J3490 — Unclassified drugs
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
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).
- Coverage determinations for off-label use require supporting peer-reviewed literature, specialty consultant advice as indicated, and reference to accepted standards of medical practice; documentation of these sources must be provided for review.
- Provider requests to add an off-label use must be submitted in writing with supporting data consisting of either at least two Phase III trials demonstrating safety and effectiveness, or if no Phase III evidence exists, at least two large Phase II trials from different centers or other overwhelming Phase II evidence for rare diseases.
- Trials cited must be published in national or international peer-reviewed journals (editorial committees comprised of physicians); abstracts and non-peer-reviewed or in-house publications are not acceptable.
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.
- NGS covers leuprolide acetate (LHRH analog) as palliative treatment of advanced breast carcinoma in premenopausal and perimenopausal women.
- A drug use is covered if it is an FDA-approved labeled indication or is a medically accepted off-label indication supported by one of the accepted compendia at the specified levels (AHFS-DI supportive; NCCN Category 1 or 2A; Micromedex DrugDex Class I/IIa/IIb or Clinical Pharmacology supportive; Lexi-Drugs Evidence Level A) or by articles or LCDs published by National Government Services (NGS).
- Off-label uses in anti-cancer chemotherapeutic regimens are covered when they meet the Medicare definition of a medically accepted indication per the Medicare Benefit Policy Manual (Pub 100-02, Ch.15, §50.4.5).
- Medicare pays for an FDA-approved injectable drug when it was injected on or after the FDA approval date, is reasonable and necessary for the individual patient, and all other coverage requirements are met.
- NGS covers denosumab (Prolia, Xgeva) for its FDA-approved and approved compendia uses.
20 Active Policies
L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
J06
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
CGS-L33960 — Cardiovascular Nuclear Medicine
J18 MAC Part B
CGS-L34338 — Transthoracic Echocardiography (TTE)
J18 MAC Part B
NORIDIAN-L36538 — Treatment of Males with Low Testosterone
JF Part B
NORIDIAN-L34324 — Cardiovascular Stress Testing, Including Exercise and/or Pharmacological Stress and Stress Echocardiography
JF Part B
PALMETTO-N/A — N/A
JJ Part B
PALMETTO-L39086 — Treatment of Males with Low Testosterone
JJ Part B
N/A — N/A
JJ Part B
NGS-L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
JK MAC Part B
HUMANA-KEBILIDI-ELADOCAGENE-EXUPARVOVEC-TNEQ-MA — Kebilidi (eladocagene exuparvovec-tneq) - Medicare Advantage
UHC-POL-sodium-hyaluronate — Sodium Hyaluronate
ANTHEM-MED.00140 — MED.00140 Gene Therapy for Beta Thalassemia
ANTHEM-MED.00135 — MED.00135 Gene Therapy for Hemophilia
UHC-POL-review-at-launch-new-to-market-medications — Review at Launch for New to Market Medications
HUMANA-AMTAGVI-LIFILEUCEL-FL-MEDICAID — Amtagvi (lifileucel) - MEDICAID - FLORIDA
HUMANA-GENE-THERAPY-TREATMENTS-FOR-SICKLE-CELL-DISEASE-MA — Gene Therapy Treatments for Sickle Cell Disease - Medicare Advantage
UHC-POL-chelation-therapy-non-overload-conditions — Chelation Therapy
ANTHEM-MED.00144 — MED.00144 Gene Therapy for Duchenne Muscular Dystrophy
HUMANA-LENMELDY-ATIDARSAGENE-AUTOTEMCEL-FL-MEDICAID — Lenmeldy (atidarsagene autotemcel) - MEDICAID - FLORIDA
Related Codes
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