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Photodynamic therapy (PDT), also called phototherapy, photoradiotherapy, photosensitizing therapy, or photochemotherapy, is an ablative treatment consisting of administration of a photosensitizing agent and subsequent exposure of tumor cells to a light source of a specific wavelength to induce cellular damage. 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 selectivity for tumor cells occurs through a selective retention of photosensitizing agent and selective delivery of light.
PDT has been investigated for use in a wide variety of tumors, including cholangiocarcinoma and esophageal, prostate, bladder, lung, breast, brain (administered intraoperatively), skin, and head and neck cancers. Barrett esophagus also has been treated with PDT.
The esophagus is normally lined by squamous epithelium. Barrett’s esophagus is a condition in which the normal squamous epithelium is replaced by specialized columnar-type epithelium known as intestinal metaplasia, in response to irritation and injury caused by gastroesophageal reflux disease (GERD). Barrett’s esophagus occurs in the distal esophagus, may be of any length, focal or circumferential, and is visualized on endoscopy with a different color than the background squamous mucosa. Confirmation of Barrett’s esophagus requires biopsy of the columnar epithelium and microscopic identification of intestinal metaplasia.
Intestinal metaplasia is a precursor to esophageal adenocarcinoma, and patients with Barrett’s esophagus are at a 40-fold increased risk for developing this disease compared to the general population. Esophageal adenocarcinoma is thought to result from a stepwise accumulation of genetic abnormalities in the specialized epithelium, which results in the phenotypic expression ranging from low-grade dysplasia to high-grade dysplasia to carcinoma. Most patients with nondysplastic Barrett’s esophagus do not progress beyond nondysplasia; the estimted rate of progression is 0.9% per patient, per year. In comparison, the rate of progression from low-grade dysplasia to either high-grade dysplasia or esophageal adenocarcinoma ranges from 0.5%-13.4% per patient per year. Once high-grade dysplasia is present, the risk of developing adenocarcinoma is 2%–10% per patient per year; approximately 40% of patients with high-grade dysplasia on biopsy are found to have associated carcinoma in the resection specimen.
Several different photosensitizing agents have been used: porfimer sodium (Photofrin®), administered intravenously 48 hours before light exposure, and 5-aminolevulinic acid (5-ALA), administered orally 4 to 6 hours before the procedure. ALA is metabolized to protoporyphyrin IX, which is preferentially taken up by the mucosa. Clearance of porfirmer occurs in a variety of normal tissues over 40-72 hours, but tumor cells retain porfimer for a longer period. Laser treatment of Barrett's 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’s 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.
The indications of the U.S. Food and Drug Administration (FDA) label for porfirmer sodium as of June 2011 are as follows:
High-grade dysplasia in Barrett’s esophagus
As of February 2015, oral 5-ALA has not received FDA approval for any indication. Topical 5-ALA is used for the treatment of actinic keratoses. See Dermatologic Applications of Photodynamic Therapy.
This policy only addresses 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 in Plasmapheresis medical policy.
POLICYFor Coding Guidelines see the Anesthesia Coding Policy.
One or more courses of photodynamic therapy may be considered medically necessary for the following oncologic applications:
Other oncologic applications of photodynamic therapy including, but not limited to, other malignancies and Barrett’s esophagus without associated high-grade dysplasia are investigational.
POLICY EXCEPTIONSFor Federal Employee Program (FEP) subscribers only, photodynamic therapy may also be considered medically necessary for treatment of cholangiocarinoma.
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.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY3/1993: 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 cholangiocarinoma.
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.
SOURCESBlue Cross Blue Shield Association policy # 8.01.06
CODE REFERENCEThis 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.