Fed mandate to use opioid data-sharing technology angers states

https://www.politico.com/story/2019/04/12/opioid-data-sharing-angers-states-1320532

The Trump administration is forcing states that want millions in federal grants to use relatively untested technology to share prescription data that is key to combating the opioid crisis.

Using the software, many state officials worry, could mean turning over patient data to law enforcement and invading patients’ privacy. And it would override an already proven system used by doctors in 46 states plus Washington, D.C., and Puerto Rico.

The dispute is over prescription drug monitoring programs, which track all the drugs dispensed in a given state. While handy for doctors seeing whether patients might be receiving too many opioids, or for law enforcement looking for pill mills, it’s inherently limited: An affected patient might easily receive prescriptions from multiple states. Hence the need to share data across state lines. If states use competing systems that don’t communicate, the data-sharing work falls apart.

The dispute is particularly acute given the overdose crisis that’s claiming tens of thousands of lives each year in the U.S. Getting the data-sharing right could help doctors detect patients’ problems sooner and solve them faster.

But opioid prescribing data is already being shared across most of the U.S. That adds to states’ puzzlement that the CDC and Department of Justice’s Bureau of Justice Assistance are requiring grant applicants to provide patient information through a competing data hub called RxCheck, funded by the Bureau.

RxCheck helps pass requests from doctors and pharmacists for prescription history across state lines. The government says RxCheck, which is managed by member states’ prescription drug monitoring boards, will introduce competition in the market.

Officials in 14 states said in a series of letters last fall that the RxCheck hub is being foisted upon them to solve a problem they don’t have. The hub, with its relatively untested technical capacity, could lead to privacy invasions and incapacitate the established data-sharing system most use now, some worry.

“When you have a good thing going, to go and jump into a system that isn’t widely used — it’s kind of like, nonsense,” said Joe Fontenot, assistant executive director of the Louisiana Board of Pharmacy.

The Bureau’s grants, worth hundreds of thousands of dollars to each winning state, were awarded in September. In order to use the money, states had to connect to RxCheck. But the bigger prize is the upcoming CDC grants, worth as much as $9.1 million per state, which also come with the requirement that states use RxCheck. States need to decide on the CDC grants by a May 4 deadline.

A competing technology, backed by a firm called Appriss, has dominated the prescription drug monitoring program market since its entry in 2014. Since 2011, Appriss has also led interstate data-sharing through a system called PMP InterConnect, developed with the nonprofit National Association of Boards of Pharmacy. The federal government thinks that Appriss’ twin dominance puts RxCheck at an unfair disadvantage.

The federal government has been trying to encourage the use of RxCheck since at least May 2012, but only with this latest round of grants has it required the use of the technology.

For affected states, the preference for PMP InterConnect reflects its superiority — and a reason not to dabble with RxCheck.

“We may move from a system that works extremely well to one that has a lot of unknowns and is of uncertain capability,” said David Brown, director of Virginia’s Department of Health Professions.

Brown’s concerns about RxCheck and the grant requirements are shared by many other states. They say the language in the Bureau’s grant requirements opens the door for access by law enforcement contrary to state law. The grant requires software, data, “or other intangible property … designed, developed, acquired, or produced under this award” to be provided upon request.

That leaves open the possibility that state prescription data “owned” by the participating states will be subject to sharing without a review process, New Jersey’s attorney general wrote in an Oct. 31 letter.

Michigan won’t accept the grant money if it requires the state to “violate its own laws,” said Pardeep Toor, spokesperson for the Department of Licensing and Regulatory Affairs. North Dakota may follow suit, although Sen. John Hoeven’s office said he is working to address the state’s concerns.

The CDC grants pose slightly different concerns, mandating that states have archiving plans for their data. That requirement, some states say, would clash with their privacy laws, which require them to scrub old data.

The CDC’s money is perceived as a powerful form of leverage, because it doesn’t specifically flow to drug monitoring programs but rather to state departments of health. A monitoring program director’s concerns might not override a state’s broader interest in the money.

“They’re basically strong-arming the states to say if you want this money for the state, the whole state overall, not just the PDMP, you need to accept this condition,” said Mark Hardy, executive director of the North Dakota Board of Pharmacy.

Only four states use RxCheck, a state of affairs the agencies blame on Appriss, which blocks access through “influence over both the cost and timing of connections that are made at the state level,” said Tara Kunkel, an adviser to the Department of Justice’s Bureau of Justice Assistance.

Kunkel said the federal government had received complaints from 11 states who say the vendor has abused its market position. The states said they’d been unable to access their data without paying extra fees and faced prohibitively high costs to connect providers serving poor or rural areas to PDMPs through their electronic health records, she said.

But not all states agree with the complaint. Cost “has not been a barrier at all,” said North Dakota’s Hardy.

States aren’t sure they can afford to maintain RxCheck and InterConnect at the same time. The National Association of Boards of Pharmacy’s director, Carmen Catizone, says his organization may have to close InterConnect if the government continues to push RxCheck.

Justice and the CDC have attempted to calm such concerns with letters, webinars and FAQs. They say they don’t intend to circumvent relevant laws and that the provisions are methods of combating competitive abuses.

But states also worry that the RxCheck hub may be incapable of handling the demands of data-sharing. Some 20 million transactions per month pass through PMP Gateway, the EHR integration tool, the National Association of Boards of Pharmacy says. RxCheck’s EHR integration only moved out of the pilot phase last fall.

Kunkel also claimed Appriss is using its competitive position to block RxCheck and to choke off provider and government use of prescription data for things like analyses to detect over-prescribing “hot spots.”

Rob Cohen, president of Appriss’ health division, denied the government’s complaints. He said Appriss provides several tools to analyze state data, and only has minimal charges in rare circumstances.

The federal government said RxCheck enables doctors to cheaply access PDMP information directly through their computer systems. In Kentucky, state officials can provide RxCheck to doctors who want a low-cost option, according to Dave Hopkins, a program manager at Kentucky’s PDMP. The Gateway alternative has more features but costs more, he said.

But only a tiny number of doctors have connected their EHRs to PDMPs through RxCheck, Cohen said, while Appriss has connected hundreds of thousands in the state.

RxCheck, he claimed, lacks important features such as robust audit trails that allow administrators to see what user accessed data. While RxCheck may not charge for the integrations, he said, maintenance functions like call centers will get “pushed out to the states, or the vendors to the states, or the EHRs.”

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