BlueCross and BlueShield of Montana Medical Policy/Codes
Hyperthermia (Superficial/Local and Whole Body)
Chapter: Therapies
Current Effective Date: October 25, 2013
Original Effective Date: October 25, 2013
Publish Date: October 25, 2013
Description

Hyperthermia is a procedure in which body tissue is exposed to high temperatures between 106° to 108° Fahrenheit (F). Scientists think that heating tumor beds might enhance cell kill using drugs or radiation. The administration of hyperthermia is based upon the location of malignant cells or tumors and is used with other forms of therapy such as radiation, chemotherapy or biological (e.g., monoclonal antibodies). The best results with hyperthermia in conjunction with radiation therapy are seen in lesions measuring 3 cm or less in diameter. In addition, patients with widespread metastatic disease are not likely to benefit from local hyperthermia.

Hyperthermia can be administered using local and whole body techniques. Local hyperthermia entails elevating the temperature of superficial or subcutaneous tumors while sparing surrounding normal tissue. Whole body hyperthermia requires the patient to be placed under either general anesthesia or deep sedation. The patient’s body temperature is increased to 108° F by packing the patient in heated (hot water) blankets. The elevated body temperature is maintained for a period of 4 hours, while the essential body functions are closely monitored. Approximately 1 hour is required for a cooling off period after which the patient is continuously observed for approximately 12 hours. This modality has been termed “systemic thermotherapy” or “whole body hyperthermia.”

Hyperthermia is typically administered every 72 hours (i.e., twice a week) for a total of 10 to 12 treatments   This treatment schedule is based on “thermobiologic” principles; specifically, thermotolerance develops over eight to ten hours after treatment and subsides over the next 60 to 100 hours.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Superficial or local hyperthermia may be considered medically necessary when used in combination with radiation therapy for the treatment of patients with primary or metastatic cutaneous or subcutaneous superficial tumors.

Superficial or local hyperthermia is considered experimental, investigational and unproven when used alone or in combination with chemotherapy.

Whole body hyperthermia therapy is considered experimental, investigational and unproven.

Rationale

The use of hyperthermia as an adjunct to radiation or chemotherapy treatment of superficial tumors has been an area of active research for the past 20 years, in part due to improvements in instrumentation and temperature monitoring techniques, as well as an increasing understanding of the biology of hyperthermia. One of the first randomized trials of hyperthermia was reported by Overgaard, who randomized 71 patients with superficial melanoma to receive either radiation therapy or combined radiation and hyperthermia. The combined treatment group reported a 46% complete response rate compared to 28% in the radiation only group. (1)

In 1991, Perez and colleagues reported on the results of a study that randomized 236 patients with superficial tumors measuring less than 5 cm in thickness to receive either radiation alone, or radiation in conjunction with hyperthermia. (2) The major endpoints for the study were the initial tumor response, its continuous control, and treatment delivery. The overall complete response rate was not different between the 2 groups (30%–32%). However, when the treatment comparisons were made by the size of the lesion in the patients with lesions <3 cm in diameter, the difference in local control was significantly better for patients assigned to the combined treatment group (50% vs. 39%).

In 1996, the International Collaborative Hyperthermia Group reported on the outcomes of a trial that focused on hyperthermia treatment of superficial breast cancer. (3) A total of 306 patients with advanced primary or recurrent breast cancer were randomized to receive either radiation therapy alone or combined radiation and hyperthermia therapy. The primary endpoint of the trial was complete local control. For those in the combined treatment group, 59% achieved complete local response compared to 41% in the radiation therapy alone group. Similar to the findings of Perez, results were improved in patients with smaller lesions, as indicated by diameter or depth.

Other studies have reported conflicting results. For example, Emami and colleagues reported negative results in a study that randomized 173 patients with persistent or recurrent superficial tumors to receive either interstitial radiation therapy alone, or radiation combined with hyperthermia. (4) In this study, the hyperthermia was administered interstitially, primarily as a technique to provide more uniform heat to the target lesion. There was no difference between the complete response rates in the 2 groups.

There are inadequate data to permit scientific conclusions regarding the use of whole body hyperthermia as an adjunct to either radiation or chemotherapy, and inadequate data regarding the use of local hyperthermia in conjunction with chemotherapy alone.

