1 Clinical Policy Title: Infrared therapy Clinical Policy Number: 18.02.03 Effective Date: October 1, 2014 Initial Review Date: May 21, 2014 Most Recent Review Date: May 1, 2018 Next Review Date: May 2019 Related policies: None. ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas considers the use of infrared therapy to be clinically proven and, therefore, medically necessary when one of the following criteria is met (Davis, 2018; Qaseem, 2017): For treatment of early-stage (Stage I or II) internal hemorrhoids that are painful or persistently bleeding after conservative treatment (e.g., oral laxatives, local ointments, nonconstipating diets). As adjunctive treatment when used as a heat modality in physical therapy. Limitations: All other uses of infrared therapy are not medically necessary. Alternative covered services: Rubber band ligation. Sclerotherapy. Policy contains: Near-infrared light therapy. Far-infrared light therapy. Internal hemorrhoids. Physical therapy.
12
Embed
Clinical Policy Title: Infrared therapy...Far-infrared therapy is a form of heat therapy delivered via heated saunas that exposes body tissues to slightly higher temperatures. Far-infrared
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
1
Clinical Policy Title: Infrared therapy
Clinical Policy Number: 18.02.03
Effective Date: October 1, 2014
Initial Review Date: May 21, 2014
Most Recent Review Date: May 1, 2018
Next Review Date: May 2019
Related policies:
None.
ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.
Coverage policy
AmeriHealth Caritas considers the use of infrared therapy to be clinically proven and, therefore, medically
necessary when one of the following criteria is met (Davis, 2018; Qaseem, 2017):
For treatment of early-stage (Stage I or II) internal hemorrhoids that are painful or persistently
bleeding after conservative treatment (e.g., oral laxatives, local ointments, nonconstipating
diets).
As adjunctive treatment when used as a heat modality in physical therapy.
Limitations:
All other uses of infrared therapy are not medically necessary.
Alternative covered services:
Rubber band ligation.
Sclerotherapy.
Policy contains:
Near-infrared light therapy.
Far-infrared light therapy.
Internal hemorrhoids.
Physical therapy.
2
Bipolar diathermy or cautery.
Surgical hemorrhoidectomy.
Background
Infrared light is electromagnetic radiation with longer wavelengths than those of visible light, extending
from the nominal red edge of the visible spectrum at 0.7 micrometers (µm) to 1,000 µm. This region is
further divided into near-infrared, middle-infrared, and far-infrared. Infrared therapy applies low-energy
light within the infrared spectrum. Although the exact mechanism is unclear, infrared therapy is believed to
promote photochemical, photophysical, and photobiological effects in cells and tissues, without causing
temperature to rise above 98°F (Anodyne, 2014).
Several devices are available to deliver infrared therapy, but they differ in their methods (wavelength, pulse
rate, intensity, etc.), design (total surface area), and application (handheld or attachable). Medical
applications for infrared therapy incorporate either near-infrared light using laser or light emitting diodes)
or far-infrared light applied in a sauna. Near-infrared light emitting diode devices are used to treat an area
of the skin and adjacent subcutaneous tissues of a patient by affixing infrared light emitting diodes to a
flexible pad to maintain skin contact.
Near-infrared laser (also referred to as low-energy, low-level, or cold laser) has low power with
wavelengths of 600–1,000 nanometers (nm) or greater in certain cases (Chung, 2012). When applied to the
skin, it does not burn and produces little or no sensation. Near-infrared laser is proposed for three main
purposes: to promote wound healing, tissue repair, and the prevention of tissue death; to relieve
inflammation and edema because of injuries or chronic diseases; and to be used as an analgesic. It is
proposed as a treatment for serious neurological conditions such as traumatic brain injury, stroke, spinal
cord injury, and degenerative central nervous system disease (Chung, 2012).
Far-infrared therapy is a form of heat therapy delivered via heated saunas that exposes body tissues to
slightly higher temperatures. Far-infrared reportedly heats the body and achieves similar effects as a
conventional sauna but at more tolerable lower temperatures. The rationale for using far-infrared is that
the heating gently increases blood flow by expanding capillary blood flow, increasing oxygenation and
regeneration of the blood, and detoxifying the blood to improve overall health. Its purported medical
benefits include treatment of health problems such as high blood pressure, congestive heart failure, and
rheumatoid arthritis (Mayo Clinic, 2014).
Regulatory status:
The U.S. Food and Drug Administration (FDA) reclassified several earlier infrared devices as heating pads,
and their approved indications reflect these roots. Now classified as infrared lamps, these interventions are
Class II Physical Medicine Therapeutic Devices (product codes IOB, ILY, NHN, ONH) that emit energy at
infrared frequencies of approximately 700 nanometers (nm) to 50,000 nm (21CFR890.5500). Product
3
labeling varies, but generally these devices are intended for adjunctive use to provide relief of minor pain,
stiffness, and muscle spasm, and a temporary increase in local blood circulation.
In addition, the FDA has approved infrared lamps for stimulating hair growth (product code OAP), as
adjunctive treatment of post-mastectomy lymphedema (product code NZY), for electrosurgical cutting and
coagulation devices and accessories for tissue coagulation (product code GEI), and for laser treatment in
general and plastic surgery and dermatology (21CFR890.5500, 21CFR807.92, and 21CFR875.4400; FDA,
2014 using product code GEX). No devices using far-infrared have been approved for medical use, and at
least one warning letter was issued to a manufacturer of a far-infrared sauna for marketing its product in
the United States without marketing clearance or approval.
Searches
AmeriHealth Caritas searched PubMed and the databases of:
• UK National Health Services Centre for Reviews and Dissemination.
• Agency for Healthcare Research and Quality’s (AHRQ’s) National Guideline Clearinghouse and
other evidence-based practice centers.
• The Centers for Medicare & Medicaid Services (CMS).
We conducted searches on March 26, 2018. Search terms were: “Infrared Rays” (MeSH), “infrared therapy,”
and “Laser Therapy, Low-Level” (MeSH).
We included:
• Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and
greater precision of effect estimation than in smaller primary studies. Systematic reviews use
predetermined transparent methods to minimize bias, effectively treating the review as a
scientific endeavor, and are thus rated highest in evidence-grading hierarchies.
• Guidelines based on systematic reviews.
• Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple
cost studies), reporting both costs and outcomes — sometimes referred to as efficiency studies
— which also rank near the top of evidence hierarchies.
Findings
Eleven systematic and narrative reviews were identified for this policy. Ten systematic reviews examined
the effectiveness of near-infrared light therapy for treating: internal hemorrhoids (Johanson, 1992); anal