ModifiedCenCal HealthPolicy N/A

COVID-19 Antigen OTC Test Coverage

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This policy governs Medi-Cal Rx pharmacy coverage, prescribing, dispensing, quantity limits, and authorization requirements for contracted over-the-counter self-administered COVID-19 antigen tests used to diagnose current SARS-CoV-2 infection. It applies to eligible Medi-Cal members and Medi-Cal Rx pharmacy providers, with certain supplies potentially covered through a member’s medical benefit.

Policy Summary

PayerCenCal Health

PolicyCOVID-19 Antigen OTC Test Coverage

Policy CodePolicy N/A

Change TypeModified

Effective DateOctober 1, 2024

Next Review DateN/A

Key ActionDocument one-on-one contact with the member or caregiver before dispensing each test.

SourceLink

POLICY UPDATE CHANGES

The quantity limit for contracted OTC COVID-19 antigen tests changed from 8 tests per member per month to 4 tests total per member per 30-day period.

Tests removed from the contracted-test list may be covered through December 31, 2024 only when an approved prior authorization demonstrates medical necessity.

Coverage remains a Medi-Cal Rx pharmacy benefit for contracted OTC self-administered antigen tests used to diagnose current SARS-CoV-2 infection.

Pharmacy providers must document one-on-one contact with the member or caregiver before dispensing and may not use autofill.

4 testsMaximum quantity per member per 30 days

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ModifiedCenCal HealthPolicy N/A

COVID-19 Antigen OTC Test Coverage

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Sign up for all cencalhealth policy alerts

Know when cencalhealth releases new policies or updates existing guidance.

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Policy Summary

PayerCenCal Health

PolicyCOVID-19 Antigen OTC Test Coverage

Policy CodePolicy N/A

Change TypeModified

Effective DateOctober 1, 2024

Next Review DateN/A

Key ActionDocument one-on-one contact with the member or caregiver before dispensing each test.

SourceLink

POLICY UPDATE CHANGES

The quantity limit for contracted OTC COVID-19 antigen tests changed from 8 tests per member per month to 4 tests total per member per 30-day period.

Tests removed from the contracted-test list may be covered through December 31, 2024 only when an approved prior authorization demonstrates medical necessity.

Coverage remains a Medi-Cal Rx pharmacy benefit for contracted OTC self-administered antigen tests used to diagnose current SARS-CoV-2 infection.

Pharmacy providers must document one-on-one contact with the member or caregiver before dispensing and may not use autofill.

4 testsMaximum quantity per member per 30 days

Maximum when each kit contains 2 tests

Dec. 31, 2024Deleted-list tests covered with approved PA through

Jan. 1, 2025Deleted-list tests cease to be billable

Medi-Cal Rx benefitCoverage classification

Coverage Requirements

Contracted OTC Antigen Test Coverage

Covered as a Medi-Cal Rx pharmacy benefit when ALL of the following requirements are met:

ALL of the following

The test is an OTC, self-administered COVID-19 antigen test for diagnosis of a current infection with SARS-CoV-2.
The test is included on the current List of Contracted COVID-19 Antigen Over-the-Counter Tests.
The prescription, or electronic equivalent, is written and signed by a licensed prescriber or pharmacist, and the test is dispensed by a Medi-Cal Rx pharmacy provider.
Applicable medical-supplies prescription requirements are met; a licensed pharmacist may also prescribe the test.
The member is eligible for Medi-Cal on the date of service.
The pharmacy provider has one-on-one documented contact with the member or caregiver before dispensing, by in-person, telehealth, or telephone contact.
The quantity does not exceed 4 tests total per 30-day period per member, provided as 2 kits containing 2 tests each or 4 individually packaged single-test kits.
No refill is requested; a new prescription is required for each dispensing.

Prior Authorization Exceptions

Prior authorization may support coverage only under the applicable exception and transition rules below:

ONE of the following exceptions or transition rules

Deleted contracted test through December 31, 2024
- The test was removed from the List of Contracted COVID-19 Antigen Over-the-Counter Tests.
- The date of service is on or before December 31, 2024.
- An approved prior authorization request demonstrates medical necessity.
Quantity above the standard limit
- The requested quantity exceeds 4 tests per 30-day period per member.

