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As they lay dying: Medicare rules rob voiceless ALS patients of the ability to communicate

Editor’s Note: Journalist Philip Moeller, who writes widely on health and retirement, is here to provide the Medicare answers you need in “Ask Phil, the Medicare Maven.” Send your questions to Phil.

Moeller is a research fellow at the Center on Aging & Work at Boston College and co-
author of “How to Live to 100.” He wrote his latest book, “How to Get What’s Yours: The Secrets to Maxing Out Your Social Security,” with Making Sen$e’s Paul Solman and Larry Kotlikoff. He is now working on a companion book about Medicare. Follow him on Twitter @PhilMoeller or e¬mail him at medicarephil@gmail.com.


In the pantheon of dreaded diseases, amyotrophic lateral sclerosis (ALS) stands at the top. It attacks and kills motor neurons that control just about everything that makes our bodies and minds work. As the neurons die, so do the muscles and related functions they control. About 5,000 people in the U.S. are diagnosed with ALS each year. Most are dead within a few years.

Small motor skills tend to go first, and then larger muscle groups stop working. Some forms of ALS first attack the hands, arms, and legs. Others target speech and breathing. Some PALS – People with ALS – die quickly, while others survive for years and even decades. Near the end, people often lose the ability to do anything on their own and become trapped in their motionless bodies, unable to speak or eat or breathe without mechanical assistance.

I have written about ALS for several years. The PALS I have met are never without a communications device, be it a laptop computer or, increasingly, a smart phone slung around their necks.

New York Yankee Lou Gehrig died from ALS nearly 75 years ago. He is remembered for his farewell speech at Yankee Stadium in 1939, but not for the images of what he was like when he died nearly two years later in June 1941. Scientist Stephen Hawking miraculously has survived with ALS for more than 50 years, permitting the world to see what the disease can do and allowing us all to marvel at how he has persevered, and how technology has allowed him to continue his work and life.

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Hawking’s synthesized voice has become famous in its own right, most recently in the hit biopic “The Theory of Everything.”

In the United States, Steve Gleason has become a prominent face of ALS. Gleason, a former New Orleans Saints’ football player, was diagnosed with ALS in 2011. Today, ALS has taken away literally all his body’s capabilities. He retains voluntary control of his eyes and, by using a computer and sophisticated software, he is able to communicate by turning his eye movements into text and synthesized speech. He and his foundation are working with vendors — particularly Microsoft — to develop better and cheaper communications solutions for people who no longer can write or speak for themselves.

Now, imagine if Stephen Hawking had no voice and that he was unable to communicate at all with the outside world. Imagine if Steve Gleason’s eye-gaze technology was taken away from him. In early 2014, Medicare changed some of its rules and effectively took away the ability of many to communicate at a time in their lives when this often is the only link they have to the outside world.

The Medicare policy switch involves speech generating devices, also known as SGDs. The changes were harmful and, from a vantage point of more than a year removed, appear incredibly insensitive if not cruel on humanitarian grounds. The numbers of people affected are relatively small and the amount of annual claims involved, advocates say, is on the order of $20 million. In the big picture of an agency that spends roughly $600 billion every year, SGDs are a financial afterthought. But they are an enormously big deal to the ALS community.

I wrote about this situation last year. So did other journalists. Exposing this problem would lead to its quick solution, I thought. And when last year’s Ice Bucket Challenge raised more than $100 million for ALS research, I again thought that all these resources would help overturn or at least negate Medicare’s actions. I was wrong.

After an extended campaign to boost awareness, including massive letter-writing efforts to U.S. senators and representatives, a solution to these issues finally appears at hand. But it’s not here yet. And during the 18 to 24 months that it may take to resolve these issues, hundreds of PALS and thousands of their family members and friends have been and are being denied the opportunity to communicate, often very near the end of their lives.

The changes began early last year with what Medicare officials describe as a routine mandated review of existing Medicare rules. This is not an uncommon process. In the case of SGDs, the review included revisiting the terms of what is called a National Coverage Directive, or NCD. There are many, many NCDs affecting the things that Medicare will and won’t cover and the often technical definitions of what constitutes a covered claim eligible for payment under Medicare.

The NCD for computer-based SGDs had been in effect since about 2001. Louis Golinker is a lawyer and relentless supporter of ALS causes. He set up an organization called the Assistive Technology Law Center in Ithaca, New York, to deal with SGDs and related issues.

Going back to 2001, he recalled in an interview, Medicare paid the full share of SGDs when they were delivered, at which time they became the property of the recipient. The devices were shipped in what is called “unlocked” form, meaning that recipients could use them not only for their approved communication purpose but also as computing devices, to access the Internet, send emails and browse websites for information, news and entertainment. Medicare never paid for any of these additional uses, and it was understood by the ALS community that such auxiliary uses were out-of-pocket expenses not covered by Medicare.

