Photodynamic Therapy
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This Aetna Clinical Policy Bulletin (0375) defines medical necessity criteria, investigational/excluded indications, and coding guidance for photodynamic therapy (topical and intravenous photosensitizers) for commercial medical plans. It includes covered indications (esophageal cancer, lung cancer, certain non-melanoma skin tumors, cholangiocarcinoma) with criteria, lists of covered and not-covered CPT/HCPCS/ICD-10 codes, and background/evidence discussion.
No material clinical or coverage changes in this update.
Coverage Summary
This document is Aetna Clinical Policy Bulletin 0375 addressing photodynamic therapy (PDT) for commercial medical plans. Scope: the policy defines medical necessity criteria for specific covered indications (notably certain esophageal cancer, endobronchial non-small cell lung cancer, selected non-melanoma skin tumors using topical photosensitizers, and PDT as an adjunct to stenting for inoperable cholangiocarcinoma), lists investigational/excluded indications (many cancer and non-cancer uses), and provides coding guidance. Policy status is CURRENT with policy number 0375; effective date 2000-01-31; last review date 2023-06-21.
Medical-Necessity Criteria
Esophageal Cancer - Medical Necessity
Covered when ANY of the following are met:
ANY of the following
- Barrett's esophagus carcinoma in-situ and high-grade disease in members who are not candidates for esophagectomy.
- Completely obstructing esophageal cancer.
- Partially obstructing esophageal cancer, in members who cannot be satisfactorily treated with Nd:YAG laser therapy.
Lung Cancer (endobronchial non-small cell) - Medical Necessity
Covered when ANY of the following are met:
ANY of the following
- Completely obstructing endobronchial non-small cell lung cancer.
- Microinvasive endobronchial non-small cell lung cancer at an early stage, for whom surgery and radiotherapy are not indicated.
- Partially obstructing endobronchial non-small cell lung cancer.
Non-melanoma Skin Tumors - Medical Necessity (topical photosensitizers)
ONE of
- Basal cell carcinoma.
- Cutaneous lesions of Bowen's disease (carcinoma in situ of skin).
- Refractory actinic keratoses.
Other covered skin indications using specified agents
- Photodynamic therapy using methyl aminolevulinate for low-risk squamous cell carcinoma in-situ where surgery or radiation is contraindicated or impractical.
- Photodynamic therapy using aminolevulinic acid or methyl aminolevulinate for erythroplasia of Queyrat.
Not covered with intravenous photosensitizers for skin indications
- Photodynamic therapy using intravenous photosensitizers (e.g., porfimer sodium) for the skin indications listed above is considered experimental and investigational.
Cholangiocarcinoma - Medical Necessity
Covered when used as an adjunct:
ALL of the following
- Photodynamic therapy used as an adjunct to stenting for palliation of inoperable cholangiocarcinoma.
Background Evidence Summaries
- Photodynamic therapy (PDT) uses a photosensitizing agent activated by light to produce reactive oxygen species that destroy targeted tissue. Agents include intravenous porfimer sodium (Photofrin) for internal malignancies and topical aminolevulinic acid or methyl aminolevulinate for cutaneous lesions.
- For esophageal and endobronchial tumors, PDT has been used for palliation of obstructing lesions and for treatment of superficial or microinvasive disease when surgery or radiotherapy are not options; evidence includes case series and nonrandomized studies demonstrating symptomatic relief and tumor ablation, though randomized comparative data are limited.
- For non-melanoma skin tumors, topical PDT with aminolevulinic acid or methyl aminolevulinate has demonstrated efficacy for superficial basal cell carcinoma, Bowen's disease, refractory actinic keratoses, and selected in-situ squamous cell carcinomas when other treatments are contraindicated or impractical; outcomes include lesion clearance and cosmetic benefits in multiple clinical trials and systematic reviews.
- For cholangiocarcinoma, small randomized and nonrandomized studies suggest PDT combined with biliary stenting can improve biliary drainage and may prolong survival or quality of life compared with stenting alone, supporting its role as an adjunct for palliation in inoperable cases.
