External Upper Limb Tremor Stimulator Therapy

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act §1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

• The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
• The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
• Refer to the Supplier Manual for additional information on documentation requirements.
• Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act §1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

INITIAL COVERAGE:

An external upper limb tremor stimulator of the peripheral nerves of the wrist (E0734) is covered when the beneficiary has had a clinical evaluation (in-person or via Medicare-approved telehealth) by the treating practitioner, and all of the following criteria are met (See the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section of the LCD-related Policy Article):

1. The beneficiary has a diagnosis of essential tremor (ET) (Refer to the Group 1 ICD-10 code list in the LCD-related Policy Article for applicable diagnoses);and,

2. The beneficiary is 18 years or older; and,

3. The beneficiary has no contraindications to external upper limb tremor stimulator therapy; and

4. The external upper limb tremor stimulator is being prescribed to treat the beneficiary’s dominant upper limb; and,

5. The severity of ET symptoms significantly impairs the beneficiary’s ability to perform dominant hand, upper-limb-related activities of daily living (ADLs) as indicated by a score of greater than or equal to 3 on the Bain & Findley Tremor ADL Scale (BF-ADL) for at least one (1) assessment item for eating, drinking, self-care, or writing (See Appendix A); and,

6. If medically appropriate, tremor exacerbating medications (e.g., stimulants, beta agonists) have been reduced or eliminated; and,

7. At least two (2) pharmacological treatment options for the management of ET symptoms have been either tried and failed at maximal tolerable treatment dosages (i.e., no or limited effect, intolerable side effects) or considered and ruled out (e.g., not appropriate in the context of the beneficiary’s medical history); and,

8. External upper limb tremor stimulator therapy is being prescribed as an alternative to invasive and/or permanent surgical treatment options (e.g., deep brain stimulation, magnetic resonance guided focused ultrasound, radiosurgery).

When an external upper limb tremor stimulator (E0734) is covered, the supplies and accessories (A4542) will also be covered.

If all of the initial coverage criteria 1 through 8 are not met, claims for codes E0734 and A4542 will be denied as not reasonable and necessary.

An external upper limb tremor stimulator (E0734) for the non-dominant upper limb will be denied as not reasonable and necessary.

CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

Continued coverage of external upper limb tremor stimulator therapy, and related supplies and accessories (E0734 and A4542) beyond the first three (3) months of therapy requires that no sooner than the 60th day but no later than the 91st day after initiating therapy, the treating practitioner must conduct a clinical re-evaluation (in-person or via Medicare-approved telehealth) and document that the beneficiary is:

1. Deriving benefit from external upper limb tremor stimulator therapy as indicated by a 1-point improvement in BF-ADL score in any eating, drinking, self-care, or writing task scored as greater than or equal to 3 prior to the initiation of therapy; and,
2. Adhering to external upper limb tremor stimulator therapy (adherence is defined as use of external upper limb tremor stimulator therapy on 70% of the days during a consecutive thirty (30) day period anytime during the first three (3) months of initial use).

If the treating practitioner’s clinical re-evaluation does not occur until after the 91st day, but the re-evaluation demonstrates that the beneficiary is benefiting from and adhering to external upper limb tremor stimulator therapy, continued coverage of external upper limb tremor stimulator therapy will commence with the date of that re-evaluation.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

Background

A task force of the International Parkinson and Movement Disorder Society has defined tremors as an involuntary, rhythmic, oscillatory movement of a body part.¹ The task force also proposed a definition for essential tremor (ET) as a tremor syndrome of at least 3 years duration, excluding isolated head or isolated voice tremors, in the absence of inherited dystonia, ataxia, or parkinsonism.¹ Based on a 2014 epidemiological study, the estimated number of ET cases in the United States was 7 million (6.38 to 7.63 million), corresponding to approximately 2.2% of the population, making it one of the most common movement disorders.² The prevalence of ET increases with age, with reported rates of 4% or higher in people over the age of 60 years.³ An exponential increase is seen with advancing age, with rates reaching in excess of 20% in those 95 years and older.³ The aim of this summary of evidence was to determine if external upper limb tremor stimulator therapy, also known as transcutaneous afferent patterned stimulation (TAPS) therapy, reduces ET symptoms immediately and 60-minutes after a therapy session, and if tremor stimulation therapy reduces ET symptoms in the longer term (≥ 3 months).

