CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

photodynamic_therapy_criteria

Defines medical necessity criteria and coding guidance for photodynamic therapy (PDT) for commercial products, specifying covered indications (nonhyperkeratotic actinic keratoses of face/scalp and upper extremities; select low-risk BCC and Bowen disease when surgery/radiation contraindicated), noncovered cosmetic/other dermatologic uses, and associated CPT/HCPCS/J-codes and ICD-10 diagnosis codes.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

Policyphotodynamic_therapy_criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument diagnosis and that surgery and radiation are contraindicated when using PDT for low-risk BCC or Bowen disease.

SourceLink

POLICY UPDATE CHANGES

No material change

3Primary covered indications (AK face/scalp, AK upper extremities, select BCC/Bowen)

7+Noncovered / insufficient evidence example conditions listed

>=4Lesion threshold for AK per site

Coverage Summary

Defines medical necessity criteria and coding guidance for photodynamic therapy (PDT) for commercial products: covered indications include nonhyperkeratotic actinic keratoses of the face and scalp and nonhyperkeratotic actinic keratoses of the upper extremities; select low-risk basal cell carcinoma (superficial and nodular) and Bowen disease (cutaneous squamous cell carcinoma in situ) when surgery and radiation are contraindicated. Also specifies associated covered CPT/HCPCS/J-codes and appropriate ICD-10 diagnosis codes and states that other dermatologic or cosmetic uses are not medically necessary or have insufficient evidence.

Thresholds and Quick Facts

Primary covered indications3 (AK face/scalp; AK upper extremities; select low-risk BCC/Bowen when surgery/radiation contraindicated)

Noncovered / insufficient evidence examples listed7+ (acne vulgaris; high-risk BCC; hidradenitis suppurativa; mycoses; skin rejuvenation/hair removal/cosmetic uses; nonmetastatic invasive SCC; other noncancerous conditions)

Lesion count threshold for PDT (AK)>= 4 lesions per site (face, scalp, or upper extremities)

Medical-Necessity Criteria

Medically Necessary Indications (Commercial Products)

Photodynamic therapy may be considered medically necessary...

Covered Indications

Nonhyperkeratotic actinic keratoses of the face and scalp
Nonhyperkeratotic actinic keratoses of the upper extremities
Low-risk basal cell carcinoma (BCC)
- Low-risk (e.g., superficial and nodular) basal cell skin cancer
- Surgery and radiation are contraindicated
  Document that surgery and radiation are contraindicated
Cutaneous squamous cell carcinoma in situ (Bowen disease)
- Diagnosis of cutaneous squamous cell carcinoma in situ (Bowen disease)
- Surgery and radiation are contraindicated
  Document that surgery and radiation are contraindicated

Operational / Treatment Protocol Notes

Protocol and usage considerations described in background

Typical PDT involves 2 office visits: one to apply topical aminolevulinic acid and a second visit to apply light exposure; the second visit performed solely to administer blue light should not warrant a separate Evaluation and Management CPT code
Billing guidance: do not bill separate E/M for light-only visit
PDT protocols typically involve 2 treatments spaced about a week apart; more than one treatment series may be required
Threshold for use of PDT for nonhyperkeratotic AKs: 4 or more lesions per site (face, scalp, or upper extremities)>=4 lesions per site
Based on RCT populations

Not Medically Necessary / Insufficient Evidence

Photodynamic therapy may be considered medically necessary as a treatment of the following or may be not medically necessary/insufficient evidence for the list below

All other dermatologic applications not specifically listed as medically necessary
Acne vulgaris
Evidence insufficient
High-risk basal cell carcinoma
Hidradenitis suppurativa
Evidence insufficient
Mycoses (fungal infections)
Evidence insufficient
Technique of skin rejuvenation, hair removal, or other cosmetic indications
Evidence insufficient
Nonmetastatic invasive squamous cell carcinoma (insufficient evidence)
Other noncancerous dermatologic skin conditions (e.g., port-wine stain) unless supported by adequate RCT evidence
Evidence insufficient

Randomized controlled trials and meta-analyses show that PDT improves complete lesion clearance for nonhyperkeratotic actinic keratoses on the face, scalp, and upper extremities, supporting net health benefit. For low-risk basal cell carcinoma and Bowen disease, RCTs and systematic reviews indicate PDT can improve outcomes and offers better cosmetic results, but has lower cure rates versus surgery and is appropriate mainly when surgery or radiation are contraindicated. For many other dermatologic conditions (for example acne, hidradenitis suppurativa, mycoses, port-wine stain, and nonmetastatic invasive squamous cell carcinoma) the evidence is inconsistent or insufficient to demonstrate improved net health outcomes.

