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LEVULAN® KERASTICK® has you covered

We understand that at times, the coverage, coding, and billing process can be complicated. Let us be your resource for any and all questions you may have about reimbursement for LEVULAN KERASTICK plus BLU-U.

Coverage

It’s important to properly verify the benefits for each individual patient to make sure that their treatment is being coded and billed properly. Here are some helpful steps to follow:

  • Verify patient coverage by utilizing:
    • Individual online payer portals
    • Provider services hotline on patient’s ID card
    • Pinnacle benefit investigation service: 866-369-9290
  • Review patient benefits for LEVULAN KERASTICK plus BLU-U and provider-specified photodynamic therapy (PDT) CPT® code for:
    • Deductible
    • Copay
    • Coinsurance
    • LEVULAN KERASTICK plus BLU-U coverage
      • Check coverage for body site and number of sticks requested
  • Identify whether treatment will fall under Medical and/or Pharmacy benefits
  • Identify any potential policy restrictions such as stick limitations, step edits, or only covering face and scalp treatments*

  • Coverage policies do not always update immediately
  • Many plans currently cover only face and scalp treatments, and may not have updated plans to reflect recent label expansion for upper extremities
  • Strict adherence to expanded label use may allow for coverage of upper extremities

  • Limits treatment to one stick per session
  • Currently requires step edit: failure of cryosurgery or 5-fluorouracil (5-FU) prior to treatment with PDT

Questions about coverage?

Get in touch with your Field Reimbursement Manager


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Billing & coding

Exclusive HCPCS J-code

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
  • 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 and Medicaid Services (CMS)

CPT Codes

There are 3 different CPT codes associated with PDT treatment. These codes differ based on how and by whom the treatment is applied.

LEVULAN KERASTICK is not intended for application by patients or unqualified staff.

Click on a code to learn more

CPT Code

96567

CPT Code

96567

PDT 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

CPT Code

96573

CPT Code

96573

PDT by external application of light to destroy premalignant lesions of the skin and adjacent mucosa with application and illumination/activation of photosensitizing drug(s) provided by a physician or other qualified healthcare professional (HCP), per day

CPT Code

96574

CPT Code

96574

Debridement of premalignant hyperkeratotic lesion(s) followed with photodynamic therapy by external application of light to destroy premalignant lesions of the skin and adjacent mucosa with application and illumination/activation of photosensitizing drug(s) provided by a physician or other qualified HCP, per day

LEVULAN KERASTICK for topical solution should only be used by a qualified healthcare professional.

Important information to know about CPT codes

  • Any one of these codes may be used to report a single PDT treatment per patient, per day, regardless of length or number of lesions treated
  • There is no global period for any of the three codes
  • Follow-up evaluation and management (E&M) visits are permissible
  • Only one CPT code is billable per day
  • It is up to the provider’s discretion to use the appropriate code for the treatment performed

LEVULAN KERASTICK is not intended for application by patients or unqualified staff.

Supporting patient documentation

Proper documentation is a vital part of the billing and reimbursement process. To help ensure a seamless experience, be sure to keep the following records:

  • Pre-treatment information sheet (similar to pre-surgery 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
 

Everything you need, in one place

Visit SunAccessSupport.com for all the coding, coverage, contracting, and purchasing resources you need for LEVULAN KERASTICK plus BLU-U and much more.


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LEVULAN KERASTICK Access and Reimbursement Programs

You have access to comprehensive programs offered exclusively by LEVULAN KERASTICK. Click here to sign up for an Access and Reimbursement dinner meeting in your area.

During this program, you’ll learn about:

  • Setting up PDT in your practice
  • Coverage
  • Coding and billing
  • Reimbursement
  • Additional practice considerations
  • SUN Dermatology Support

Interested in registering for an upcoming meeting in your area?

Click to sign up for one today.


Register Now

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%.

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. Data on file, Sun Pharma.
  3. LEVULAN KERASTICK full Prescribing Information, April 2018.
  4. Shergill B, Zokaie S, Carr AJ. Non-adherence to topical treatments for actinic keratosis. Patient Prefer Adherence. 2014;17(8):35-41.
  5. Taub AF. Photodynamic therapy in dermatology: history and horizons. J Drugs Dermatol. 2004;3(suppl 1):S8-S25.
  6. BLU-U Blue Light Photodynamic Therapy llluminator Model 4170 Operating manual.
  7. AMELUZ® Prescribing Information, BioFrontera Pharma GmbH. Wakefield, MA. 2016