Local Coverage Determination (LCD)

Intraoperative Radiation Therapy

L37779

Expand All | Collapse All

Contractor Information

LCD Information

Document Information

LCD ID
L37779
LCD Title
Intraoperative Radiation Therapy
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL37779
Original Effective Date
For services performed on or after 09/24/2018
Revision Effective Date
For services performed on or after 07/29/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
08/09/2018
Notice Period End Date
09/23/2018
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2022, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, §1862(a)(1)(D) in the case of clinical care items and services provided with respect to research and experimentation.

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §90 X-Ray, Radium, and Radioactive Isotope Therapy

CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.1 General Requirements

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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 <= 2cm (T1 disease)

• 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 <= 2.5 cm

• 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.

Summary of Evidence

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:

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

• 50 years or older

• Invasive ductal carcinoma

• Tumor size <= 2cm (T1 disease)

• Negative margins >= 2mm

• No lymphovascular invasion

• ER positive

• BRCA negative

or

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

• Low or intermediate nuclear grade

• Screen-detected DCIS

• Tumor size <= 2.5 cm

• Negative margins >= 3 mm

Colorectal Cancer

For decades, a treatment for colorectal cancer has been surgical resection. However, recurrence rates post-operatively and mortality are quite high, particularly among rectal carcinomas.11 The use of pre-operative and post-operative adjuvant therapies has been tried to improve outcomes. A large study of externally applied radiation in rectal cancer found that while external beam radiation enhanced outcomes related to the primary cancer, an overall mortality benefit, while present, was attenuated by a rise in the rate of non-rectal cancer related deaths among radiation treated patients. This suggested that benefits of radiation could be improved if the safety of radiation could be enhanced.12  

Intraoperative radiation has been developed as a potential method of delivering a high dose of radiation to a focused area of concern for malignancy, while limiting radiation exposure and toxicity to non-cancer tissue.

There are no large randomized controlled trials (RCTs) of intraoperative radiation in colorectal cancer, and 2 smaller RCTs showed local tumor control, but no 5 year mortality benefit of intraoperative radiation in populations with a large proportion of T3 cancers.13-14 However, a number of non-randomized comparative and non-comparative studies have collectively indicated that IORT provides both enhanced local tumor control and a mortality benefit, particularly in patients with T4 tumors and not unresectable or positive margin tumors.15

NCCN guidelines for the treatment of colon and rectal cancers recommend consideration of intraoperative radiation in patients who have at least 1 of the following characteristics of their cancer16-17:

• T4 tumor

• Recurrent cancer

• Positive or close surgical margins

Soft Tissue Sarcoma

Soft tissue sarcoma is relatively rare, but treatment is difficult. Surgical resection is a mainstay of treatment.18 However, for retroperitoneal sarcomas, which can be quite large and involve numerous anatomic areas, complete resection is often not achievable, and even with complete resection, recurrence rates are still quite high.19 This prompted interest in the use of radiation, which must be applied to a large area near many organs that are potentially quite sensitive to radiation.

This prompted an interest in intraoperative radiation in the treatment of soft tissue sarcomas. There is limited evidence on the use of intraoperative radiation with only a single RCT studying its effect in retroperitoneal sarcomas, which showed a significant reduction in local disease recurrence at 5 years.20 A number of observational studies have also suggested that intraoperative radiation may have a benefit in the treatment of retroperitoneal sarcomas.21

Uterine and Cervical Cancer

The management of uterine and cervical cancer has variation among oncologists, though surgical resection is often an important component in the treatment of endometrial cancer. While no large RCTs exist, smaller studies and observational studies suggest that intraoperative radiation may be an appropriate means of delivering a sufficiently large dose of radiation to involved tissues while sparing healthy tissues of the pelvis in appropriately selected patients with uterine cancer and may be an appropriate treatment option in patients with recurrent cervical cancer.22-24

NCCN guidelines recommend that intraoperative radiation be considered in patients with recurrent tumor burden following external beam radiation or in patients for whom surgical resection by itself would be unlikely to achieve adequate local disease control.25-26

Gastric and gastroesophageal junction cancers

Surgical resection has been a mainstay of treatment for gastric cancer. External beam radiation, when combined with chemotherapy, has been shown to improve survival.27-28 Due to concerns for toxicity, intraoperative radiation has been an area of interest, but data from recent RCTs and trials comparing intraoperative radiation to external beam radiation are lacking. Observational and single-arm studies have not consistently shown that intraoperative radiation provides a clear benefit in relation to well proven treatment options.29

Guidelines from NCCN recommend the use of external beam radiation where radiation is appropriate.30-31

Esophageal cancers

Surgical resection has been a mainstay of treatment for esophageal cancer. External beam radiation in conjunction with chemotherapy has been shown to improve survival and has become an important component of surgically treated esophageal cancers.32-35 However, there is a paucity of high quality research examining the benefits of intraoperative radiation.

