CurrentAgency for Health Care AdministrationPolicy 2022-05

Community Pharmacy Dispensed Over-the-Counter (OTC) COVID-19 Home Tests

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Florida Medicaid coverage of FDA-authorized or FDA-approved over-the-counter COVID-19 diagnostic and screening tests intended for home use, including self-collected specimens, for Managed Medical Assistance, MMA Specialty, and Long-Term Care enrollees.

Policy Summary

PayerAgency for Health Care Administration

PolicyCommunity Pharmacy Dispensed Over-the-Counter (OTC) COVID-19 Home Tests

Policy CodePolicy 2022-05

Change TypeNew coverage

Effective DateJanuary 4, 2022

Next Review DateN/A

Key ActionEnsure the enrollee has a prescription and that the eligible OTC COVID-19 home test kit is dispensed by a community pharmacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4/monthMaximum eligible OTC COVID-19 home tests per enrollee

$8.00Maximum reimbursement per test kit

$2.00Additional incentive payment per claim

1 or 2 testsPermitted package sizes

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CurrentAgency for Health Care AdministrationPolicy 2022-05

Community Pharmacy Dispensed Over-the-Counter (OTC) COVID-19 Home Tests

Customize your policy alerts

Sign up for Agency for Health Care Administration Policy 2022-05 alerts

Get alerted when Policy 2022-05 changes without checking for updates manually.

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Policy Summary

PayerAgency for Health Care Administration

PolicyCommunity Pharmacy Dispensed Over-the-Counter (OTC) COVID-19 Home Tests

Policy CodePolicy 2022-05

Change TypeNew coverage

Effective DateJanuary 4, 2022

Next Review DateN/A

Key ActionEnsure the enrollee has a prescription and that the eligible OTC COVID-19 home test kit is dispensed by a community pharmacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4/monthMaximum eligible OTC COVID-19 home tests per enrollee

$8.00Maximum reimbursement per test kit

$2.00Additional incentive payment per claim

1 or 2 testsPermitted package sizes

Eligible Home Test Coverage

Eligible OTC COVID-19 Home Test

An OTC COVID-19 home test kit is covered when all eligibility and medical-appropriateness requirements are met.

Eligible test and medical appropriateness: The attending health care provider has determined that the test is medically appropriate for the individual based on current accepted standards of medical practice; the test has FDA emergency use authorization or FDA approval for home use in symptomatic and asymptomatic patients; the test permits self-collection without medical observation; the package contains one or two home tests; and the FDA listing identifies 'Home' as the Authorized Setting.Package size: 1 or 2 tests

Coverage is effective January 4, 2022 and is subject to the statutory criteria in section 6001(a)(1) of the Families First Coronavirus Response Act.

Prescription and Community Pharmacy Requirements

Coverage and dispensing require all of the following operational conditions.

Prescription and dispensing: The enrollee has a prescription, and the eligible OTC COVID-19 home test kit is dispensed by a community pharmacy.

Pharmacists may prescribe and dispense when authorized under the Public Readiness and Emergency Preparedness (PREP) Act.

Quantity Override

Additional quantities require prior authorization.

Maximum-unit override: The requested quantity exceeds four eligible OTC COVID-19 home test kits per month per enrollee and the additional quantity is medically necessary and approved through the prior authorization process.More than 4 kits per month

The standard monthly maximum remains four kits per enrollee.

COVID-19 home test kits are not covered when they lack FDA emergency use authorization or FDA approval for home use in both symptomatic and asymptomatic patients, require medical observation for specimen collection, are packaged with other than one or two tests, or are not listed with “Home” as the Authorized Setting.

Dispensing by providers other than community pharmacies is not covered under this policy. Eligible OTC COVID-19 home test kits must be dispensed through a community pharmacy.

Coverage and Reimbursement Parameters

Monthly Home Test Quantity

Maximum quantity4 eligible OTC COVID-19 home test kits

FrequencyPer month per enrollee

Quantity overrideAvailable for medical necessity through the prior authorization process

Maximum Reimbursement

Maximum reimbursement$8.00 per unit (test kit)

Billing basisNational Drug Code (NDC) for the eligible OTC COVID-19 home test kit dispensed

Reimbursement limitMaximum rate per test kit

Ordering, Dispensing, and Authorization Actions

Prior Authorization

Request a quantity override when medically necessary

A maximum of four eligible OTC COVID-19 home test kits per month per enrollee is covered. Maximum-unit overrides are available when medically necessary through the prior authorization process.

Documentation Required

Maintain or submit the prescription

Maintain or submit the prescription required for the enrollee to obtain the eligible OTC COVID-19 home test kit.

Documentation Required

Document medical necessity for additional kits

For a maximum-unit override, document medical necessity and submit the request through the prior authorization process.

Policy Background

This policy addresses Florida Medicaid coverage for FDA-authorized or FDA-approved COVID-19 diagnostic and screening tests intended for at-home use, including tests for which the individual self-collects a specimen at home. The attending health care provider must determine that testing is medically appropriate under current accepted standards of medical practice.

Eligible Home Test Kit

Eligible OTC COVID-19 Home Test Kit

FDA statusEmergency use authorization or FDA approval for home use in both symptomatic and asymptomatic patients

Specimen collectionAllows self-collection without medical observation

Package sizeOne or two home tests only

Authorized settingFDA listing identifies “Home” as the Authorized Setting

Covered At-Home Testing

COVID-19 Diagnostic and Screening Testing Performed at Home

Coverage includes COVID-19 diagnostic and screening testing performed at home, including self-collection of a specimen at home, when the attending provider determines that testing is medically appropriate.

Medical appropriateness: The attending health care provider orders the test and determines that testing is medically appropriate for the individual based on current accepted standards of medical practice.

Monthly Quantity Limit

Eligible OTC COVID-19 Home Test Kits

Monthly maximum4 eligible OTC COVID-19 home test kits

Applies toEach enrollee

Standard periodPer month

ExceptionMaximum-unit overrides are available for medical necessity through the prior authorization process

Provider Ordering Requirements

Documentation Required

Order the test and determine medical appropriateness

The attending health care provider must order the test and determine that it is medically appropriate for the individual based on current accepted standards of medical practice.

Order the COVID-19 diagnostic or screening test intended for at-home testing, including self-collection of a specimen at home.
Make the medical-appropriateness determination before the test is obtained.

Excluded Home Test Kits and Arrangements

The following are not covered: home test kits without FDA emergency use authorization or FDA approval for home use in symptomatic and asymptomatic patients; kits requiring medical observation for specimen collection; kits packaged in sizes other than one or two tests; and tests not listed with “Home” as the Authorized Setting. Dispensing arrangements involving providers other than community pharmacies are also excluded. Coverage is limited to four eligible kits per month per enrollee, unless an additional quantity is medically necessary and approved through prior authorization.