You may also be interested in these TPA Practice-Based Resource Pages:
On April 8, 2020, the Office of the Assistant Secretary for Health (OASH) for the Department of Health and Human Services (HHS) released its “HHS Statements on Authorizing Licensed Pharmacists to Order and Administer COVID-19 Tests” guidance. As noted in the HHS Guidance for Licensed Pharmacists, “the vast majority of Americans live close to a retail or independent community-based pharmacy. That proximity reduces travel to testing locations, which is an important mitigation measure. Pharmacists also have strong relationships with medical providers and hospitals to appropriately refer patients when necessary.”
This HHS guidance:
- Authorizes licensed pharmacists to order and administer FDA-authorized COVID-19 tests, including serology tests.
- Establishes that pharmacists qualify as “covered persons” under the PREP Act.
- Provides pharmacists with immunity under the PREP Act with respect to all claims for loss caused by, arising out of, relating to, or resulting from, the administration or use of FDA-authorized COVID-19 tests.
Yesterday, the Trump Administration announced another round of sweeping regulatory waivers and rule changes through the Centers for Medicare & Medicaid Services (CMS) to deliver expanded care to the nation’s seniors and provide flexibility to the healthcare system as America reopens. CMS recently released new regulations regarding pharmacist-provided services, including testing, immunizations, medication management, and telehealth. The American Pharmacists Association (APhA) has created a high-level summary of these new regulations. Under the new waivers and rule changes, Medicare will no longer require an order from the treating physician or other practitioner for beneficiaries to get COVID-19 tests and certain laboratory tests required as part of a COVID-19 diagnosis. During the Public Health Emergency, COVID-19 tests may be covered when ordered by any healthcare professional authorized to do so under state law. To help ensure that Medicare beneficiaries have broad access to testing related to COVID-19, a written practitioner’s order is no longer required for the COVID-19 test for Medicare payment purposes.
- Pharmacists can work with a physician or other practitioner to provide assessment and specimen collection services, and the physician or other practitioner can bill Medicare for the services.
- Pharmacists also can perform certain COVID-19 tests if they are enrolled in Medicare as a laboratory, in accordance with a pharmacist’s scope of practice and state law. With these changes, beneficiaries can get tested at “parking lot” test sites operated by pharmacies and other entities consistent with state requirements. Such point-of-care sites are a key component in expanding COVID-19 testing capacity.
Recent Actions by the Tennessee Medical Laboratory Board: Earlier this week, the Tennessee Medical Laboratory Board voted to add FDA-authorized point-of-care rapid diagnostic tests for the detection of SARS-CoV-2 to the state’s waived test list and to specifically designate pharmacies as authorized sites to perform these tests, for the time period that the FDA Emergency Use Authorization (EUA) is active. Please note: Pharmacists who proceed with SARS-CoV-2 testing must report all test results to the Tennessee Department of Health, as outlined below.
Pharmacists’ Scope of Practice: Under the definition of “Practice of Pharmacy” in Tennessee Code Annotated 63-10-204 (39)(b), “pharmacists are authorized to conduct and assist patients with tests approved for home use.” The FDA states that “tests that are waived by regulation under 42 CFR 493.15(c), or cleared or approved for home use, are automatically categorized as waived following clearance or approval.”
CLIA Waiver Applications: Pharmacies wishing to perform CLIA-waived testing will need to obtain a federal CLIA waiver and file a state CLIA application with the Tennessee Medical Laboratory Board. TPA members have access to important links, instructions, and a step-by-step guide to assist pharmacists in completing this process, on TPA’s Point-of-Care Testing Practice-Based Resource Page.
FDA-Authorized Waived Tests: There are three SARS-CoV-2 rapid diagnostic tests that have been approved and designated as “waived” by the FDA through Emergency Use Authorization (EUA). New SARS-CoV-2 tests that are granted EUAs will be listed on the FDA Emergency Use Authorizations website. To identify tests that have been approved by the FDA as “waived,” look for the “W” designation under the Authorized Setting(s) column. At this time, only the tests listed below are authorized as “waived” by the FDA. Currently, no serological tests for SARS-CoV-2 have been designated as “waived” through the FDA EUA process, although the FDA states that several serology tests are being evaluated.
Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19
Mesa Biotech Inc. Accula SARS-CoV-2 Test
Cepheid Xpert Xpress SARS-CoV-2 Test
Billing and Payment for Pharmacy-Based COVID-19 Testing:
- Insured Patients: The federal government is easing restrictions to allow for pharmacy-based administration and billing for COVID-19 testing for Medicare beneficiaries, as well as the provision of other patient care services by pharmacists. Today, NCPDP released its updated Emergency Preparedness Information. TPA is currently working with payers to identify specific processes for pharmacy-based administration and billing of COVID-19 tests through both public and private insurance plans in Tennessee. More information will be provided as it becomes available.
- Uninsured Patients: The Health Resources & Services Administration (HRSA) has launched a new program to provide claims reimbursement to healthcare providers for testing uninsured patients for COVID-19 and treating uninsured patients with a COVID-19 diagnosis. Per guidance provided by HRSA, “pharmacists and pharmacy providers with a Tax Identification Number (TIN) are included and can submit claims for the testing or treatment of uninsured COVID-19 patients.” Pharmacists and pharmacy providers can register for the program here.
|Reporting COVID-19 Test Results
Positive test results must be reported to the Tennessee Department of Health with patient information; negative results must be reported daily in aggregate (number) without patient information.
Who should report? 1) Healthcare providers who receive positive COVID-19 test results on their patients or patients in their facility. 2) Healthcare providers who suspect that a death in their facility may be associated with COVID-19.
When should we report? Healthcare providers should report within 24 hours of receiving a COVID-19 diagnosis or positive lab report on a patient, and/or becoming aware of a suspected or confirmed COVID-19 associated death.
What should we report?
- Please submit a PUI Form on all positive COVID-19 test results from commercial labs only; you do not need to submit further information on a lab result from the TDH Public Health Laboratory. Please include a copy of the positive lab result.
- Please submit a PUI Form on all suspected or confirmed COVID-19 associated deaths. Please include a copy of the positive lab result regardless of the lab that performed the testing (commercial labs as well as state public health labs).
How should we report?
There are 3 options for reporting positive cases:
- Fax the PUI Form and a copy of the positive laboratory report to 615-741-3857.
- Call the TDH COVID-19 call center between 8am-8pm Central, 615-741-7247.
- Submit an electronic Morbidity Report*
*If you already report diseases or conditions to TDH via Morbidity Reports, you can continue to do this for COVID-19 positive labs and suspected or confirmed deaths. These are electronically submitted to NBS through https://hssi.tn.gov/auth/login.
There are 2 options for reporting suspected or confirmed COVID-19 associated deaths:
- Call your county medical examiner.
- Fax the PUI Form and a copy of the positive laboratory report to 615-741-3857.
- Be sure to mark the field indicating death.
- An updated form can be submitted indicating death if you have previously reported the individual as a case.
This guidance document can be found here or by visiting the Tennessee Department of Health’s COVID-19 website. As a reminder, we continue to update TPA’s Practice-Based Resource Page on COVID-19, so be sure to check the page frequently for updates