Washington Watch for September 28, 2020

Carter L. Alleman, J.D.

Supreme Court Justice Ruth Bader Ginsberg Dies at 87
Supreme Court Justice Ruth Bader Ginsburg passed away on Friday September 18 at the age of 87 due to complications of metastatic pancreatic cancer. She was appointed to the Supreme Court by President Bill Clinton in 1993 and was only the second woman to serve on the high court. She was one of the Supreme Court’s most liberal justices and was the senior member of the court’s liberal wing since 2010. The push to fill her seat is expected to start today.

If President Trump is successful in appointing his third Supreme Court justice, it could result in the most significant ideological shift for the Court in decades. With the presidential election less than seven weeks away, Majority Leader Mitch McConnell (R-Ky.) has vowed to bring President Trump’s nominee up for a vote on the Senate floor, but McConnell did not clarify the timing of the vote, which will likely occur after the election, during the lame duck session. Democrats are arguing that the seat should remain open through the November 3 election and be filled by Democratic candidate Joe Biden if he wins the presidency. Republicans made similar arguments in 2016 after Justice Antonin Scalia passed away.

Senator Lisa Murkowski (R-Alaska) released a statement that the Senate should not hold a vote prior to the election, while Senator Susan Collins (R-Maine) went further and noted that the decision for the new judge should be made by the president who is elected on November 3rd. In contrast, other republicans have urged for a vote. Should the Supreme Court see an ideological shift to the right, conservatives are hopeful that challenges to Roe v. Wade, the Affordable Care Act (ACA), gun rights restrictions, and anti-discrimination laws would be successful. Another conservative on the high court could also change the balance of justices in favor of slashing federal regulatory power. The court is scheduled to convene for the October 2020 term and will hear arguments on the 2010 health care law a week after the election.

Energy and Commerce Republicans Request Info on Coinciding Flu Season, Pandemic
Republican leadership of the House Energy and Commerce Committee has written to Centers for Disease Control and Prevention (CDC) Director Robert Redfield to ask how the agency is planning to manage its response to the coinciding seasonal flu and COVID-19 pandemic during the fall and winter months.

The letter notes that experts have predicted as many as “100 million cases of influenza-like symptoms that could overwhelm current testing capacity” and greatly increase stress on hospitals. The lawmakers underscore the need to increase the flu vaccination rate and ask what the CDC is planning to due to ensure access to the flu vaccine.

White House Releases “Most Favored Nation” Drug Pricing Order
The White House released its latest executive order (E.O.) on drug pricing that would ensure that Medicare pay no more than the lowest price for a drug than it is sold for in any Organization for Economic Co-operation and Development (OECD) country with a comparable per capita GDP. The E.O. directs the U.S. Department of Health and Human Services (HHS) to immediately begin a demonstration project to test the “most favored nation” approach under Medicare Part B. A similar model would be implemented for Medicare Part D for those products without competition for which patients pay prices higher than in comparable OECD nations. The President had previewed a version of the directive last month but provided industry time to propose an alternative policy before moving forward. The President’s deadline passed, however, without pharmaceutical companies and the administration reaching an agreement on an alternative plan.

COVID Vaccine Trial Halted, CEOs Pledge Commitment to Safety
AstraZeneca announced that it has halted its COVID-19 vaccine clinical trial to review safety data while investigating a single adverse event that occurred in a person enrolled in one of its studies. The company characterized the pause as a routine action taken so that an independent review of a potentially unexplained illness could be conducted. This is the first safety issue that has arisen for the several coronavirus vaccines in late-stage trials. AstraZeneca’s vaccine is being developed in partnership with scientists at Oxford University. Phase three trials are currently taking place in the U.S., U.K., Brazil, and South Africa. It is one of the vaccines receiving support from the White House’s Operation Warp Speed; the federal government has agreed to pay up to $1.2 billion toward the development and manufacturing of 300 million doses.

