HCPCS Code J7308: Aminolevulinic acid HCl billing guide

Key takeaways

HCPCS Code J7308 describes aminolevulinic acid HCl (Levulan Kerastick) 20%, billed per 354 mg single unit dosage form for photodynamic therapy.

Coders report J7308 with just one companion CPT code per patient per day — 96567, 96573, or 96574. The choice depends on who performs the PDT, not on the number of areas or lesions treated.

Medicare reimburses J7308 under the buy-and-bill model at ASP+6%; practices must check rates quarterly via CMS before claim submission.

Practice management software like Pabau helps dermatology practices keep HCPCS drug codes, diagnoses, and companion CPT selections linked in structured, audit-ready clinical documentation.

HCPCS Code J7308 is the Level II drug supply code for aminolevulinic acid HCl (Levulan Kerastick) 20%. It is billed per 354 mg single unit dosage form for photodynamic therapy.

Dermatology coders who understand the billing mechanics of dermatology EMR software and photodynamic therapy drug codes avoid the claim errors that recur most for this code. Those errors are missing NDC information, incorrect unit counts, and companion CPT codes that do not match the treatment delivered.

This reference covers HCPCS Code J7308 end to end. It walks through the official code description, clinical indications, billing workflow, Medicare reimbursement, NDC crosswalk, documentation requirements, and common errors to avoid.

HCPCS Code J7308: definition and official description

HCPCS Code J7308 is the Level II drug supply code for aminolevulinic acid hydrochloride (ALA) for topical administration at a 20% concentration. It is supplied as a single unit dosage form of 354 mg. The Centers for Medicare and Medicaid Services (CMS) maintains the code under the HCPCS Level II classification system.

The billing unit is strict. One unit of HCPCS Code J7308 equals one 354 mg Levulan Kerastick applicator used during the photodynamic therapy session. Billing two units when the clinician used only one applicator is an overcoding error that triggers claim review.

Drug overview: Levulan Kerastick (aminolevulinic acid HCl 20%)

Levulan Kerastick is the only FDA-approved brand of aminolevulinic acid HCl for photodynamic therapy (PDT) in the United States. The drug is a photosensitizing agent applied topically to actinic keratosis lesions on the face, scalp, and upper extremities.

A blue light source activates face and scalp lesions roughly 14 to 18 hours after application. Upper extremity lesions use a shorter incubation of about 3 hours. Dermatology practices offering PDT treatments can streamline the drug tracking and workflow side with skin clinic software designed for multi-step procedure documentation.

• Mechanism: Rapidly dividing cells absorb ALA and convert it to protoporphyrin IX (PpIX). PpIX becomes cytotoxic when blue light (BLU-U device, 417 nm) activates it.
• Indication: FDA-approved for minimally to moderately thick actinic keratosis of the face, scalp, and upper extremities. Practices must not bill off-label use as though it carries the same coverage status. This includes use on the trunk and on thick or hypertrophic AK lesions.
• Administration model: Provider applies the drug in-office and bills under the buy-and-bill model. This means the practice buys the Kerastick, applies it to the patient, and bills J7308 on the professional claim.
• Incubation period: Face and scalp lesions use a standard ALA incubation of 14 to 18 hours. Upper extremity lesions use a shorter incubation of about 3 hours. The clinical note should document the incubation time used.

Clinical uses: when is J7308 billed?

A provider bills J7308 when buying and applying aminolevulinic acid HCl to treat actinic keratosis via photodynamic therapy. The ICD-10-CM diagnosis code most often linked to J7308 is L57.0 (actinic keratosis). Documentation must show that the patient has AK of the face, scalp, or upper extremities. Clinical examination or biopsy should confirm this where appropriate.

Actinic keratosis can coexist with other dermatologic findings found during the same visit.

• Covered indication: Actinic keratosis (L57.0) of the face, scalp, or upper extremities, minimally to moderately thick lesions
• Not covered off-label: AK of the trunk, or thick/hypertrophic lesions, without supporting LCD criteria
• Medicare Local Coverage Determinations (LCDs): Some Medicare Administrative Contractors publish PDT-specific LCDs that add site, lesion count, or thickness criteria. Check your MAC’s LCD before billing
• Commercial payers: Coverage varies; many follow Medicare criteria but some require prior authorization for PDT drug codes

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How to bill HCPCS Code J7308

Billing J7308 correctly requires pairing the drug code with the correct PDT procedure CPT codes. It also means reporting the right unit count, including the NDC, and linking to the diagnosis. Practices using structured documentation software built for dermatology workflows can keep these checks linked at the point of care. That avoids rebuilding them later. Here is the step-by-step process:

