Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for (1) red light therapy machine for home use, (2) ultrasound machine for home use, and (3) cold therapy unit for home use. There is limited evidence in current medical literature supporting the use of red-light therapy, also referred to as low-level laser therapy (LLLT). Childress and Beutler report regarding the management of chronic tendon injuries, Other modalities such as prolotherapy, topical nitroglycerin, iontophoresis, phonophoresis, therapeutic ultrasound, extracorporeal shock wave therapy, and low-level laser therapy have less evidence of effectiveness but are reasonable second-line alternatives to surgery for patients who have persistent pain despite appropriate rehabilitative exercise. However, Baktir and colleagues report regarding the short-term effectiveness of LLLT, LLLT provides a benefit only for pain, whereas iontophoresis is beneficial for both pain and function. If the effect size is evaluated, LLLT is more influential than iontophoresis for decreasing pain. However, when we compared phonophoresis and iontophoresis in terms of effectiveness, we found that iontophoresis has better effects for pain, function, and grip strength. Lastly, in a systematic review and meta-analysis of randomized control trials on the effect of low-level red and near-infrared photobiomodulation on pain and function in tendinopathy, Tripoldi and colleagues concluded, There is very-low-to-moderate quality evidence demonstrating that photobiomodulation has utility as a standalone and/or adjunctive therapy for tendinopathy disorders. In this case, the patient is undergoing treatment for pain in both hands and chronic low back pain and has diagnoses including lateral epicondylitis, systemic lupus erythematosus, and chronic left sided radiculopathy. In notes, the provider recommended red light therapy for the associated diagnoses of lupus and lateral epicondylitis. Given the very-low-to-moderate quality of evidence supporting this treatment as an adjunctive therapy for tendinopathy disorders, the requested red-light therapy is not medically indicated. Therefore, a (1) red light therapy machine for home use is not medically necessary for the treatment of this patient.There is a paucity of controlled studies supporting the use of ultrasound therapy. Regarding physical modalities that are accepted among conservative treatment of wrist and hand tenosynovitis, Ferrara and colleages note, Laser therapy and therapeutic ultrasound were the most used and effective physical therapies for De Quervain tenosynovitis. Extracorporeal shock wave therapy (ESWT) was found to be the most efficient and safe therapy for Dupuytren disease; radiotherapy, electron beam therapy, targeted radiofrequency and laser therapy could be promising therapeutic options at Dupuytrens onset. ESWT turned out to be the most frequent physical means used for functional improvement and pain control in trigger finger. However, more high-quality studies are still needed to further define evidence-based practices for patients with trigger finger, Dupuytren disease, and De Quervain disease. In a narrative review of physical therapies for the conservative treatment of the trigger finger (TF), Ferrara and colleagues report, Ultrasound therapy (UST) has proven to be useful to prevent the recurrence of TF symptoms. Even if the results suggest the effectiveness of ESWT and UST for TF, future studies are necessary to understand the characteristics of the optimal treatment protocol for trigger finger. In a systematic review, Aiyer and colleagues explain, Therapeutic ultrasound is frequently used in the treatment of knee, shoulder and hip pain and is often combined with other physiotherapeutic modalities. The literature on knee arthritis is most robust, with some evidence supporting therapeutic ultrasound, though the delivery method of ultrasound (pulsed vs continuous) is controversial. As a monotherapy, ultrasound treatment may not have a significant impact on functional improvement but can be a reasonable adjunct to consider with other common modalities. In all three pain syndromes, especially for hip pain, further trials are needed to define the true effect of low-intensity ultrasound therapy on knee, shoulder, and hip pain. There is a paucity of evidence in current medical literature supporting the use of a cold therapy unit over self-applications of cryotherapies such as ice or cold packs. In an analysis on the effects of pain education and the combined use of cryotherapy and transcutaneous electrical nerve stimulation on the pain sensation, functional capacity, and quality of life of patients with nonspecific chronic low back pain, Caldas and colleagues concluded, With pain education, there was no difference between cryotherapy and transcutaneous electrical nerve stimulation alone, combined, or placebo mode in improving pain, functional capacity, and quality of life in patients with nonspecific chronic low back pain. In a literature review of the mechanisms and efficacy of heat and cold therapies for musculoskeletal injury, Malanga and colleagues found, There is limited evidence from randomized clinical trials supporting the use of cold therapy following acute musculoskeletal injury and delayed-onset muscle soreness. In this case, a note reported that the patient is undergoing treatment for post-laminectomy syndrome, and that the provider recommended cold therapy with an aqua release system at home as it was helping in physical therapy. However, despite being requested, the submitted records did not document a rationale on why the use of a formal cold therapy unit at home is required rather than a simpler technology such as the application of simple cold packs for the treatment of the patient's low back pain. Given that current medical literature does not support the efficacy of a cold therapy unit over simpler cold technologies, the requested cold therapy unit is not medically indicated. Therefore, a (3) cold therapy unit for home use is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested devices are not medically necessary for the treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in physical medicine and rehabilitation with sub-specialty certification in pain medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable