Strategizing for Health Care Interoperability Regulation Changes

Explore the future of interoperability regulation and how organizations can adapt and thrive in the changing regulatory landscape in an exclusive interview with an industry expert.

Don Rucker, MD: Hi, folks. Don Rucker, I'm Chief Strategy Officer at 1upHealth. We're a Fast Healthcare Interoperability Resource (FHIR) data platform in the cloud. We'll talk more about application programming interfaces (APIs) later. My history in this field goes way, way back to when I was a medical student in the 1970s and realized how little data we had in health care to do computing.  I’ve been involved in all kinds of stuff including building EHRs and computerized physician order entry. Many people know me as the former national coordinator for Health IT. I implemented the Cures Act APIs that deliver patients their data in a modern computable data standard without being forced to go through brokers implementing the Cures Act. 

What kind of interoperability regulation updates is the industry experiencing currently?  

Dr Rucker: A theme since the Cures Act has been using modern data standards that, in many cases, at least have the hope of computing data at the back end. That may sound obvious, but by comparison, a lot of what we did before is sort of ‘paving the cow path’. The base assumption was digitizing a paper chart. But the only computing going on, besides moving data around, was whatever the doctors, nurses, physical therapists, occupational therapists, radiologists, techs, pharmacists, and everybody else in the ecosystem could do in their brains. None of us got much help from the computer. 

Now we're starting to get the same type of computing that every other person has on their smartphone whenever they check the weather, watch entertainment and sports, make a reservation, check a bank account balance, text, email, take a photo, etc. All of those things are task-based activities. That's what these rules are starting, fitfully, to get us to.

Looking ahead over the next few years, what kinds of significant changes and trends do you anticipate for the regulatory landscape?

Dr Rucker: The Cures Act focused on electronic health records. The Office of the National Coordinator for Health Information Technology (ONC), which has now been renamed Assistant Secretary for Technology Policy (ASTP)/ONC in the best DC tradition because why have a 3-letter or 5-letter acronym when you can just double the number of letters in your acronym? I think there's an increasing focus on the API, the connectivity, rather than what the software does. 

For health care, maybe the biggest thing with the CMS 0057 rule, and now the proposed ONC HTI-2 rule. The actual titles are almost meaningless, everybody refers to them by the abbreviation. Historically, we had the EHR and as a patient, I should have a right to get that data out, not just for me, in case I happen to be a computer programmer, but for apps of my choosing. Now, with both of those regs, this burden is also being put on payers. It takes 2 to tango. Instead of just having an API on the EHR side, we now have it on the insurer side. CMS has already done that with Blue Button, going back even before that in Medicare. CMS has been ‘eating their own dog food’ to use a famous Steve Ballmer phrase from back in the day. But now this is a regulatory function for both parties. 

You have not just the original EHR to patient connection, but now also payer to patient. And now we have payer to provider and provider to payer and payer to payer. And probably initially the interaction of the payer and the provider is certainly important because payers tend to have more information on the totality of a patient's care than a provider does. Even if you're in a big, consolidated delivery system where patients are getting most of their care from you—almost inevitably they're not getting all their care from you. And with the payer provider, you can see both of those. The real forcing function here is not the rulemaking on the API, the real forcing function here is at-risk value-based contracts. You cannot provide value unless you have complete information. 

We sometimes think there's a regulation that says I need to do an API here or an API there and I must treat this like getting my car inspected. But unless your car is about to die, in which case that inspection might be very helpful, that's compliance. The winners on both the provider side and the payer side are the people who integrate these claims and clinical data and use that for real-time decision-making and communication with patients and providers. Suddenly you can look at an API not as something to plug in the socket but seeing what plugging it into a socket is doing for me. Very few of us even for a moment ponder if an appliance is doing what I want it to do once it's plugged in. 

How can organizations best prepare to comply with changing regulations and stay relevant in an ever-evolving industry landscape? 

