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ASHP Issue Brief: COVID-19 Diagnostic Testing and Immunization

Issue Brief

May 28, 2020


On March 27, 2020, the “ Coronavirus Preparedness and Response Supplemental Appropriations 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 the medical response, including coverage of COVID-19 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

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 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.

Pharmacists Can Provide COVID-19 Testing

On April 8, HHS released a guidance authorizing pharmacists to order and administer COVID-19 tests that are FDA-approved or authorized (i.e., under an Emergency Use Authorization). Previously, in most cases tests could not be ordered except by a physician or non-physician practitioner. However, the guidance alone does not preempt any state scope of practice laws or regulations prohibiting pharmacists from ordering and administering tests. To address potential state roadblocks, on May 19, HHS released an advisory opinion, stating that the Public Readiness and Emergency Preparedness (PREP) Act, which underpins HHS’s authorization of pharmacists to order and administer COVID-19, supersedes any state laws that would prohibit it. In practice, this means that the PREP Act effectively nullifies state laws that would prevent pharmacists from ordering or administering COVID-19 tests.

Medicare Payment for Testing – Dependent on Site of Care and Not Made Directly to Pharmacists

The HHS guidance and advisory opinion regarding pharmacist testing do not address payment. Instead, reimbursement for pharmacist testing is outlined in CMS’s Interim Final Rule on COVID-19 regulatory flexibilities (the “IFR”). Under the IFR’s testing framework, Medicare does not pay pharmacists directly and reimbursement for testing and specimen collection varies based on the site of care:

  • Community Pharmacy: In the community pharmacy setting, Medicare will reimburse pharmacies for the COVID-19 test, but not for specimen collection when patients walk into the pharmacy for testing. However, if the pharmacist goes into a patient’s home or a skilled nursing facility to collect specimens, Medicare will pay a specimen collection fee. To receive payment, the pharmacy will need to enroll in Medicare as an independent clinical laboratory. Pharmacies that have a private arrangement with a high throughput lab may also receive payment for specimen collection, but in such cases payment would come directly from the laboratory rather than Medicare. Although uncommon, a community pharmacist may also enter a contractual relationship with a physician that would allow the pharmacist to provide testing incident to a physician as described below.
  • Hospitals and Ambulatory Care Sites: Medicare will also pay pharmacists for testing in the hospital and ambulatory care setting. In these settings, payment is made for pharmacists’ assessment and specimen collection when provided incident to a physician’s or non-physician practitioner’s services. For testing provided in a physician’s office to both new and established patients, evaluation and management (E/M) code 99211 should be used. Under normal circumstances, 99211 can only be billed for established patients, but to ensure access CMS is opening the code to new patients for COVID-19 testing purposes only. In a hospital outpatient department, CMS has created a new HCPCS code, C9803, which is specific to COVID-19 assessment and specimen collection.

COVID-19 tests do not carry a cost-sharing requirement for Medicare beneficiaries. ASHP and other pharmacy groups are seeking clarification from CMS regarding how Medicaid will cover pharmacist testing. We are also monitoring private insurance coverage for pharmacist-provided COVID-19 testing.

Vaccination Coverage

CARES 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.

Practical Implications and Questions

CARES expands diagnostic testing access and CMS is allowing pharmacists to order and administer COVID-19 diagnostic tests, but coverage may shift as new tests and vaccines become available. For example, CMS has not yet proposed a framework for immunization coverage (when a vaccine becomes available). ASHP will regularly update members on agency actions and legislative developments related to all elements of COVID-19 response, including diagnostic testing and immunizations.