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## **What is CDC’s RT-PCR diagnostic panel?**
HCPCS code U0001 is designated for the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel, a molecular assay specifically developed by the Centers for Disease Control and Prevention (CDC) to detect SARS-CoV-2 (the virus that causes COVID-19).
This code was introduced early in the pandemic to enable precise billing and tracking of CDC-developed COVID-19 PCR tests in Medicare and other health insurance claims processing systems. It became effective for billing purposes on April 1, 2020, with dates of service backdated to February 4, 2020.
## **HCPCS code U0001 documentation requirements**
HCPCS code U0001 documentation must verify that the test was performed with the CDC-provided kit and in accordance with protocol.
It should include:
- Proof that the test performed was the CDC-developed RT-PCR diagnostic panel
- Confirmation that the CDC-provided test kit was used
- Specimen type (e.g., nasopharyngeal swab, or other accepted collection method)
- Date of specimen collection
- Laboratory methodology consistent with CDC protocol
- Documentation that the claim was billed under U0001
## **U0001 billing guidelines**
In addition to documentation, you have to follow certain rules to avoid delays and claim denials:
- Use HCPCS U0001 when the CDC RT-PCR test panel is performed and specifically used for CDC testing laboratories to test patients.
- Do not use for non-CDC laboratory-tests. Those require other codes (e.g., U0002 or CPT 87635)
- Medicare and most payers generally apply no patient cost-sharing (deductible, coinsurance, or copayment waived) for U0001 claims as part of the COVID-19 public health response.
Following these will help you avoid denials and delays.
## **Other relevant codes**
- **U0002** – 2019-nCov coronavirus, SARS-Cov-2/2019-ncov (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC U0002
- **CPT 87635** – Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique
Frequently asked questions
No. U0001 is exclusively for CDC-developed RT-PCR diagnostic panels using the CDC kit. Non-CDC or laboratory-developed diagnostic tests require U0002 or CPT 87635, depending on method and payer policy.
Generally, no. Under the COVID-19 public health emergency, cost-sharing (deductibles, copayments, coinsurance) for COVID-19 diagnostic lab testing (including U0001) has been waived by Medicare and many insurers.
HCPCS code U0001 is used only for the CDC 2019 novel coronavirus (2019-nCoV) Real-Time RT-PCR diagnostic panel performed with the CDC-developed kit, while U0002 applies to non-CDC laboratory tests for SARS-CoV-2/2019-nCoV (COVID-19), regardless of the technique used, and includes multiple types or subtypes with all testing targets.