In its 2014 NCD review, Medicare decided it had been misinterpreting the earlier NCD all along. In an updated communication called a “coverage reminder,” it said the earlier rule clearly intended to exclude the approval of SGDs that could be used as computing and communications devices outside the scope of the person’s narrowly defined medical need for the device. The actual NCD did not change, just the agency’s interpretation of the document’s intent.

“Medicare policy said before, and I think it still says now, that you can do what you want with the device,” Golinker maintains. But that’s not the way it’s worked out. “The policy change in February (of 2014) says they can never be unlocked,” he says. “The manufacturer of the device was told by Medicare that if you unlock the device, we won’t pay for it.”

At about the same time, and for reasons it has never fully explained, Medicare moved SGDs from a category of items that were purchased by recipients to a regulatory category called “capped rental.” In this rental program, Medicare would cover rental of an approved SGD for 13 months, at which time it would become the property of the recipient.

This may seem like a benign bureaucratic change but it is not. Placing SGDs in this new billing category has forced manufacturers to continue locking all SGDs that are shipped, preventing their recipients from using the devices to access the Internet and for remote communications, even though they are willing to pay for these expanded capabilities themselves.

It also has forced manufacturers and health care providers to physically remove SGDs from people who used them at home when, for various medical reasons, they later needed to enter a hospital or nursing home or hospice care. In fact, even entering a hospice program in the patient’s own home has been cause enough to remove the SGD they were using in the same setting as before.

SGD claims are administered by four companies that oversee geographic service regions for processing Medicare claims involving durable medical equipment (DME), a category that includes SGDs. In addition to regular SGDs, some severely disabled people such as Steve Gleason need SGDs that include what is called eye gaze tracking technology.

At about the same time that Medicare changed its interpretation of the NCD for SGDs and moved them into the capped-rental category, three of the four DME contractors dramatically increased their rejections of claims for eye gaze SGDs, often on the basis that the units were not covered under Medicare rules.

The largest U.S. maker of such units is called Tobii Dynavox. Tara Rudnicki, president of its North American operations, says the company has never been told why Medicare changed its approval policies. The company has documented subsequent claim approvals and rejections and found significantly higher rejection rates among three of the four DME contractors. The behavior of the fourth vendor did not change at all, she notes. Efforts to get comments from the DME contractors were unsuccessful.

“This has been, to be honest, a little bit baffling,” says Patrick Wildman, vice president of public policy for the ALS Association, the disease’s primary advocacy and fund-raising group. “You had these three different issues that came out at about the same time, for reasons that were never really explained.” Further, the three issues interacted in ways that worsened the impact of the changes.

The rented SGDs now being shipped only as locked units still could perform at least basic communications services to caregivers and family members in the same room as the patient in the home where he or she lived. But if the patient needed to go into a hospital, nursing home or, as it often turns out, a hospice program, the capped-rental program no longer pays for the device.

“Technically, Medicare will stop paying the rent on your device because under the rules, the facility that you go to is supposed to get a bundled payment from Medicare that should cover everything you need in the facility,” explained Kathleen Holt, associate director of the Center for Medicare Advocacy.

Tobii Dynavox and other SGD vendors are caught in the middle of these regulatory changes. “The way CMS (the Centers for Medicare and Medicaid Services) did this was awful,” Rudnicki says. “All along, we have been trying to get them to understand what the devices do and what they deliver to the customer.”

The combined effect of the three policy changes “has been devastating,” she says. “I don’t think they really understood; they did not actually understand the impact of these decisions on the person.”

She says the company feels forced to ship only locked SGDs. “We have to do that” but “we have tried in every case not to do that because this is not in the interest of the patient.” The company has appealed rejections of eye gaze claims, which has the effect of allowing the patient to keep the unit while the appeal is being heard. To date, Rudnick says, the company has units worth nearly $2 million in patients’ possession for which it has not yet been paid.

The ALS Association has a “loaner” program in its local chapter offices around the country, but its meager supplies of SGDs was overwhelmed by demand. Although the organization was in the enviable position last year of receiving a bonanza from the Ice Bucket Challenge, these funds were contributed to support research into ALS treatment and cures, not to buy SGDs.

That emergency role has fallen to the charitable foundation set up by Steve Gleason. When word got out that SGDs were no longer being provided with Internet capabilities and that Medicare contractors were rejecting claims for eye gaze technology, people started turning to what’s known as Team Gleason for help.

“We’re a very small grass-roots organization,” says Clare Durrett, the associate executive director at the Gleason Initiative Foundation. “We’ve really been maxed out on this.”

Normally, the foundation might spend $30,000 or so every three months helping out people with communications emergencies. Durrett estimates it has spent $1.5 million during the past six months buying SGDs – often at prices above what Medicare would pay. “We’ve bought nearly 100 devices in the last six months and have 12 on order right now,” she says.

After the ALS community began lobbying individual members of Congress to look into the situation, Medicare said it would suspend the effective date of the revised NCD and look into redrafting the rules. This apparently led some officials to believe the problem was over, but the withdrawal had nothing to do with the capped-rental rule or the stepped-up rejections of claims for eye gaze devices. Tobii Dynavox has continued to ship only locked units.

In January, Gleason went to Washington as a guest at the State of the Union Address. He also attended a meeting with legislators, ALS advocates and two key health care officials, Sylvia Burwell, secretary of the Department of Health and Human Services, and CMS Medicare director Sean Cavanaugh.

Holt attended the meeting and says she was struck by the clear sense that the government officials didn’t really understand the hardships experienced by PALS because of their altered policies.

“We said to them, ‘Why are you doing this? Why are you taking away the capabilities that you’ve let people have for the past 13 years?’ It’s so mean-spirited. It just felt like an assault.”

The government officials in the meeting mistakenly thought that withdrawing the revised NCD had restored the manufacturers’ ability to once again ship unlocked devices. “We communicated this to Medicare,” Holt said. “I think they didn’t understand how urgent this is.”

Durrett, also at the meeting, recalled that “Cavanaugh told us they were mandated to go back and take a look at all of their rules, and they were not following the letter of the law” in their earlier interpretation of the NCD. Secretary Burwell, Durrett recalled, said that legislation might resolve the issues more quickly than further regulatory action.

“She seemed completely receptive, and disheartened about the situation,” Durrett said, adding that Burwell’s father-in-law died of ALS and that she had been active in an ALS Association chapter in the Seattle area.

Less than 10 days after the meeting, the Steve Gleason Act was introduced in Congress. It would end rentals of SGDs and rejections of claims for eye gaze technology. Assuming that Medicare went ahead with its plans to revise the disputed NCD, the problems finally would be addressed.

On April 22, the Senate passed the Steve Gleason Act. It is scheduled for House action next month.

On April 29, Medicare issued a revised NCD for SGDs that also could take effect in July. It included an expanded definition of allowable communications technologies that acceptable SGDs may employ. The revised NCD is similar to the policy Medicare followed from 2001 to early 2014.

CMS declined to answer specific questions submitted to it about SGD regulatory actions other than to say that the agency is committed to helping beneficiaries. A spokesman pointed to the revised NCD as evidence that the agency is being responsive to changing technology and understands the need to allow beneficiaries broader access to new communications technologies.

Despite the rosy sunset taking shape, SGDs are still locked today. And the impact of the capped-rental policy is still being felt.

Rick is 58 and was an assistant manager at a Kroger’s in London, Kentucky, before being diagnosed with ALS in 2012. His legs went first and then his hands and, more recently his vocal chords. “It started taking over his speech at the end of 2014,” says his wife, Judy, who asked that their last name not be used because she didn’t want to upset anyone at Medicare.

“I can barely hear him, and I have to get really close to do that,” she says. “He can’t hold a magazine. He can’t read a book. He can’t do anything.”

Judy says she heard about eye gaze technology and that Rick was approved for a device by Medicare. Even though the device would be locked, being able to communicate with her husband at home was enormously important. After months of paperwork and approvals, the couple was ready to take delivery of a machine last February, with specialized training to follow.

The day before the device was scheduled to arrive, Judy recalls, she spoke with a Tobii Dynavox sales representative and told him that Rick’s condition had worsened to the point that he would be starting a hospice program later in the week. Even though he would be staying in his home, entering hospice triggered provisions of the capped-rental program, she said.

“I told him they were putting him on hospice later that week,” she said. “He told me we wouldn’t be able to use the machine and said, ‘You’ll have to send it back.’” The machine sat unused in their home for four weeks until it was picked up and shipped back to Tobii. During this time, Judy had sought help from Team Gleason.

Four days after the machine left Rick’s home, the same unit was overnighted back to him after being purchased by the Gleason Initiative. “We spent $12,000 on the same device that he had had four days earlier,” an exasperated Durrett says. Rick has begun to use the device although he is now so disabled that his wife will be the one getting training on its use.

Rudnicki, the Tobii executive, has trouble believing that Medicare actually did what it did. “People are literally dying without voices out there,” she says, “while everybody sits here and argues.”

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