Polymerase Chain Reaction (PCR) tests for diagnosis of a current infection with SARS-CoV-2 are not a Medi-Cal Rx pharmacy benefit. They are covered as a Medi-Cal medical benefit and must be billed through the member’s medical coverage; members should contact their medical benefits plan for PCR testing information.

Packages and kits cannot be broken or sold as individual tests and must be dispensed whole. Only contracted billing codes for kits containing 1 test or 2 tests—the applicable 11-digit NDC-like numbers—are reimbursable. Items not listed in the Medi-Cal Rx Provider Manual may instead be covered through the member’s medical coverage; managed care members should contact their individual medical plan for more information.

The member or caregiver must request that the pharmacy provider dispense the COVID-19 OTC tests after the required documented contact. Autofill is not permitted. Items dispensed without a valid, documented request will be denied as not reasonable or necessary and are subject to post-adjudication audit review by the Department of Health Care Services (DHCS).

Billing and Quantity Parameters

Diagnosis restrictionmixed

Code I

Restriction for diagnosis of a current infection with SARS-CoV-2

Contracted OTC antigen test billing codesNDCCovered

11-digit NDC-like number

Contracted billing codes for one-test-per-kit or two-tests-per-kit products

OTC Antigen Test Quantity Limit

Maximum quantityUp to 4 tests total

Limit periodPer 30-day period

Applies toEach member

Permitted Kit Configurations

Two-test configuration2 kits containing 2 tests each

Single-test configuration4 individually packaged single-test kits

Packaging requirement

Provider Requirements and Denial Risks

Prior Authorization

Prior Authorization for Excess Quantities or Deleted-List Tests

Prior authorization is required for quantities outside the allowed amount and for certain tests removed from the List of Contracted COVID-19 Antigen Over-the-Counter Tests. PA requests must demonstrate medical necessity and meet the applicable ordering or administration requirements.

Quantities are limited to 4 tests per 30-day period per member beginning October 1, 2024.
Deleted-list tests may be covered through December 31, 2024 only with an approved PA request demonstrating medical necessity.
On and after January 1, 2025, deleted-list tests are not billable through Medi-Cal Rx, even with an approved PA.
For quantities above the limit, the test must be ordered or administered by a licensed prescriber, pharmacist, or pharmacy provider following an individualized clinical assessment with appropriate medical necessity demonstrated.

Documentation Required

Prescription and Dispensing Documentation

Policy Background

This policy covers over-the-counter, self-administered COVID-19 antigen tests used to diagnose a current infection with SARS-CoV-2. When applicable prescription, dispensing, utilization, and billing requirements are met, these products remain a Medi-Cal Rx pharmacy benefit. PCR testing follows a different benefit pathway: PCR tests for current SARS-CoV-2 infection are covered through the member’s Medi-Cal medical benefit rather than Medi-Cal Rx.

Key Definitions

COVID-19 Antigen OTC Test

Test typeAn over-the-counter, self-administered COVID-19 antigen test

PurposeUsed to diagnose a current infection with SARS-CoV-2

VirusSARS-CoV-2, the virus that causes COVID-19

Contracted Test

DefinitionA COVID-19 antigen over-the-counter test included on the Medi-Cal Rx list of contracted tests

ListList of Contracted COVID-19 Antigen Over-the-Counter Tests

Coverage relevanceMedi-Cal Rx coverage is limited to tests on the contracted-test list

Quantity Limit

Contracted OTC Self-Administered COVID-19 Antigen Tests

Maximum quantityUp to 4 tests total

Limit periodPer 30 days per member

Eligible productsContracted OTC self-administered COVID-19 antigen tests on the current contracted-test list

Dispensing Site and Process

Note

Dispense tests through the pharmacy for home use

Dispense the OTC self-administered COVID-19 antigen test from a Medi-Cal Rx pharmacy provider for use by the member at home. Before dispensing, obtain a prescription or electronic equivalent signed by a licensed prescriber or pharmacist and document one-on-one contact with the member or caregiver.

