Advocacy Update

Read the Latest Issue of Advocacy Update

February 25, 2020

In This Issue:

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The Centers for Disease Control & Prevention (CDC) reiterated that only CDC public health, CDC state, and Department of Defense laboratories can use the Emergency Use Authorization (EUA) tests at this time. Moreover, the CDC reminded clinical laboratories that this is the only EUA assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes the CDC 2019-Novel Coronavirus (COVID-19).

On February 20, the CDC published frequently asked questions [CF(1] about specimen handling for COVID-19. The FDA granted a EUA for COVID-19 Real-Time RT-PCR Diagnostic Panel, which is to be used in qualified laboratories for testing patient respiratory specimens that meet CDC criteria for COVID-19 testing.

Any laboratory that is not designated by the CDC as a qualified laboratory and is implementing a COVID-19 diagnostic test other than the CDC EUA assay must contact the FDA to obtain a EUA before any COVID-19 diagnostic testing may be performed in their facilities.

The CAP will work with the CDC to monitor the outbreak and laboratory capacity to provide testing. The CAP will provide further updates as new information becomes available.

The Secretary of the Department of Health and Human Services issued an emergency declaration that justifies the authorization of emergency use of in vitro diagnostics for the detection of SARS-CoV-2 and the diagnosis of COVID-19. All tests for SARS-CoV-2, including laboratory-developed tests (LDTs), must be reviewed and cleared or authorized by the FDA for emergency use, or they cannot be used for diagnostic testing. The FDA requests that developers of such LDTs submit information about their tests to help FDA better understand their design, validation, and performance characteristics.

Qualified laboratories for the use of the CDC-distributed 2019-nCoV Real-Time RT-PCR Diagnostic Panel, as defined by the EUA, include select US state and local public health laboratories and Department of Defense laboratories. Diagnostic testing with this assay can only be done at the CDC and by these qualified laboratories. The state and local public health laboratories are in the process of implementing the CDC EUA assay.

Clinical laboratories should contact their state health departments for guidance if they have a suspected COVID-19 case specimen. Moreover, clinical laboratories that need a diagnostic test for COVID-19 performed should contact their local health department, which will either provide testing or facilitate referral of the specimen to the CDC for testing.

Clinical laboratories should not attempt viral isolation from specimens collected from COVID-19 persons under investigation (PUIs). For interim guidelines for collecting, handling, and testing clinical specimens from PUIs for COVID-19, please see the CDC Coronavirus Disease 2019 (COVID-19) website. For additional information, please refer to the FDA: Information for Laboratories Implementing IVD Tests Under EUA.

Congress will soon hold hearings regarding funding to combat the COVID-19. The CAP will continue to provide updates.

With renewed attention on surprise bills, the CAP strongly advocates for reimbursement provisions that fairly compensate physicians for medical care provided out-of-network. In a recent CAPcast, David Gang, MD, FCAP, and Mathew Foster, MD, FCAP, the respective chair and vice-chair of the Federal and State Affairs Committee, discussed their recent trips to Capitol Hill to meet with legislators on surprise billing.

In the CAPCast, both Dr. Gang and Dr. Foster discussed the essential role pathologists play in the surprise billing debate. Because of the CAP’s member grassroots advocacy on the topic, congressional leaders included CAP-backed provisions in updated surprise billing legislation. For example, new legislation features an open mediation, or independent dispute resolution, a process without an arbitration threshold. Further, the House Ways & Means legislation does not have a benchmark payment and includes several patient protections supported by the CAP.

Urge Your Representatives to Act on Surprise Bills
Go to the CAP’s action center to tell your representatives in Congress to support our positions on surprise medical bill legislation. Enter your email and ZIP code to login and select the legislative alert on surprise billing. In just a few clicks, you can easily communicate with your elected officials.

It’s the last week to take the Advocacy News Quiz and see how you stack up against your fellow CAP members. Tray and share your results on social media. Take the February news quiz today.