Local or Whole Body Hyperthermia - CAM 20105

Description:
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, using either external or interstitial modalities. 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 four hours, while the essential body functions are closely monitored. Approximately one hour is required for a "cooling off" period, after which the patient is constantly observed for a minimum of 12 hours. This modality has been variously termed "systemic thermotherapy" or "whole body hyperthermia."

Policy:
MEDICALLY NECESSARY:

  • Local hyperthermia therapy when used in combination with radiation therapy for the treatment of patients with primary or metastatic cutaneous or subcutaneous superficial tumors (e.g., superficial recurrent melanoma, chest wall recurrence of breast cancer and cervical lymph node metastases from head and neck cancer)

INVESTIGATIONAL:

  • Local hyperthermia, using either external or interstitial modalities, in conjunction with radiation therapy for all other uses not identified as medically necessary
  • Regional deep tissue hyperthermia in the treatment of malignancies
  • Whole body hyperthermia therapy
  • Hyperthermic melphalan perfusion in stage I, IIIB and IIIAB extremity melanoma, as well as hyperthermia in conjunction with any other chemotherapy

Policy Guidelines:
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 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 more than eight to10 hours after treatment and subsides over the next 60 to 100 hours.

Rationale:
The use of hyperthermia as an adjunct to radiation or chemotherapy of superficial tumors has been an area of active investigation for the past 20 years, in part due to improvements in instrumentation and temperature-monitoring technique, 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 percent complete response rate compared to 28 percent 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 two groups (30 – 32 percent). 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 (52 percent vs. 39 percent). 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; 59 percent of those in the combined treatment group achieved complete local response compared to 41 percent 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. 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 two groups.4 The Radiation Trials Oncology Group (RTOG) has published guidelines outlining quality control criteria for adequate hyperthermia treatment.5 When the investigators compared these criteria to their data, they found that only one 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.2,6 Identification of the optimal parameters for hyperthermia has also been researched. The majority of the clinical trials describe eight to 12 hyperthermia regimens delivered twice weekly, or every 72 hours. These schedules recognize the phenomenon of thermotolerance, a transient resistance to subsequent heat treatment.

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. A literature search of the MEDLINE database targeted at clinical articles published between 1995 and 2001 found citations describing technical feasibility studies and a few phase I and II studies, but there were no controlled studies reporting on patient outcomes.7,8,9 There were no studies identified that focused on the use of local hyperthermia with chemotherapy alone.

References

  1. 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 1995;345(8949):540-3.
  2. Perez CA, Pajak T, Emami B 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. Am J Clin Oncol 1991;14(2):133-41.
  3. 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 1996;35(4):731-44.
  4. Emami B, Scott C, Perez CA 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. Int J Radiat Oncol Biol Phys 1996:34(5):1097-04.
  5. 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.
  6. 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.
  7. Robins HI, Rushing D, Kutz M et al. Phase I clinical trial of melphalan and 41.8 degrees C whole-body hyperthermia in cancer patients. J Clin Oncol 1997;15(1):158-64.
  8. 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.
  9. 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.
  10. Kouloulias V, Plataniotis G, Kouvaris J, et al. Chemoradiotherapy combined with intracavitary hyperthermia for anal cancer: Feasibility and long-term results from a phase II randomized trial. Am J Clin Oncol. 2005;28(1):91-99.
  11. ones EL, Oleson JR, Prosnitz LR, et al. Randomized trial of hyperthermia and radiation for superficial tumors. J Clin Oncol. 2005;23(13):3079-3085.
  12. Issels RD, Schlemmer M, Lindner LH. The role of hyperthermia in combined treatment in the management of soft tissue sarcoma. Curr Oncol Rep. 2006;8(4):305-309.

