Letter to Marilyn Tavenner, Administrator Centers for Medicare and Medicaid Services - Make Speech Devices More Affordable

Letter

Administrator Marilyn Tavenner
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244

Dear Administrator Tavenner:

We write to urge the Centers for Medicare and Medicaid Services (CMS) to quickly update its national coverage determination (NCD) for speech generating devices (SGDs) under Medicare. Patients who use SGDs are some of Medicare's most vulnerable beneficiaries and CMS policy must ensure access to devices and accessory technologies that meet patients' health needs.

As defined by the 2001 NCD, SGDs are "speech aids that provide an individual who has severe speech impairment with the ability to meet his functional speaking needs." Over the last year, CMS and Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have made significant changes in several policies adversely affecting patient access to speech generating technology.

1. DME MACs issued a "Coverage Reminder" in 2014 as a means to issue policies that limit patients' abilities to use technological advances to expand the functionality of their current device. Given concerns expressed by the stakeholder community, CMS rescinded this "Coverage Reminder" and opened the 2001 SGD NCD for revision.

2. CMS changed the payment mechanism for SGDs from "Routinely Purchased" to a "Capped Rental" designation. This change in the designation of SGDs to Capped Rental results in Medicare ceasing rental payments for the device if the patient receives treatment in a hospital, hospice, or is admitted to another facility.

3. CMS and DME MACs have provided inconsistent guidance and claims processing for SGD accessories such as eye tracking technology. Patients have seen a significant increase in denials for eye tracking technology, with the DME MACs often claiming there is no benefit category for the device. Yet every DME MAC's local coverage determination for SGDs states "Accessories (E2599) for E2500 - E2510 are covered if the basic coverage criteria (1-7) for the base device are met and reasonable and necessary criteria for each accessory is clearly documented in the formal evaluation by the SLP."[1] It is critically important that patients with cerebral palsy, amyotrophic lateral sclerosis (ALS), Rett Syndrome, brain stem stroke, and other conditions in which patients experience paralysis have access to these technologies- without which access to the underlying SGD has no value.

As a result of outdated regulations and denied claims, some of Medicare's most vulnerable patients have been refused access to technology that allows them to communicate with family, physicians, and caregivers. As CMS seeks input on how to resolve this significant problem, we ask that you consider the following recommendations for a new NCD for SGDs that will better meet the medical and physical needs of patients.

1. With any new national coverage determination consider whether the device qualifies for coverage at the time the coverage criteria are assessed as opposed to how the device might be altered in the future.

2. Utilize the Secretary of Health and Humans Services' authority to create a process that allows patients to upgrade their SGDs without losing coverage of current devices. The NCD should make clear that SGDs with the capability to be upgraded with additional functionalities should not be considered non-covered.

3. Follow the DME MAC Local Coverage Determinations (LCDs) which states that SGD accessories, such as eye tracking technology, meet the criteria of reasonableness and necessity by specifically recognizing these devices are both medically necessary and covered by Medicare for patients.

4. Given the confusion around coverage of SGDs and devices, many claims have ended up in the overburdened Medicare appeals and redetermination processes. When CMS reaches the final stages of a new NCD for SGDs, we ask that you carefully review patients currently stuck in the appeals process and expedite approval for patients in need of SGDs and necessary accessories.

We are pleased that your agency has recognized that these policies need review, and believe that this vulnerable patient population deserves a prompt issuance of a revised national coverage determination that will afford patients access to these important SGDs.

Sincerely,