The response presented here is specific to individuals seeking government insurance coverage in the US.

That being said, it isn't uncommon for laws passed in the US to set a trend for other western nations. Also private insurance companies in the US tend to look to the trends of what Medicare and Medicaid cover and how they cover it.

Quick Notes

• Rent for 13 months => ownership
• No access to rented devices while in a hospital.
• Devices must be completely locked down and can't have other purposes.
• CMS reconsidering the restrictive coverage. See post dated Nov 7, 2014.
• CMS is researching a new definition of SGD. See post dated, Nov 25, 2014 below.
• A new congressional bill is in the House of Representatives, See post dated, May 2, 2015 below.
• The Steve Gleason Act passes!!! See post dated, July 16, 2015 below.

AAC

Augmentative and alternative communication

First paragraph from Wikipedia's article on it.

Augmentative and alternative communication (AAC) is an umbrella term that encompasses the communication methods used to supplement or replace speech or writing for those with impairments in the production or comprehension of spoken or written language. AAC is used by those with a wide range of speech and language impairments, including congenital impairments such as cerebral palsy, intellectual impairment and autism, and acquired conditions such as amyotrophic lateral sclerosis and Parkinson's disease. AAC can be a permanent addition to a person's communication or a temporary aid.

Many eye tracking users fall under this category. Anyone that uses eye tracking instead of using their vocal cords.

SGD

Speech Generation Device.

First paragraph from the Wikipedia article on it:

Speech-generating devices (SGDs), also known as voice output communication aids, are electronic augmentative and alternative communication (AAC) systems used to supplement or replace speech or writing for individuals with severe speech impairments, enabling them to verbally communicate their needs. SGDs are important for people who have limited means of interacting verbally, as they allow individuals to become active participants in communication interactions.

In the world of Eye Tracking and Gaze Tracking, people that need to speak using a computer, and use an eye tracker to point at words or phrases to be spoken are considered to be using a SGD, or Speech Generation Device.

Often times this will look like a tablet computer mounted to a wheel chair with an eye tracker mounted below the screen, aimed at the users eyes.

CMS

Centers for Medicare & Medicaid Services

First paragraph from Wikipedia's page on the institution.

The Centers for Medicare & Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the State Children's Health Insurance Program (SCHIP), and health insurance portability standards. In addition to these programs, CMS has other responsibilities, including the administrative simplification standards from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), quality standards in long-term care facilities (more commonly referred to as nursing homes) through its survey and certification process, clinical laboratory quality standards under the Clinical Laboratory Improvement Amendments, and oversight of HealthCare.gov.

Basically it is the government entity that makes the decisions about who and under what circumstances gets insurance from these two large US government insurance programs.

NCD

National Coverage Determination

First paragraph from Wikipedia's page on it.

A national coverage determination (NCD) is a United States' nationwide determination of whether Medicare will pay for an item or service. Medicare coverage is limited to items and services that are considered "reasonable and necessary" for the diagnosis or treatment of an illness or injury (and within the scope of a Medicare benefit category). In the absence of a NCD, an item or service is covered at the discretion of the Medicare contractors based on a Local Coverage Determination (LCD).

What Happened and is Happening

https://www.google.com/search?q=medicare+medicaid+funding+changes+2014+speech+generation+device

Below are the top hits when doing the above search on google on 10 October 2014. With quotes and comments.

Proposed Changes to Medicare Coverage for Speech-Generating Devices (SGDs) https://www.prentrom.com/news/proposed-changes-to-medicare-coverage-for-speech-generating-devices-sgds

Then, in March 2014, CMS issued a devastating blow to the community of disabled people who need SGDs with a “Coverage Reminder” which amended the 2001 coverage decision that allowed reimbursement of SGDs. (The devices are subject to regulation by the FDA as Class II medical devices 21 C.F.R. 870.3910.) This amendment severely limits the permitted functionality of the devices by stating that the device cannot perform non-speech functions and cannot be “unlocked” to access other applications such as email.

