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Ask me MD medical

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school for the real world with

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the MD Dr. DJ Verret

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And thank you for joining us for another edition of Ask me MD medical

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school for the real world. I'm

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Dr. DJ Verret and today we're

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alking with Leiza Dolghi, a p

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rtner at the law firm of Lewis

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Brisbois about the Cures Act,

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act and information blocking. W

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're going to take a quick break

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and talk to Leiza right after

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asked me MD medical

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school for the real world.

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Commercial Here

1:08

Welcome

1:08

back to ask me MD medical school

1:10

for the real world. I'm Dr. DJ

1:10

Verret. And today we're talking

1:14

about Leiza Dolghi, a partner at

1:14

the law firm of Louis Brisbois

1:18

about the Cures Act and

1:18

information blocking. Lisa,

1:21

thanks, again for joining us.

1:24

Thank you for having me.

1:26

So we're

1:26

going to use some of your legal

1:28

expertise today to talk about

1:28

something that, at least for me,

1:32

kind of came on the scene at the

1:32

beginning of November, but had,

1:36

I guess, been percolating for

1:36

several years now. And it's the

1:40

information blocking parts of

1:40

the Cures Act. Can you kind of

1:44

explain what that all means for

1:44

physicians just from a high

1:48

level and then we'll kind of

1:48

talk about some of the some of

1:51

the finer points there.

1:52

Sure. So back

1:52

in 2016, Congress passed the

1:57

what they called the 21st

1:57

Century Cures Act, referred to

2:01

as Cures Act. And to until

2:01

earlier this year for them to

2:06

issue some rules actually, kind

2:06

of giving adding meat to to the

2:11

statute itself and explaining

2:11

how it's going to apply when

2:14

it's going to apply. And the

2:14

Office of the National

2:18

Coordinator for Health

2:18

Information Technology. All NC

2:22

is the one that issued the final

2:22

rule. in it. Basically, the

2:26

statue kind of has two

2:26

components. One is a permit or

2:30

the general purposes to prevent

2:30

information blocking. And that's

2:34

patient information. And the two

2:34

components are one, the statute

2:40

wants all of the EMR systems and

2:40

providers have those systems to

2:47

make sure that those systems can

2:47

operate with each other. So if a

2:52

hospital wants to switch from

2:52

one EMR system to another, for

2:55

example, they can easily do so.

2:55

So it kind of sets up technical

2:59

requirements for that. And then

2:59

the second component of the

3:03

statute is that it requires

3:03

healthcare providers to provide

3:08

patients with access to their

3:08

EMR to their medical records,

3:14

easily. So those are kind of the

3:14

two main portions of the

3:19

statute.

3:20

So I

3:20

heard you say EMR, does this

3:24

apply to physician practices

3:24

that don't have an EMR?

3:29

No. So the practice

3:29

does not have an electronic

3:33

medical record system, then the

3:33

statute would not apply.

3:39

Now, I

3:39

know some of the hospitals

3:41

around here had announced that

3:41

starting November 1, they would

3:44

make all medical records

3:44

immediately available to

3:47

patients through their portal.

3:47

Does the statute have a

3:51

timeframe for providing that

3:51

access? Or is the immediate

3:56

access? Was that just a way that

3:56

the hospitals were dealing with

3:59

the act? What what is what is

3:59

the actual rule?

4:03

Yes, there is a

4:03

particular deadline. Originally,

4:07

the app, the statue was supposed

4:07

to become effective when the

4:11

rules were supposed to become

4:11

effective on November 2. And so

4:16

what you are describing in all

4:16

likelihood is the hospital's

4:19

preparation for that deadline.

4:19

The deadline has been moved to

4:24

the rules are not going to

4:24

become effective or become

4:27

enforceable until April 5 of

4:27

next year. So we have a little

4:32

bit more time to work, the

4:32

providers have a little bit more

4:37

time to figure out their

4:37

compliance issues and how to

4:41

make sure that they're compliant with the rules.

4:43

Now,

4:43

within the rules, is there a

4:46

timeframe for making the patient

4:46

data available? In other words,

4:50

is it within 24 hours of when

4:50

it's created or within a week or

4:55

is there is there anything

4:55

within the rules that defines

4:59

that timeframe at this point,

5:02

no specific timeline.

