C9399 — Unclassified drugs or biologicals
HCPCS/CPT
Prior Authorization
No Prior Auth Required
No active coverage policies found for this code (low confidence)
Documentation Required
- Medical record must document indication, route (intravitreal), dose and dosing frequency consistent with the FDA label or include literature support when dosing/frequency deviates from the FDA label.
- The intravitreal administration must be billed with CPT 67028 on the same claim as the drug (or CPT 67027 for SUSVIMO) and must include the appropriate site modifier (RT, LT, or 50).
- For Part A and Part B MAC claims, report the drug using the specified HCPCS/J-codes or Q-codes as listed by product (e.g., ranibizumab J2778/J2779 or Q5124/Q5128, aflibercept J0178 or J0177/Q-codes for biosimilars, brolucizumab-dbll J0179, faricimab-svoa J2777).
- On the claim providers must report the National Drug Code (NDC), the total quantity administered expressed in the applicable unit of measure, and the date the drug was administered.
Key Coverage Criteria
- Intravitreal administration of ranibizumab (including ranibizumab-nuna and ranibizumab-eqrn), aflibercept (including aflibercept HD and biosimilars PAVBLU™, AHZANTIVE®, ENZEEVU™, OPUVIZ™, YESAFILI™), brolucizumab-dbll, and faricimab-svoa is covered when used consistent with the FDA-approved package insert or supported compendia/literature for off-label uses.
- HCPCS C9399 may be used only for new FDA-approved drugs or biologicals approved on or after 2004-01-01 that have not yet been assigned a specific HCPCS code.
- Drugs and biologicals appropriately billed with C9399 are separately payable and will be priced using Average Wholesale Price (AWP) and CMS pricing methodology by this A/B MAC.
- Hospital OPPS claims for drugs and biologicals (separately payable or packaged) should be billed with the correct HCPCS code under revenue code 0636.
- Hospital OPPS claims for Self‑Administered Drugs (SAD) listed on this A/B MAC's JM and JJ websites must be billed with the appropriate HCPCS code.
- NGS covers leuprolide acetate (LHRH analog) as palliative treatment of advanced breast carcinoma in premenopausal and perimenopausal women.
20 Active Policies
A52451 — Billing and Coding: Ranibizumab and biosimilars, Aflibercept, Aflibercept HD, Brolucizumab-dbll, Faricimab-svoa, PAVBLUaflibercept-ayyh, AHZANTIVEaflibercept-abzv. ENZEEVUaflibercept-mrbb, OPUVIZaflibercept-yszy and YESAFILI aflibercept-jbvf
J06
L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
J06
HUMANA-AMTAGVI-LIFILEUCEL-MA — Amtagvi (lifileucel) - Medicare Advantage
HUMANA-LENMELDY-ATIDARSAGENE-AUTOTEMCEL-SC-MEDICAID — Lenmeldy (atidarsagene autotemcel) - MEDICAID - SOUTH CAROLINA
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