LCD L39591: 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):

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,

The beneficiary is 18 years or older; and,

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

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

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,

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

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,

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:

• 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,

• 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):