Description

Hyperthermia treatment involves exposing body tissues to high temperatures of up to 113˚F using various heating methods. Hyperthermia may be used with other treatments (eg, chemotherapy, radiation) to kill cancer cells and shrink tumors with little or no harm to normal tissue.

Local hyperthermia confines the treatment to a small area, such as a tumor. Various methods to deliver local hyperthermia may be used, which include heated probes, lasers, needles, or ultrasound.

Approaches to local hyperthermia include:

• External – Used to treat tumors that are near the body surface in which external applicators are placed around or near the appropriate region and energy is focused on the tumor to raise the temperature.
• Interstitial – Used to treat tumors deep within the body (eg, brain tumors) where probes or needles are inserted into the tumor under anesthesia and heated to higher temperatures than external techniques. (Refer to Coverage Limitations Section)
• Intracavity (also called intraluminal) – Used to treat tumors within body cavities (eg, esophagus, prostate) by placing probes inside the cavity to deliver energy and heat to the tumor. (Refer to Coverage Limitations Section)

the tumor cells to damage or destroy them. Examples of this procedure include, but may not be limited to, magnetic resonance imaging (MRI) guided laser ablation (Refer to Coverage Limitations Section) and MRI guided laser interstitial thermal therapy (LITT). For information regarding LITT, please refer to Laser Interstitial Thermal Therapy Medical Coverage Policy.

within a tumor. Nanoparticles injected into the tumor or delivered to the tumor via an intravenous solution are exposed to heat either by changing the magnetic polarity of the nanoparticles (eg, MagForce AG) or by utilizing near-infrared light that is targeted to the lesion (AuroLase). At this time, there are no US Food & Drug Administration (FDA) approved devices for this treatment. (Refer to Coverage Limitations Section)

Ultrasound – Used to destroy tumor tissue by utilizing sound energy to generate heat. Typically, high intensity focused ultrasound (HIFU) is used and is being investigated for various cancers (eg, hepatocellular, palliative treatment of pain associated with bone metastases, prostate). Regarding use for prostate cancer, ultrasound therapy purportedly may be delivered by either using a transrectal or a transurethral approach (eg, transurethral ultrasound ablation [TULSA]). Either approach may utilize magnetic resonance (MR) and/or real-time imaging to guide treatment. FDA-approved HIFU devices (eg, Sonablate) have been indicated for the destruction of prostate tissue; however, they have not been approved specifically for the treatment of prostate cancer. An example of a HIFU device that is under study for treatment of prostate cancer is the Exablate prostate system. (Refer to Coverage Limitations Section)

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

The technology utilizes short microsecond bursts of ultrasound energy to mechanically create microbubbles in the gas of the extracellular matrix of tissues (also known as acoustic cavitation). Reportedly, the expansion and collapse of the microbubbles mechanically destroys targeted tissues. There are currently no FDA approved devices to deliver histotripsy. (Refer to Coverage Limitations Section)

Regional hyperthermia treats large areas of tissue, such as a body cavity or organ. It is usually combined with chemotherapy or radiation therapy.

• Deep tissue – May be utilized to treat cancers within the body. External applicators are placed around the body cavity or organ to be treated and energy is focused on the area to raise the temperature. (Refer to Coverage Limitations Section)
• Hyperthermic intraperitoneal chemotherapy (HIPEC) – Used in treatment along with surgery for cancers in the peritoneum (space that contains the intestines and other digestive organs). During surgery, heated chemotherapy drugs are circulated through the peritoneal cavity.
• Isolated limb infusion (ILI)/perfusion (ILP) – Used to treat in-transit metastases that occur in the upper and lower limbs of the body. ILI is less invasive and uses smaller catheters to infuse the chemotherapy into the main artery and vein, while a tourniquet blocks blood flow between the affected limb and the rest of the body. ILP involves the placement of catheters in the limb’s main artery and vein to create an arterio-venous loop, followed by circulation in the limb of high- dose chemotherapy, which is often heated.

Hyperthermia Treatment for Cancer (Local, Regional and Whole Body) Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2023 Policy Number: HUM-0400-020 Page: 4 of 15

Whole-body hyperthermia is reportedly used to treat metastatic cancer that has spread throughout the body. It can be performed using warm water blankets, inductive coils (like those in electric blankets) or thermal chambers (similar to large incubators). (Refer to Coverage Limitations Section)

High-energy water vapor thermotherapy is also being investigated for the treatment of malignancies of the prostate; however, at this time it appears to only be utilized for benign prostatic hyperplasia (BPH).

