Congress passed the ALS Registry Act in 2008, and President George Bush signed the legislation into law on October 8, 2008 (Public Law 110-373). The legislation provides ATSDR with the authorization and guidance necessary to create a national ALS registry. Representatives Eliot Engel (D-NY) and Lee Terry (R-NE) and Senators Harry Reid (D-NV) and John Warner (R-VA) were the primary sponsors of the legislation, which garnered broad bipartisan support in both the House of Representatives and the Senate. The House of Representatives passed the legislation by an overwhelming 415-2 vote, and the Senate passed it by unanimous consent.
Before the ALS Registry Act was enacted, Congress appropriated funding to enable ATSDR to conduct pilot projects to evaluate the feasibility of creating a National ALS Registry and to determine the most effective ways to create the National ALS Registry. Over a nearly three year period, ATSDR sponsored four pilot projects. The pilots were conducted in:
The projects evaluated 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 diagnosed easily ,and often is misdiagnosed or confused with other diseases. 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. Results from the projects guided creation and implementation of the National ALS Registry.
Using data from the pilot projects, the ATSDR created an algorithm that enables the agency to identify approximately 80-85% of ALS cases in the United States accurately by examining large national administrative databases, such as those maintained by Medicare, Medicaid, the Veterans Health Administration (VHA), and the Veterans Benefits Administration (VBA).
The effectiveness of these databases in identifying cases may be unique to ALS and is made possible because of changes The Association has championed at Medicare, Social Security, and the VA. For example, because Medicare waives its 24-month waiting period for persons with ALS, many more people with the disease 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 significantly help to identify an increasing number of cases through VA records.
Once an ALS case is identified via these methods, it is included in the National ALS Registry.
In order to identify the remaining 15-20% of cases, ATSDR has launched an on-line web portal that allows persons with ALS to self-enroll in the National ALS Registry via a secure website. The first phase of the portal (www.cdc.gov/als) was unveiled in October 2009 and included general information about ALS and answers to frequently asked questions. On October 19, 2010, ATSDR launched the completed web portal.
The web portal allows any person with ALS to access the site to self-enroll in the National ALS Registry. The web portal utilizes a combination of strategies to avoid duplication of individuals already enrolled in the National ALS Registry.
The web portal also includes “modules” or questionnaires that collect additional detailed information about ALS cases, including:
As with other elements of the National ALS Registry, The ALS Association and ALS researchers partnered with ATSDR as it developed the web portal. Persons with ALS also tested the web portal before its implementation, including during The ALS Association’s 2010 National ALS Advocacy Day and Public Policy Conference. All persons with ALS are encouraged to self-register and complete the surveys regardless of whether they may be enrolled via the national databases.
