Description/Background
The FDA has approved hyperthermia in combination with radiation therapy for the “palliative management of certain solid surface and subservice malignant tumors (i.e., melanoma, squamous or basal cell tumors, adenocarcinoma, or sarcoma) that are progressive or recurrent despite conventional radiation therapy." The National Cancer Center Network recommends “that the use of hyperthermia be limited to treatment centers with appropriate training, expertise and equipment.” 

Overview
(Adapted from the National Cancer Institute, Hyperthermia in Cancer Treatment, 2011) 

Hyperthermia is a treatment for cancer in which body tissue is exposed to high temperatures. Research has shown that hyperthermia can damage and kill cancer cells in some circumstances when it is used with radiation therapy.

Local hyperthermia — Heat is applied to a small area only. Local hyperthermia is typically administered every 72 hours (i.e., twice a week) for a total of 10 to 12 treatments using applicators that are placed close to, or in, the tumor. Local hyperthermia can be administered using various techniques: external, intraluminal or endocavitary, and interstitial. 

• External hyperthermia — This technique is used for cancers that are on, or just below, the skin. The tumor is heated externally using applicators that are placed on, or near to, the affected area. Heat is then applied using high-frequency energy waves generated from a device outside the body (such as a microwave or ultrasound).
• Intraluminal or endocavitary hyperthermia — This technique may be used to treat cancers that are within or near to body cavities. A sterile probe that can be heated is placed inside the cavity where the tumor is. This heats the affected area.
• Interstitial hyperthermia — This is used to treat tumors that are deep within the body. Under anesthetic, probes or wires are placed within the tumor tissue and then heated. This method allows tumors to be heated to a higher temperature than external techniques.

Regional hyperthermia — Various approaches may be used to heat large areas of tissue, such as a body cavity, organ or limb. This includes all of the following: 

• Deep tissue — This may be used to treat cancers within the body, such as cervical or bladder cancer. External applicators are positioned around the body cavity or organ to be treated, and microwave or radiofrequency energy is focused on the area to raise its temperature.
• Regional perfusion — In this procedure, some of the patient’s blood is removed, heated, and then perfused back into the limb or organ.
• Continuous hyperthermic peritoneal perfusion (CHPP) — This is a technique used to treat cancers within the peritoneal cavity. During surgery, heated chemotherapy drugs flow from a warming device through the peritoneal cavity. The peritoneal cavity temperature reaches 106° – 108° F.

Whole-body hyperthermia — Used to treat metastatic cancer. This can be accomplished by several techniques that raise the body temperature to 107° – 108° F, including the use of thermal chambers or hot water blankets. 

Additional Terminology
Hyperthermia is also called thermal therapy or thermotherapy.

Policy 
Indications for Hyperthermia With Radiation Therapy

• Superficially recurrent melanoma (Overgaard, 1995)
• Chest wall recurrence of breast cancer (NCCN, 2018)
• Recurrent cervical lymph nodes from head and neck cancer (Huilgol, 2010)

Frequency of procedure
A maximum of 10 hyperthermia treatments may be delivered two times per week at 72-hour intervals. 

Contraindications for Hyperthermia

• The use of intraluminal, endocavitary, interstitial, regional deep tissue hyperthermia exceeding 4 cm. in depth and whole body hyperthermia is considered investigational/unproven and therefore NOT MEDICALLY NECESSARY.
• There cannot be any evidence of depth of tumor recurrence greater than 4 cm.
• There can be no evidence of metastatic disease for which systemic chemotherapy or hormonal therapy is planned or being given. 

NOTE: Hyperthermia is not approvable when used alone. 