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

(Refer to Coverage Limitations Section).For information regarding water vapor thermotherapy for the treatment of BPH, please refer to Benign Prostatic Hyperplasia Treatments Medical Coverage Policy.

Coverage Determination

Please refer to the member’s applicable pharmacy benefit to determine benefit availability and the terms and conditions of coverage for medications used in conjunction with hyperthermia treatment.

Humana members may be eligible under the Plan for local hyperthermia treatment for cancer if used in conjunction with radiation therapy for the treatment of primary or metastatic cutaneous or subcutaneous superficial malignancies (eg, superficial recurrent melanoma, chest wall recurrence of breast cancer).

Note: The criteria for local hyperthermia are consistent with the Medicare National Coverage Policy and therefore apply to Medicare members.

Humana members may be eligible under the Plan for HIPEC when the following criteria are met:

• 18 years of age or older; AND
• Used in conjunction with cytoreductive surgery (CRS);AND any of the following:
• Gastric (stomach) cancer without macroscopic peritoneal metastases or distant metastases; OR
• Peritoneal carcinomatosis without extraperitoneal metastases; OR
• Pseudomyxoma peritonei

Note: The criteria for HIPEC are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Humana members may be eligible under the Plan for isolated limb infusion or perfusion for the treatment of stage III in-transit melanoma.

Coverage Limitations

Humana members may NOT be eligible under the Plan for hyperthermia treatment for cancer for any indications other than those listed above including, but may not be limited to:

• Deep tissue hyperthermia (greater than 4 cm); OR
• Histotripsy (eg, RAST [HistoSonics]); OR
• Interstitial and intracavity (also called intraluminal) hyperthermia; OR
• Magnetic nanoparticle hyperthermia (eg, AuroLase, MagForce AG); OR
• MRI-guided laser ablation (eg, prostate cancer); OR
• Repeat HIPEC or repeat CRS plus HIPEC; OR
• Ultrasound ablation (eg, HIFU [eg, Sonablate, Exablate], TULSA); OR
• Water vapor thermotherapy for prostate cancer; OR
• Whole-body hyperthermia

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about cancer may be found from the following websites:

• American Cancer Society
• National Comprehensive Cancer Network
• National Library of Medicine

Medical Alternatives

Alternatives to hyperthermia include, but may not be limited to, the following:

• Chemotherapy
• Radiation therapy
• Surgery

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Do not rely on the accuracy and inclusion of specific service or procedure.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

CPT® Code(s)

Description

Comments

• 36823 - Insertion of arterial and venous cannula(s) for isolated extracorporeal circulation including regional chemotherapy perfusion to an extremity, with or without hyperthermia, with removal of cannula(s) and repair of arteriotomy and venotomy sites
• 55880 - Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (HIFU), including ultrasound guidance - Not Covered
• 55899 - Unlisted procedure, male genital system - Not Covered if used to report any treatment as outlined in Coverage Limitations section
• 64999 - Unlisted procedure, nervous system - Not Covered if used to report any treatment as outlined in Coverage Limitations section

Hyperthermia Treatment for Cancer (Local, Regional and Whole Body) Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2023 Policy Number: HUM-0400-020 Page: 7 of 15

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• 76999 - Unlisted ultrasound procedure (eg, diagnostic, interventional) - Not Covered if used to report any treatment.

CPT® Code(s)

• 77600 - Hyperthermia, externally generated; superficial (ie, heating to a depth of 4 cm or less)
• 77605 - Hyperthermia, externally generated; deep (ie, heating to depths greater than 4 cm) - Not Covered
• 77610 - Hyperthermia generated by interstitial probe(s); 5 or fewer interstitial applicators - Not Covered
• 77615 - Hyperthermia generated by interstitial probe(s); more than 5 interstitial applicators - Not Covered
• 77620 - Hyperthermia generated by intracavitary probe(s) - Not Covered
• 96446 - Chemotherapy administration into the peritoneal cavity via indwelling port or catheter - Not Covered if used to report any treatment outlined in Coverage Limitations section
• 96549 - Unlisted chemotherapy procedure - Not Covered if used to report any treatment outlined in Coverage Limitations section

CPT® Category Ill Code(s)

Description: Treatment planning for magnetic field induction ablation of malignant prostate tissue, using data from previously performed magnetic resonance imaging (MRI) examination

New Code Effective 01/01/2023

Hyperthermia Treatment for Cancer (Local, Regional and Whole Body) Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2023 Policy Number: HUM-0400-020 Page: 8 of 15

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• 0739T - Ablation of malignant prostate tissue by magnetic field induction, including all intraprocedural, transperineal needle/catheter placement for nanoparticle installation and intraprocedural temperature monitoring, thermal dosimetry, bladder irrigation, and magnetic field nanoparticle activation - Not Covered. New Code Effective 01/01/2023

HCPCS Code(s)

• 9790 - Histotripsy (ie, non-thermal ablation via acoustic energy delivery) of malignant renal tissue, including image guidance - Not Covered New Code Effective 10/01/2023

References

Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness Review. Therapies for clinical localized prostate cancer. Published September 2020. Accessed October 24, 2023.

