The Company follows federal, state and local regulatory guidance related to COVID-19 testing. COVID-19 tests will only be covered when ordered by a healthcare professional licensed and/or authorized to do so under state law.
SPECIMENS COLLECTED BY A HEALTHCARE PROFESSIONAL
Diagnostic COVID-19 Testing (RT-PCR, Antigen Tests, or Other Diagnostic Tests for SARS-CoV-2 (e.g., tests that analyze breath samples))
The Company will cover (i) certain diagnostic COVID-19 tests (diagnostic RT-PCR and antigen tests), including COVID-19 tests that have been approved, cleared, or authorized by the FDA or for which the developer has requested, or intends to request, Emergency Use Authorization (EUA) for the COVID-19 pandemic; and (ii) the administration of such tests, when ordered by a licensed health care provider and performed at an approved healthcare setting. (This includes drive through testing). Such testing will only be covered if medically appropriate as determined by the member's health care provider in accordance with accepted standards of current medical practice. We recommend that health care providers confirm with the Company if such lab is an authorized and/or contracted lab and if they have the ability to perform such testing. Diagnostic COVID-19 testing will be covered for:
- Individuals with signs or symptoms consistent with COVID-19
- Asymptomatic individuals with recent known or suspected exposure to SARS-CoV-2 to control transmission
When ordered by a healthcare provider, the Company will cover medically necessary diagnostic pooled testing only for testing that is associated with Company members' samples.
Antibody COVID-19 Testing
The Company will cover (i) certain antibody COVID-19 tests including COVID-19 tests that have been approved, cleared, or authorized by the FDA or for which the developer has requested, or intends to request, Emergency Use Authorization (EUA) for the COVID-19 pandemic; and (ii) the administration of such tests, when ordered by a licensed health care provider and performed at an approved healthcare setting. (This includes drive through testing). Such testing will only be covered if medically appropriate as determined by the member's health care provider in accordance with accepted standards of current medical practice. We recommend that health care providers confirm with the Company if such lab is an authorized and/or contracted lab and if they have the ability to perform such testing. Currently, antibody testing for COVID-19 has clinical support in these scenarios, and will be covered when:
- Antibody tests are used to support the clinical assessment of COVID-19 illness for individuals who are being tested 9 to 14 days after illness onset, in addition to recommended virus detection methods such as PCR. This may maximize sensitivity as the sensitivity of nucleic acid detection is decreasing and serologic testing is increasing during this time period.
- Antibody testing is being used to help establish a clinical picture when individuals have late complications of COVID-19 illness, such as multisystem inflammatory syndrome in children.
- Neutralizing antibody screening and titer testing, and surrogate viral neutralization testing are used exclusively for the purpose of convalescent plasma administration during a hospital admission at the decision of the individual's medical providers.
Antibody test results should not be used to diagnose someone with an active infection.
NONPRESCRIPTION OVER-THE-COUNTER (OTC)/DIRECT-TO-CONSUMER (DTC) DIAGNOSTIC COVID-19 TESTING
Reimbursement may be provided for 08 tests per member per calendar month for nonprescription over-the-counter (OTC)/direct-to-consumer (DTC) diagnostic COVID-19 tests, which have received emergency use authorizations by the FDA. Reimbursement for additional diagnostic tests, beyond this number of tests, will require a prescription from a healthcare provider.
Coverage of nonprescription OTC/DTC COVID-19 tests is provided either through the member's pharmacy benefit, or medical benefit as detailed in the following Company communications (as they apply to members of AmeriHealth Pennsylvania & AmeriHelath Administrators :
- https://www.amerihealth.com/htdocs/custom/covid-19/index.html (refere to the Testing Section)
Diagnostic OTC/DTC COVID-19 tests with FDA EUAs are not covered or reimbursed for screening. Screening includes - but is not limited to - the following per the CDC:
- Testing employees in a workplace setting
- Testing students, faculty, and staff in a school or university setting
- Testing a person before or after travel
- Testing at home for someone who does not have symptoms associated with COVID-19 and no known exposures to someone with COVID-19
REQUIREMENTS REGARDING FDA AUTHORIZATIONS FOR COVID-19 TESTING
A developer's COVID-19 diagnostic or antibody test kit will be considered non-covered unless (i) the FDA approves the test for use; (ii) the developer has submitted an Emergency Use Authorization application (EUA) to the FDA for approval during the time of the public health emergency (or intends to do so within a reasonable period of time, which is currently 15 days for RT-PCR and antigen tests and 10 days for serology (antibody tests)*; or (iii) the test was developed in and authorized by a State that has notified the Secretary of Health and Human Services of its intention to review tests intended to diagnose COVID-19.
*The FDA expects commercial manufacturers to submit Emergency Use Authorization (EUA) requests, including their validation data, within 10 days of publication of the updated policy or the date they notify the FDA of their test validation, whichever is later.
If the FDA denies an EUA application for a COVID-19 diagnostic or antibody test or the test's developer fails to timely submit the EUA to the FDA for approval, the test will no longer be covered.
A diagnostic or antibody COVID-19 test will not be covered if does not meet the requirements, including technical, analytic, and clinical performance measures, detailed by the FDA in the most recent version of Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency -- Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff.
