Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Selective Photothermolysis Using Pulsed-Dye Lasers (PDL)
Policy #:MA11.071a

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

Selective photothermolysis using pulsed-dye laser (PDL) is considered medically necessary and, therefore, covered for the treatment of any of the following conditions:
  • Congenital port-wine stain (PWS) with either of the following circumstances:
    • When the lesion is located on the face, head, or neck
    • When the lesion is located on other areas (e.g., trunk, limbs) and a functional skin impairment related to the port wine stain (e.g., ulceration, recurrent bleeding, infection, restricted range of motion due to lesion) exists
  • Hemangiomas of infancy (HOI), when any of the following criteria are met:
    • When the lesion is superficial or mixed, and the potential for functional impairment exists (e.g., obstruction of vital structures involved in respiration, vision, and/or feeding)
    • When ulceration, recurrent bleeding, and/or infection exists
    • When the location of the lesion causes an increased risk of ulceration and/or recurrent bleeding
  • Hypertrophic or keloidal scars, when injectable corticosteroids are not indicated or if attempts at treatment with injectable corticosteroids have proved unsuccessful, and any of the following criteria are met:
    • When the scar is documented to be causing a functional impairment (e.g., the individual has restricted range of motion or contracture due to the scar) and selective photothermolysis using PDL will improve and restore normal body function
    • When the scar causes chronic pain that requires the use of analgesic medication, which is documented in the individual's medical record
  • Small pyogenic granulomas, when attempts at conventional treatment (e.g., cryosurgery, surgical excision, electrodesiccation) have proven unsuccessful
  • Viral warts, when attempts at treatment with cryosurgery, topical agents, and/or electrodesiccation have proven unsuccessful
  • Rosacea-associated conditions of erythema and telangiectasias when both of the following criteria are met:
    • Clinically significant stage of rosacea is present (e.g., chronic inflammatory infiltrate, lasting erythema, facial edema, prominent areas of telangiectasias, rhinophyma), which is documented in the individual's medical record.
    • Failed medical management (i.e., not responding to or not tolerating oral and topical treatments) following a six-month course of conventional treatment in accordance with current standards of practice as documented in the individual's medical record. Examples of agents that may be used for conventional treatment include the following:
      • Topical sodium sulfacetamide
      • Topical antibiotics/antimicrobial agents (e.g., erythromycin, clindamycin, metronidazole)
      • Topical azelaic acid
      • Oral antibiotics/antimicrobial agents (e.g., tetracycline, anti-inflammatory doses of doxycycline, minocycline, metronidazole)
      • Topical retinoid (e.g., tretinoin)
      • Oral retinoids (e.g., isotretinoin)

COSMETIC

When selective photothermolysis using PDL does not meet these above-listed criteria, it is considered a cosmetic service. Services that are cosmetic are not covered by the Company because cosmetic services are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

All requests for selective photothermolysis using PDL require review by the Company and must include color photographs, letter of medical necessity from the provider, and documentation from the individual's medical records regarding previous treatment.
Policy Guidelines

There is no Medicare coverage criteria addressing this service; therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, selective photothermolysis using pulsed-dye laser (PDL) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company:
  • Active acne vulgaris

Services that are cosmetic are excluded for the Company’s Medicare Advantage products because they are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved several types of PDLs for use with selective photothermolysis under the 510(k) process.

Description

Selective photothermolysis is the process in which the transfer of laser energy is restricted to a particular site because of the selective absorption of a chromophore at that site. Selective photothermolysis, induced by high-energy pulsed-dye laser (PDL), uses a combination of selective absorption and thermal energy confinement to yield highly specific damage to pigmented microscopic structures in the skin. The possibility for exquisite tissue sensitivity is currently the most compelling reason for the use of selective photothermolysis. PDLs are used to treat dermatologic conditions that may lead to medical complications as well as conditions that already have medical complications.

This procedure is also used to treat cosmetic indications. Cosmetic services are those provided to improve an individual's physical appearance, from which no significant improvement in physiologic function can be expected. Emotional and/or psychological improvement alone does not constitute improvement in physiologic function.

