Local Coverage Determination (LCD) for Actinic Keratosis (L28232)

Transcription

1 Page 1 of 12 Search Home Medicare Medicaid CHIP About CMS Regulations & Guidance Research, Statistics, Data & Systems Outreach & Education People with Medicare & Medicaid Questions Careers Newsroom Contact CMS Acronyms Help Print Back to Local Coverage Determinations (LCDs) for Palmetto GBA (01192, MAC - Part B) Local Coverage Determination (LCD) for Actinic Keratosis (L28232) Select the Print Record, Add to Basket or Record buttons to print the record, to add it to your basket or to the record. Section Navigation Select Section Go Contractor Information Contractor Name Palmetto GBA Contractor Number Contractor Type MAC - Part B Back to Top LCD Information Document Information LCD ID Number L28232 LCD Title Actinic Keratosis Contractor's Determination Number J1B L AMA CPT/ADA CDT Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. 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 Primary Geographic Jurisdiction California - Southern Oversight Region Region X Original Determination Effective Date For services performed on or after 09/02/2008 Original Determination Ending Date Revision Effective Date For services performed on or after 12/23/2011

2 Page 2 of 12 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. Revision Ending Date CMS National Coverage Policy Title XVIII of the Social Security Act, 1862(a)(1)(A). Allows coverage and payment for only those services that are considered to be medically reasonable and necessary. Title XVIII of the Social Security Act, 1833(e). Prohibits Medicare payment for any claim which lacks the necessary information to process the claim. CMS Manual System, Pub , Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, CMS Manual System, Pub , Medicare Benefit Policy Manual, Chapter 16, 120 Indications and Limitations of Coverage and/or Medical Necessity Actinic keratoses are a frequent, disturbing consequence of many years of overexposure to sunlight. Actinic keratoses are seen as single or multiple lesions on sun-exposed areas of the skin and can occur from early adulthood on and become more frequent with increasing age. Actinic keratoses vary in color and can be flesh-colored, pink, red or brown (pigmented actinic keratoses) and usually have ill-defined borders. Their texture varies from a subtle, rough, scaly patch to a very thick scaly plaque that may be hyperkeratotic. Most actinic keratoses are asymptomatic. However, some may be "sensitive" or tender to touch. Patients with sun-damaged skin are at an increased risk for the development of squamous cell carcinoma within preexisting actinic lesions. It is frequently difficult to distinguish clinically between an actinic keratosis and a more invasive squamous cell carcinoma because they are part of a continuum. Histologically, actinic keratosis is confined to the epidermis. It is the first lesion of a continuum of clinical and histologic abnormalities that progresses to invasive squamous cell carcinoma. Currently, there are no reliable indices that can determine when an actinic keratosis may develop into an aggressive squamous cell carcinoma. The latent period (transition from benign to malignant) is unpredictable, typically slow but can be aggressive. The standard methods of treatment for actinic keratoses are destructive methods. Commonly, actinic keratoses are treated by cryotherapy and/or electrodesiccation or by medical means such as 5-fluorouracil. Lesions may be treated as actinic keratoses but may be invasive squamous cell carcinomas. The persistence of the same lesion after destruction is suspicious and may warrant a biopsy. Certain individuals and certain areas of the body are more likely to experience conversion of actinic keratoses to squamous cell carcinomas, and also subsequent metastases, especially if left untreated. Photodynamic therapy (PDT) employs a light-sensitive chemical and a light source that activates this chemical. When applied to tissue, this activation causes tissue destruction. The chemicals for AKs are aminolevulinic acid HCl 20% solution (ALA) and methyl aminolevulinate(mal). The light source used with aminolevulinic is a blue light stimulator. The light source used with the methyl aminolevulinate is red light-emitting diode light. The chemical aminolevulinic acid HCL 20% solution is applied to non-hyperkeratotic AKs

3 Page 3 of 12 on the face or scalp, and the patient returns within hours for about 17 minutes of blue light exposure. Alternatively methyl aminolevulinate is applied to a non-hyperkeratotic AKs lesion and the lesion and 5mm of surrounding normal appearing skin is covered with an occlusive, nonabsorbent dressing for at least three hours. The dressing is then removed and the cream wiped with gauze dipped in 0.9% saline solution, immediately before illumination with red LED light for approximately eight minutes. The Aktilite lamp, specifically designed for use with Metvixia (methyl aminolevulinate) cream, has an emission spectrum that closely matches the red light absorption profile of PpIX (protoporphyrin IX). Either of these treatments "causes a complex process that leads to tissue destruction at both the macrostructural and microstructural levels." The great majority of AKs clear with this therapy. However, at an eight-week re-evaluation, those few AKs that did not clear may be treated again. Some actinic keratoses lesions can be treated with medical approaches as listed earlier, but there may be instances in which a surgical approach to the treatment of actinic keratoses is warranted. Given that the skin lesion correctly diagnosed as an actinic keratosis is a premalignant lesion with a low but real possibility of malignant transformation, its presence alone justifies its removal. Progression of actinic keratoses may rapidly evolve into an invasive squamous cell carcinoma in some patients. These include, but are not limited to, the following predisposing factors: 1. Immuno-compromised patients associated with organ transplantation, primary and secondary immunodeficiency syndromes, acquired immunodeficiency syndromes (AIDS) or patients receiving any immunosuppressive drug 2. Extremely sun-damaged skin in patients secondary to voluntary or occupational exposure to actinic radiation 3. Therapeutic radiation exposure or exposure to other known skin carcinogens 4. Xeroderma pigmentosium or epidermodysplasia verruciformis 5. Albinism 6. Known prior exposure to arsenicals, or other drugs with a known propensity to develop skin cancer 7. Personal history of skin cancer Patients with actinic keratoses associated with predisposing conditions may require an increase in the frequency of visits for the evaluation and destruction of the skin lesions. Cosmetic surgery or expenses incurred in connection with such surgery is not covered. Cosmetic surgery includes any surgical procedure directed at improving appearance, except when required for the prompt (i.e., as soon as medically feasible) repair of accidental injury or for the improvement of the functioning of a malformed body member. This exclusion does not apply to surgery in connection with treatment of severe burns or repair of the face following a serious automobile accident, or to surgery for therapeutic purposes which coincidentally also serves some cosmetic purpose. This policy does not apply to the treatment of actinic keratoses by medical means, for

4 Page 4 of 12 example, with the use of topical patient-administered chemotherapeutic agents. The physicians direction and supervision of a patient s use of these agents will be reimbursed via the Evaluation and Management (E/M) service that is most appropriate for the level of service rendered. Back to Top 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. 999x Not Applicable 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 Not Applicable CPT/HCPCS Codes The HCPCS codes listed below apply to all benign lesions, but this policy is specific only to removal or destruction of actinic keratoses and not to other cutaneous lesions which may re treatment by surgical means. See also the J1 A/B MAC Skin Lesion (non-melanoma) Remova Non-malignant Skin Lesion Removal) SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, TRUNK, ARMS OR LEGS; LESION DIAMETER 0.5 CM OR LESS SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, TRUNK, ARMS OR LEGS; LESION DIAMETER 0.6 TO 1.0 CM SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, TRUNK, ARMS OR LEGS; LESION DIAMETER 1.1 TO 2.0 CM SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, TRUNK, ARMS OR LEGS; LESION DIAMETER OVER 2.0 CM

