State ALS Registries Collect Valuable Data, but Few Are in Process

Only Massachusetts has a mandatory registry, though 2 more are on the way

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by Hawken Miller |

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Patient registries help record how many cases of a particular disease there are across the country, and many also log related genetic, clinical, and biological information.

Some U.S. registries, including those dealing with infectious diseases, have mandatory reporting requirements. But for many other diseases, including amyotrophic lateral sclerosis (ALS), they do not. 

The National ALS Registry, for example, is run by the Centers for Disease Control and Prevention (CDC) and collects data from the federal government, such as the U.S. Department of Veterans Affairs and the Centers for Medicare & Medicaid Services. It also collects voluntary data from people with ALS who sign up via its web portal.

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Technology Helping to Make Registries, Databases More Efficient

Clinics across the U.S., however, are under no obligation to report a case of ALS, which means some diagnoses may be missing. That’s where state-level registries, which are gaining traction in the Northeast, could come in.

These registries can make mandatory requirements for clinics in their jurisdictions in a way that can’t always be done at the federal level. Scientists hope that might help pave the way for the National ALS Registry to become mandatory.

“It would be best if the national registry is reportable and mandatory, but it’s not. And it’s harder to get things on a country’s national level versus a state level, because it’s a smaller operation and probably [has] fewer hurdles,” Elijah Stommel, MD, PhD, a neurologist with Dartmouth Hitchcock Medical Center in New Hampshire, said in an interview with ALS News Today.

Stommel sees ALS patients across the Northeast and is researching how the environment there could be a risk factor for developing ALS.

Massachusetts leads the way with state registries

Right now, only one state — Massachusetts — has a fully functioning ALS Registry. Some states are working on developing their own registries, and governors have signed bills to establish them in Vermont and Maine. But only Massachusetts has one that’s up and running.

“There’s been a hunger with patients and groups asking for what’s happening in my backyard,” said Paul Mehta, the principal investigator of the National ALS Registry. “And we want to go ahead and provide more granular information at the state level.”

More in-depth, state-level information about ALS cases could bring state legislatures to allocate more funding for ALS research and clinical care. Such knowledge also could help in linking ALS cases to environmental issues, such as airborne pollutants.

Just as cancers and infectious diseases have environmental risk factors and are tracked in registries, scientists are learning neurodegenerative diseases have similar risk factors, so a state registry makes sense for ALS, Stommel said.

Smaller states, such as Vermont, are expected to have about 20–25 new patients a year, he added. Maine might get double that. While a few dozen people might seem of little relevance, connecting their cases to databases that show residency over time can be quite powerful.

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“If you get all the cases reported in a state … you can really do some analyses of what patients had done and what they had been exposed to,” Stommel said. “It’s also useful for the patients. If they’re in a registry, then they’re going to be informed of ALS clinics. They’re going to be informed of potential clinical trials. If they’re [Veterans Affairs] patients, they’ll be informed about benefits that they might not know about. It’s a two-way street.”

The legislation that created the Massachusetts registry makes ALS a reportable condition, which means the state Department of Public Health will collect medical records from healthcare providers of those diagnosed with the disease. The fine for not reporting ALS is up to $500 a day and can result in revoking or changing the license of a healthcare facility or related party.

Part of the reason why Massachusetts was an early registry adopter is because a former governor, Paul Cellucci, was diagnosed with the disease after leaving office, and he died of disease complications in 2013. State officials named the registry after him.

State registries also don’t have to contend with the kinds of regulatory and political hurdles for reporting that exist on the national level, Stommel said.

Where state registries stand in US

Governors in Vermont and Maine signed bills in May to set up registries in their states. Maine’s CDC confirmed to ALS News Today that it’s drafting rules for its registry, and rule-making will be initiated during this legislative session, which opened Dec. 7.

Some efforts are underway in other states. With federal funding from the CDC, officials in Ohio, working with Stommel and others, set up a two-year registry of new cases. From October 2016 through September 2018, the registry identified 333 newly diagnosed ALS patients.

Registry analyses also found age- and gender-standardized incidence to be 1.71/100,000 person-years (meaning that 1.71 out of 100,000 people living in Ohio would be diagnosed with ALS in a given year). This statistic tracks closely with the national incidence rate measured in the National ALS Registry, between 1.5 and 1.7 per 100,000 people.

With Massachusetts, the National ALS Registry is working to match existing cases in their respective registries. It’s part of a CDC registry goal to provide information on disease burden to help inform public health policy, such as ALS research in federal government funding bills.

“ALS is a very relevant and relatively opportune neurodegenerative disease to research and can shed light on some of the more common neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease,” Stommel stated in a written summary of testimony to state Sen. Virginia Lyons of Vermont. It “also would be very helpful to patients and their families who … often have no direction from ALS experts.”

A real need exists “for states to come together to help create a mandatory national registry. Setting a precedence on the state level will likely make this happen,” Stommel added. “If large states such as California, Michigan and Florida follow suit, we would be on our way to a mandatory National ALS Registry.”

That registry, in turn, could help researchers tease out why certain areas of the U.S. have higher ALS rates than others and potentially discover ways the disease could be prevented.

This article is one of three published as part of the Rare Disease Fellowship through the National Press Foundation.