- PDT is considered experimental and investigational for numerous other cancer and non-cancer indications due to insufficient or conflicting evidence regarding effectiveness. Safety considerations include photosensitivity reactions, procedure-related local tissue injury, and potential need for repeat treatments; agent- and indication-specific adverse effects are described in the literature.
Not Covered / Experimental Indications
Experimental and Investigational - Cancer Indications (Not Covered)
PDT is considered experimental and investigational for ANY of the following cancer indications:
ANY of the following
- Brain tumors (e.g., glioma)
- Breast cancer
- Cervical intraepithelial neoplasia/cervical cancer
- Colon cancer
- Gastric cancer
- Intra-ocular choroidal metastases
- Mediastinal carcinoid tumor
- Mycosis fungoides
- Pancreatic cancer
- Pleural mesothelioma
- Peritoneal carcinomatosis
- Prostate cancer (interstitial motexafin lutetium-mediated PDT)
- Retinal hamartomas/tuberous sclerosis
- Squamous cell carcinoma in the head and neck
- Squamous dysplasia of the oral cavity
- Uveal melanoma
Experimental and Investigational - Non-Cancer Indications (Not Covered)
PDT is considered experimental and investigational for ANY of the following non-cancer indications:
ANY of the following
- Actinic cheilitis
- Actinic dermatitis
- Atopic dermatitis (eczematous dermatitis)
- Central serous chorioretinopathy
- Chronic rhinosinusitis
- Chronic ulcers (including diabetic ulcers)
- Condyloma (genital warts)
- Darier's disease (keratosis follicularis)
- Disseminated superficial actinic porokeratosis
- Dyspigmentation
- Endodontic infections
- Extra-mammary Paget's disease (e.g., Paget's disease of the vulva)
- Granulomatous dermatitis
- Halitosis
- Herpes labialis
- Hidradenitis suppurativa
- Human papilloma virus infection
- Liposclerosis (lipodermatosclerosis)
- Keratitis
- Nekam's disease (keratosis lichenoides chronica)
- Onychomycosis
- Oral leucoplakia / leukoplakia
- Oral lichen planus
- Peri-implantitis / peri-implant mucositis
- Periodontitis
- Photoaging
- Plantar wart
- Psoriasis
- Radiation retinopathy
- Respiratory papillomatosis
- Rosacea
- SARS-CoV-2 (COVID-19)
- Scarring
- Sebaceous hyperplasia
- Superficial mycosis
- Type II diabetes mellitus
- Verrucous vulgaris (common wart) of the face
- Vulvar lichen sclerosus
- Wound healing
Coding
| 96570 | Photodynamic therapy by endoscopic application of light to ablate abnormal tissue via activation of photosensitive drug(s); first 30 minutes (list separately in addition to code for endoscopy or bronchoscopy procedures of lung and esophagus). |
| 96571 | Photodynamic therapy by endoscopic application of light to ablate abnormal tissue via activation of photosensitive drug(s); each additional 15 minutes (list separately in addition to code for endoscopy or bronchoscopy procedures of lung and esophagus). |
| 96567 | Photodynamic therapy by external application of light to destroy pre-malignant and/or malignant lesions of the skin and adjacent mucosa (e.g., lip) by activation of photosensitive drug(s) each phototherapy exposure session. |
| 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 a physician or other qualified health care professional, per day. |
| 96574 | Debridement of premalignant hyperkeratotic lesion(s) 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 a physician or other qualified health care professional, per day. |
| 31641 | Bronchoscopy (rigid or flexible); with destruction of tumor or relief of stenosis by any method other than excision (e.g., laser therapy, cryotherapy). |
| 43228 | Esophagoscopy, rigid or flexible; with ablation of tumor(s), polyp(s), or other lesion(s), not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique. |
| 43229 | Esophagoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed). |
| 43270 | Esophagogastroduodenoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed). |
| 43278 | ERCP; with ablation of tumor(s), polyp(s), or other lesion(s), including pre- and post-dilation and guide wire passage, when performed. |