5 Page 5 of SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, SCALP, NECK, HANDS, FEET, GENITALIA; LESION DIAMETER 0.5 CM OR LESS SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, SCALP, NECK, HANDS, FEET, GENITALIA; LESION DIAMETER 0.6 TO 1.0 CM SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, SCALP, NECK, HANDS, FEET, GENITALIA; LESION DIAMETER 1.1 TO 2.0 CM SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, SCALP, NECK, HANDS, FEET, GENITALIA; LESION DIAMETER OVER 2.0 CM SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, FACE, EARS, EYELIDS, NOSE, LIPS, MUCOUS MEMBRANE; LESION DIAMETER 0.5 CM OR LESS SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, FACE, EARS, EYELIDS, NOSE, LIPS, MUCOUS MEMBRANE; LESION DIAMETER 0.6 TO 1.0 CM SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, FACE, EARS, EYELIDS, NOSE, LIPS, MUCOUS MEMBRANE; LESION DIAMETER 1.1 TO 2.0 CM SHAVING OF EPIDERMAL OR DERMAL LESION, SINGLE LESION, FACE, EARS, EYELIDS, NOSE, LIPS, MUCOUS MEMBRANE; LESION DIAMETER OVER 2.0 CM (UNLESS LISTED ELSEWHERE), TRUNK, ARMS OR LEGS; EXCISED DIAMETER 0.5 CM OR LESS (UNLESS LISTED ELSEWHERE), TRUNK, ARMS OR LEGS; EXCISED DIAMETER 0.6 TO 1.0 CM (UNLESS LISTED ELSEWHERE), TRUNK, ARMS OR LEGS; EXCISED DIAMETER 1.1 TO 2.0 CM (UNLESS LISTED ELSEWHERE), TRUNK, ARMS OR LEGS; EXCISED DIAMETER 2.1 TO 3.0 CM (UNLESS LISTED ELSEWHERE), TRUNK, ARMS OR LEGS; EXCISED DIAMETER 3.1 TO 4.0 CM (UNLESS LISTED ELSEWHERE), TRUNK, ARMS OR LEGS; EXCISED DIAMETER OVER 4.0 CM (UNLESS LISTED ELSEWHERE), SCALP, NECK, HANDS, FEET, GENITALIA; EXCISED DIAMETER 0.5 CM OR LESS

6 Page 6 of (UNLESS LISTED ELSEWHERE), SCALP, NECK, HANDS, FEET, GENITALIA; EXCISED DIAMETER 0.6 TO 1.0 CM (UNLESS LISTED ELSEWHERE), SCALP, NECK, HANDS, FEET, GENITALIA; EXCISED DIAMETER 1.1 TO 2.0 CM (UNLESS LISTED ELSEWHERE), SCALP, NECK, HANDS, FEET, GENITALIA; EXCISED DIAMETER 2.1 TO 3.0 CM (UNLESS LISTED ELSEWHERE), SCALP, NECK, HANDS, FEET, GENITALIA; EXCISED DIAMETER 3.1 TO 4.0 CM (UNLESS LISTED ELSEWHERE), SCALP, NECK, HANDS, FEET, GENITALIA; EXCISED DIAMETER OVER 4.0 CM EXCISION, OTHER BENIGN LESION INCLUDING MARGINS, EXCEPT SKIN TAG (UNLESS LISTED ELSEWHERE), FACE, EARS, EYELIDS, NOSE, LIPS, MUCOUS MEMBRANE; EXCISED DIAMETER 0.5 CM OR LESS EXCISION, OTHER BENIGN LESION INCLUDING MARGINS, EXCEPT SKIN TAG (UNLESS LISTED ELSEWHERE), FACE, EARS, EYELIDS, NOSE, LIPS, MUCOUS MEMBRANE; EXCISED DIAMETER 0.6 TO 1.0 CM EXCISION, OTHER BENIGN LESION INCLUDING MARGINS, EXCEPT SKIN TAG (UNLESS LISTED ELSEWHERE), FACE, EARS, EYELIDS, NOSE, LIPS, MUCOUS MEMBRANE; EXCISED DIAMETER 1.1 TO 2.0 CM EXCISION, OTHER BENIGN LESION INCLUDING MARGINS, EXCEPT SKIN TAG (UNLESS LISTED ELSEWHERE), FACE, EARS, EYELIDS, NOSE, LIPS, MUCOUS MEMBRANE; EXCISED DIAMETER 2.1 TO 3.0 CM EXCISION, OTHER BENIGN LESION INCLUDING MARGINS, EXCEPT SKIN TAG (UNLESS LISTED ELSEWHERE), FACE, EARS, EYELIDS, NOSE, LIPS, MUCOUS MEMBRANE; EXCISED DIAMETER 3.1 TO 4.0 CM EXCISION, OTHER BENIGN LESION INCLUDING MARGINS, EXCEPT SKIN TAG (UNLESS LISTED ELSEWHERE), FACE, EARS, EYELIDS, NOSE, LIPS, MUCOUS MEMBRANE; EXCISED DIAMETER OVER 4.0 CM DESTRUCTION (EG, LASER SURGERY, ELECTROSURGERY, CRYOSURGERY, CHEMOSURGERY, SURGICAL CURETTEMENT), PREMALIGNANT LESIONS (EG, ACTINIC KERATOSES); FIRST LESION DESTRUCTION (EG, LASER SURGERY, ELECTROSURGERY, CRYOSURGERY, CHEMOSURGERY, SURGICAL CURETTEMENT), PREMALIGNANT LESIONS (EG, ACTINIC KERATOSES); SECOND THROUGH 14 LESIONS, EACH (LIST SEPARATELY IN ADDITION TO CODE FOR FIRST LESION) DESTRUCTION (EG, LASER SURGERY, ELECTROSURGERY, CRYOSURGERY, CHEMOSURGERY, SURGICAL CURETTEMENT), PREMALIGNANT LESIONS (EG, ACTINIC KERATOSES), 15 OR MORE LESIONS

