Legislative Advocacy

Congress votes to set up registry for ALS sufferers

By Burton Bollag

Congress has voted to establish the first-ever national patient registry of people with Lou Gehrig’s Disease, or amyotrophic lateral sclerosis (ALS), to be administered by the Centers for Disease Control and Prevention.

The aim is to use the collected data to help discover the cause, and develop treatments and a cure for the deadly neurological disease that took the life of baseball legend Lou Gehrig in 1941.

“This bill will arm scientists with the tools they need to make progress in the search for a cure for ALS, or possibly a way to prevent this devastating disease in the first place," said Senate Majority Leader Harry Reid (D-Nev.).

“It’s long overdue," said Gary Leo, president of the ALS Association.

In 2005, the association got Congress to direct nearly $1 million of existing CDC funds to begin three pilot projects to to guide the creation of a national registry. Those projects, in Georgia, Minnesota and South Carolina, have two goals: to develop and test strategies to efficiently identify ALS patients; and to determine effective ways to obtain and share data from existing sources, such as ALS Association chapters and the Veterans Affairs Department's ALS Registry.

In the South Carolina program, for example, the Office of Research and Statistics of the South Carolina Budget and Control Board has been collecting data from more than 40 public and private statewide partnerships. Individuals with ALS are identified using International Classification of Diseases codes. If available, specific procedures and prescription medication data are used to select potential ALS patients who were not identified using the codes. Once individuals are identified, medical records are reviewed to confirm that the diagnosis coding was correct.

VA To Provide Full Benefits for All Veterans With ALS

The Department of Veterans Affairs on Tuesday announced that all veterans with amyotrophic lateral sclerosis, or Lou Gehrig's disease, will receive full disability, lifetime health and death benefits, a move that effectively acknowledges a general link between the condition and military service, the New York Times reports. According to VA, all veterans with ALS will qualify for disability benefits, regardless of when or where they served.

VA expects 416 new cases of ALS among veterans in 2009 and a total of about 700 veterans who qualify for the benefits annually. Disability and death benefits will cost about $23 million in 2009 and $505,839,000 over 10 years, according to Tom Pamperin, deputy director of the compensation and pension service at VA. VA based the decision to provide the benefits on studies that found veterans are more likely than the general population to develop ALS, although the reason for the link remains undetermined.

Pamperin said that VA Secretary James Peake "felt the right thing to do was to give veterans the benefit of the doubt, particularly since this disease is so debilitating." Jinsy Andrews, a neurologist at the center for ALS at New York-Presbyterian Hospital, said, "There are many theories of why veterans may be having an increased risk of ALS, which include psychological or physical stress, or even vaccinations or exposure to electromagnetic fields, or to toxic agents that have been used in the Gulf War," adding, "And that may lead [us to] discover possible associations and mechanisms involved in the disease that have been unknown for so long" (Grady, New York Times, 9/24).

Medicare Improvements for Patients and Providers Act (HR 6331)

It's official! After more than two years of outreach to Congress, victory has been achieved in the fight to ensure access to power wheelchairs. Last week Congress voted to override the President's veto of Medicare legislation that would exclude high-end power wheelchairs from Medicare's competitive bidding program. This victory means that people with ALS no longer need to worry that competitive bidding will limit the types of chairs available to people with ALS or reduce access to needed services and suppliers. The bill is now law!

