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.

J7308 is reported alongside exactly one companion CPT code per patient per day — 96567, 96573, or 96574 — chosen by who performs the PDT, not by the number of areas or lesions treated.

Medicare reimburses J7308 under the buy-and-bill model at ASP+6%; rates update quarterly via CMS and must be verified 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%, 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: 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: 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, supplied as a single unit dosage form of 354 mg. The code is maintained by the Centers for Medicare and Medicaid Services (CMS) 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 one applicator was used 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.

Face and scalp lesions are activated by a blue light source roughly 14 to 18 hours after application, while upper extremity lesions use a shorter incubation of approximately 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: ALA is absorbed by rapidly dividing cells and converted to protoporphyrin IX (PpIX), which is cytotoxic when activated by blue light (BLU-U device, 417 nm).
• Indication: FDA-approved for minimally to moderately thick actinic keratosis of the face, scalp, and upper extremities. Off-label use — including the trunk and thick or hypertrophic AK lesions — must not be billed as though it carries the same coverage status.
• Administration model: Provider applies the drug in-office and bills under the buy-and-bill model, meaning the practice purchases 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 approximately 3 hours. The incubation time used should be documented in the clinical note.

Clinical uses: when is J7308 billed?

J7308 is billed when a provider purchases and applies aminolevulinic acid HCl to treat actinic keratosis via photodynamic therapy. The ICD-10-CM diagnosis code most commonly linked to J7308 is L57.0 (actinic keratosis). Documentation must establish that the patient has AK of the face, scalp, or upper extremities, confirmed by clinical examination or biopsy where appropriate.

Actinic keratosis can coexist with other dermatologic findings identified during the same visit, such as L08.9, each carrying its own documentation requirements.

• 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; verify your MAC’s LCD before billing
• Commercial payers: Coverage varies; many follow Medicare criteria but some require prior authorization for PDT drug codes

How to bill HCPCS Code J7308

Billing J7308 correctly requires pairing the drug code with the correct PDT procedure CPT codes, 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 instead of reconstructing 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 two applicators were used and documented, 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 exactly one of CPT 96567, 96573, or 96574 per patient per day, based 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 and 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 purchased and applied the drug.

Companion CPT codes for J7308

J7308 is always billed with a companion CPT procedure code for the photodynamic therapy itself. These three codes are mutually exclusive per patient per day, regardless of the number of areas or lesions treated; the choice between them depends on who performs the application and illumination, and whether debridement precedes it.

Report only one of 96567, 96573, or 96574 per patient per day, regardless of the number of areas or lesions treated; these codes are not stacked by treated area, and 96574 is not an add-on code to 96573 for a larger surface area.

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

NDC to HCPCS crosswalk for J7308

The National Drug Code (NDC) must be reported 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 a new lot is released. 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 methodology: Average Sales Price (ASP) plus 6%. CMS updates ASP-based payment rates quarterly, so this article does not publish a fixed dollar figure.

Always verify the current rate directly 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 purchasing Levulan Kerastick at the time of procurement, then recoups that cost through the J7308 reimbursement after the claim processes. Practices with tight drug acquisition margins 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 J7308 claims are denied after incorrect unit reporting. Every claim for HCPCS Code J7308 must be supported by a complete clinical record that demonstrates medical necessity. Practices transitioning to digital forms for clinical documentation can build these requirements directly into the pre-treatment and treatment note templates.

The documentation checklist below covers the minimum elements CMS auditors and MAC reviewers expect to find in the patient record for a J7308 claim. Organized structured medical forms for clinical documentation ensure no field is missed 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 acquired 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, duration, 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 centralized 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 several errors that consistently surface 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 on drug supply codes like this one.

• Incorrect unit count: Billing two units of J7308 when only one 354 mg applicator was used. Each unit must correspond to 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, or reporting more than one of 96567, 96573, and 96574 per patient per day regardless of 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.
• Unbundling errors: Billing a separate office visit evaluation and management (E&M) code on the same date as PDT without 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 genuinely separate and unrelated service.
• Diagnosis linkage failure: Failing to link L57.0 directly to the J7308 line item on the claim. Some billing systems require explicit 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 automatically reimbursable.

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. However, coders sometimes encounter 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, such as J9070, follow the same buy-and-bill logic even though 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 Ameluz or Metvixia was administered, or vice versa, constitutes incorrect coding regardless of the ALA drug class similarity.

How Pabau supports dermatology PDT documentation and coding accuracy

PDT billing for actinic keratosis involves several moving parts on a single claim: 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 and procedure codes at the point of documentation. The NDC, unit count, and companion CPT selection are captured in the same workflow as the clinical note rather than reconstructed later.

That keeps the two most error-prone parts of a J7308 chart accurate from the start: NDC data and companion CPT selection matched to who actually 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 acquisition 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 exactly right: one unit per applicator, the NDC on every claim line, and the one companion CPT code that actually matches who performed the application, activation, or debridement that day. Missing any of these elements converts a billable service into a denial.

Pabau helps dermatology practices build structured documentation workflows for drug supply codes like J7308, with diagnosis linking and treatment-note prompts that 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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