L31807-LCD

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Local Coverage Determination (LCD) for Topical Photosensitizers used with PDT for Actinic Keratoses and Certain Skin Cancers (L31807)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number

09101

Contractor Type

MAC - Part A

LCD Information

Document Information

LCD ID Number L31807

LCD Title

Topical Photosensitizers used with PDT for Actinic Keratoses and Certain Skin Cancers

Contractor's Determination Number AJ7308

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 06/07/2011 Original Determination Ending Date

Revision Effective Date

For services performed on or after 10/01/2011 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 15, Section 50

CMS Manual System, Pub. 100-03, Medicare National Coverage Determination, Part 4, Section 250.4. CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40

CMS Manual System, Pub. 100-08, Medicare Program Integrity, Chapter 13, Section 13.1.3

Indications and Limitations of Coverage and/or Medical Necessity

Actinic keratoses (AKs) are a premalignant condition of thick, scaly, or crusty patches of skin. They are more common in fair-skinned people and associated with years of exposure to ultraviolet light, such as sunlight.

Various modalities are used in the treatment of actinic keratosis, one of which is photodynamic therapy (PDT). PDT treatment involves the use of photochemical reactions mediated through the interaction of photosensitizing agents, light, and oxygen for the treatment of malignant or benign diseases. PDT is a 2-step process. The first step involves administration of the photosensitizer, and the second step involves the activation of the photosensitizer in the presence of oxygen with a specific wavelength of light directed toward the target tissue. Because the photosensitizer is preferentially absorbed by hyperproliferative tissue and the light source is directly targeted on the lesional tissue, PDT achieves dual selectivity, minimizing damage to adjacent healthy structures.

The most commonly used topical photosensitizers in PDT are aminolevulinic acid HCL (ALA) and methyl aminolevulinate (MAL). Both ALA and MAL are approved by the Food and Drug Administration (FDA) for the treatment of AKs on the face and scalp. The use of these drugs is not indicated for treatment of AKs located on areas other than the face or scalp.

The following topical photosensitizer drugs for PDT for AKs are covered when used on the face or scalp for the following approved FDA indications:

• Levulan® Kerastick® (ALA) for topical solution, 20%, a porphyrin precursor, 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.

Levulan® Kerastick® (ALA) topical solution, 20% should be used by a qualified health professional. The first step in Levulan® Kerastick® PDT for AKs is application of this topical solution to the face or scalp in the physician’s office (or other appropriate outpatient setting). After application of Levulan® Kerastick® (ALA) topical solution, the patient will receive blue light treatment, which is the second and final step in the treatment and lasts for approximately 17 minutes. For treated lesions that have not completely resolved after 8 weeks, a second treatment may be administered.

• Metvixia (MAL) Cream, 16.8% for topical use, a porphyrin precursor, in combination with the Aktilite CL 128 lamp, a narrowband, red light illumination source, is indicated for treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation in the physician’s office.

Metvixia (MAL) Cream 16.8% for topical use is to be used only by physicians in the physician’s office (or other appropriate outpatient setting). Physicians should be knowledgeable about PDT and familiar with the Aktilite Operators Manual prior to use of Metvixia Cream. Two treatment sessions one week apart should be administered. Multiple lesions on the face and/or scalp may be treated during the same treatment session, and lesion response should be assessed 3 months after the last treatment session. Use of

Metvixia Cream without subsequent red light illumination is non-covered.

In addition to the above approved FDA indications for Levulan® Kerastick® (ALA) topical solution, 20%, and Metvixia (MAL) Cream, 16.8% topical use, the following compendia listed off-label indications for treatment of Basal cell carcinoma and Squamous cell carcinoma in situ (Bowen’s disease) will also be considered medically reasonable and necessary for both drugs when used as photosensitizers with approved light source when other therapies are considered medically less appropriate, and if the therapy is one that meets, but does not exceed, the patient’s medical need; and is at least as beneficial as an existing and available medically appropriate alternative.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

013x Hospital Outpatient 085x Critical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0636

CPT/HCPCS Codes

J7308 AMINOLEVULINIC ACID HCL FOR TOPICAL ADMINISTRATION, 20%, SINGLE UNIT DOSAGE FORM (354 MG)

J7309 METHYL AMINOLEVULINATE (MAL) FOR TOPICAL ADMINISTRATION, 16.8%, 1 GRAM

ICD-9 Codes that Support Medical Necessity

173.00 - 173.09 opens in new window

173.10 - 173.19 opens in new window

173.20 - 173.29 opens in new window

173.30 - 173.39 opens in new window

173.40 - 173.49 opens in new window

173.50 - 173.59 opens in new window

173.60 - 173.69 opens in new window

173.70 - 173.79 opens in new window

173.80 - 173.89 opens in new window

UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP - OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP

UNSPECIFIED MALIGNANT NEOPLASM OF EYELID, INCLUDING CANTHUS - OTHER SPECIFIED MALIGNANT NEOPLASM OF EYELID, INCLUDING CANTHUS UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF EAR AND EXTERNAL AUDITORY

CANAL - OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE - OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

UNSPECIFIED MALIGNANT NEOPLASM OF SCALP AND SKIN OF NECK - OTHER SPECIFIED MALIGNANT NEOPLASM OF SCALP AND SKIN OF NECK

UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF TRUNK, EXCEPT SCROTUM - OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF TRUNK, EXCEPT SCROTUM UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF UPPER LIMB, INCLUDING SHOULDER

- OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UPPER LIMB, INCLUDING SHOULDER

UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LOWER LIMB, INCLUDING HIP - OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LOWER LIMB, INCLUDING HIP UNSPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SKIN - OTHER SPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SKIN

232.1 CARCINOMA IN SITU OF SKIN OF LIP

232.2 CARCINOMA IN SITU OF EYELID INCLUDING CANTHUS

232.3 CARCINOMA IN SITU OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

232.4 CARCINOMA IN SITU OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

232.5 CARCINOMA IN SITU OF SCALP AND SKIN OF NECK

232.6 CARCINOMA IN SITU OF SKIN OF TRUNK EXCEPT SCROTUM

232.7 CARCINOMA IN SITU OF SKIN OF UPPER LIMB INCLUDING SHOULDER

232.8 CARCINOMA IN SITU OF SKIN OF LOWER LIMB INCLUDING HIP

232.9 CARCINOMA IN SITU OF OTHER SPECIFIED SITES OF SKIN

702.0 ACTINIC KERATOSIS

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation maintained by the physician must substantiate the medical need for the PDT treatment used. The type and size of lesion treated with PDT must be documented. The medical record must be made available upon request.

PDT treatment for skin lesions using topical solution Levulan® Kerastick&reg: (ALA), or topical Metvixia (MAL) Cream, 16.8% as photosensitizers are covered when used for FDA and off-labeled indications outlined under the “Indications and Limitations of Coverage and/or Medical Necessity” section above. Other indications for these drugs will not be covered.

When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862(a)(1) of the Social Security Act.

Appendices

Utilization Guidelines Levulan® Kerastick® (ALA) topical solution, 20% may be administered a second time with PDT for lesions that have not completely resolved after 8 weeks.

Metvixia (MAL) Cream 16.8% for topical use should be administered in two treatment sessions one week apart. Multiple lesions may be treated during the same treatment session using a total of not more than 1 gram (half tube) of Metvixia Cream.

Sources of Information and Basis for Decision

Aetna Clinical Policy Bulletin: Photodynamic Therapy, # 0375. (2010).

Babilas, P., Schreml, S., Landthaler, M., & Szeimies, R. (2010). Photodynamic therapy in dermatology: state-of- the-art. Photodermatology, Photoimmunology & Photomedicine 26,118-132.

Clinical Pharmacology Compendia. Aminolevulinic Acid (Levulan Kerastick), 2009. Clinical Pharmacology Compendia. Methyl aminolevulinate (Metvixia), 2010.

De Berker, D., McGregor, J., & Hughes, B. (2007). Guidelines for the management of actinic keratoses. British Journal of Dermatology 156, 222-230.

Food and Drug Administration (FDA) product label for Levulan® Kerastick® (aminolevulinic acid HCl) for topical solution 20%. Revised 2010.

Food and Drug Administration (FDA) product label for Metvixia (methyl aminolevulinate) Cream, 16.8% for topical use. Revised 2008.

Issa, M., & Azulay, M. (2010). Photodynamic therapy: a review of the literature and image documentation. Anais Brasileiros De Dermatologia, 85(4), 501-11.

Issa, M., Piñeiro-Maceira, J., Vieira, M., Olej, B., Mandarim-de-Lacerda, C., Luiz, R., & et al. Photorejuvenation with topical methyl aminolevulinate and red light: a randomized, prospective, clinical, histopathologic, and morphometric study. Dermatologic Surgery, 36(1) 49-51.

McIntyre, W., Downs, M., & Bedwell, S. (2007). Treatment Options for Actinic Keratoses. American Academy of Family Physicians, 76(5), 667-671.

Morton, C., McKenna, K., & Rhodes, L. (2008). Guidelines for topical photodynamic therapy: update. British Journal of Dermatology 159, 1245-1266.

National Comprehensive Cancer network, Inc. (NCCN) Drugs & Biologics Compendium. Methyl aminolevulinate (Metvixia). 2011.

National Comprehensive Cancer network, Inc. (NCCN) Drugs & Biologics Compendium. Aminolevulinic acid hydrochloride (Levulan® Kerastick®). 2011.

Other Medicare contractors.

Rao, J. & Bissonnette, R. (2010). Photodynamic Therapy for the Dermatologist. eMedicine from WebMD. Retrieved January 6, 2011, from http://emedicine.medscape.com/article/1121517-print

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Florida Contractor Advisory Committee Meeting held on February 19, 2011.

Puerto Rico/U.S. Virgin Islands Contractor Advisory Committee Meeting held on February 24, 2011.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 04/22/2011

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2011 Revised Effective Date:10/01/2011

LCR A2011-078

September 2011 Connection

Explanation of Revision: Annual 2012 ICD-9-CM Update. Deleted diagnosis codes 173.0, 173.1, 173.2, 173.3,

173.4, 173.5, 173.6, 173.7, and 173.8. Added new diagnosis codes 173.00-173.09, 173.10-173.19, 173.20-

173.29, 173.30-173.39, 173.40-173.49, 173.50-173.59, 173.60-173.69, 173.70-173.79, and 173.80-173.89.

The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:02/03/2011 Start Date of Notice Period:04/22/2011 Original Effective Date 06/07/2011

LCR A2011-046

April 2011 Bulletin

08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.

Reason for Change