One Industry Expert’s View of How State Efforts to Manage the Opioid Crisis Will Affect HIT Leaders

March 26, 2018
Connie Sinclair, R.Ph., has been leading a team of researchers and analysts at the Point-of-Care Partners consulting firm in tracking the exploding state-level requirements around the prescribing of opioids—with a new summary report on the phenomenon

As everyone involved in U.S. healthcare knows, the United States is mired in a broad and intense crisis around opioid abuse and addiction. Much of the action taking place has involved state governments, but the actions of state governments have been extremely diverse, and often, for providers, confusing and overly complex—especially for the leaders of patient care organizations with patient care presence in more than one state.

With regard to all of that, last month, leaders at the Coral Springs, Fla.-based Point-of-Care Partners consulting firm released a broad report looking at what actions state governments have been taking in order to address the opioid crisis. Under the title, “Fighting the Opioid Epidemic at the State- and Rx-Level Report,” the new report examines the diversity of efforts and actions, in considerable detail.

As explained on the consulting firm’s website, “The 33-page report includes details of state responses to opioid prescribing organized around three main trends: 1) prescribing, 2) curbing fraud and abuse, and 3) preventing and treating addiction.” And, it “explains overarching trends across the states on opioid prescribing and provides the latest summary details on a state-by-state basis,” based on original research and data collection by Point of Care Partners researchers in 2017.

There are many implications of all this activity, for healthcare IT leaders. One of the report’s co-authors, Connie Sinclair, R.Ph., the director of POCP’s Regulatory Resource Center, spoke recently with Healthcare Informatics Editor-in-Chief Mark Hagland, about the implications for CIOs, CMIOs, clinical informaticists, and other healthcare IT leaders in patient care organizations. Below are excerpts from that interview.

Overall, what were your team’s high-level findings, as detailed in the report?

There are lots of avenues of attack for this opioid crisis—the federal level, the state level, the provider level, the idea of law enforcement, of getting more people into treatment—but what we’re saying in the report is that if you want to reduce the number of addicts, which really is the long-term goal, you have to impact this at the point of prescribing—it’s at the moment when that prescriber is writing that prescription. And states have a lot to say about this—treating addicts, dealing with the fallout of all of that, is very expensive for the states, especially as Medicaid payers. Their Medicaid populations are very heavily hit by this crisis. And states have a lot to gain from solving this. And of course, there are task force recommendations, and activity is taking place on the part of the FDA [Food and Drug Administration], DEA [Drug Enforcement Administration], and other agencies.  But states have been at this for a long while, really dealing with this since 2012; so they’ve been passing lots of new laws and adopting new rules, to curb this.

Meanwhile, at POCP, our Regulatory Center has been tracking all these rules and regulations, including anything that ties into e-prescribing or EHR [electronic health record] regulations. Hundreds of elements are involved—from whether e-prescribing is allowed, whether it’s mandated, and if so, for which schedules; and hundreds of data elements are involved. How do you prevent generic substitution of drugs? And so on. And our work has exploded over the past few years. I have a team of pharmacists who are also informaticists—I’ve been an e-prescribing product manager many times—I’ve spent more than 30 years in HIT.

I’ve been a product manager, a product marketing person, and a business analyst, before I became a consultant. So that’s the lens we’re looking at all this through: what’s the impact of all of this on healthcare systems, and healthcare information systems? So the whole report is relevant to that; but we’re really zeroing in on the regulations and laws that impact that prescriber at the moment of prescribing. It might be a limit on quantity. Is it a first-time patient who’s never had an opioid before, just broke their arm and needs a few pills? Or is it a cancer patient? And states are doing things like quantity limits. But they’re all doing all different things, and in different ways.

And in many cases, that means curbs on how much quantity of any opioid can be prescribed, correct?

Yes, that’s right, it means quantity limitations, and also the mandated use of state prescription drug monitoring programs, or PDMPs. The state-run databases of controlled substances, etc. There are many new requirements—over 30 states now require the prescriber to look at the PDMP before writing the prescription. And then the pharmacist dispensers may have that requirement as well. And then things like mandating electronic prescriptions to prevent fraud and abuse—we have several states in process. That is to prevent paper prescriptions from being manipulated.

About how many states have done that?

It’s about nine right now, but there are several that are debating that in legislatures right now. And of course, some have already implemented, and others have future deadlines.

And the other piece of the PDMP is the profiles. And it might be just for opiates, or for anti-anxiety drugs like Xanax, and opiates, or for all Schedule 2 drugs. But the other challenge with those profiles is that these state-run databases are accessed via portals. So for a physician to stop in the middle of a prescription and have to log into a new portal, that takes an average of four-and-a-half minutes. Every patient has a profile of controlled substances that they’ve had prescriptions filled for, from all pharmacies. That is available to prescribers, but typically, by exiting their EHR and logging into a specific state site.

Do all 50 states have PDMPs now?

Yes. Missouri is kind of in that gray area, but everybody else has one, and it’s up and running.

