Does J3490 require prior authorization?

Yes, J3490 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J3490?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J3490`, Unclassified drugs

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

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).
No documentation requirements are specified in the provided excerpt.
No documentation requirements are specified in this excerpt.
No explicit documentation requirements are specified in the provided document text.

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.
Clinical presentation in affected individuals: developmental delay, hypotonia (low muscle tone), oculogyric crises (involuntary upward deviation of the eyes), autonomic dysfunction, disturbances in mood and sleep, and intellectual impairment.
Typical onset and course: symptoms usually appear within the first year of life and affected individuals generally require lifetime care.
No explicit covered indications are stated in the provided text.
Inferred indication: Treatment of aromatic L‑amino acid decarboxylase (AADC) deficiency with Kebilidi (eladocagene exuparvovec‑tneq) as a gene therapy approach (text states Kebilidi has been developed as a potential approach for AADC deficiency).
Treatment of adult and pediatric individuals with AADC deficiency.

20 Active Policies

CGS-J15-L34338, Transthoracic Echocardiography (TTE)

J15

CGS-J15-L33960, Cardiovascular Nuclear Medicine

J15

CGS-J18-L33960, Cardiovascular Nuclear Medicine

J18

CGS-J18-L34338, Transthoracic Echocardiography (TTE)

J18

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

NGS-J6-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

NORIDIAN-JE-L36538, Treatment of Males with Low Testosterone

NORIDIAN-JE-L34324, Cardiovascular Stress Testing, Including Exercise and/or Pharmacological Stress and Stress Echocardiography

NORIDIAN-JF-L36538, Treatment of Males with Low Testosterone

NORIDIAN-JF-L34324, Cardiovascular Stress Testing, Including Exercise and/or Pharmacological Stress and Stress Echocardiography

PALMETTO-JJ-L39086, Treatment of Males with Low Testosterone

NGS-JK-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

PALMETTO-JM-L39086, Treatment of Males with Low Testosterone

ANTHEM-MED.00132, Autologous Adipose-derived Regenerative Cell Therapy

ANTHEM-MED.00151, Gene Therapy for Aromatic L-Amino Acid Decarboxylase Deficiency

ANTHEM-MED.00129, Gene Therapy for Spinal Muscular Atrophy

ANTHEM-MED.00146, Gene Therapy for Sickle Cell Disease

ANTHEM-MED.00147, Cellular Therapy Products for Allogeneic Stem Cell Transplantation

ANTHEM-MED.00135, Gene Therapy for Hemophilia

HUMANA-KEBILIDI-ELADOCAGENE-EXUPARVOVEC-TNEQ-MA, Kebilidi (eladocagene exuparvovec-tneq)

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J3490, Unclassified drugs