Introduction
Magnetic resonance – guided high – intensity ultrasound uses two technologies: magnetic resonance imaging (MRI) and ultrasound. It is a noninvasive procedure, which means the skin is not cut . MRI uses a magnetic field, radio frequency, and a computer to create detailed images of organs, tissues, and bones. Ultrasound uses sound waves at a higher frequency than a person can hear. Ultrasound is usually used to create images of body structures to help diagnose illnesses. But in this treatment, the ultrasound beams are at a different frequency and are focused on one area. Heat is created at the point where the high frequency beams meet , and the heat ablates ( destroys ) unhealthy tissue . The MRI is used to both guide the location of the ultrasound beams and to monitor treatment. This policy discusses when magnetic resonance – guided high – intensity ultrasound ablation may be considered medically necessary and covered by the health plan.
Note:
The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria . The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.
Documentation Requirements
The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following:
* Documentation that the requested service is for pain control that has failed for patient with bone metastases, or not a candidate for radiotherapy
OR
* Documentation that patient has essential tremors not responding to medication (such as beta – blockers or anticonvulsants)
Coding Code Description CPT
0398T Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation lesion, intracranial for movement disorder including stereotactic navigation and frame placement when performed
0071T Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume of less than 200 cc of tissue
0072T Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume greater or equal to 200 cc of tissue
53899 Unlisted procedure, urinary system
55899 Unlisted procedure, male genital system
76999 Unlisted ultrasound procedure (eg diagnostic, interventional
Note : CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).
Magnetic resonance – guided high – intensity ultrasound ablation of uterine fibroids is specifically identified by the following category III CPT codes:
* 0071T Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume of less than 200 cc of tissue
* 0072T As above, but with total leiomyomata volume great er or equal to 200 cc of tissue.
These CPT codes should not be used with 51702 (insertion of temporary indwelling bladder catheter, simple) or 77022 (magnetic resonance imaging guidance for, and monitoring of, visceral tissue ablation). Before the introduc tion of the specific category III CPT codes, the procedure may have been coded using several codes describing the individual components of the procedure. CPT codes 0071T – 0072T describe the comprehensive service.
The procedure may be performed in a magnetic resonance imaging suite with an open magnetic resonance scanner, which might not be available at many institutions. The procedure is performed in an outpatient setting, with the patient under conscious sedation. There are no specific CPT codes for the use of magnetic resonance – guided high – intensity ultrasound ablation in metastatic bone cancer. An unlisted code would be used based on the anatomic location of the metastasis being treated (eg, 23929 for the clavicle) or perhaps an unlisted radiation oncology code (eg, 77299 or 77499)
Consideration of Age
Magnetic resonance*guided focused ultrasound (MRgFUS) is considered medically necessary for bone metastases in adult patients, age 18 and older.
This is based on the randomized controlled trial that studied the use of MRgFUS in patients with bone metatsase
Evidence Review Description
An integrated system providing magnetic resonance*guided focused ultrasound (MRgFUS) treatment is proposed as a noninvasive therapy for uterine fibroids and pain palliation of bone metastases. MRgFUS is also being investigated as a treatment of other benign and malignant tumors.
Background
Uterine Fibroids
Uterine fibroids are one of the most common conditions affecting women in the reproductive years. Symptoms of uterine fibroids include menorrhagia, pelvic pressure, or pain.
Treatment
Several approaches currently available to treat symptomatic uterine fibroids include: hysterectomy, abdominal myomectomy, laparoscopic and hysteroscopic myomectomy, hormone therapy, uterine artery embolization, and watchful waiting. Hysterectomy and various myomectomy procedures are considered the criterion standard treatment.
Metastatic Bone Disease
Metastatic bone disease is one of the most common causes of cancer pain. Treatment Existing treatments include conservative measures ( eg, massage, exercise) and pharmacologic agents ( eg, analgesics, bisphosphonates, corticosteroids). For patients who do not respond to these treatments, standard care is external – beam radiotherapy. However, a substantial proportion of patients have residual pain after radiotherapy, and there is a need for alternative
treatments for these patients. One option, radiofrequency a blation, is addressed in a related policy.