5:02

And there are there are a lot of

5:07

gaps in the statute and the

5:07

rules, it's still kind of is

5:12

half baked. For for the lack of

5:12

a better phrase. The oaG and OMC

5:21

are still saying that they're

5:21

looking at, you know, different

5:25

rules that they're going to

5:25

issue related to enforcement. So

5:29

there's still a lot of guidance

5:29

that's going to be issued before

5:32

the room rules are going to

5:32

become effective in April. And

5:37

maybe perhaps one of those rules

5:37

is going to specify a deadline

5:41

for for providing the record.

5:45

Now, if

5:45

you have an electronic medical

5:48

record, but don't have an

5:48

outward facing patient portal,

5:53

is it does this require you to

5:53

develop that patient portal?

5:59

Yes. So that's one of

5:59

the kind of main focuses of the

6:02

statute is to allow patients to

6:02

access their electronic records.

6:08

You know, and that would require

6:08

a patient portal. The good news

6:12

is that most of the companies

6:12

that provide EMR systems already

6:18

have a patient portal

6:18

functionality, or are going to

6:23

build one in because the statute

6:23

applies not just to physicians

6:27

and hospitals, and that applies

6:27

to it healthcare IT providers

6:32

and developers. So anyone who

6:32

develops or provides an EMR

6:37

system, it has an obligation to,

6:37

to provide a patient portal will

6:44

have an application to do that.

6:46

I've seen

6:46

discussions in some of the

6:49

physician online forums, about

6:49

concerns that physicians have

6:54

with providing all of medical

6:54

records to patients,

6:58

particularly in cases of new

6:58

cancer diagnoses, or potentially

7:03

abuse situations. Are there

7:03

exceptions in the current rules

7:08

where information can be

7:08

withheld?

7:12

Yes, there are

7:12

currently eight exceptions. Each

7:17

of them has several conditions

7:17

that have to be met. The details

7:22

can be found on them on see

7:22

website. But yes, one of the

7:27

exception is is preventing harm

7:27

exception. And so a provider who

7:32

doesn't provide information in

7:32

order to prevent harm to a

7:37

patient would not be would not

7:37

be liable for information

7:42

blocking would not be penalised.

7:42

So doctors are going to have to

7:46

exercise some discretion in

7:46

those situations where they

7:49

think that the release of the

7:49

information can harm a patient,

7:54

they will be able to withhold

7:54

that information.

7:59

And is

7:59

that taken on a case by case

8:02

basis? Or can a policy be

8:02

developed in the office to

8:07

encompass all of the medical

8:07

records?

8:10

There should be policy?

8:10

Absolutely. And so, between now

8:14

and April, what every physician

8:14

should be doing or hospital

8:18

system is actually taking a look

8:18

at what system that they have

8:22

now for release of patient

8:22

information, what policies they

8:27

have in modifying them to build

8:27

in some of the exceptions. For

8:31

example, you know, if a policy

8:31

could be if there is evidence or

8:36

suspicion of domestic abuse from

8:36

a spouse, perhaps releasing

8:41

information via a certain

8:41

information via a patient

8:45

portal, where the abusive spouse

8:45

can access it could put the

8:51

patient in in danger. So in

8:51

those situations where there is

8:54

a suspicion of domestic abuse,

8:54

maybe the policy is that you do

8:58

not release that information

8:58

through a patient portal. But it

9:02

has to be consistent

9:02

application, whatever policy

9:07

there is in place, it should be

9:07

consistently applied in a non

9:12

discriminatory manner.

9:15

One of

9:15

the other concerns I've seen is

9:18

HIPAA concern with sharing data

9:18

with third party vendors. Is

9:23

there anything in the

9:23

regulations as written that

9:27

provides some cover for

9:27

physicians who may provide

9:31

access to third party vendors in

9:31

good faith? But that third party

9:36

vendor ends up violating HIPAA

9:36

has that been addressed at this

9:40

point?

9:42

Not at this point. We

9:42

have a generic statement and the

9:45

rules and in the statute that,

9:45

you know, the parties are not

9:48

the covered parties by the

9:48

statute are not required to do

9:53

anything that would violate

9:53

HIPAA. And so I think the same

9:56

thought process would apply that

9:56

the applied before the statute,

10:02

if the release of records could

10:02

possibly, you know, violate

10:07

HIPAA, HIPAA, then then it

10:07

shouldn't be done.

10:12

Let's talk a little bit about penalties for violations. You

10:14

mentioned a whole hodgepodge of

10:20

letters, who is actually

10:20

responsible for policing the the

10:25

rules and regulations around

10:25

information blocking and the

10:28

Cures Act.

10:29

So the oaG right now

10:29

has been charged by Congress

10:34

with investigating the

10:34

information blocking practices.

10:38

And so that that will be the the

10:38

government agency that will be

10:42

in charge of that. And they

10:42

issued a proposed rule that,

10:47

among other things, or YG, can

10:47

impose civil monetary penalties

10:53

up to 1 million per violations.

10:53

Will those actors that have been

10:59

found to knowingly interfere

10:59

with the access use or exchange

11:03

of electronic information? Now

11:03

there's penalties only apply? So

11:07

the statute itself covers, you

11:07

know, everyone, physicians,

11:10

hospitals, pharmacies, and it

11:10

providers are developers. So

11:18

this penalties would apply to 80

11:18

providers, they would not apply

11:22

to physicians. The rules

11:22

regarding what penalties could

11:27

apply to physicians have not

11:27

been issued yet. And all we know

11:32

is that, you know, the agency is

11:32

going to come up with some

11:36

program that is supposed to

11:36

disincentivize physicians from

11:40

violating information blocking

11:40

rules, and figure out who will

11:45

be enforcing those rules against

11:45

them, possibly state agencies,

11:48

Texas Medical Board or or its

11:48

equivalent in other states.

11:53

But at

11:53

this point, those haven't been

11:56

haven't been written. Is that correct?

11:58

That's right.

12:01

Any

12:01

thoughts as to if the the

12:03

implementation implementation

12:03

date in April is gonna hold? Has

12:07

there been any guidance as to

12:07

how firm the the April date is

12:12

going to be? You know, it's

12:14

kind of consistent with

12:14

a lot of deadlines that have

12:17

been moved because of COVID.

12:17

Everyone is kind of postering to

12:22

thinking that maybe by March,

12:22

we'll be done with COVID. It

12:27

depends on what happens in the

12:27

fall or in the winter. With

12:30

that, if we have another spike

12:30

that, you know, really creates a

12:34

lot of problems for the

12:34

healthcare industry and takes

12:37

away their resources to from

12:37

from implementing, you know,

12:41

compliance with the statute,

12:41

then we could see that the

12:46

deadline being moved again.

12:49

Is there.

12:49

I also saw in the in the act,

12:53

there was some difference in

12:53

what information needed to be

12:56

provided early on versus a

12:56

longer term allowance for more

13:03

information. Could Could you

13:03

explain that a little bit

13:06

better?

13:08

Sure. So now

13:08

or not, not all, but when the

13:12

rules become effective in April,

13:12

what the information that will

13:17

have to be provided include, you

13:17

know, consultation, notes,

13:22

images, lab reports, procedure

13:22

notes, and then the timeline for

13:28

provision of all sort of medical

13:28

electronic information is set

13:34

for some point in 2022. So we

13:34

have some time to make sure that

13:39

all of that information is

13:39

accessible through a patient portal.

13:47

Leiza thanks so much for th information. I guess the rea

13:48

take home story, though, i

13:53

there's a lot more to come i

13:53

the rules and regulations aroun

13:56

this. Is that fair

13:58

It is fair, fair. Yes.

14:01

We've been talking with Leiza Dolg ih partner and Luis Perez b

14:03

ys about the information block

14:06

ng portions of the Cures A

14:06

t. You're listening to ask me

14:10

MD medical school for the r

14:10

al world. I'm Dr. DJ Verret. Tha

14:14

ks for listening. Until next ti

14:14

e, make it an awesome we

14:18

Thank you for joining

14:18

us for another episode of Ask me

14:22

MD medical school for the real

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world with Dr. D.J. Verret. I

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