COVID-19 Over-the-Counter Tests

Over-the-Counter COVID-19 Test Demonstration

The OTC COVID-19 test demonstration ended on May 11, 2023. Starting on May 12, 2023, Medicare no longer covers or pays for OTC COVID-19 tests for those with Medicare Part B benefits.

Medicare patients with Part B benefits still have access to laboratory-conducted COVID-19 tests (like PCR tests), even after the COVID-19 PHE ends. Eligible patients will continue to get these lab-conducted tests at no cost, and their annual deductible, coinsurance, and copayment doesn’t apply. This is because Part B covers a variety of outpatient services, including medically necessary clinical diagnostic laboratory tests, but doesn’t cover or pay for OTC services and tests. Medicare only paid for OTC COVID-19 tests during this demonstration, which ended after May 11, 2023.

After May 11, 2023, you can continue to sell OTC COVID-19 tests to patients, including those enrolled in Part B or MA plans. But, starting on May 12, 2023, Medicare won’t cover or pay for OTC COVID-19 tests for Medicare Part B patients.

• Only give patients OTC COVID-19 tests when they request them, and inform patients (or their caregivers) that Medicare doesn’t cover or pay for these tests.
• You can voluntarily give the patient an Advanced Beneficiary Notice of Non-Coverage (ABN) before you give them an OTC COVID-19 test. The ABN isn’t required, but it tells the patient that Medicare doesn’t cover OTC COVID-19 tests and lets them know they’ll pay out-of-pocket for the tests.

What Was Covered Through May 11, 2023?

From April 4, 2022 – May 11, 2023, Medicare covered and paid for up to 8 OTC COVID-19 tests for people with Medicare Part B, including those enrolled in MA plans under the terms of this demonstration. Eligible Medicare patients could get these OTC tests at no cost from eligible participating providers, and their annual deductible, coinsurance, and copayment don’t apply.

How Many Tests Were Covered Through May 11, 2023?

Each eligible Medicare patient could get up to 8 tests per calendar month through May 11, 2023. Medicare didn’t pay for more than 8 OTC tests in a month. If a patient got more than 8 tests in a calendar month, they may have to pay out-of-pocket for the extra tests unless they had additional health coverage. Some MA plans may have covered and paid for OTC COVID-19 tests as an added benefit. Your patient can check with the plan to see if it covered and paid for these tests.

Who Could Participate Through May 11, 2023?

Institutional and non-institutional ambulatory health care providers and suppliers could participate in the demonstration. These eligible providers must have been enrolled in Medicare and bill for these tests (for dates of service between April 4, 2022 – May 11, 2023) on a standard claims format (such as the 837 Professional or Institutional format). Participating eligible providers can’t use roster bills.

Eligible providers included:

• Physicians and other non-physician practitioners
• Clinic/group practices
• Hospital outpatient departments
• Critical access hospitals (CAHs)
• Skilled nursing facilities (SNFs)
• Home health agencies (HHAs)
• Federally Qualified Health Centers (FQHCs)
• Rural health clinics (RHCs)
• Opioid treatment programs (OTPs)
• Independent laboratories
• Independent renal dialysis facilities
• Comprehensive Outpatient Rehabilitation Facilities (CORFs)
• Mass immunizers (only those that bill on standard claim format)
• Indian Health Service (IHS) facilities
• Pharmacies that were enrolled in Part B as a particular kind of entity (like CLIA-certified laboratories, mass immunizers, or those under the enrollment of a professional, like a nurse practitioner to provide ambulatory health care services). For example, if you administered and submitted claims for services like COVID-19 vaccines, lab tests and/or clinic visits, you could also bill under this demonstration for OTC COVID-19 tests. You could provide and bill for OTC COVID-19 tests for anyone with Part B. They didn’t need to be an existing customer or get their prescription drugs from you.
• Institutional providers, like inpatient hospitals or other hospital providers, when you furnished the tests after the patient was discharged from the inpatient stay

Medicare didn’t cover OTC COVID-19 tests under this demonstration when billed:

• By those who were enrolled in Medicare only as a Durable Medical Equipment Prosthetics, Orthotics, & Supplies (DMEPOS) supplier
• By providers who gave OTC COVID-19 tests to patients during an inpatient stay, like a hospital or SNF stay

Participation in this demonstration was voluntary. If you met the criteria:

• You didn’t need to sign a participation agreement to bill Medicare for these tests
• You didn’t need to complete a new enrollment if you were already enrolled in Medicare and could provide ambulatory health care services such as lab tests, preventive vaccines, or other clinic visits

How Do I Bill for Tests Provided Through May 11, 2023?