Food and Drug Administration (FDA) Approval

Cala Trio (External Upper Limb Tremor Stimulator):

https://www.accessdata.fda.gov/cdrh_docs/pdf17/DEN170028.pdf

https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203288.pdf

Literature Analysis

A randomized, double-blinded, sham-controlled pilot trial, by Lin, et al.,⁴ compared the efficacy of either median and radial nerve stimulation with a non-invasive, wrist-worn, peripheral nerve stimulation device (n = 10), or a sham device (n = 13) for the symptomatic relief of hand tremors in participants with ET. Efficacy was measured using a change in the Tremor Research Group’s Essential Tremor Rating Assessment Scale (TETRAS) Archimedes spiral drawing task post-stimulation compared with pre-stimulation, after a single treatment session. In the treatment group, blinded rater scores significantly improved post-stimulation (1.77 + 0.21) compared to pre-stimulation (2.77 + 0.22; p = 0.01). In the sham group, scores did not change significantly following stimulation (2.37 + 0.22) compared to pre-stimulation (2.62 + 0.14; p = 0.37). The response to treatment corresponded to an estimated hand tremor amplitude reduction of 60% + 8.4% and was significantly greater in the treatment than in the sham group (p = 0.02). Limitations of the study included the small cohort, short duration, limited details on the study methodology, and possible confounding of results due to pharmacologic treatments in use.

A multi-center double-blinded, randomized, sham-controlled trial, by Pahwa, et al.,⁵ evaluated the safety and effectiveness of a wrist-worn peripheral nerve stimulation device in 77 patients with ET (treatment n = 40, sham n = 37). The primary outcome of the study was improvement in tremor severity in the hand as measured by the TETRAS task 6 Archimedes spiral score following stimulation compared to sham stimulation based on a single in office session. The study failed to reach its primary endpoint; there was not a significantly larger improvement in the Archimedes spiral rating with stimulation treatment compared to sham (p = 0.26). There were statistically significant improvements in some secondary endpoints compared to sham including the individual forward postural hold upper limb tremor task (TETRAS task 4) sub-score (p = 0.004), the combined upper limb tremor task (TETRAS task 4) score (p = 0.017), and the total TETRAS performance score (p = 0.015). Subject-rated improvements in activities of daily living (ADLs) were significantly greater in 4 out of 7 ADL tasks in the treatment group compared with sham. A greater percentage of ET patients (88%) reported improvement in the stimulation group as compared to the sham group (62%) (p = 0.019) based on the clinical global impression-improvement (CGI-I) ratings. The study limitations included the small sample size, single treatment session, and sham device effects, which were not subtracted from the active scores.

The objective of a single-session, open-label study, by Yu, et al.,⁶ was to determine the time profile of therapeutic benefit from TAPS therapy for up to 60 minutes following a stimulation session in 15 patients (mean age 72.2 ± 8.6) with ET. Four hand tremor-specific tasks (postural hold, spiral drawing, finger-to-nose reach, and pouring) from the Fahn-Tolosa-Marin Clinical Rating Scale (FTM-CRS) were performed and assessed prior to, during, and 0-, 30- and 60-minutes following TAPS therapy. Mean FTM-CRS rating improved with TAPS therapy, with the peak tremor reduction occurring 30 minutes following the end of stimulation. Twelve (12) of 15 patients had improvement in mean clinical rating at least 60 minutes following the end of stimulation (p = 4.6e-9). Accelerometer-measured tremor power improved with TAPS therapy across all tasks; the postural hold task had the greatest reduction in tremor power, with a median peak 5.9-fold improvement (83% reduction) in tremor power occurring 30 minutes following the end of stimulation. Median peak improvements for the other tasks were 2.4-fold (57% reduction) for spiral drawing, 1.6-fold (38% reduction) for finger-to-nose reach, and 2.5-fold (59% reduction) for pouring. Eleven (11) of 15 patients had at least 60 minutes of benefit for postural hold, spiral drawing, and finger-to-nose reach tasks (p = 9.8e–8), while 10 of 14 patients had at least 60 minutes of benefit for the pouring task (p = 5.8e–7). Limitations of this study include the small sample size, the open-label design, the short duration of follow-up (single-session), heterogeneity in baseline ET severity, and 5 of 15 participants remained on their standard-of-care ET medication during the study, which may have confounded the results.

