Help! Someone, Please Help!

Eight years of advocating for a national ALS Registry.

I felt and still feel strongly that we need a census of cases of ALS.

$40 million taxpayer dollars spent.

This is the spring when we finally expect to see some numbers.

And so far we see a flock of poster sessions from this week's AAN meeting.  Here are a couple.

I feel like I've been spun around a few times and the blindfold has been partially removed.  Now I certainly need some help with some questions.  My comments and questions are in hot pink below.  These are things that we need to understand.  I think we've earned that right.


http://www.neurology.org/content/82/10_Supplement/P5.077.short?sid=85093e2b-8d66-4dd4-9722-dfa4458c5825

Using the National Amyotrophic Lateral Sclerosis Registry as a Subject Recruitment Tool for Research (P5.077)

1. D. Kevin Horton₁,₂, 
2. Vinicius Antao₁,₂ and 
3. Paul Mehta₁,₂

+SHOW AFFILIATIONS

1. Neurology April 8, 2014 vol. 82 no. 10 Supplement P5.077

ABSTRACT

Objective: To describe how the National ALS Registry links persons with ALS (PALS) to scientists who are conducting ALS research.Background: Subject recruitment for research is critical for understanding inherently fatal diseases like ALS, however, linking patients with researchers is not so straight-forward. Researchers often face challenges in timely recruitment, obtaining sufficient sample sizes, and/or in enlisting patients that meet certain eligibility requirements. Similarly, patients can face difficulties in finding specific research studies for which they are eligible.Design/Methods: The federal Agency for Toxic Substances and Disease Registry’s (ATSDR) National ALSRegistry now links Registry-enrolled PALS with external scientists who are conducting ALS research. TheRegistry’s new online Research Notification Mechanism allows ALS researchers to upload an application that briefly describes their research study and objectives, while PALS can elect to be notified about these opportunities.If the application is approved, ATSDR then queries the Registry for PALS meeting the study’s specific eligibility criteria (e.g., age, sex), Does the registry have onset date? and then distributes the researcher’s study material and contact information to PALS via email. PALS have to directly contact the researcher to take part in any research.Results: Since the Research Notification Mechanism’s May 2012 deployment, approximately 96% of Registry enrollees have elected to be notified about ALSresearch opportunities. Additionally, ATSDR has approved a number Do we know what the number is? of institutions to use the Registry for research recruitment, sending out thousands Do we know how many thousands? of e-mail notifications to PALS Do we know how many PALS have been targeted? on behalf of the recruiting And do we know what percentage of the open recruiting clinical trial seats were represented? institutions. And do we know the most important metric of all, how many clinical trial seats have been filled because of this mechanism? Conclusions: The National ALS Registry’s Research Notification Mechanism is an effective ??? tool for linking PALS with ALS researchers who are conducting epidemiologic studies or clinical trials. The Mechanism benefits PALS by conveniently delivering timely and tailored research opportunities via email. It also benefits researchers by helping to speed-up the recruitment process, increasing the study sample size, and efficiently identifying PALS meeting specific eligibility requirements.  Do we know it actually sped or increased sample size in any studies?

Disclosure: Dr. Horton has nothing to disclose. Dr. Antao has nothing to disclose. Dr. Mehta has nothing to disclose.

Wednesday, April 30 2014, 3:00 pm-6:30 pm

http://www.neurology.org/content/82/10_Supplement/P2.072.short?sid=e107f57f-3dcb-4ff4-a777-7245f9f289f7

Amyotrophic Lateral Sclerosis (ALS) Estimates from National Databases in the United States - 2001-2010 (P2.072)

