ALS Advocacy

ALS Advocacy
Lou Gehrig's Disease - Motor Neuron Disease - Amyotrophic Lateral Sclerosis
Thought it had been cured by now? Still no known cause. Still no cure. Still quickly fatal. Still outrageous.

Saturday, November 22, 2014

We Need An Air-Quotes Dictionary For The Fight Against ALS

From the day a neurologist made air-quotes with his hands when he used the word promising to
describe experimental clinical trials for ALS, I knew we were in trouble.

Over many years we hear words over and over used to generate promise and hope and donations.  The words have become devalued.  They don't mean diddle without specifics.  They all need air-quotes.

We have to press for what they really mean.  Words are cheap.  We need substance.

Here are some that set off bells after you've been around the fight against ALS for a few years --
• Breakthrough 
• Collaboration 
• Consortium
• Exciting
• Game-changing
• Groundbreaking
• Hopeful 
• Leading
• Partnership
• Promising
• Transformative

They make us all feel good.  They deserve air-quotes.  We need to press for details from those who use them.

As an ALS advocate once said, "If something is called 'exciting' in a press release, it probably isn't."

Or maybe there's a drinking game here...

Thursday, November 20, 2014

Please Speak Up So That People With ALS Are Not Silenced

Medicare CMS has a public comments period that ends on December 6.  It involves their rules on so-called Speech Generating Devices and related technology.  We must submit comments on behalf of all those who can't.  We must make it clear that technology that enables people with ALS to communicate in any manner and, therefore, participate in their healthcare and lives is not a luxury.  It is a necessity.

Here is the issue we need to address as stated by CMS:

Effective January 1, 2001, speech generating devices are considered to fall within the durable medical equipment (DME) benefit category defined in section 1861(n) of the Social Security Act (the Act).   Speech generating devices are covered if the patient suffers from severe speech impairment and the medical condition warrants the use of a device. Speech generating devices are defined for Medicare coverage purposes to include dedicated speech devices used solely by the individual who has severe speech impairment.   Speech generating devices also include software that allows a laptop computer, desktop computer or personal digital assistant (PDA) to function as a speech generating device.  Devices that are not considered speech generating devices include devices that are not dedicated speech devices, or devices that are capable of running software for purposes other than for speech generation.  The national coverage determination (NCD) is available in section 50.1 of the Medicare NCD Manual (Pub. No. 100-3, Ch. 1, Part 1).
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.

Here are the comments that I just submitted.

When Mom was dealing with ALS in 1996, there was a huge lesson in our lives -- we take so much for granted. 
This morning I sat down in a comfortable recliner and am typing on a laptop to participate as a citizen in communicating with my government.  I can reach to the left and turn on a light switch.  I can get up and turn up the thermostat when the room gets cold.  If I need someone else in the house, I can yell (or better yet, text).  If, God forbid, I have an emergency, I can dial 911 and get some help. 
It was not so easy for Mom.  We worried about her needing to call 911 in an emergency and not being understood or being dismissed as a drunk. There was some technology that helped.  She had a little Franklin talking dictionary that we programmed with some emergency information.  The Clapper let her triumphantly control the lights... until she could no longer clap.  Communicating with her healthcare providers was difficult to impossible.  
Fortunately technology has leapt forward from the days of talking dictionaries and The Clapper.  There has been a remarkable convergence of technologies that can let people with ALS lead fuller lives more safely and be in charge of their own healthcare decisions.  Thank heavens, they can be enabled to communicate clearly and directly with healthcare providers from home without relying on speech.  Technology today can let them turn on the lights even when they can't clap.  They can control the temperature in the room or beckon a caregiver downstairs doing laundry.  They can tell a power-wheelchair to adjust to avoid the dreaded pressure sores.  They can even advise a commode when it's time to start cleansing.  Yes, we healthy people take so much for granted that technology can now assist.  Consumer devices are getting amazingly smart thanks to two-way communications.  
I feel strongly that CMS needs rules that will let CMS make smart decisions as technologies advance and converge.  We saw Steve Gleason in a Super Bowl commercial demonstrating some empowering software that is pretty mainstream today.  As consumer technology gets better and more affordable, CMS needs to be able to adapt its policies to take advantage of that.  It's good for those with ALS and it's good for the taxpayers.  As our world gets smarter, we need to make smarter policy decisions.  Communications today are so much more than speech. 
Thank you.  We take so much for granted, and technology can help give back some of life's basics that are stolen from those with ALS.

Please add yours.  We must be heard so that people with ALS are not silenced.  Thank you.

Click here for the link to submit your comments.  There are only 51 comments posted as of today.  Please spread the word so that there will be hundreds or thousands!  We must be heard.

Friday, November 14, 2014

Please, Let The Conversations Begin

The abstracts for the big annual ALS MND Symposium have been posted --

There's something for everyone interested in defeating ALS.

I hope that next year they will post those abstracts in a framework that would permit some public
conversations.  Every study is extremely important both to the authors and to all dealing with ALS.  How energizing it would be if patients, caregivers, authors, and others could comment and ask questions on the important "so what" that goes with every one of those research findings!