A prospective, multi-center, single-arm, open-label clinical trial, by Isaacson, et al.,⁷ evaluated the safety and efficacy of TAPS therapy in 205 patients over a 3-month period using a wrist-worn neuromodulation device. The study included 3 in-clinic visits consisting of a screening and enrollment visit, and a 1- and 3-month follow-up visit. Between visits, patients were instructed to use the device 2x/day for 40 minutes. The clinician rated TETRAS dominant hand score and patient-rated Bain & Findley Activities of Daily Living (BF-ADL) were the co-primary efficacy endpoints, while improve­ment in tremor power between the pre- and post-stimulation postural holds (measured by accelerometer) was the secondary efficacy endpoint. On average, patients completed at least one stimulation session per day for 78% of the days they were enrolled in the study and completed 68% of their total instructed stimulation sessions. The TETRAS dominant hand scores improved from baseline to the third study visit from a mean (standard deviation (SD)) of 12.6 (2.7) to 9.8 (3.5) (mean difference -2.8 (2.8), p < 0.0001). There was also a statistically significant improvement in the combined BF-ADL dominant hand score from a baseline mean (SD) of 18.4 (3.8) to 13.4 (4.4) (mean difference -5.0 (4.3), p < 0.0001). Accelerometer recordings before and after 21,806 treatment sessions showed that 92% of patients experienced improvement in tremor power, with 54% of patients experiencing ≥50% improvement; mean tremor power decreased from 1.1 ± 0.3 (m/s²)² pre-stimulation to 0.3 ± 0.1 (m/s²)² post-stimulation (p < 0.0001). No device-related serious adverse events (AEs) were reported, and 18% of patients experienced non-serious device-related AEs. Limitations of the study included its open-la­bel, single-arm design, high drop-out rate, lack of sham control, and unblinded clinical raters. Although the data did produce statistically significant results, the authors noted a large variability in the magnitude of effect on different tasks.