7 Page 7 of J7308 J7309 PHOTODYNAMIC THERAPY BY EXTERNAL APPLICATION OF LIGHT TO DESTROY PREMALIGNANT AND/OR MALIGNANT LESIONS OF THE SKIN AND ADJACENT MUCOSA (EG, LIP) BY ACTIVATION OF PHOTOSENSITIVE DRUG (S), EACH PHOTOTHERAPY EXPOSURE SESSION AMINOLEVULINIC ACID HCL FOR TOPICAL ADMINISTRATION, 20%, SINGLE UNIT DOSAGE FORM (354 MG) METHYL AMINOLEVULINATE (MAL) FOR TOPICAL ADMINISTRATION, 16.8%, 1 GRAM ICD-9 Codes that Support Medical Necessity This is the only covered diagnosis code for CPT codes 17000, 17003, 17004, and HCPCS code J7308 and J7309 for this policy: Note: ICD-9-CM may also be used for CPT Codes 17000, and as listed in the J1 A/B MAC Skin Lesion (non-melanoma) Removal (formerly Non-malignant Skin Lesion Removal) LCD ACTINIC KERATOSIS Diagnoses that Support Medical Necessity All ICD-9-CM codes listed in this policy under ICD-9-CM Codes That Support Medical Necessity above. ICD-9 Codes that DO NOT Support Medical Necessity All ICD-9-CM codes not listed in this policy under ICD-9-CM Codes That Support Medical Necessity applies only to CPT codes 17000, 17003, 17004, and J7308. The procedures described by t CPT codes listed above are appropriately applied to other lesions. ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation Diagnoses that DO NOT Support Medical Necessity All ICD-9-CM codes not listed in this policy under "ICD-9-CM Codes That Support Medical Necessity" above. Back to Top General Information Documentations Requirements The patient s medical record must document the method of destruction or removal. Such documentation must, at a minimum, accurately and completely describe the number and location(s) of the lesions so treated. A photograph or drawing of the lesion will also be acceptable. When appropriate, due to any unusual aspect of a specific lesion, this A/B MAC recommends that such documentation contain a written description including size and physical characteristics. Signs and symptoms, if any, should be recorded. Instances may arise in which an actinic keratosis requires biopsy. The medical record must indicate why a biopsy was necessary, contain a description of the lesion and indicate the method of biopsy employed. The record should also contain a formal written report referencing the specimen, its gross appearance, size, microscopic histopathology, a description of lesion margins and the final diagnosis as is necessary for any