In the meantime, we have been advised that people can submit their questions to . That's an appreciated resource, but if we learned one thing about ALS and buckets of ice, it's that there are millions of people interested in ALS who are active in our world of social media, and many have invested heavily in these projects.  Please give them ways to comment, ask questions, and share the good news publicly.

Please, let the conversations begin.

Monday, November 10, 2014

Finally, A Pearl

There are a few people who get a case of ALS rage after helping a loved one through the difficult journey.  Nothing is easy with ALS, and it is an outrageous disease.

One such person fights relentlessly on behalf of those with ALS.  It's not her job.  It's her passion.  She is quiet about what she does.  She knows who she is.

She's the one who first pointed out the change in Medicare CMS administration of Speech Generating Devices that was a disaster for those with ALS.  When told by organizations that they had it covered, she kept pressing.  When told by professionals that these things take time, she pushed and prodded because time is the one thing that those with ALS don't have.  When one advocacy organization sloughed her off or offered feckless statements, she pressed others.  When told to stand down, she stood up and fought.

She was an irritant to many.  Too bad.  You can't be afraid to irritate a few on the way to fixing a
problem for those with ALS.

Last week, all of that irritation resulted in a pearl.

As she said to me last week, "It's so rare to have positive news."  Amen.  Finally people with ALS got some positive news with the announcement from Medicare CMS that the Speech Generating Device rules were being fixed.  Were it not for that one advocate who pushed and prodded and irritated and found individuals who could be effective, I'm sure we would still be in the bureaucratic morass.

Here's an article on the announcement.

And you can see that there is more to do.

Special thanks to this remarkable advocate and to Team Gleason and the Center for Medicare Advocacy and the other amazing irritants who joined forces.

It was a pearl of a week.  Finally.

Sunday, November 2, 2014

T Minus 29 Days And Counting

A solution regarding the Medicare CMS Speech Generating Device problem is due by December 1.

The following message is from The Center for Medicare Advocacy.  Note that they are considering action if CMS does not reach an acceptable decision.

Please help them know of people with ALS who have been affected, and please help spread the word.

Thank you.


We Need Your Speech Generating Device (SGD) Stories!

Thank you again for taking action to preserve the voices of those in need of Speech Generating Devices. Because of your advocacy, CMS is currently reviewing its SGD policies. We are hopeful that CMS will revise these policies to allow SGD users to keep their speech when they’re admitted into health care facilities and be able to use their SGDs to communicate with the outside world.
However, in the event CMS does not reach an acceptable decision about SGDs, we are considering action to help people who will lose access to SGD communications.
If you, or someone you know, have been harmed by these policies, please contact us at SGD@MedicareAdvocacy.orgWe are gathering information and data from anyone who wants to be heard, but we are particularly interested in those who can share stories because they have been affected by any of the following:
  • They experienced problems keeping their SGD since capped rental payments went into effect.
  • They experienced problems getting or keeping non-speech communication functions on their SGD in 2014.
  • They experienced problems getting or keeping environmental control functions on their SGD in 2014.
  • CMS denied their request for eye-tracking, or other SGD attachments in 2013 or 2014.
If you or someone you know can answer "yes" to any of the questions above, please contact us at SGD@MedicareAdvocacy.orgInclude the name of the SGD user, email address, phone number, street address, and a summary of the experience.  We will not use any of the information you share without your express permission.

Every story we receive helps us advocate to maintain the voices of our most vulnerable citizens. Thank you for your continued support of all those affected by CMS’s SGD policies.

Kathy Holt
Associate Director/Attorney
Center for Medicare Advocacy

For more information see:

Monday, October 27, 2014

"I Was Hungry, And You Formed A Committee"

They say that those will be the bitterest words at final judgement.

I think that, "I lost my tools to communicate, and you signed a letter," will be right up there, too.

Washington Post
ALS Patients Face Loss Of Medicare Coverage For Devices Used To Help Speech
"But unless CMS changes its interpretation by December, the delay doesn't make much difference, Wildman said."


Thursday, October 23, 2014

Let's Talk About Ebola, Placebos, and ALS

Ebola is dreadful and quickly fatal.  The only "promising" treatments are experimental and yet unproven.

Sound familiar?

There have been a number of articles on the experimental drugs that have been provided for Ebola patients in hopes that something might help.  It bothers the human conscience to hand placebos to these dying people in urgent need of help.  It bothers the human conscience  a lot.

"Experts Question Ethics of Placebo Drug Trials in Case of Ebola" 

"Use of Placebos in Ebola Drug Trials Unethical: Experts" 

"Issues Continue To Dog the Testing of Ebola Drugs and Vaccines"

Why aren't our human consciences bothered by the idea of handing a person with ALS, another  quickly fatal disease with no effective treatment, a placebo?

It's interesting.  What's the difference?  Why is a placebo so clearly an unacceptable tactic to Ebola clinicians and at the same time the "gold standard" of good research to ALS clinicians?

Let's talk.  Seriously, let's talk.  What's the diff?

