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indigosd

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I just got this today from the ALSA. It seems to me that it is taking a long time to get anywhere. :-(



National ALS Registry Timeline
(as of February, 2010)
October – December 2009
• Launch National ALS Registry website:
Now available on the CDC website at CDC - Amyotrophic Lateral Sclerosis, the National ALS Registry
website includes general information about the ALS Registry, about ALS and answers to
frequently asked questions. The website ultimately will include an online portal that will
enable people with ALS to self enroll in the registry.
• Obtain IRB approval:
Federal law requires that research projects involving humans receives the approval of
Institutional Review Boards (IRBs) to ensure that the rights of patients are protected and
that research meets scientific, ethical and regulatory standards. The ALS Registry has
received IRB approval.
• Send registry data collection to the OMB:
Under the federal Paperwork Reduction Act, all federal agencies are required to obtain
approval from the Office of Management and Budget (OMB) before any data can be
collected from United States citizens. OMB approval ensures that data collection is
justified and meets other requirements, including privacy requirements. The Centers
for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry
(CDC/ATSDR) has submitted the registry to OMB for review, which may take as long as
9‐12 months. The notice that the project has been submitted to OMB is available here:
http://edocket.access.gpo.gov/2010/pdf/2010‐1718.pdf.
• Complete pilot projects
• Analyze pilot data
• Develop web portal for self‐registration
• Select 3 states for state base registry projects:
The CDC/ATSDR will partner with three states to create state based registry projects.
The purpose of the projects is solely to obtain additional data that will identify gaps that
may exist in the National ALS Registry, particularly cases of ALS occurring in rural and
urban underserved areas. The CDC/ATSDR is not duplicating state registry projects in all
50 states. Rather information from the three states will be used to improve the
operation of the National ALS Registry.
January – March 2010
• Write scientific papers for publication
• Hold state‐based registries kick‐off meeting
• Continue development of web portal for self‐registration
• Submit data requests for additional national data:
The CDC/ATSDR will collect information for the registry from national data sets,
including Medicare and Medicaid and the Veterans Administration
April – June 2010
• Submit congressional report for National ALS Registry:
This Report to Congress is required pursuant to the ALS Registry Act (Public Law 110‐
373)
• Hold Annual ALS Surveillance Meeting: The meeting was first convened in 2006 when
The ALS Association worked with Congress to obtain the first year of funding for the
registry. The meeting brings together ALS scientists and clinicians, representatives of
the CDC/ATSDR, national ALS organizations including The ALS Association, and experts in
disease registries.
• Continue development of web portal for self‐registration
• Receive additional data from national data sources
• Submit scientific papers for publication
July – September 2010
• Analyze updated data from national data sources
• Continue development of web portal for self‐registration capability
• Update ALS Registry website
• Develop media campaign announcing self‐registration in ALS Registry:
The ALS Association is partnering with the CDC/ATSDR to promote the ALS Registry,
raise awareness and drive participation in the Registry.
October – December 2010
• Complete web portal development
• Begin registration in web portal, pending OMB approval
• Launch media campaign
 
Re: National ALS Registry Update

More information;
National ALS Registry Update
February, 2010
The ALS Association is the leading organization championing the establishment of a national
ALS patient registry that will identify cases of ALS in the United States and collect information
that will advance research into the cause, treatment and cure for Lou Gehrig’s Disease.
Significant progress has been achieved to date including the following:
Congress Enacts the ALS Registry Act, Appropriates $16 Million for ALS Registry
Thanks to the outreach of people with ALS and ALS Association advocates across the country,
The ALS Association has partnered with Congress to enact the ALS Registry Act (Public Law 110‐
373). Signed into law in October, 2008 the legislation provides the Centers for Disease Control
and Prevention (CDC) with the authorization and guidance necessary to create a national ALS
registry. At the same time, The Association has worked with Congress to secure nearly $16
million in funding for the registry over the past five years (FY 2006‐ FY 2010), including $6
million in FY 2010, enacted into law in December 2009. This funding has enabled the CDC to
conduct four pilot projects to determine the most effective and efficient ways to accurately
identify ALS cases in the United States and to share information. It also has enabled the Agency
to take the first steps towards enrolling patients in the registry as discussed below.
Importantly, because The ALS Association pursued funding for the registry even before
enactment of the ALS Registry Act, the CDC will be able to implement the National ALS Registry
much sooner than otherwise would have been possible.
Creating the Registry: Pilot Project Results, Identifying Cases
Pilot Projects
Over a nearly three year period, the CDC sponsored four pilot projects in order to create the
building blocks for the registry. The pilots were conducted in Georgia, Minnesota, and South
Carolina and at the Kaiser Permanente HMO network. The projects evaluated several different
strategies to identify ALS cases, learning how to overcome the significant challenges of
effectively and efficiently ascertaining cases of ALS, a disease that progresses rapidly, is not
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easily diagnosed and often is misdiagnosed or confused with other diseases ranging from
Primary Lateral Sclerosis to Parkinson’s disease to Lyme disease. The projects also examined
challenges associated with obtaining data, such as privacy and confidentiality laws, regulations
and policies, as well as the limitations of administrative databases and medical records, which
in addition to potentially including incorrect diagnoses also include administrative errors in the
coding of ALS cases. Preliminary results from the projects were presented to the CDC in June
2009 and are guiding the next steps in creating the registry.
How to Identify ALS Cases: National Databases (Medicare, Medicaid, VA)
Using data learned from the projects, the CDC has created an algorithm that will enable the
Agency to accurately identify approximately 80‐85% of ALS cases in the United States by
examining large national administrative databases, such as those maintained by Medicare,
Medicaid and the Veterans Administration.
The effectiveness of these databases in identifying cases is relatively unique to ALS and is made
possible because of recent changes The Association has championed at Medicare, Social
Security and the VA. For example, because the 24‐month Medicare waiting period is waived for
people with ALS, many more PALS are enrolled in the program and therefore can be identified
through Medicare records. Similarly, regulations implemented by the VA in 2008 to make ALS a
service connected disease also will significantly help to identify an increasing number of cases
through VA records.
Once an ALS case is identified via this method, it will be included in the National ALS Registry.
How to Identify ALS Cases: Web Portal, Self‐Registration
In order to identify the remaining 15‐20% of cases, the CDC is launching an on‐line web portal
that will allow people with ALS to self‐enroll in the registry via a secure website. The first phase
of the portal (CDC - Amyotrophic Lateral Sclerosis) was unveiled in October 2009 and currently includes general
information about ALS and answers to frequently asked questions. Self registration is expected
to begin in late 2010 after the Agency has obtained approval from the Office of Management
and Budget (OMB), which can take 9‐12 months and is required by law to comply with privacy
and data collection laws. CDC submitted the registry for OMB approval in January 2010. A
notice of the submission is available here: http://edocket.access.gpo.gov/2010/pdf/2010‐
1718.pdf.
Once operational, the web portal will utilize a combination of strategies, including those
learned from the pilot projects, to verify true cases of ALS and to avoid duplication of
individuals already enrolled in the registry. The web portal ultimately is expected to allow any
person with ALS to access the site to enroll in the registry or confirm that they already are
enrolled.
As with other elements of the registry, The ALS Association is partnering with the CDC in the
design of the web portal. We have submitted formal comments, available here,
http://capwiz.com/alsa/attachments/07_27_09_ALS_Assoc_Comments.pdf, that also include
recommendations on how the web portal and the registry can provide PALS with additional
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information about ALS research, including clinical trials, as well as how they may obtain needed
care, services and information. In addition, The Association is preparing to actively assist PALS
across the country in enrolling in the registry.
Identifying Gaps: Targeted State Based Registry Projects
Although the National ALS Registry is expected to identify that vast majority of ALS cases
utilizing the online web portal and National databases, the CDC/ATSDR anticipates that gaps
may exist in the data collected, particularly in rural and underserved areas of the country.
Therefore, the Agency is partnering with three states to create state registry projects. These
projects are designed to obtain more detailed information about how to identify additional ALS
cases. The CDC is not duplicating state registry projects in all 50 states. Rather, data collected
will be used to identify gaps in the National Registry and to develop strategies to improve the
operation of the National Registry so that it identifies as many people with ALS as possible
throughout the country, including those in underserved areas.
Next Steps
The ALS Association is working closely with the CDC to take the steps that are necessary to fully
implement the registry as soon as possible. Several vital activities will be taking place in the
coming months and we are pleased to share with you a timeline that outlines what will be
happening. The timeline is available here:
https://ssl.capwiz.com/alsa/attachments/National_ALS_Registry_Timeline__Feb_2010_.pdf.
Enrolling in the Registry
Although self enrollment in the ALS registry has not yet begun, The ALS Association is working
with the CDC to ensure that as many people with ALS as possible enroll in the registry once self
enrollment is available. Therefore, we urge all PALS to sign‐up as ALS Advocates via our website
here: Public Policy - The ALS Association. By selecting ALS Registry when signing‐ up, PALS
will be notified as soon as the self enrollment phase of the web portal becomes operational and
they also will receive detailed instructions on how they can enroll.
Congressional Funding Needed
The ALS Association is working with Congress to appropriate $10 million in funding in FY 2011
to continue the Registry and enable this important research project to continue. Funding in FY
2011 also is needed to begin to realize the promise of the registry as an engine that will drive
research forward, helping to generate vital data that will advance our understanding of the
disease, its causes and how it can be diagnosed and treated.
The ALS Association will provide additional information about the ALS registry as it becomes
available. If you have any questions, please contact us at advocacy@alsa‐national.org or tollfree
at 1‐877‐444‐ALSA.
 
KM.
Thank you very much for sharing the information on Pl 110--373. As it's administrated by the government, we will all keep our fingers crossed. In the meantime I believe it should be nicknamed" The Flying Monkeys Act".--JK
 
Thanks! I was just going to post about this, but I see ya beat me to it!
 
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