Coding Section

Codes Number Description
CPT 77600 Hyperthermia, externally generated, superficial (to a depth of 4 cm or less)
  77605 Hyperthermia, externally generated, deep (to a depth greater than 4 cm)
  77610 Hyperthermia generated by interstitial probes; five or fewer interstitial probes
  77615 Hyperthermia generated by interstitial probes; more than five interstitial probes
ICD-9 Procedure 92.21-92.25 Radiation code range
  99.85 Hyperthermia for treatment of cancer
ICD-9 Diagnosis 171.0-171.9 Malignant neoplasm of the skin range
  173.0-173.9 Other malignant neoplasms of skin code range
  198.2 Secondary malignant neoplasm of skin
  198.89 Secondary malignant neoplasm of other specified areas
HCPCS No code  
ICD-10-PCS (effective 10/01/15) D0Y07ZZ Contact Radiation of Brain
  D0Y17ZZ Contact Radiation of Brain Stem
  D0Y67ZZ Contact Radiation of Spinal Cord
  D0Y77ZZ Contact Radiation of Peripheral Nerve
  D8Y07ZZ Contact Radiation of Eye
  D9Y07ZZ Contact Radiation of Ear
  D9Y17ZZ Contact Radiation of Nose
  D9Y37ZZ Contact Radiation of Hypopharynx
  D9Y47ZZ Contact Radiation of Mouth
  D9Y57ZZ Contact Radiation of Tongue
  D9Y67ZZ Contact Radiation of Salivary Glands
  D9Y77ZZ Contact Radiation of Sinues
  D9Y87ZZ Contact Radiation of Hard Palate
  D9Y97ZZ Contact Radiation of Soft Palate
  D9YB7ZZ Contact Radiation of Larynx
  D9YD7ZZ Contact Radiation of Nasopharynx
  D9YF7ZZ Contact Radiation of Oropharynx
  DBY07ZZ Contact Radiation of Trachea
  DBY17ZZ Contact Radiation of Bronchus
  DBY27ZZ Contact Radiation of Lung
  DBY57ZZ Contact Radiation of Pleura
  DBY67ZZ Contact Radiation of Mediastinum
  DBY77ZZ Contact Radiation of Chest Wall
  DBY87ZZ Contact Radiation of Diaphragm
  DDY07ZZ  Contact Radiation of Esophagus 
  DDY17ZZ Contact Radiation of Stomach
  DDY27ZZ  Contact Radiation of Duodenum 
  DDY37ZZ  Contact Radiation of Jejunum 
  DDY47ZZ Contact Radiation of Ileum
  DDY57ZZ Contact Radiation of Colon
  DDY77ZZ Contact Radiation of Rectum
  DFY07ZZ Contact Radiation of Liver
  DFY17ZZ Contact Radiation of Gallbladder
  DFY27ZZ Contact Radiation of Bile Ducts
  DFY37ZZ Contact Radiation of Pancreas
  DGY07ZZ Contact Radiation of Pituitary Gland
  DGY17ZZ  Contact Radiation of Pineal Body 
  DGY27ZZ   Contact Radiation of Adrenal Glands
  DGY47ZZ    Contact Radiation of Parathyroid Glands 
  DGY57ZZ    Contact Radiation of Thyroid 
  DHY27ZZ  Contact Radiation of Face Skin 
  DHY37ZZ  Contact Radiation of Neck Skin 
  DHY47ZZ  Contact Radiation of Arm Skin 
  DHY67ZZ  Contact Radiation of Chest Skin 
  DHY77ZZ Contact Radiation of Back Skin 
  DHY87ZZ Contact Radiation of Abdomen Skin
  DHY97ZZ Contact Radiation of Buttock Skin
  DHYB7ZZ Contact Radiation of Leg Skin
  DMY07ZZ Contact Radiation of Left Breast
  DMY17ZZ  Contact Radiation of Right Breast 
  DPY07ZZ  Contact Radiation of Skull
  DPY207ZZ   Contact Radiation of Maxilla
  DPY37ZZ  Contact Radiation of Mandible
  DPY47ZZ  Contact Radiation of Sternum
  DPY57ZZ  Contact Radiation of Rib(s)
  DPY67ZZ  Contact Radiation of Humerus
  DPY77ZZ  Contact Radiation of Radius/Ulna
  DPY87ZZ  Contact Radiation of Pelvic Bones
  DPY97ZZ  Contact Radiation of Femur
   DPYB7ZZ  Contact Radiation of Tibia/Fibula 
  DPYC7ZZ  Contact Radiation of Other Bone
  DTY07ZZ  Contact Radiation of Kidney 
  DTY17ZZ Contact Radiation of Ureter
  DTY27ZZ Contact Radiation of Bladder
  DTY37ZZ Contact Radiation of Urethra
  DUY07ZZ Contact Radiation of Ovary
  DUY17ZZ Contact Radiation of Cervix
  DUY27ZZ Contact Radiation of Uterus
  DVY07ZZ Contact Radiation of Prostate
  DVY17ZZ Contact Radiation of Testis
  DWY17ZZ Contact Radiation of Head and Neck
  DWY27ZZ Contact Radiation of Chest
  DWY37ZZ Contact Radiation of Abdomen
  DWY47ZZ Contact Radiation of Hemibody
  DWY57ZZ Contact Radiation of Whole Body
  DWY67ZZ Contact Radiation of Pelvic Region
  DWY18ZZ  Hyperthermia of Head and Neck 
  DWY28ZZ  Hyperthermia of Chest
  DWY38ZZ Hyperthermia of Abdomen
  DWY48ZZ Hyperthermia of Hemibody
  DWY58ZZ Hyperthermia of Whole Body
  DWY68ZZ Hyperthermia of Pelvic Region
  C44.90
Unspecified malignant neoplasm of skin
  C44.99
Other specified malignant neoplasm of skin, unspecified
  C79.2 Secondary malignant neoplasm of skin
  C79.89 Secondary malignant neoplasm of other specified sites

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.  

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.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2014 Forward     

08/17/2023 Annual review, no change to policy intent.
08/01/2022 Annual review, no change to policy intent.

07/22/2021 

Annual review, no change to policy intent. 

07/27/2020 

Annual review, no change to policy intent. 

07/08/2019 

Annual review, no change to policy intent. 

07/30/2018 

Annual review, no change to policy intent. 

07/31/2017 

Annual review, no change to policy intent. 

07/06/2016 

Annual review, no change to policy intent.  

07/27/2015

Annual review, no change to policy intent. Added coding. 

07/10/2014

Annual review, no changes made.

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