COVID-19 Over-the-Counter Tests

Over-the-Counter COVID-19 Test Demonstration

Starting April 4, 2022, and through the end of the COVID-19 public health emergency (PHE), Medicare covers and pays for over-the-counter (OTC) COVID-19 tests at no cost to people with Medicare Part B, including those with Medicare Advantage (MA) plans (referred to throughout this webpage as “patients”).

In addition to helping prevent the spread of COVID-19, the goal of this demonstration is to find out if Medicare payment for OTC COVID-19 tests will improve access to testing and result in Medicare savings or other program improvements.

What’s Covered

Eligible providers or suppliers can distribute U.S. FDA-approved, authorized, or cleared OTC COVID-19 tests to patients enrolled in Part B, including those enrolled in MA plans. Patients who only have Medicare Part A can get free OTC COVID-19 tests through other government-led programs, like covidtests.gov, which operates through the United States Postal Service (USPS). Or, they may have coverage through a private insurance plan, if they’re enrolled in a plan.

Eligible Medicare patients will get these tests at no cost, and their annual deductible, coinsurance, and copayment don’t apply.

How Many Tests Are Covered

Each eligible Medicare patient can get up to 8 tests per calendar month until the PHE ends. Medicare won’t pay for more than 8 OTC tests in a month. If a patient gets more than 8 tests in a calendar month, they may pay out-of-pocket for the extra tests unless they have additional health coverage.

Who Can Participate

Institutional and non-institutional ambulatory health care providers and suppliers can participate in the demonstration. Eligible health care providers and suppliers must be enrolled in Medicare and bill for these tests on a standard claims format (such as the 837 Professional or Institutional format). Participating eligible providers can’t use roster bills.

Eligible providers and suppliers include:

• 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 are 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 currently administer and submit claims for services like COVID-19 vaccines, lab tests and/or clinic visits, you can also bill under this demonstration for OTC COVID-19 tests. You can provide and bill for OTC COVID-19 tests for anyone with Part B. They don’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 furnish the tests after the patient is discharged from the inpatient stay

Medicare doesn’t cover OTC COVID-19 tests when billed by:

• Those who are enrolled in Medicare only as a Durable Medical Equipment Prosthetics, Orthotics, & Supplies (DMEPOS) supplier
• Providers who give OTC COVID-19 tests to patients during an inpatient stay, like a hospital stay or a SNF stay

How to Participate

Participation in this demonstration is voluntary. If you meet the criteria and want to participate:

• You don’t need to sign a participation agreement to bill Medicare for these tests.
• You initiate participation in the demonstration when you submit a Medicare claim for OTC COVID-19 tests.
• You don’t need to complete a new enrollment if you’re currently enrolled in Medicare and can provide ambulatory health care services such as lab tests, preventive vaccines, or other clinic visits.
• Submit Medicare claims using HCPCS code K1034. See “How to Bill.”
• You’ll procure the OTC COVID-19 tests yourself to furnish to Medicare patients. See “Tips for Providing Tests.”

What if I Choose Not to Participate

Providers and suppliers who don’t participate in this demonstration can continue to sell OTC COVID-19 tests to patients, including those enrolled in Part B or MA plans.

Tips for Providing Tests

• Only give patients the tests when they request them. Discuss test availability and the 8 tests per calendar month limit with your patients (or their caregivers).
• We encourage you to ask the patient if a provider or supplier has already given them other OTC COVID-19 tests in the current calendar month. If they aren’t sure or don’t know about the limit, 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 how many tests they can get and lets them know they’ll pay out-of-pocket if they go over that limit.
  • If we deny your claim under this demonstration, both you and the patient can appeal the denial.
• Procure FDA-approved, authorized, or cleared OTC COVID-19 tests from your supplier. Participating eligible pharmacies and health care providers aren’t required to carry all types of FDA-approved, authorized, or cleared OTC COVID-19 tests, but we encourage you to provide equitable access to these for your patients.
• You can operate an online or telephone program to ship tests directly to patients when they request them.
• 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.

If you submit a claim for a number of tests that’s more than the 8 per calendar monthly limit, we’ll deny payment. If we deny a claim for this reason, you can bill the patient directly for the excess tests.

How to Bill

Use HCPCS code K1034 to bill for a single test. 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

Your patients don’t need a physician’s order or supervision for OTC tests provided under the demonstration.

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 to Bill for MA Plan Patients

For patients enrolled in a MA plan, submit claims to Original Medicare through your Medicare Administrative Contractor (MAC). Use your patients’ Medicare Beneficiary Identifiers (MBIs) (not their Medicare Advantage Plan Member IDs) to bill Original Medicare.

Tips for Billing

• 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.

Medicare Payment Amount

• We’ll pay a fixed national payment rate of $12 per OTC COVID-19 test
• We won’t geographically adjust this payment rate
• If you usually charge less than $12 per test, then we’ll pay the lesser of the 2 amounts
• 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 to Get Paid

We’ll pay you directly when you submit valid claims for eligible Medicare patients who ask for tests and haven’t reached the OTC COVID-19 test quantity limit of 8 tests per calendar month. 

We’ll pay claims in the order we get them. Be sure to submit claims promptly. We’ll only pay claims with dates of services starting on or after April 4, 2022, through the last day of the COVID-19 PHE.

If you participate, you agree 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’d normally charge)
• Not collect any additional payment from patients for tests you provide within the 8 per calendar month limit