References  

1. American Cancer Society (ACS).  Hyperthermia to Treat Cancer.  Accessed May 16, 2016 http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/hyperthermia. 
2. American College of Radiology (ACR) / American Society of Radiation Therapy (ASTRO) Coding Guide. https://www.astro.org/Practice-Management/Radiation-Oncology-Coding/Index.aspx. Accessed October 14, 2015. 
3. American College of Radiology (ACR) / American Society of Radiation Therapy (ASTRO) Practice Parameter for Radiation Oncology. https://www.acr.org/-/media/ACR/Files/Practice-Parameters/radonc.pdf. Revised 2014. Accessed May 1, 2018.  
4. American Society of Clinical Oncology (ASCO). Using Hyperthermia for Cancer Treatment: Proofs, Promises, and Uncertainties.  http://www.ascopost.com/issues/january-15-2014/using-hyperthermia-for-cancer-treatment-proofs-promises-and-uncertainties/. Accessed May 16, 2016. 
5. Centers for Medicare and Medicaid Services (CMS). Hyperthermia for Treatment of Cancer. National Coverage Determination (NCD) 110.1. http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx. Accessed October 14, 2015. 
6. Department of Health and Human Services (HHS).  Letter: Conditions of Approval For An HDE.  HUD and HDE for BSD-2000. http://www.accessdata.fda.gov/cdrh_docs/pdf9/H090002a.pdf. Accessed October 14, 2015. 
7. Dooley WC, Vargas HI, Fenn AJ, et al. Focused microwave thermotherapy for preoperative treatment of invasive breast cancer: A review of clinical studies. [Published online ahead of print December 22, 2009]. Ann Surg Oncol. April 2010; 17(4):1076-1093.
8. Feldman AL, Libutti SK, Pingpank JF, et al. Analysis of factors associated with outcome in patients with malignant peritoneal mesothelioma undergoing surgical debulking and intraperitoneal chemotherapy. J Clin Oncol. 2003; 21(24):4560-4567.
9. Gardner RA, Vargas HI, Block JB, et al. Focused microwave phased array thermotherapy for primary breast cancer. Ann Surg Oncol. May 2002; 9(4):326-332.
10. Hildebrandt B, Wust P, Ahlers O, et al. The cellular and molecular basis of hyperthermia. Crit Rev Oncol Hematol. 2002; 43(1):33-56.
11. Huilgol NG, Gupta S, Sridhar CR. Hyperthermia with radiation in the treatment of locally advanced head and neck cancer: A report of randomized trial. J Cancer Res Ther. October-December 2010; 6(4):492-496.
12. Jones EL, Oleson JR, Prosnitz LR, et al. Randomized trial of hyperthermia and radiation for superficial tumors.  J Clin Oncol. May 1, 2005; 23(13):3079-3085. 
13. Kiel KD, Refaat T, Navanandan N, et al. Breast cancer - local-regional and adjuvant therapy. J Clin Oncol. 2009; 27:15Suppl. 
14. Linthorst M, Van Rhoon GC, Van Geel AN, et al. The tolerance of reirradiation and hyperthermia in breast cancer patients with reconstructions. Int J Hyperthermia. 2012; 28(3):267-277. 
15. Muller AC, Eckert F, Heinrich V, et al. Re-surgery and chest wall re-irradiation for recurrent breast cancer - a second curative approach. BMC Cancer. May 25, 2011; 11(1):197. 
16. National Cancer Institute (NCI).  Hyperthermia in Cancer Treatment.  http://www.cancer.gov/about-cancer/treatment/types/surgery/hyperthermia-fact-sheet. Reviewed August 31, 2011. Retrieved May 16, 2016. 
17. National Comprehensive Cancer Network (NCCN).  Breast Cancer Version 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Retrieved May 1, 2018. 
18. Oldenborg S. Elective re-irradiation and hyperthermia following resection of persistent locoregional recurrent breast cancer: A retrospective study. Int J Hyperthermia. January 1, 2010; 26(2):136-144. 
19. Overgaard J, Gonzalez Gonzalez D, Hulshof MC, et al. Randomised trial of hyperthermia as adjuvant to radiotherapy for recurrent or metastatic malignant melanoma. European Society for Hyperthermic Oncology. Lancet. March 4, 1995; 345(8949):540-543.  http://www.ncbi.nlm.nih.gov/pubmed/7776772. Accessed July 7, 2016. 
20. Pyrexar Medical. BSD-2000 Brochure. http://hyperthermia.pyrexar.com/acton/attachment/15060/f-0001/1/-/-/l-0001/l-0001:4a/BSD-2000_brochure.pdf. Accessed October 14, 2015. 
21. Pyrexar Medical. BSD-500 Brochure. http://hyperthermia.pyrexar.com/acton/attachment/15060/f-0002/1/-/-/l-0001/l-0001:4a/BSD-500_brochure.pdf. Accessed October 14, 2015. 
22. Singletary SE. Minimally invasive ablation techniques in breast cancer treatment. Ann Surg Oncol. 2002 May; 9(4):319-20.
23. Van Der Zee J. Heating the patient: A promising approach? Ann Oncol. 2002; 13(8):1173-1184.
24. Vargas HI, Dooley WC, Gardner RA, et al. Focused microwave phased array thermotherapy for ablation of early-stage breast cancer: results of thermal dose escalation. Ann Surg Oncol. February 2004; 11(2):139-146. 
25. Vernon CC, Hand JW, Field SB, et al. Radiotherapy with or without hyperthermia in the treatment of superficial localized breast cancer: Results from five randomized controlled trials. International Collaborative Hyperthermia Group.  Int J Radiat Oncol Biol Phys. July 1, 1996; 35(4):731-744. 
26. Vlastos G, Verkooijen HM. Minimally invasive approaches for diagnosis and treatment of early -stage breast cancer. Oncologist. 2007; 12(1):1-10.
27. Wust P, Hildebrandt B, Sreenivasa G, et al. Hyperthermia in combined treatment of cancer. Lancet Oncol. August 2002; 3(8):487-497.
28. Zagar TM, Higgins KA, Miles EF, et al. Durable palliation of breast cancer chest wall recurrence with radiation therapy, hyperthermia, and chemotherapy. Radiother Oncol. December 2010; 97(3):535-540. 
29. Zhao Z, Wu F. Minimally-invasive thermal ablation of early-stage breast cancer: A systemic review. Eur J Surg Oncol. December 2010; 36(12):1149-1155.

Coding Section

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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