Wednesday, October 24, 2018

CPT CODE 0398T, 0071T, 0072T - Magnetic resonance procedure

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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