A 1-month, prospective, open-label, randomized trial by Dai, et al.,⁸ evaluated the clinical benefits of the addition of TAPS therapy to standard of care (SOC) compared to SOC alone for the management of upper limb ET symptoms in 310 patients (treatment n = 158, SOC n = 152) in the home setting. The primary endpoint was the difference in tremor power between the two study populations (measured before and after each TAPS session in the treatment group and once daily in the SOC group using device integrated motion sensors during postural holds). The secondary endpoint was the difference in the BF-ADL upper limb score (collected using patient surveys) improvement from baseline to the end of 1-month in the TAPS treatment arm compared to the SOC arm. The study met the primary endpoint in both the modified ITT analysis population (mITT, prespecified as all participants who completed the study duration) and PP analysis population, with significantly lower tremor power in the TAPS group compared to the SOC group [mITT: TAPS 0.017 ± 0.003 (m/s²)² (n = 133) vs. SOC 0.08 ± 0.014 (m/s²)² (n = 143); PP: TAPS 0.018 ± 0.003 (m/s²)² (n = 119) vs. SOC 0.082 ± 0.015 (m/s²)² (n=123); both p < 0.0001]. The secondary endpoint was also met in both the mITT and PP analyses. A total of 134 mITT participants (TAPS: n = 51; SOC: n = 83) and 114 PP participants (TAPS: n = 47; SOC: n = 67) completed BF-ADL scoring at baseline and 1-month. The improvement in BF-ADL scores was significantly greater in the TAPS group compared to the SOC group (mITT: TAPS 1.6 ± 0.43 vs. SOC 0.22 ± 0.37; p = 0.0187; PP: TAPS 1.5 ± 0.45 vs. SOC -0.1 ± 0.37; p = 0.0077). Additional exploratory endpoints found that 82% of patients experienced tremor improvement from before to after a treatment session, with 45% of patients experiencing a ≥ 50% tremor power reduction, and BF-ADL scores improved significantly from baseline to one month in the TAPS arm (p = 0.0006), with no significant improvements observed in the SOC arm (p = 0.55). A total of 169 (82%) of the patients ≥ 65 years older met the criteria for the severe ET subgroup analysis, which found a 5-fold greater improvement in tremor power in the TAPS arm compared to the SOC arm (p < 0.0001) and a 2.2-point greater improvement in BF-ADL score in the TAPS arm compared to the SOC arm (p = 0.0096). No serious device-related adverse events were reported. The study was limited by the open-label design, short duration of follow-up, lack of a placebo-controlled arm, variability in baseline SOC ET therapy, missing BF-ADL data, and self-reported outcome measures, such as the BF-ADL survey, potentially being subject to response bias.

A retrospective, post-market surveillance study, by Brillman, et al.,⁸ aimed to evaluate real-world usage and effectiveness of TAPS delivered by a non-invasive, wrist-worn, neuromodulation device in 321 patients (mean age 71 years) for the management of hand tremors associated with ET. Effectiveness was assessed by measurement of tremor power (i.e., frequency and amplitude of tremor motion to characterize tremor severity), via device-prompted postural hold tremor accelerometry measurements, immediately before and after a session of stimulation. Habituation of therapy was assessed in patients using the device for at least 1 year by evaluating effectiveness of therapy in their first 90 days of use compared to effectiveness after 90 days of use. Usage was defined as the average number of sessions, of at least 20 minutes duration, per week, and was gathered from data collected from integrated device logs. A total of 216 participants provided data that met effectiveness analysis criteria; immediately after TAPS therapy, 93% of patients had some reduction in tremor severity, with 59% of patients experiencing at least 50% reduction. Patients with the most severe pre-therapy tremors experienced the greatest reduction of tremor severity after stimulation (89% reduction). For patients who used TAPS therapy for greater than 1 year (n = 89), there was no significant habituation to therapy noted. Usage analysis identified total usage periods ranging from 90 to 633 days, with patients using the device 5.4 times per week, on average. Of the 69 participants (representing 21.5% of total patients) who returned a voluntary survey, 84% reported improvement in at least one key activity (i.e., eating, drinking, or writing), 65% reported improvement in overall quality of life, and 65% indicated a preference for TAPS therapy over both medication and surgical intervention for tremor management. The investigators recommended additional studies to better define TAPS dosing (i.e., number of sessions per week) and delivery. The study was limited by the retrospective design, lack of control for confounding, and the amount of missing or excluded data. Additionally, because postural hold data was only obtained immediately after a stimulation session, the duration of treatment effect is not known.

