COVID-19 Sample Collection and Testing Claims Submission for Pharmacies

In response to the COVID-19 emergency, New York State Executive Order #202.24, and New York State Circular Letter 12, here is important guidance for pharmacists administering COVID-19 tests.

-  The Executive Order allows pharmacists to order and administer COVID-19 tests for patients who may be infected with, or may have recovered from, COVID-19. Pharmacists must comply with, and complete, appropriate training developed by the Department of Health.

 

- Licensed Pharmacists employed by pharmacies with a CLIA Certificate of Waiver, or that are registered per state’s guidance as a Limited Service Laboratory (LSL), may administer any COVID-19 test to detect infection or antibodies.

o The test(s) must have been approved by the FDA or granted Emergency Use Authorization (EUA) and which are CLIA-waived.

o Pharmacists can perform sample collection to refer to external labs to perform higher complexity laboratory testing.

o See below for additional guidance.

 

There is no member cost-sharing (copayments, coinsurance, or deductibles) for medically appropriate COVID-19 diagnostic testing regardless of whether the testing is performed in-network or out-of-network (57th Amendment to Insurance Regulation 62 distributed on March 13, 2020, and the CARES Act).

 

Claims for COVID-19 testing and collection may be retroactively billed to April 25, 2020, the date Executive Order #202.24 was signed. Claims for COVID-19 testing prior to the May 26, 2020 release of Circular Letter 12 that otherwise meet the criteria for coverage may be subject to retroactive application of this policy.

 

Submitting Pharmacy Claims for COVID Test Administration

  1. Provider Validation:

    a. The Type 2 NPI for the pharmacy contracted for COVID-19 test services should be submitted as the Service Provider ID (201-B1).

    b. Pharmacies should acquire the applicable CLIA Waiver certificate (refer to FAQ: Clinical Laboratory Improvement Amendments (CLIA) below). This information may need to be communicated through trading partner agreements to allow for provider validation.

  2. Product/Service Identifiers:

    a. Test kits will contain a Universal Product Code (UPC) or Unique Device Identifier (UDI) code. Convert the code assigned to the test kit product to the NCPDP 11-digit NDC format for the Product/Service ID (407-D7) field and associate the Product/Service ID Qualifier (436-E1) of NDC (03).

For CLIA-Waived COVID-19 testing, Participating Pharmacies must complete/comply with all the following:

  1. Have either a CLIA Certificate of Waiver or an applicable state license/registration;
  2. Have insurance coverage to perform CLIA-waived tests;
  3. Complete all federal and state training to perform these tests;
  4. Follow the manufacturer’s instructions for use of the test they are performing;
  5. Tests must be approved by the FDA or granted Emergency Use Authorization (EUA);
  6. Accept the reimbursement as determined at the point of sale adjudication, with no copayment or coinsurance from our Enrollees for all COVID-19 tests administered.
  7. Bill using NDCs as noted above.
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