Dermatologic Applications of Photodynamic Therapy

POLICY NUMBER

A.2.01.44

DESCRIPTION

Photodynamic therapy (PDT) refers to light activation of a photosensitizer to generate highly reactive intermediaries, which ultimately cause tissue injury and necrosis. Photosensitizing agents are being proposed for use with dermatologic conditions such as actinic keratoses and non-melanoma skin cancers.

Photodynamic Therapy

Two common photosenitizing agents are 5-aminolevulinic acid (ALA) and its methyl ester, methyl aminolevulinate. When applied topically, these agents pass readily through abnormal keratin overlying the lesion and accumulate preferentially in dysplastic cells. The agents ALA and methyl aminolevulinate are metabolized by underlying cells to photosensitizing concentrations of porphyrins. Subsequent exposure to photoactivation (maximum absorption at 404 to 420 nm and 635 nm) generates reactive oxygen species that are cytotoxic, ultimately destroying the lesion. PDT can cause erythema, burning, and pain. Healing occurs within 10 to 14 days, with generally acceptable cosmetic results. PDT with topical ALA has been investigated primarily as a treatment of actinic keratoses.

In 1999, Levulan® Kerastick^TM, a topical preparation of ALA, in conjunction with illumination with the BLU-U^TM Blue Light Photodynamic Therapy Illuminator, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of non-hyperkeratotic actinic keratoses of the face and scalp. In 2018, the indication was expanded to include nonhyperkeratotic actinic keratoses of the upper extremities. The product is applied in the physician's office.

In 2016, the FDA approved Ameluz® (aminolevulinic acid hydrochloride) gel, 10% (BF-200 ALA; Biofrontera AG) in combination with PDT using BF-RhodoLED® or RhodoLED XL lamp, to be used for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp. The treatment is to be administered by a healthcare provider.

ALA patch technology is available outside of the U.S through an agreement between Intendis (now Bayer HealthCare) and Photonamic. The ALA patch is not approved by the FDA.

Another variant of photodynamic therapy (PDT) for skin lesions is Metvixia® used with the Aktilite CL128 lamp, each of which received the FDA approval in 2004. Metvixia® (Galderma; Photocure) consists of the topical application of methyl aminolevulinate (in contrast to ALA used in the Kerastick procedure), followed by exposure with theAktilite CL 128 lamp, a red light source (in contrast to the blue light source in the Kerastick procedure). Broadband light sources (containing the appropriate wavelengths), intense pulsed light, pulsed dye lasers, and potassium-titanyl-phosphate (KTP) lasers have also been used. Metvixia® is indicated for the treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used with lesion preparation (debridement using a sharp dermal curette) in the physician's office when other therapies are unacceptable or considered medically less appropriate. There are currently no methyl aminolevulinate products available in the US.

POLICY

Photodynamic therapy may be considered medically necessary as a treatment of:

• Non-hyperkeratotic actinic keratoses of the upper extremities (See Policy Guidelines).

Photodynamic therapy is considered investigational for other dermatologic applications, including, but not limited to, acne vulgaris, high-risk basal cell carcinomas, hidradenitis suppurativa, and mycoses.

Photodynamic therapy as a technique of skin rejuvenation, hair removal, or other cosmetic indications is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Surgery and radiation are the preferred treatments for low-risk basal cell cancer and Bowen disease. If photodynamic therapy is selected for these indications because of contraindications to surgery or radiation, patients and physicians need to be aware that it may have a lower cure rate than surgery or radiation.

Photodynamic therapy typically involves 2 office visits: 1 to apply the topical aminolevulinic acid and a second visit to expose the individual to blue light. The second physician office visit, performed solely to administer blue light, should not warrant a separate Evaluation and Management CPT code. Photodynamic protocols typically involve 2 treatments spaced a week apart; more than 1 treatment series may be required.

Based on characteristics of individuals enrolled in randomized controlled trials, 4 or more lesions per site (face, scalp, or upper extremities) is an appropriate threshold for use of photodynamic therapy for individuals with nonhyperkeratotic actinic keratosis.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

8/2001: Approved by Medical Policy Advisory Committee (MPAC).

11/14/2001: Hyperlink inserted.

1/23/2002: "Sources," "Type of Service," and "Place of Service" sections updated; Noncovered codes added.

2/14/2002: Investigational definition added.

5/2/2002: Type of Service and Place of Service deleted.

