Appropriate $10 million to continue the National ALS Registry at the Centers for Disease Control and Prevention.
The Administration and Congress have made the establishment of the National ALS Registry a top priority through the enactment of the ALS Registry Act in 2008 (P.L. 110-373) and by appropriating funding to develop and implement the registry in each of the past nine years. Using a variety of enrollment strategies, including online self-enrollment, the registry currently is identifying the number of cases of ALS in the U.S. and collecting data that may help us learn what causes the disease and how it can be treated, prevented and, ultimately, cured. However, funding is necessary in FY 2017 to continue the registry, fund registry-related ALS research, help people with ALS enroll in the registry, conduct outreach activities to identify ALS cases across the country, establish an ALS biorepository that collects blood and tissue samples and enable the registry to advance clinical trials to develop new treatments for the disease.
Appropriate $10 million to continue the ALS Research Program (ALSRP) at the Department of Defense (DOD).
Studies supported by the DOD, Department of Veterans Affairs, National Institutes of Health, Harvard University and the Institute of Medicine among others repeatedly have found that military veterans, regardless of branch or era of service, are approximately twice as likely to die from Lou Gehrig’s Disease as those who have not served in the military. In order to support our nation’s military heroes in the fight against ALS, Congress and the DOD established the ALS Research Program (ALSRP) in FY 2007. The ALSRP is promoting translational research and is specifically designed to find new treatments for ALS, a disease for which an effective treatment currently does not exist. The ALSRP also is funding the best science as funding is provided on a competitive grant basis and projects are peer reviewed. While Congress has continued to appropriate funding for the ALSRP, the current level leaves more than 95% of submitted projects unfunded. Opportunities to discover and deliver a treatment to veterans will be lost, leaving them and all people living with the disease with no effective treatment option. Congress can continue this vital program and take steps to ensure that our nation continues to fight for our veterans just as they fought for us.
Regulatory barriers and limited incentives to pursue innovation have hindered the development of new treatments for ALS and other diseases with unmet medical needs. In fact, people with ALS will die in an average of just two to five years because an effective treatment does not exist. The House of Representatives passed the 21st Century Cures Act, sweeping legislation that included provisions to strengthen the accelerated approval process at FDA, expand the use of patient input in regulatory decision-making and drug development, and provide new incentives to develop treatments for rare diseases among many other provisions. The Senate currently is working on its version of the legislation called the Health Innovation Package.
The Dormant Therapies Act would accelerate the search for a treatment for ALS and other diseases by removing the barriers that limit medical innovation and by providing incentives to develop new treatments that can improve, prolong and, ultimately, save lives. Specifically the bill will: Encourage research on treatments that hold promise for treating diseases with unmet medical needs, but have been set aside in the lab because they lack or have weak patents. The Association is working to include Dormant within the Senate’s larger Health Innovation Package.
In 2015, The Association worked with Congress and coalition partners such as MDA to enact legislation in December to help preserve access to power wheelchair accessories such as custom head support and seating systems, mounting hardware, adjustable leg rests, and specialty drive controls among other wheelchair accessories upon which people with ALS depend. The Centers for Medicare and Medicaid Services (CMS) was schedule to significantly reduce payments for these accessories on January 1, 2016; however, the Department worked with Congress to delay implementation of these cuts by one year.
In 2016, The Association will work to implement a permanent solution through the legislative or regulatory process.
The Association is looking to find opportunities to waive the five month waiting period for Social Security Disability Insurance (SSDI). After a disability claimant has been approved to receive SSDI benefits, the individual is subject to a five month waiting period before the individual will receive the disability benefits. During these five months, many families who already have paid into social security are left with no form of income creating hardships.
The Association has twice worked with Members of Congress to introduce legislation to eliminate the five month waiting period. While this is a challenging issue in the current political climate, The Association recognizes the importance of the issue to the ALS community and will continue to work to find opportunities to eliminate the five month waiting period.