On The Hill

 

On Tuesday (May 12), House Speaker Nancy Pelosi (D-CA) released the ‘Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act’. The $3 trillion recovery package would provide additional relief for healthcare providers and more funding to ramp up testing, contract tracing, and surveillance programs. Additionally, the HEROES Act includes: $875 billion for state and local governments, $20 billion each for tribal nations and U.S. territories, another round of stimulus checks, an additional $10 billion for the Paycheck Protection Program (PPP), and a number of other key Democratic priorities.^[1] The bill is a nonstarter for Republicans and is even facing opposition among both the progressive and moderate wings of Pelosi’s caucus.

 

Friday (May 15) afternoon, the White House released a Statement of Administrative Policy (SAP) opposing the legislation. The House will vote on the HEROES Act on Friday (May 15).

 

To view a section-by-section summary of the HEROES, click here.

To view the SAP, click here.

 

Energy and Commerce Chairman Frank Pallone (D-NJ), Ways and Means Chairman Richard Neal (D-MA), and Education and Labor Chairman Bobby Scott (D-VA) outlined the health provisions in the HEROES Act in a press release. Key provisions include:

 

Testing and Contact Tracing: The legislation provides $75 billion in grants to public health departments and workforce agencies to support testing, contact tracing, surveillance and mitigation efforts. Health departments would be required to use multilingual strategies and engage in public awareness campaigns regarding COVID-19. Additionally, HEROES requires the administration to issue a strategic testing plan with clear numerical benchmarks and times for testing efforts.

 

Reimbursement for COVID-19 Treatments: To ensure free access to treatment, HEROES eliminates cost sharing for COVID-19 treatment for Medicare and Medicaid beneficiaries, and those covered by private health insurance, TRICARE, Veteran’s Affairs and the Federal Employee Health benefit Program. The legislation increases payments to facilities serving a high proportion of Medicaid patients, allows State Medicaid programs to cover the cost of COVID-19 treatment for uninsured patients and allows early enrollment in Medicaid for individuals soon to be released from prison to ensure they have access to care upon release.

 

Provider Support: HEROES includes an additional $100 billion for the Provider Relief Fund. Funds would be attached to an allocation requirement that ensures they are distributed in an equitable way. The bill also modifies the Accelerated and Advance Payment Program.

 

State Medicaid Programs: The legislation increases the Federal Matching Assistance Percentage (FMAP) by 14 percent through June 30, 2021. In addition, HEROES increase FMAP by 10 percent for state Medicaid services for patients in home and community-based care.

 

 

 

Recently, the FDA has issued a number of emergency use authorizations (EUA) for COVID-19 diagnostic tests.

 

At-Home Diagnostic Test Using Saliva Specimen: Last Friday (May 8), the FDA authorized the first at-home COVID-19 diagnostic tests using collection of saliva specimens, issuing an EUA to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT). The test is available by prescription only.

 

To view the FDA’s announcement, click here.

 

Test Using CRISPR: On May 6, the FDA issued the first EUA for a diagnostic test using CRISPR technology to Sherlock BioSciences’ Sherlock CRISPR SARS-CoV-2 kit. The test looks for the specific target RNA or DNA sequences of the SARS-CoV-2 virus.

 

To view the EUA, click here.

 

Serology Test Report: On Wednesday (May 13), the FDA shared its first test report detailing data from the independent validation study of certain serological tests. The study was performed at Frederick National Laboratory for Cancer Research (FNLDR) in collaboration with FDA, NIH, CDC, and BARDA. The results indicate that serology tests may not be effective at detecting COVID-19 antibodies in the early days of infection and, therefore, should not be used as the sole basis to diagnose COVID-19.

 

To view the full test report, click here.

 

 

 

On Monday (May 11), CMS released a proposed rule on the FY 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH). The deadline for submitting comments on the proposed rule is July 10, 2020.

 

To view the CMS fact sheet, click here.

 

 

 

Over the weekend, CDC updated their interim guidance for laboratory professionals working with COVID-19 specimens.

 

To view CDC guidance, click here.

To view CDC laboratory FAQs, click here.

 

 

 

The White House outlined their plan to ensure the Strategic National Stockpile (SNS) is fully stocked and ensure the U.S. has a domestic industrial base to combat future supply chain challenges.

 

To view the White House announcement, click here.

 

 

 

On Monday (May 11), President Trump and federal health officials unveiled a plan to help states test at least two percent of their population in May, a goal that would require at least 12.9 million tests to be administered. The federal government will be providing states with 12.9 million swabs to meet that need.

 

Additionally, the White House revealed its distribution plans for the $11 billion provided by the CARES Act to support state testing. Funds will be distributed based on the prevalence of the virus in states and their overall populations.^[2]

 

 

 

^[1]Caygle, Heather & Ferris, Sarah & Bresnahan, John “Pelosi unveils $3 trillion coronavirus relief plan amid squeeze from left and right” Politico Pro, 12 May 2020

 

^[2]Lim, David & Ollstein, Alice Miranda “White House pushes states to test 2 percent of population for coronavirus” Politico Pro, 11 May 2020