The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna Inc., Novavax Inc., Pfizer Inc., and Sanofi have signed a pledge outlining their commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles. The companies pledge to always make the safety and well-being of vaccinated individuals their top priority, continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes, to only submit for approval or emergency use authorization (EUA) after demonstrating safety and efficacy through a phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities, and to work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

Lawmakers Call for Speedy Approval of Rapid COVID Tests
Fourteen bipartisan House lawmakers have sent a letter to Administrator of Food and Drugs Stephen Hahn calling for expedited authorization and lower sensitivity standards for rapid, in home COVID-19 tests. The letter was led by Reps. Ro Khanna (D-Calif.) and Rodney Davis (R-Ill.). The lawmakers underscore the promise of low-cost, saliva-based, self-administered tests in supporting the affordable and frequent testing that is necessary for Americans to return to a normal way of life. They urge the FDA to “utilize its existing authority and consider options such as providing an expedited pathway for authorization” for the tests.

Lawmakers Press White House for Vaccine Distribution Plans
House Oversight and Reform Chair Carolyn Maloney (D-N.Y.), Economic and Consumer Policy Subcommittee Chair Raja Krishnamoorthi (D-Ill.), and Coronavirus Crisis Select Subcommittee Chair Jim Clyburn (D-S.C.) have written to the U.S. Department of Health and Human Services (HHS) requesting written information as well as a staff briefing on the administration’s plans to distribute an eventual COVID-19 vaccine. The letter expresses concerns that the White House has not yet begun to engage with communities of color about a vaccine or determined how vaccine prioritization decisions will be made. The lawmakers request the information within three weeks. Senate Appropriations Subcommittee Health and Human Services Chairman Roy Blunt (R-Mo.) also sent a letter to Centers for Disease Control and Prevention (CDC) Director Robert Redfield requesting information about the agency’s plans for distributing an eventual COVID-19 vaccine in a fair and equitable way. Blunt’s panel plans to hold a hearing later this month on vaccine development and distribution.

Democrats Release Report Questioning CMS Administrator Verma’s Spending
Democrats have released a report detailing Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma’s nearly $6 million in spending on private communications consultants. The report follows a 17-month probe into the CMS administrator and calls on the Government Accountability Office (GAO) to investigate potential violations of federal spending laws. The report was compiled by the staff of House Energy and Commerce Committee Chair Frank Pallone (D-N.J.), House Oversight and Reform Committee Chair Carolyn Maloney (D-N.Y.), Senate Finance Committee Ranking Member Ron Wyden (D-Ore.), and Senate Health, Education, Labor, and Pensions (HELP) Ranking Member Patty Murray (D Wash.). “Congress did not intend for taxpayer dollars to be spent on handpicked communications consultants to promote Administrator Verma’s public profile and personal brand,” the lawmakers said in a statement.

HHS Released Additional Details on the CARES Act Provider Relief Fund Reporting Requirements
The CARES Act Provider Relief Fund (PRF) has provided funding to assist providers who have increased expenses or revenue losses due to the COVID-19 pandemic. The program details requirements primarily through the various Terms and Conditions, and those suggest extensive reporting requirements for the program. In July, the U.S. Department of Health and Human Services (HHS) provided additional clarity regarding the reporting requirements. As part of the notice, HHS stated: “The purpose of this notice is to inform PRF recipients that received one or more payments exceeding $10,000 in the aggregate from the PRF of the timing of future reporting requirements.” These revised requirements have lowered the threshold – from $150,000 in the Terms and Conditions to $10,000 in the notice. On September 19, HHS released additional details regarding the specific reporting elements. Of note, with respect to the revenue losses, the reporting requirements state that “PRF payment amounts not fully expended on health care related expenses attributable to coronavirus are then applied to lost revenues, represented as a negative change in year-over-year net patient care operating income (i.e., patient care revenue less patient care related expenses for the Reporting Entity, defined below, that received funding), net of the health care related expenses attributable to coronavirus calculated under step 1. Recipients may apply PRF payments toward lost revenue, up to the amount of their 2019 net gain from health care related sources. Recipients that reported negative net operating income from patient care in 2019 may apply PRF amounts to lost revenues up to a net zero gain/loss in 2020.” (emphasis added) In addition, HHS detailed the other sources of 2020 revenue to help ensure that any payments from the fund are not used to reimburse expenses or losses that have been reimbursed from other sources or that other sources are obligated to reimburse. A short summary of the reporting requirements can be found here. Shortly after the release of this information, HHS further clarified the timeframe for these reporting requirements. All recipients must submit a report by February 15, 2021, and this can be a final report if all funds have been expended by December 31, 2020. Otherwise, the final report deadline is July 31, 2021. The portal for report submission will be open as of January 15, 2021.