Reimbursement
Support

Current ASP update

Download the ASP letter now

Keep the following records for a seamless billing and reimbursement process:

  • Pretreatment information sheet (similar to presurgery sheet)
  • Informed consent for treatment
  • Photos
  • Number, location, and grade of lesions
  • Medical necessity for treatment
  • Plan of care
  • Appropriate ICD-10 code
  • Appropriate CPT® code
  • Qualified HCP involvement
  • Post-care instructions

J7308 is a code exclusive to LEVULAN® KERASTICK® and should be reported for each unit utilized.

  • It is against the law to bill another drug or variation of concentration under this code, including compounded formulas
  • Pursuant to the Prescription Drug and Marketing Act of 1987 (“PDMA”), prescription drug samples provided to a physician from a pharmaceutical company may never be billed to patients for any reason or at any time. Violation of the PDMA may result in a penalty, such as monetary fines or incarceration
  • Reimbursement is dependent upon the payer's payment policy and physician contracted rates
  • Medicare physician office payment:
    • Basis of payment is Average Sales Price (ASP) plus 6%
    • ASP is updated quarterly by the Centers for Medicare & Medicaid Services (CMS)

See the annual CPT®
reimbursement rate
by locality

Download now

See the LEVULAN KERASTICK
J-Code flashcard containing the
CMS-1500 sample claim form

Download now

There are different CPT® codes associated with PDT treatment.*

These codes differ based on how and by whom the treatment is applied. The provider is required to report the most appropriate diagnosis code based upon the patient’s condition and reason for treatment. LEVULAN KERASTICK is not intended for application by patients or unqualified staff.

For more information on CPT® codes, visit the CMS website’s Physician Fee Schedule Search.

  • * The provider must report the most appropriate CPT® code. Regardless of the CPT® code reported, the first stage (application) must always be performed by a qualified healthcare professional.
  • CPT® 5-digit numeric codes, descriptions, and numeric modifiers are exclusive copyrights of AMA. All rights reserved.

Reconciliation Tracker

Help keep track of your LEVULAN KERASTICK utilization

Download now
Reconciliation Tracker thumbnail

Frequently Used Forms & Resources

Download the following reimbursement resources and tools for more information on filing claims.

Coverage & Coding thumbnail

COVERAGE & CODING

Browse coverage and coding guidelines for photodynamic therapy provided by Sun Pharma.

Download now
Sample Letters thumbnail

SAMPLE LETTERS

Discover sample letters to amend your contracted rate, request a prior authorization for a patient or plan, appeal a denied claim, and more.

Download now
Payer Research Worksheet thumbnail

PAYER RESEARCH WORKSHEET

Fill out the form to submit a request for information about the billing status of LEVULAN KERASTICK + BLU-U® for a specific provider.

Download now
Provider Claim Appeal Form thumbnail

PROVIDER CLAIM APPEAL FORM

If an insurance company denies coverage, use this form to appeal the claim.

Download now

Need additional support?

Enroll into our Pinnacle support program.

The Pinnacle Health Group is partnered with Sun Pharma to provide precertification, coding and reimbursement support for LEVULAN KERASTICK + BLU-U® patients.

Once enrolled, Pinnacle can:

  • Perform verification of coverage and benefits for your LEVULAN KERASTICK + BLU-U patients. (This is recommended for all photodynamic therapy (PDT) patients with the exception of Medicare Fee-for-Service Plans.)
  • Initiate the prior authorization and predetermination
Download enrollment form

Already enrolled and need a precertification or prior authorization?

Download forms here

Watch now: billing and coding support

Explore a guided video about LEVULAN KERASTICK access topics.

Topic: OPENING

Attend our peer-to-peer reimbursement support programs

Sign up today
Learn more about contracts

Important Safety Information

LEVULAN® KERASTICK® (aminolevulinic acid HCl) for topical solution, 20%, plus blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratosis of the upper extremities.

Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400–450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the LEVULAN KERASTICK topical solution.

Application of LEVULAN KERASTICK topical solution should involve lesions on the face or scalp, or upper extremities. Multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.

Do not apply to the eyes or to mucus membranes. Irritation may be experienced if LEVULAN KERASTICK topical solution is applied to eyes or mucous membranes. Treatment of upper extremities is approved after an incubation time of 3 hours under occlusion. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.

Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. To avoid unintended photosensitivity, LEVULAN KERASTICK topical solution should be applied by a qualified health professional to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion.

Advise patients to wear a wide-brimmed hat or similar head covering of light-opaque material or a long-sleeved shirt and/or gloves to shade the treated actinic keratoses from sunlight or other bright light sources until at least 40 hours after the application of LEVULAN KERASTICK topical solution. Sunscreens will not protect against photosensitivity reactions caused by visible light. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.

LEVULAN KERASTICK topical solution has not been tested on patients with inherited or acquired coagulation defects.

It is possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with the LEVULAN KERASTICK topical solution.

During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions.

The most common local adverse reactions (incidence ≥ 10%) were erythema, edema, stinging/burning, scaling/crusting, itching, erosion, hypo/hyperpigmentation, oozing/vesiculation/crusting, scaling and dryness.

In clinical trials, severe stinging and/or burning was reported by at least 50% of face and scalp patients and 9% of upper extremity patients at some time during treatment. However, less than 3% of subjects receiving treatment for face or scalp lesions discontinued light treatment because of stinging/burning. No subjects discontinued light treatment in the trial for upper extremity lesions.

Please refer to the full Prescribing Information for complete discussion of the risks associated with LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%.

References:

  1. Symphony Health. Actinic Keratosis Total Patient Share. June 2018.
  2. LEVULAN KERASTICK. Package insert. Sun Pharma; 2020.
  3. Nestor MS, Gold MH, Kauvar AN, et al. The use of photodynamic therapy in dermatology: results of a consensus conference. J Drugs Dermatol. 2006;5(2):140-154.
  4. MacCormack MA. Photodynamic therapy. Adv Dermatol. 2006;22:219-258. doi:10.1016/j.yadr.2006.09.008.
  5. U.S. Department of Health and Human Services. FDA approval letter. March 2018.
  6. Model 4170 System Specifications. BLU-U® Optical Specifications Document. Wilmington, MA: DUSA Pharmaceuticals, 2006.
  7. AMELUZ®. Package insert. Biofrontera Pharma GmbH; 2016.
  8. Data on file, Sun Pharma.
  9. Fuchs A, Marmur E. The kinetics of skin cancer: progression of actinic keratosis to squamous cell carcinoma. Dermatol Surg. 2007;33(9):1099-1101. doi:10.1111/j.1524-4725.2007.33224.x.
  10. Criscione VD, Weinstock MA, Naylor MF, Luque C, Eide MJ, Bingham SF; Department of Veterans Affairs Topical Tretinoin Chemoprevention Trial Group. Actinic keratoses: natural history and risk of malignant transformation in the Veterans Affairs Topical Tretinoin Chemoprevention Trial. Cancer. 2009;115(11):2523-2530. doi:10.1002/cncr.24284.
  11. Pyne JH, Myint E, Barr EM, Clark SP, Hou R. Basal cell carcinoma: variation in invasion depth by subtype, sex, and anatomic site in 4,565 cases. Dermatol Pract Concept. 2018;8(4):314-319. doi.10.5826/dpc.0804a13.
  12. Lee CN, Hsu R, Chen H, Wong TW. Daylight photodynamic therapy: an update. Molecules. 2020;25(21):5195. doi:10.3390/molecules25215195.
  13. Patel G, Armstrong AW, Eisen DB. Efficacy of photodynamic therapy vs other interventions in randomized clinical trials for the treatment of actinic keratoses: a systemic review and meta-analysis. JAMA Dermatol. 2014;150(12):1281-1288. doi.10.1001/jamadermatol.2014.1253.
  14. Taub AF. Photodynamic therapy in dermatology: history and horizons. J Drugs Dermatol. 2004;3(suppl 1):S8-S25.
  15. Kochevar I, Taylor C. Photophysics, photochemistry, and photobiology. In: Freedberg IM, Eisen AZ, Wolff K, Austen KF, Goldsmith LA, Katz S, eds. Fitzpatrick’s Dermatology in General Medicine. 6th ed. McGraw-Hill Professional; 2003:1417-1426.
  16. Shergill B, Zokaie S, Carr AJ. Non-adherence to topical treatments for actinic keratosis. Patient Prefer Adherence. 2014;17(8):35-41. doi.10.2147/PPA.S47126.