In an effort to rapidly expand COVID-19 testing, including antibody testing, across America, the US Department of Health and Human Services (HHS) issued sweeping guidance under the Public Readiness and Emergency Preparedness (PREP) Act on April 8 authorizing licensed pharmacists to order and administer COVID-19 tests that the US Food and Drug Administration (FDA) has authorized. The HHS guidance states that in providing COVID-19 testing, pharmacists will qualify as “covered persons” under the PREP Act and have some immunity under the PREP Act for the front-line efforts they are providing.
On April 12, Governor Cuomo issued Executive Order 202.16, which seemed to clear the way for pharmacy testing. The order allowed testing to be performed by suspending many of the requirements applicable to testing in New York State. Specifically, the order allowed testing by individuals who “meet the federal requirements for testing personnel appropriate to the assay or device authorized by the FDA or the NYS Department of Health[.]”
The HHS guidance and EO 202.16 appeared to grant pharmacies the authority to order and administer COVID-19 testing at point of care in community pharmacies as authorized by the FDA. However, a regulatory snag appeared when the NY Office of Professions (NYOP) updated its COVID-19 FAQs.
Initially, the NYOP stated that pharmacies were not permitted to even administer tests under NYS law. Then, this week, the guidance changed in an FAQ permitting a pharmacy to administer diagnostic testing if certain, very limiting conditions were met that traditionally applied to laboratories. The impact of these requirements is that NYS pharmacies now have conflicting regulatory messages regarding whether they can conduct the COVID-19 testing that is so critical to the state’s plans to reopen.
Specifically, the NYOP stated entities that wish to conduct high and moderately complex testing must obtain a full clinical laboratory permit from the NYS Department of Health (DOH) unless administering a Clinical Laboratory Improvement Amendments (CLIA)-waived test. In New York State, there are three CLIA-waived diagnostic COVID-19 tests that can be performed by entities holding only a limited service laboratory (LSL) registration through the DOH. However, the NYOP guidance fails to explicitly permit antibody testing to be performed by an LSL, even though the FDA has authorized the use of four tests under the emergency use authorization guidelines and allowed serological test developers to market and use their tests without prior FDA review under certain restrictions.
Even where has a pharmacy has an LSL license, it may perform COVID-19 testing only when it is ordered by a “qualified health care professional”—another roadblock to scaled-up testing in the community contrary to the spirit, if not the letter, of Governor Cuomo’s executive order. For independent pharmacies, the situation becomes more confusing as large chain pharmacies are conduct COVID-19 testing that is being overseen by pharmacists. Moreover, several other states, including Pennsylvania, have issued executive orders and guidance expressly permitting pharmacists to order and administer testing as authorized by the federal government.
Barclay Damon LLP is closely monitoring updates in New York State and elsewhere as developments on these critical COVID-19 community testing issues unfold.
If you have any questions regarding the content of this alert, please contact Linda Clark, Health Care Controversies Team leader, at lclark@barclaydamon.com; Brad Gallagher, counsel, at bgallagher@barclaydamon.com; or Bridget Steele, associate, at bsteele@barclaydamon.com.
We also have a specific team of Barclay Damon attorneys who are actively working on assessing regulatory, legislative, and other governmental updates related to COVID-19 and who are prepared to assist clients. You can reach our COVID-19 Response Team at COVID-19ResponseTeam@barclaydamon.com.