Pharmacy reimbursement issues and state imposed limits on pharmacist’s scope of practice have been major hurdles to increased COVID-19 testing at pharmacies. The Department of Health and Human Services has now intervened stating that federal orders of pharmacist authority to order/administer COVID-19 tests supersedes state pharmacist practice limitations.
Pursuant to that authority, states, including New York (NY), Ohio and Maryland, have now created Medicaid billing pathways for pharmacies to conduct either COVID-19 specimen collection or CLIA-waived COVID-19 tests. Reimbursement is permitted even in non-pharmacy settings (i.e. parking lots or other outdoor locations). On May 22, 2020, NY Governor Cuomo issued a billing guidance together with billing codes and values. Dual eligible will be reimbursable under Medicare and the Medicaid Managed care program will issue a separate guidance to pharmacies. New York pharmacies that perform and bill Medicaid cannot also bill for specimen collection, since reimbursement will include both specimen collection and the generation of a lab report. Pharmacies who are already being provided payment from another source, either for laboratory specimen collection or for COVID-19 testing may not additionally bill Medicaid.
Medicare may cover COVID-19 diagnostic tests when ordered by any healthcare professional, authorized to do so under state law, including pharmacists. CMS has indicated that Medicare and Medicare Advantage will cover COVID-19 testing, including non-pharmacy settings. Medicare will also cover FDA authorized COVID-19 serology tests, as they fall under the Medicare benefit category of diagnostic laboratory test (section 1861(s)(3) of the Act). Pharmacies enrolled in Medicare may also enroll temporarily under Medicare Part B as an Independent Clinical Laboratory. The enrollment application may be found at https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/cms855b.pdf. Pharmacies The enrollment application must be submitted to the Medicare Administrative Contractor (MAC) serving your geographic area. To locate your designated MAC, contact the provider enrollment hotline. Once enrolled, the pharmacy must seek a waiver of the laboratory standards under the CLIA Act. The CLIA waiver application may be found at https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf.
When the waiver is authorized, a pharmacy may seek approval to begin billing Medicare for the tests administered. The approval and waiver will permit Medicare reimbursement for the FDA-approved COVID-19 diagnostic tests administered, and the amount reimbursed will depend on the type of test administered and the pharmacy’s geographic area. https://www.cms.gov/files/document/mac-covid-19-test-pricing.pdf. Reimbursement falls under the Clinical Laboratory Fee Schedule, without any beneficiary cost-sharing requirements.
It is important for pharmacists to be aware of the two scenarios where they can conduct specimen collection in addition to providing the test:
(1) Pharmacists can work with a physician/other practitioner to provide specimen collection services, and the physician/other practitioner can bill Medicare for the services under “incident to” billing.
(2) Pharmacists enrolled as an Independent Clinical Laboratory can either 1) go to patient’s home and collect a specimen, or 2) go to a skilled nursing facility to collect the patient’s specimen.
Note, there is no scenario under which a pharmacist can bill for specimen collection performed for a patient in his/her own pharmacy. Pharmacists could also partner with a lab and perform the specimen collection on the lab’s behalf, but Medicare would not pay any additional amount to the pharmacy. This would be a strict business arrangement between the lab and the pharmacy.
While current law prohibits insurers from charging patients for testing, it does not block medical providers from doing so. Also, while patients cannot be charged by pharmacies, there is no guarantee that pharmacies will actually be reimbursed. Billing under private insurers remains piecemeal and health plans are required to post a negotiated cash price on their websites. NCPDP has released an Emergency Preparedness Information Document that provides some payer consideration information as well as guidance on completing a claim request. Unfortunately, individual plans will need to be directly contacted for claim information and approvals. Pharmacists can also contact large employers for direct billing options.
Health Resources & Services Administration (HRSA) is paying for tests for the uninsured (if pharmacies are testing they are eligible for funds) under an arrangement with UnitedHealthcare. To participate, pharmacies will need Optum ID and Optum Pay accounts https://coviduninsuredclaim.linkhealth.com/get-started.html.
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