Oncologic Applications of Photodynamic Therapy, Including Barrett Esophagus

POLICY NUMBER

A.8.01.06

DESCRIPTION

Photodynamic therapy (PDT; also called phototherapy, photoradiotherapy, photosensitizing therapy, or photochemotherapy) is an ablative treatment that uses a photosensitizing agent to expose tumor cells to a light source of a specific wavelength for the purpose of damaging the cells. After administration of the photosensitizing agent, the target tissue is exposed to light using a variety of laser techniques. For example, a laser fiber may be placed through the channel of the endoscope, or a specialized modified diffuser may be placed via fluoroscopic guidance. Treatment for tumor cells occurs through selective retention of the photosensitizing agent and selective delivery of light.

Photodynamic Therapy

Photodynamic therapy (PDT) has been investigated for use in a wide variety of tumors, including esophageal, lung, cholangiocarcinoma, prostate, bladder, breast, brain (administered intraoperatively), skin, and head and neck cancers. Barrett esophagus also has been treated with PDT. PDT for focal treatment of prostate cancer is discussed in the Focal Treatments of Prostate Cancer medical policy.

Several photosensitizing agents have been used in PDT: porfimer sodium (Photofrin®), administered intravenously 48 hours before light exposure, and 5-aminolevulinic acid, administered orally 4 to 6 hours before the procedure. Aminolevulinic acid is metabolized to protoporphyrin IX, which is preferentially taken up by the mucosa. Clearance of porfirmer occurs in a variety of normal tissues over 40 to 72 hours, but tumor cells retain porfimer for a longer period. Laser treatment of Barrett esophagus may be enhanced by the use of balloons containing a cylindrical diffusing fiber. The balloon compresses the mucosal folds of the esophagus, thus increasing the likelihood that the entire Barrett mucosa is exposed to light. All patients who receive porfimer become photosensitive and must avoid exposure of skin and eyes to direct sunlight or bright indoor light for 30 days.

Labeled indications for porfirmer sodium (Photofrin; Pinnacle Biologics), as approved by the U.S. Food and Drug Administration (FDA), are as follows.

Esophageal Cancer

• Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with neodymium-doped yttrium aluminum garnet laser therapy.

Endobronchial Cancer

• Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non-small-cell lung cancer (NSCLC).

• Treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated.

High-Grade Dysplasia in Barrett Esophagus

• Treatment of high-grade dysplasia in Barrett esophagus patients who do not undergo esophagectomy.

As of June 2025, oral 5-aminolevulinic acid has not received FDA approval as a photosensitizing agent for PDT. It is currently only indicated as an adjunct for the visualization of malignant tissue during surgery in individuals with glioma. Topical 5-aminolevulinic acid, used for the treatment of actinic keratosis, is addressed separately. See Dermatologic Applications of Photodynamic Therapy.

This policy only addresses only the nondermatologic oncology applications of photodynamic therapy and does not address its use in dermatologic applications, such as actinic keratosis and superficial basal cell cancer, or age-related macular degeneration. In addition, photodynamic therapy should not be confused with extracorporeal photopheresis, which involves withdrawing blood from the patient, irradiating it with ultraviolet light, and then returning the blood to the patient. Extracorporeal photopheresis is addressed separately.

POLICY

For Coding Guidelines see the Anesthesia Coding Policy.

One or more courses of photodynamic therapy may be considered medically necessary for the following oncologic applications:

• palliative treatment of obstructing esophageal cancer

• palliative treatment of obstructing endobronchial lesions

• treatment of early-stage non-small-cell lung cancer in individuals who are ineligible for surgery and radiotherapy

• treatment of high-grade dysplasia in Barrett esophagus

• palliative treatment of unresectable cholangiocarcinoma when used with stenting.

Other oncologic applications of photodynamic therapy are investigational including, but not limited to, other malignancies and Barrett esophagus without associated high-grade dysplasia.

POLICY EXCEPTIONS

For Federal Employee Program (FEP) subscribers only, photodynamic therapy may also be considered medically necessary for treatment of cholangiocarcinoma.

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.

Focal therapy using photodynamic therapy for individuals with localized prostate cancer is addressed in the Focal Treatments for Prostate Cancer medical policy.

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

3/1993: Approved by Medical Policy Advisory Committee (MPAC).