8 Page 8 of 12 pathological report. The slides forming the basis of the report must be on file and be available for review upon request. Medicare will not pay for a separate E/M service on the same day that dermatologic surgery is performed unless a significant and separately identifiable medical service was rendered and its nature is clearly documented in the patient s medical record. Medicare will not pay for a separate E/M service by the same operating physician during a post-operative global period unless the service is for a medical problem unrelated to the prior procedure. The nature of the E/M visit must be fully and clearly documented in the patient s medical record and must be entirely unrelated to the prior surgical service. The medical record must be made available to Medicare on request. The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare. 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. When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the request. In usual treatment situations, neither laser resurfacing nor chemical peel (CPT 15788, 15789, 15792, and 15793) is covered as treatment for actinic keratoses. Individual consideration for these procedures can be given on reconsideration (formerly appeal) with appropriate documentation. Appendices Utilization Guidelines This A/B MAC understands that the customary frequency for reviewing and treating patients with recurrent or new actinic keratoses is up to six times per 12-month period. However, as noted above under Indications and Limitations of Coverage and/or Medical Necessity, some conditions predispose the patient to more rapid malignant degeneration of the actinic keratosis. Based on review of claims, the outgoing contractor found a remarkable array of diagnoses billed with ICD-9-CM 702.0, actinic keratoses (most of which do not justify an increase in the frequency of visits). Therefore, this A/B MAC offers this list of diagnoses that will help the J1 A/B MAC staff to more appropriately process your claims. Conditions that may justify an increased frequency of visits for procedure codes and with diagnosis (AK) 1) Immunocompromised patient a. Transplant V42.0, V42.1, V42.6, V42.7, V42.81-V42.89 b. AIDS 042 c. Immunodeficiency d. Immunosuppressive drugs V ) Sun-damaged skin, extreme

9 Page 9 of 12 3) Exposure to therapeutic radiation V15.3 4) Xeroderma pigmentosium ) Epidermodysplasia verruciformis ) Albinism ) Exposure to drugs that cause skin cancer V15.9 8) Personal hx of skin cancer V10.83 Note that these diagnoses, by themselves, will not allow payment for these destruction codes, but must be billed with ICD-9-CM diagnosis as the primary code. Further, the outgoing contractor found that many physicians were billing with diagnoses of malignant skin cancers or "neoplasms of uncertain behavior." Given that these CPT codes are described as "Destruction all benign or premalignant lesions," these ICD-9-CM codes are inappropriate for CPT Destruction of malignant skin lesions should be billed with CPT codes Management of the neoplasm of uncertain behavior is not addressed in this policy. Accordingly, this A/B MAC will deny claims for CPT codes when the diagnoses submitted are: 1) Malignant melanoma of skin ) Other malignant neoplasms of skin ) Neoplasms of uncertain behavior, skin CPT code does list malignant lesions as part of its description. However, this policy addresses the treatment of actinic keratoses only. Further, this A/B MAC is not aware of any PDT that is used for malignant skin lesions or benign skin lesions other than actinic keratoses, and will, accordingly, restrict the coverage of to the treatment of actinic keratoses. Sources of Information and Basis for Decision Physician s Desk Reference 2002;56:973. (Levulan) Luvulan Kerastick Aminolvulinic acid HCl Topical Solution, 20%, DUSA Pharmaceuticals, INC. Consultants Carrier Medical Directors Updated sources: Tadiparthi SMR, Falder SF, Saour SM, Hills SJ, Liew, SF. Intense Pulsed Light with Methyl-Aminolevulinic Acid for Treatment of Actinic Keratoses. Plastic & Reconstructive Surgery. May 2008;121(5):351e-2e. Pariser D, Loss R, Jarratt M, Abramovitis W, Spencer J, Geronemus R, et al. Topical Methyaminolevulinate Photodynamic Therapy Using Red Light Emitting Diode Light for Ttreatment of Multiple Actinic Keratoses: A randomized double-blind, placebo-controlled study. J AM Acad Dermatol. Oct 2008;59(4):

