Questions Remain for Pharmacy Test-to-Treat Programs

Last week, the U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for Paxlovid to authorize state-licensed pharmacists to prescribe the medication to eligible patients, with certain limitations.[1]

Paxlovid is an oral antiviral pill that reduces the risk of severe illness, hospitalization, and death from COVID-19.[2] According to the FDA, “Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.”[3] The FDA’s decision is unique because it explicitly authorizes a specific health care provider type to prescribe a product. More narrowly, the action provides increased access points for eligible patients infected with COVID-19 by allowing pharmacists to independently order and dispense Paxlovid.

While this action advances COVID-19 response efforts, it has also prompted several questions surrounding how pharmacies and pharmacists can use the authorization to further build robust and successful test-to-treat programs with the Paxlovid pharmaceutical product. Currently, some pharmacies participate in a nationwide “Test to Treat” initiative that provides access to treatments for COVID-19, including Paxlovid, but the program relies on other practitioners, like nurses, to prescribe the COVID-19 treatment.[4] In the program, people can receive COVID-19 testing, a prescription for oral antivirals, and, when appropriate, fill their prescription all at one location.[5]

Scope of the Revised EUA

The revised EUA requires state-licensed pharmacists who are seeking to prescribe Paxlovid to first evaluate a patient’s health record, provided that the health record is less than 12 months old. While reviewing the record, the EUA specifies that pharmacists should go over “the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems.” Pharmacists must also evaluate all current patient medications, including over-the-counter medications, to screen for serious interactions with Paxlovid.[6]

In addition, the revised EUA requires a pharmacist to refer patients for further clinical evaluation to a physician, advanced practice registered nurse (APRN), or physician assistant licensed or authorized under state law to prescribe drugs if any of the following apply:

• Sufficient information is not available to assess renal and hepatic function.
• Sufficient information is not available to assess for a potential drug interaction.
• Modification of other medications is needed due to a potential drug interaction.
• Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.[7]

Pharmacist Authorization Blocked in December 2021

Under state scope-of-practice laws, pharmacists have historically been proscribed from performing certain clinical activities, such as assessing patients (e.g., administering tests) or independently prescribing medications. During the pandemic, however, the U.S. Department of Health and Human Services (HHS) exercised its declaration authority under the Public Readiness and Preparedness Act (PREP Act) to authorize pharmacists, pharmacy technicians, and pharmacy interns to engage in the COVID-19 response, despite state scope-of-practice limitations.[8] Indeed, very early in the pandemic, HHS amended its PREP Act declaration to authorize pharmacists to order and administer COVID-19 tests and vaccines, as well as flu and childhood vaccines.[9] According to the federal government, including the U.S. Department of Justice, “the PREP Act preempts state and local requirements that would prohibit or effectively prohibit qualifying state-licensed pharmacists covered by a [PREP Act] declaration . . . .”[10]

In October 2021, ahead of the FDA’s authorization for Paxlovid and other COVID-19 treatments, HHS amended its PREP Act declaration once more to authorize pharmacists to order and administer certain COVID-19 therapeutics.[11] The proactive measure signaled a general recognition of the importance of pharmacists in expanding access to COVID-19 treatments. However, this spirit was incongruent with the parameters of the FDA’s initial EUA for Paxlovid released in December 2021, which specifically stated the product could only be “prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs”—not pharmacists.[12]

Considerations

Seven months later, the FDA’s amended EUA revised the intent of the PREP Act declaration amendment and provided a new avenue for patients to receive COVID-19 treatment from pharmacists. The action releases pharmacies and pharmacists to deploy bespoke test-to-treat programs at pharmacy locations. However, pharmacies and pharmacists seeking to institute test-to-treat programs for Paxlovid under the PREP Act declaration and the new EUA may want to consider the following:

• Access to Product: The U.S. government purchased 10 million courses of the product on an exclusive basis when Pfizer received its EUA for Paxlovid.[13] Accordingly, the product is required to flow directly through channels that have direct contracts with the federal government. For example, pharmacies participating in the current federal Test-to-Treat program receive direct shipments of the product from the federal government.[14] Pharmacies and pharmacists wishing to establish test-to-treat programs outside of the federal program should consider how locations can receive the product from the federal government and establish relevant agreements in advance of setting up those programs.
• Reimbursement for Services: Currently, pharmacies can receive reimbursement for dispensing treatments like Paxlovid, but similar reimbursement pathways for a pharmacist’s clinical workup to prescribe the treatment may not be available with some payers. For example, under Medicare, reimbursement for Paxlovid is provided under Medicare Part D, a pharmacy benefit, while clinical services are traditionally paid under Medicare Part B. Pharmacists, however, are not permitted to submit claims to Medicare Part B for most services. Yet, pharmacies and pharmacists may expend significant resources to set up such programs at the pharmacy, underscoring the increasing importance of recognizing pharmacist provider status. Outside of significant policy changes to create such a reimbursement pathway in Medicare Part B, pharmacies and pharmacists may wish to consider viable reimbursement pathways to pay for a pharmacist’s services through a patient’s pharmacy benefit, including the establishment of an “enhanced dispensing fee” with payers.
• Liability Protections: The COVID-19 PREP Act declaration permits pharmacists to conduct certain activities, including prescribing Paxlovid, outside of a pharmacist’s legal scope of practice because the declaration provides pharmacists with immunity from liability for carrying out such activities. While the declaration has been an important tool in the federal government’s COVID-19 response, it will eventually expire, along with the corresponding liability protections. Indeed, the declaration contains two separate expiration dates for actions taken with respect to “covered countermeasures,” a term that includes COVID-19 vaccines and treatments. For example, providers identified under the PREP Act declaration receive liability protection through October 1, 2024, as long as those providers administer covered countermeasures that are related to any federal agreement.[15] In contrast, some providers outside of federal agreements are only provided immunity from liability until October 1, 2024, or when the Public Health Emergency (PHE) declaration ends, whichever occurs first.[16] It should be noted that the PHE declaration is a separate and distinct declaration outside of the PREP Act declaration. Still, the expiration of the PHE declaration is used in the PREP Act declaration to determine liability immunity expiration dates for certain providers. In setting up long-term test-to-treat programs, pharmacies and pharmacists should evaluate the applicable expiration dates under the PREP Act declaration. Pharmacies and pharmacists will also want to consider the possibility of enforcement actions if a provider is acting outside of the PREP Act declaration’s scope.
• Operational Complexity: The EUA established limitations that require pharmacists to evaluate patients for kidney and liver problems, as well as any medication interactions. The complexity of the clinical work authorized under the revised EUA raises questions surrounding a pharmacy’s standard operating procedures for servicing patients inside the pharmacy. Pharmacies and pharmacists should consider pharmacy workflow implications and training necessary to establish a well-functioning test-to-treat program inside the pharmacy. Likewise, pharmacists are required to refer patients to physicians, APRNs, and physician assistants under certain circumstances enumerated under the EUA. Pharmacies and pharmacists should therefore evaluate whether any existing or new referral arrangements with practitioners comply with anti-kickback and Stark laws. Finally, pharmacies and pharmacists should consider what constitutes “sufficient” information under the EUA. Pharmacies and pharmacists may wish to review information from the FDA on the EUA revision, published in its “Frequently Asked Questions” document[17] and its “Fact Sheet for Healthcare Providers: Emergency Use Authorization for Paxlovid”[18] for additional context.

Conclusion

The FDA’s decision expands access to treatment options for patients and is consistent with previous federal guidance under the PREP Act that greatly expanded the ability of pharmacists to offer COVID-19-related services. Beyond the more immediate considerations highlighted above, the revised EUA further catalyzes the role of the pharmacist in health care delivery and sets the stage for post-pandemic scope-of-practice decisions in the states.

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ENDNOTES

[1] Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations (July 6, 2022), available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pharmacists-prescribe-paxlovid-certain-limitations.

[2] Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 (Dec. 22, 2021), available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19.

[3] Id.

[4] COVID-19 Test to Treat Locator, available at https://aspr.hhs.gov/TestToTreat/Pages/default.aspx.

[5] Fact Sheet: Federally-Supported Test to Treat Sites, available at https://aspr.hhs.gov/TestToTreat/Pages/fact-sheet-t2t-fed.aspx.

[6] Coronavirus (COVID-19) Update: FDA Authorizes Pharmacist to Prescribe Paxlovid with Certain Limitations (July 6, 2022), available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pharmacists-prescribe-paxlovid-certain-limitations.

[7] Id.

[8] Public Readiness and Emergency Preparedness Act, available at https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx.

[9] Id.  

[10] U.S. Department of Justice, Office of Legal Counsel, Memorandum Opinion for the General Counsel Department of Health and Human Services (Jan. 19, 2021), available at https://www.justice.gov/olc/file/1356956/download.

[11] HHS PREP Act Declaration: 9th Amendment, available at https://www.phe.gov/Preparedness/legal/prepact/Pages/PREPact-NinethAmendment.aspx.

[12] https://www.fda.gov/media/155049/download.

[13] Pfizer to Provide U.S. Government with an Additional 10 Million Treatment Courses of its Oral Therapy to Help Combat COVID-19 (Jan. 4, 2022), available at https://www.pfizer.com/news/press-release/press-release-detail/pfizer-provide-us-government-additional-10-million.

[14] Distribution to Pharmacy-based Clinics and Long-term Care Pharmacies, available at https://aspr.hhs.gov/TestToTreat/Pages/distribution.aspx.

[15] 87 Fed. Reg. 982, 988 (Jan. 7, 2022), available at https://www.govinfo.gov/content/pkg/FR-2022-01-07/pdf/2022-00151.pdf (showing that the most recent amendment to the PREP Act declaration revised section XII to specify expiration dates for certain providers under certain circumstances).

[16] Id.

[17] Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19 (July 6, 2022), available at https://www.fda.gov/media/155052/download.

[18] Fact Sheet for Healthcare Providers: Emergency Use Authorization for Paxlovid (July 6, 2022), available at https://www.fda.gov/media/155050/download.