American Academy of Dermatology (AAD). Guideline of care for the management of basal cell carcinoma. Published March 2018. Accessed October 21, 2023.

American Academy of Dermatology (AAD). Guideline of care for the management of squamous cell carcinoma. Published March 2018. Accessed October 21, 2023.

American Cancer Society (ACS). Hyperthermia to treat cancer. Published May 3, 2016. Accessed October 24, 2023.

American College of Chest Physicians (ACCP). Diagnosis and management of lung cancer, 3rd ed; American College of Chest Physicians evidence-based clinical practice guidelines. Published May 2013.

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American Radium Society (ARS). ACR Appropriateness Criteria. Locally advanced, high-risk prostate cancer. https://www.americanradiumsociety.org. Published 1996. Updated 2016. Accessed October 22, 2023.

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American Society of Breast Surgeons (ASBS). Consensus guideline on the use of transcutaneous and percutaneous ablation for the treatment of benign and malignant tumors of the breast. https://www.breastsurgeons.org. Published October 16, 2018. Accessed October 21, 2023.

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American Society of Clinical Oncology (ASCO). Treatment of malignant pleural mesothelioma: American Society of Clinical Oncology clinical practice guideline. https://www.asco.org. Published May 1, 2018. Accessed October 21, 2023.

American Society of Colon and Rectal Surgeons (ASCRS). American Society of Colon and Rectal Surgeons clinical practice guidelines for the management of appendiceal neoplasms. https://www.fascrs.org. Published 2019. Accessed October 21, 2023.

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American Urological Association (AUA). Renal mass and localized renal cancer: evaluation, management and follow-up: AUA guideline. https://www.auanet.org. Published April 2021. Accessed October 22, 2023.

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Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Laser procedures (140.5). https://www.cms.gov. Published May 1, 1997. Accessed October 21, 2023.

ClinicalKey. Ferri F. Prostate cancer. In: Ferri F. Ferri's Clinical Advisor 2024. Elsevier; 2024:1154-1159.e1. https://www.clinicalkey.com. Accessed October 24, 2023.

ClinicalKey. Kundra V, Chery L, Hoffman K. Prostate cancer. In: Silverman P. Oncologic Imaging: A Multidisciplinary Approach. 2nd ed. Elsevier; 2023:370-393. https://www.clinicalkey.com. Accessed October 24, 2023.

ECRI Institute. Clinical Evidence Assessment. Edison histotripsy system (HistoSonics, Inc.) for treating liver tumors. https://www.ecri.org. Published October 25, 2022. Accessed October 12, 2023.

ECRI Institute. Clinical Evidence Assessment. High-intensity focused ultrasound for treating localized prostate cancer. https://www.ecri.org. Published October 22, 2004. Updated April 12, 2022. Accessed October 12, 2023.

ECRI Institute. Clinical Evidence Assessment.

Hyperthermic intraperitoneal chemotherapy and cytoreductive surgery for colorectal peritoneal metastases. https://www.ecri.org. Published April 7, 2004. Updated September 17, 2022. Accessed October 12, 2023.

ECRI Institute. Clinical Evidence Assessment. NanoTherm magnetic nanoparticle hyperthermia (MagForce AG) for treating pancreatic cancer. https://www.ecri.org. Published November 13, 2018. Updated October 18, 2023. Accessed October 18, 2023.

ECRI Institute. Clinical Evidence Assessment. Tulsa-Pro transurethral ultrasound ablation system (Profound Medical Corp.) for treating localized prostate cancer. https://www.ecri.org. Published November 9, 2020. Accessed October 12, 2023.

Hayes, Inc. Clinical Research Response. Sonablate (Sonablate Corp.) for the treatment of prostate cancer. https://evidence.hayesinc.com. Published April 14, 2023. Accessed October 12, 2023.

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Hayes, Inc. Emerging Technology Report. Aurolase therapy for localized prostate cancer. https://evidence.hayesinc.com. Published September 29, 2022. Accessed October 12, 2023.

Hayes, Inc. Emerging Technology Report. Edison system (HistoSonics) for histotripsy of liver tumors. https://evidence.hayesinc.com. Published October 12, 2023. Accessed October 12, 2023.