10 Page 10 of 12 Rhodes LE, de Rie M, Enstrom Y, et al. Photodynamic Therapy Using Topical Methyl Aminolevulinate vs Surgery for Nodular Basal Cell Carcinoma. Arch Dermatol. Jan 2004;140: Piacquadio DJ, Chen DM, Farber HF, et al. Photodynamic Therapy with Aminolevulinic Acid Topical Solution and Visible Blue Light in the Treatment of Multiple Actinic Keratoses of the Face and Scalp. Arch Dermatol. 2004;140(1):41-6. Metvixia (methyl aminolevulinate) cream. Prescribing Information. Available at: Accessed 9/29/11 Advisory Committee Meeting Notes This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which include representatives from the affected provider community. Contractor Advisory Committee meeting dates: California - Hawaii - Nevada - Start Date of Comment Period 10/15/2010 End Date of Comment Period 12/03/2010 Start Date of Notice Period 12/21/2010 Revision History Number Revision #7 Revision History Explanation Revision #7, effective for dates of service on or after 12/23/2011 Revision made: Under Indications and Limitations of Coverage and/or Medical Necessity removed the following paragraph which was repeated verbatim further down in the LCD same section, "Some actinic keratoses lesions can be treated with medical approaches as listed earlier, but there may be instances in which a surgical approach to the treatment of actinic keratoses is warranted. Given that the skin lesion correctly diagnosed as an actinic keratosis is a premalignant lesion with a low but real possibility of malignant transformation, its presence alone justifies its removal." Revision #6 Under Utilization Guidelines was deleted and was added. This LCD is being revised due to the annual FY 2012 ICD-9-CM code update. Under Sources of Information of Basis for Decision updated reference web site citation for Metvixia cream Accessed Removed the reference "Other carriers' policies" as no LCDs were named nor were the other carriers named, statement was not specific to be included as a reference. This revision will become effective 10/01/2011. Revision #5 Draft final, effective for dates of service on or after 03/07/2011 Revisions made: Under Indications and Limitations of Coverage and/or Medical Necessity, changed the word and to "and/or" in the sentence, "Commonly, Actinic Keratosis are treated by cryotherapy and/or electrodesiccation or by medical means such as 5-fluorouracil." Spelled out the trade name for the drug of Metvixia to read (methyl