1. Confirm indication and document: Record the diagnosis of actinic keratosis (L57.0) in the clinical note before the session. Include lesion count, anatomical location, and thickness classification.
2. Report the correct unit count: Bill one unit of J7308 for each 354 mg Levulan Kerastick applicator used. One applicator per session is typical; if the clinician used and documented two applicators, bill two units.
3. Add the NDC on the claim: HCPCS drug codes require the 11-digit National Drug Code reported in the narrative qualifier field (N4 qualifier). Missing NDC data is a leading cause of J7308 claim rejection. See the NDC crosswalk section below for Levulan Kerastick’s NDC.
4. Select the correct companion CPT code: Report just one of CPT 96567, 96573, or 96574 per patient per day. Base the choice on who performed the service, not on the number of areas treated. See companion codes table below.
5. Link diagnosis to procedure: Use L57.0 as the primary diagnosis. Link it to both the J7308 drug code and the companion CPT code on the claim form.
6. Submit under buy-and-bill rules: J7308 is a Part B physician-administered drug. Bill on a professional claim (CMS-1500 or electronic equivalent) from the practice that bought and applied the drug.

Companion CPT codes for J7308

Coders always bill J7308 with a companion CPT procedure code for the photodynamic therapy itself. These three codes are mutually exclusive per patient per day, no matter the number of areas or lesions treated. The choice between them depends on who performs the application and illumination, and whether debridement comes before it.

Rules for choosing the correct companion code

Report only one of 96567, 96573. Practices do not stack these codes by treated area, and 96574 is not an add-on code to 96573 for a larger surface area.

Picking the wrong one of the three is a documentation-driven error, not a payer LCD choice. It means the note does not support who performed the application, activation, or debridement. Check the AAPC Codify HCPCS lookup tool for full CPT descriptors before picking a companion code.

NDC to HCPCS crosswalk for J7308

Practices must report the National Drug Code (NDC) on all Medicare Part B drug claims submitted for J7308. Using paperless billing documentation workflows that capture NDC at the point of dispensing reduces the risk of missing this field on submission.

Always confirm the NDC against the actual product packaging or the current FDA label before submission. NDC numbers can change when a manufacturer updates packaging or releases a new lot. Report the NDC in 5-4-2 format using the N4 qualifier on the claim line.

Medicare reimbursement and fee schedule for J7308

Medicare reimburses J7308 under the Part B drug payment method: Average Sales Price (ASP) plus 6%. CMS updates ASP-based payment rates quarterly, so this article does not publish a fixed dollar figure.

Always check the current rate through the CMS ASP Drug Pricing Files before submitting claims. The Physician Fee Schedule does not carry Part B drug pricing, so it is not a substitute source for this rate.

HCPCS J7308 fee schedule by payer

The buy-and-bill model means the practice absorbs the cost of buying Levulan Kerastick up front. It then recoups that cost through the J7308 reimbursement after the claim processes. Practices with tight margins on drug purchases should track ASP quarterly. The NLM Clinical Table Search API provides a free programmatic HCPCS lookup that can support internal pricing tools.

Documentation requirements for J7308

Missing or incomplete documentation is the second-most common reason payers deny J7308 claims after incorrect unit reporting. A complete clinical record that shows medical necessity must support every claim for HCPCS Code J7308. Practices moving to digital forms for clinical documentation can build these requirements into the pre-treatment and treatment note templates.

The documentation checklist below covers the minimum parts CMS auditors and MAC reviewers expect to find. It reflects what belongs in the patient record for a J7308 claim. Organized structured medical forms for clinical documentation ensure staff do not miss any field during a busy treatment day.

• Diagnosis confirmation: Clinical or histopathological documentation of actinic keratosis (L57.0) affecting the face, scalp, or upper extremities
• Lesion count and location: Number of AK lesions, specific anatomical sites (e.g. left temple, vertex scalp), and thickness classification
• Drug purchase record: Invoice or purchase documentation showing the practice bought Levulan Kerastick; required for buy-and-bill audit support
• Application note: Date and time of ALA application, incubation period documented, provider or qualified staff member who applied the drug
• Light activation note: Date and time of BLU-U light activation, length, device used
• NDC from packaging: The 11-digit NDC from the actual Kerastick used, recorded in the chart
• Treatment response plan: Post-treatment follow-up documented, especially for patients receiving repeat PDT sessions

Practices managing repeat PDT patients benefit from central medical records management that keeps lesion counts, locations, and treatment dates consistent across visits.