• Use HCPCS code K1034 to bill for a single test. K1034 was only effective for dates of service from April 4, 2022 – May 11, 2023. This code applies to all OTC, FDA-approved, authorized, or cleared COVID-19 tests (that are self-administered with a specimen that’s self-collected):
  • K1034 Short Descriptor: Covid test self-admn/collect
  • Long Descriptor: K1034: Provision of COVID-19 test, nonprescription self-administered and self-collected use, FDA approved, authorized or cleared, one test count
• If you gave a patient more than 1 test on the same day, adjust the quantity and billed amount for the number of tests on a single claim line. Don’t submit multiple claims or multiple claim lines for a patient on the same day for the same service.
• Your patients didn’t need a physician’s order or supervision for OTC tests provided under the demonstration.
• Keep good documentation. We may ask to see documentation showing a patient’s request for tests. If you don’t provide the documentation, we could recoup payment and may take other administrative actions.

We’ll deny payment if you:

• Submit a claim for a number of tests that’s more than the 8 per calendar monthly limit. If we deny a claim for this reason, you can bill the patient directly for the excess tests.
• Submit more than 1 claim or claim line per patient per day for the same service.
• Submit a claim for tests your patient ordered after May 11, 2023.

If we deny your claim under this demonstration, both you and the patient can appeal the denial.

Professional Claims:

• Use the same NPI, TIN, or PTAN that you use when you bill for flu, pneumococcal, or COVID-19 vaccines

Institutional Claims:

• Revenue Codes:
  • Use Code 0300
  • CORF providers: Use Code 0274
• FQHCs and RHCs:
  • Hospital-based: Bill tests through your hospital
  • Free standing or independent: Bill tests on a CMS-1500, as you would other normal laboratory services
• Renal dialysis facilities: Bill tests with the AY modifier
• CAHs and IHS facilities: Bill tests on a TOB 014x
• OTPs: Be sure each test is a separate line item with a unit of 1, with a maximum of 8 lines for each patient per claim per calendar month. Don’t add any other services (like demo code 99) to the claim.
• If you have no other diagnoses for the OTC COVID-19 tests: Use suggested diagnosis code Z20.822: Contact with and (suspected) exposure to COVID-19
• If you don’t have an attending physician for the OTC tests claim, enter:
  • A billing provider NPI
  • “Self-referred” in the Corresponding name field

How Do I Bill for MA Plan Patients' Tests Provided Through May 11, 2023?

For patients enrolled in a MA plan, submit claims to Original Medicare through your Medicare Administrative Contractor (MAC) for dates of service from April 4, 2022 – May 11, 2023. Use your patients’ MBIs (not their MA plan member IDs) to bill Original Medicare.

Tips for Billing

• We’ll deny payment if you submit a claim for OTC COVID-19 tests that you provided after May 11, 2023.
• You can bill for multiple tests, including single-test and multiple-test packages.
• If a package has more than 1 test, be sure to bill for the total number of tests (1 test = 1 unit). For example, if a package has 2 tests, submit a claim for 2 units of HCPCS code K1034.
• All payer types, including private insurance and Medicaid programs, can use HCPCS code K1034.
• Submit claims using the standard claim format (the 837 Professional or Institutional format).
• If you use free PC-ACE billing software, add HCPCS code K1034 to submit electronic claims.
• You can’t use roster bills to bill Medicare for OTC COVID-19 tests.
• If a patient submits a claim, we’ll return it. They can then ask you to submit a claim for processing. If we deny your claim, the patient can appeal this decision once a determination is made. Patients will get a determination through the Medicare Summary Notice. Providers will get a Remittance Advice.

What Was the Medicare Payment Amount Through May 11, 2023?

• We paid a maximum fixed national payment rate of $12 per OTC COVID-19 test
• We didn’t geographically adjust this payment rate
• If you usually charged less than $12 per test, we’ll pay the lesser of $12 or what you charged
• You must accept the Medicare payment amount as payment in full and not collect any additional amounts from patients for tests provided within the quantity limit

How Do I Get Paid for Tests Provided Through May 11, 2023?

We’ll pay you directly when you submit valid claims for eligible Medicare patients who:

• Asked for tests through May 11, 2023
• Hadn’t reached the OTC COVID-19 test quantity limit of 8 tests per calendar month

Only submit 1 claim per patient per day. If you gave a patient more than 1 test on the same day, adjust the quantity and billed amount for the number of tests.

We pay claims in the order we get them. Be sure to submit claims promptly. We’ll only pay claims with dates of service from April 4, 2022 – May 11, 2023.

If you participated in the demonstration, you agreed to:

• Submit a claim to get paid
• Get paid as a participating eligible provider under the demonstration
• Accept payment in full (the fixed national payment rate of $12 per test or any lower amount you normally charged)
• Not collect any additional payment from patients for tests you provided within the 8 per calendar month limit