Response To Comments Article

Response to Comments: External Upper Limb Tremor Stimulator Therapy - DL39591

A59679

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
CGS Administrators, LLC	DME MAC	17013 - DME MAC	J-B	Illinois Indiana Kentucky Michigan Minnesota Ohio Wisconsin
CGS Administrators, LLC	DME MAC	18003 - DME MAC	J-C	Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi New Mexico North Carolina Oklahoma Puerto Rico South Carolina Tennessee Texas Virgin Islands Virginia West Virginia
Noridian Healthcare Solutions, LLC	DME MAC	16013 - DME MAC	J-A	Connecticut Delaware District of Columbia Maine Maryland Massachusetts New Hampshire New Jersey New York - Entire State Pennsylvania Rhode Island Vermont
Noridian Healthcare Solutions, LLC	DME MAC	19003 - DME MAC	J-D	Alaska American Samoa Arizona California - Entire State Guam Hawaii Idaho Iowa Kansas Missouri - Entire State Montana Nebraska Nevada North Dakota Northern Mariana Islands Oregon South Dakota Utah Washington Wyoming

Article Information

General Information

Article ID
A59679

Article Title
Response to Comments: External Upper Limb Tremor Stimulator Therapy - DL39591

Article Type
Response to Comments

Original Effective Date
02/22/2024

Retirement Date
N/A

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Article Text

During the 45-day comment period, which was open from May 25, 2023 through July 8, 2023, the DME MACs received comments from 26 commenters.

NOTE: DME MACs review all submitted comments and may choose to consolidate similar thematic comments or redact or withhold certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language or duplicate/near duplicate submissions. As a result, there may be a discrepancy between the number of comments in the article and the actual number of comments received.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the open comment period for the proposed External Upper Limb Tremor Stimulator Therapy Local Coverage Determination (LCD) (DL39591).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13:

“In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines."

Accordingly, the final policy and our response to comments are based on the best currently available published clinical evidence, to support optimal health outcomes in Medicare beneficiaries.

