Medicare Advantage

Medical Policy

Title:

Photodynamic Therapy (PDT) Using Porfimer Sodium (Photofrin®)

Policy #:

MA07.030c

Policy

In the absence of coverage criteria from applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals, or other Medicare coverage documents, this policy uses internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, and/or regulatory status.

Photodynamic therapy (PDT) using porfimer sodium (Photofrin®) is considered medically necessary and, therefore, covered for any of the following conditions:

Ablation of high-grade dysplasia (HGD) in individuals with Barrett’s esophagus (BE) who do not undergo esophagectomy (surgery to remove the esophagus)
Palliation in individuals with completely obstructing esophageal cancer, or in individuals with partially obstructing esophageal cancer when, in the opinion of the physician, the disease cannot be satisfactorily treated with Nd:YAG laser therapy
Palliation in individuals with unresectable cholangiocarcinoma, when used as an adjunct to biliary stenting
Palliation in individuals with completely or partially obstructing endobronchial non-small-cell lung cancer (NSCLC), including relief of symptoms and reduction of obstruction
Treatment of microinvasive endobronchial NSCLC in individuals for whom surgery and radiotherapy are not indicated
Treatment of low-risk superficial basal cell carcinoma in individuals for whom surgery or radiation therapy is contraindicated or impractical
Treatment of actinic keratoses and low-risk squamous cell carcinoma in situ (Bowen's disease)

All other uses for photodynamic therapy with porfimer sodium (Photofrin®) are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published literature.

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.

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, photodynamic therapy (PDT) using porfimer sodium (Photofrin®) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Photodynamic therapy (PDT) using porfimer sodium (Photofrin®) was approved by the FDA on December 22, 1998.

Description

Photodynamic therapy (PDT) involves the use of a photosensitizing agent and subsequent exposure of tumor cells to a laser light source to induce cellular damage. Porfimer sodium (Photofrin®) is a photosensitizing agent that has been approved by the US Food and Drug Administration (FDA) for the PDT of esophageal and endobronchial tumors and high-grade dysplasia (HGD) in individuals with Barrett’s esophagus (BE). It is chemically designed to have a unique affinity for the neoplastic tissue to be treated. Once introduced into the body, porfimer sodium (Photofrin®) accumulates and is retained in the neoplastic tissue to a greater degree than in normal tissue. The cytotoxic and antitumor actions of porfimer sodium (Photofrin®) depend on light and oxygen. The cancer cells are destroyed once the porfimer sodium (Photofrin®) accumulates in the tumor cells, and those cells are exposed to a nonthermal laser light. The nonthermal laser light can be performed as an endoscopic application or external application depending on the location of targeted cells.

PDT with porfimer sodium (Photofrin®) is a two-stage process. The first stage involves the intravenous injection of porfimer sodium (Photofrin®). lllumination with 630-nm wavelength laser light constitutes the second stage of therapy. This stage begins 40 to 50 hours following the injection. The targeted irradiation of the tissue is calibrated to emit light at a wavelength that corresponds to the drug's absorption peak. This activates the drug, enabling it to locally treat the neoplastic tissue without affecting surrounding normal tissue. A second laser light application may be performed 96 to 120 hours after the porfimer sodium (Photofrin®) injection, preceded by gentle debridement of the residual tumor.

Per the US Food and Drug Administration (FDA) labeling for porfimer sodium (Photofrin®), the treatment of esophageal and endobronchial cancer may warrant a second course of PDT a minimum of 30 days after the initial therapy; up to three courses of PDT (each separated by a minimum of 30 days) can be given. For the ablation of HGD in BE, individuals may receive an additional course of PDT a minimum of 90 days after the initial therapy. Up to three courses of PDT (each injection separated by a minimum of 90 days) can be given to a previously treated segment that still shows HGD, low-grade dysplasia or Barrett’s metaplasia, or to a new segment if the initial Barrett’s segment was more than 7 cm in length.

In addition to the use of porfimer sodium (Photofrin®) in the PDT of esophageal and endobronchial tumors and HGD in individuals with BE, professional literature suggests that as a palliative strategy for inoperable, unresectable cholangiocarcinoma, biliary stenting in combination with PDT using porfimer sodium (Photofrin®) as an adjunct therapy leads to prolongation of survival when compared to stenting alone. Generally, PDT is administered via endoscopy to the tumor mass in the bile ducts. Further treatment with PDT using porfimer sodium (Photofrin®) may be performed in cases of residual tumor in the bile ducts. Further studies of PDT with other treatment combinations are warranted to determine optimal palliation therapy. Currently, adjuvant therapy is not usually recommended outside of clinical trials.