One-on-one contact may occur in person, by telehealth, or by telephone.
The member or caregiver must request the test; autofill is not permitted.
Test kits may be dispensed from a pharmacy.

Policy Summary

PayerCenCal Health

PolicyCOVID-19 Antigen OTC Test Coverage

Policy CodePolicy N/A

Change TypeModified

Effective DateOctober 1, 2024

Next Review DateN/A

Key ActionDocument one-on-one contact with the member or caregiver before dispensing each test.

SourceLink

On This Page

The quantity is ordered or administered by a licensed prescriber, pharmacist, or pharmacy provider following an individualized clinical assessment.

Appropriate medical necessity is documented and the applicable prior authorization request is submitted.

On or after January 1, 2025, tests removed from the contracted list are no longer billable through Medi-Cal Rx, even with an approved prior authorization.

Kits must be dispensed whole and may not be broken or sold as individual tests

Providers must maintain documentation supporting each dispensing of a contracted OTC self-administered COVID-19 antigen test for diagnosis of a current SARS-CoV-2 infection. The test must be dispensed by a Medi-Cal Rx pharmacy provider under a valid prescription or electronic equivalent.

The prescription must be written and signed by a licensed prescriber or pharmacist and include the Code I restriction for diagnosis of a current SARS-CoV-2 infection.
Medical-supplies prescription requirements apply; a licensed pharmacist may also prescribe these tests.
A pharmacy provider must document one-on-one contact with the member or caregiver before dispensing, conducted in person, by telehealth, or by telephone.
No refills are allowed; a new prescription is required for each dispensing.
Autofill is not permitted, and the member or caregiver’s request to dispense must be documented.

Documentation Required

Medical Necessity Documentation

Documentation for a PA request must establish why the requested quantity or transition-period deleted-list product is medically necessary. The record should support the individualized clinical assessment and the licensed professional’s order or administration, when applicable.

For quantities above 4 tests per 30 days, document the individualized clinical assessment and appropriate medical necessity.
For deleted-list tests dispensed through December 31, 2024, document medical necessity with the PA request.
Ensure the requested product and quantity correspond to the applicable contracted-list status and the member’s clinical need.

Denial Risk

No Documented Member Request

The member or caregiver must affirmatively request that the pharmacy dispense the COVID-19 OTC tests. Dispensing without a valid, documented request is not reimbursable.

Autofill dispensing is prohibited.
Items dispensed without a valid, documented member or caregiver request will be denied as not reasonable or necessary.
Such dispensing is subject to post-adjudication audit review by the Department of Health Care Services (DHCS).

Unsupported block type: denial_risk

Billing Rule

Noncontracted or Deleted Test

Medi-Cal Rx coverage is restricted to tests on the current List of Contracted COVID-19 Antigen Over-the-Counter Tests. Products absent from the current list may not be reimbursable through Medi-Cal Rx under the applicable timing rules.

Tests removed from the list may be covered through December 31, 2024 only with an approved PA demonstrating medical necessity.
On and after January 1, 2025, deleted tests are no longer billable through Medi-Cal Rx, even with an approved PA.
Tests not listed in the Medi-Cal Rx Provider Manual may be covered through the member’s medical coverage; managed care members should contact their individual medical plan.

Billing Rule

Improper Packaging or Quantity

Packages and kits must be dispensed whole and billed only in the contracted package configuration. Packaging or quantity-limit violations are not reimbursable unless an applicable approved exception is met.

Packages or kits cannot be broken or sold as individual tests.
Only contracted billing codes for 1 test per kit or 2 tests per kit—the applicable 11-digit NDC-like numbers—are reimbursable.
Dispense no more than 4 tests total per 30 days per member: 2 two-test kits or 4 single-test kits.
No refills are allowed; each dispensing requires a new prescription.

PCR Test

Test typeA laboratory-based test for current SARS-CoV-2 infection

AdministrationUsually administered by a health care provider in a clinic and transported to a laboratory

Coverage distinctionA covered Medi-Cal medical benefit billed through the member’s medical coverage, not a Medi-Cal Rx pharmacy benefit