Pancreatic Cancer

Most pancreatic cancers are unresectable, and among those that are, the prognosis for 5 year survival is still quite poor. Radiation has been pursued as a way to enhance survival, including IORT. NCCN guidelines explicitly indicate that there is no known role for IORT in pancreatic cancer.36

There have been observational studies employing IORT, but there have been no large RCTs, and the evidence that has been published does not suggest a mortality benefit.29,37 NCCN guidelines note that there is no clearly identified role for intraoperative radiation in the treatment of pancreatic cancer.

Lung Cancer

Surgical treatment is an important component of many patients with non-small cell lung cancer.38-41 However, there is a lack of evidence regarding the use of intraoperative radiation.

Surgical treatment is generally not considered indicated in small cell lung cancer, which would preclude the use of intraoperative radiation. In the subpopulation of patients with small cell lung cancer for whom limited evidence suggests surgery may offer appropriate treatment, there is a paucity of evidence regarding the use of intraoperative radiation.42-43

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

Brain

While whole brain radiation has become a recognized component of high grade gliomas, studies using intraoperative radiation have been limited to small observational studies, with inconsistent results.44-45 While there is a phase I/II trial currently underway, intraoperative radiation for brain cancer is presently an experimental treatment and not reasonable and necessary.46

Analysis of Evidence (Rationale for Determination)

Intraoperative radiation has been studied in a variety of conditions and has been shown to offer specific benefits over alternative radiation delivery methods for some conditions.

In the treatment of breast cancer, evidence supports the use of a single dose of IORT in lieu of a course of external beam radiation to the whole breast in selected women who undergo breast-sparing surgery, producing similar disease recurrence outcomes as whole breast irradiation with potentially less toxicity to healthy tissues and may be an appropriate treatment approach for appropriately selected women.

In colon and rectal cancers, evidence supports the role of intraoperative radiation for reducing local disease recurrence and potentially prolonging life in colon and rectal cancers for which there is significant concern that surgical resection will be incomplete.

Soft tissue sarcomas can be difficult to treat in their entirety surgically, leaving small amounts of malignant tissue, and they may be close to radiation-sensitive tissues. There is evidence that intraoperative radiation may reduce local disease recurrence in these tumors.

For recurrent uterine and cervical cancers, in which there is a role for surgery, and in cancers for which there is a reason to be concerned about surgical resection not getting all malignant tissue, evidence suggests that IORT may have a treatment benefit.

For gastric and esophageal cancers, evidence supports a benefit of treatment regimens using combined external beam radiation and chemotherapy. These findings in conjunction with a lack of data supporting the use of intraoperative radiation, mean that intraoperative radiation is not currently reasonable and necessary in the treatment of gastric cancer and esophageal cancer.

There is a paucity of evidence regarding the use of IORT in the treatment of pancreatic cancer, lung cancer, and brain cancer. At this time, intraoperative radiation for these diagnoses is not considered reasonable and necessary.

General Information

Associated Information

Documentation Requirements

Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to the A/B MAC upon request. 

Any diagnosis submitted must have documentation in the patient’s record to support coverage and medical necessity.

