New POC Antigen Test Needs No Lab Equipment
A new 10-minute Covid-19 test that doesn’t need added equipment to process has was cleared by the FDA on Oct. 13. Like all antigen tests, Access Bio's CareStart rapid antigen test detects the novel coronavirus by identifying proteins on the virus surface and IT produces results in 10 minutes without additional equipment. Most antigen tests require a laboratory analyzer to process the patient sample. However, the test does require that the patient sample be obtained with a nasopharyngeal (NPG) swab, which is more challenging to do correctly and requires more PPE than the simpler nasal swab.
The CareStart assay includes an NPG swab, a vial of extraction solution and a cassette the size of a small flash drive. A line appears visible on the cassette if the test is positive. Access Bio has stated that pricing is less than $20 per unit; actual pricing depends on the quantity ordered.
Antibody & Antigen Tests Are the Best Opportunity for Pharmacies
Pharmacy owners must decide for themselves if they want to conduct COVID-19 testing and what type(s) of tests they want to order and administer. American Pharmacies believes the best fit and revenue opportunity for pharmacies is in providing antibody testing:
- PCR/molecular tests are more complex, more expensive, and require (sometimes expensive) analyzers and hard-to-get chemical reagents to process.
- Antibody and antigen tests are in high demand across the country. The fastest and most accessible place to get the test is at a pharmacy.
- Antibody and antigen tests generally deliver results onsite in15 minutes or less. They have a long shelf life and can be stored at cool room temperature.
- Antibody and antigen tests are far less expensive at wholesale than PCR/molecular tests (<$20 vs. $80 to $100). The tests are much more affordable for patients and can drive significant cash revenue for your pharmacy.
- Most of these tests are in plentiful supply.
Authorization for Pharmacy-Based COVID-19 Testing
CMS has authorized CLIA-waived pharmacies that are enrolled in Medicare to enroll temporarily as independent clinical diagnostic laboratories during the COVID-19 public health emergency via the provider enrollment hotline. (The expedited enrollment process waives requirements for criminal background checks and site visits.)
Billing & Payment for Testing
- Medicare will cover certain COVID-19 tests (including serological and antibody tests) administered by pharmacists if they are enrolled in Medicare as an Independent Clinical Laboratory in accordance with scope of practice and state laws. This means Medicare beneficiaries can get tested at sites operated by pharmacies consistent with state rules.
- Medicare may cover COVID-19 diagnostic tests when ordered by any health-care professional, authorized to do so under state law, including pharmacists. This coverage includes influenza and respiratory syncytial virus (RSV) tests when ordered in conjunction with a COVID-19 diagnostic test.
- Medicare Part B covers clinical diagnostic laboratory tests, including COVID-19 diagnostic tests, under the Clinical Laboratory Fee Schedule with no beneficiary cost-sharing.
- When COVID-19 tests are furnished without an order from a physician or non-physician practitioner during the current emergency, the laboratory conducting the tests is required to directly notify the patient of the results.
- Reimbursement has yet to be determined for antibody tests.
- Specimen Collection:
- Pharmacists enrolled as an Independent Clinical Laboratory can either 1) go to patient's home and collect a specimen (G2023), or 2) go to a skilled nursing facility to collect the patient's specimen (G2024).
- Note, there is no scenario under which a pharmacist can bill for specimen collection performed for a patient in his/her own pharmacy.
NOTE: If your pharmacy decides to accept commercial insurance coverage for COVID-19 testing services, you will need to enroll with each payer/plan as a medical provider. This process may be simple or complicated. Each health plan or payer has its own reimbursement process and fee schedules. Patient co-pays are almost always waived for the tests.
Get a CLIA Waiver Now to Prepare for the Boom In POC Testing
Pharmacies are well-positioned to be highly visible and trusted locations where patients can get an antibody test and learn quickly if they have been exposed to the virus. A CLIA waiver will enable your pharmacy to be a vital part of the nation's screening network for COVID-19 and will position you to take advantage of expanded testing opportunities in the future. Opportunities for in-pharmacy testing based on new technologies that make accurate blood- and urine-based testing possible at the point of care will soon be on the market. These products have the potential to significantly alter the current testing landscape and provide significant revenue for pharmacies that are credentialed and prepared to capitalize.
How to Apply for a CLIA Waiver
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Download the CLIA waiver application from the CMS website.
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Complete the application. This should take no more than 10 minutes. We highly recommend that you view our guidance document as well as NCPA's useful video for help on each part of the application.
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Submit your completed application to the specific agency in your state that processes them. You can use this CMS document to find the email address or FAX number for the agency for submitting your application.
- Do not send payment with the application. After your application is processed and approved by your state agency, you will receive an invoice (CLIA user fee coupon) for $150 from CMS in Maryland. Once the invoice is paid, CMS will mail your CLIA certificate. The entire process usually takes 4-6 weeks, but of course can vary from state to state depending on volume of applications and resources.
- Your CLIA certificate will be valid for a period of two years from the date of issuance.
