An on-demand, effective therapy for tremor relief
- Stephanie Soto
- 18 hours ago
- 3 min read
The FDA has approved the new Cala kIQ Plus system - a wearable neurostimulation device aimed to help control hand tremors in PD.
There was a previous device made by Cala, but this is a new and improved system! The device is meant to be work like a wristwatch. It delivers electrical stimulation to the nerves in the arm to stimulate the brain. The new system adds more ways to personalize treatment in attempts to optimize tremor control. Cala's system is based on similar principles to DBS. It used AI to personalize the amount of stimulation that gets delivered.
“Cala continues to elevate the patient experience and therapy outcomes by advancing wearable neuromodulation technology that treats action hand tremor in essential tremor and Parkinson’s disease. The Cala kIQ Plus system gives patients more control over how, when, and where TAPS Therapy is delivered for tremor management” - Deanna Harshbarger, Cala’s CEO
Studies showed that this device can limit arm and hand tremors, but this was shown in short term studies. It does not appear that long term studies have been conducted. The interesting part is that tremor improved in both arms, even though the device was only worn on one!
Does Medicare cover it?
A. Criteria for Initial Medicare Coverage of TAPS Therapy
1. The beneficiary has a diagnosis of essential tremor (ET); 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 TAPS Therapy 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 (1: no difficulty doing the activity, 4: cannot do the activity alone due to tremor) (Refer to LCD L39591 Appendix A); AND
6. If medically appropriate, tremor exacerbating medications (eg. stimulants, beta agonists) have been reduced or eliminated; AND
7. At least two pharmacological treatment options for the management of ET symptoms have been either tried and failed at maximal tolerable dosages (i.e., no or limited effect, intolerable side effects) OR considered and ruled out (e.g., not appropriate in context of the beneficiary's medical history); AND 8. TAPS therapy is prescribed as an alternative to invasive and/or permanent surgical treatment options (e.g., deep brain stimulation, magnetic resonance guided focused ultrasound, radiosurgery).
B. Continued Medicare Coverage Beyond First Three Months
Continued Medicare coverage of TAPS Therapy 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) to determine and document whether the beneficiary is:
1. Deriving benefit from TAPS Therapy as indicated by a 1-point improvement in the BF-ADL score in any eating, drinking, self care OR writing task scored as ≥ 3 prior to the initiation of therapy; AND
2. Adhering to therapy defined as use of TAPS therapy on 70% of days during a consecutive thirty (30) day period anytime during the first three (3) months of initial use.
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