HHS Recognizes the Role of Pharmacists in COVID-19 Testing

Pharmacists are frequently the first point of contact with a healthcare provider for many Americans. In an effort to implement large-scale testing for COVID-19, on April 8, 2020, the Office of the Assistant Secretary of Health, HHS, authorized licensed pharmacists to order and administer FDA-approved COVID-19 tests, including serology tests.[1]  Pharmacies, located across the U.S., are well positioned to become testing sites and pharmacists’ extensive training make them capable of performing nasopharyngeal swabs. Approximately 44 states, including New Jersey (but not as yet New York) permit pharmacists to perform CLIA-waived tests (available without a prescription or medical order) (e.g. strep throat test kits).[2],[3] CLIA-waived COVID-19 testing is permitted pursuant to other state requirements. For example, a state may require a collaborative practice agreement, between the pharmacist and a physician, to allow the pharmacist to administer the test. The HHS Guidance includes pharmacists under the PREP Act, thereby providing immunity for all claims of loss from administration or use of the COVID-19 tests.[4]  Additionally, when a vaccine becomes available, pharmacists, the primary immunizers in the U.S., will be on the front lines to immunize patients.

The Guidance does not address or change whether pharmacists may be reimbursed for ordering or providing such tests under either federal healthcare programs or other third-party payors. However, CMS has already announced that Medicare, Medicare Advantage, and Medicaid will cover COVID-19 testing. The Coronavirus Aid, Relief, and Economic Security Act (CARES)[5] does not include a reimbursement amount and this would likely depend largely on negotiated rates. Health plans are required to post a cash price for COVID-19 testing on their websites.

How Frier Levitt Can Help

Contact a Frier Levitt, LLC attorney to navigate pharmacy reimbursement issues COVID-19 testing may generate.

 

[1] Guidance for Licensed Pharmacists, COVID-19 Testing and Immunity Under the PREP Act, U.S. Dept HHS, Office of Assistant Secretary for Health. April 8, 2020.

[2] Clinical Laboratory Improvement Act of 1988. P.L. 100-578. Oct. 31, 1988.

[3] Point-of-Care Testing Background Paper Prepared for the 2015–2016 APhA Policy Committee Marsha Gilbreath, PharmD.

[4] 42 U.S.C. ¶ 247d-6d(a)(1).

[5] P.L. 116-136. March 27, 2020.

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