Authorized labs must notify local public health authorities before initiating testing with a COVID-19 diagnostic or antibody test kit, follow the terms and conditions described in the applicable EUA for an approved at-home diagnostic or antibody test kit, and administer the test in accordance with the applicable test procedures referenced therein.
Lab specimens for members enrolled in HMO and HMO-POS products may need to be sent to a different in-network approved laboratory, which is not the member's designated capitated laboratory site, when the designated capitated laboratory site does not have the ability to perform the COVID-19 test.
Referral and out of capitation authorization requirements have been waived for COVID-19 Laboratory Testing HCPCS codes U0001, U0002, U0003, U0004, U0005, G2023, G2024, and CPT codes 0202U, 0223U, 0224U, 0225U, 0226U, 0240U, 0241U, 86328, 86408, 86409, 86413, 87428 , 86769, 87246, 87635, 87636, 87637, and 87811.
Laboratory Corporation of America® Holdings (LabCorp), the national outpatient laboratory provider for the Company, is equipped to process diagnostic (RT-PCR) and antibody (IgG) COVID-19 specimen testing for our members. Details are available on the LabCorp website available at:
Laboratory Testing for COVID-19 Differential Diagnosis
The Company will cover testing of other clinically relevant respiratory pathogens, for the differential diagnosis of COVID-19. These tests include testing of the following pathogens through any clinically established method:
- Human metapneumovirus (HmPV)
- Respiratory syncytial virus (RSV)
- Rhinovirus (common cold)
Referral and out of capitation authorization requirements have also been waived for COVID-19 Differential Diagnosis Laboratory Testing procedure codes when performed in conjunction with COVID-19 Laboratory Testing.
SPECIMEN COLLECTED BY AN AUTHORIZED WORKER FROM HOME HEALTH AGENCIES
To help reduce potential exposure of COVID-19, the Company is waiving the requirement that a member be homebound for the purpose of laboratory specimen collection for diagnostic COVID-19 testing in their home.
In response to the COVID-19 outbreak, home specimen collection for diagnostic COVID-19 and related diagnostic respiratory pathogens' testing is considered medically necessary and, therefore, covered when all of the following criteria are met:
- The specimen is collected by a nurse from a home health agency or by a trained laboratory technician.
- The requirement that a member must be homebound (as defined in the medical policy) is waived, in order to receive a nurse visit from a home health agency for the purpose of laboratory specimen collection for COVID-19 testing in their home.
- The specimen collection is medically necessary for the individual's condition and has been ordered by an eligible professional provider.
- The specimen will be delivered to the appropriate Company participating laboratory to perform the test and send the results to the prescribing professional provider.
SPECIMENS COLLECTED BY A MEMBER:
Testing of Samples Self-Collected by Members
The Company will cover testing of samples self-collected by members when the testing is conducted at FDA-approved locations as detailed in the EUA (including home), and all FDA EUA Requirements are followed for the specific test being administered. This includes self-collection materials (including kits) and other related equipment having received specific FDA EUA approval.
For example, the FDA re-issued the Emergency Use Authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by members at home using LabCorp's Pixel by LabCorp COVID-19 Test home collection kit.
ROUTINE COVID-19 TESTING
In Advance of Procedures
Reimbursement for routine COVID-19 laboratory testing, for asymptomatic and/or nonexposed individuals, (e.g., preadmission testing; screening prior to procedures as part of an institutional protocol) is reimbursed as part of the procedural or surgical payment and is not eligible for separate reimbursement.
Testing of Nursing Home Residents and Patients
Based on the evolving recommendations from the CDC for Testing Guidelines for Nursing Homes, (https://www.cdc.gov/coronavirus/2019-ncovs/hcp/nursing-homes-testing.html), Centers for Medicare & Medicaid Services (CMS) has issued communications for COVID-19 testing for nursing home residents and patients.
Reimbursement of routine COVID-19 testing in these contexts is reimbursed as part of the per diem payment to the facility and is not eligible for separate reimbursement for members admitted to skilled nursing facilities for short-term medical or rehabilitation purposes.
PUBLIC HEALTH SURVELLIANCE AND SCREENING
The Company does not cover COVID-19 testing when the primary purpose of this testing is for public health surveillance and/or screening. This includes tests using pooling methodologies or any others with a current FDA EUA.
The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.
The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. This includes verification that laboratory or home test kits have been approved, cleared, or authorized by the FDA and/or that the developer has adequately abided by the FDA guidance before and after formally requesting EUA for the COVID-19 testing, including – but not limited to – test validation standards, reporting requirements, clinical testing to establish acceptable performance characteristics, and timeline adherence. This also includes review of any tests whose EUA has been revoked by the FDA.
All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Eligible professional providers performing SARS-CoV-2 (COVID-19) laboratory testing must report the most appropriate procedure code to represent the method of testing used. Additionally, the clinically appropriate diagnosis code(s) must be reported to support the testing being performed (e.g., diagnosis code(s) representing CDC listed signs and symptoms &/or required exposure to COVID-19 must be reported for any diagnostic testing).
Eligible professional providers performing diagnostic pooled SARS-CoV-2 (COVID-19) laboratory testing must report the most appropriate procedure code to represent the method of testing used and only one unit of service for each of the Company's members tested.