The misinformation floating around the Cures Act requirements and an incomplete understanding of it can be detrimental to all the Actors defined in the Cures Act. Our team is here to shatter misconceptions and address questions from both EHR developers and Healthcare Providers as they try to understand what the Cures Act entails for them. Patrick Schiess and Wayne Singer from our team discuss what Cures Act means for different stakeholders in the video below.

 
 

 

Patrick: How's it going, everyone? I'm Patrick Schiess, and today we are going to look at the Information Blocking requirements of the 21st Century Cures Act. I am extremely excited to be joined here today by the legendary Wayne Singer. Wayne has been a fixture in the health IT community for many years and knows way more about this stuff than anyone else I’ve ever met. How's it going, Wayne? 

Wayne: I’m doing well, Patrick. How about you? 

Patrick: I am doing great myself. Do you want to give a quick intro about yourself and then we'll pop into some of this other content? 

Wayne: Sure, I'm currently VP of Regulatory Services with Darena Solutions. My background ranges from Durable Medical Equipment (DME) to disposable medical equipment. I was part of the evolution when even the Durable Medical Equipment acquired software knowledge or the brains behind the system to operate things like OR tables and the beds that patients are on. Then I've also evolved into the health IT environment, where I started with designing and developing EHRs and watched that evolve from the early 90s. 

Patrick: Yeah, it sounds like you've got quite a bit of experience in this space. 

Wayne: Yeah, I have the advantage of watching the evolution where the dream of interoperability has been around since the early days of meaningful use. And now I see it finally jelling and taking the opportunity to take off and be shared by all stakeholders. 

Patrick: That's a great segue into my first big question for you, what is the deal with this whole Cures Act thing? 

Wayne: Sure, the 21st Century Cures Act is also I could say, an accumulated effort from back in the day of Meaningful Use and other programs. It was signed into law back in 2016 with overwhelming bipartisan support (when that used to happen). It had multiple facets that included a moon shot for cancer cure. It includes the Opioid epidemic and trying to control that from the standpoint of who is prescribing where and when. But the two components that came out of it that are specific to our environment are health information exchange, and obviously, the other counterpart of that is the Information Blocking rule to avoid any type of barrier to a patient having access to their information in a timely fashion. So, it's now a mandated law that has something that people can point to for behavior modification in all stakeholders. 

Patrick: It sounds like these regulations have been around for a while, so why should we care about this now, specifically? 

Wayne: As per any mandate that's come out of the government, it went through many different iterations, rulemaking processes, and comment periods. What began in 2016 is taking obviously until now, or in fact till January 1, 2023, to go into effect. We look back at HIPPA: 1996 is when HIPPA became a law. It took at least until 2010 before the whole element of privacy, and patient privacy acts within HIPAA jelled and became a household word we know, what to live by, and how to work with patient-protected information. The Cures Act is coming through that similar evolution, from early adoption to now we're going to put it into a mandate. 

Patrick: Gotcha! So, who should be concerned about this? 

Wayne: Anyone who is in and around patient information from Cures Act standpoint.  

  1. Providers who document care and treatment.  

  2. EHR developers who enable documentation to be obtained through any of the actions of the providers.  

  3. Health Information Exchanges, which serve as a clearing house or a reservoir for health information as it's temporarily stored and exchanged across the continuum. 

  4. Payers as they gather health information for the care and treatment of patients.  

They're all Actors under the Cures Act and are subject to making it easy for a patient to access, use and exchange their information. 

 
ONC's-Information-Blocking-Actors

ONC’s Information Blocking Actors

 

Patrick: You mentioned earlier this concept of Information Blocking. What does that mean and what are some of the consequences? 

Wayne: Information Blocking would be any occurrence where there are either actual physical barriers that don't enable a person to be able to gain access, or if there's any other infringement that's put into place like a cost, if that's too absorbent and say I can give you your records, however, it's $3 a page, or yes, I can give it to you, but because of my timeline, it's going to take me 3 months. Any of those impairments to easy access to information could be deemed Information Blocking. 

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Patrick: Let’s say that I am a patient of a particular healthcare institution, and I would like to get my data from them. What would that process look like, or what is the expectation that I should have as a patient? 