Medicare’s Reluctance to Embrace Technology: Effects on the Coverage of Speech Generating Devices http://www.medicareadvocacy.org/medicares-reluctance-to-embrace-technology-effects-on-the-coverage-of-speech-generating-devices/

Medicare Coverage for Speech Generating Devices http://www.alsa.org/news/archive/medicare-coverage-for-speech.html

CMS Capped Rental Rule http://www.aacinstitute.org/funding/CMSCappedRental.html

(linked from above CMS Capped Rental Rule) https://www.change.org/p/congress-white-house-centers-for-medicare-and-medicaid-services-request-that-speech-generating-devices-sgds-are-exempt-from-all-rental-requirements-and-remove-sgds-from-the-capped-rental-rule-that-takes-effect-april-1-2014

The video on the above link is very telling of the story. It is 6 minutes long, and worthwhile to listen to.

Capped Rental Description

Effective April 1, 2014, Medicare will no longer purchase an SGD for a beneficiary; instead it must be rented. Further, if a person is in the first 13 months of using a rented SGD and he or she enters a hospital, long term care facility, or hospice, Medicare will take the person's SGD and "voice" away.

Effective September 1, 2014, if a person's SGD has the potential for any function other than speaking (for example, email), then Medicare will not pay for the person's ability to speak through an SGD – even though Medicare has never paid for additional functionality beyond speaking (any additional functionality has always had to be privately paid).

Another recent article covers the issues very well.

ALS patients face loss of Medicare coverage for devices used to help speech

http://wapo.st/1zdevDK

or

http://www.washingtonpost.com/politics/als-patients-face-loss-of-medicare-coverage-for-devices-used-to-help-speech/2014/10/26/bb8f07ac-5d40-11e4-8b9e-2ccdac31a031_story.html

Here a response from one of the US Senators (Jeff Flake, AZ), dated October 30th, 2014, in response to one of form petitions listed above:

Thank you for contacting me about Medicare coverage for speech-generating devices. I appreciate your taking the time to share your comments on this issue with me.

As you know, in April 2014, the Centers for Medicare and Medicaid Services (CMS) made significant changes to several policies affecting access to speech-generating devices, which are electronic devices that enable those who are unable to speak to communicate by selecting messages to be spoken aloud. Medicare has covered the devices since January 2001 as part of its durable medical equipment benefit.

Among the changes, Medicare will now require users to rent the device for 13 months before owning it. Should patients require a hospital, hospice, or other facility admission, they may temporarily lose access to their device because Medicare payments for the machine are suspended during that time. During this period, patients will be forced to pay out of pocket for a device that would otherwise be covered by Medicare. Additionally, Medicare will no longer cover speech-generating devices that can be "unlocked" to expand their functionality, even if the patient pays for the additional services. This change will hinder a patient's choice about the functionality of the device once he or she owns it.

I am concerned that these policies could harm patients who require these devices to maintain communication in their lives. Patients who use these devices are Medicare's most vulnerable beneficiaries and it is critical to ensure that their medical needs are met. On September 11, 2014, I sent a letter with a number of my colleagues to CMS Administrator Marilyn Tavenner inquiring about these changes to CMS' policy. I look forward to receiving Administrator Tavenner's response and working with CMS to address these issues as quickly as possible.

Thank you again for contacting me. Please do not hesitate to do so again in the future. I also encourage you to visit my website, which may be found at flake.senate.gov.

Sincerely,

JEFF FLAKE United States Senator

Another important update!

http://www.medicareadvocacy.org/welcome-reprieve-for-people-who-need-speech-generating-devices-sgds-to-communicate/ Text of the article is included below:

CMS Rescinds Restrictive Policy and Will Reconsider Technological Advances

CMS announced yesterday that it has begun the process of updating its Medicare coverage policy for Speech Generating Devices (SGDs). A new SGD National Coverage Determination (NCD) is expected to be completed by July 31, 2015. While CMS considers a new coverage rule for SGDs, it announced that beneficiaries will “continue to have access to this critical technology.”

Accordingly, CMS instructed its contractors to rescind a restrictive proposed "Coverage Reminder" and coding review that was to be effective on December 1, 2014. The proposed Coverage Reminder would have limited Medicare coverage only to devices that were dedicated to speech, but were not capable of any other form of communication, such as text or email. The Center for Medicare Advocacy and other groups met with CMS to urge reconsideration of this harmful policy.