11 Page 11 of 12 aminolevulinate) cream and named the acronym for PpIX (protoporphyrin IX). Under HCPCS/CPT Codes added HCPCS code J7309 and removed HCPCS code J3490 (Not otherwise classified). This code is effective for dates of service on or after 01/01/2011. Under ICD-9 Codes that Support Medical Necessity added HCPCS code J7309 as the HCPCS code that would be covered for diagnosis code. Under Sources of Information and Basis for Decision added two additional citations which support the LCD titled "Photodynamic Therapy with Aminolevulinic Acid Topical Solution and Visible Blue Light in the Treatment of Multiple Actinic Keratosis of the Face and Scalp" and "Photodynamic Therapy Using Topical Methyl Aminolevulinate vs Surgery for Nodular Basal Cell Carcinoma." Also added the Prescribing Information for Metvixia. Removed the following citation articles and reference books from the LCD as these sources were unable to be located and not verifiable: Actinic Keratosis A Common Precancer; Actinic Keratosis, Health Watch; Skin Cancer, Tried and True Ways for Dealing with the Diagnosis; Actinic Keratosis, Skin Cancer and Sun Damage to the Skin and Actinic Keratosis of the Scalp. Revision #4 Draft Revision made: Under "Indications and Limitations of Coverage and/or Medical Necessity added methyl aminolevulinate.(mal) and the statement "Alternatively methylaminolevulinate is applied to the to a non-hyperkeratotic AKs lesion and the lesion and 5mm of surrounding normal appearing skin is covered with an occlusive, nonabsorbent dressing for at least three hours. The dressing is then removed and the cream wiped with gauze dipped in 0.9% saline solution, immediately before illumination with red LED light for approximately eight minutes. The Aktilite lamp, specifically designed for use with Metvix cream, has an emission spectrum that closely matches the red light absorption profile of PpIX." Under CPT /HCPCS Codes added J3490 to be used for claims submission of methyl aminolevulinate. Under Sources of information and Basis for Decision added reference citations Tadiparthi SMR, Falder SF, Saour SM, Hills SJ, Liew, SF. Intense Pulsed Light with Methyl-Aminolevulinic Acid for Treatment of Actinic Keratoses. Plastic & Reconstructive Surgery. May 2008, 121(5):351e-2e; and Pariser D, Loss R, Jarratt M, Abramovitis W, Spencer J, Geronemus R, et al. Topical Methyaminolevulinate Photodynamic Therapy Using Red Light Emitting Diode Light for Ttreatment of Multiple Actinic Keratoses: A randomized double-blind, placebo-controlled study. J AM Acad Dermatol, Oct 2008;59(4): Corrected Berlex Laboratories with DUSA Pharmaceuticals. Revision #3, 02/26/2009 This LCD is being revised to implement the streamlining of the Part B LCDs per the published article Palmetto Team to Streamline Part B LCDs in Jurisdiction 1 (J1). This article can be viewed at by searching for the above article name. This revision will become effective on 02/26/2009. Revision #2, 10/30/2008 Revisions Made: In the "CMS National Coverage Policy" section of the LCD the redundant verbiage was removed and corrected the Manual citations. In the section titled "Indications and Limitations of Coverage and/or Medical Necessity" removed the National Coverage Determinations (NCD) statement as the NCD is not to be in the LCD. The NCD is referenced in the "CMS National Coverage Policy" section of the LCD. Under "Sources of Information and Basis for Decision section of the LCD the references were placed in the AMA citation format. This revision becomes effective on 10/30/2008. Revision #1, 09/02/2008 This LCD is being revised to add Bill Type 999X because the automated system transcription process was incomplete. 11/21/ For the following CPT/HCPCS codes either the short description and/or the

12 Page 12 of 12 long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: descriptor was changed in Group descriptor was changed in Group 1 11/21/ For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: descriptor was changed in Group 1 Reason for Change Maintenance (annual review with new changes, formatting, etc.) Related Documents This LCD has no Related Documents. LCD Attachments There are no attachments for this LCD. Back to Top All Versions Updated on 06/05/2012 with effective dates 12/23/ N/A Updated on 12/16/2011 with effective dates 12/23/ N/A Updated on 12/13/2011 with effective dates 12/23/ N/A Updated on 11/21/2011 with effective dates 10/01/ /22/2011 Updated on 09/02/2011 with effective dates 10/01/ N/A Updated on 01/14/2011 with effective dates 03/07/ /30/2011 Updated on 11/21/2010 with effective dates 10/21/ /06/2011 Updated on 10/15/2010 with effective dates 10/21/ N/A Some older versions have been archived. Please visit the MCD Archive Site them. to retrieve Read the LCD Disclaimer Back to Top Department of Health & Human Services Medicare.gov USA.gov Web Policies & Important Links Privacy Policy Freedom of Information Act No Fear Act Centers for Medicare & Medicaid Services, 7500 Security Boulevard Baltimore, MD