Wayne: What is now mandated under the Cures Act is upon request from a patient or their authorized representative, a provider is to make available whatever requested information in a timely fashion. So, it's a request to the provider's office, and then they have the ability through their EHR to answer that request by providing an invite to that patient. The patient can use an application of their choice, a third-party app as it's called to access their information electronically. None of the ways is through what they call the API method, and that's where a patient has a third-party app on their iPhone or their Android, and they can then request an invite to allow them to go into their individual record and obtain the information that they're looking for. Any encounter summaries, procedures, or any of their information. In fact, as of October 6th, it expands to everything that's clinical or stored on behalf of the patient like excuse slips or permissions to go back to work (Electronic Health Information (EHI)). 

 

Patrick: Traditionally, a provider might do something like fax a copy to someone, or they might print it out and send it home with a patient. So, it sounds like this is quite different, and the expectations should be different. 

Wayne: What they are looking for is the electronic exchange of information so that downstream from wherever this source is created can also incorporate that information into their care and treatment plan and not have to worry about reading or looking at a paper and then transposing it into their records which is obviously as a time delay or even can cause errors. The objective is for easy Information exchange and true interoperability of electronic patient health information from one point of service to the other, and they're enabling the patient to play a critical role in that information exchange process. They're the ones who've got the most vested interest in having their information at that point of care in the quickest, in as near real-time fashion as possible. 

Patrick: I want to explore a little bit more on something you mentioned earlier about an authorized person or maybe a caregiver. So, who does this apply to? Does it apply to newborn babies? Or maybe travelers, non-permanent residents, or elderly people? Or those who may not have like immediate access to technology? Are they still covered, and should they still be able to retrieve their data in these formats? 

Wayne: Right, the engagement of the patient is what is top of mind here and at any given point from you could say cradle to grave, that patient, newborn, or elderly is entitled to their information and the means to get it could be through that authorized representative. The parents for the child, the older adult children for the elderly parent, who's maybe not techno-savvy. In fact, the younger the patient might be, or the older the patient might be, you could say it would raise the sense of urgency that accurate information is exchanged in near real-time fashion so that the next delivery of care downstream can be as smart as possible on that patient, so there's no redundant testing. Maybe it can avail additional labs or imaging studies. They're now smarter to know two points of reference, and that caring treatment plan can be developed with a lot more deliberation because they're now more in tune with what the patient situation is currently. 

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Patrick: What about the delivery of sensitive medical information? Let's say that I have some test results that have not been properly interpreted by a provider yet and I get access to that data early. Are we worried about some of the effects that that could have on the patient’s care? 

Wayne: Yeah, that's one of the early pinch points that people bring out quite often about the Information Blocking rule. You might remember that it's upon request, so if the patient is not aware of the results that are in, it’s more than likely they're not going to request it. The provider can use judgment still to say what the consequence would be for the patient knowing this information. There are eight reasons in the Information Blocking act why a provider cannot be held as an information blocker. One of them is in the psychotherapy notes section. Those are off the board. They can be withheld by the provider. They can be shared if indicated, but providers can hold them back because of potential harm to the patient in sharing that information. Now there are other reasons that a provider can hold back information for there are contended manner we can in another video go through the eight reasons, but essentially what it's meant to be is the patient should have access to their information in a timely fashion. And again, the provider can say if something is requested and yet it's too sensitive, then they can take additional measures to notify the patient of this information, whatever that might be, coming and talking to us first, or any kind of you know information exchange that could reduce the potential of emotional harm to the patient. It's still up to the provider to use their clinical judgment, and again, since it's upon request that will allow minimization, let's say information going out, that's not ready for patient consumption. 

Patrick: You mentioned psychotherapy notes. That also makes me wonder what specialities and subspecialties does this apply to? Are there any limitations or restrictions? Where do we draw the line? 

Wayne: Yeah, there isn't a line to draw. If you are a clinician documenting the care of a patient in any former fashion, that's as I would call it from behavioural health to Podiatry. What I kind of jokingly call it from head to toe. Small practices, and large practices, they're all included.  If you're a solo practitioner and you know you see only 10 patients a day. If you see patients, you document the record. You're basically under the Information Blocking rule to exchange information upon the request of a patient or their representative. 

