked the Supreme Court to review an August 2020 ruling by the Court of Appeals for the Federal Circuit that CSR payments were mandatory, arguing that the decision allows the government to avoid paying out its full obligation in CSR payments. In late March, the Association for Community Affiliated Plans, Anthem, and the U.S. Chamber of Commerce filed briefs supporting the insurers’ position.

In an April 9 brief, the administration explains that the federal appeals court had correctly determined that the money insurers gained by hiking silver-level premiums can be deducted from the damages owed to them. They note that since the ACA does not include language on how to remedy a situation in which the government breaches payment obligation, the appeals court was correct to look to contract law. Additionally, the administration filed a cross petition stating that if the Supreme Court chooses to take up this case, it should also review the appeals court ruling that the government was liable to pay the CSRs.

Cavazzoni Named as FDA Drug Center Director

Last Monday, Acting Food and Drug Administration Commissioner Janet Woodcock named Patricia Cavazzoni as her successor to be the permanent Director of the FDA Center for Drug Evaluation and Research. The decision has left many to speculate whether Acting Commissioner Woodcock expects to be named as the permanent FDA Chief, or if she wanted to secure long-term leadership of the drug center before ultimately retiring. Director Cavazzoni joined the FDA in 2018 as Deputy Director of Operations for the Center for Drug Evaluation and Research, and has led several key efforts to transition the agency to a cloud-based system, establish more real-time and near-time reviews of drug applications, and more. Additionally, she served as Acting Principal Deputy Commissioner of Food and Drugs from January 2019 to February 2019, and has been filling the role of Acting Director of the Center for Drug Evaluation and Research since Woodcock left the role in May 2020. Director Cavazzoni has a background in Psychiatry and Mood Disorders, as well a clinical development, regulatory affairs, and safety risk management in the pharmaceutical industry.

Biden Administration Announces $1.7 Billion Investment to Fight COVID-19 Variants

On Friday, the Biden administration announced $1.7 billion in investments from the American Rescue Plan to assist states and other jurisdictions in combatting COVID-19 variants. The funding will be allocated through the Centers for Disease Control and Prevention (CDC) and will help the CDC, states, and other jurisdictions more effectively detect and track variants by increasing genomic sequencing efforts. The administration noted that additional data from the genomic sequencing will be used to inform and implement additional prevention measures to stop the spread. The funding is expected to grow the current rate of genomic sequencing from 29,000 samples a week and provide states with additional resources to grow their own resources to increase geographic coverage of sequencing.

Specifically, $1 billion of the funding will be dedicated solely to the CDC and jurisdictional health districts to conduct, expand, and improve activities to sequence genomes and identify mutations. Further, $400 million will be used to support innovation initiatives, including the launch of six new Centers of Excellence in Genomic Epidemiology to operate as partnerships between state health departments and academic institutions. Efforts to build and support a National Bioinformatics Infrastructure will receive $300 million in funding and help create a unified system for sharing and analyzing sequence data in a way that protects privacy but allows more informed decision making.

CDC Data Shows Drug Overdose Deaths Grew During Pandemic

New data released last Wednesday from the Centers for Disease Control and Prevention (CDC) shows that more than 87,000 Americans died from a drug overdose between October 2019 and September 2020. The newest data shows a 29 percent increase in overdose deaths compared to the previous 12-month period ending in September 2019. The largest increase in deaths occurred in March and April 2020, when shutdowns due to the COVID-19 pandemic began in earnest and more workers lost jobs. The CDC noted that the actual number of deaths is likely larger as death records sometimes list the cause of death as “pending investigation.”

The new data represents a setback after overdose deaths were trending downward in 2018 for the first time in decades and the previous administration had spent billions at tackling the opioid epidemic. The COVID-19 pandemic has overshadowed many substance abuse disorder prevention and treatment initiatives, drawing resources away to fight the coronavirus public health emergency. The release of data follows a report earlier this year that found that emergency department visits for overdoses, mental health conditions, and suicide attempts increased in 2020, including a significant increase in opioid overdoses from March to October 2020 compared to the same time period in 2019.