2004 Update

A literature search of the MedLine database targeted at clinical articles published between 1995 and 2003, found citations describing technical feasibility studies and a few Phases I, II and III studies, but there were no controlled studies reporting on patient outcomes. (5-8) No additional studies were noted that focused on the use of local hyperthermia alone, with chemotherapy or whole body hyperthermia as an adjunct to either radiation or chemotherapy.

2007 Update

A literature search of the MedLine database targeted at clinical articles published between 2002 and 2007 was completed. No studies were found that would alter the position of this policy.

2013 Update

The Radiation Trials Oncology Group (RTOG) has published guidelines outlining quality control criteria for adequate hyperthermia treatment. (8) When the investigators compared these criteria to their data, they found that only 1 patient met the criteria for adequate hyperthermia sessions. The issue of quality assurance and reproducible parameters for delivering hyperthermia has been identified as an obstacle by other authors as well. (2, 9) Identification of the optimal parameters for hyperthermia have also been researched. The majority of the clinical trials describe 8 to12 hyperthermia regimens delivered twice weekly, or every 72 hours. These schedules recognize the phenomenon of thermotolerance, a transient resistance to subsequent heat treatment.

A search of peer reviewed literature through June 2013 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

92.21-92.25, 93.35, 99.85, 171.0-171.9, 173.0-173.9, 198.2, 198.89, 232.2, 239.2

ICD-10 Codes

C44.00-C44.99, C47.0-C47.9, C49.0-C49.9, C79.2-C79.9, D04.20-D04.22, D49.2-D49.9, D0Y07ZZ-DWY67ZZ, D0000ZZ-DW060ZZ, D01097Z-DW1697Z, 6A3Z0ZZ, 6A3Z1ZZ

Procedural Codes: 77600, 77605, 77610, 77615, 77620
References
  1. Overgaard J, Gonzalez Gonzalez D, Hulshof MC et al. Randomized trial of hyperthermia as adjuvant to radiotherapy for recurrent or metastatic malignant melanoma. European Society for Hyperthermic Oncology. Lancet 1995; 345(8949):540-3.
  2. Perez, C.A., Pajak, T., et al. Randomized phase III study comparing irradiation and hyperthermia with irradiation alone in superficial measurable tumors. Final report by the Radiation Therapy Oncology Group. American Journal of Clinical Oncology (1991)14(2):133-141.
  3. Vernon, C. C., Hand, J. W., 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. International Journal of Radiation Oncology Biology Physics (1996) 35(4):731-744.
  4. Emami, B., Scott, C., et al. Phase III study of interstitial thermoradiotherapy compared with interstitial radiotherapy alone in the treatment of recurrent or persistent human tumors. A prospectively controlled randomized study by the Radiation Therapy Group. International Radiation Oncology Biology Physics (1996) 34(5):1097-2004.
  5. Robins, H.I., Rushing, D., et al. Phase I clinical trial of melphalan and 41.8 degrees C whole body hyperthermia in cancer patients. Journal of Clinical Oncology (1997 January) 15(1): 158-164.
  6. Mittal BB, Zimmer MA, Sathiaseelan V et al. Phase I/II trial of combined 131I anti-CEA monoclonal antibody and hyperthermia in patients with advanced colorectal adenocarcinoma. Cancer 1996; 78(9):1861-70.
  7. Wiedemann GJ, Robins HI, Gutsche S et al. Ifosfamide, carboplatin and etoposide (ICE) combined with 41.8 degrees C whole body hyperthermia in patients with refractory sarcoma. Eur J Cancer 1996; 32A(5):888-92.
  8. Emami B, Stauffer P, Dewhirst M et al. RTOG quality assurance guidelines for interstitial hyperthermia. Int J Radiat Oncol Biol Phys 1991; 20(5):1117-24.
  9. Sherar M, Liu FF, Pintilie M et al. Relationship between thermal dose and outcome in thermoradiotherapy treatments for superficial recurrences of breast cancer: data from a phase III trial. Int J Radiat Oncol Biol Phys 1997; 39(2):371-80.
  10. Local or Whole Body Hyperthermia (Archived). Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2003 April) Medicine 2.01.05.
History
October 2013  New 2013 BCBSMT medical policy.
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Hyperthermia (Superficial/Local and Whole Body)