 
 

Patrick: It sounds like there is a lot of very intricate knowledge to be had about this Information Blocking requirement. If I wanted to read more about this, or maybe validate my own understanding, where would I even go to look for this? 

Wayne: HealthIT.gov would be the place to go. You'd see Information Blocking webinars, blogs, and factsheets. Even some of the clinical specialities, or if you are a member of the American Academy, they're putting out even their information-sharing material, but if you look at the references, they all link back to the HealthIT.gov site where ONC has been sponsoring multiple facets of education on the Information Blocking role as well as they put out a new portal, which is the place where you go to submit Information Blocking claims. It makes it very easy; you can quantify it and you can also submit it anonymously.  So, they're taking this very seriously, all the way from the education to the implementation, as well as the ability to file claims for Information Blocking or suspected Information Blocking. 

Patrick: Let's change gears a bit. I have been compiling a list of some of the most common questions that we have received at Darena Solutions about what applies and does it necessarily need to be something I'm worried about. I'm just going to quickly fire go through this list, and I would love to hear your perspective on some of them.  

I run a small EHR platform that only services a few providers. Does this still apply to me? 

Wayne: Yes, again, even if you're not certified under the 2015 Edition certification for EHRs, you are a health IT provider, and therefore an Actor. And then your providers who are documenting the care and treatment of patients is considered as Actors under the provider provision. So yes, absolutely it applies to you. 

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Patrick: Who is policing this? Should I be worried? 

Wayne: Yeah, well I would say yes, because over the years the CMS has done these meaningful use programs, PQRS, it's all evolving, value-based programs like MIPS and a lot of the different APM or ACO models that are out there. According to a recent article I read, the CMS has spent $31 billion on incentives to meaningfully use and meaningfully exchange information over the years, starting from 2011, right up till now. So now they're at a point where they're saying the industry, “I’ve tried to have you do it yourself, now I'm going to put a little bit more of an emphasis on it with this Cures Act.”  It's a law and ONC is policing it from the EHR health IT developer side, and The Secretary of Health & Human Services through the Office of the Inspector General will police it from the other actor's perspective of providers. We're expecting them to have their announcement of how they're going to litigate it by the end of this year. They've made several announcements at several meetings that ONC was first out of a block. They're saying penalties can range as high as $1,000,000. Won't happen that way out of the box, but they're serious about infractions.

 
“The Office of National Coordinator for Health IT (ONC) is policing it from the health IT developer side and Health and Human Services (HHS) have charged the Office of the Inspector General (OIG) to police it from the provider side. ”
 

Patrick: Are there any implications for Medicare? 

Wayne: Yes, I might call it almost piling on, but Medicare has come out recently and said they're also looking at civil monetary penalties that would be placed on providers who are Information Blocking to the Medicare Medicaid beneficiaries. So, the Information Blocking covers all payers; even if a patient is you know paying themselves that's still covered. Medicare Medicaid is expanding to say they're going to look over the shoulders and say if the infringement was specifically to one of their beneficiaries that they will all put their penalties in place. 

Patrick: Gotcha. All right next question. As a provider or an EHR, how quickly do I have to be able to provide the records upon request for a patient? 

Wayne: Right, well, it's on a timely basis as the kind of that catchall phrase, it used to be under HIPAA, you have 30 days to do it. This Information Blocking and the Cures Act is condensing it to be that as soon as practical, there can't be these barriers of I'm busy, I'll get to you, and eventually you know whatever time. The best way to look at it is an EHR and/or provider should establish an actual policy that says - we do support your requests for information. We will honor it and then put a 3 to 5 business days to avoid it, you know this is Friday afternoon at 3:00 o'clock, and I want it for Monday. Be careful with those holidays, so if you have it published that you have this set expectation, I will be able to honor your request in X amount of time. That also would be going a long way to avoiding the cold information blockers because you've set the expectation, and you've made them aware of it. People are posting things in exam rooms and in the waiting rooms. I've heard of people including a flyer or what they call the stuffer in the bills that they send out. They're putting it as part of their recording when their patients are on hold. Instead of music, they're saying we honor the new information exchange policy. However, please allow us 3 to 5 business days to fulfill your request. The expectation is what would get most people out of trouble. 

 

Patrick: Sounds like it might be beneficial to be more proactive rather than reactive. 