Tuesday, October 14, 2014

You Can Get Better Information On Where To Park Your Car In Chicago Than Where To Find Good Care For ALS

This is an idea whose time is way overdue.  I write today because last week I heard a story that should be the last straw.  A man with ALS who must rely on a professional care facility somehow received a painful injury attributed to a simple piece of equipment.   That is terrible.   As someone trying to help him from afar said, "The bedsores should have been a clue."  And I wondered what will keep the next person with ALS from ending up in this same place.

It's 2014.

Who doesn't look up a hotel on TripAdvisor before making a reservation?

Who doesn't look up a restaurant on Yelp or UrbanSpoon to see what people think of the food and service?

Who doesn't read the reviews of items for sale on Amazon?

Who doesn't look for online ratings of roofers or painters or butchers or bakers or candlestick makers?

There are even online tools that help us find the safest and most economical parking lots when we drive to a strange city.

(And it's always helpful to see how restaurants and hotels and merchants address bad reviews.  Yes, they pay attention.)
Yet there are no good online tools for people dealing with ALS to help share experiences to rate a nursing home or equipment dealer or pharmacy or brace fitter or an online nutrition vendor or a VA clinic or even a clinical trial site.

Almost two decades ago we needed to find a new neck brace for Mom that would work with difficult ALS neck weakness.  I found that the ALS clinic staff had no ideas.  They referred  me to an occupational therapy department that was ALS-clueless.  I spent an entire day on the phone and driving around trying to find someone who could help.  Finally we found him.  There was an excellent fitter at a large brace company who had the right brace and got the job done.  At Mom's next clinic visit I told the neurologist about the hunt and the good result and the name of the young man and the company that was so helpful.  A month later I asked the doctor if he remembered where Mom got her neck brace and the name of the brace fitter.  He didn't.  Would the next caregiver spend a day off work looking for a neck brace and not be so fortunate as we were?  ALS was and still is the disease of reinventing wheels.

We need a Yelp-like tool where people can share their experiences with those who provide goods and services to those with ALS. If someone has a good experience, others should know about it.  If the experience is bad, why should the next person blindly stumble into a disaster?

Decisions that you have to make quickly when dealing with ALS are a matter of life and death.  They are also expensive, and it's hard to undo a bad one.  They are a lot more important than my travel or dining choices where I am so well-armed with information today.

Capturing and sharing experiences could be a tangible game-changer for people with ALS and their caregivers.  Finally.

Tuesday, October 7, 2014

Who Is Leading Us To Our Promontory Summit?

And what will we find when we get there?

Thanks to all who have mentioned the use and interest in a Global Unique (or Unifying depending on what you read) Identifier, GUID, for people in research studies. We now know that the NeuroBANK project that received a big bucket of funding from the ALSA windfall will be using GUIDs to key its data.

I found the information from the NIH National Database for Autism Research to be a most helpful  backgrounder on the concept --

The words that we are getting from ALS organizations and researchers are reassuring.  Since a wise parent once said, "The best predictor of future behavior is past behavior," we have questions about how this it will really happen.  How will will ALS researchers actually deliver new repositories of ALS data containing this common thread that can potentially relate data from multiple data silos?

Here are some questions --

  • Will the GUID generator be available to all researchers?
  • It appears that it's uncommon but possible for a GUID generator to come up with a previously assigned ID, and someone needs to referee and fix that problem.  Who is doing this small but important function for ALS studies? 
  • There won't be any proprietary pieces to getting and using GUIDs, will there?  The last thing in the world we need is for anyone to "own" or charge others for this simple collaborative piece of information.
  • When the personal information that is fed into the GUID generator is not available for a patient, it looks like a researcher can assign a temporary fake GUID.  Will there be a way to insure that fake GUIDs are consistent among studies or replaced quickly?  These pseudo-GUIDs could defeat the whole purpose.
  • Will people with ALS be told what their GUIDs are?  That would make a nice safety net to make sure that their subsequent studies are using the correct GUID, and maybe some of them will wear their GUIDs proudly as study participants.
  • Who is leading to make sure GUIDs in ALS research happen now?  We are at a critical juncture for ALS research and it's important that things move quickly and smartly, but somebody has to lead!   
If we don't get this right now, we'll pay the price forever. Studies are starting and expanding at this very moment. We're not asking organizations to share data today.  We're simply asking that they don't eliminate that possibility in the future by talking about GUIDs but not delivering now in a way that works for all researchers.

I'm sure that we'll have more questions.  Thanks to all who have enlightened us so far.

Saturday, October 4, 2014

Be Prepared

So far we have some "don't worry" and "we have it covered" and a "we'll encourage" reactions from ALS organizations regarding using a common, universal patient identifier among their newly funded information repositories.

I do worry, and I think that all involved can do more than encourage.

Will ALSA, each of it's IBC grantees, ALSTDI, AnswerALS, Project ALS, and others pledge to use a common, universal patient identifier in their IBC-funded information repositories?

We're not asking that they share data.  We're simply asking that they establish the groundwork so that if anyone would ever decide to share data, we would have a prayer that they would be meaningful. It's collaborate 101. Be prepared.

We've devalued so many words in the fight against ALS over the years -- "promising," "breakthrough," "exciting."  Please don't let "collaborate" be the next.

Thursday, October 2, 2014

NOW Is The Time To Get This Right! Collaborate.

The ALS Ice Bucket Challenge has primed the pump and we're starting to see some projects leave the starting gates.

At least three of the new ALS research initiatives involve people with ALS having their genomes mapped and a wealth of information assembled on each participant for researchers to mine.

Will it be business as usual?

Picture this --

Joe Doe has ALS.  He volunteers for Project Purple and is assigned a de-identified code 13579.  Joe leaves tissue and his genome is mapped. He leaves all kinds of health data that will be mined by researchers.  Joe gets a device that will measure his movements and the disease trajectory at periodic intervals.  Joe's tissue can be used as a lab model of ALS.  Project Purple even promises that other researchers will have access to its data.  Cool. 
Joe hears about Project Black and is assigned a code of 24680 when he is accepted into Project Black.  Joe leaves tissue and his genome is mapped.  He leaves all kinds of health data that will be mined by researchers, with many of the types of information different from what he gave Project Purple.  Joe will be contacted by Project Black researchers from time to time for more data and perhaps to be approached as a candidate for trials needing his variety of ALS, and again his tissue can become a lab model. Great. 
Wanting to give back as much as possible to the fight against ALS, Joe asks to be a part of Project Red that just got started in the U.S. as a result of some new funding.  Joe is given research patient  code ABCD12 and gives some tissue and his genome is mapped.  Joe becomes part of a huge data global bank of genetic mapping of people with ALS.  Awesome.

OK, we know that organizations and researchers love to say that they collaborate but they seldom really do.  Business as usual gives us three silos that don't even know whether Joe is in one, two, or three projects' gold mines of data.  And did they duplicate expensive screening processes that they could have shared?  Who knows?

Now's the time to put a very easy collaboration concept to good use.  Let's get this right. Now.

If all three projects would simply agree to share a research identifier for a person with ALS, think of the potential that we would have for the future.  If Joe were patient 265371 in all three projects, that would be one small step that would turn into a giant leap in the fight against ALS.  It would finally be possible to get inter-silo insights.

This is about as easy as collaboration gets.  This is about as valuable as collaboration gets.

We must get this right.  We must do it now.

Wednesday, October 1, 2014

We Learn From Questions AND Answers

Recently there have been some public online events on ALS organizations, their work, and the
#ALSicebucketchallenge windfall.  All have welcomed questions.

All have left my questions submitted online unasked publicly and unanswered.

While there is never enough time to get to every question during these events, there is surely time afterward to answer the unanswered questions in a public milieu.

We learn from questions and answers.

Burying questions isn't a healthy sign.

Friday, September 26, 2014

There Are Better Ways To Keep Track Of A Portfolio

For years we've asked for an orderly, searchable portfolio of ALS research grants.  Trying to keep track of press releases with no accounting of outcomes is a poor way for donors and people with ALS to understand and evaluate the research portfolio.

We recently got a Word document with new research grants.

There are better ways, and they're not rocket science.  Try this.

Search and find.  Leave fields empty to find all.

And wouldn't it be nice if the projects were soon to be filled in with grant amounts and outcomes?

Online Database by Caspio

Click here to load this Caspio Online Database.

Thursday, September 25, 2014

Gone In Sixty Seconds

On Sunday, August 31, I posted the following in the comments area of the ALS Association facebook page:

Some folks who participate supportively on an ALS message board started a petition a few days ago to ask that the ALSA IBC windfall be substantially directed to research.  They asked me to post the petition here.  It now has over 1000 signatures that include PALS, CALS, families, friends, donors. The message is simple. Thank you for listening.

Within minutes (literally) it was deleted and I was blocked from commenting or liking anything there again.

Also deleted in the Sunday-night purge was one other posting that I had made days earlier  suggesting that an infographic showing what happens to a hundred dollar walk donation and what happens to a hundred dollar national donation would be most helpful.

ALSA certainly has every right and responsibility to manage its facebook area as it thinks best.

I still believe that both comments are worth some thought and archive them here.

Wednesday, September 24, 2014

Let's Rewind The #ALSIceBucketChallenge Tapes And Look Again

It's remarkable as you look up old ALS ice bucket challenge videos on YouTube or national media websites.  Most of the big ones mentioned donating to "ALS research" or "to find a cure" before flashing the link to donate at  The frenzy was built around that message blurted out by so many national celebrities and leaders.

Clearly, donor intent was ALS research.  One can't assume otherwise, especially since the online #IceBucketChallenge donation form had no gift-restriction options for weeks.

As the long-awaited plan for the funds is being designed and the fight against ALS moves into high gear thanks to the buckets of generous donations, we trust that donor intent for ALS research is being honored.

It's simply the right thing to do for many reasons.

Sunday, September 21, 2014

Was Basketball A Better Game Before The Shot Clock?

Were plays executed better?  Hardly.  Were more clever strategies employed?  No. Playcalling was quite the opposite.

Was football a better game before fans were allowed to see the play clock?  Not really.  Do play clocks spoil games?  No, in fact they have really added some ingenuity to modern football. Ask Peyton Manning.