Key Provisions also Included

In addition to competitive bidding, the bill enacted into law includes a number of other critical provisions important to people with ALS. These provisions provide important protections to people with ALS, improve coverage for prescription drugs under the Medicare program, and help ensure access to other critical Medicare benefits, like physical therapy. The key provisions of the Medicare Improvements for Patients and Providers Act (HR 6331) include:

• Ensures Access to Power Wheelchairs
  
• Improves Medicare Prescription Drug Coverage
  
• Provides Additional Coverage for Physical Therapy, Occupational Therapy and Speech Language Pathology Services
  
• Improves Access to the Medicare Savings Program (MSP)
  

House of Representatives Votes to Create National Registry for Lou Gehrig’s Disease

The House of Representatives took a major step in the fight against Lou Gehrig’s Disease on October 16 when it passed The ALS Registry Act (H.R. 2295) by an overwhelming 411-3 vote. The legislation would establish the first ever national patient registry of people with Lou Gehrig’s Disease, or amyotrophic lateral sclerosis, to be administered by the Centers for Disease Control and Prevention. The registry would collect information leading to the cause, treatment and cure of the deadly neurological disease that took the life of baseball legend Lou Gehrig in 1941.

Senator Reid Reintroduces Legislation to Create ALS Registry

May 14, 2007 -- Washington, D.C. - Working to increase understanding of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease, U.S. Senator Harry Reid of Nevada reintroduced legislation today to establish a single, national ALS patient registry at the Centers for Disease Control (CDC) to collect data and study ALS.

"Creating a national registry is crucial to understand patterns and examine causes of this debilitating disease," said Reid. "It means so much to me to sponsor such an important piece of legislation, which offers hope to ultimately find treatments and a cure for ALS." The Amyotrophic Lateral Sclerosis (ALS) Registry Act authorizes $25 million for fiscal year 2008 and such sums as necessary for fiscal years 2009 through 2012. In the two years since Reid first introduced this bill, Reid and Senator Harkin have secured funding ($900,000 in FY 2006 and $900,000 in FY 2007) so that the CDC may begin pilot programs that will aid in the development of a national ALS registry. These pilots will help expedite the creation of the registry should the legislation become law.

Stem Cell Research

Stem cell research holds promise for ALS and may lead to new discoveries and possibly additional therapies for the disease. However, while stem cell research has potential for ALS, more work needs to be done before its potential can be determined.

The ALS Registry Act

A single national patient registry which collects and stores information on the prevalence and incidence of ALS does not exist in the United States today. The establishment of a national registry will help identify the incidence and prevalence of ALS in the United States and collect data which is urgently needed for ALS research, disease management and the development of standards of care. A national ALS registry also will promote a better understanding of the disease, help to determine causes of ALS and significantly enhance the nation’s efforts to find a treatment and cure for ALS.

Department of Defense Appropriations

ALS was included as one of just twenty-eight diseases eligible for the Peer Reviewed Medical Research Program in the 2003 fiscal year budget of the Department of Defense Appropriations bill. Researchers have submitted applications, which are currently being reviewed by the DOD. Continued funding for ALS specific research in the 2004 fiscal year budget will allow researchers to continue moving forward towards finding a cause, treatment and eventual cure in regards to environmental factors.

Medicare Drug Benefit

Medicare should be reformed to meet the needs of beneficiaries with ALS by adding a prescription drug coverage plan that includes a provision for catastrophic coverage without a co-pay; that is structured in a manner that will ensure the continued vitality of the drug discovery process and development of new and better pharmaceutical treatments; that is universal; and that has consistent and meaningful appeals like other Medicare covered services.

Presumptive Eligibility for Social Security Disability

Individuals with ALS should be eligible for Social Security Disability immediately after they receive an ALS diagnosis by their primary neurologist rather than having to endure an assessment process that often takes a year or longer. This type of coverage is called presumptive eligibility and has been included in the recently released legislative and regulatory package sent to Congress from the Office of Commissioner Jo Anne Barnhart of the Social Security Administration.

National Institutes of Health

The NIH provides roughly three-quarters of all the funding devoted to ALS research in the United States. Thus, it is critical to continue increasing the NIH budget by 8-10% annually, specifically within the National Institute for Neurological Disorders and Stroke (NINDS), and to allow NINDS to coordinate, and collaborate on, ALS research with other appropriate NIH Institutes, such as the National Institute of Environmental Health Sciences (NIEHS).