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.
- For C9399 the quantity administered should be billed on one claim line for one unit dose for the date of service, and the total dose quantity administered must be indicated in the remarks field (UB-04 FL 80) or the equivalent 5010 electronic claims field.
- Hospitals must use the most current HCPCS Level II codes (refer to CMS.gov HCPCS Level II updates) when selecting HCPCS codes for drugs and biologicals.
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.
- Echocardiograms performed as part of the CAMZYOS REMS program are covered when billed with modifier KX and all REMS program requirements are met for patients with NYHA Class II–III obstructive hypertrophic cardiomyopathy (I42.1).
20 Active Policies
CGS-L34338, Transthoracic Echocardiography (TTE)
J15
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
J6
NGS-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
JK
HUMANA-GENE-THERAPY-TREATMENTS-FOR-SICKLE-CELL-DISEASE-MA, Gene Therapy Treatments for Sickle Cell Disease
HUMANA-AMTAGVI-LIFILEUCEL-FL-MEDICAID, Amtagvi (lifileucel)
HUMANA-KEBILIDI-ELADOCAGENE-EXUPARVOVEC-TNEQ-MA, Kebilidi (eladocagene exuparvovec-tneq)
HUMANA-LENMELDY-ATIDARSAGENE-AUTOTEMCEL-FL-MEDICAID, Lenmeldy (atidarsagene autotemcel)
ANTHEM-MED.00140, MED.00140 Gene Therapy for Beta Thalassemia
ANTHEM-MED.00135, MED.00135 Gene Therapy for Hemophilia
ANTHEM-MED.00120, MED.00120 Gene Therapy for Ocular Conditions
ANTHEM-MED.00144, MED.00144 Gene Therapy for Duchenne Muscular Dystrophy
ANTHEM-MED.00147, MED.00147 Cellular Therapy Products for Allogeneic Stem Cell Transplantation
ANTHEM-MED.00146, MED.00146 Gene Therapy for Sickle Cell Disease
ANTHEM-MED.00151, MED.00151 Gene Therapy for Aromatic L-Amino Acid Decarboxylase Deficiency
ANTHEM-CG-SURG-127, CG-SURG-127 Products for Wound Healing and Soft Tissue Grafting: Medically Necessary Uses
HUMANA-AMTAGVI-LIFILEUCEL-SC-MEDICAID, Amtagvi (lifileucel)
A55913, Billing and Coding: Hospital Outpatient Drugs and Biologicals Under the Outpatient Prospective Payment System (OPPS)
A57306, Billing and Coding: Transthoracic Echocardiography (TTE)
UHC-POL-clotting-factors-coagulant-blood-products, Clotting Factors, Coagulant Blood Products, & Other Hemostatics
HUMANA-LENMELDY-ATIDARSAGENE-AUTOTEMCEL-SC-MEDICAID, Lenmeldy (atidarsagene autotemcel)
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