Essential Tremors
Essential tremor (ET) is the most common movement disorder, with an estimated prevalence of 5% worldwide. ET most often affects the hands and arms, may affect the head and voice, and rarely includes the face, legs, and trunk. ET is heterogeneous among patients, varying in frequency, amplitude, causes of exacerbation, and association with other neurologic deficits
Treatment
The neuropathology of ET is uncertain, with some evidence suggesting that ET is localized in the brainstem and cerebellum. If patients with ET experience intermittent or persistent disability due to the tremors, initial therapy is with drugs (*-blockersor anticonvulsants). For medicine-refractory patients, surgery (deep brain stimulation or thalamotomy) may be offered, though high rates of adverse events have been observed
Magnetic Resonance*Guided Focused Ultrasound
Magnetic resonance – guided focused ultrasound ( MRgFUS ) is a noninvasive treatment that combines 2 technologies : focused ultrasound and magnetic resonance imaging (MRI). The ultrasound beam penetrates through the soft tissues and, using MRI for guidance and monitoring, the beam can be focused on targeted sites. Ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures. Ultrasound waves from each sonication are directed at a focal point that has a maximum focal volume of 20 nm in diameter and 15 nm in height/length. This causes a rapid rise in temperature (ie , to 65°C – 85°C), which is sufficient to ablate tissue at the focal point. In addition to providing guidance, the associated MRI can provide online thermometric imaging, a temperature “map” , to confirm the ther apeutic effect of the ablation treatment and allow for real – time adjustment of the treatment parameters
The U.S. Food and Drug Administration (FDA) has approved the ExAblate MRgFUS system (InSightec) for two indications : treatment of uterine fibroids (leiomyomata) and palliation of pain associated with tumors metastatic to bone. The ultrasound equipment is specially designed to be compatible with magnetic resonance magnets and is integrated into standard clinical MRI units; it also includes a patient table, which has a cradle that houses the focused ultrasound transducer in water or a light oil bath. Some models have a detachable cradle; only certain cradle types can be used for palliation of pain associated with metastatic bone cancer. For treating pain associated with bone metastases, the aim of MRgFUS is to destroy nerves in the bone surface surrounding the tumor. MRgFUS is also being investigated for treatment of other tumors, including breast, prostate, brain , and desmoid tumors as well as nonspinal osteoid osteoma.(For prostate cancer see Related Policy8.01.61 Focal Treatments for Prostate Cancer)
Summary of Evidence
For individuals who have uterine fibroids who receive MRgFUS, the evidence includes 2 small RCT s , nonrandomized comparative studies, and case series. Relevant outcomes are symptoms, quality of life, resource utilization, and treatment – related morbidity. One RCT (N=20) has reported some health outcomes, but its primary purpose was to determine the feasibility of a larger trial. It did not find statistically significant differences in quality of life outcomes between active and sham treatment groups, but it did find lower fibroid volumes after active treatment. This trial did not have an active comparator , the clinical significance of the primary outcome was unclear, and there were no follow – up data beyond 1 year. The second RCT (N=49) is ongoing; preliminary results at 6 weeks posttreatment, comparing MRgFUS with uterine artery embolization have shown that the 2 groups are comparable in medication use and symptom improvement following treatments. Patients in the MRgFUS group reported recovering significantly faster than patients in the
uterine artery embolization group, as measured by time to return to work and time to normal activities. In a separate 2013 comparative study, outcomes appeared to be better with uterine artery embolization than with MRgFUS. Long – term data on the treatment effects, recurrence rates, and impact on future fertility and pregnancy are lacking . The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals with metastatic bone cancer who failed or are not candidates for radiotherapy who receive MRgFUS, the evidence includes a sham- controlled randomized trial and several case series . Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment – related morbidity. The RCT found statistically significant improvements after MRg FUS in a composite outcome comprised of reduction in pain and morphine use, and in pain reduction as a stand – alone outcome. A substantial proportion of patients in the treatment group experienced adverse events, but most events were transient and not severe. The case series reported reductions in pain following MRgFUS treatment, consistent with the RCT. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome
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