The Roadblocks to Recovery: Expanding Public Access to Community Pharmacy Services Beyond the COVID-19 Pandemic, Part 4

The following is part 4 of 6 in a series of articles titled, "Expanding Public Access to Community Pharmacy Services Beyond the COVID-19 Pandemic" by Jason Ausili, PharmD, MSLS, Head of Pharmacy Transformation for EnlivenHealth.

Enter the 9th Amendment & REGEN-COV

In September of 2021, pharmacists were granted authority to order and administer certain COVID-19 therapeutics under the 9th Amendment to the PREP Act. Immediately following this news, pharmacists eagerly anticipated the opportunity to treat patients with mild to moderate COVID-19 using the monoclonal antibody REGEN-COV.

The healthcare provider fact sheet for REGEN-COV, aligned with the Food and Drug Administration's (FDA) Emergency Use Authorization (EUA), had language supportive of the pharmacist's privilege to order and administer the product under the PREP Act amendment. This drug showed promising efficacy in reducing the risk of COVID-19 related hospitalization and death during the delta variant phase.

Treatment by Pharmacists Authorized, Then Restricted

Although product supply was scarce, pharmacists played a direct role in preventing hospitalization or death in the most vulnerable patients. Despite being authorized to order and administer COVID-19 therapeutics, pharmacists have been unnecessarily restricted from helping millions of patients in desperate need and are at risk for losing these privileges when the public health emergency (PHE) expires.

In December of 2021, the U.S. Food and Drug Administration (FDA) announced the EUA approval of two oral antiviral products for the treatment of COVID-19, Paxlovid™ and molnupiravir. To the surprise of many public health advocates, the EUAs and the healthcare provider fact sheets for Paxlovid™ and molnupiravir explicitly called out licensed physicians, nurse practitioners (NPs), and physician assistants (PAs) as the only prescribers.

In conflict with the PREP Act declaration, the FDA intentionally blocked pharmacists from being able to prescribe these products, rendering them significantly less accessible to those in desperate need. The American Pharmacists Association (APhA), American Society of Consultant Pharmacists (ASCP), American Society of Health-System Pharmacists (ASHP), National Alliance of State Pharmacy Associations (NASPA), and the National Community Pharmacists Association (NCPA) responded immediately after the EUA approval, issuing a joint statement that condemned the decision. "The ability of pharmacies to be a one-stop shop for testing, patient assessment, ordering, and dispensing would be a game-changer for timely access to these needed treatments — just as it has been for the administration of COVID vaccines," concluded the statement.

During the State of the Union address on March 1, 2022, President Biden announced, "And now we're launching the ‘Test to Treat' initiative so people can get tested at a pharmacy and, if they prove positive, receive the antiviral pills on the spot at no cost ". Many professionals took this message at face value, believing that armed with the President's support, pharmacists were going to get a second chance to leverage PREP Act authorities to help their communities and improve access to the oral antiviral products.

Unfortunately, the FDA's EUA block held strong, preventing any such expansion from happening. The AMA's response not only discredited the move by stating, "the pharmacy-based clinic component of the test-to-treat plan flaunts patient safety and risks significant negative health outcomes," but also tactically cornered the expansion into clinics located in pharmacies already staffed by NPs and PAs.

"Extremely Unfortunate, But Also Extremely Predictable"

If the President's true intent were to make these products more accessible to the public, this model would fall dramatically short of the goal in the absence of broad community pharmacy support. The National Association of Chain Drug Store's (NACDS) President and CEO, Steve Anderson, promptly responded to AMA's announcement, stating, "The AMA's criticism of the role of pharmacy-based clinics in the new ‘test-to-treat' COVID antivirals program is extremely unfortunate, but also extremely predictable."

Anderson later called out the limited benefit of expanding access to oral antivirals to pharmacy-based clinics staffed by NPs and PAs, and mentioned the minimized role of pharmacists "to dispense the medications." He added, "If anything, the patient journey for these medications would benefit further from the inclusion of pharmacists as prescribers, consistent with the Ninth Amendment to the current declaration of the Public Readiness and Emergency Preparedness Act, or PREP Act."