Common billing errors and how to avoid them

A review of PDT-related claim patterns shows many errors that keep showing up for J7308 claims. Each one is preventable with the right documentation habits and billing workflow. Practices investing in medical spa compliance requirements and dermatology billing training tend to see lower denial rates. This holds true on drug supply codes like this one. Cross-referencing a rejection against the CARC denial code list narrows down which requirement got missed.

• Incorrect unit count: Billing two units of J7308 when the clinician used only one 354 mg applicator. Each unit must match one physical applicator documented in the chart.
• Missing NDC: Submitting the J7308 drug code without the 11-digit NDC in the N4 qualifier field. Medicare will deny or pend the claim. The NDC must match the lot on the actual packaging used.
• Wrong companion CPT code: Reporting 96573 or 96574 (physician/QHP work) when the chart shows staff performed the application and activation with no physician/QHP involvement. This also includes reporting more than one of 96567, 96573, and 96574 per patient per day, no matter the number of areas or lesions treated. Always match the code to what the note documents about who performed the service, not to the size of the treated area.

Documentation and coverage errors for J7308

These remaining errors trip up a J7308 claim even when the drug code and companion CPT code are both correct.

• Unbundling errors: Billing a separate office visit evaluation and management (E&M) code on the same date as PDT. This requires a distinct, separately documented service. A brief medication check does not support a separate E&M on a PDT day. The medical decision making for that encounter must reflect a truly separate and unrelated service.
• Diagnosis linkage failure: Failing to link L57.0 to the J7308 line item on the claim. Some billing systems require a clear diagnosis pointer assignment per claim line; missing this causes automatic denial.
• Off-label indication billing: Billing J7308 for AK of the trunk, or for thick/hypertrophic lesions, without payer-specific prior authorization. The FDA-approved indication for Levulan Kerastick covers the face, scalp, and upper extremities; off-label use beyond those sites is not always payable.

J7308 vs related HCPCS drug codes

Aminolevulinic acid is the only FDA-approved topical photosensitizer for AK-PDT in the United States billed under HCPCS Code J7308. But coders sometimes come across adjacent drug codes in the J7300 range or ask whether other photosensitizing agents have their own J-codes.

Other single-source injectable or topical drug HCPCS codes. The clinical indication is entirely different.

The distinction between J7308 (Levulan Kerastick, 354 mg unit) and J7345 (Ameluz, 10 mg unit) is clinically important. Ameluz uses a different vehicle formulation and concentration, and J7309 (Metvixia) uses a different ester of aminolevulinic acid entirely. Billing J7308 when the practice administered Ameluz or Metvixia, or vice versa, counts as incorrect coding no matter the ALA drug class similarity.

Related HCPCS codes

• HCPCS code J7030 — Normal Saline Infusion
• HCPCS code J7312 — Dexamethasone Intravitreal Implant
• HCPCS code J7318 — Durolane
• HCPCS code J7321 — Hyaluronan injection

How Pabau supports dermatology PDT documentation and coding accuracy

PDT billing for actinic keratosis involves many moving parts on a single claim. These include the J7308 unit count, the NDC, the ICD-10 diagnosis, and the correct companion CPT code for who performed the application, activation, or debridement that day. Pabau helps dermatology practices keep these pieces linked instead of tracking them across separate spreadsheets and paper charts.

Pabau’s structured treatment-note templates let a practice link HCPCS drug codes such as J7308 to the supporting diagnosis. Procedure codes attach at the same point of documentation. The same workflow captures the NDC, unit count, and companion CPT selection with the clinical note rather than rebuilding them later.

That keeps the two most error-prone parts of a J7308 chart accurate from the start. NDC data and companion CPT selection stay matched to who performed the service.

Keep drug costs and documentation in one place

Pabau helps dermatology practices link HCPCS drug codes to diagnoses, track buy-and-bill drug purchase costs, and keep treatment documentation audit-ready with structured note templates.

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Conclusion

Photodynamic therapy reimbursement hinges on getting the J7308 drug code just right. That means one unit per applicator, the NDC on every claim line, and the one companion CPT code that matches who performed the application, activation, or debridement that day. Missing any of these parts converts a billable service into a denial.

Pabau helps dermatology practices build structured documentation workflows for drug supply codes like J7308. Diagnosis linking and treatment-note prompts catch errors before they reach a claim. To see how Pabau supports accurate dermatology coding and documentation, book a demo with the team.

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