5/28/2002: Code Reference section updated

3/25/2004: Reviewed by MPAC, remains investigational, Description section aligned with BCBSA policy # 2.01.44, FEP exception added, Sources updated.

5/19/2004: Coding reviewed, no changes.

7/15/2005: Policy reviewed by MPAC, Description section updated to include verbiage for acne vulgaris and other skin related conditions. Policy section updated to indicate that photodynamic therapy with topicalALA and exposure to blue and red light and photodynamic therapy with methyl aminolevulinate and exposure to red light are considered investigational for acne vulgaris and other skin related conditions. Photodynamic therapy for cosmetic indications is not considered medically necessary. Policy titled "Photodynamic Therapy (PDT) for Actinic Keratoses (AKs)" renamed "Photodynamic Therapy."

10/17/2005: Code Reference table reviewed, diagnosis code 702.0 deleted.

8/3/2007: Policy reviewed, description updated to include BCC and change Metvix to Metvixia®. Policy title "Photodynamic Therapy for the Treatment of Actinic Keratoses and Other Skin Lesions" renamed "Dermatologic Applications of Photodynamic Therapy." Policy statement revised: Non-hyperkeratotic actinic keratoses, superficialBCC, and Bowen's disease changed from investigational to may be considered medically necessary; non-superficial BCC is considered investigational. CPT 96567, ICD-9 procedure code 99.83, and HCPCS J7308 moved to covered with note to see POLICY. Added ICD-9 codes173.0-173.9, 232.0-232.9, and 702.0 with note to see POLICY.

11/15/2007: Policy revisions approved by MPAC.

8/21/2008: Policy reviewed, no changes.

9/28/2009: Verbiage, "* Some covered procedure codes may have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement section." added to Coding Section.

04/23/2010: Policy description and guidelines updated regarding treatment approaches. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section.

08/03/2010: Policy description updated to add Metvixia® and the Aktilite CL128 lamp as an approved variant of PDT for skin lesions. Policy statement unchanged. Added HCPCS code J3490 for reporting Metvixia®.

03/07/2011: Added new HCPCS code J7309 for reporting Metvixia® and deleted J3490. Added ICD-9 codes 209.31-209.36 to the Code Reference section.

02/24/2012: Policy reviewed; no changes.

04/03/2013: Policy reviewed; no changes.

03/11/2014: Policy reviewed; no changes.

02/12/2015: Policy reviewed; description updated. Medically necessary policy statement updated to change "Superficial basal cell skin cancer" to "Low-risk (eg superficial and nodular) basal cell skin cancer." Investigational statement revised to change "non-superficial basal cell carcinomas" to "high-risk basal cell carcinomas." Policy guidelines updated to change "superficial basal cell cancer" to "low-risk basal cell cancer."

08/25/2015: Code Reference section updated for ICD-10.

03/07/2016: Policy reviewed; no change in policy statements. Policy guidelines updated to add medically necessary and investigative definitions.

06/01/2016: Policy number A.2.01.44 added.

12/21/2016: Policy reviewed; no changes.

12/20/2017: Code Reference section updated to add new 2018 CPT codes 96573 and 96574. Added new 2018 HCPCS code J7345. Revised CPT code 96567 effective 01/01/2018.

01/15/2018: Policy description updated regarding treatments. Policy statements unchanged.

09/24/2018: Code Reference section updated to add ICD-10 diagnosis codes C44.1121, C44.1122, C44.1191, C44.1192, C4A.111, C4A.112, C4A.121, C4A.122, D04.111, D04.112, D04.121, and D04.122, effective 10/01/2018.

01/11/2019: Medically necessary policy statement updated with minor change: "squamous cell carcinoma" updated to "cutaneous squamous cell carcinoma."

06/22/2020: Policy description updated to add product indications and to remove information regarding applications. Added non-hyperkeratotic actinic keratoses of the upper extremities as a medically necessary indication for photodynamic therapy. Policy Guidelines updated regarding photodynamic therapy for patients with nonhyperkeratotic actinic keratosis. Code Reference section updated to remove deleted ICD-10 diagnosis codes C44.112 and C44.119.

01/27/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

02/02/2022: Policy reviewed; no changes.

01/24/2023: Policy reviewed. Policy statement updated to change "not medically necessary" to "investigational." Policy intent unchanged. Policy Guidelines updated regarding photodynamic therapy.

01/08/2024: Policy reviewed; no changes.

02/05/2025: Policy description updated regarding products. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.01.44

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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