Dr Rucker: Sometimes we think of providers as captives of their EHRs. But that's not 100% true. Big, smart providers are moving to outside data stores and APIs. If you look at a number of large organizations, some of those folks moving outside of the EHR. It's timid. It's like the little lion cub in the Serengeti leaving their den. It's timid, but they're starting to because they don't want to go through the expense and the hassle of doing it through the EHR. But providers must come to grips with something we hate to do, which is to give those damn payers our information despite being scared that they're going to screw us in payment. You're already giving it to them in the most painful way in prior authorizations. Far better to write a win-win contract, because most of these transactions are people already bound by a formal contract. Let's rewrite these contracts to be smart about what we're doing and what we're getting. 

Suddenly, as a provider, you have a very different way of looking at chronic illnesses. You have better and more effective ways of treating hypertension, elevated limits, type 2 diabetes, obesity, and behavioral health issues. All these things that we're spending our money on. And with more information, you can catch diseases earlier before they’re more expensive. And if you're at risk, if you're writing an at-risk contract, those will be critical functions, especially in a world where all that is increasingly being measured explicitly by quality measures, either as a payer or a provider. You're at contractual risk already. Pretty much everybody now is in some type of value-based arrangement. Early Medicare fee for services are just starting, but even there many of the patients are in some type of accountable care organization (ACO) arrangement. 

On the payer side, payers don't in general have EHRs. Payers live in a very different data stream of X12 claims. Increasingly, payers are going to have to get smarter about allocating care. And getting smarter will not mean doing more prior authorization. Prior authorization is a failure mode for not being smart and not using computers. It's like having a crack in the wall and painting over it rather than thinking about what caused the crack. Ultimately, payers need clinical data if they are going to be smart. If you're going to be smart about prior authorization, you're going to be smart about network design, plan design, and direct patient interaction. You're going to need clinical data. And of course, when can you get that? Well, when you write your contract. 
This all comes together contractually and computationally, now it's coming together through the APIs. The new data standard is FHIR, an updated version of JavaScript Object Notation (JSON). I'd be willing to bet that some part of the API that set up this Zoom call is going through JSON. And every app, every one of those little icons on your smartphone is communicating back with a server through JSON. This allows pooling of both claims and clinical data together. And whether you do that for artificial intelligence (AI) or whatever else, APIs are the enablement.

One thing we just maybe want to touch more explicitly is Medicare Advantage. It is worth thinking about how modern data in computing interacts with Medicare Advantage. Medicare Advantage is a program that started to imitate the health maintenance organizations (HMOs), most notably Kaiser, which had great success with populations at very reasonable costs. And now a bit over half of all Medicare beneficiaries are in a Medicare Advantage plan. They didn't fully imitate Kaiser because of huge concerns with the moral hazard of fee for service. The moral hazard being of if I pay you to do more, you'll do more and probably do too much. The problem with Medicare Advantage is you can't write a law to change human nature.

How do you prevent payers who are getting the money from skimping on the care of patients? What we've come up with is an elaborate set of measures that tries to put the government in the shoes of the patient. Let's think about being in the shoes of a patient or taxpayer. Am I getting the best preventative care and access? Can I get an appointment? Can I get a translator? All these are huge issues. Anybody who is in the American health care system knows that getting appointments is a bear. How does CMS prevent that? In Medicare Advantage, it's through the star ratings. They are measures of plan performance meant to buffer moral hazard. Some think they've been pretty generous, and it is the explicit stated report of the agency in the legislative branch called MedPAC, which is part of the US Congress. It's one of the rare agencies that's not in the executive branch. They said in July, in the MedPAC report, that Medicare Advantage is overpaid by 22%. Roughly half of that is patient selection, and half of that is, let's say, upcoding. And 22% of hundreds of billions of dollars is real money. All of a sudden, CMS has to tighten on these star ratings. Which is how plans get paid. Humana went from having almost all their patients in a 4-star plan to only having a quarter. Their market capitalization dropped by 25%. The entire value of the business forevermore dropped on that bad report card. 

Of course, the plans are still being overpaid. It's not like it's going to get easier. You're going to have to go beyond interoperability with a platform capable of real-time change in behavior, communication, impact, and outreach to patients and providers to get better scores and to be more responsive. That is the future.