Leiza Dolghih, JD - Cures Act and Information Blocking

Learn more about the information blocking portions of the CURES Act, set to take effect in April 2021.

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Ask me MD medical school for the real world with the MD Dr. DJ Verret

D.J. Verret, MD, FACS: 0:06

And thank you for joining us for another edition of Ask me MD medical school for the real world. I'm Dr. DJ Verret and today we're alking with Leiza Dolghi, a p rtner at the law firm of Lewis Brisbois about the Cures Act, act and information blocking. W're going to take a quick break and talk to Leiza right after

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asked me MD medical school for the real world.

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D.J. Verret, MD, FACS: 1:08

Welcome back to ask me MD medical school for the real world. I'm Dr. DJ Verret. And today we're talking about Leiza Dolghi, a partner at the law firm of Louis Brisbois about the Cures Act and information blocking. Lisa, thanks, again for joining us.

Leiza Dolghih, JD: 1:24

Thank you for having me.

D.J. Verret, MD, FACS: 1:26

So we're going to use some of your legal expertise today to talk about something that, at least for me, kind of came on the scene at the beginning of November, but had, I guess, been percolating for several years now. And it's the information blocking parts of the Cures Act. Can you kind of explain what that all means for physicians just from a high level and then we'll kind of talk about some of the some of the finer points there.

Leiza Dolghih, JD: 1:52

Sure. So back in 2016, Congress passed the what they called the 21st Century Cures Act, referred to as Cures Act. And to until earlier this year for them to issue some rules actually, kind of giving adding meat to to the statute itself and explaining how it's going to apply when it's going to apply. And the Office of the National Coordinator for Health Information Technology. All NC is the one that issued the final rule. in it. Basically, the statue kind of has two components. One is a permit or the general purposes to prevent information blocking. And that's patient information. And the two components are one, the statute wants all of the EMR systems and providers have those systems to make sure that those systems can operate with each other. So if a hospital wants to switch from one EMR system to another, for example, they can easily do so. So it kind of sets up technical requirements for that. And then the second component of the statute is that it requires healthcare providers to provide patients with access to their EMR to their medical records, easily. So those are kind of the two main portions of the statute.

D.J. Verret, MD, FACS: 3:20

So I heard you say EMR, does this apply to physician practices that don't have an EMR?

Unknown: 3:29

No. So the practice does not have an electronic medical record system, then the statute would not apply.

D.J. Verret, MD, FACS: 3:39

Now, I know some of the hospitals around here had announced that starting November 1, they would make all medical records immediately available to patients through their portal. Does the statute have a timeframe for providing that access? Or is the immediate access? Was that just a way that the hospitals were dealing with the act? What what is what is the actual rule?

Unknown: 4:03

Yes, there is a particular deadline. Originally, the app, the statue was supposed to become effective when the rules were supposed to become effective on November 2. And so what you are describing in all likelihood is the hospital's preparation for that deadline. The deadline has been moved to the rules are not going to become effective or become enforceable until April 5 of next year. So we have a little bit more time to work, the providers have a little bit more time to figure out their compliance issues and how to make sure that they're compliant with the rules.

D.J. Verret, MD, FACS: 4:43

Now, within the rules, is there a timeframe for making the patient data available? In other words, is it within 24 hours of when it's created or within a week or is there is there anything within the rules that defines that timeframe at this point,

Unknown: 5:02

no specific timeline. And there are there are a lot of gaps in the statute and the rules, it's still kind of is half baked. For for the lack of a better phrase. The oaG and OMC are still saying that they're looking at, you know, different rules that they're going to issue related to enforcement. So there's still a lot of guidance that's going to be issued before the room rules are going to become effective in April. And maybe perhaps one of those rules is going to specify a deadline for for providing the record.

D.J. Verret, MD, FACS: 5:45

Now, if you have an electronic medical record, but don't have an outward facing patient portal, is it does this require you to develop that patient portal?

Unknown: 5:59

Yes. So that's one of the kind of main focuses of the statute is to allow patients to access their electronic records. You know, and that would require a patient portal. The good news is that most of the companies that provide EMR systems already have a patient portal functionality, or are going to build one in because the statute applies not just to physicians and hospitals, and that applies to it healthcare IT providers and developers. So anyone who develops or provides an EMR system, it has an obligation to, to provide a patient portal will have an application to do that.

D.J. Verret, MD, FACS: 6:46

I've seen discussions in some of the physician online forums, about concerns that physicians have with providing all of medical records to patients, particularly in cases of new cancer diagnoses, or potentially abuse situations. Are there exceptions in the current rules where information can be withheld?