Photodynamic therapy is also recognized as an appropriate medical treatment in published clinical research and in several drug compendia for the treatment of some low-risk nonmelanoma skin cancers. The NCCN Clinical Practice Guidelines in Oncology–Basal Cell Skin Cancer and the NCCN Clinical Practice Guidelines in Oncology–Squamous Cell Skin Cancer note that in individuals with low-risk, superficial basal cell skin cancer, for whom surgery and radiation are contraindicated or impractical, or with squamous cell carcinoma in situ (Bowen's disease) that is low risk, alternative therapies such as topical 5-fluorouracil, topical imiquimod, photodynamic therapy (e.g., aminolevulinic acid [ALA], porfimer sodium), or vigorous cryotherapy may be considered, although the cure rates may be lower than with surgical treatment modalities. The same Squamous Cell Skin Cancer guidelines also recommends PDT (e.g., ALA, porfimer sodium) as an accepted treatment for actinic keratoses (AKs). AKs are premalignant skin lesions that result from damaging ultraviolet sunlight exposure. A small percentage of AKs may develop into squamous cell carcinomas.

Clinical research on the use of photodynamic therapy using porfimer sodium (Photofrin®) in the treatment of other cancers is ongoing, including its use in the treatment of cancers of the brain, prostate, breast, and bladder. Whether photodynamic therapy using porfimer sodium (Photofrin®) has an effect on health outcomes for individuals with those types of cancer has yet to be determined.

References

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Hillemanns P, Petry KU, Soergel P, et al. Efficacy and safety of hexaminolevulinate photodynamic therapy in patients with low-grade cervical intraepithelial neoplasia. Lasers Surg Med. 2014;46(6):456-461.

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Coding

CPT Procedure Code Number(s)

96567, 96570, 96571, 96573

THE FOLLOWING CODE IS USED TO REPRESENT PHOTODYNAMIC THERAPY FOR BASAL CELL CARCINOMA AND SQUAMOUS CELL CARCINOMA:

96999

THE FOLLOWING CODES ARE REPORTED IN CONJUNCTION WITH PHOTODYNAMIC THERAPY APPLIED THROUGH ENDOSCOPY:

31641, 43229, 43270, 43278

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

C15.3 Malignant neoplasm of upper third of esophagus

C15.4 Malignant neoplasm of middle third of esophagus

C15.5 Malignant neoplasm of lower third of esophagus

C15.8 Malignant neoplasm of overlapping sites of esophagus

C15.9 Malignant neoplasm of esophagus, unspecified

C22.0 Liver cell carcinoma

C22.1 Intrahepatic bile duct carcinoma

C22.2 Hepatoblastoma

C22.3 Angiosarcoma of liver

C22.4 Other sarcomas of liver

C22.7 Other specified carcinomas of liver

C22.8 Malignant neoplasm of liver, primary, unspecified as to type

C22.9 Malignant neoplasm of liver, not specified as primary or secondary

C24.0 Malignant neoplasm of extrahepatic bile duct

C24.1 Malignant neoplasm of ampulla of Vater

C24.8 Malignant neoplasm of overlapping sites of biliary tract

C24.9 Malignant neoplasm of biliary tract, unspecified

C34.00 Malignant neoplasm of unspecified main bronchus

C34.01 Malignant neoplasm of right main bronchus

C34.02 Malignant neoplasm of left main bronchus

C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11 Malignant neoplasm of upper lobe, right bronchus or lung

C34.12 Malignant neoplasm of upper lobe, left bronchus or lung

C34.2 Malignant neoplasm of middle lobe, bronchus or lung

C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31 Malignant neoplasm of lower lobe, right bronchus or lung

C34.32 Malignant neoplasm of lower lobe, left bronchus or lung

C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91 Malignant neoplasm of unspecified part of right bronchus or lung

C34.92 Malignant neoplasm of unspecified part of left bronchus or lung

C44.01 Basal cell carcinoma of skin of lip

C44.02 Squamous cell carcinoma of skin of lip

C44.111 Basal cell carcinoma of skin of unspecified eyelid, including canthus

C44.1121 Basal cell carcinoma of skin of right upper eyelid, including canthus

C44.1122 Basal cell carcinoma of skin of right lower eyelid, including canthus

C44.1191 Basal cell carcinoma of skin of left upper eyelid, including canthus

C44.1192 Basal cell carcinoma of skin of left lower eyelid, including canthus

C44.1221 Squamous cell carcinoma of skin of right upper eyelid, including canthus

C44.1222 Squamous cell carcinoma of skin of right lower eyelid, including canthus

C44.1291 Squamous cell carcinoma of skin of left upper eyelid, including canthus

C44.1292 Squamous cell carcinoma of skin of left lower eyelid, including canthus

C44.211 Basal cell carcinoma of skin of unspecified ear and external auricular canal

C44.212 Basal cell carcinoma of skin of right ear and external auricular canal

C44.219 Basal cell carcinoma of skin of left ear and external auricular canal

C44.221 Squamous cell carcinoma of skin of unspecified ear and external auricular canal

C44.222 Squamous cell carcinoma of skin of right ear and external auricular canal

C44.229 Squamous cell carcinoma of skin of left ear and external auricular canal

C44.310 Basal cell carcinoma of skin of unspecified parts of face

C44.311 Basal cell carcinoma of skin of nose

C44.319 Basal cell carcinoma of skin of other parts of face

C44.320 Squamous cell carcinoma of skin of unspecified parts of face

C44.321 Squamous cell carcinoma of skin of nose

C44.329 Squamous cell carcinoma of skin of other parts of face

C44.41 Basal cell carcinoma of skin of scalp and neck

C44.42 Squamous cell carcinoma of skin of scalp and neck

C44.510 Basal cell carcinoma of anal skin

C44.511 Basal cell carcinoma of skin of breast

C44.519 Basal cell carcinoma of skin of other part of trunk

C44.520 Squamous cell carcinoma of anal skin

C44.521 Squamous cell carcinoma of skin of breast

C44.529 Squamous cell carcinoma of skin of other part of trunk

C44.611 Basal cell carcinoma of skin of unspecified upper limb, including shoulder

C44.612 Basal cell carcinoma of skin of right upper limb, including shoulder

C44.619 Basal cell carcinoma of skin of left upper limb, including shoulder

C44.621 Squamous cell carcinoma of skin of unspecified upper limb, including shoulder

