LCD L37779: Intraoperative Radiation Therapy

Definitions and Scope:

This policy addresses intraoperative radiation for the treatment of cancer. Intraoperative radiation for the purposes of this Local Coverage Determination (LCD) is any method of radiation administered to the patient in the operating room (OR), such that the initiation of radiation exposure begins following the surgical exposure of the tumor or tumor bed, and the cessation of radiation exposure occurs prior to the patient leaving the OR. This includes radiation that is delivered by a beam from a device or placement of a radioactive material in tissues. Therapeutic radiation delivered as defined by this time frame should be coded using the codes in the related billing and coding article. Therapies termed “brachytherapy” in the medical literature that involve removal of the radiation source prior to the patient leaving the OR should be considered “intraoperative radiation” rather than “brachytherapy” for the purposes of this LCD.

This policy does not address general diagnosis or management of malignancies, nor does it address specific surgical or chemotherapy treatments. Radiation delivered outside of the OR and brachytherapy are not specifically covered here either.

Background:

For many cancers, surgical resection is an established method to either achieve a prolongation of life or a cure. Radiation delivered in conjunction with surgery improves outcomes for some types of cancer presumably through its ability to reduce tumor volume, kill grossly visible neoplastic tissue that was not resected due to technical infeasibility, and destroy microscopic foci of cancer surrounding the known tumor site. However, radiation is toxic not only to the neoplastic but also to healthy tissues, and in some cases mortality benefits due to cancer related deaths appear to be attenuated by non-cancer related mortality from complications of radiation to healthy tissue. Intraoperative radiation has been posed as a radiation delivery method that allows providers to deliver a large dose of radiation focally to the tumor bed, thereby aggressively treating the tumor but sparing healthy tissues.

General Indications and Principles

• Surgical resection of the tumor must be reasonable and necessary for the treatment of the patient’s malignancy based on all available information at the time that the decision to put the patient through surgery is made. As such, the medical record should reflect that surgical resection was indicated. Palmetto GBA recognizes that intraoperative findings may change the course of treatment, and resection may not be carried out or completed in such cases.

• Surgery strictly for the sake of delivery of intraoperative radiation is not supported by the evidence and is not considered reasonable and necessary.

• This LCD is not intended to provide recommendations regarding treatment. Radiation treatment should be reasonable and necessary for a patient’s individual case, in light of that patient’s cancer diagnosis and cancer stage or grade, as well as the patient’s comorbid clinical conditions.

• The choice of radiation dose and areas to irradiate should be derived from evidence-based treatment protocols. The relevant evidence should be on hand for review if requested.

• Radiation treatment planning and delivery should be handled by an experienced and qualified team with the necessary knowledge and skills to ensure that appropriate precautions are taken to protect the patient, healthcare providers, and the public from the hazards of radiation in the OR environment. The relevant professionals with such skills and knowledge who are involved in the case must be documented. All federal, state, and local laws governing the use and handling of radiation must be followed.

General Procedure Requirements:

• Pre-procedural documentation must include a complete initial evaluation, including history and an appropriately focused physical examination with review of relevant pathology and imaging results. Treatment plans formulated in conjunction with other providers (e.g., medical oncologist, surgeon, tumor board, etc.) should be included if these discussions support that the procedure is reasonable and necessary.

• A procedure note must be legible and include sufficient detail to allow reconstruction of the procedure. Required elements of the note include a description of the mode of radiation delivered, anatomic sites to which it is delivered, dose of radiation (in Gray), as well as any necessary pre- and post-procedural assessments. This note must have a legible signature, time, and date.