On November 6th, CMS backed away from this position, stating: “Since 2001, the technology of devices that generate speech and the ways in which the devices are used by patients to meet their medical needs has changed significantly. For example, patients now use speech devices to generate text and email messages for the purpose of communicating with their caregivers and physicians. Therefore, in light of the changes in technology and use of devices that generate speech, we are internally generating a reconsideration of this NCD to address coverage of devices that generate speech as well as other forms of communication.”

"The Center for Medicare Advocacy is grateful for and encouraged by CMS's announcement," says Judith Stein, Executive Director of the Center for Medicare Advocacy. "We applaud CMS leaders for reconsidering their position and articulating a plan that recognizes the importance of technological advances for the health and quality of life for all beneficiaries."

CMS also announced a public comment period, from November 6, 2014 to December 6, 2015, to review its technology policies and coverage for augmentative and alternative communication devices, such as Speech Generating Devices. "We look forward to participating in the comment period," says Kathleen Holt, an Associate Director at the Center for Medicare Advocacy. "We will continue to advocate for Medicare coverage of the full range of communication modalities so important to all people today – especially to people with debilitating and degenerative conditions."

"There is no way to describe losing the ability to communicate,” said Steve Gleason, former NFL player living with ALS and founder of Team Gleason. "With the recent policy changes, communication for those with the greatest need were being left to fade away quietly and die. But, with the help of the Center for Medicare Advocacy, we and others were able to launch a legislative email campaign resulting in over 40,000 emails submitted.” Gleason continued. “While we would all like to take credit for this news, I believe it was a unified effort that resulted in the policy reversal."

To further ensure access to SGDs, the Center continues to urge CMS to find ways to continue coverage for beneficiaries in Skilled Nursing Facilities and to monitor contractors that frequently deny Medicare for eye-tracking technology, needed by the most vulnerable beneficiaries to operate their SGDs.

Another excellent article that describes the issues as it relates to eye tracking. This one was posted by the Pittsburgh Post-Gazette dated November 16, 2014.

Medicare policy changes rattle those who depend on communication devices

http://www.post-gazette.com/news/transportation/2014/11/16/Medicare-policy-changes-rattle-those-who-depend-on-communication-devices/stories/201411160076

Below is a quote from the tail end of the article about it specifically hurting eye tracking/gaze tracking users.

Eye tracking

Speech-generating devices are needed by people with multiple disabilities.

Some people, like Ms. Sweterlitsch, use a head-controlled mouse. Others may be able to use their hands or even their toes.

And then there are people like Mr. Thomas, who is almost completely paralyzed. He can still smile, especially at any mention of his children, but otherwise, he mostly conveys his thoughts by darting his eyes at the appropriate letters or icons.

Eye-tracking technology is one of the most advanced and expensive ways of accessing the communication device.

Though Medicare hasn’t explicitly said it’s no longer covering eye tracking, manufacturers and assistive technology experts say they’ve recognized a pattern of denials.

In fact, Tobii Dynavox, a leader in eye-tracking technology, has taken at least a $1.6 million hit in the past 14 months because it has not been reimbursed by Medicare for the eye-tracking technology it has provided to beneficiaries, Ms. Rudnicki said. “You can certainly see how much we have put in and how much we don’t want the beneficiary to suffer.”

It’s unclear why it’s being denied. Again, CMS wouldn’t say.

But manufacturers have heard the technology has caused CMS to bristle because it is becoming a hot item in commercial products and anyone can use it, so they might wonder if people who don’t need it are jumping to ‘the cadillac’ when they could still be using a head mouse or another cheaper option.

Mr. Thomas doesn’t see it as a luxury — it bridges the divide between his mind and body.

“It allows me to keep my mind sharp and active instead of dwelling on this disease and sinking into a deep depression.”

Another excellent article on the issue. This one from AT Policy Advocacy, dated Winter 2014 by Amy S. Goldman. (AT = Assistive Technology)

http://us6.campaign-archive1.com/?u=e96897714b9d9d83d03182247&id=dd8bd585d8&e=6ae934c6e8#SGD_CMS

or

http://bit.ly/11UMT7O

ATIA Member Newsletter Excerpt

ATIA (Assistive Technology Industry Association) posted a letter to its members with regards to the CMS and SGD changes.

