LCD Reference Article Response To Comments Article

Response to Comments: Magnetic-Resonance-Guided-Focused Ultrasound Surgery (MRgFUS) for Essential Tremor

A58049

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Article ID
A58049
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Article Title
Response to Comments: Magnetic-Resonance-Guided-Focused Ultrasound Surgery (MRgFUS) for Essential Tremor
Article Type
Response to Comments
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05/28/2020
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The following are the comment summaries and contractor responses for the Novitas Solutions Proposed Local Coverage Determination (LCD) DL38495, Magnetic-Resonance-Guided-Focused Ultrasound Surgery (MRgFUS) for Essential Tremor which was posted for comment on December 26, 2019 and presented at the Open Meeting on January 16, 2020. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments

Number Comment Response
1

Multiple commenters wanted to bring it to the attention of Novitas that the service/procedure code 0398T is billed using a Category III CPT code, which would pose a challenge for professionals to secure an appropriate reimbursement level. Also, the commenters stated that the Centers for Medicare and Medicaid Services (CMS) does not set a national rate for the physician office setting (NFPE) for Category III CPT codes, but allows local MACs to determine the payment amounts to pay. For this reason, they would urge Novitas to assign physician fees appropriately in both the facility and non-facility setting for MRgFUS, as well as carrier price the service when performed in a non-facility setting.

We want to thank you for your comments. Fees are not set by a Local Coverage Determination (LCD) or its accompanying article. The process for submitting pricing information for an item is listed on our website and would be useful after a claim is submitted.

2

Multiple commenters stated that while it was reasonable to limit the treatment to a patient who was refractory to many medications, it is also reasonable to allow treatment of patients refractory to a standard medication, given the confidence they gained through the trial of the safety profile and efficacy of the procedure. They recommend that Novitas change the language for this criterion to: “a confirmed diagnosis of Essential Tremor refractory to medication such as propranolol, primidone, topiramate, gabapentin or benzodiazepines.”

Thank you for the comments; however, according to the American Society for Stereotactic and Functional Neurosurgery, an indication for the use of MRgFUS as a treatment option is the failure to respond to, intolerance of, or medical contraindication to use of at least two medications for ET, one of which must be a first line medication. Since no peer reviewed articles were submitted with this request, and the literature utilized during the creation of this policy supports the Covered Indications and Limitations, no changes will be made. Should data be forthcoming and support the recommended changes, it may be submitted through the reconsideration process.

3

A commenter noted that tremors can be more disabling in the non-dominant hand. Also, neurosurgeons do not routinely use the CRST and believe that other scales may be more relevant for some patients. They recommend that Novitas change the language for this criterion to: “moderate to severe postural or intentional tremor of the hand to be treated.” They also recommend that Novitas change the language to: “tremor that is sufficiently disabling with home or work activities,” since many clinicians do not routinely use the CRST as a clinical assessment.

We appreciate your comment; however, according to the Health Quality Ontario, essential tremors are the most common movement disorder and most often affects the dominant hand and arm. Since no peer reviewed articles were submitted with this request, and the literature utilized during the creation of this policy supports the Covered Indications and Limitations, no changes will be made. Should data be forthcoming and support the recommended changes, it may be submitted through the reconsideration process.

4

One commenter strongly disagreed with the requirement that the patient not be a surgical candidate. They believe that some patients and surgeons may have valid reasons for choosing MRgFUS over DBS.

We appreciate your comment; however, the policy currently states “the beneficiary is not a candidate for deep brain stimulation (DBS) (e.g., advanced age, anticoagulant therapy, surgical comorbidities, or has failed DBS, but has no retained cranial implants).” We believe the way it is currently written gives the surgeon the ability to make a sound medical decision.

5

A commenter would like to see some changes made to the “Limitations (not covered).” The first change the commenter would like to see made is with the limitation of a neurodegenerative condition. They believe the wording should be changed to “an advanced neurodegenerative condition.” They also believe that the degree of unstable cardiac disease, the severity of depression, cognitive impairment, and previous brain procedures should be made on a case-by-case decision between the surgeon and patient.

Thank you for your comments. Our current policy already states “treatment of beneficiaries who have an advanced neurodegenerative condition.” Also, according to the American Society for Stereotactic and Functional Neurosurgery, the degree of unstable cardiac disease, the severity of depression, cognitive impairment, and previous brain procedures are all limitations. Since no peer reviewed articles were submitted with this request, and the literature utilized during the creation of this policy supports the Covered Indications and Limitations, no changes will be made. Should data be forthcoming and support the recommended changes, it may be submitted through the reconsideration process.

6

Finally, the commenters would like to advise caution on the application of a skull density ratio.

Thank you for the comments; however, according to the American Society for Stereotactic and Functional Neurosurgery, a contraindication to the use of MRgFUS would be a skull density of <0.40. Since no peer reviewed articles were submitted with this request, and the literature utilized during the creation of this policy supports the Covered Indications and Limitations, no changes will be made. Should data be forthcoming and support the recommended changes, it may be submitted through the reconsideration process.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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