Sources of Information
N/A
Bibliography
  1. Fisher B, Anderson S. Bryant J, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002;347(16):1233-1241.
  2. Veronesi U, Luini A, Del Vecchio M, et al. Radiotherapy after breast-preserving surgery in women with localized cancer of the breast. N Engl J Med. 1993;328(22):1587-1591.
  3. START Trialists Group. The UK standardisation of breast radiotherapy (START) trial B of radiotherapy hypofractionation for treatment of early breast cancer: A randomised trial. Lancet. 2008;371(9618):1098-1107.
  4. Whelan T, MacKenzie R, Julian J, et al. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. Journal of the National Cancer Institute. 2002;94(15):1143-1150.
  5. Whelan TJ, Pignol JP, Levine MN, et al. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010;362(6):513-520.
  6. Njeh CF, Saunders MW, Langton CM. Accelerated partial breast irradiation using external beam conformal radiation therapy: A review. Critical Reviews in Oncology/Hematology. 2012;81(1):1-20.
  7. Vaidya JS, Joseph DJ, Tobias JS, et al. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): An international, prospective, randomised, non-inferiority phase 3 trial. Lancet. 2010;376(9735):91-102.
  8. Vaidya JS, Wenz F, Bulsara M, et al. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-a randomised trial. Lancet. 2014;383(9917):603-613.
  9. Veronesi U, Orecchia R, Maisonneuve P, et al. Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): A randomised controlled equivalence trial. The Lancet Oncology. 2013;14(13):1269-1277.
  10. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Breast Cancer. Accessed 6/22/2021.
  11. Abulafi AM, Williams NS. Local recurrence of colorectal cancer: The problem, mechanisms, management and adjuvant therapy. British Journal of Surgery. 1994;81(1):7-19.
  12. Colorectal Cancer Collaborative Group. Adjuvant radiotherapy for rectal cancer: A systematic overview of 8507 patients from 22 randomised trials. Lancet. 2001;358(9290):1291-1304.
  13. Dubois JB, Bussieres E, Richaud P, et al. Intra-operative radiotherapy of rectal cancer: Results of the French multi-institutional randomized study. Radiotherapy and Oncology. 2011;98(3):298-303.
  14. Masaki T, Takayama M, Matsuoka H, et al. Intraoperative radiotherapy for oncological and function-preserving surgery in patients with advanced lower rectal cancer. Langenbeck's Arch Surg. 2008;393(2):173-180.
  15. Mirnezami R, Chang GJ, Das P, et al. Intraoperative radiotherapy in colorectal cancer: systematic review and meta-analysis of techniques, long-term outcomes, and complications. Surg Oncol. 2013;22(1):22-35.
  16. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colon Cancer. Accessed 6/22/2021.
  17. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Rectal Cancer. Accessed 6/22/2021.
  18. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Soft Tissue Sarcoma. Accessed 6/22/2021.
  19. Storm FK, Mahvi DM. Diagnosis and management of retroperitoneal soft-tissue sarcoma. Ann Surg. 1991;214(1):2-10.
  20. Sindelar WF, Kinsella TJ, Chen PW, et al. Intraoperative radiotherapy in retroperitoneal sarcomas: Final results of a prospective, randomized, clinical trial. Arch Surg. 1993;128(4):402-410.
  21. Windham TC, Pisters PW. Retroperitoneal sarcomas. Cancer Control. 2005;12(1):36-43.
  22. del Carmen MG, McIntyre JF, Goodman A. The role of intraoperative radiation therapy (IORT) in the treatment of locally advanced gynecologic malignancies. The Oncologist. 2000;5(1):18-25.
  23. Dowdy SC, Mariani A, Cliby WA, et al. Radical pelvic resection and intraoperative radiation therapy for recurrent endometrial cancer: Technique and analysis of outcomes. Gynecologic Oncology. 2006;101(2):280-286.
  24. Tran PT, Su Z, Hara W, Husain A, Teng N, Kapp DS. Long-term survivors using intraoperative radiotherapy for recurrent gynecologic malignancies. Int J Radiation Oncology Biol Phys. 2007;69(2):504-511.
  25. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Uterine Neoplasms. Accessed 6/22/2021.
  26. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Cervical Cancer. Accessed 6/22/2021.
  27. Zhang ZX, Gu XZ, Yin WB, Huang GJ, Zhang DW, Zhang RG. Randomized clinical trial on the combination of preoperative irradiation and surgery in the treatment of adenocarcinoma of gastric cardia (AGC)—Report on 370 patients. Int J Radiation Oncology Biol Phys. 1998;42(5):929-934.
  28. Macdonald JS, Smalley SR, Benedetti J, et al. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001;345(10):725-730.
  29. Skandarajah AR, Lynch AC, Mackay JR, Ngan, S, Heriot AG. The role of intraoperative radiotherapy in solid tumors. Ann Surg Oncol. 2009;16(3):735-744.
  30. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Gastric Cancer. Accessed 6/22/2021.
  31. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Esophageal and Esophagogastric Junction Cancers. Accessed 6/22/2021.
  32. Tepper J, Krasna MJ, Niedzwiecki D, et al. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008;26(7):1086-1092.
  33. Cooper JS, Guo MD, Herskovic A, et al. Chemoradiotherapy of locally advanced esophageal cancer: Long-term follow-up of a prospective randomized trial (RTOG 85-01). JAMA. 1999;281(17):1623-1627.
  34. Enzinger PC, Mayer RJ. Esophageal cancer. N Engl J Med. 2003;349(23):2241-2252.
  35. Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013;381(9864):400-412.
  36. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Pancreatic Adenocarcinoma. Accessed 6/22/2021.
  37. Sindelar WF, Kinsella TJ. Studies of intraoperative radiotherapy in carcinoma of the pancreas. Annals of Oncology. 1999;10(Suppl 4):S226-S230.
  38. Scott WJ, Howington J, Feigenberg S, Movsas B, Pisters K. Treatment of non-small cell lung cancer stage I and stage II: ACCP evidence-based clinical practice guidelines. Chest. 2007;132(3 Suppl):234S-242S.
  39. Robinson LA, Ruckdeschel JC, Wagner H, Stevens CW. Treatment of non-small cell lung cancer-stage IIIA: ACCP evidence-based clinical practice guidelines. Chest. 2007;132(3 Suppl):243S-265S.
  40. Jett JR, Schild SE, Keith RL, Kesler KA. Treatment of non-small cell lung cancer, stage IIIB: ACCP evidence-based clinical practice guidelines. Chest. 2007;132(3 Suppl):266S-276S.
  41. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Non-Small Cell Lung Cancer. Accessed 6/22/2021.
  42. Yu JB, Decker RH, Detterbeck FC, Wilson LD. Surveillance epidemiology and end results evaluation of the role of surgery for stage I small cell lung cancer. J Thorac Oncol. 2010;5(2):215-219.
  43. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Small Cell Lung Cancer. Accessed 6/22/2021.
  44. Giordano FA, Abo-Madyan Y, Brehmer S, et al. Intraoperative radiotherapy (IORT)—A resurrected option for treating glioblastoma? Translational Cancer Research. 2014;3(1):94-105.
  45. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Central Nervous System Cancers. Accessed 6/22/2021.
  46. Giordano FA, Brehmer S, Abo-Madyan Y, et al. INTRAGO: Intraoperative radiotherapy in glioblastoma multiforme–A phase I/II dose escalation study. BMC Cancer. 2014;15:992.