Information pertaining to specific malignancies based on anatomic location and tissue type

Breast Cancer

Intraoperative Radiation Therapy (IORT) in breast cancer should be used only in patients in whom there is a reasonable expectation at the time of surgery that Accelerated Partial Breast Irradiation (APBI) may be appropriate. Even in patients who meet these criteria, clinicians should provide appropriate informed consent regarding the fact that whole breast irradiation is still considered standard treatment. Palmetto GBA considers patients to be appropriate for APBI based on the criteria set forth by the National Comprehensive Cancer Network (NCCN) to describe candidacy for use of APBI outside of a clinical trial. These criteria are as follows:

1. A woman who meets all of the following criteria:

• 50 years or older

• Invasive ductal carcinoma

• Tumor size

• Negative margins >= 2mm

• No lymphovascular invasion

• Estrogen receptor (ER) positive

• BRCA negative

or

2. A woman who meets all of the following criteria:

• Low or intermediate nuclear grade

• Screen-detected ductal carcinoma in situ (DCIS)

• Tumor size

• Negative margins >= 3 mm

Palmetto GBA recognizes that new findings following surgery, including but not limited to final pathology results, may be found, and that based on such findings the patient would be determined not to be a suitable candidate based on the above criteria after the IORT dose has already been given. As long as information is available at the time of surgery that indicates it is reasonable to expect that the patient did meet the above criteria, IORT may still be considered reasonable and necessary. If further radiation treatment is deemed necessary based on the new information learned after IORT is given, further radiation should be provided as clinically appropriate.

Intraoperative radiation is not considered reasonable and necessary in women who undergo a complete or a radical mastectomy.

Colon and Rectal Cancer

Intraoperative radiation for colon cancer may be reasonable and necessary in patients who warrant surgical resection and at least 1 of the following:

• T4 tumor

• Recurrent cancer

• Positive or close surgical margins

Intraoperative radiation may be given as a boost dose in conjunction with pre- or post-operative external beam radiation.

Soft Tissue Sarcoma

Intraoperative radiation may be considered reasonable and necessary in the treatment of soft tissue sarcomas for which there is a substantial risk that surgical resection will be insufficient to avoid local recurrence because of the tumor’s location, surrounding anatomy, or other technical aspects of the procedure which may limit surgical effectiveness.

Uterine and Cervical Cancer

Intraoperative radiation may be considered reasonable and necessary in patients with recurrent tumor burden following external beam radiation. Intraoperative radiation may also be considered reasonable and necessary in patients without metastatic disease for whom surgical resection by itself would be unlikely to achieve adequate local disease control.

Gastric and Gastroesophageal Junction Cancer

Intraoperative radiation is not currently considered reasonable and necessary in the treatment of gastric and gastroesophageal junction cancers.

Pancreatic Cancer

Intraoperative radiation is not currently considered reasonable and necessary in the treatment of pancreatic cancer.

Esophageal Cancer

Intraoperative radiation is not currently considered reasonable and necessary in the treatment of esophageal cancer.

Lung Cancer

Intraoperative radiation is not currently considered reasonable and necessary in the treatment of lung cancer.

Brain Cancer

Intraoperative radiation is not currently considered reasonable and necessary in the treatment of brain cancer.

Breast Cancer

For many women with breast cancer, surgical resection is an important component of treatment. This resection may involve either mastectomy or breast-conserving therapy (BCT) depending on the tumor histology and disease stage. For some women, breast conserving surgery in conjunction with radiation may offer similar cancer-related outcomes as mastectomy. 1-5 The standard of treatment has conventionally been post-operative external beam whole breast radiation delivered over roughly 3 weeks. However, APBI has started to gain interest as a possible therapeutic approach that may increase accessibility of adequate radiation treatment and BCT to women. 6 Intraoperative radiation in breast cancer is among potential APBI delivery methods.

Initial research has provided some evidence that IORT may be non-inferior to and equivalent to whole breast irradiation in women who have had BCT with regards to tumor recurrence, potentially offering reduced radiation toxicity. 7-9 However, whole breast irradiation is still considered the standard treatment option per NCCN guidelines.

NCCN guidelines generally consider APBI including IORT experimental and recommend its use in clinical trials. But note that it may be appropriate for women who meet specific criteria. 10 These criteria are as follows: