LCD Reference Article Response To Comments Article

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

A59679

Expand All | Collapse All
Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A59679
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: External Upper Limb Tremor Stimulator Therapy - DL39591
Article Type
Response to Comments
Original Effective Date
02/22/2024
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

N/A

Article Guidance

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:

  1. A beneficiary has been diagnosed with essential tremor (ET) based on postural or kinetic tremors of the hand(s), without other neurologic signs;
  2. 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;
  3. The beneficiary’s tremor has not been sufficiently improved through the use of one or more first-line pharmacologic agents (propranolol or primidone);
  4. The beneficiary is not a candidate for deep brain surgery (DBS), or DBS is not otherwise available or practical; AND
  5. 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. 

N/A

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L39591 - External Upper Limb Tremor Stimulator Therapy
Related National Coverage Documents
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
02/16/2024 02/22/2024 - N/A Currently in Effect You are here

Keywords

N/A