Are golfers better when the PGA ignores speed-of-play rules?  Golfers never think they're playing slowly and they never seem have enough time to read a shot and rethink and rethink and change their minds and reread the shot.  Are slow players' shots better?  No.

Time taken for work and decisions has a bad habit of expanding to fit the time allowed, and the longer they take, the more "comfortable" the decisions become.

Sometimes an acknowledgement of extraordinary urgency can push someone to be creative and fresh and come up with decisions and execution that open new possibilities.

ALS is a disease of extraordinary urgency.  Time for a two-minute offense!

Friday, September 5, 2014

Easy Peasy Can Work

Yesterday I spent a day discussing patient engagement in clinical research with some impressive e-patients, healthcare professionals, and pharmaceutical company experts.  There is a critical area of mutual benefit, especially for patients with dire, untreatable conditions, that needs to be seized better.  It's a complicated problem.

People with ALS have a very short window of eligibility for clinical trials.  Trial sponsors have a problem akin to trying to catch fish in a very fast-moving river.  It's a constantly changing population and they're not in front of them for long.

After a good night's sleep, my mind is saying that maybe some of the solution isn't so complicated.

Here are two extremely easy ideas that could make a positive difference for both people with ALS and clinical trial sponsors --

  1. Start every ALS support group meeting with an announcement of all enrolling clinical trials within 500 miles.  Make it an institution.  That's the way every support meeting starts, everywhere.
  2. Put a 3-ring binder in every ALS clinic with a page for every enrolling clinical trial.  In addition to the old issues of People and Readers Digest, people with ALS and families can flip through clinical trials. PALS and CALS are actually at the perfect spot to talk to the doctors about anything interesting that they may see in that binder, even trials that are being conducted elsewhere.  It would be easy enough for a national organization to provide a fresh file to print and put into the binders weekly.

That's it -- two simple, easy ideas, and they don't take buckets of money.

Every day wasted filling a clinical trial is as important as a day of lab work or a day of data analysis or a day in the FDA approval process.  Every day is precious.

Thursday, September 4, 2014

This Is Not A Wish List

Yesterday a man with ALS asked some important questions.  We have so much to do.
"What topics are most urgent!? What needs to be discussed?"
Today's blog has my two-item response, but first, I had to find the right picture.  I didn't want a picture of a wish list.  These are not wispy dreams.  These are important. They can and must be delivered.  I rejected pictures of to-do lists. Those make us feel good when we cross off the trivial and recycle the important things.

This is a must-do list.

1.  The Medicare CMS handling of Speech Generating Devices is urgent and must be fixed immediately.   Current policies and execution hurt people with ALS and the American taxpayer.  We must fix this.  Now. It should never have been recycled on to-do lists for the last year.  It belongs at the top of a must-do list. Today.

2.  Now more than ever we need a good accounting of all ALS research grants made by our grantmaking organizations.  Nowhere is there a good, searchable list for donors (or for taxpayers or for scientists, for that matter) to see grant dates, amounts, subject matter, recipients, and outcomes.  We don't need cherry-picked project announcements and accounting by press release.  We need an orderly portfolio of the buckets of investments and outcomes. Yes, now.

That's it.

That's a two-item must-do list.

No wishing.  No putting things off.  No prioritizing until we get nothing done.

We must do these two things.  Now.

Wednesday, September 3, 2014

We Need To Press Medicare CMS Regarding Speech Generating Devices

Yesterday's article in the Washington Post and the related, delicately worded statement by CMS on their
policy on speech generating devices drew a lot of insightful comments online.

In addition, a relentless advocate for those with ALS who also knows a lot about these devices submitted a very informative letter to the Washington Post.

With her permission, I include it below.  I hope that the press will press for more information.  This is far too important to be glossed over with spin from a government agency.

Almost simultaneously with an op-ed piece by Steve Gleason on the importance of technology and communication for those diagnosed with ALS and other physical disabilities, the Health & Science section of the Washington Post, published a statement from Medicare regarding speech generating devices. 
As a volunteer advocate for people with ALS, I can tell you unequivocally that the statement they made is not true. 
I realize this is a bold statement to make, but since April 1, 2014, CMS has been denying as well as requiring manufacturers to remove all software and internet capabilities from the devices or they will not be covered for payment. 
One such distributor is Eyegaze, Llc. Feel free to contact them and inquire as to what they are now permitted to ship. 
I have been trying to help people with ALS obtain these communication devices for many years and the sudden change as of April, has truly affected the lives of people with ALS in a detrimental way. Many are losing their will to live as the speech generating device they now have is a very expensive alphabet box. No access to even save their sentences or manage their finances via internet.

I'd just like to note, there is no cost savings to Medicare by implementing these new rules. As a matter of fact, it is more costly due to the administrative costs they now must carry. The device costs exactly the same as it used to, except it simply has been stripped of its capabilities to add software or to access the internet.
Since 2001, SGD's have always been shipped "locked" from the internet and a user could call the manufacturer of their device and pay a small fee to have it unlocked. Usually about $50.
That capability has been removed with no explanation and causing months of letter writing campaigns and lobbying.
To read this statement from CMS is actually a slap in the face to all who have been suffering because of its implementation as well as all who have been trying to reverse the coverage rules. I urge you to dig a little but deeper and help make a change for those who are already locked inside their bodies. They shouldn't also be locked away from the world due to Medicare.

