On The Cover
Rachel Balick
The framework is there: The U.S. Office of the Assistant Secretary for Health issued guidance authorizing licensed pharmacists to test for COVID-19 in April 2020, later clarifying that this authorization superseded state scopes of practice. Clinical Laboratory Improvement Act (CLIA) waivers are needed in some cases, and payment is still a barrier, but there are avenues to bill for COVID-19 testing. Pharmacies across the country have gotten in the game. Could you be one of them? Arm yourself with the information to get started.
The information in this article is current as of press time, but the COVID-19 situation is evolving rapidly. Consult your state board of pharmacy, state and local health departments, and CDC to verify that requirements and restrictions have not changed.
Before you begin
Pharmacies wishing to participate in COVID-19 testing—either by collecting respiratory specimens and sending them to a lab or processing tests at point of care—must become familiar with the federal, state, and local testing considerations and requirements. First, review CDC’s COVID-19 testing guidance at https://apha.us/CDCTestingGuidance. Next, investigate state and local agency restrictions and requirements—contact state boards of pharmacy, local and state health departments, and the state survey agencies that oversee laboratories to get the information. The National Alliance of State Pharmacy Associations (NASPA) tracks state testing actions at https://apha.us/NASPAresource.
Additionally, regardless of how pharmacies choose to provide COVID-19 testing services, they must be prepared to document each patient encounter.
Pharmacies must also evaluate their supplies of personal protective equipment (PPE) and have a plan to ensure an adequate supply of PPE is maintained, as well as to be familiar with recommendations for how to handle patients who may have the virus. Refer to CDC’s Interim Infection Prevention and Control Recommendation for Patients with Suspected or Confirmed COVID-19 in Health Care Settings at https://apha.us/CDCPreventionControl for that information.
Recommended PPE includes an N95 or higher-level respirator, or surgical face mask if those products are not available; eye protection; gloves; and a gown.
Alternatively, a pharmacy could utilize a test designed for patient self-collection, where the pharmacist delivers the testing supplies to a patient’s car, and then from 6 feet away, observes the collection process with the car windows closed. This method only requires a face mask and gloves.
There are also medical waste disposal and workflow factors that must be considered. For more information on these, consult APhA and NASPA’s Pharmacy Models for COVID-19 Testing at https://apha.us/TestingModels.
Choose your model
There are two primary practice models for pharmacies that want to conduct COVID-19 testing.
First, pharmacies can partner with a laboratory (see Figure 1). In this model, patient assessment and collection of respiratory samples is done at the pharmacy, usually at a drive-through or in a parking lot—patients never have to leave their cars or enter the physical pharmacy. The collected specimen is then sent to a lab that performs the actual diagnostic test using devices that have been granted emergency use authorization (EUA) by FDA. Specimens can be collected for both viral tests for active infection and antibody—serological—testing.
Pharmacies and the labs with which they partner should establish a communication plan for reporting results before they begin testing. Test results are reported to the patient, primary care provider, and authorities as mandated by state and local requirements. Note that some agencies require reporting of both positive and negative test results, while others only require reporting of positive results. This can vary from state to state. Reporting methods also differ depending on local requirements; for example, in some jurisdictions, results must be submitted manually.
Pharmacies do not need a CLIA Certificate of Waiver to collect specimens. A CLIA waiver applies to tests that are simple to perform with a low risk for error or harm to the patient. CLIA-waived tests include influenza, blood glucose, and urine dipstick tests. Specimen collection does not fall into that category. The laboratory a pharmacy partners with, however, will have authority under CLIA to perform moderate- or high-complexity testing.
The second model is to conduct a COVID-19 test at point of care. Unlike the first model, pharmacies providing testing at point of care must hold a current CLIA Certificate of Waiver or apply for one. CLIA waivers must be renewed every 2 years, so pharmacies should make sure their waivers have not expired. To receive reimbursement from Medicare, pharmacies providing point-of-care testing must enroll in the program as an independent clinical laboratory (see Figure 2).
Next, the pharmacy must select a testing device that has been granted EUA by FDA. The COVID-19 testing device must be authorized to be performed in a patient care setting, since FDA classifies pharmacies as patient care settings.
In this model, the pharmacist assesses the patient, the pharmacist or patient collects a specimen, and then the pharmacist uses the testing machine to run the test and interpret the results. The pharmacist is then responsible for reporting the results of the test to the patient, state health department, and the patient’s other health care providers as appropriate. Pharmacists should follow state health department guidance on reporting the test results and further education to the patient.
