Summary Of Evidence

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Analysis of Evidence

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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.

For the purposes of this policy, speech generation is defined as audible generation of words or phrases and in addition, may include:

1. Communication via written text (i.e., email or text (SMS) messaging); or,

2. Communication via phone messaging.

Speech generating devices are defined as durable medical equipment that provides an individual who has a severe speech impairment with the ability to meet his or her functional, speaking needs. Speech generating devices are speech aids consisting of devices or software that generate speech (as defined above) and are used solely by the individual who has a severe speech impairment. The speech is generated using one of the following methods:

• Digitized audible/verbal speech output, using prerecorded messages;

• Synthesized audible/verbal speech output which requires message formulation by spelling and device access by physical contact with the device-direct selection techniques;

• Synthesized audible/verbal speech output which permits multiple methods of message formulation and multiple methods of device access; or

• Software that allows a computer or other electronic device to generate speech.

A speech generating device (SGD) (E2500, E2502, E2504, E2506, E2508, E2510, E2511) is covered when all of the following criteria (1-7) are met:

1. Prior to the delivery of the SGD, the beneficiary has had a formal evaluation of their cognitive and communication abilities by a speech-language pathologist (SLP). The formal, written evaluation must include, at a minimum, the following elements:
   

   1. Current communication impairment, including the type, severity, language skills, cognitive ability, and anticipated course of the impairment;

   2. An assessment of whether the individual's daily communication needs could be met using other natural modes of communication;

   3. A description of the functional communication goals expected to be achieved and treatment options;

   4. Rationale for selection of a specific device and any accessories;

   5. Demonstration that the beneficiary possesses a treatment plan that includes a training schedule for the selected device;

   6. The cognitive and physical abilities to effectively use the selected device and any accessories to communicate;

   7. For a subsequent upgrade to a previously issued SGD, information regarding the functional benefit to the beneficiary of the upgrade compared to the initially provided SGD; and

2. The beneficiary's medical condition is one resulting in a severe expressive speech impairment; and

3. The beneficiary's speaking needs cannot be met using natural communication methods; and

4. Other forms of treatment have been considered and ruled out; and

5. The beneficiary's speech impairment will benefit from the device ordered; and

6. A copy of the SLP's written evaluation and recommendation have been forwarded to the beneficiary's treating practitioner prior to ordering the device; and

7. The SLP performing the beneficiary evaluation may not be an employee of or have a financial relationship with the supplier of the SGD.

If one or more of the SGD coverage criteria 1-7 is not met, the SGD will be denied as not reasonable and necessary.

Codes E2500, E2502, E2504, E2506, E2508, E2510, E2511 perform the same essential function - speech generation. Therefore, claims for more than one SGD will be denied as not reasonable and necessary.

The capability to download updates to the covered features of the device from the manufacturer or supplier of the device is covered. See related Policy Article for additional Non-Medical Necessity Coverage and Payment Rules.

ACCESSORIES:

Claims for accessories to SGDs must meet the general coverage requirements for the base SGD described in criteria 1-7 above. Claims for SGD accessories for beneficiaries who do not meet criteria 1-7 above will be denied as not reasonable and necessary.

Alternative input devices are covered when a beneficiary is unable to use standard input devices. Claims for alternative input devices for beneficiaries who are able to use standard input devices will be denied as not reasonable and necessary.

Eye tracking and gaze interaction accessories for speech generating devices are covered when furnished to individuals with a demonstrated medical need for such accessories.

If the SGD is denied as not reasonable and necessary, any related accessories will be denied as not reasonable and necessary.

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.