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Diagnostic Testing and Patient Screening Are Key to Successful US COVID-19 Response

Summary

As the novel coronavirus (COVID-19) spreads throughout the United States, media and policy focus on the rollout of diagnostic testing for the disease has greatly increased. Understanding the role of testing and screening is key to the control of this outbreak.

Note: This insight was originally posted on March 13, 2020. It was updated on April 22, 2020, to reflect the most recent information.

The US has been working to keep pace with other countries in number of tests performed and turnaround time to results reporting. Additionally, the Coronavirus Aid, Relief, and Economic Security (CARES) Act and Families First Coronavirus Response (FFCR) Act jointly require coverage and no cost-sharing for COVID-19 testing, with an additional requirement in CARES that provider relief grant funding be tied to a commitment not to balance bill COVID-19 positive or suspected-positive patients.

COVID-19 Tests and Logistics

Multiple versions of a laboratory test for COVID-19 have been developed since publication of the virus’ genome. The US Center for Disease Control (CDC) test and many commercial laboratory tests are real-time polymerase chain reaction tests that allow for rapid identification of the viral genetic material from samples taken from persons under investigation. Test marketing and distribution is authorized by the Food & Drug Administration (FDA) under an Emergency Use Authorization (EUA). The FDA recently expanded the EUA to allow individual CLIA-certified laboratories to develop and run their own versions of the COVID-19 test.

While recently developed test kits can theoretically return results in hours, a primary challenge will continue to be testing access and turnaround time logistics. Limitations on nasal swab kits and nurses available to administer them are creating restrictions on the number of patients who can be sampled per day. In addition, limitations on the supply chain for PCR reagents, such as Taq polymerase, are creating upper limits on the number of tests that individual laboratories can perform. This may necessitate additional logistic work to send overflow samples to areas with fewer cases, increasing turnaround time by days.

The FDA also recently expanded the EUA to include serological tests, which detect antibodies to SARS-CoV-2 and thus potentially identify previously infected patients who may have some level of immunity. Eventual widespread availability of this type of test is likely, with the FDA stating that over 70 test developers have notified the agency of serological tests in development.

With the advent of serological testing for SARS-CoV-2 antibodies, the testing and screening dynamic is likely to shift toward expanded screening of asymptomatic persons. Screening asymptomatic/recovered patients for antibodies to the novel coronavirus has been put forward as a key component of a “back to work” strategy in which healthy individuals with antibodies are presumed to have some level of immunity. Antibody testing is also crucial to the use of convalescent plasma, which has been suggested as a possible treatment for COVID-19. Thus, we may see more use of this diagnostic as a screening tool outside of the clinical setting.

Coding and Payment for COVID-19 Testing

The Centers for Medicare & Medicaid Services has created 4 Healthcare Common Procedure Coding System codes to describe COVID-19 PCR-based testing, U0001 and U0002, for the CDC test and testing using any technique, respectively, and U0003 and U0004, for use with high throughput technologies (defined as 200+ specimens/day). In addition, the American Medical Association created 2 new Current Procedural Terminology (CPT) codes, 86328 and 86769, for COVID-19 antibody testing. Payment rates for Medicare patients are currently left to the discretion of Medicare Administrative Contractors (MACs). As of March 12, the MACs have established payment for the CDC test (described by U0001) at approximately $36, and payment for all other COVID-19 tests (described by U0002) at approximately $51. Payment for the high throughput tests will be $100 to reflect the increase in resources costs. Payment rates for serological tests are not yet established, but a similar test for the Zika virus is currently reimbursed at approximately $17 (CPT code 86794 Antibody; Zika virus, IgM).

Coverage and Cost Sharing for COVID-19

The FFCR Act and CARES Act both mandate zero cost-sharing coverage for COVID-19 testing for both the diagnostic and serological tests, as well as any “items or services” that relate to the furnishing or administration of the test. However, this extension raises questions about coverage for other services associated with diagnosis and treatment of the virus, such as lung CT, which may still require cost-sharing. Under Medicare, this may include standard Medicare Part B 20% coinsurance up to a beneficiary’s deductible limit, which many patients may not have yet reached given that it is early in the year. This is likely mitigated by supplemental insurance coverage, which most Medicare patients have.

Medicaid cost sharing for services other than testing will vary by state across services but is expected to be limited. Finally, commercial insurers are also required to cover testing with no cost sharing, and although CARES grant funding prevents providers from balance billing COVID-19 testing, it is unclear whether the requirements in FFCR or CARES leave room for balance billing in cases where a lab does not receive a CARES grant and a lab’s published cash rate differs from the standard negotiated rate paid by an insurer.

Over 4 million total tests have been performed to date in the US, which equals a per capita rate of testing at over 12 tests per 1,000 people; however, this rate has increased linearly since mid-March and continues to lag testing rates in many European countries. Testing rates across states are highly variable but appear to be driven in part by outbreak hotspots within the country, with relatively high rates of testing in New York, Washington, Louisiana, and Florida.

Serology testing rates are likely to be determined by a variety of factors, including test availability across settings, state public health department policies, and employer return-to-work policies.

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