The HHS Office of the Assistant Secretary for Health issued guidance on April 8, 2020 authorizing pharmacists to order and administer COVID-19 tests. The guidance recognized pharmacists as trusted healthcare professionals with established patient relationships, are accessible, and have strong relationships with medical providers and hospitals.
The guidance includes pharmacists as “covered persons” under the Public Readiness and Emergency Preparedness (PREP) Act when ordering and administering COVID-19 tests. Pharmacists are immune from liability for any claims resulting from ordering or administering FDA-authorized COVID-19 tests.
The National Community Pharmacist Association and the Florida Pharmacy Association have put together a FAQ of Pharmacists Ability to Provide COVID-19 Testing. Here is what pharmacies need to know, courtesy of NCPA and FPA.
- Which tests am I allowed to perform?
Under the State Surgeon General’s Emergency Order 20-006, a pharmacist may order and administer any COVID-19 test, including serology tests, authorized by the FDA. A list of FDA-approved tests can be found here.
However, a pharmacist may only perform complete testing at a pharmacy if the pharmacy holds a CLIA certificate of waiver and utilizes an FDA-approved test that is approved for use in a CLIA-waived laboratory. FDA-approved tests that can be performed in a laboratory operating under a CLIA certificate of waiver are denoted by a “W” at the above link. If the pharmacy does not have a CLIA certificate of waiver, the pharmacist may only collect a specimen from the patient and ship it to the appropriate laboratory to complete the testing.
To obtain a CLIA certificate of waiver, the pharmacy will need to complete an application for certification and file it with the Agency for Healthcare Administration.
The application form can be found here.
NCPA has prepared a video to assist pharmacies in completing the application form. The video can be viewed here.
- How do I perform these tests?
When conducting a COVID-19 test, a pharmacist should follow:
- The test manufacturer’s Instructions For Use.
- The Department of Health’s guidance on COVID-19 testing.
- CDC’s Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 available here.
- CDC’s Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 in Healthcare Settings available here.
A pharmacist may consult his or her county health department for additional guidance.
- Where do I buy these tests?
Check with your wholesaler to see if test kits can be purchased. Through our partnerships, PPSC will have access to antigen tests directly from our vendor partners. We will share more information on this program as it is available.
- Where can I perform these tests?
Pharmacists may administer COVID-19 tests at a location that holds a clear and active pharmacy license. However, if the pharmacy does not hold a CLIA certificate of waiver, the pharmacist may only collect a patient specimen at the pharmacy. The test will need to be completed at the appropriate laboratory.
- Where do I get the results from?
The results can be obtained from the laboratory that conducts the test.
- To whom do I report the results?
A pharmacist who orders and/or administers the test is required to report the results to the patient and their state’s Department of Health. The Department of Health has established a secure electronic reporting system for reporting positive, negative, and inconclusive test results. (For example: Florida pharmacists who order and conduct COVID-19 tests should contact the Florida Department of Health at DLElectronicLabReporting@flhealth.gov to create an account for reporting COVID-19 test results.)
- What protective gear should I be using?
Per the CDC’s guidelines a healthcare provider should wear the following when administering a COVID-19 test:
- An N95 or higher-level respirator (or facemask if a respiratory is not available)
- Eye protection
- A gown
Pharmacists should also be aware of OHSA’s guidelines for preventing exposure to the novel coronavirus. These guidelines can be found here.
- Is there any special licensing that I need to have?
You must be licensed as a pharmacist and must conduct the test at a licensed pharmacy. No additional licensure is required.
- How do I bill for testing?
COVID-19 diagnostic and antibody tests can be billed under Medicare Part B. Watch this video to see how to enroll or how to update your existing enrollment. Note: To bill Medicare, you will need to enroll as an Independent Clinical Laboratory. See page 3 of the NCPA Summary below for step-by-step instructions.
- NCPA Summary of CMS Rules Regarding Pharmacists Ability to Provide COVID-19 Testing
- MLN Matters: Temporarily enroll as Independent Clinical Lab
- CMS Form 855b – Enrollment Application
- PECOS – Online Medicare Enrollment Application
Medicaid may cover COVID-19 tests, including tests administered in non-office settings (such as parking lots or other temporary outdoor locations), and laboratory processing of self-collected COVID-19 tests that are FDA-authorized for self-collection.
The flexibility would apply not only during the current COVID-19 PHE, but also during any subsequent periods of active surveillance to detect recurrence of the virus.
CMS is looking to put out guidance to states as to how states can submit amendments to get pharmacists covered to provide tests and get paid.
Pharmacists should work with their state partners to ensure Medicaid coverage of pharmacist administered COVID-19 tests.
While it is possible to submit prescription claims for COVID-19 tests, including using codes to indicate that a specimen was collected or that the test was performed at the pharmacy, it is not known if health plans will cover this in the pharmacy benefit. Recommendations for processing these claims is available in the NCPDP Emergency Preparedness Information document updated 5/1/20.
- Consider contacting the health plan or pharmacy helpdesk for any large employers in your area to determine coverage for COVID-19 testing.
- Consider contacting large employers in your area directly to propose direct billing for testing.
- Joining a CPESN USA Network may lead to access to reimbursement opportunities based on submitting care plans. Reach out to your network.
At this time, it seems unlikely that FEMA will directly compensate or issue federally sourced test resources to pharmacies.
- Reimbursement for testing would be possible through the Emergency Prescription Assistance Program, but HRSA has a program for the uninsured.
- Federally sourced test resources are being distributed through state, local, and tribal health departments. Some of these have chosen to partner with pharmacies to expand testing capability.
HRSA is paying for tests for the uninsured (if pharmacies are testing, they are eligible for funds).
Companies that assist with medical billing
- Am I required to have liability insurance?
The State Surgeon General’s Emergency Order does not require a pharmacist to maintain liability insurance in order to order or administer COVID-19 tests. It is recommended that any pharmacist who is administering COVID-19 tests maintain liability insurance.
- Would I be immune from liability?
On April 8, 2020, the U.S. Department of Health and Human Services issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) authorizing pharmacists to order and administer FDA-approved COVID-19 tests. Under this guidance, a pharmacist who orders and/or administers an FDA-approved COVID-19 is entitled to immunity against claims for loss relating to the administration or use of the COVID-19 test. The HHS guidance is available here.
Pharmacists are encouraged to consult an attorney for any questions relating to the scope of PREP Act immunity.
- Am I required to have a collaborative agreement with a physician?
- What are the record keeping requirements?
The State Surgeon General’s Emergency Order does not address record-keeping requirements. It is recommended that pharmacists maintain the following records:
- Patient history
- Examination results
- Test results
- How long do I keep records?
It is recommended that the records be maintained for at least 5 years.
- What can I allow my technician to do with COVID-19 testing?
The State Surgeon General’s Emergency Order does not address technician responsibilities. Only the pharmacist should conduct the testing. Pharmacists should use their professional judgment in determining which tasks can be delegated to a technician.
- Will this new authority to test allow me to treat patients with COVID-19?
The State Surgeon General’s Emergency Order only allows pharmacists to order and administer COVID-19 tests. It does not authorize pharmacists to treat patients for COVID-19.
As the global effect of Coronavirus continues to evolve, PPSC is committed to keeping our pharmacy customers informed with ways they can better serve their patients and communities. It is important to note that each state has different requirements to qualify for testing. Please check with your state’s pharmacy association, board of pharmacy, and department of health for more detailed information relating to testing.
If you have any questions, please connect with us. Together, we will get through this universal health crisis and emerge stronger as a community. For more Coronavirus pharmacy and patient resources, please visit our COVID-19 toolkit.