Tuesday, September 2, 2014

I Have Options. People With ALS Do Not.

It was pouring rain when I awoke this morning.

My early morning routine starts with a big pot of tea and my morning newspapers, read at the kitchen table as they were meant to be read.  It's a quiet time to read and learn and think that I've enjoyed since I was a child.  Real newspapers give me a good start to my day.

The papers had not been at the foot of the driveway for long when I went out to retrieve them in the dark this morning, and they were in a plastic bag.  When I picked the bag up, I knew today was not getting off to a great start.  The bag was heavy.  Two hours later the papers are still hanging on a clothes rack in front of a fan as I try to get them dry enough to read.  So much for my morning routine.

I am fortunate to have the digital option for my morning papers.  I have a good internet connection and can read the news that is drying in the laundry room.  If need be, I can pay to get behind the paywall for an interesting story, and I can even forward news to friends or write a blog post on something.  I have really good options.

Online I read a Washington Post story of Steve Gleason that was about much more than Steve Gleason.  It was about living a full and meaningful life with the assistance of technology, including the same internet technology and text editor that I use to write this blog.

Then I read a statement in the same newspaper from Medicare CMS about the devices that they are supplying to people with ALS.

A spokesman for the Centers for Medicare and Medicaid Services said last week that coverage rules relating to speech-generating devices are being reviewed but that no change or reinterpretation will reduce access for ALS patients who need them.
“We are committed to ensure that beneficiaries have access to needed technologies to improve their quality of life, including the coverage of speech-generating devices for individuals with a severe speech impairment,” the spokesman, Aaron Albright, said via e-mail. “Medicare has covered speech-generating devices since 2001, which greatly improve the day-to-day lives of many beneficiaries. This policy has not changed, nor have we proposed this coverage to change. With the rapidly evolving technology in this area, our Medicare payment contractors are currently undergoing a product review of available speech-generating devices to ensure that they comply with our coverage rules and the Medicare law. CMS extended this review until Dec. 1, 2014 to ensure that we [are] able to review and address issues that stakeholders have ... raised, including the ALS community’s desire for beneficiaries to have access to devices with expanded functionality.”

Say what?  Is this good news?  Nope.  Read again.  Read again.  Read again. Dad would say that this was written by a Philadelphia lawyer.  Read again.

CMS is supplying speech-generating devices.  They will generate speech.  They won't let you do anything else that requires "expanded functionality."  No internet.  No word processor.  No email.  And they'll make darned sure to uphold the rules so that speech-generating devices are as functional as the ones people got in 2001.

People with ALS don't have options like the rest of us.  They can't even turn the pages of a newspaper, and those who have received their Medicare-supplied devices lately can't even read the Washington Post online or see this blog.

The internet is their lifeline.  It's not "expanded functionality."

If there were ever an issue of respecting life in the United States, this is it.  We have vibrant, bright people who want to live their difficult lives to the fullest.  Boat-anchor speech-generating-devices that are "dumbed down" to prevent communication beyond speech in a room are simply morally wrong and a bad business decision on the part of CMS.  Why is the government purchasing technology with locks and blocks that is more expensive in the long run?

I'm grateful that I had the option this morning to jump online and read and give my two cents.  Doesn't everyone with ALS deserve as much?

Sunday, August 31, 2014

Do What's RIght - ALS Ice Bucket Challenge Edition

The thoughts below are from a response I made to a prominent ALS clinician who had given his opinion on how the ALS Ice Bucket Challenge windfall should be spent by the ALS Association. I couldn't have disagreed more with his priorities.  I share my thoughts here because I think that the ALS Association has both an obligation and an opportunity to do the right thing.  It's also the smart thing.


Donor Intent Cannot Be Ignored

Donor intent simply cannot be ignored.  Millions of dollars were donated
spontaneously after celebrities and corporate leaders and friends urged people to join with donations for ALS research or to find a cure, followed by a mention or flash on the screen to donate at  Jimmy Fallon's or GMA's cries were not to support a three-pronged organizational infrastructure. The call was to support ALS research.  Whether or not ALSA authorized the enthusiastic research pleas, the fact is that those millions flowed in from generous people who intended to fund ALS research.  That cannot be ignored.

Well over $60 million in ALSA national's donations were made before there was even an option on its donation form to clearly restrict donations to research.  Every organization loves unrestricted gifts, but to ignore the intentions of donors who thought they were giving to research is just wrong.

ALSA has since told people that they can contact them with details of their gifts and they will backtrack and restrict them.  That will eat those donations up in an administrative circus.  ALSA should just do the right thing, earmarking for research everything donated under the IBC that did not have an option to restrict.  

Will (Or Should) The Mississippi River Suddenly Flow North?