A retrospective, post-market analysis by Lu, et al.,¹⁰ evaluated the usage, effectiveness, and safety of TAPS non-invasive neuromodulation therapy for the management of hand tremors in patients with ET (n = 1,223 for usage analysis; n = 808 for effectiveness analysis) who had been using TAPS beyond a 90-day trial period in a real-world setting. The usage analysis included 260,207 TAPS sessions with a duration of usage between 90-1,233 days with an average usage of 5.6 sessions per week across time periods. Patients ≥ 65 years had approximately one more weekly therapy session compared to those < 65 (5.7 vs. 4.8 sessions per week, respectively). Of the 693 patients with a usage period of at least 360 days, 61% continued to use TAPS therapy. Of the 168 patients with a usage period of at least 720 days, 55% continued to use TAPS therapy. Effectiveness data included 36,411 TAPS sessions with patients recording an improvement in tremors in 60.5% of sessions, 37.1% rating as unchanged, and 2.4% rating as worsened. Accelerometry data showed that 88% of patients experienced tremor improvement in at least 50% of sessions, with an average 64% reduction in tremor power (tremor improvement ratio: 2.8), and 50% of patients experiencing a tremor reduction of at least 50%. Of note, patients with more severe pre-stimulation tremors experienced more tremor improvement after treatment sessions compared to patients with less severe pre-stimulation tremors, (mean within-subject tremor improvement ratio: 9.6; mean between-subject tremor improvement ratio: 7.5; post-hoc pairwise comparison: p < 0.001). Based on analysis of 17,527 session in 303 patients with a usage period of at least 360 days, no significant habituation was observed, with a 68-73% reduction in tremor power across all time periods. Minor safety complaints of discomfort (e.g., burning, pain, numbness, tingling) or skin irritation (e.g., itchiness, redness, rash) were reported in 10% of patients, but no serious safety events were reported. Study limitations included the retrospective design, exclusion of data due to the reliance on patients’ adherence to device utilization and performance of postural hold, low response rate to the voluntary survey, and potential for response bias for self-reported outcome measures.

Evidence Based Guidelines

The American Academy of Neurology (AAN) first developed an evidenced based guideline for the treatment of essential tremor in 2005, which was updated in 2011 and reaffirmed in 2022. These guidelines do not offer a recommendation for or against the use of the external upper limb tremor stimulation.¹¹

Professional Society Recommendations

No relevant Professional Society Recommendations were identified

Other

International Essential Tremor Foundation (IETF) – Essential Tremor in Adult Patients¹²

Summary of Consensus Guide (in relevant part):

Figure 1. Overview of Management of Essential Tremor

Step 1 – Examination to establish presence of tremor

Step 2 – Rule out other causes of tremor, such as medications, Parkinson’s disease, dystonia, etc.

Step 3 – First-line pharmacological approaches: propranolol, primidone, or a combination. Optional add-ons: Cala Trio and/or other non-invasive devices

Step 4 – Cala Trio and/or other non-invasive devices (if not added during Step 3). Second-line and third-line pharmacological approaches: topiramate, gabapentin, other beta blockers, or benzodiazepines

Step 5 – DBS [Deep Brain Stimulation], FUS [Focused Ultrasound], or other surgical approaches

At any time during steps 3-5:

• • • Assistive devices can be used
    • Discussions with patients regarding social stigmas, and for severe cases, social security/disability support