Payment efforts trudge forward
Jean-Venable “Kelly” R. Goode, PharmD, BCPS, FAPhA, FCCP, has been a high-profile pharmacist for years, so it’s no surprise that Virginia Gov. Ralph Northam appointed her to his COVID-19 testing advisory council. The council has subcommittees on communication and technology, along with testing best practices. That’s where Goode serves.
“Pharmacy has been part of the conversation all along, and we’ve been working to see how that can scale up. We’ve had some good support for the idea that community-based pharmacy testing can help the Commonwealth meet its testing goals, and as we look at that, it’s really wrapped around best practices for payment for the pharmacist and pharmacy,” Goode said.
Virginia pharmacies, for the most part, are doing swabs and sending them to a partner lab. “We do have some pharmacies beginning to emerge as point-of-care testing sites. One Walgreens is using a point-of-care device to test.”
There may be an opportunity for pharmacies to use an antigen point-of-care device supplied through the government, but the Virginia Department of Health (VDH) hadn’t yet worked out the details of how test results would be reported at press time. “Right now, only molecular [polymerase chain reaction] test results are being reported.”
Most of the COVID-19 testing in Virginia pharmacies has been paid for by a U.S. Department of Health and Human Services grant, and some pharmacies have nonpharmacy personnel as part of a medical clinic who perform the tests.
“There’s also a Health Resources and Services Administration portal where you can submit for funding for uninsured patients, but you have to be registered as a provider under the Optum network to be able to do that,” Goode said. Pharmacies can also bill Medicare if they enroll as an independent clinical laboratory and have a CLIA waiver.
“We’re waiting on a special session by the governor for budget language to be submitted from the Secretary for Health and Human Resources for for funding for pharmacists doing COVID-19 testing through Medicaid,” Goode said. “Our Medicaid has pushed back a lot, even though other states’ Medicaid programs do pay, saying they don’t have the funding to do it or the mechanism to do that, but what we’re hearing is that perhaps, if we even get the funding, it’s only going to be for specimen collection.”
Health plans have also said they won’t pay for pharmacists’ COVID-19 testing because they don’t recognize that pharmacists have the authority to order tests.
“We’re going to need pharmacists, especially in rural areas, to be able to step up and figure it out. We have a really good partner in VDH,” Goode said. “What’s been really nice is that they’re really the ones going to bat against the payers to help make this happen.”
A busy pharmacy signs on for testing pilot program
Apple Discount Drugs, a four-store independent chain on the Eastern Shore of Maryland, is a busy place: Prescriptions. Oxygen. Medical equipment. Custom compounding. I.V. home infusion. The only certified diabetes educator pharmacists’ program in a community pharmacy in the region. A PGY-1 ambulatory care residency program.
When the call went out through a company called eTrueNorth and the pharmacy services administrative organization Health Mart for community pharmacies to participate in a COVID-19 swab-and-send testing pilot program, Apple accepted.
“Our owner, Jeff Sherr, RPh, FACA, said, ‘Well, of course we would like to try it,” said Matthew D. Balish, PharmD, RPh, CDE, Apple staff pharmacist. At the time, 90% of COVID-19 testing was being conducted through hospitals, health departments, and immediate care centers. “[Health Mart selected] Apple as a pilot project site, one of the few independent pharmacies in Maryland doing COVID-19 testing.
Apple used Balish’s national provider identifier number on the contract as the pharmacist of record. Apple provides oxygen services, so it already had respiratory therapists on staff. “I was the pharmacist responsible for helping to do this testing, along with two of our respiratory therapists,” Balish said. Health Mart and eTrueNorth sent Apple a turnkey package with swab kits, PPE, education and training materials, and approved marketing language—just insert tools material that was approved by them. “You just had to insert your pharmacy name. You advertised your COVID-19 testing, and patients would come to get drive-up testing.”
Patients would visit www.doineedacovid19test.com or call its associated 800 number to register. The patient would fill out a questionnaire and then receive a voucher to be used at the testing site of their choice.
“Once the patient drove up and we instructed them how to self-collect, we [sent] the samples to the lab, and then we were out of the process,” Balish said. Balish saw people getting tested so they could go back to work, because their children had failed to follow social distancing guidelines, or so they could visit loved ones in nursing facilities.
Balish has advice for the pharmacists of the future. “Based on my experience, I can tell you that pharmacy was not adequately prepared [for the pandemic] as a profession,” Balish said. “We’re not viewed as health care providers. We had trouble getting PPE. In Maryland, we don’t have authority to do point-of-care testing. We can’t test for flu or strep throat. That’s a gap in health care that this pandemic brings to light, particularly the PPE issue.”