Coding

Covered CPT / HCPCS / J-codesmixedCovered

96567	Photodynamic therapy by external application of light to premalignant lesions of the skin and adjacent mucosa with application and illumination, activation of photosensitive drug(s), per day
96573	Photodynamic therapy 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 physician or other qualified health care professional, per day
96574	Debridement of premalignant hyperkeratotic lesion(s) (e.g., targeted curettage, abrasion) followed with photodynamic therapy 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 physician or other qualified health care professional, per day
J7308	Aminolevulinic acid HCl for topical administration, 20%, single unit dosage form (354 mg)
J7309	Methyl aminolevulinate (MAL) for topical administration, 16.8%, 1 g
J7345	Aminolevulinic acid HCl for topical administration, 10%, 10 mg gel

Associated ICD-10 Diagnosis Codes (when filing)ICD-10Covered

C44.0-C44.99	Malignant neoplasm of skin (range for cutaneous basal cell carcinoma, squamous cell carcinoma, etc.)
D04.0-D04.9	Carcinoma in situ of the skin (including Bowen disease)
L57.0	Actinic keratosis

Billing guidance: document the indication and that surgery and radiation are contraindicated when using PDT for low-risk BCC or Bowen disease. The second physician visit performed solely to administer light should not be billed as a separate E/M service. The listed CPT/HCPCS/J-codes should be reported filed with the appropriate ICD-10 diagnosis codes (e.g., C44.*, D04.*, or L57.0) and are considered medically necessary when the clinical criteria are met.

Provider Actions

Documentation Required

Indication and contraindication documentation

Document diagnosis and that surgery and radiation are contraindicated when using PDT for low-risk BCC or Bowen disease

Billing Rule

Do not bill separate E/M for light-only visit

The second physician office visit performed solely to administer blue light should not warrant a separate Evaluation and Management CPT code

96567
96573

Billing Rule

CPT/HCPCS and ICD-10 linkage

Report listed CPT/HCPCS photodynamic therapy procedure codes filed with one of the specified ICD-10 diagnosis codes C44.*, D04.*, or L57.0 as appropriate; these code pairings are considered medically necessary when criteria met

Procedures/Codes: 96567, 96573, 96574, J7308, J7309, J7345
Diagnosis Codes: C44.0-C44.99, D04.0-D04.9, L57.0

Background & Evidence

Photodynamic therapy uses topical photosensitizers such as 5-aminolevulinic acid (ALA) or methyl aminolevulinate that accumulate in dysplastic cells and, when activated by light (peaks ~404–420 nm and 635 nm), generate reactive oxygen species that destroy target tissue. Clinical evidence from multiple randomized controlled trials and meta-analyses supports PDT for nonhyperkeratotic actinic keratoses of the face, scalp, and upper extremities. Evidence also suggests a role for PDT in low-risk basal cell carcinoma and Bowen disease when surgery or radiation are contraindicated, noting that PDT may have lower cure rates than surgical treatments for some malignancies. For many other dermatologic conditions, available trials are small or inconsistent and evidence is insufficient to conclude benefit.

Evidence Topic	Summary
RCT / meta-analysis support	Multiple randomized controlled trials and meta-analyses show PDT improves complete clearance for nonhyperkeratotic actinic keratoses on the face/scalp and upper extremities versus placebo or other interventions; evidence considered sufficient to improve net health outcome.
Comparative efficacy for BCC	Systematic reviews and RCTs indicate PDT may be less effective than surgery for low-risk superficial and nodular BCC but yields better cosmetic outcomes; evidence supports use when surgery/radiation are contraindicated.
Insufficient evidence (acne, HS, mycoses, port‑wine stain, other)	RCTs and reviews for acne, hidradenitis suppurativa, fungal infections, port‑wine stain and many noncancerous dermatologic uses are inconsistent or limited (case series/uncontrolled studies); evidence is insufficient to determine net health benefit.

Photodynamic therapy (PDT): Light activation of a topical photosensitizer (e.g., ALA, methyl aminolevulinate) to generate reactive intermediates causing tissue destruction.

Nonhyperkeratotic actinic keratosis: Actinic keratoses without significant hyperkeratosis located on the face, scalp, or upper extremities as referenced for PDT eligibility.

Year	Title/Number	Type
2001	Treatment of Actinic Keratosis (250.4)	NCD