| 43272 | ERCP; with ablation of tumor(s), polyp(s), or other lesion(s) not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique. |
| J7309 | Methyl aminolevulinate (MAL) for topical administration, 16.8%, 1 gram [product discontinued]. |
| C15.3 - C15.9 | Malignant neoplasm of esophagus [obstructing]. |
| C34.00 - C34.92 | Malignant neoplasm of bronchus and lung [microinvasive endobronchial non-small cell] [obstructing]. |
| D00.1 | Carcinoma in situ of esophagus [Barrett's]. |
| C44.01 | Basal cell carcinoma (covered when criteria met). |
| C44.111 - C44.119 | Basal cell carcinoma codes (covered when criteria met). |
| C44.211 - C44.219 | Basal cell carcinoma codes (covered when criteria met). |
| C44.310 - C44.319 | Basal cell carcinoma codes (covered when criteria met). |
| C44.510 - C44.519 | Basal cell carcinoma codes (covered when criteria met). |
| C44.611 - C44.619 | Basal cell carcinoma codes (covered when criteria met). |
| C44.711 - C44.719 | Basal cell carcinoma codes (covered when criteria met). |
| C43.0 - C43.9 | Malignant melanoma and melanoma in situ of skin (not covered). |
| D03.0 - D03.9 | Melanoma in situ (not covered). |
| A63.0 | Anogenital (venereal) warts. |
| B00.1 | Herpesviral vesicular dermatitis. |
| B07.0 | Plantar wart. |
| B07.8 | Other viral warts [verrucous vulgaris of the face]. |
| B35.0, B35.1, B35.3, B35.6 | Dermatophytosis (superficial mycosis). |
| B36.0 | Pityriasis versicolor [superficial mycosis]. |
| B97.7 | Papillomavirus as the cause of diseases classified elsewhere. |
| C21.0 | Malignant neoplasm of anus. |
Provider Actions & Billing Guidance
Demonstrate criteria for covered indications
Document in the medical record that the patient's diagnosis and clinical situation meet the policy's medical necessity criteria. Include specifics that map to covered indications such as obstruction status (completely or partially obstructing lesions), Barrett's esophagus when the patient is not a candidate for esophagectomy, inability to use Nd:YAG laser therapy for partially obstructing esophageal cancer, or inoperable cholangiocarcinoma being treated adjunctively with stenting.
- Completely or partially obstructing esophageal cancer; note if Nd:YAG is not an option
- Barrett's esophagus carcinoma in-situ / high-grade disease in patients not candidates for esophagectomy
- Inoperable cholangiocarcinoma receiving PDT as an adjunct to stenting
Report endoscopic PDT codes in addition to endoscopy/bronchoscopy
When performing endoscopic PDT procedures of the lung or esophagus, report the PDT time-based CPT codes separately in addition to the code for the endoscopy or bronchoscopy procedure. These codes are listed in the policy and should be billed separately from the scope procedure.
Drug coding for photosensitizers
Use the HCPCS/J-codes specified for photosensitizing agents when selection criteria for coverage are met. Include the intravenous porfimer sodium code and the topical aminolevulinic acid product codes as applicable and distinguish topical versus systemic usage per policy.
Policy effective and review dates
Include the policy effective date, the most recent review date, and the scheduled next review in documentation and when checking policy applicability.
- Effective date: 2000-01-31
- Last review date: 2023-06-21
- Next review date: 2024-04-11
Background & Evidence Summary
Background: The FDA has approved porfimer sodium (Photofrin) with specified laser systems for treatment of early-stage microinvasive lung cancer and for palliation/relief of obstruction in completely or partially obstructing endobronchial non-small cell lung cancer. PDT has been evaluated as an alternative to esophagectomy for Barrett's esophagus and as adjunctive palliation with stenting for unresectable cholangiocarcinoma, with randomized trials reporting improved survival in some studies. For superficial non-melanoma skin cancers, topical photosensitizers (e.g., ALA, MAL) have evidence of effectiveness; systemic (intravenous) photosensitizers for skin indications are generally avoided because they can cause prolonged photosensitivity.