ALSA currently has a sustainable revenue model that flows from chapters to the national office.  Contrary to some people's perceptions, funds donated to ALSA chapters (including the substantial walk donations) are shared with the national office.  Chapters have to sustain themselves and most do a good job of that.  They supply a portion of their donations to the national office, some of which comes back to the local clinics in the form of grants.  Money does not rain down on chapters (and their clinics) from the national office.  And even if buckets of IBC (Ice Bucket Challenge) dollars would suddenly start pouring down from the national ALSA heavens onto chapter patient services, would it end up breaking the sustainable revenue engine they already have?  

Catsup Is Not A Vegetable

Some at ALSA have asserted that clinics are really research, so money to clinics is really research money.   Nice try, but until ALSA can deliver on the concept that every clinic patient is a research patient, clinics are patient care.  The spotty uptake on ALS Registry self-enrollment is testament to the fact that not all clinic patients are getting consistent messages of their important role in ALS research.  The fact that a lot of clinic patients are not aware of clinical trial opportunities makes it clear that clinics today are not intrinsic gears in an ALS research machine.  I truly wish that would change, but lack of funds isn't the root cause.

Don't Waste 93 Octane Fuel In A Car That Runs Well On 90

The ALSA public policy organization boasts of being a stellar success.  It attracts its own sponsors and donations directly, has revenues from its conference,  and in addition has a substantial revenue stream from being paid by the CDC for the ALS Registry project.  Even ALSA has not suggested that it is a prong in need of any help from the IBC windfall.  Can they do more regarding public policy?  Sure.  Is it important?  Absolutely.  Does it require IBC money?  No.

Research Isn't Like Mindlessly Buying Lottery Tickets

I understand that the odds of a research success that will work for people with ALS are long.  A high school math teacher (who made a very good living investing) once told his students only to gamble on things where you can increase your odds.  Walk away from lottery tickets.  Walk away from slot machines.  Study and make smart investments.  We know that ALS research is going to produce a lot more failures than successes, yet we can do things that increase the odds of success.  It's worth the investment if we make smart choices that give us the best odds possible, and then we can build on the information that failures provide to make the next bets even smarter.  If we don't invest more in ALS research, we are raising white flags in the war on ALS.  That's just wrong.  

A 21st Century version of the parable of the talents keeps running through my head with the reluctance to move forward now with even a small IBC injection of funds into ALS research.  We don't want ready-fire-aim, but right now it's feeling a lot more like ready-aim-aim-aim-aim with the IBC money. 

Neuroscience research is dreadfully expensive, but information is its sustainable feature.  If we gather and use the information well, even the failures will have been a good investment. 

Bringing Us Full Circle -- Donor Intent Aligns With A Good Change In The War Against ALS

If we beef up three prongs and do what we've always done, we'll just get more expensive versions of the past.  That's not good enough.  Let's keep doing what already works (and has already proven to be monetarily sustainable) and add some brains and resources to research efforts.  Donor intent matters, and in this case, it can indeed change the game with some new game plans and execution dedicated to smarter ALS research.

Thanks for listening.  If I'm wrong on anything, I'm all ears.

Wednesday, August 27, 2014

Do We Have An App For You!

It will send you a text message with the name of a person who just died from ALS.

You'll get a new message every four minutes.

That's every four minutes all day.  During breakfast. During conference calls.  Through lunch. During meetings.  Every four minutes your dinner will be interrupted with the news of another death.

Turn on your phone after a 3 hour flight, and you're looking at 45 names of people who just died.  You may have five more messages when you get out of the shower.  And 30 more people are gone in the time it takes you to mow the lawn.

ALS doesn't take weekends off.  During an hour at church you get another 15 new names.  And after a concert, there may be 50 more.

It won't stop while you sleep.  Every four minutes.  After a blissful night of sleep, you'll wake up to over a hundred new names of people who died while you snoozed.

Every four minutes.

And for those waiting until October for a meeting where you will work on a plan for the #ALSIceBucketChallenge windfall, you will have been informed of over 10,000 new deaths before you've invested a dime in new ALS research.

Sunday, August 24, 2014

Let's Have A National Science Lesson

The ALS Association recently announced that over the years they have provided some funding for 98 research projects that are still active.

They also have what must now be close to a million #ALSicebucketchallenge investors of all ages and stations in life.  Many are even students who were drawn in with buckets of ice and now know that ALS is an unsolved medical mystery -- and what student doesn't love an unsolved mystery?

How great would it be to turn this into a national online science lesson that would stimulate interest in ALS and help all of those young and old investors be excited about their new projects?

I'll bet you could hire some high-school science teachers to write summaries of the 98 projects in language that turns on those mental light bulbs that let us understand the basics of the science.  No doubt a social media location with information and conversation could be a lively place that ignites interest and insights into ALS science and scientists.

This could be a sustainable classroom for our nation on the science of ALS.

And there's no need to dip into the research windfall to start such a thing.  This could be a winning grant request. Time to strike while the ice-bucket-challenge iron is hot and STEM education is a national priority.

Saturday, August 23, 2014

Information -- It's What's Sustainable

Last night we heard an interesting interview by Judy Woodruff on the PBS Newshour about the #ALSIceBucketChallenge and the use of the windfall of donations --
"... whatever we do in research, care services, and even advocacy has to be sustainable, has to be sustainable."  Barbara Newhouse, President and CEO, ALS Association
Often not-for-profits think of sustainability as the fuel that feeds next year's revenue machine.

