## **What is HCPCS code A9595?**
The code A9595, maintained by the Centers for Medicare and Medicaid Services (CMS), has the following descriptor: "Piflufolastat f-18, diagnostic, 1 millicurie". It falls under the HCPCS category for Administrative, Miscellaneous, and Investigational services, specifically within the Diagnostic and Therapeutic Radiopharmaceuticals group (A9500-A9800).
This code identifies explicitly the drug Piflufolastat F 18 injection (trade name, e.g., Pylarify), a radiopharmaceutical agent used for PET scans to detect Prostate-Specific Membrane Antigen (PSMA) positive lesions in men with prostate cancer.
It is used in PET imaging for prostate cancer, typically in cases of suspected metastasis or suspected recurrence based on an elevated serum PSA level.
## **Billing and documentation requirements**
Thorough documentation in the patient's medical record is critical for both medical necessity and audit compliance. Key documentation requirements generally include:
- **Medical necessity**: Relevant medical history and physical examination findings, rationale for the decision to perform the PET scan, including the reason the PET scan is necessary over standard imaging modalities, and documentation or notes of the role the PET scan plays in clinical management (e.g., initial treatment strategy or subsequent treatment strategy).
- **Radiopharmaceutical details**: The dose administered in millicuries (mCi), the National Drug Code (NDC) of the radiopharmaceutical, and the acquisition/invoice cost of the agent (often reported on the claim, and an actual invoice may be requested during an audit).
- **Procedure report**: A formal, written PET scan report with clear patient demographics, the name of the interpreting provider, the reason for the test, an interpretive report(s), and copies of images, and computerized image reconstruction data should also be maintained.
### **Reimbursement and coverage**
Specific billing rules apply to radiopharmaceuticals like A9595:
- **Unit reporting**: The code represents one millicurie (mCi). If, for example, nine mCi is administered, the number of units to be reported on the claim form (Box 24G on the CMS 1500 or electronic equivalent) would be 9. But in some settings, payers may impose rounding rules or maximum allowed units per claim—always check payer guidance.
- **Payment basis**: Diagnostic radiopharmaceuticals like A9595 are typically paid based on the acquisition/invoice cost reported on the claim. However, some Medicare contractors may apply adjustments or use other pricing methodologies in the absence of invoice data.
- **Diagnosis codes (ICD-10-CM)**: Claims must include an appropriate ICD-10-CM code that justifies the medical necessity of the scan.
- **Modifiers (Medicare)**: When submitting for Medicare, specific modifiers are often required for the associated PET or PET/CT procedure code (the procedure itself, not the drug code A9595) to indicate the reason for the scan like PI (Used for PET/CT to inform the initial treatment strategy), and PS (Used for PET/CT to inform the subsequent treatment strategy (e.g., suspected recurrence)).
## **Related HCPCS codes**
- **A9594**: Gallium ga-68 psma-11, diagnostic, 1 millicurie.
- **A9596**: Gallium Ga-68 gozetotide, diagnostic, 1 millicurie.
- **A9608**: Flotufolastat f-18, diagnostic, 1 millicurie.
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