So the IT challenge is, if you’re going to mandate that prescribers do this, it needs to be integrated into their workflow. So there are many efforts underway to facilitate that integration. And as you know, there are so many EHRs. At least the top ten EHRs are trying to figure out this integration piece; they may only be working on this for a particular client or particular state—it’s a nascent thing to figure out this integration piece. There are some standards, but it’s a huge area. And states are starting to realize that their mandate is not enough, that they need to put this into prescribers’ workflows. Most are not mandating yet that EHRs put them into the workflow, but they’re encouraging the large EHRs do do something about this.

How quickly will that process happen?

It’s already happening. There was a pilot done in Washington state, and pilots in a couple of other states. There’s a vendor called Appriss. They’ve been gradually taking over the management of these PDMPs on behalf of the states; they’re basically running these PDMPs for some 40 of the states. A lot of the efforts I’m aware of are involving some of the leading EHRs working with them.

The National Association of Boards of Pharmacy, in conjunction with Appriss, has developed a network of states, called PMP Interconnect. These states have agreed to share PDMP data. Appriss offers an API gateway that facilitates EHRs and pharmacy systems to connect multi-state PDMP access into clinician workflow. States are subsidizing, via grant programs, for their largest health systems, to get connected through this gateway. There are other things that can go along with that. Appriss also provides a risk assessment to help the prescriber determine which patients are more likely to be using too many opiates.

Nebraska’s state legislature passed a law requiring that all electronic prescriptions be entered in that state’s HIE.

Yes, and California will charge the EHR vendors for the privilege of connecting to their PDMP. So it’s kind of all over the map. I will say that the NABP/Appriss collaboration brings a lot of bang for the buck; but that doesn’t apply in every state.

Another piece of this is that the states are beginning to mandate that prescribers do counseling about the risk of addiction before they prescribe, or have them sign an informed consent, or the patient could be offered that they could sign a form saying they don’t ever want to be prescribed opiates. In most cases, this has to be noted in the EHR. And when you add in requirements that they can only prescribe a seven-day set of doses, for example, it gets very complex.

For HIT leaders, it’s the level of complexity in dealing with all these different cross hatches and dimensions that is most challenging, correct?

Yes. There is, though, a lot of commonality among the various state requirements. Limits are usually by number of days, or there’s a calculation called morphine milligram equivalence. Those are the two primary ways for limiting the quantity. So if your EHR can handle those two elements—parameter for default of day’s supply or MME, you can limit the complexity. Or it might not even be a default. There are various ways to handle it. Every state has a different print template for how a printed prescription should look. So the EHRs have adapted to those variations. So these might be new types of edits, pop-ups, or even guidelines.

So in our report, we cover these trends at a high level and their impact, but then we also have a fair amount of detail at the state level; it’s not the 500 data elements we track at the consulting firm. But with this report, we’ve picked out and culled some of those, especially where you can see a trend or commonality, and we’ve put those state-by-state data elements in this report. Another piece is, who can prescribe? Are you a physician assistant or advanced nurse practitioner? Your rules may be different from an MD’s.

So the point of the report really is—for an EHR manager, or someone who manages this, it’s, what do people need to be planning for? This provides an introduction to that, but with a fair amount of detail.

What are the two or three things that CIOs and CMIOs should be doing right now, per all this?

The number-one thing is to make sure that the version of the EHR they have running is fully certified for EPCS, electronic prescribing of controlled substances, because the DEA has very stringent rules and a certification process, in order to clear a vendor to process controlled-substance prescriptions. So you want to make sure that you have something installed that can actually do that. The problem is that most vendors are certified, but provider organizations may be three versions behind. And certainly the states that are mandating it are getting more attention from the vendors. So if you really want to make a difference, make sure your prescribers can prescribe controlled substances.

The second would be this PDMP integration: you can try this with your state government, and with your vendor. Who can you call? What do you need to do to make sure your EHR is fully integrated with the PDMP—make sure both your state and vendor are able to do that.

And the third thing would be the limits on prescribing, whether a quantity or day’s supply, or certain types of prescriptions—all those limits, as well as all the consent forms, etc.—to be aware that prescribers are being mandated in various ways, and to do what they can to help them comply. That may be working with their vendor, so that they have mechanisms to help their prescribers—and understanding their state requirements. Hopefully, their prescribers do know, but they might not.

Will state governments move towards some broadly consistent themes or areas of focus in the next few years, around all of this?

You would think that the formats of printed prescriptions would be the same across the country, but they’re not; you’d think that the DEA controlled substance schedules for what’s in Schedule 2 and Schedule 3, would be consistent; but they’re not. Many times, states are the leaders. They’re seeing what’s going on, and so the states are kind of in the forefront of things. Given all of that, there will be some variability always, for some reasons. But I do think there’s the potential for activity at the federal level—a mandate for electronic prescribing, or a mandate for how PDMPs operate; and maybe federal guidelines for what kinds of day’s supply is allowed. But even if those things happen, states will always have their own twists on things. Because what might pass at the federal level would probably be less restrictive than what some states might choose to do. There will always room for some variability.

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