piflufolastat F18 Injection, for Intravenous Use (Pylarify®) HCPCS Code A9595 - Piflufolastat f-18, diagnostic, 1 millicurie: Billing Guidelines

Effective with date of service, Dec. 21, 2022, the NC Medicaid and NC Health Choice programs cover piflufolastat F18 injection

Effective with date of service, Dec. 21, 2022, the NC Medicaid and NC Health Choice programs covers piflufolastat F18 injection, for intravenous use (Pylarify) for use in the Physician’s Administered Drug Program (PADP) when billed with HCPCS code A9595 - Piflufolastat f-18, diagnostic, 1 millicurie.

Strength/Package Size: Injection: clear, colorless solution in a single-dose syringe containing 296 MBq to 370 MBq (8 mCi to 10 mCi) of piflufolastat F 18

Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

  • with suspected metastasis who are candidates for initial definitive therapy.
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

The recommended dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection. See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • Providers must bill the product with HCPCS code: A9595 - Piflufolastat f-18, diagnostic, 1 millicurie.
  • Providers must indicate the number of HCPCS units.
  • One Medicaid and NC Health Choice unit of coverage is: 1 millicurie
  • The maximum reimbursement rate per unit is: $511.70400
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDC is: 71258-0022-00.
  • The NDC units should be reported as “UN1”
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website.
  • Providers shall bill their usual and customary charge for non-340B drugs
  • PADP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the “UD” modifier on the drug detail.
  • The fee schedule for the PADP is available on Medicaid's PADP web page.

Contact

NCTracks Call Center:  800-688-6696 

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