Background evidence summaries (major themes):
• Dermatologic/pre-malignant skin lesions: multiple systematic reviews and RCTs report PDT efficacy for Bowen disease (pooled clearance ~76%) and more limited/heterogeneous results for cutaneous SCC (pooled clearance ~51%) and nodular BCC (higher recurrence vs excision but better cosmetic outcomes).
• Wound healing and antimicrobial effects: systematic reviews of human and animal studies suggest PDT can reduce bacterial counts, stimulate fibroblasts and collagen, and accelerate healing, but data are heterogeneous and largely from small or preclinical studies.
• Endodontic/periodontal infections and peri-implant disease: multiple meta-analyses and systematic reviews report mixed or limited benefit of adjunctive antimicrobial PDT (aPDT) with some short-term microbial load reductions and small clinical gains; high heterogeneity and limited high-quality RCTs.
• Cervical intraepithelial neoplasia/HPV: meta-analysis of RCTs showed increased complete response and HPV clearance with PDT (ORs reported) but overall evidence quality rated very low and higher adverse event rates were observed.
• Oral leukoplakia and other oral premalignant lesions: systematic reviews indicate PDT may be useful as a non-surgical option with variable complete/partial response rates and need for standardized PDT parameters and more RCTs.
• Ophthalmologic indications (e.g., chronic central serous chorioretinopathy, wet AMD combinations): trials/meta-analyses show short-term benefits (e.g., reduced subretinal fluid, fewer injections when combined therapy used) but mixed effects on vision outcomes and limited long-term data.
• Actinic cheilitis and other cutaneous precancerous conditions: case series and systematic reviews report clinical responses with variable histologic cure; daylight-PDT may be better tolerated; evidence limited and heterogeneous.
• Other indications (lichen sclerosus, herpes labialis, dyspigmentation/photoaging/scarring, chronic rhinosinusitis, SARS-CoV-2 inactivation, peritoneal carcinomatosis, mesothelioma, brain tumors, extra-mammary Paget's disease, peri-implantitis): substantial literature exists but consists largely of small studies, case series, or preclinical data; many uses remain investigational with predominantly low-quality, heterogeneous evidence and a need for larger, well-designed RCTs.
| Study / Topic | Key finding |
|---|---|
| Ortner et al (2003) RCT for cholangiocarcinoma | |
| PDT + stenting prolonged median survival: 493 days vs 98 days (p < 0.0001) | |
| Zoepf et al (2005) RCT (phase IIb) for cholangiocarcinoma | |
| Median survival 21 months with PDT vs 7 months control (p = 0.0109); higher cholangitis rate in PDT group | |
| Rhodes et al (2007) RCT MAL-PDT vs excision for nodular BCC | |
| 5-year recurrence 14% MAL-PDT vs 4% excision; cosmetic outcomes better with PDT | |
| Zhang 2018 meta-analysis (CIN/HPV pooled ORs) | |
| PDT increased complete response: OR 2.51 for CIN and OR 3.82 for HPV; higher AE rate (OR 13.32); overall evidence very low | |
| Yongpisarn 2022 pooled clearance (Bowen disease / cSCC) | |
| Pooled clearance: Bowen disease 76% (95% CI: 71%–80%); cutaneous SCC 51% (95% CI: 35%–66%) | |
| References count: 163+ |
Definitions
Definitions:
PDT — Photodynamic therapy: light-based therapy following administration of a photosensitizing agent to induce localized tissue necrosis or antimicrobial effect.
Revision History
Policy effective date as listed in the Clinical Policy Bulletin.
Most recent policy review date listed in the Clinical Policy Bulletin.
Next scheduled policy review date as listed in the Clinical Policy Bulletin.
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