Wayne: Absolutely. This is, you know, again from an ONC and Health and Human services perspective, they wanted this to go into effect in November of 2020. They pushed it out because again, trying to reduce the burden on providers and health IT developers. And that's why the first of the process for the health information Exchange started April 5th, 2021. Even that was kind of a soft launch, and that had a provision that you can exchange information clinically using the new US core data for interoperability data elements. That was an advancement over what we had in the past, but even then, the enforcement was more like I say, a soft launch. Up to October of this year just a few weeks ago. So that it is going to expand from that clinical data perspective to all health information. That's what they call EHI, that's stored in a medical record on behalf of a patient. Billing information, living wills, and power of attorney, those things could be available and would be available upon request. What's happened is this should have gone into effect a year, year and a half ago, and now it's coming into effect as of January of 2023. They're really serious and you know, they've said we've given you extensions, you know we all talked about internally how some of these mandates have been as we called it kicked down the road. It's kind of a ‘just kidding’ as I call it, but this time I think they've given the extensions and now the January one will be it, you know official launch and essentially you know where people could be called out as information blockers if they haven't changed their methodology. 

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Patrick: Let's say I am an EHR or a provider and I already have a patient portal for this kind of thing. Does this apply to me? 

 
 

Wayne: Yes, because what they've done is responded to patient complaints, especially in the Medicare services group. You can imagine that a Medicare beneficiary who has a dermatologist, an orthopod, a primary care specialist, or a cardiologist, has been to one or two hospitals. Each one of those points of service and each one of those providers is saying, “please go to my portal to see your info.” Each little silo of information exists out there. It's also another username and password that they must remember. Considering that complaint is what CMS responded to, add another aspect of this, these API capabilities for a patient to be able to obtain their information using a third-party app of their choice. So, in other words, the portal is the patient’s app that resides in whatever PC, smartphone, or whatever they want to use and then they can now request information from their cardiologists using an EHR, their hospital who's using another EHR, and now they can have this longitudinal record that's consolidated on an application that they have. That's the ‘access’ and then ‘use’ it so they can review it, and understand it, but more importantly, they can exchange it with the next provider downstream so they have a better snapshot of the most current. What are the meds that they're on? What's their latest treatment? What's their status post? That’s important for the next provider to know. It's also important to include dentists in this process as well. That's another caregiver, but they add pharmacists, labs, and pathologists, so everyone can communicate now through this process. 

Patrick: I feel like everyone probably has their Horror Story of the time that they got a scan done at one, you know, maybe an urgent care facility and they ended up needing to get a referral to a hospital or something like that and the hospital was not able to see that particular scan, so they had to get it again, which is, you know, in some cases, very invasive and can be costly, so that certainly seems like this would be a good thing for just everyone, like overall. 

Wayne: Right, and even if we can't minimize the repeat, you know blood draws or the repeat imaging, if that next provider has the benefit of the results of the previous one, those two points-three points of data is very important in the caring treatment. If someone sees a value of 12 on their most recent lab and then realizes the last four labs had the same 12 or in the same range, that might alter their care and treatment plan because they see that's more of a normal for that patient, rather than be alarmed that that's high and out of whack. So, again, that makes everyone smarter, even if they again the ideal is to minimize you know, repeat studies if they're close enough together to be clinically relevant, but you know anyone who's ever had an X-ray always fears, or radiologist says were there any other X-rays. They love prior films for comparison. That dot on the film, was it there 10 years ago or is this something new? This is what we're trying to do is break down that silo where information is in one place, very solidly documented, but over the next place there's no exchange, and so therefore that patient is almost treated brand new every time they walk into a new institution or new point of service. Interoperability is what this is all about, and the patient is that mode of easy transfer, because also they are the ones with the biggest, greatest vested interest in making sure they don't get poked two or three extra times, or all the information is now provider validated and in the hands of their next point of service. 

 
 

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 Patrick: It sounds like a dream. Maybe it didn't come true for some people and maybe a nightmare for others. 