C44.622 Squamous cell carcinoma of skin of right upper limb, including shoulder

C44.629 Squamous cell carcinoma of skin of left upper limb, including shoulder

C44.711 Basal cell carcinoma of skin of unspecified lower limb, including hip

C44.712 Basal cell carcinoma of skin of right lower limb, including hip

C44.719 Basal cell carcinoma of skin of left lower limb, including hip

C44.721 Squamous cell carcinoma of skin of unspecified lower limb, including hip

C44.722 Squamous cell carcinoma of skin of right lower limb, including hip

C44.729 Squamous cell carcinoma of skin of left lower limb, including hip

C44.81 Basal cell carcinoma of overlapping sites of skin

C44.82 Squamous cell carcinoma of overlapping sites of skin

C44.91 Basal cell carcinoma of skin, unspecified

C44.92 Squamous cell carcinoma of skin, unspecified

C78.00 Secondary malignant neoplasm of unspecified lung

C78.01 Secondary malignant neoplasm of right lung

C78.02 Secondary malignant neoplasm of left lung

C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct

C78.80 Secondary malignant neoplasm of unspecified digestive organ

C78.89 Secondary malignant neoplasm of other digestive organs

C7A.090 Malignant carcinoid tumor of the bronchus and lung

D00.1 Carcinoma in situ of esophagus

D01.5 Carcinoma in situ of liver, gallbladder and bile ducts

D02.20 Carcinoma in situ of unspecified bronchus and lung

D02.21 Carcinoma in situ of right bronchus and lung

D02.22 Carcinoma in situ of left bronchus and lung

D04.0 Carcinoma in situ of skin of lip

D04.10 Carcinoma in situ of skin of unspecified eyelid, including canthus

D04.111 Carcinoma in situ of skin of right upper eyelid, including canthus

D04.112 Carcinoma in situ of skin of right lower eyelid, including canthus

D04.121 Carcinoma in situ of skin of left upper eyelid, including canthus

D04.122 Carcinoma in situ of skin of left lower eyelid, including canthus

D04.20 Carcinoma in situ of skin of unspecified ear and external auricular canal

D04.21 Carcinoma in situ of skin of right ear and external auricular canal

D04.22 Carcinoma in situ of skin of left ear and external auricular canal

D04.30 Carcinoma in situ of skin of unspecified part of face

D04.39 Carcinoma in situ of skin of other parts of face

D04.4 Carcinoma in situ of skin of scalp and neck

D04.5 Carcinoma in situ of skin of trunk

D04.60 Carcinoma in situ of skin of unspecified upper limb, including shoulder

D04.61 Carcinoma in situ of skin of right upper limb, including shoulder

D04.62 Carcinoma in situ of skin of left upper limb, including shoulder

D04.70 Carcinoma in situ of skin of unspecified lower limb, including hip

D04.71 Carcinoma in situ of skin of right lower limb, including hip

D04.72 Carcinoma in situ of skin of left lower limb, including hip

D04.8 Carcinoma in situ of skin of other sites

D04.9 Carcinoma in situ of skin, unspecified

D09.8 Carcinoma in situ of other specified sites

D09.9 Carcinoma in situ, unspecified

K22.711 Barrett's esophagus with high grade dysplasia

L57.0 Actinic keratosis

HCPCS Level II Code Number(s)

J9600 Injection, porfimer sodium, 75 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA07.030c:

07/09/2025	This policy has been reissued in accordance with the Company's annual review process.
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
07/03/2023	This version of the policy will become effective 07/03/2023. The following CPT codes have been added to this policy: 96567, 96573, 96999 The following ICD-10 Diagnosis Codes codes have been deleted from this policy: C23, D13.0, D37.8, D37.9

07/09/2025

This policy has been reissued in accordance with the Company's annual review process.

01/01/2024

Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.

07/03/2023

This version of the policy will become effective 07/03/2023.

The following CPT codes have been added to this policy:

96567, 96573, 96999

The following ICD-10 Diagnosis Codes codes have been deleted from this policy:

C23, D13.0, D37.8, D37.9

Revisions From MA07.030b:

11/02/2022	This policy has been reissued in accordance with the Company's annual review process.
10/20/2021	This policy has been reissued in accordance with the Company's annual review process.
07/01/2020	This policy has been reissued in accordance with the Company's annual review process.
11/06/2019	The policy has been reviewed and reissued to communicate the Company’s continuing position on Photodynamic Therapy (PDT) Using Porfimer Sodium (Photofrin®).
12/17/2018	The following conditions were added to the policy as Medically Necessary: Treatment of low-risk superficial basal cell carcinoma in individuals where surgery or radiation therapy is contraindicated or impractical Treatment of actinic keratoses and low-risk squamous cell carcinoma in situ (Bowen's disease) The following ICD-10 Diagnosis Codes were added to the policy: C44.01, C44.02, C44.111, C44.1121, C44.1122, C44.1191, C44.1192,C44.1221, C44.1222, C44.1291, C44.1292, C44.211, C44.212, C44.219, C44.221, C44.222, C44.229, C44.310, C44.311, C44.319, C44.320, C44.321, C44.329, C44.41, C44.42, C44.510, C44.511, C44.519, C44.520, C44.521, C44.529, C44.611, C44.612, C44.619, C44.621, C44.622, C44.629, C44.711, C44.712, C44.719, C44.721, C44.722, C44.729, C44.81, C44.82, C44.91, C44.92, D04.0, D04.10, D04.111, D04.112, D04.121, D04.122, D04.20, D04.21, D04.22, D04.30, D04.39, D04.4, D04.5, D04.60, D04.61, D04.62, D04.70, D04.71, D04.72, D04.8, D04.9, D09.8, D09.9, L57.0

Revisions From MA07.030a:

06/21/2017	This policy has been reissued in accordance with the Company's annual review process.
03/02/2016	The policy has been reviewed and reissued to communicate the Company’s continuing position on Photodynamic Therapy (PDT) using Porfimer Sodium (Photofrin®).
07/01/2015	The policy has been reviewed and reissued to communicate the Company’s continuing position on Photodynamic Therapy (PDT) using Porfimer Sodium (Photofrin®).

Revisions From MA07.030:

01/01/2015

This is a new policy.

Version Effective Date:

1/1/2024

Version Issued Date: