Advocacy Update

Read the Latest Issue of Advocacy Update

• House Passes $3 Trillion Emergency Spending Legislation, CAP Advocates for Relief for Pathologists
• CAP Raises Concerns on Current Serologic COVID-19 Testing
• SBA Releases Paycheck Protection Program Loan Forgiveness Application
• Tennessee Suspends Lab Inspections, Allows for Remote Work
• Take a Break With The May Advocacy News Quiz
• Editor’s Note

The House of Representatives passed a $3 trillion legislative package on May 15 to further combat the coronavirus pandemic and provide economic relief. Unlike previous relief packages enacted into law, the House legislation was passed along political party lines and is not expected to be taken up by the Senate immediately. The CAP has engaged with lawmakers to support certain provisions in the bill, but also called for additional changes to address specific issues concerning pathologists.

The CAP has advocated for a coordinated testing strategy for current and future pandemics. A recent survey of CAP-accredited laboratories revealed that nearly 80% of respondents had excess capacity for COVID-19 testing. A significant majority of respondents also documented challenges in obtaining necessary supplies for COVID-19 testing. The House legislation, entitled Helping Emergency Responders Overcome Emergency Situations (HEROES) Act, includes a requirement for the Department of Health and Human Services to offer an updated plan, which would address the concerns of laboratories reported in the CAP’s survey, for COVID-19 testing by June 15. For instance, the updated plan must include specific plans and benchmarks with clear timelines, regarding how to ensure sufficient availability and allocation of all testing materials and supplies, sufficient laboratory and personnel capacity, and specific guidelines to ensure adequate testing. In a May 14 letter to lawmakers, the CAP said a coordinated response among federal, state, and local governments should allow for regulatory flexibility and additional funds to support testing services and laboratory frontline providers.

The act also would make changes, advocated for by the CAP and many other physician associations, to the Medicare Accelerated and Advance Payment Program. The CAP said it was “encouraged by the language in the HEROES Act to lower the interest rate for loans to Medicare providers, reduce the per claim recoupment percentage, and extend the period before repayment begins. This is an important program and these changes will better ensure that pathologists can utilize this support and continue to focus on the essential task of testing and ensuring proper treatment of patients,” the CAP said. Because the program was halted on April 26, the CAP has asked Congress to have the Centers for Medicare & Medicaid Services (CMS), which oversees the program, to reinstate it.

In addition, the CAP has advocated for additional relief provisions to be included in the final COVID-19 legislation package. These provisions include:

• Stopping Medicare cuts to pathology services as a result of a budget mechanism and changes to evaluation and management services.
• Providing student loan relief
• Allocating funds to assist state and local medical examiner and coroner offices in supporting COVID-19 related diagnostic services

In a May 13 statement CAP President Patrick Godbey, MD, FCAP, expressed concern on the validity of the newly available serologic (antibody) tests, whose effectiveness remains unclear until more reliable studies and information about COVID-19 become available.

“There are still significant unknowns with respect to SARS-CoV-2 antibody testing, ranging from uncertainty regarding the accuracy of many commercially available assays to the clinical significance of positive results. Importantly, serologic testing is not currently recommended for detection of an active SARS-CoV-2 infection. Clinical laboratories should continue to employ the use of SARS-CoV-2 molecular tests performed from respiratory specimens for the diagnosis of acute COVID-19 infection in symptomatic patients. It is important for clinical laboratories to understand and communicate to providers that SARS-CoV-2 serology tests should not replace nucleic acid amplification tests for diagnosis of acute infection. Tests to detect SARS-CoV-2 antigen are beginning to come to market, but the clinical performance characteristics of these antigen tests have not been well studied, yet,” explained Dr. Godbey in the statement.

“The clinical and social implications of a detectable antibody response to SARS-CoV-2 remain unclear at this time, primarily because it is not yet known whether antibody presence correlates with longstanding protective immunity (as of May 2020). At this time, serology is best used for epidemiologic purposes, identifying possible donors of convalescent plasma, and for verification of vaccine response.

“Currently, neither changes in the use of personal protective equipment or adherence to social distancing practices can be made based on serologic test results,” Dr. Godbey stated.

