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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 + 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 + BLU-U and provider-specified photodynamic therapy (PDT) CPT® code for:
    • Deductible
    • Copay
    • Coinsurance
    • LEVULAN KERASTICK + 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 updated on 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

  • To provide coverage for PDT, BCBS FEP medical plans may require:
    1. Proof of inadequate treatment response, intolerance, or contraindication to at least one topical skin product (eg, imiquimod)
    2. LEVULAN KERASTICK to be used in combination with the BLU-U Blue Light PDT Illuminator
    3. Patients to have NO history of photodermatoses
    4. Patients to have NO dual therapy with another aminolevulinic acid (ALA) agent and ALL of the following:
      1. Reevaluation of lesion(s) for improvement must be done before PDT treatment
      2. There must be a minimum of 3 months since last therapy
      3. LEVULAN KERASTICK must be used in combination with the BLU-U Blue Light PDT Illuminator
      4. There must not be dual therapy with another ALA agent
  • Pharmacy policies do not have any of the above restrictions
  • BCBS Verizon employees require pharmacy benefits for coverage

Questions about coverage?

Request to be contacted by a 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 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.

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

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.

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

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 these 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
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Everything you need, all in one place

Watch this video to learn how to navigate SunAccessSupport.com for all the coding, coverage, contracting, and purchasing resources you need for LEVULAN KERASTICK + BLU-U.

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

Interested in registering for an upcoming meeting in your area?

Click to sign up for one today.


Register Now

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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. LEVULAN KERASTICK full Prescribing Information, April 2018.
  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.
  5. Data on file, Sun Pharma.
  6. Department of health and human services. FDA approval letter. March 2018.
  7. 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.
  8. Criscione VD, Weinstock MA, Naylor MF, Luque C, Eide MJ, Bingham SF; Department of Veteran 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.
  9. Shergill B, Zokaie S, Carr AJ. Non-adherence to topical treatments for actinic keratosis. Patient Prefer Adherence. 2014;17(8):35-41.
  10. 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.
  11. Taub AF. Photodynamic therapy in dermatology: history and horizons. J Drugs Dermatol. 2004;3(suppl 1):S8-S25.
  12. Fuchs A, Marmur E. The kinetics of skin cancer: progression of actinic keratosis to squamous cell carcinoma. Dermatol Surg. 2007;33(9):1009-1101.
  13. Dirschka T, Gupta G, Micali G, et al. Real-world approach to actinic keratosis management: practical treatment algorithm for office-based dermatology. J Dermatolog Treat. 2017;28(5):431-442.
  14. Model 4170 System Specifications. BLU-U® Optical Specifications Document. Wilmington, MA: DUSA Pharmaceuticals, 2006.
  15. AMELUZ® Prescribing Information. Wakefield, MA: BioFrontera Pharma GmbH, 2016.