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September 18, 2020
Health Law Weekly

COVID-19 Updates and Developments (Week of September 14)

  • September 18, 2020

A bipartisan group of House lawmakers is trying to broker another COVID-19 relief package, unveiling September 15 a $1.5 trillion proposal that seeks a middle ground to restart stalled negotiations.

The Problems Solvers Caucus—a group of 50 House lawmakers divided equally between Democrats and Republicans—called the framework its “March to Common Ground.” The package includes some Democratic priorities, including more than $500 million in funding for state and local governments, though less than the nearly $1 billion in aid sought by House Speaker Nancy Pelosi (D-CA), and some Republican priorities, including liability protections for businesses.

The measure allocates $25 billion for COVID-19 testing and contact tracing; $30 billion for health care provider support, including telehealth expansion; and $45 billion in Medicare loan forgiveness. The measure also includes additional direct assistance to individuals and families, small business and nonprofit support, and unemployment assistance.

The group, which is co-chaired by Reps. Josh Gottheimer (D-NJ) and Tom Reed (R-NY), said the package spans the next six months, through the next inauguration, except for state and local funding, which extends a full year. The measure also builds in additional relief if the pandemic worsens and reduces funding if less aid is needed.

“Our framework reflects months of bipartisan consensus-building on the actions the federal government can take to help working families and local communities across the country as they navigate the impacts of COVID-19. We are hopeful this package will help bring negotiations back to the table as we try to solve this problem for the American people,” Reed said.

Senate Republicans last week fell short of the votes needed to bring a pared-down COVID-19 relief measure to the floor. In May, House Democrats cleared a $3 trillion bill that included $1 trillion in funding for state and local governments. 

Meanwhile, the White House seemed to signal a willingness to consider a larger relief package. In a September 16 tweet, President Trump urged Republicans to “[g]o for the much higher numbers” in reference to stimulus payments.

“We look forward to hearing from the President’s negotiators that they will finally meet us halfway with a bill that is equal to the massive health and economic crises gripping our nation,” Pelosi and Senate Minority Leader Chuck Schumer (D-NY) said in a joint statement following the President’s tweet.

Department of Health and Human Services (HHS)

September 16—HHS, in coordination with the Department of Defense and Centers for Disease Control and Prevention (CDC), released the administration’s strategy for distributing a COVID-19 vaccine. Planning documents include an overall strategic distribution overview along with an interim playbook for state, tribal, territorial, and local public health programs and their partners on how to plan and operationalize a vaccination response to COVID-19. CDC in August executed an existing contract option with McKesson Corporation, which also distributed the H1N1 vaccine during the 2009-210 pandemic, for distributing a COVID-19 vaccine. The current contract with McKesson, awarded in 2016, includes an option for the distribution of vaccines in the event of a pandemic.

Centers for Medicare & Medicaid Services (CMS)

September 17—CMS issued revised guidance on how nursing homes can safely facilitate visitation during the COVID-19 pandemic. "After several months of visitor restrictions designed to slow the spread of COVID-19, CMS recognizes that physical separation from family and other loved ones has taken a significant toll on nursing home residents," the agency said. The revised guidance encourages nursing homes to facilitate outdoor visitation, which poses a lower risk of transmission. The guidance also allows for indoor visitation if there has been no new onset of COVID-19 cases in the past 14 days and subject to other requirements. Facilities also should consider their community positivity rate in developing indoor visitation policies. 

September 15—CMS issued the report from the Coronavirus Commission on Safety and Quality in Nursing Homes, which was convened this summer to conduct an independent review and comprehensive assessment of the nursing home response to the COVID-19 pandemic. The 25-member Commission, which included a range of perspectives from nursing home residents and consumer advocates, nursing home owners and administrators, and infectious disease experts, among others, was tasked with recommending actions and best practices in three key areas: protecting patients from COVID-19; strengthening efforts to identify and mitigate COVID-19 transmission and other infectious diseases in nursing homes; and improving compliance with infection control policies. The report includes 27 recommendations with specific “action steps” on issues such as the ongoing need for testing, supplies, and personal protective equipment and visitation and cohorting policies. Specific recommendations ranged from implementing a national strategy for testing and delivering rapid turnaround of COVID-19 results—less than 24 hours in nursing homes—to updating cohorting guidance to balance resident and staff psychological safety and well-being with infection prevention and control to emphasizing that visitation is a vital resident right. CMS also issued a response detailing some of the steps that it has taken or that are in progress to address the recommendations.

Centers for Disease Control and Prevention

September 15—A new report from the CDC indicates that COVID-19 is disproportionately fatal for minority children, tracking the same well-documented trend in adults. According to the data, of the 121 reported children who died from the coronavirus as of July, 78% (94) were either Hispanic, Black, or American Indian/Alaskan Native. The report also confirmed that the coronavirus is more deadly as age increases—with 70% (85) of the 121 children who died between the ages of 10 and 20. Seventy-five percent of the children who died had at least one underlying medical condition like asthma or obesity, CDC reported. 

Food and Drug Administration (FDA)

September 15—FDA released performance data for 55 molecular diagnostic tests for COVID-19 to help patients and providers compare tests and inform their choices. In May, FDA began distributing a reference panel of samples to more than 150 developers without disclosing the amount of viral material in the samples. The blind test was aimed at helping to validate the accuracy and reliability of the growing number of COVID-19 diagnostic tests that currently are available. “Reference panels can be used in many ways to support test development and authorization, but most importantly, they are a powerful tool in monitoring test performance and ensuring that Americans have access to diagnostics they can trust,” FDA Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D. said.

National Institutes of Health (NIH)

September 15—NIH announced a $12 million award for an outreach and engagement campaign to help raise awareness about COVID-19 and increase clinical trial enrollment in ethnic and racial minority communities disproportionately affected by the pandemic. RTI International, a nonprofit research institution, will support teams in 11 states established as part of the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. “The burden of the COVID-19 pandemic borne by diverse communities, especially those that include Blacks and Latinos, makes clear the urgent need for treatments and vaccines that are effective for all Americans. Inclusive research that reflects the entire population is essential to this goal.”

 

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