Secondary Analysis

Isaacson et al., 2023¹³ performed a literature search and secondary analysis to assess the clinical response of patients with ET who had high unmet need and/or were early responders to TAPS therapy. The high unmet need subgroup was defined as patients ≥ 65 years with severe tremor (defined as a score of ≥ 3 on at least one BF-ADL task related to eating, drinking, or writing activities) who had either failed or had a contraindication to use of at least one first-line ET medication (i.e., propranolol or primidone). From Pahwa, et al., 2019,⁵ 61% (47/77) of participants met criteria for the high unmet need subgroup. After a single treatment, the high unmet need subgroup had significant change in BF-ADL subset total score (p < 0.0001) and TETRAS Archimedes spiral score (p = 0.028) compared to sham; the significant change in TETRAS score was not seen in the entire treatment cohort when compared to sham. From Isaacson et al., 2020,⁷ 67.3% (138/205) of participants met the high unmet need subgroup criteria. Compared to baseline, there was a significant change in BF-ADL dominant hand score, TETRAS total score, and tremor power reduction (all p < 0.001) in the high need subgroup after three months of TAPS therapy; these changes were comparable to those experienced by the entire treatment cohort. The early responder cohort was defined as patients who used TAPS at home for at least 30 days for at least 5 days per week (i.e., 70% usage minimum) and who had: (1) an improvement of at least 1 point in a BF-ADL eating, drinking, or writing task that was scored of 3 or 4 at baseline, and/or (2) 50% median tremor power improvement across sessions. From Isaacson et al., 2020,⁷ 37% (51/138) of the high unmet need population were also identified as early responders. After 3 months of TAPS treatment, compared to baseline, there was a significant change in BF-ADL dominant hand score, TETRAS total score, and tremor power reduction in the early responder cohort (all p < 0.001). Additionally, of the early responder cohort, 94% had ≥ 50% reduction in tremor power, 94% reported at least 1 point improvement in BF-ADL score, and 98% continued using therapy ≥ 5 days a week. From Lu et al., 2023,¹⁰ 23.9% (191/799) of patients met the early responder criteria. After 3 months of TAPS treatment, compared to baseline, there was significant reduction in median tremor power in the early responder cohort and the original population (both p < 0.001). Of the early responder cohort, 86% had continued tremor reduction of ≥ 50% at 3 months, while 63% continued therapy ≥ 5 days a week. At 12 months follow-up, 76 participants met early responder criteria; 79% had continued tremor reduction of ≥ 50%, while 33% continued therapy ≥ 5 days a week. This study was limited by being a retrospective data analysis, and the heterogeneity of methodology in the studies identified from the literature search prevented a systematic review and meta-analysis from being performed.

The aim of this summary of evidence was to determine if external upper limb tremor stimulator therapy, also known as TAPS therapy, reduces ET symptoms immediately and up to 60-minutes after a stimulation session, as well as continues to reduce ET symptoms after stimulation sessions after longer term (≥ 3 months) use. Additionally, the evidence was examined to determine the clinical benefits (i.e., tremor severity, ADL performance) of TAPS therapy plus SOC compared to SOC alone, and to determine if long term (12 month) use of TAPS therapy led to clinically significant habituation to stimulation effects. Studies that were reviewed were analyzed for risk of bias (ROB). For randomized control trials (RCTs), ROB was assessed using the Cochrane Collaboration’s tool for assessing risk of bias.¹⁴ To evaluate the ROB in non-randomized studies, the ROB in Non-Randomized Studies of Interventions (ROBINS-I) tool was used.¹⁵ The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used as a method of grading the certainty of evidence, which can range from high to very low, and is defined as follows:¹⁶

Certainty of Evidence
Outcomes:

Symptom reduction with stimulation compared to sham: Low
Symptom reduction with stimulation compared to Standard of Care (SOC): Moderate
Symptom reduction 60 minutes after stimulation: Very Low
Symptom reduction long-term use (3 months): Very Low
Symptom reduction long-term use (greater than 3 months): Very Low
Improvement in upper limb ADL performance: Very low to Low
Habituation to stimulation with long-term use (≥ 360 days): Very low

Conclusion

Based on review of the currently available clinical literature, there is very low to moderate certainty evidence that TAPS therapy for the management of ET leads to a statistically and clinically significant reduction in tremor symptoms in the short-term (i.e., up to 3 months). One randomized controlled trial⁸ provided moderate certainty evidence that TAPS therapy in addition to standard of care (SOC) resulted in a significant reduction in tremor power immediately post-therapy compared to SOC alone. This same study provided low certainty evidence that TAPS therapy plus SOC was associated with a significantly greater improvement in the ability of participants to complete upper-limb-related ADLs compared to SOC alone. Two single-session, in clinic, randomized control trials^4,5 provided low certainty evidence that TAPS therapy may lead to a significant improvement in upper limb ET symptoms; however, the larger of the two studies did not meet its primary endpoint of a greater improvement in Archimedes spiral rating with TAPS therapy compared to sham. Additionally, two nonrandomized studies provided very low certainty evidence that TAPS therapy may improve ADL performance⁷ with a therapeutic benefit duration of up to 60 minutes post-stimulation.⁶ These studies were limited by heterogeneity in baseline patient characteristics (e.g., severity of ET, medication use), a high dropout rate, and potential bias in outcome measurement due to the open-label design.

