Subject:
Hyperthermia in Conjunction with Radiation Therapy
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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After initial enthusiasm for the use of hyperthermia in the late 1970’s, interest waned with the publication of studies showing little or no benefit in the mid-1980s. Later review of the negative findings disclosed that the critical temperature necessary for hyperthermic cell death, 42 to 43 degrees centigrade (C), was either poorly measured or poorly maintained in these studies. Point measurements rather than volume mapping of thermal gradients were relied upon in planning these hyperthermia studies.
Renewed interest in the use of hyperthermia began to emerge in both Europe and the United States (US) in the 1990’s. Research from Duke University, Northwestern University, University of Southern California, Stanford University, Washington University, as well as centers in Holland, Germany, Norway, Austria, Italy and Switzerland have contributed substantially to the emergence of hyperthermia as a useful treatment modality when combined with radiation therapy.
Currently, in the US, the Food and Drug Administration (FDA) has approved hyperthermia for use in the treatment of cancer when combined with radiation therapy for the “…palliative management of certain solid surface and subsurface malignant tumors (i.e. melanoma, squamous or basal cell tumors, adenocarcinoma, or sarcoma) that are progressive or recurrent despite conventional therapy.” The National Cancer Center Network (NCCN) recommends “…that the use of hyperthermia be limited to treatment centers with appropriate training, expertise and equipment...”. The NCCN Panel on Breast Cancer concluded that it was a controversial Category 3 recommendation in the treatment of local or regional recurrent breast cancer.
Following FDA approval, Medicare approved coverage for local hyperthermia when used together with radiation therapy. A National Coverage Determination (NCD 110.1) was issued by Medicare (CMS) in December 1984 and remains unchanged. It states, “Local hyperthermia is covered under Medicare when used in conjunction with radiation therapy for the treatment of primary or metastatic cutaneous or subcutaneous superficial malignancies. It is not covered when used alone or in connection with chemotherapy.” Coding for this treatment is recognized and published in the current 2018 ACR/ASTRO guide.
Although research into hyperthermic treatments at depths greater than 4 cm. is ongoing in the US, it is currently recognized only as investigational as are intraluminal, endocavitary, and interstitial applications.
On May 15, 2009, the FDA granted humanitarian use device (HUD) status to the BSD-2000 and on November 18, 2011, the FDA granted humanitarian device exemption (HDE) to the BSD-2000 for the treatment of cervical cancer patients ineligible for chemotherapy (treatment population less than 4,000). This is the only approval for deep heating and only actual costs incurred in the research may be billed. Other applications for deep heating are pending for both BSD and Medifocus devices.
In the US, only the BSD-500 has FDA commercial clearance for superficial heating (less than a 4 cm. depth). This is currently the only device approved for reimbursement. It operates at the microwave range of 915 MHz with different applicators and power setting ranging from 20 to 250 watts. The standard recommended treatment regimen for use with radiation therapy is a “…total of 10 hyperthermia treatments delivered two times per week at 72-hour intervals, with each heat treatment preceded or followed by a standard prescribed dose of ionizing radiation within 30 minutes of the heat treatment.” A sustained intratumoral temperature of 42.5 degrees C for 60 minutes is recommended.
The FDA granted pre-market approval for the Sonotherm® 1000 Ultrasound Therapy System on September 29, 1989. This approval was for hyperthermia to treat tumors at a depth of 8 cm. Although FDA approval was granted, the device remains in clinical study and is designated investigational.
Policy:
(NOTE: This policy only applies to adult members. It does not apply to pediatric members.
For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
I. The use of hyperthermia and concurrent external beam radiation therapy treatment is medically necessary for any of the following:
A. Superficially recurrent melanoma
B. Chest wall recurrence of breast cancer
C. Recurrent cervical lymph nodes from head and neck cancer
Treatment of the above conditions will be approved in the absence of both of the following:
A. Metastatic disease for which chemotherapy or hormonal therapy is being given concurrently
B. Evidence of tumor recurrence exceeding 4 cm in depth
When hyperthermia is indicated, no more than 10 hyperthermia treatments delivered twice weekly at 72-hour intervals should be utilized.
II. The use of hyperthermia in the following scenarios is considered investigational:
A. Intraluminal hyperthermia
B. Endocavitary hyperthermia
C. Interstitial hyperthermia
D. Regional deep tissue hyperthermia exceeding 4 cm in depth
E. Whole body hyperthermia
Medicare Coverage:
Per National Coverage Determination (NCD) for Hyperthermia for Treatment of Cancer 110.1, local hyperthermia is covered when used in connection with radiation therapy for the treatment of primary or metastatic cutaneous or subcutaneous superficial malignancies. It is not covered when used alone or in connection with chemotherapy. For additional information and eligibility, refer to NCD (110.1). Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=66&ncdver=1&bc=AgAAgAAAAAAAAA%3d%3d&.
[INFORMATIONAL NOTE:
There are three clinical sites in which randomized studies have documented the benefit of hyperthermia given in conjunction with radiotherapy.
1. Melanoma – 134 metastatic or recurrent lesions of malignant melanoma in 70 patients were randomly assigned to receive radiation therapy (three fractions of 8 or 9 Gy over 8 days) alone or followed by hyperthermia (43 degrees C for 60 minutes). Beneficial local effect was 28% for radiation alone, and 46% for combined treatment. Toxicity was not higher with hyperthermia (Overgaard, 1995).
2. Breast – Five randomized trials were combined to report the benefit of combined treatment for superficial localized breast cancer. The control rate for radiation therapy alone was 41%, while that for combined treatment was 59%. The greatest effect was observed in patients with recurrent lesions in previously irradiated lesions where further irradiation was limited to low doses (Vernon, 1996).
3. Head and neck metastatic lymph nodes – a randomized study of 44 nodes in 41 patients confirmed the improved five-year actuarial nodal control of the combined treatment arm. In addition, the study reports a statistically significant improvement in survival at five years, and no increased toxicity from combined modality therapy (Valdagni, 1994).]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Hyperthermia in Conjunction with Radiation Therapy
References:
1. American College of Radiology (ACR)/American Society of Radiation Therapy (ASTRO) Coding Guide.
2. BSD-2000 Brochure.
3. BSD-500 Brochure.
4. HUD and HDE for BSD-2000.
5. Hyperthermia for Treatment of Cancer. National Coverage Determination (NCD) 110.1.
6. National Comprehensive Cancer Network (NCCN) Guidelines®. Version 1.2020 – January 15, 2019. Breast Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer Version 1.2020. 2020 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN®. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org
7. Overgaard J, 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 Mar 4; 345(8949):540-543.
8. PMA for BSD-500 and supplement.
9. Sonotherm® 1000 Ultrasound Therapy System.
10. Valdagni R, Amichetti M. Report of long-term follow up in a randomized trial comparing radiation therapy and radiation therapy plus hyperthermia to metastatic lymph nodes in stage IV head and neck patients. Int. J. Radiat. Oncol. Biol. Phys. 1994 Jan 1; 28(1):163–169.
11. 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 Jul 1; 35(4):731-744.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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