Wayne: It has been that Holy Grail forever. Meaningful use was the first term, and you know that truly was trying to say, “Are you meaningfully using the information not only for yourself?” That was the first step in going from paper to electronic, but then now that it's electronic, can we share amongst ourselves? Initially, the barrier was EHR ‘A’ didn't talk to EHR ‘B’, they were disparate in one form or another. Then we opened with the ability to share things called CCDA, which was a common language term or common expression of how clinical documentation could be rendered in an electronic document that with certification EHRs now were, in a sense, agreeing to accept the CCDA’s from other EHR’s and be able to not only bring it in and consume it from a machine-readable standpoint but also render it for a human-readable standpoint. That interoperability for bi-directional exchange, that's what we're going to do, and then obviously this is the next mandated step where we're enhancing that information exchange by another standard, which is the FHIR standard. Another way to render clinical data in a very easy-to-use and exchange process that again has been around for many years, it's now coming of age and is now finding its way into the health information exchange network. 

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Patrick: So, we talked about the dream. Let's talk about the nightmare. Maybe as a provider or an EHR, I just absolutely cannot make this happen, especially by the deadline. Is there any way that I can get an extension or maybe opt out of it? What are the risks involved in this particular situation because it sounds like the stakes could be potentially high if there's like a million dollar penalty? 

 
 

Wayne: Right, well I would say the extension potential is very minimal to nonexistent. There might be an ability to have a temporary game plan that says, “I didn't do it by January 1, but here's how I'm going to do it in three weeks or less.” There won't be 3 months or more. Even three weeks might be a little on the edge because ONC and Health and Human Services are saying this started in 2016. We had many iterations where they came out to stakeholders. They didn't just do it in a vacuum. They had panels of providers, patients, of nurses, of all walks of providers giving their input. They went through and diligently covered comments to say here's why I like what you said, here's what I don't like, and here's what we're going to settle on based on everything we heard. Some people won, and some people lost, but overall, it was a consensus. And so over time, even going back to when it was supposed to start and they go all right, we heard you, it was going to be a little bit of a stretch, and a burden, and we certainly don't want to infringe on the quality of care of the patients, so I'll give you this year, year and a half extension. So, I think for those who aren't able to do it, it's too little, too late. Again, unless you have been in the proverbial hole in the ground where you haven't heard anything. There's been so many different webinars, emails, and blogs. Even the New York Times came out with a program with an article on it. All the associations, like American Academy, have put out and they have on their website a special tab now which covers the general Information Blocking rules, and they always funnel it down, and what does it mean to us, the cardiologists, the podiatrist, the orthopod, whatever, the specialty they have that statement and the bottom line? You're in it. You might as well adopt it. Call your EHR, talk to your EHR, and see what they're doing to make the provision. It should be electronically enabled so that it is easy to do. It should not deviate too much from your normal everyday workflow. And in fact, as it was going to go to the full, you are responding to information upon request to share with the patient. But really, the word interoperability should be you should expect to get information back from that patient as they are being the clearinghouse of their own care and treatment. So, the bidirectional exchange is where this will ultimately give in, or play out, especially when we include health information exchanges, Health Information networks. They're part of the actor profile as well. So again, my advice would be if you're not capable of fulfilling it, there are third-party applications. MeldRx is one of them that you can interface with and immediately be in compliance with. So even the fact that internal capability might be limited because of resources and all these things going on, there are simple interfaces that can take place, that will enable you to be fully compliant with the letter of the law from an Information Blocking standpoint. 

 

Patrick: That sounds awesome. Thank you so much Wayne for clarifying some of those things. I want to go ahead and start wrapping up, and to do this I want to leave the listeners with three top takeaways. What would you say if anybody could take anything from this video? What should they remember? 

Wayne:

  • The first takeaway is, I would say, look at the Cures Mandate specifically to Health IT, as a real must-do. It's not going to be, you know, the can won't be kicked down the road, so take it seriously. 

  • The other one is to embrace the interoperability benefits that come out of this. Now, how would everyone benefit by exchanging information in what I would hope is the next Holy Grail, which is the near real-time exchange of information. I need it, I have it, right at my fingertips.

  • And then obviously education of everyone involved, that would be the provider, the patients, the EHR, staff and development. What is the importance of what? What role do you play in the Information Blocking mandate and how do you enhance all the stakeholders around you? 

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Patrick: That's awesome. Thank you again so much Wayne for your time and for sharing with all of us. I really appreciate it, going to go ahead and wrap this up. Thank you so much for watching everyone, stay safe and we'll see you in the next one. 

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