On July 6, 2022, the FDA revised the EUA for Paxlovid to "authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid." The director for FDA's Center for Drug Evaluation and Research added, "The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic," and further supported that since the drug "must be taken within five days after symptoms begin," pharmacists prescriptive authority on this front "could expand access to timely treatment for some patients who are eligible to receive this drug for treatment of COVID-19."

Although the FDA's actions represent an important win for patient access and health equity, the COVID-19 treatment privileges afforded by lawmakers are temporary in nature and are at risk for expiration if immediate action is not taken.

A New Hope: Introducing the ECAPS Act

Another glimmer of hope appeared on March 24, 2022, when the Equitable Community Access to Pharmacist Services (ECAPS) Act, H.R. 7213, was introduced in the U.S. House of Representatives. Introduced by Congressman Ron Kind (D-WI), Congressman David B. McKinley (R-WV), Congresswoman Nanette Diaz Barragan (D-CA), and Congressman Buddy Carter (R-GA), this provider status bill has strong bipartisan support and should carry promise in the crosswinds of a global pandemic.

If enacted, this bill would recognize pharmacists federally as eligible providers under the Medicare Part B program and would enable Medicare patients to receive "timely and consistent treatment from pharmacists for pandemic-related health services and would allow pharmacists to respond to ongoing and future public health threats to our nation." The legislation would amend title XVII of the Social Security Act and create a pharmacist reimbursement mechanism under CMS for pandemic-related services, such as testing, treatment, and vaccination for COVID-19, influenza, respiratory syncytial virus (RSV) or streptococcal pharyngitis (Strep).

This bill would also open the door to additional public health needs pursuant to a public health emergency and further position community pharmacy to help balance the growing PCP shortage and combat health disparities. Payment for these services, set at 85 percent of the physician fee schedule, would be equal to that of mid-level practitioners, PAs, and NPs.

Throughout the COVID-19 pandemic, pharmacists have received a reasonable administration fee of $40 per COVID-19 vaccination to incentivize COVID-19 vaccinations in the Medicare population. That said, this type of reimbursement is refined to one category of vaccines and falls short of recognizing pharmacists for their time caring for the patient. Without recognizing the service component of patient evaluation and assessment, payment is reduced to that of dispensing a product, which in modern times is minimal and barely covers the cost of the medication alone.

Although the pharmacist provider status scope, indicated by the ECAPS Act, is limited to pandemic-related services and payment is on par with that of mid-level professionals, this would be a colossal step forward for pharmacists as healthcare providers. Certain states have recognized and reimbursed pharmacists on this level, but there has never been a federal mechanism to reimburse pharmacists for the evaluation and management of patients.

More Pushback from the AMA

Again, in a predictable fashion, the AMA's CEO and Executive Vice President, James Madara, MD, responded in opposition to the ECAPS Act by sending a letter to Representatives Kind and McKinley, stating, "I am writing to express our opposition to H.R. 7213, the Equitable Community Access to Pharmacist Services Act, which would inappropriately expand Medicare payment for pharmacists in limited but significant ways and undermine state scope of practice laws and the ability of states to regulate pharmacists."

AMA's attempt to block this meaningful expansion of pandemic-related public health services underscores a selfish and competitive position at the expense of community access to care. The continual efforts to shut down pharmacy-based service expansion during a pandemic, in the face of growing PCP shortage and worsening health disparities, is nothing short of an atrocity.

The American Pharmacists Association's (APhA) response to the AMA letter points out the group's inaccurate description of the ECAPS Act and its absent power to undermine state scope of practice. The bill clearly states, "under State law," when referring to the scope of services furnished by a licensed pharmacist and is designed to support services that pharmacists are already trained to do under state practice laws. APhA also points out that the AMA opposition fails to represent the viewpoints of the "majority of physicians" that work collaboratively with pharmacists daily to promote a "team approach" to healthcare.

There is no time for a turf battle during a global pandemic, especially in the face of a physician workforce shortage. The ECAPS Act would provide long-overdue pharmacist provider status recognition that will improve community access to public health services, combat health inequities and disparities, help our nation heal from this pandemic, and be better prepared for the next one.

NEXT — Part 5: What Happens When the PHE Ends? »