1. Marchelle Sanchez₁,₂, 
2. Paul Mehta₁,₂, 
3. Wendy Kaye₃, 
4. Vinicius Antao₁,₂ and 
5. D. Kevin Horton₁,₂

+SHOW AFFILIATIONS

1. Neurology April 8, 2014 vol. 82 no. 10 Supplement P2.072

ABSTRACT

Objective - To present preliminary ALS estimates from national databases in the United States.Background - The uncertainty about the incidence and prevalence of amyotrophic lateral sclerosis (ALS) in the United States, as well as lack of knowledge about the role of environmental exposures in the etiology of ALS, have created a need for data collection through a national ALS registry. In 2008, the Agency for Toxic Substances and Disease Registry (ATSDR) conducted four pilot projects to determine the feasibility of creating a national registry. It showed that approximately 80% of ALS patients can be found through national databases. The first approach utilizes existing national administrative databases to identify prevalent cases. The second approach uses a secure web portal to identify cases not included in the national databases. This latter approach allows patients to self-identify and enroll in the ALSregistry and take risk factor surveys. Design/Methods - We sought to identify U.S. residents with ALS in Medicare, Medicaid, Veterans Health Administration (VHA), and Veterans Benefits Administration (VBA) databases for the years 2001-2010. Records were searched and identified in these databases for ALS and Motor Neuron Disease (MND) codes.Results - A total of 147,889 individuals, with any MND code Are those distinct individuals? So over a period of nine years, 147,889 distinct MND individuals were identified?, were identified across the four national databases. Medicare contributed the largest number of individuals. The total number of individuals identified having ALS was 36,547, which is 24.7% of the total number of individuals identified with any MND. I always thought that ALS was by far the largest subset of Motor Neuroon Diseases.  Am I wrong?  Do they really think that over 75% of the MND cases are not ALS... or did they just fail to identify a lot of MND cases as ALS?  Conclusions - This is the first effort to identify ALS cases for a national registry. The number of individuals identified via the national administrative databases is not a prevalence estimate Why not?; however, it does indicate that a large portion Based on what assumption? of ALS individuals can be identified for the National ALS Registry by using the national databases selected. How do you arrive at that conclusion?  It sure seems like a jump to me!  

Disclosure: Dr. Sanchez has nothing to disclose. Dr. Mehta has nothing to disclose. Dr. Kayehas received personal compensation for activities with McKing Consulting Corporation as an employee. Dr. Antao has nothing to disclose. Dr. Horton has nothing to disclose.

Tuesday, April 29 2014, 7:30 am-11:00 am

Here's A Different Wrinkle on ALS Awareness Month

A classic from an ALS advocate on facebook yesterday --

ALS Awareness: Where every size Allen wrench is required and every screw costs $60.

Let's Raise The Bar Ever So Slightly - Step 2

This one's so simple, too.

Every year we are surprised by events when we get social media updates from the events themselves.  Every year one ALS organization schedules an event on the same dates as another organization's event.  They schedule so far in advance that who knew?

Let's be efficient.  Let's be informative about what events agencies are sponsoring or attending.  Let's raise the energy bar on all that you do.

Technically a common, shared calendar where all ALS organizations contribute content would not be difficult.  The human and organizational factors may be a little more difficult, eh?  If you expect us to believe that you can advance the science against ALS, then you should be able to do this.  It's not hard. To do it the way you always have seems nuts.

Let's Raise The Bar Ever So Slightly - Step 1

Let's raise the bar on how things are done in the fight against ALS.

My first plea is for all organizations and individuals who publish statements and documents in the fight against ALS to please date your documents.

We have web pages and documents and publications online and in print with no clue as to the publication date.

This is simple. Nobody would argue that this is a good practice.  Please take the pledge to raise the bar ever so slightly.

Thank you.

April 20, 2014
Easter Sunday

Now THIS Would Be Patient-Centric

"I feel like I've left tissue all over the country." -- Words of a man with ALS

Today there are countless opportunities for people with ALS and their healthy relatives to give blood and skin and fingernails and all kinds of tissue samples for ALS research.  Unfortunately the donors are treated like renewable sources of tissue rather than valued people.  Researchers who often brag that they work together all gather their own samples for their own needs.  It's not about the patients. It's about their immediate research needs.

Picture this.

A person diagnosed with ALS is given a unique identifier on the day of diagnosis.  Maybe even a nice card with a bar code is included.  After that, every medical record, every blood sample, every MRI, every test result includes that identifier.  A person's information and samples are suddenly connected with the person rather than with a scientist.  And shortly after diagnosis, people with ALS are offered the opportunity to opt-in to a master bio-bank.  The tissue isn't stored in one place, but the information about where the tissue samples reside is stored centrally.  It's called patient-centric.

Think about the way your tire store can find a set of tires that fit your car overnight, even if two tires come from a warehouse in Saint Louis and two from a warehouse in Cleveland.

When a researcher or a pharmaceutical company needs a random set of blood samples from people with C9 genes, they can get them.  When a researcher needs a completely random set of skin sample from people with ALS, they are accessible.  When a research needs some blood from young SOD1 male PALS with slow limb-onset, they can get them.