The following conditions are sometimes treated with selective photothermolysis using PDL:
  • Congenital port-wine stain (PWS) is a congenital capillary malformation. PWSs initially are faint and pink; as they mature, the lesions darken and become nodular. Approximately five percent of PWSs occur in conjunction with vascular defects in the meninges and central nervous system with resultant seizures, intellectual disability, and/or glaucoma (Sturge-Weber syndrome).
  • Hemangiomas of infancy (HOI) are common vascular tumors that can be superficial, deep, or mixed. Ulceration is the most common local complication of hemangiomas, and treatment with selective photothermolysis leads to a decrease in pain and promotes healing of the ulcerated area. Occasionally these hemangiomas result in impairment of visual or respiratory function due to mass effect and platelet sequestration. Sudden-onset coagulopathy may also occur.
  • Hypertrophic and keloid scars are characterized by an abnormal proliferation of fibrous dermal tissue that develops after healing of a cutaneous injury. Hypertrophic scars stay within the edges of the wound, whereas keloids extend beyond the borders of the original insult and create a thick, puckered effect. Selective photothermolysis using PDL is considered by some to be the first-line treatment for abnormal scars, specifically hypertrophic and keloid scars. Adjuvant radiation therapy and/or intralesional injections of corticosteroids may be necessary to gain successful results.
  • Pyogenic granuloma is a rapidly developing vascular lesion that often arises at sites of minor trauma; it may represent a reactive phenomenon. PDL is effective for small pyogenic granulomas. Larger lesions are preferably treated by other therapeutic alternatives (e.g., surgical excision).
  • Rosacea is a progressive, chronic acneiform disorder of the pilosebaceous units of the skin coupled with an increase in the reactivity of the local skin capillary beds to heat. The disorder is characterized by redness, pimples, small visible vessels called telangiectasias (i.e., erythrotelangiectatic rosacea) and, in advanced stages, thickened skin. Rosacea usually affects the face, as in rhinophyma, which is hyperplasia of the sebaceous glands of the nose. Other parts of the upper body are only rarely involved. According to the American Academy of Dermatology (AAD), topical and oral medications are common treatment modalities of conventional rosacea treatment and maintenance of rosacea. Evidence has shown PDL to be effective in treating erythrotelangiectatic rosacea, including persistent erythema and phymatous rosacea. The energy of the lasers is targeted at the vessels that comprise the lesion, thus selective destruction of the lesion is accomplished.
  • Viral warts (or verruca) are small, rough tumors that resemble cauliflower in appearance. Warts are commonly caused by the human papillomaviruses (HPV), but there are other viruses that cause warts as well. The hands, feet, face, and genital areas are typical sites of infection. At this time, there is no evidence that selective photothermolysis using PDL is more effective than conventional treatment. Consequently, conventional treatments such as liquid nitrogen cryotherapy and cantharidin should be tried before PDL therapy for viral wart clearance.
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    Coding

    Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

    The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

    In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

    The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

17000, 17003, 17004, 17106, 17107, 17108, 17110, 17111


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

B07.9 Viral wart, unspecified

A63.0 Anogenital (venereal) warts

B07.0 Plantar wart

B07.8 Other viral warts

D18.01 Hemangioma of skin and subcutaneous tissue

D18.09 Hemangioma of other sites

L92.8 Other granulomatous disorders of the skin and subcutaneous tissue

L98.0 Pyogenic granuloma

L91.0 Hypertrophic scar

L71.1 Rhinophyma

L71.8 Other rosacea

L71.9 Rosacea, unspecified

L73.0 Acne keloid

L90.5 Scar conditions and fibrosis of skin

Q82.5 Congenital non-neoplastic nevus



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

Revisions from MA11.071a
09/25/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on Selective Photothermolysis Using Pulsed-Dye Lasers (PDL).
03/01/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on Selective Photothermolysis Using Pulsed-Dye Lasers (PDL).
12/07/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Selective Photothermolysis Using Pulsed-Dye Lasers (PDL).
12/16/2015This policy will become effective on 12/16/2015.

This policy was updated to communicate the Company's continuing position on selective photothermolysis using pulsed-dye lasers (PDL).

Revisions from MA11.071
01/01/2015This is a new policy.




Version Effective Date: 12/16/2015
Version Issued Date: 12/16/2015
Version Reissued Date: 09/25/2019