The COVID-19 pandemic has also made clear the importance of being prepared: To disinfect, put up cough guards, and appropriately wear rubber gloves. “But the other thing I would tell pharmacists 10 years from now is be ready for the educational component because, as an accessible provider, you have the opportunity to educate your patient base and your walk-in customers on proper mask wearing, proper glove wearing, and hand sanitizer versus hand washing and soap,” Balish said.
“Even though our just-in-time supply system is a great thing, owners, chains, and the profession as a whole need to think ahead and have stockpiles available for these sorts of emergencies. I don’t mean a warehouse-full—if you run a small pharmacy, have a few boxes of N95s, some gloves, some bleach, a couple of cases of hand sanitizer tucked away.”
A personal touch
“We do the swabs and send them off to the lab. Then they also take care of the billing. We do not do any billing for the tests at the pharmacy,” said M. Tariq Amin, CPhT, director of retail sales at Preston’s Pharmacy in Arlington, VA. “What we charge is a scheduling fee that covers all the administrative work that goes on behind the scenes before you get swabbed: filling out the lab form, confirming the appointment—all that stuff that nobody sees.”
Preston’s uses an online calendar-based system that allows patients to book appointments.
The lab fee, per federal mandate, is 100% covered by the patient’s insurance—patients never get a bill. “And let’s say a patient does not have insurance, but they do have a social security number, they will also not get a bill because the lab will go after federal grants given to them,” Amin said.
Patients pull up to assigned parking spots to get their active tests, most of the time in their cars but sometimes on bikes. Once they’ve arrived, the patients text the pharmacy to let them know what spot they’re in, and medical assistants go outside to perform the tests.
The patients visiting for an active test never enter the pharmacy. “Nobody wants somebody that’s having symptoms of this to be in the pharmacy.”
The medical assistant first verifies patients’ identity. “We’ll already have paperwork ready for them. They just need to sign the lab form, and we’ll take a copy of their insurance card for the lab.”
Antibody tests are done by blood draw. “We have a phlebotomist on site and it’s the same kind of concept, except these patients do come into the pharmacy.”
The lab delivers results to the pharmacy, which the pharmacy in turn shares with the patient. To share the results, Preston’s uses the e-mail address the patient used when they scheduled their appointment. “As far as turnaround time, for the active tests it’s 3 to 5 days,” Amin said. “We tell the patients to expect antibody results in that same time frame, but we often have them within a day.”
Amin estimates that Preston’s does 40 to 45 antibody draws and more than 200 swabs a day—they’re fully booked every day, and for many of the patients who come for tests, it’s the first time they’ve heard of Preston’s Pharmacy.
“I posted on the Facebook Arlington community group and on this app called Nextdoor. Through that, I got to know people personally and help meet their needs, but it also helped the pharmacy from a business standpoint,” Amin said. “People reach out to me directly via e-mail, and I give my cell phone to people. I have no problem talking to people, helping them get their desired outcomes not only with this COVID test, but with their overall health goals. We want to help people as much as possible, and it’s very important to me to be a positive force in the community.”
Getting paid
Pharmacies conducting point-of-care tests can bill Medicare by enrolling as an independent clinical laboratory. The pharmacies can also receive indirect payment from Medicare for testing-related services—such as patient assessment and specimen collection, among others. If they have a financial relationship with a Medicare-enrolled provider (e.g., a physician or nurse practitioner), they can be paid for basic clinical services under an “incident-to physician services” arrangement, where the enrolled provider bills for the service then pays the pharmacy under the terms of a contract.
While this normally requires pharmacists’ services to be directly overseen by a physician or qualified nonphysician provider (NPP), these rules have been relaxed during the public health emergency. Now, policy requires only that the physician or NPP be available by audio and visual technology in real time.
There is currently no route for pharmacists doing specimen collection only to be directly reimbursed through the program, though they could also enter into an “incident-to” arrangement. In the outpatient hospital setting, however, the health system can bill for pharmacists’ specimen collection. Pharmacies that have contracted with a laboratory to collect specimens may also be paid by the laboratoty based on the terms of that contract, and pharmacies doing specimen collection can also receive indirect Medicare payment if they have entered into an “incident-to physician services” arrangement, just like point-of-care testers.
Pharmacies may also be able to bill Medicaid and private payers. Consult with individual payers to see if you are eligible to bill and for what services.
To learn more about billing, review the APhA and NASPA resource Pharmacy Models for COVID-19 Testing at https://apha.us/TestingModels. The National Council for Prescription Drug Programs has also released payment guidance for COVID-19 testing and associated services by pharmacists. That guidance is available at https://apha.us/NCPDPGuidance.