Hayes, Inc. Evidence Analysis Research Brief. High-intensity focused ultrasound for salvage therapy of recurrent prostate cancer. https://evidence.hayesinc.com. Published October 10, 2023. Accessed October 12, 2023.

Hayes, Inc. Evidence Analysis Research Brief. Intraoperative hyperthermic intraperitoneal chemotherapy for gastric cancer. https://evidence.hayesinc.com. Published September 20, 2022. Accessed October 12, 2023.

Hayes, Inc. Health Technology Assessment. Hyperthermic intraperitoneal chemotherapy for peritoneal carcinomatosis resulting from ovarian cancer. https://evidence.hayesinc.com. Published August 26, 2019. Updated September 14, 2022. Accessed October 12, 2023.

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Hayes, Inc. Health Technology Assessment. Hyperthermic intraperitoneal chemotherapy for sarcoma with peritoneal involvement. https://evidence.hayesinc.com. Published December 13, 2019. Updated March 7, 2023. Accessed October 13, 2023.

Hayes, Inc. Health Technology Assessment. Ultrasound-guided high-intensity focused ultrasound for primary treatment of localized prostate cancer. https://evidence.hayesinc.com. Published November 22, 2022. Accessed October 12, 2023.

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Hayes, Inc. Health Technology Brief (ARCHIVED). High-intensity focused ultrasound (HIFU) for treatment of hepatocellular carcinoma. https://evidence.hayesinc.com. Published December 10, 2012. Updated October 29, 2014. Accessed October 13, 2023.

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33. MCG Health. High intensity focused ultrasound (HIFU), prostate. 27th edition. https://www.mcg.com. Accessed August 30, 2023.

34. Merck Manual: Professional Version. Prostate cancer. https://www.merckmanuals.com. Updated October 2023. Accessed October 20, 2023.

35. National Cancer Institute (NCI). Gastric cancer treatment (PDQ) – health professional version. https://www.cancer.gov. Updated May 11, 2023. Accessed October 21, 2023.

36. National Cancer Institute (NCI). Malignant mesothelioma treatment (PDQ) – health professional version. https://www.cancer.gov. Updated May 17, 2023. Accessed October 21, 2023.

37. National Cancer Institute (NCI). Melanoma treatment (PDQ) – health professional version. https://www.cancer.gov. Updated January 31, 2023. Accessed October 21, 2023.

38. National Cancer Institute (NCI). Non-small cell lung cancer treatment (PDQ) – health professional version. https://www.cancer.gov. Updated February 17, 2023. Accessed October 21, 2023.

39. National Cancer Institute (NCI). Ovarian epithelial, fallopian tube and primary peritoneal cancer treatment (PDQ) – health professional version. https://www.cancer.gov. Updated March 14, 2023. Accessed October 21, 2023.

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40. National Cancer Institute (NCI). Penile cancer treatment (PDQ) – health professional version. https://www.cancer.gov. Updated June 2, 2023. Accessed October 21, 2023.

41. National Cancer Institute (NCI). Prostate cancer treatment (PDQ) – health professional version. https://www.cancer.gov. Updated February 13, 2023. Accessed October 21, 2023.

42. National Cancer Institute (NCI). Transitional cell cancer of the renal pelvis and ureter treatment (PDQ) – health professional version. https://www.cancer.gov. Updated January 30, 2023. Accessed October 22, 2023.

43. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Colon cancer. https://www.nccn.org. Updated September 21, 2023. Accessed October 22, 2023.

44. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Cutaneous melanoma. https://www.nccn.org. Updated March 10, 2023. Accessed October 22, 2023.

45. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Gastric cancer. https://www.nccn.org. Updated August 29, 2023. Accessed October 22, 2023.

46. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Melanoma: uveal. https://www.nccn.org. Updated May 4, 2023. Accessed October 22, 2023.

47. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Mesothelioma: peritoneal. https://www.nccn.org. Updated July 20, 2023. Accessed October 22, 2023.

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49. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Ovarian cancer including fallopian tube cancer and

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Primary peritoneal cancer. https://www.nccn.org. Updated June 2, 2023. Accessed October 22, 2023.
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• UpToDate, Inc. Localized hepatocellular carcinoma: liver-directed therapies for nonsurgical candidates who are eligible for local ablation. https://www.uptodate.com. Updated September 2023. Accessed October 13, 2023.
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• UpToDate, Inc. Radiofrequency ablation, cryoablation and other ablative techniques for renal cell carcinoma. https://www.uptodate.com. Updated October 1, 2023. Accessed October 19, 2023
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