Everyone who was active in contacting their Congressional representatives, contacting CMS directly or encouraging others, including those people who benefit from the use of speech devices, to tell their story had a role in convincing CMS to re-consider its regulatory actions. This is a very positive first step for our industry and particularly for those very vulnerable populations we all serve.

The NCD revision process has a 30-day window for initial public comments, which started on November 6. A second comment period will be available some months from now, after CMS completes its research process.

While the NCD review is a very helpful step, the concerns related to the impact of capped rental reimbursement rules on our clients and the continued lack of timely review and approval of eye-gaze accessories remain to be addressed.

To learn more, you can read this informative article written by Amy Goldman for AT Program News: http://bit.ly/11UMT7O. The article gives a thorough outline of the issues at hand.

Read and Post Comments to CMS

If you are interested or involved in these issues, please read and respond here:

Comments are rolling in to CMS. Read comments. Submit yours by December 6th.

http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=26

Commentary

This is a positive first step by CMS regarding funding in the USA for SGDs, see below. Hopefully they can over turn the whole lock-down issue and approve funding for eye gaze again. We should know more in January about this.

November's Medicare Action on SGD Coverage

In response to a myriad of advocacy efforts that brought pressure on the agency, on November 6th, CMS issued a statement rescinding the February “clarification” and opened a benefit category determination process and 30-day comment period on SGDs. Disability advocates were initially encouraged. CMS appears to be reconsidering what constitutes a SGD:

Since 2001, the technology of devices that generate speech and the ways in which the devices are used by patients to meet their medical needs has changed significantly. For example, patients now use speech devices to generate text and email messages for the purpose of communicating with their caregivers and physicians. Therefore, in light of the changes in technology and use of devices that generate speech, we are internally generating a reconsideration of this NCD to address coverage of devices that generate speech as well as other forms of communication.

Medicare has also directed its payment contractors to revert to their pre-February 2014 treatment of SGD claims during this period. Advocates believe this action reverses--at least for the time being--the policy of refusing to cover SGDs that may be "unlocked."

Here is a related article tied to this same date:

Welcome Reprieve for People Who Need Speech Generating Devices (SGDs) To Communicate

CMS Rescinds Restrictive Policy and Will Reconsider Technological Advances

http://www.medicareadvocacy.org/welcome-reprieve-for-people-who-need-speech-generating-devices-sgds-to-communicate/

H.R. 628: Steve Gleason Act of 2015

https://www.govtrack.us/congress/bills/114/hr628

Full Title: To amend title XVIII of the Social Security Act to provide Medicare beneficiary access to eye tracking accessories for speech generating devices and to remove the rental cap for durable medical equipment under the Medicare Program with respect to speech generating devices.

Introduced: Jan 30, 2015

Medicare Advocacy call to action for Steve Gleason Act of 2015

http://org.salsalabs.com/o/777/p/dia/action3/common/public/?action_KEY=17777

Below is a quotation from the article

Tell Your Representatives to Pass the Steve Gleason Act

On April 29, 2015 the Centers for Medicare & Medicaid Services proposed revisions to a National Coverage Determination for Speech Generating Devices, which acknowledge that this technology has a vital impact on more than just "speech," and will allow coverage for a much broader array of communication.

From the CMS Proposed Decision Memo:

"...Since 2001, the technology of devices that generate speech and the ways in which the devices are used by patients to meet their medical needs has changed significantly. For example, patients now use speech devices to generate text and email messages for the purpose of communicating with their caregivers and physicians. Therefore, in light of the changes in technology and use of devices that generate speech, we are internally generating a reconsideration of this NCD to address coverage of devices that generate speech as well as other forms of communication."

We thank CMS - and all of you - who took action to make these proposed revisions possible, but there is more to do - now Congress needs to act!

The Steve Gleason Act (HR 628/S 984) of 2015 would improve access to Medicare coverage of eye tracking and gaze interaction accessories for Speech Generating Devices, and remove the rental cap that prevents SGD users from taking their communication devices into care settings such as long term care hospitals, skilled nursing facilities or hospice.

The Act has already passed the Senate. We need the House of Representatives to stand up for people with disabilities and pass this legislation now.