Response To Comments

Number	Comment	Response
1	All commenters were opposed to non-coverage of external upper limb tremor stimulator therapy (EULTST) for individuals with essential tremor (ET) and supported extending coverage to this therapy. The commenters reasoning for supporting coverage included the limited treatment options available, treatment gaps, side effects of the pharmacological treatment options, and the risks/costs associated with surgical options (e.g., deep brain surgery, focused ultrasound). The commenters noted EULTST is a non-invasive alternative to medications which may have been ineffective or not tolerated. Additionally, many patients are not candidates for surgical options or are not willing to try invasive treatment options. Several of the commenters discussed the literature and noted the International Essential Tremor Foundation (IETF) treatment algorithm as support for coverage of external upper limb tremor stimulator therapy for individuals with ET.	The proposed EULTST LCD was based upon the best available evidence at the time of posting. After consideration of the comments and additional supporting literature (published shortly after the comment period), the DME MACs are finalizing an EULTST LCD which extends coverage to EULTST for a select population of patients with ET. Refer to the final EULTST LCD for further details and coverage criteria.
2	Many commenters shared their personal experience and anecdotal evidence supporting the use of EULTST for the treatment of ET.	The DME MAC Medical Directors would like to thank the Medicare beneficiaries and their families for sharing their stories and experiences. We acknowledge that all were earnestly conveying their personal or loved ones' experiences with use of an external upper limb tremor stimulator. However, when determining if a treatment is “reasonable and necessary” for purposes of Medicare reimbursement, CMS instructs the DME MACs to rely on published peer-reviewed clinical evidence. Per CMS Program Integrity Manual (Pub. 100-08), Chapter 13, Section 13.5.3 (in relevant part): “In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.”
3	Several commenters noted that lack of access to EULTST will lead to added costs to the Medicare program for beneficiaries with ET due to the higher cost of surgical alternatives.	The determination of whether an item is reasonable and necessary is based upon the best available evidence and alternative treatment costs are not factored into the determination of coverage.
4	One commenter noted the lack of EULTST coverage may lead to inequity because lower income beneficiaries will not be able to access the alternative treatment.	The DME MACs are sensitive to these concerns when developing LCDs. The DME MACs are required to ensure DMEPOS items are reasonable and necessary based on the best available evidence prior to extending coverage. After consideration of additional literature that published shortly after the comment period, the DME MACs are extending coverage to EULTST for a select population of patients with ET. Refer to the final EULTST LCD for further details and coverage criteria.
5	Several commenters, including the American Academy of Neurology (AAN), noted that the AAN guidelines, while reaffirmed in 2022, did not evaluate literature for newer technology, such as EULTST, due to a guideline backlog.	The DME MACs appreciate the clarification provided by the commenters and have factored this information into our decision.
6	One commenter questioned why the evidence reviews on EULTST by UpToDate and ECRI were not cited in the proposed LCD.	When available, literature reviews conducted by UpToDate and ECRI are reviewed by the DME MACs during LCD development. The bibliographies of these reviews are hand-searched for any additional relevant primary publications; however, secondary sources (e.g., UpToDate, ECRI) are not themselves influential to our determination of reasonable and necessary, and are not typically cited in LCD bibliographies.
7	One commenter explained the mechanism of action of transcutaneous afferent patterned stimulation (TAPS) therapy in comparison to deep brain stimulation (DBS). The commenter explained why TAPS therapy is different than DBS in terms of potential habituation.	The DME MACs appreciate the clarification provided by the commenters and have factored this into our decision. Refer to the final EULTST LCD for further details and coverage criteria.
8	One commenter requested a delay in finalization of the proposed LCD until the results from two relevant clinical trials are published. The commenter provided advance copies of the manuscripts and indicated they would be published in the coming weeks.	The DME MACs appreciate the advance notice of the upcoming publications and waited to issue a final LCD until the publications were published in peer-reviewed journals. These additional publications have been incorporated into an updated Summary of Evidence and factored into the conclusion for the final EULTST LCD. Refer to the final EULTST LCD for further details and coverage criteria.
9	One commenter suggested the following coverage criteria for EULTST for individuals with ET: A beneficiary has been diagnosed with essential tremor (ET) based on postural or kinetic tremors of the hand(s), without other neurologic signs; The beneficiary is experiencing disabling hand tremors, as documented in a score of 3 or more on the Bain & Findlay Activities of Daily Living (BF-ADL) assessment of a dominant-hand activity related to eating, drinking, writing, or self-care; The beneficiary’s tremor has not been sufficiently improved through the use of one or more first-line pharmacologic agents (propranolol or primidone); The beneficiary is not a candidate for deep brain surgery (DBS), or DBS is not otherwise available or practical; AND Prior to 3 months of use, the beneficiary undergoes a clinical re-evaluation to document the clinical effect of the EULTS therapy, requiring (i) tremor improvement of at least 50% in the first 30-60 days of use, OR (ii) documented improvement in the beneficiary’s ability to perform one or more dominant-hand tasks in the BF-ADL evaluation, AND (iii) use of the EULTS device an average of 5 or more times per week.	The DME MACs have considered the suggested proposed coverage criteria and have incorporated many of these coverage criteria into the final EULTST LCD with some modifications based upon the best available evidence. Refer to the final EULTST LCD for further details and coverage criteria.
10	One commenter indicated that new medical devices will not be invented or available to Medicare beneficiaries if Medicare fails to extend coverage for innovative new technology when supported by multiple published studies.	The DME MACs are required to ensure DMEPOS items are reasonable and necessary based on the best available evidence prior to extending coverage. After consideration of additional literature that published shortly after the comment period, the DME MACs are extending coverage to EULTST for a select population of patients with ET. Refer to the final EULTST LCD for further details and coverage criteria.
11	One commenter suggested the DME MACs rushed to propose a noncoverage policy after the completion of the coding and fee schedule process in comparison to other technologies.	The DME MACs must prioritize the development of LCDs based on operational need and consider factors such as claim volume into such decision making.

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Non-Excluded CPT/HCPCS Ended Codes - Table Format

Code	Descriptor Generic Name	Descriptor Brand Name	Exclusion Effective Date	Exclusion End Date	Reason for Exclusion

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Associated Documents

Related Local Coverage Documents
LCDs
L39591 - External Upper Limb Tremor Stimulator Therapy

Updated On	Effective Dates	Status
02/16/2024	02/22/2024 - N/A	Currently in Effect	You are here

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Response to Comments: External Upper Limb Tremor Stimulator Therapy - DL39591

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