Unknown: 7:12

Yes, there are currently eight exceptions. Each of them has several conditions that have to be met. The details can be found on them on see website. But yes, one of the exception is is preventing harm exception. And so a provider who doesn't provide information in order to prevent harm to a patient would not be would not be liable for information blocking would not be penalised. So doctors are going to have to exercise some discretion in those situations where they think that the release of the information can harm a patient, they will be able to withhold that information.

D.J. Verret, MD, FACS: 7:59

And is that taken on a case by case basis? Or can a policy be developed in the office to encompass all of the medical records?

Unknown: 8:10

There should be policy? Absolutely. And so, between now and April, what every physician should be doing or hospital system is actually taking a look at what system that they have now for release of patient information, what policies they have in modifying them to build in some of the exceptions. For example, you know, if a policy could be if there is evidence or suspicion of domestic abuse from a spouse, perhaps releasing information via a certain information via a patient portal, where the abusive spouse can access it could put the patient in in danger. So in those situations where there is a suspicion of domestic abuse, maybe the policy is that you do not release that information through a patient portal. But it has to be consistent application, whatever policy there is in place, it should be consistently applied in a non discriminatory manner.

D.J. Verret, MD, FACS: 9:15

One of the other concerns I've seen is HIPAA concern with sharing data with third party vendors. Is there anything in the regulations as written that provides some cover for physicians who may provide access to third party vendors in good faith? But that third party vendor ends up violating HIPAA has that been addressed at this point?

Unknown: 9:42

Not at this point. We have a generic statement and the rules and in the statute that, you know, the parties are not the covered parties by the statute are not required to do anything that would violate HIPAA. And so I think the same thought process would apply that the applied before the statute, if the release of records could possibly, you know, violate HIPAA, HIPAA, then then it shouldn't be done.

D.J. Verret, MD, FACS: 10:12

Let's talk a little bit about penalties for violations. You mentioned a whole hodgepodge of letters, who is actually responsible for policing the the rules and regulations around information blocking and the Cures Act.

Unknown: 10:29

So the oaG right now has been charged by Congress with investigating the information blocking practices. And so that that will be the the government agency that will be in charge of that. And they issued a proposed rule that, among other things, or YG, can impose civil monetary penalties up to 1 million per violations. Will those actors that have been found to knowingly interfere with the access use or exchange of electronic information? Now there's penalties only apply? So the statute itself covers, you know, everyone, physicians, hospitals, pharmacies, and it providers are developers. So this penalties would apply to 80 providers, they would not apply to physicians. The rules regarding what penalties could apply to physicians have not been issued yet. And all we know is that, you know, the agency is going to come up with some program that is supposed to disincentivize physicians from violating information blocking rules, and figure out who will be enforcing those rules against them, possibly state agencies, Texas Medical Board or or its equivalent in other states.

D.J. Verret, MD, FACS: 11:53

But at this point, those haven't been haven't been written. Is that correct?

Leiza Dolghih, JD: 11:58

That's right.

D.J. Verret, MD, FACS: 12:01

Any thoughts as to if the the implementation implementation date in April is gonna hold? Has there been any guidance as to how firm the the April date is going to be? You know, it's

Unknown: 12:14

kind of consistent with a lot of deadlines that have been moved because of COVID. Everyone is kind of postering to thinking that maybe by March, we'll be done with COVID. It depends on what happens in the fall or in the winter. With that, if we have another spike that, you know, really creates a lot of problems for the healthcare industry and takes away their resources to from from implementing, you know, compliance with the statute, then we could see that the deadline being moved again.

D.J. Verret, MD, FACS: 12:49

Is there. I also saw in the in the act, there was some difference in what information needed to be provided early on versus a longer term allowance for more information. Could Could you explain that a little bit better?

Leiza Dolghih, JD: 13:08

Sure. So now or not, not all, but when the rules become effective in April, what the information that will have to be provided include, you know, consultation, notes, images, lab reports, procedure notes, and then the timeline for provision of all sort of medical electronic information is set for some point in 2022. So we have some time to make sure that all of that information is accessible through a patient portal.

D.J. Verret, MD, FACS: 13:47

Leiza thanks so much for th information. I guess the rea take home story, though, i there's a lot more to come i the rules and regulations aroun this. Is that fair

Leiza Dolghih, JD: 13:58

It is fair, fair. Yes.

D.J. Verret, MD, FACS: 14:01

We've been talking with Leiza Dolg ih partner and Luis Perez b ys about the information block ng portions of the Cures A t. You're listening to ask me MD medical school for the r al world. I'm Dr. DJ Verret. Tha ks for listening. Until next ti e, make it an awesome we

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