Medical research is expensive.  Medical research in neurosciences is mega-expensive.  There are many experiments that go plop.  We know that all too well from years of "promising" experiments and trials for ALS treatments that have proven to be duds.  ALS research is costly, risky business.

So how can you possibly look upon some big, immediate investments in this kind of research as being sustainable?  They could follow the trail of decades of failures.  They could be risky money pits, and not-for-profits often aren't good at risky anything.

It's all in the information that we retain and make accessible, both to scientists and to next year's donors.   It's going to take a lot of smart investments to beat the cunning ALS beast, and we know that many more battles will be lost before the war is won.  We need to document every investment and every outcome. We need to open up results.  That's how you sustain both the research environment and attract new, smart investments.  That's how you avoid reinventing wheels and duplicating efforts among organizations.

A simple start would be to have a transparent, organized, searchable, complete portfolio of research project investments and amounts and outcomes.  Today we get research grant announcements via press release and occasional reports of "promising" results via a few more press releases.  It's impossible to leverage the information when we just can't get to it.

We can build on what we learn from failures.  We must.  We can get better from the information that every research investment leaves behind.  If only we would treat the information as the precious sustainable resource that it is.

Thursday, August 21, 2014

National Discussions Only Work If We Talk About the Answers to the (Impolite) Questions

On Monday in the Los Angeles Times, Michael Hiltzik wrote "A Few (Impolite) Questions About The Ice Bucket Challenge."

With all of the marvelous visibility given to ALS, I hope that our organizations will embrace all  questions and be part of a very public and continuing conversation about ALS.

One part of the article jumped out at me --
But ALS is also, by any definition, a rare disease; the threshold specified in the federal Rare Disease Act of 2002 is a nationwide incidence of 200,000 patients. The CDC estimates the prevalence of ALS in the U.S. at about 12,000 persons. The ALS Association says 30,000, but hasn't responded to my inquiry about the discrepancy.
I hope that the ALS Association has responded by now, and if they have, we would all benefit from their insights.  If they've not, I'll take a stab at it.  Forgive me if I sound like a middle-school math teacher, but it's my comfort zone.

Yes, legally, rare diseases are those "affecting fewer than 200,000 people in the U.S." "Affecting" is usually interpreted as "having it at any given moment."  That's prevalence.

Let's consider a factory.  The assembly line produces things and the warehouse holds things.  Prevalence is like the warehouse.  Incidence (the number of people diagnosed with a disease in a time period) describes the speed of the assembly line.

ALS is a high-incidence (you're very likely to get ALS -- as likely to get ALS as MS), low-prevalence (you're not likely to be alive with ALS) disease.  ALS has a fast assembly line and a very small warehouse.  What happens to everyone who doesn't fit in that small prevalence warehouse?  It's not good.

Now for the discrepancy.  All ALS numbers in the United States are extrapolated, based on smaller studies.  We don't have mandatory reporting of ALS by physicians.  Nobody is really counting every nose.  And you can sense that with the fast-moving numbers in and out of that prevalence warehouse that the numbers don't stand still very long.

The 30,000 number is a swag.  It has been used by organizations for decades.  In perhaps the only area where ALS organizations have cooperated and shared data, they have been complicit in propagating a 30,000 number that has been convenient but not well-rooted in reality.  ALSA has actually been quietly distancing itself from the 30,000.  Why?  As I said, nobody is counting noses and some people have a fixation on prevalence as being the important number.  It's not.  It's a one-legged data stool.  If you talk about a small warehouse without paying any attention to the speed of the assembly line, you miss the boat on the impact of a disease (or as I sometimes call ALS, a "diesease").

We're pretty sure that around 5500-6000 Americans are diagnosed with ALS every year.  Arithmetic tells us that if they live an average of 3 years after diagnosis, then we're talking around 16,000-18,000  Americans alive with ALS at any moment.  If they live an average of 5 years post dx, then maybe the number could approach 30,000, but that's a stretch.

Now for that 12,000 number that was published in the recent CDC ATSDR ALS Registry report.  This gets interesting.  We have paid over $40 million taxpayer dollars for a national registry and this was the first published report.  They gathered data from Medicare (people with ALS usually go on to Medicare quickly), Medicaid, and VA files along with a self-enrollment web portal.  They identified just over 12,000 people alive with ALS in the U.S. in a one-year period. Ugh.  How many Americans were living with ALS in that period who were not in those government files and who did not self-enroll?  We simply don't know.  How complete was their counting technique?  We just don't know.

And the clunker in all this is that the Registry did not address incidence (that pesky assembly line speed) at all in that period.  It gave us a one-legged data stool of a very low prevalence with no other supporting incidence or mortality data.

ALSA is obviously proud of getting the ALS Registry project passed.  I so hope that they have answered Mr. Hiltzik's question by now.  If not, you have my answer.

And with ALS in a wonderful national spotlight right now, what better time is there to talk of the correct numbers correctly?  ALS is a high-incidence, low-prevalence disease, and that's a troubling combination that should make every American squirm.

#ALSicebucketchallenge  #icebucketchallenge  #strikeoutals