2/1998: Revision approved by MPAC.

11/14/2001: Hyperlink inserted.

2/14/2002: Investigational definition added.

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

5/29/2002: Code Reference section updated, non-covered ICD-9 diagnosis code 140-145.9, 151.0-153.9, 170.0, 170.1, 171.0, 173.0-173.9, 174.0-174.9, 175.0-175.9, 185, 188.0-188.9, 190.0-190.9, 191.0-191.9, 192.0-192.9, 195.0, 196.0, 197.4, 197.5, 197.8, 198.2, 198.3, 198.81, 198.82, 198.89, 230.0, 230.2, 230.3, 230.7, 230.9, 231.8, 232.0-232.9, 233.0, 233.3, 233.4, 233.5, 233.6, 233.7, 234.0, 234.8 added.

3/25/2004: Reviewed by MPAC, PDT for Barrett's esophagus remains investigational, Policy title "Photodynamic Therapy" renamed "Oncologic Applications of Photodynamic Therapy, Including Barrett’s Esophagus," Description section revised to be consistent with BCBSA policy 8.01.06, Policy Exceptions added, Sources updated.

5/19/2004: Code Reference section updated, CPT code 31641, 43228 description revised, CPT code range 150.0-150.9, 162.2-162.9 listed separately, ICD-9 diagnosis code 230.1 deleted from covered codes, non-covered table deleted, ICD-9 diagnosis code 140-145.9, 151.0-153.9, 170.0, 170.1, 171.0, 173.0-173.9, 174.0-174.9, 175.0-175.9, 185, 188.0-188.9, 190.0-190.9, 191.0-191.9, 192.0-192.9, 195.0, 196.0, 197.4, 197.5, 197.8, 198.2, 198.3, 198.81, 198.82, 198.89, 230.0, 230.2, 230.3, 230.7, 230.9, 231.8, 232.0-232.9, 233.0, 233.3, 233.4, 233.5, 233.6, 233.7, 234.0, 234.8 deleted from non-covered.

8/3/2007: Policy reviewed, no changes.

7/18/2008: Anesthesia Coding Policy hyperlink added.

12/19/2008: Policy reviewed, no changes.

12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions.

04/26/2010: Policy description updated regarding disease prevalence and treatment approaches. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section.

06/22/2011: Policy reviewed; no changes.

04/26/2012: Policy reviewed; policy statement unchanged. Policy exception revised regarding FEP subscribers to state that photodynamic therapy may also be considered medically necessary for treatment of cholangiocarcinoma.

08/07/2013: Policy reviewed; no changes.

05/07/2014: Policy reviewed; description updated regarding indications of the FDA label for porfirmer sodium. Policy statement unchanged.

04/22/2015: Policy reviewed; description updated. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigational definitions.

08/28/2015: Medical policy revised to add ICD-10 codes. Removed CPT code 43228 and ICD-9 procedure code 99.83 from the Code Reference section. Added ICD-9 diagnosis code 230.1.

05/25/2016: Policy number added.

12/15/2017: Policy description updated regarding obstructing tumors, early-stage lung cancer, and cholangiocarcinoma. Policy statement updated to change "radiation therapy" to "radiotherapy" and to add "palliative treatment of unresectable cholangiocarcinoma when used with stenting" as medically necessary. Code Reference section updated to add ICD-10 diagnosis code C22.1.

08/13/2018: Policy description updated regarding early-stage lung cancer and treatment of Barrett Esophagus. Policy statements unchanged.

05/15/2019: Code Reference section updated to replace deleted CPT code 43228 with 43229.

08/15/2019: Policy description revised. Policy statements unchanged.

08/19/2020: Policy reviewed; no changes.

08/31/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

08/11/2022: Policy description updated. Policy statements unchanged.

08/10/2023: Policy description updated. Policy statement updated to change "patients" to "individuals."

08/14/2024: Policy description updated regarding oral 5-ALA. Policy statements unchanged.

09/12/2025: Policy description updated. Policy statements unchanged. Policy Guidelines updated regarding focal therapy.

SOURCE(S)

Blue Cross Blue Shield Association policy # 8.01.06

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.

For Coding Guidelines see the Anesthesia Coding Policy.

Covered Codes

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