It is followed by information for contacting your Representatives, based on your zipcode.

Here is Medicare Advocacy's core site talking about SGDs

http://www.medicareadvocacy.org/medicare-info/medicare-part-b/durable-medical-equipment/speech-generating-devices-sgds/

The Center of Medicare Advocacy posted the following:

Forward Steve Gleason's Letter to Your Congressperson In Support of the Steve Gleason Act

http://org.salsalabs.com/o/777/p/dia/action3/common/public/

Steve Gleason wrote the following letter with regards to the Steve Gleason Act, and getting it through the House of Representatives.

The silence and isolation that comes from losing the ability to communicate does not discriminate between types of injuries, diseases, accidents or conditions. Speech Generating Devices (SGDs) are a critical pathway out of the silence and isolation for those who have experienced strokes, traumatic brain injury, cerebral palsy, Parkinson’s, ALS, spinal cord injuries, chemical accidents, many other types of injuries, and other complex neurological conditions.

I have ALS (Lou Gehrig’s Disease). When I was diagnosed in 2011, I was expected to fade away quietly and die, much like Lou Gehrig was expected to do after his famous speech 75 years ago. I am unable to move my body, except for my eyes. Through the use of eye tracking technology, I communicate through a device much like a tablet computer. This tablet is called a Speech Generating Device - SGD. The SGD allows me to maintain contact with the world around me – to express my thoughts, feelings and needs. It allows me to participate in everyday life with my family, friends, and community, to retain some independence. To continue living productively and purposefully.

A few others who have used SGD’s to communicate include Professor Stephen Hawking, and critic Roger Ebert. Imagine a world where they were silenced. Just as important are the tens of thousands who use this technology daily to continue living their lives with purpose. Teachers continuing to teach, architects continuing to design, veterans reentering society, and parents continuing to parent.

Congress is on the verge of passing legislation, known as the Steve Gleason Act of 2015 (H.R. 1919), that allows Americans covered by Medicare to have uninterrupted coverage of their ability to communicate. Without this legislation, Medicare takes away a person’s SGD if they have to leave their home to be admitted into a health care facility. Without the Steve Gleason Act, Medicare takes away a person’s SGD if they chose to elect home hospice care. Without the Steve Gleason Act, Medicare may not cover the accessories that are necessary to make an SGD work properly. Without this legislation, we will be turning the dial back to the days of Lou Gehrig, when people with debilitating diseases were simply expected to fade away quietly and die. That is not ok.

The Steve Gleason Act removes barriers to continuous, effective SGD Medicare coverage. It provides complete confidence and security. If a person qualifies for an SGD, they will be allowed to communicate for the rest of their lives. Medicare will not take away their SGD nor ability to communicate, and be productive. They will not be silenced nor isolated when they are the most vulnerable.

The Senate passed the Steve Gleason Act unanimously. The House Ways and Means Committee approved the Steve Gleason Act unanimously.

After the Steve Gleason Act is passed in the House of Representatives and signed by the President, people who use SGDs will be assured they have access to communication without fear of being silenced and isolated. People may have come to need SGDs by way of many types of injuries, diseases, accidents, or conditions, but like everyone, they all share a fundamental human need to communicate and live purposefully.

We need your support to help pass the Steve Gleason Act into law. Every day that passes without this legislation means people who want to be productive, will be forced to fade into a silent death.

Steve Gleason

Steve Gleason Bill Passes House: Landmark Victory For ALS Patients

http://www.techtimes.com/articles/69269/20150716/steve-gleason-bill-passes-house-landmark-victory-for-als-patients.htm

ALS patients with speech and motor disabilities may soon have easier access to better health care services and machines that will help them go through the demands of everyday life.

Last April 22, the US Senate passed the Steve Gleason Act (S. 984) that would allow ALS patients to keep their speech generating devices (SGD) as long as they are admitted to a hospital, nursing facility or hospice. The Steve Gleason Act will also provide ALS patients access to the internet and environmental controls and restore a patient's ability to upgrade his or her SGD.

The legislation then proceeded to the House of Representatives where the bill was introduced by Representative Cathy McMorris Rodgers (R-WA).

Today, the US House passed the bill which is now on its way to getting signed by President Barack Obama.

...