Under the Food and Drug Administration (FDA) policy, commercial manufacturers will submit emergency use authorization requests, including their validation data, for serology tests for COVID-19. The FDA released this policy, which revised previous guidance, on May 4, following concerns regarding serology tests from the public.

There are currently three types of laboratory tests available for the detection of the novel (new) coronavirus SARS-CoV-2:

• Nucleic acid amplification tests to detect the RNA of SARS-CoV-2, thus an active or recent infection.
• Serology tests to detect antibodies against the SARS-CoV-2 virus and provide evidence that a person’s immune system has mounted a response to the viral antigens.
• Antigen tests to directly detect viral antigens in a specimen are beginning to come to the market, but their performance characteristics are not well studied.

Serology (or antibody) tests are designed to determine if a person was exposed to or infected with SARS-CoV-2 at some point. SARS-CoV-2 antibodies will be produced if a person had COVID-19 or if an individual had an asymptomatic or mild infection with SARS-CoV-2. Interestingly, several studies suggest that not all individuals will mount an antibody response post-infection. Serologic testing alone should not be relied upon to detect the active infection as antibodies can take days to weeks to develop, and testing too soon following infection may lead to a false-negative result. 

Read the full statement.

On May 15, the Small Business Administration (SBA) released the Paycheck Protection Program (PPP) Loan Forgiveness Application and detailed instructions for the application. The SBA will issue regulations and guidance to assist borrowers further as they complete their applications, and to provide lenders with advice on their responsibilities. The CAP will review these policies and provide additional guidance to members.

The PPP loan forgiveness is consistent with the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The form and instructions include several measures to reduce compliance burdens and simplify the process for borrowers, including:

• Options for borrowers to calculate payroll costs using an “alternative payroll covered period” that aligns with borrowers’ regular payroll cycles
• Flexibility to include eligible payroll and non-payroll expenses paid or incurred during the eight weeks after receiving their PPP loan
• Step-by-step instructions on how to perform the calculations required by the CARES Act to confirm eligibility for loan forgiveness
• Borrower-friendly implementation of statutory exemptions from loan forgiveness reduction based on rehiring by June 30
• Addition of a new exemption from the loan forgiveness reduction for borrowers who have made a good-faith, written offer to rehire workers that were declined

Click here to view the application and instructions. The CAP has additional resources to help pathology practices navigate government resources available to alleviate the economic impact from COVID-19.

Tennessee Gov. Bill Lee issued an executive order on May 12 that would, among other things, suspend state and medical laboratory inspections and allow laboratory directors and laboratory staff to work remotely when possible.

Tennessee joins other states, including New York, California, and Maryland, that have issued executive orders easing some regulations to allow health care professionals flexibility in dealing with the COVID-19 pandemic.

The order issued by Gov. Lee suspended several statutory provisions to facilitate the treatment and containment of COVID-19. Of importance to the pathology and clinical laboratory community, the order allows for suspension of all laboratory inspections during the pandemic. It also allows medical laboratory directors to monitor facilities remotely through the use of technology.

In addition, the order allows medical laboratory personnel to review electronic data remotely and report laboratory results without having a separate laboratory license for each remote location. Such personnel must be employed by a licensed medical laboratory and working under the supervision of a laboratory director.

The order allows testing of COVID-19 to occur at alternate testing sites without prior approval by the state Medical Laboratory Board, provided the board is notified of such sites.

The Council of State Governments has compiled a full list of COVID-19-related executive orders issued across the United States. The CAP also has compiled useful information about the COVID-19 pandemic, including how to implement a SARS-CoV-2 test in your laboratory and best practices for using biologic safety cabinets while testing for COVID-19.

Need a break? Why don’t you take the May Advocacy News Quiz. See how you compare against your fellow CAP members’ in the May News Quiz. Take the May news quiz.

Advocacy Update will take a scheduled break on May 26. You will receive the next edition of Advocacy Update in your email inbox on June 2. Please continue to check our Twitter, Facebook, and LinkedIn accounts for updates from the CAP.