E2500 Medicare coverage

Local coverage indication

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: 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: Current communication impairment, including the type, severity, language skills, cognitive ability, and anticipated course of the impairment; An assessment of whether the individual's daily communication needs could be met using other natural modes of communication; A description of the functional communication goals expected to be achieved and treatment options; Rationale for selection of a specific device and any accessories; Demonstration that the beneficiary possesses a treatment plan that includes a training schedule for the selected device; The cognitive and physical abilities to effectively use the selected device and any accessories to communicate; 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 The beneficiary's medical condition is one resulting in a severe expressive speech impairment; and The beneficiary's speaking needs cannot be met using natural communication methods; and Other forms of treatment have been considered and ruled out; and The beneficiary's speech impairment will benefit from the device ordered; and 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 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.

Excerpt from LCD L33739 version 23, effective 10/01/2024. CMS LCD L33739.

What NCD 50.1 says the item is

A. General Speech generating devices are considered to fall within the durable medical equipment (DME) benefit category established by §1861(n) of the Social Security Act. They are covered for patients who suffer from a severe speech impairment and have a medical condition that warrants the use of a device based on the following definitions. 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 and are used solely by the individual who has a severe speech impairment.

National coverage indication, NCD 50.1

B. Nationally Covered Indications N/A C. Nationally Non-Covered Indications Internet or phone services or any modification to a patient’s home to allow use of the speech generating device are not covered by Medicare because such services or modifications could be used for non-medical equipment such as standard phones or personal computers. In addition, specific features of a speech generating device that are not used by the individual who has a severe speech impairment to meet his or her functional speaking needs are not covered. This would include any computing hardware or software not necessary to allow for generation of audible/verbal speech, email, text or phone messages, such as hardware or software used to create documents and spreadsheets or play games or music, and any other function a computer can perform that is not directly related to meeting the functional speaking communication needs of the patient, including video communications or conferencing. These features of a speech generating device do not fall within the scope of § 1861(n) of the Social Security Act and the cost of these features are the responsibility of the beneficiary.

Excerpt from NCD 50.1 version 2. CMS NCD 50.1.

From A52469

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD. Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below. The medical necessity requirements for each accessory (E2599) for E2500, E2502, E2504, E2506, E2508, E2510 must be clearly documented in the formal evaluation by the SLP. For alternative input devices, there must be information in the SLP evaluation about why standard input access devices are unable to be used. When codes E2511, E2512, E2513, E2599 are billed, the claim must include all of the following information: Description of the item or service Manufacturer name Product name and number Additionally, claims for HCPCS code E2599 must include the supplier price list (PL) amount. If billing a multicomponent mounting system, list each component’s manufacturer and product name and number.

CMS source A52469

From A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs

GENERAL There are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Before submitting a claim to Medicare, the DMEPOS supplier must have on file an SWO, a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific

CMS article A55426