Inability to Bill Prevents Pharmacists from Prescribing Paxlovid

Terry Ann Donner, BSN, RN

On July 6, 2022, the FDA updated the Emergency Use Authorization (EUA) for the COVID-19 antiviral Paxlovid, to permit pharmacists to prescribe Paxlovid under limited circumstances. The FDA hoped to help populations at high risk of hospitalization or death from COVID-19 to quickly receive treatment.

With the updated EUA, Pharmacists can prescribe Paxlovid within five (5) days of a positive COVID-19 test to two at risk groups:

Those 65 years of age and older, or
Those 12 years of age and older, weighing at least 40 kilograms (88 pounds), who are obese, diabetic, have a cancer diagnosis or another chronic disease.

CVS has created a process for its pharmacists to follow in the limited locations where it does allow pharmacists to prescribe Paxlovid. The first step involves the customer completing a digital eligibility screen to determine if Paxlovid is potentially a treatment option. If the customer is determined to be a candidate based upon the digital screening, the customer is then subject to a more in depth clinical assessment by a pharmacist. The information gathered from the customer in the digital screen, includes:

General identification information
Weight screening (you must be at least 88 pounds or 40 kilograms)
Confirmation that the customer has tested positive for COVID-19 in the past 5 days
Whether the customer has at least one chronic condition
Whether the customer has liver or kidney disease
If the customer has had a blood test in last 12 months, so lab results can be accessed electronically or by talking with the person's physician
Screening for potential drug interactions with Paxlovid
Whether the customer takes supplements or over-the-counter medications
Allergies to food or medication
Whether the customer is a Medicare or Medicaid beneficiary

The pharmacist must then assess each candidate that makes it through the digital screen for potential liver and kidney disease and for potential drug interactions. The clinical assessment is time-consuming, requiring that the pharmacist obtain access to electronic or printed health record information for lab results on the customer's hepatic and renal function that are no more than 12 months old. If there are no records available, the pharmacist must then consult with the customer's health care provider regarding the individual's liver and kidney function. This must all be done timely, as Paxlovid must be given within 5 days of a positive COVID-19 test.

The pharmacist must also obtain a comprehensive list of prescribed medications, supplements and over-the-counter medications so potential drug interactions with Paxlovid can be ruled out. If there are potential interactions or any of the medications must be modified in order for the individual to take Paxlovid, the pharmacist cannot prescribe the medication.

As a result of the significant time involved in completing the clinical assessment, pharmacies, which are already short-staffed, must be able to bill for their pharmacists' time. This fee is not covered by private insurance, Medicare or Medicaid. CVS has determined that a fee of up to $60 will be charged by its participating pharmacies for the clinical assessment. Customers can pay in cash, by using a flexible spending account (FSA) or through a health spending account (HSA).

Currently, the Medicare and Medicaid programs do not have a way to submit or authorize a clinical assessment fee for pharmacists. As a result, CVS is temporarily excluding Medicare and Medicaid beneficiaries from the group of high-risk candidates for whom its pharmacists can prescribe Paxlovid. The website specifically instructs Medicare and Medicaid beneficiaries to see their physician to get a Paxlovid prescription.

The American Society of Health System Pharmacists, representing over 60,000 pharmacists, pharmacy technicians and pharmacy students, crafted a letter on July 21, 2022, to the Administrator for the Centers for Medicare & Medicaid Services and to the Deputy Administrator and Director of the Center for Medicaid and CHIP Services explaining that no reimbursement mechanism exists for the patient assessment and counseling that pharmacists are required to do in connection with the prescribing of Paxlovid. ASHP indicated that given the current uptick in COVID-19 cases, it is imperative for pharmacies to be able to allow their pharmacists to prescribe Paxlovid. However, due to the time involved in conducting the clinical assessment, the costs associated with providing this service will not be feasible without some form of reimbursement.

The result is that those over 65 (and covered by Medicare) and those with low income who are chronically ill (and covered by Medicaid) are at higher risk of hospitalization or death from COVID-19 and will not be able to get a timely prescription for Paxlovid from their neighborhood pharmacist. They will have to see another licensed health care provider to try to get treated with Paxlovid within 5 days of a positive COVID-19 test, which is not always possible.

Medicare and Medicaid beneficiaries constitute a large portion of the population that the updated EUA was designed to protect. The lack of reimbursement for pharmacist clinical assessment services by Medicare and Medicaid is having a chilling effect on the ability of pharmacies to decrease potential negative outcomes in this population. It is unclear how long it will take for the Centers for Medicare and Medicaid to act; however, pharmacies are unlikely to roll out training and allow pharmacists at all locations to prescribe Paxlovid until reimbursement mechanisms exist. The result will be a chilling effect on what could have been an early intervention tactic in the treatment of COVID-19 in high-risk populations.

References/Resources

Coronavirus What You Need to Know NCPA National Community Pharmacists Association: Billing for assessment by a pharmacist for Paxlovid treatment

CVS® pharmacists can now prescribe Paxlovid to treat COVID-19

FDA Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers

ASHP July 21, 2022 Letter to Administrator of CMS and Deputy Administrator of Medicaid & CHIP

Inability to Bill Prevents Pharmacists from Prescribing Paxlovid

About Terry Ann Donner, BSN, RN

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