NOTE: NCCN is a publicly available website. Please register for free to view the citations in their entirety.

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
07/29/2021 R5

Under CMS National Coverage Policy updated section headings for regulations. Under Coverage Indication, Limitations and/or Medical Necessity revised verbiage in 1st paragraph to read “Therapeutic radiation delivered as defined by this time frame should be coded using the codes in the related billing and coding article.” Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted and defined where appropriate throughout the LCD.

  • Provider Education/Guidance
10/10/2019 R4

This LCD is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Title XVIII of the Social Security Act, §1833(e) was removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Intraoperative Radiation Therapy A56684 article.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

  • Provider Education/Guidance
07/11/2019 R3

All coding located in the Coding Information section has been moved into the related Billing and Coding: Intraoperative Radiation Therapy A56684 article and removed from the LCD.

All verbiage regarding billing and coding under the Associated Information section has been removed and is included in the related Billing and Coding: Intraoperative Radiation Therapy A56684 article. Formatting, punctuation and typographical errors were corrected throughout the LCD. 

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
04/11/2019 R2

Under Summary of Evidence changes were made to citations to reflect AMA citation guidelines. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted and defined where appropriate throughout the LCD. CPT® was inserted throughout the LCD where applicable. 

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
09/24/2018 R1

Under CPT/HCPCS Codes the Group 1 and Group 2 Codes were combined into one group. Under ICD-10 Codes that Support Medical Necessity Group 1: Paragraph added verbiage. Under Group 1:Codes deleted C50.011, C50.012, C50.111, C50.112, C50.211, C50.212, C50.311, C50.312, C50.411, C50.412, C50.511, C50.512, C50.611, C50.612, C50.811, C50.812, C50.911 and C50.912. Under Group 2: Paragraph added the applicable CPT/HCPCS codes and verbiage regarding requirements for coverage for invasive malignancies of the breast. Under Group 2: Codes added Z17.0. The Group 3: Paragraph and Group 3: Codes were added.

  • Provider Education/Guidance
  • Other (Clarification of the LCD)

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
07/23/2021 07/29/2021 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • IORT
  • Radiation Therapy

Read the LCD Disclaimer