In the longer-term (i.e., greater than 3 months), two real-world evidence studies^8,10 provided very low certainty evidence that TAPS therapy may lead to statistically and clinically significant reductions in ET symptoms, with participants with more severe pre-stimulation tremors experiencing greater reductions in symptoms post-stimulation. Additionally, in participants with a usage period of at least 360 days, there was no significant habituation to the therapeutic effectiveness of TAPS across time periods. These studies were limited by missing or excluded data, lack of control for confounding, and potential bias in patient selection.

A secondary analysis¹³ of data from a RCT,⁵ an open-label study,⁷ and a real-world evidence study⁸ suggested that TAPS therapy may have a statistically significant effect on tremor severity and ability to perform ADLs in patients with high unmet need (i.e., individuals with either severe tremors that affect ADLs, or who have failed or cannot use first-line ET medications), or in patients who are early responders (i.e., individuals who are 70% compliant with TAPS therapy in the first 30 days of treatment, and who experience either an improvement in upper limb ADL performance or a 50% reduction in median tremor power). Therapeutic response to TAPS therapy in the high unmet need subgroup was found to be similar to or greater than the overall population of patients with ET (e.g., when compared to sham, a significantly larger improvement in the Archimedes spiral rating with TAPS therapy was observed in the high unmet need subgroup, while the difference in improvement did not reach significance in the overall study population⁵). Additionally, participants in the early responder subgroup continued to experience clinically meaningful tremor power reduction with long-term (12 months) TAPS usage without habituation to the therapy.

In summary, in the short term, there is evidence to support that TAPS therapy leads to a decrease in tremor severity (moderate certainty) and improvement in the ability to perform upper-limb-related ADLs (low certainty) in patients diagnosed with ET compared to SOC. In the longer-term, there is evidence to support that TAPS therapy may provide continued post-therapy reduction in tremor severity without habituation (very low certainty). Finally, a secondary analysis described ET patient populations for whom TAPS therapy may lead to a greater therapeutic response compared to the overall ET population. Of additional note, there are limited non-invasive and/or non-permanent alternatives for patients with medication refractory ET symptoms that significantly affect their ability to perform ADLs.

Therefore, based on the currently available clinical evidence, initial coverage will be extended for a select patient population with limited available treatment options, and continued coverage, beyond three months, will be based upon documented benefit and compliance with TAPS therapy.

DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider.” It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

• SWO
• Medical Record Information (including continued need/use if applicable)
• Correct Coding
• Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.

Miscellaneous

Appendices

APPENDIX A:

Bain & Findley Activities of Daily Living (BF-ADL)¹⁷

For each item circle the number which describes how easy or difficult it is for you to perform the activity.

KEY:

Utilization Guidelines

Refer to Coverage Indications, Limitations and/or Medical Necessity

1. Bhatia KP, Bain P, Bajaj N, et al. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018;33(1):75-87.
2. Louis ED, Ottman R. How many people in the USA have essential tremor? Deriving a population estimate based on epidemiological data. Tremor Other Hyperkinet Mov (N Y). 2014;4:259.
3. Louis ED. The Roles of Age and Aging in Essential Tremor: An Epidemiological Perspective. Neuroepidemiology. 2019;52(1-2):111-118.
4. Lin PT, Ross EK, Chidester P, et al. Noninvasive neuromodulation in essential tremor demonstrates relief in a sham-controlled pilot trial. Mov Disord. 2018;33(7):1182-1183.
5. Pahwa R, Dhall R, Ostrem J, et al. An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor. Neuromodulation. 2019.
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