Fix the information problem  Fix the center of attention.  It's the patient.  Donate once, use many times.

This would be patient-centric.

Next time you hit a chuckhole and need a new tire, think about the days when Lou had to wait for the factory to make more 4.50x21s to fix the Model A.

Your Best Salespeople Understand the Features, Advantages, and Benefits

I'm still trying to learn about the MODDERN Cures Act.  Examples would finally make it come to life for me.

http://www.nationalhealthcouncil.org/pages/page-content.php?pageid=163


OK, for dormant therapies, we've often been frustrated by a lack of study of repurposing old drugs for ALS since they aren't commercially attractive to drug developers.  Some examples of how MODDERN Cures features work would be so helpful!

Is it correct that the dormant therapies must be things that have never made it to market?  Are old drugs that were on pharmacy shelves for other indications part of the MODDERN Cures Act?

1. What if there is a drug that is within a year of losing its patent and the manufacturer holding the patent decides to pursue testing of that drug for ALS?  It will take years to test the drug for ALS.  What happens?  What does it mean to waive the old patent rights?  What does the 15-year period of "data exclusivity" mean?
2. What if there is a drug that is within a year of losing its patent and another manufacturer is interested in pursuing it for ALS?  How would that work?
3. What if there is an old drug whose patent protection has long since passed.  Can it get new patent protection with this?

We will be dynamite salespeople if we understand the features, advantages, and benefits in some real-life situations that relate to people with ALS.

And does the following link mean that the companion diagnostic features of the MODDERN Cures Act have al been taken care of?  http://capwiz.com/alsa/issues/alert/?alertid=63177606

Thanks to whomever can help.

Sometimes A Single Voice IS All It Takes

This is a story of two funerals and those single voices.

1.  Last week a powerful single voice was buried at Arlington National Cemetery.  An Army colonel, retired by ALS, had become a voice that called out weakness in the VA healthcare system for veterans.  He called out ALSA, the CDC, and ATSDR for weakness in the ALS Registry.  He called out the FDA for a system that needed to get ALS patients' perspectives.  He never minced words.  He knew how to lead and how to cut through government-speak.  He caused discomfort in a system that needs to change.  Our nation paid beautiful tribute to him for his military service.  Everyone involved with the fight against ALS should pay tribute to that single voice, too.  He asked good questions and demanded answers... regardless of how uncomfortable he made you.

2.  Last week a wife/full-time caregiver/soulmate to a man with ALS died unexpectedly.  It's not supposed to work that way.  The shock, pain, and practical problems were huge.  An individual woman who helps people who fall through the considerable cracks in ALS organizations' support systems stepped up.  She is one of those single voices who does not take "no" for an answer.  There were funds to raise for a funeral.  There were short-term and long-term arrangements to be made for the care of the gentleman with ALS.  There were difficult logistics in a system that doesn't move quickly enough.  Phone calls weren't being returned and a hospital's policies needed to be challenged.  Nobody should be kept from attending his own wife's funeral by a hospital's risk-management person.  And everybody with ALS deserves to live in a respectful setting that understands ALS.  And families need to grieve.  Yes, a single voice helped make it all happen.

This weekend I hope that all who pray will say prayers for those dealing with ALS and its aftermath... and special prayers of thanks for those single voices.  We need more like them.

And The Answers Are ???

Words from one of the three patients selected to attend the ALS Registry Annual Meeting in July:

Following up from last year, I wasn’t here last year, but one of the big questions I received from patients was, "What were the actions taken from last year’s meeting? Was it productive?" I’m sure many of you knew a great man, Rob Tison, who was here and put a lot of work into trying to give feedback. Just a really good person, and a very smart person. One of the questions I received was, "What was done with that?" How were the questions that were raised last year resolved? I’m sure they all were resolved. I’m sure action was taken, but if not everyone realizes it, it doesn’t do any good.

I find no evidence in the meeting report that the questions were ever answered. I looked and I looked.  It's like the questions just rolled off the backs of everyone.  Click here for the meeting minutes.  If I've missed something, I'm all ears.  We're not so sure that Rob Tison's issues and questions were all resolved. We're not so sure any were resolved.  Time to stop the slow-pitch softball.

It's Simple

"I'm not asking for another $10 million for you until you tell me what you're going to do with it."

-Words of an ALS advocate

http://www.alsa.org/advocacy/legislative-priorities.html 

It's time for a high-level accounting of where the ALS Registry money goes.

It's called good stewardship.

Picture This

In the past week we've learned bits and pieces about various not-for-profits' positions on a number of issues that are important to those with ALS.  There does not seem to be a place where we can read the letters and statements that they have made to government agencies and other not-for-profits about various policies and legislation.

We pretty much have our friend google guiding our way as we stumble along trying to find out about governmental agendas and policy statements that have happened in the past.

Picture how helpful it would be if organizations that take positions or make statements or send letters would simply post them for us to see them as they are made.

It would add perspective and information that would make advocacy efforts much more powerful and cohesive.  Please post those documents in a visible place so we can read them and learn and understand.

It's simple.  Transparency is good.  Timely transparency is best.  Everybody wins.

Times Have Changed, Thank Heavens

Yesterday I saw a new For-Sale sign in front of a home in my neighborhood. 

A couple of decades ago I either would have written down the brokerage phone number and made a call or stopped in at an open house to find the price on the home.  You see, the real estate broker owned "the book," and "the book" had all of the listings and prices.

Real estate brokers controlled the most precious information to potential buyers and sellers.  If you were shopping for a home, you never got to take "the book" home to shop in privacy.  If you just wanted to keep track of asking prices in your neighborhood, the real estate broker controlled that information.  You had to ask.  You could usually get the price, but the rest of the story could be quite selective.

When it was time for serious buyers and sellers to make decisions, brokers had a great deal of power to control the conversation with the information that they chose to share or not share.  And "the book."

Times changed quickly, thank heavens.  Enter the internet.  Consumers demand access to information.  They want to be fully informed as they make decisions.  Real estate brokers have had to change.  They can no longer define the value they add by controlling the information or the conversations.  They have to add value in different ways or find new careers.

And think about the travel-agent industry has changed.  They no longer own sole access to flights and seats and hotel prices.  Travel agents can't make a living today with control of information and access.

And think about the Voluntary-Health-Agency industry.  Whoops.  It hasn't changed yet.  It will.  It must.

And In The "You Can't Make This Stuff Up" Department

Picture this.

• One arm of our government has built a national ALS Registry featuring online information, data entry, and risk factor surveys for people with ALS.  They have spent almost $40 million taxpayer dollars and are asking for more.
• Another arm of our government has just implemented rules for people with ALS who need Speech Generating Devices.  They will not be able to access the internet during a 13-month rental period.  

Duh.  Do these people ever talk to each other

We have just built a very expensive highway and have blocked access to the people who need it most. And those signs that were put up April 1 are going to be dreadfully expensive to take down.

This is just outrageously stupid.

Costco Knows

Costco knows what I eat.  Costco knows if I'm on a diet or am not feeling well.  Costco knows if I'm on a fitness kick.  Costco knows where I live and where I travel.  Costco knows if I'm having a party.  Costco knows.

What if every physician were given a stack of coupons for people diagnosed with ALS that would give them free Costco cards.

$50 per card * n PALS ... we're probably talking about something under $1 million a year.  That's a tenth of what we're asking for the CDC ATSDR ALS Registry for another year.

And Costco can retrieve data and report quickly.

And PALS and families would enjoy those deals on big packages of things.  And doctors feel like heros to patients who get little good news after an ALS diagnosis.

And just maybe we would get some timely insights on how many people have ALS and where they live.

(This was recycled from a 2007 blog post concept, but unfortunately it still works.)
http://www.alscounts.com/slog2010/slogarchive200706.html

How Can I Help?

People want to help their friends, acquaintances, neighbors, co-workers dealing with ALS.  It's a fact.

ALS is a demanding disease and asking for help isn't easy.  You can't go around asking casual acquaintances to do caregiving that involves a suction machine or tush-wiping. 

There are some things that are helpful that involve no special skills or experience or awkward situations.  This is one of the reasons the multi-level marketing of walks has been so successful for fundraising.  People want to help.

Here's another way to help, and it's easy peasy.  Please ask every helpful person you know to tell the government that we need smart rules so that people with ALS have the right to speak and be heard.

So when you hear, "How can I help," you can say, "I have two easy things for you."

1. Please help the Executive Branch hear that some CMS Medicare rules taking effect April 1 just don't make sense for today's speech technology.  Did you see Steve Gleason in the Microsoft ad during the Super Bowl?  Please help make sure that kind of technology (not the world's most expensive) is available to all people who are silenced by ALS.  Click here for a link.

2. Please tell your Member of Congress and your two Senators to support HR942 and S948, with an inclusion for Speech Generating Devices, to put these devices under some rules that would be appropriate for the high tech that they are.  You can go to their websites and submit your thoughts. Elected officials actually like it when individual citizens speak to them.  Here are two links
-- http://www.senate.gov/general/contact_information/senators_cfm.cfm
-- http://www.house.gov/representatives/find/
If you can use the walk software, then you can do this!
You are welcome to use the words of Steve Gleason:

"Please sign S 948 and HR 942. And, please introduce immediately an exclusion for Speech Generating Devices (SGDs). Thank you for your attention to this important issue and for your voice in Washington, DC. Through your support, you will also safeguard the voices of thousands of others."

If we can raise millions of dollars and recruit hundreds of thousands of walkers who want to help, we can surely raise voices for the voiceless.  We just need to get all of those helpful people to help in another very easy way.

Thank you.

Let's Have Some March Madness

It's all starting to come together now.

It looks like we have two plays to work on regarding access to Speech Generating Devices and Power Wheel Chairs for people with ALS.

• The Easy Free Throw to get the attention of CMS Medicare (Executive Branch) that their April 1 rules implementation blocks the rights and needs of people with ALS.
• ACTION ITEM:  Please continue to exercise your right to be heard at https://petitions.whitehouse.gov/petition/stall-centers-medicaremedicaid-services-cms-capped-rental-speech-generating-devices-pending-rewrite/Fz8bfNh2
  This is exactly the reason that the White House provides such a space for citizens to be heard.  CMS ultimately reports to the person in the Oval Office.  We need to delay the April 1 implementation of these rules for SGDs (Speech Generating Devices).
• The Picket Fence to get the attention of legislators who have the power to attack the problem with a long-term solution. People with ALS and taxpayers will win.  The key to this play is HR942/S948 Ensuring Access to Quality Complex Rehabilitation Technology Act.  It is essential that Speech Generating Devices be included in this act along with complex Power Wheel Chairs!  This legislation gets these devices out from under rules that simply don't make sense for such technology.
• ACTION ITEM: Please contact your Member of Congress and your two Senators. Most take email on their websites.  Ask for them to support HR942/S948 with an inclusion of Speech Generating Devices.  Most will be in their districts the two weeks following April 15.  It would be a pretty cool civics lesson for us all (including the kids) to make an appointment and stop by and chat.

We need to take and make lots of shots if we are to win. The clock is running. Thanks to all who join the team.  Steve Gleason has already made a huge three-pointer --
http://www.vitter.senate.gov/newsroom/press/vitter-supports-team-gleason-legislation

Thank You For Your #Empowering Leadership, Steve Gleason

The person who stepped up to take a stand on this legislation can neither step nor stand.  Technology enables him to be the eloquent and effective citizen/leader we needed. 

That in itself makes the case.

Action Item! Please read Steve's letter below that was posted on the Team Gleason facebook wall last evening, and contact your Member of Congress and your two Senators.  Yes, you. Now. Please. Thank you.

An Open Letter to Louisiana Senators and Congressmen:

Dear Senators Landrieu, Vitter and all Louisiana Members of Congress,

Recently, legislation was introduced to ensure patient access to quality, complex rehabilitation technology. An example of that technology is my power chair. I cannot imagine living with ALS (or any other physically restrictive disease) without a power chair. It is not only... a necessity, it is a means of independence for me and my caregivers. The bi-partisan legislation introduced is S. 948 and HR 942. While every organization that supports the care of people with physical limitations supports this, not one legislator from Louisiana has signed it as of today.

Adding to this, the Centers for Medicare & Medicaid Services (CMMS) have new rules which become effective April 1st. Exactly the opposite of the legislation above, these superfluous rules will inhibit people from having consistent access to essential communication devices. The term essential is not hyperbole. I use my eyes to type on one of these devices. Essential communication; from requests for food or water, to telling my family I love them, advocating at the United Nations, or open letters to policy makers.

While I am very fortunate to have the ability to own and customize my equipment, most people who are dealing with ALS, and conditions like ALS, do not. Living with a physically debilitating disease is not only a tremendous emotional burden, but a financial one as well. By taking away access to these devices, the CMMS is harming the very people the institution was created to help.

Imagine if your cell phone, tablet and laptop were taken away when you had a hospital visit. While it is logical to rent “simple” machines like a car or a pressure washer for periods at a time, renting complex and customizable technology like a cell phone, tablet or laptop is far less viable, especially when that technology is your only means of connecting to the world.

I was recently in a Microsoft commercial. The commercial shows how transformative technology has been to individuals and the world. Microsoft calls these technologies "empowering". These new rules from the CMMS will quash the power that technology gives people like me... people who intend to be productive and purposeful.

Please sign S 948 and HR 942. And, please introduce immediately an exclusion for Speech Generating Devices (SGDs). Thank you for your attention to this important issue and for your voice in Washington, DC. Through your support, you will also safeguard the voices of thousands of others.

Steve Gleason

 

 

It's your turn. Please take ten minutes, go to your elected officials' websites, and follow Steve's lead.

 

Thanks, all.

 

http://www.house.gov/representatives/find/

 

http://www.senate.gov/general/contact_information/senators_cfm.cfm

 

 

Keep Calm and Stumble On

Yesterday the ALS Association finally issued a statement regarding some of the April 1 Medicare CMS changes related to Speech Generating Devices --

http://www.alsa.org/news/archive/medicare-coverage-for-speech.html

Included is a link to their submission made on the last day of the 2013 public comments period making their case --

https://filemanager.capwiz.com/filemanager/file-mgr/alsa/08_30_13_ALSA_Comments_to_CMS_1526_P__FINAL_.pdf


Yesterday's statement leaves me with three troubling observations --

1. I agree that petitions are not likely to move government bureaucrats, but there was a potentially powerful public comments period that we all missed.  That was the time for citizens to make a number of compelling cases.  That opportunity was blown.  Fixing a problem is always more difficult than it would have been to prevent the problem.
2. There is a legislative item on the table, the Ensuring Access to Quality Complex Rehabilitation Technology Act (S. 948/H.R. 942), that could provide a long-term solution for both Speech Generating Devices and for Power Wheel Chairs.  Elected officials could be moved to make this happen.  Should this not be discussed?
3. The rules go into effect next week, for Pete's sake. Would we have heard anything had a volunteer-ALS advocate not stumbled across the rules changes last week?

And then late last night the ALS Hope Foundation shared this, what seems to be another pertinent public comments period that has only six days left --

http://www.regulations.gov/#!documentDetail;D=CMS-2014-0029-0001

Only twelve comments submitted so far.  Only six days left.

There is a long-term pattern here.  We keep stumbling across things.  We trip over pertinent things that have been be well-kept secrets. Why?  We stumble to defeat ALS.  We are told that the hurdles aren't our problem.

Hiding the hurdles until we trip on them is wrong.  Explaining and discussing the hurdles before we get there is constructive.  Transparency is essential to reach any vision of defeating ALS.

Are We Just April Fools Who Can't See All The Danger Around Us?

An ALS volunteer-advocate literally stumbled across things that we described in our prior two blog

entries earlier this week.

Here is our recap of concerns along with a couple of action items.

Effective April 1, 2014, the Medicare CMS rules for Speech Generating Devices (SGDs) are changing.  They are being classified as durable medical equipment that will fall under a “capped rental rule.”  The taxpayer in me didn’t get too upset until we found out some of the implications.  Medical devices will be rented for 13 months.  Here are some of the gotchas that we think are of concern.  If I’m wrong on any of these, I’m all ears.

• The kinds of device and technology such as the setup Steve Gleason had in the Super Bowl ad will not be allowed because they are not strictly medical devices.  God forbid that you should access the internet. 
• It’s a one-and-done for you.  If you live long enough for some stellar new $500 technology to make your 13-month device obsolete, too bad. 
• If you go into a hospital or move into a hospice during the 13 months, your device will not go with you.  CMS assumes that the facility will have whatever you need.  Right.

There was a comments period to give feedback to Medicare CMS on the rules changes last year.  I had no idea.  Unfortunately we didn’t get in front of the rule changes.
Here are a couple of action items that I’m aware of.  If anyone knows of any others, please let us know.

Action 1.       There is a petition sponsored by the AAC Institute that is trying to gather signatures to object to the rule change.  It explains things well.  I hope that you will consider adding your names and spreading the word.  https://www.change.org/petitions/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?recruiter=86717921&utm_campaign=mailto_link&utm_medium=email&utm_source=share_petition

Action 2.       There is some proposed legislation that could move Speech Generating Devices as well as Power Wheel Chairs out from Medicare’s "durable medical equipment" rules (thus escaping the April 4 rule change).  This complex medical equipment that is highly technical and personalized just doesn’t fit rules written for bedpans and commodes.  The MS Society has excellent information on this and they have an action page to submit requests to your legislators.  I their letter can be changed easily to make it about ALS (with thanks to the MS Society for being on top of the issue).  I submitted one to my Representative and Senators.  Here is the link http://www.nationalmssociety.org/Get-Involved/Advocate-for-Change/Current-Advocacy-Issues/Complex-Rehab-Technology

Some really good ALS volunteer-advocates have been trying to sort through what seems to us to be an urgent issue.  Thanks if you would review those two action items above and chime in by submitting support and asking your friends and family to do likewise.

And if you know more or different information about the issue, we would appreciate the insights.

ALS Hope Foundation has been supportive of the concerns.  Team Gleason added support to the legislation item last evening. We’ve not heard a peep from any other ALS organizations. If any had actually submitted any comments to CMS or legislators on this issue, it would be helpful if they would simply post them.

Some Cain-raising by us all is long overdue.  Thanks.

And Perhaps We Who Can Speak Were The Biggest Fools Of All

I can speak and type and do all kinds of things that ALS steals.

Yesterday as I googled for items related to the April 1 Medicare changes in the augmentative communication rules, I wondered where I was a year ago.  Indeed, I was asleep at the switch.

There was a comments period that I and thousands of us interested in the rights of those with ALS missed --
http://onceiknewbetter.blogspot.com/2013/08/proposed-changes-to-medicare-medicaid.html

There was proposed legislation that I and thousands of us interested in the rights of those with ALS missed --
http://onceiknewbetter.blogspot.com/2013/08/proposed-changes-to-medicare-medicaid.html

I and lots of us healthy people who can speak and type and do all kinds of things were cluelessly silent while the rights of people with ALS to communicate were being eroded by new rules.

That was so wrong.

April Fools!

The Medicare medical equipment rules are changing effective April 1.

Here goes...

Augmentative communication devices will be rented for 13 months rather than being purchased.  Not a bad idea, it seems.  Technology improves so quickly these days that 13 months can make a device obsolete.

Whoops... As my grandmother would say, the road to hell is paved with good intentions.

If I understand the new rules correctly, in 13 months if that device has turned into a technical boat anchor, it has become the boat anchor communication tool of the person with ALS.

Oh, and the rules limit devices to things that are strictly for augmentative communications.  In someone's infinite wisdom (that drips with sarcasm in case you're missing it) it excludes devices that can do other things like connect to the internet or run an app that provides the ability to order supplies or read a book or find a clinical trial or question a provider's Medicare charge.

Why would Medicare want to stop people with ALS from talking to people who aren't standing in the room.  The internet really works for those things, folks!

Who hasn't been amazed with the things that a tablet or lightweight new computer can do at a fraction of the cost of some clunky medical equipment devices?

Who wasn't thrilled with Steve Gleason hosted a Super Bowl ad for Microsoft using readily available technology that cost a small percentage of the cost of one of those boat anchor devices?

And  would a person with ALS be eligible for Steve's communication hardware and software under Medicare rules?  No!  Would a person with ALS get stuck with something far more expensive than Steve's $4000 Microsoft Surface-based setup and be wed to far inferior technology? Yes.

All I can find online that addresses these changes are organizations telling people to hurry up and order their devices before April 1.  Where is the outrage and aggressive advocacy to keep this from making taxpayers the fools starting April 1, 2014?


p.s. There are reports that Medicare is applying the new rules already.  So for some reason, they're anxious to spend more for less.  Taxpayers lose. People with ALS lose. Who wins? The boat anchor industry?  We don't measure value by the pound when it comes to smart devices!

Is This Not A Draconian Charade?

During a recent webinar on clinical trial enrollment, the daughter of a man with ALS explained how some stem-cell trials they considered were actually doing a placebo surgery.  All patients accepted in the trial will undergo major surgery to access their spines and brains.  Some will get stem cells. Some will get fake placebo stuff.  Let's sew them up and see how they do, eh, doc?

I was amazed that a surgeon who took the oath about "first do no harm" would even consider this.

I was amazed that volunteers would be subjected to such a cruel risk, especially in a clinical trial system that is so risk-averse about so much.

Let the conversations begin.  Is this the best we can do to evaluate safety and efficacy?

http://www.clinicaltrials.gov/ct2/show/NCT02017912?term=brainstorm&rank=3

People with ALS deserve better than risky fake surgeries and scars that are painful in many ways.

What Are The Tempo and Pace and Tone?

Following is from an interview with Adriana Karaboutis, the CIO of Dell Computers, in the March 9 Wall Street Journal:

 

WSJ: Before joining Dell, you managed IT at General Motors and Ford Motor Co. Is being an IT leader in a tech company different from being one in the automotive industry?

MS. KARABOUTIS: In the tech industry, you have three to six months to build products. You have a 24- to 30-month product life cycle in the automotive industry. That sets a certain tempo and pace and tone within the company.

 

 

What are the tempo and pace and tone of those dealing with the fight against ALS?

 

Our organizations are good at annual things, be they meetings or reports or fundraisers.

 

Sure, there are other shorter periodic reports and supports provided to those dealing with ALS, but for someone in the midst of ALS, life is on a whole different wavelength.

 

And if those working with an annual tempo and pace miss a mark, are expectations for results just pushed out another year?  Is there an undertone that there will always be new cases of ALS that will benefit, whenever the results may come.

 

It's time to make the industry of ALS one that works at a different tempo and pace and tone. 

Don't Let The Matchmakers Lull You To Sleep

It doesn't pay for people with ALS to wait patiently for a clinical trial to find you as a perfect match.

The proliferation of clinical trial matching services, whether via www.patientslikeme.com or https://www.inspire.com/groups/als-advocacy/ or http://www.cdc.gov/als offer promise to notify patients of clinical trial opportunities.

Do those give people with ALS a "don't call us, we'll call you" impression about clinical research?

Do people with ALS miss their short trial eligibility window waiting for the phone to ring?

Those matching services simply don't cover the gamut of enrolling clinical trials.  And they know nothing of patient preferences of location or the type of trial that would work for the individual. They are designed around selected clinical trial sponsor enrollment needs rather than patient needs.

They might find you as a perfect match in a timely manner.  They very well might not. 

www.clinicaltrials.gov shows 71 open ALS trials as of this morning. 

http://wwwn.cdc.gov/als/ALSResearchNotificationClinicalTrialsStudies.aspx has added a nice recap of its research matching notification.  You can see that it's a list of far fewer than 71.

Relatives often want to help when someone is diagnosed with ALS.  The search for a clinical trial can be a great project for them.  They know that you could stay with Aunt Mary in Phoenix or that you would never want to work with that doctor in Buffalo. They can work with you to sift through the variables.  They can help pose the questions that you must ask to figure out if a trial's science is new or old, more promising or less promising.

Some good tools for active ALS clinical trial searches are
www.clinicaltrials.gov (It's not pretty, but it's the most complete.)
http://www.alsconsortium.org/browse.php (They have a live person who can help.)
http://www.als.net/ALS-Research/ALS-Clinical-Trials/ (Very readable to compare trials.)

Finding a clinical trial is a job, but nothing is ever easy with ALS.  The only treatments the least bit promising for people with ALS are these experimental trials.  To miss those opportunities by being passive is tragic for both the patients and the science.

Until the matchmakers become more complete and smarter at being focused on a patient's needs and preferences, you're on your own to find the right match for you.

You snooze, you lose.

People Are Dying In A Slow-Motion World

A study was recently published about the importance of nutrition to people with ALS.  It was based on a five-month study.  A person with ALS looked up the clinicaltrials.gov announcement of this study.  It started five years ago!  What took so long?

ALS organizations have started touting the importance of IPS technology in drug development.  This technology was named Time Magazine's top technology discovery in 2008.  What took so long?

People with ALS have been discussing the recent Orphan Drug indication for a bio-drug candidate for ALS -- GM-604.  It has been around for over 20 years.  What took so long?

Can someone tell us exactly what was going on (or not) with each of these projects during all those years?

This is nuts!