On March 27, 2020, the “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act) was passed. This is the third piece of legislation to address the COVID-19 crisis, with provisions largely centered on shoring up the economy and providing additional support for medical response, including coverage of COVID-19 testing and treatment and additional money for hospitals, health centers, and other providers. The law includes several provisions specifically addressing diagnostic testing and immunizations for COVID-19.
Diagnostic Testing Coverage and Payment
As a preliminary matter, CARES makes explicit the requirement that diagnostic tests be included in the strategic national stockpile (SNS). Previously, the requirements for the SNS were vague, requiring only “other supplies” rather than specifying certain product types.
CMS has already announced that Medicare, Medicare Advantage, and Medicaid will cover COVID-19 diagnostic testing. CARES builds on the previously-enacted commercial payor coverage for COVID-19 diagnostic testing. The law expands the types of diagnostic tests that are covered to include not just FDA-approved tests, but also CLIA-waived laboratory-developed tests. It also provides the Health & Human Services (HHS) Secretary with discretion to cover additional types of diagnostic tests. Uninsured individuals who do not qualify for Medicaid may still have to pay out-of-pocket for diagnostic testing.
The law does not specify who can provide diagnostic testing nor does it include a reimbursement amount. Thus, subject to plan agreements and state scope of practice, pharmacists may be able to provide COVID-19 diagnostic testing. However, the reimbursement for testing depends largely on health plans’ arrangements. Under the law, health plans must pay either their previously negotiated rates for testing or, if they did not have an agreement in place with a provider pre-COVID-19, they can negotiate a new one or pay the provider the plan’s publicly listed cash price for the service. Health plans must list a cash price for COVID-19 testing on their websites – although the exact location for such information (e.g., a provider-facing website versus a patient portal) is not specified – or face civil monetary penalties.
The law includes provisions to ensure rapid adoption and uptake of any COVID-19 vaccination that becomes available. Under CARES, a COVID-19 vaccine will be considered a “preventive health service,” meaning that plans must cover it without cost-sharing. However, the vaccine must still be recommended by the U.S. Preventive Health Services Taskforce and the Center for Disease Control & Prevention’s Advisory Committee on Immunization Practices (ACIP) before it is covered with no cost-sharing. Under normal circumstances, health plans would have one year from the recommendation to cover the service, but CARES cuts that time down to 15 days. The 15-day window to implement cost-sharing free coverage of Taskforce and ACIP recommendations will also apply to COVID-19 treatment services.
Practical Implications and Questions
CARES expands coverage for COVID-19 testing and immunization, but many of the crucial details, including who can provide these services and how they will be reimbursed, have yet to be determined by HHS, its subagencies, and health plans. Further, coverage will shift as new diagnostic tests and vaccines become available. ASHP will regularly update members on agency actions and developments related to all elements of COVID-19 response, including diagnostic testing and immunizations.