Home Drug Codes J Codes J7345 · AMELUZ
Updated July 1st, 2026

AMELUZ J Code: J7345

Aminolevulinic acid hcl for topical administration, 10% gel, 10 mg

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Q4 2026 Medicare Payment Limit for J7345, effective October 1, 2026: $1.848 per HCPCS billing unit, unchanged from Q3 2026. From CMS's final file.

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Medicare Payment Limit ?
$1.848
/ HCPCS billing unit · Q3 2026
APC Payment Limit ?
$1.848
/ HCPCS billing unit · APC 9301
ASP ?
$•••.••
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WAC · AWP ?
$•••.••
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NDCs Crosswalked ?
3
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Drug & Product Overview

HCPCS Descriptor Aminolevulinic acid hcl for topical administration, 10% gel, 10 mg
HCPCS Added Date January 1, 2018
Manufacturer Biofrontera
Route of Administration Topical
Generic Status Single-Source; Branded
Dosage Form Gel

About AMELUZ

Ameluz is a medication aligned to the HCPCS J Code: J7345 for billing, pricing, and reimbursement purposes in the United States. It is a Misc. drug administered via the topical route and manufactured by Biofrontera.

According to CMS Drug Use Information: Drug uses not available

Disclaimer: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional.

NDC Code Information

Based on publicly available CMS files. Showing 2 of 3 NDCs — log in for the full crosswalk.

NDC Code Drug Manufacturer Billing Units / Pkg Package Size
70621-0101-10 Ameluz Biofrontera Inc. 200 100 MG
70621-0101-20 Ameluz Biofrontera Inc. 2000 100 MG
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AMELUZ Pricing & Reimbursement

J7345 Private Payer Reimbursement
$1.61 / HCPCS unit as of Jan 2026

National median reimbursement across major commercial payers.

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UnitedHealthcare, BlueCross BlueShield, Aetna, Cigna

Historical Graphing and Billing Calculator

per HCPCS unit
As of Q3 2026

AMELUZ CPT Administration Codes

The below list of CPT codes is intended for informational purposes only and may not be exhaustive. CPT® codes and descriptions are copyright American Medical Association (AMA). All rights reserved.

CPT Code Description
96567 Photodynamic therapy by external application of light to destroy premalignant lesions of the skin and adjacent mucosa (eg, lip) by activation of photosensitive drug(s), per day
96573 Intralesional injection of 0.1 cc or less of non-radioactive substance.
96574 Login for More Photodynamic therapy by external application of light to destroy premalignant and/or malignant lesions of the skin and adjacent mucosa (e.g., lip) by activation of photosensitive drug(s), each phototherapy exposure session. Login for More
Not on the CMS JW / JZ list

CMS does not include Ameluz (J7345) on its list of HCPCS pertaining to single-dose containers. Per CMS guidelines, the JZ/JW wastage modifiers may not apply when billing J7345. Wastage billing guide →

AMELUZ Medically Unlikely Edits (MUE)

The most billing units of J7345 Medicare will pay for one patient in one day, as published by CMS. 1 unit = 10 mg.

Practitioner Office & Hospital Outpatient
600 units / day
= 6,000 mg per day

MAI 3 · Date of Service Edit: Clinical. Per-day limit based on clinical expectations; excess units are denied but may be appealed with documentation of medical necessity. See all MUE limits →

mg Enter a dose to see how many billing units it is and whether it is under the limit.

AMELUZ Clinical Information

Indications and drug classification.

Treated Diseases & Conditions

This list of indications is not exhaustive and may be subject to errors. The information on BuyandBill.com is intended for informational purposes only and should not be used for medical advice.

Actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp
Drug Class
Fluorescence Contrast Activity [MoA]Optical Imaging Agent [EPC]Porphyrin Precursor [EPC]Porphyrinogens [CS]

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Frequently Asked Questions

Is there an available Ameluz billing and coding guide?
Billing and coding information for AMELUZ can be found through Biofrontera. Visit Here →
Are there any available Ameluz patient assistance programs?
AMELUZ patient assistance information can be found through Biofrontera. Visit Here →
Where can I find Ameluz prescribing information?
AMELUZ prescribing information can be found at the link below: Visit Here →
Where can I find Ameluz side effect information?
Our team has not yet identified a source of side effects information for AMELUZ. Please check back in a few weeks.
Does billing AMELUZ require JZ/JW wastage modifiers?
CMS does not include AMELUZ (J7345) on its list of HCPCS pertaining to single-dose containers. Per CMS guidelines, the JZ/JW wastage modifiers may not apply when billing J7345. For more information, visit the link below.

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