[This Transcript is Unedited]
Department of Health and Human Services
National Committee on Vital and Health Statistics
Full Committee Meeting
November 17, 2011
Holiday Inn Rosslyn at Key Bridge
1900 N. Fort Meyer Dr.
Arlington, VA 22209
Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703) 266-8402
TABLE OF CONTENTS
- Call to Order, Review Agenda
- Standards Letter—ACTION
- Standards—HIPAA Report, ACTION
- Community Health Data Report, ACTION
- Subcommittee Report outs, Strategic Plans & Next Steps
P R O C E E D I N G S (8:15 a.m.)
Agenda Item: Call to Order, Review Agenda
DR. CARR: Good morning, and welcome to Day Two of the NCVHS Full Committee
meeting. What I’d like to do is start by going around the room with
introductions. I’m Justine Carr, Chair of the Committee, Stewart Health Care
System, no conflicts.
DR. SCANLON: Good morning, Jim Scanlon, Deputy Assistant Secretary for
Planning and Evaluation and HHS Executive Staff Director for the Full
Committee.
DR. FRANCIS: Leslie Francis, University of Utah Law and Philosophy, I
co-chair Privacy, Confidentiality and Security, and I don’t have any conflicts.
DR. MAYS: Vickie Mays, University of California, Los Angeles, Member of the
Full Committee and member of Populations and Privacy and I have no conflicts.
DR. MIDDLETON: Blackford Middleton, Partners in Health Care, Member of the
Full Committee, Co-Chair of the Quality Subcommittee, Member of the Population
Subcommittee, no conflicts.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and
Quality, Liaison to the Full Committee, Staff to the Subcommittee on Standards
and on Quality.
DR. NICHOLS: Len Nichols, George Mason University, Population Subcommittee,
Quality Subcommittee, no conflicts.
DR. BURKE: Jack Burke, Harvard Pilgrim Health Care, Member of the Full
Committee, Member of the Population, Privacy Subcommittees.
DR. SCANLON: Bill Scanlon, National Health Policy Forum, Member of the
Committee and the Standards Subcommittee, no conflicts.
DR. MILAM: Sally Milam, West Virginia Health Care Authority, Member of the
Full Committee, Co-Chair of Populations, Member of Privacy, no conflicts.
DR. WARREN: Judy Warren, University of Kansas School of Nursing, Member of
the Full Committee, Co-Chair of the Standards Subcommittee and member of the
Quality subcommittee, no conflicts.
MS. DOO: Lorraine Doo, Office of eHealth Standards and Services at CMS; lead
staff to the Standards Subcommittee and no conflicts.
DR. SUAREZ: Good morning, I’m Walter Suarez, with Kaiser Permanente, a
member of the Full Committee, Co-Chair of the Standards Subcommittee, and
member of the Population, Health and Privacy Subcommittees, and no conflicts.
MS. GREENBERG: Good morning; I’m Marjorie Greenberg, from the National
Center for Health Statistics, CDC and Executive Secretary to the Committee.
DR. CHANDERRAJ: Raj Chanderraj, practicing cardiologist, Member of the
Committee, no conflicts.
DR. CARR: Is there anybody on the phone?
DR. TANG: Yes, Paul Tang, Palo Alto Medical Foundation, Member of the
Committee, no conflict. Is the connection better today?
DR. CARR: Yes, it’s better today.
DR. KLOSS: Linda Kloss, member of the Committee, Co-Chair of the Privacy
subcommittee and member of the Quality Committee, no conflicts.
(Introductions around the room)
DR. CARR: All right. Well, let’s move now to Action on the Standards Letter.
Agenda Item: Standards Letter – Action
DR. WARREN: What we did with the letters is that there were several
recommendations that we make on the letter. One was to bold out the
recommendations, so we’ve done that. The second one was to address some of the
concerns and letters we received from two of the banks who do a lot of credit
card stuff. Let me show you what I did as I get there. All of this is the same,
as I scroll rapidly down, no changes were made at all.
Here is our first recommendation, basically what I did was that we had
embedded in the paragraph that we recommend that, and I have replaced it with
recommendation on dot O. That was the only change in this and then to bold out
the recommendation, and then to separate it from the paragraph that it was in.
Any questions on that edit?
DR. CARR: Okay, keep going.
DR. WARREN: Then we had this concern about the banks. The paragraph after
the recommendation reads “At the heart of our recommendations is our
shared vision support the adoption and the use of EDI for the benefit of the
health care industry with the expectation that this will reduce cost and
administrating burden.” What I have highlighted in yellow is what we’re
adding. You’ll note there where it has in parentheses, and I’ve misspelled
“definition”, but we’re going to put in the specific definition that
we had from our previous letter in February in that section. I’ve just now
called up the words. Forgive me; I don’t have them right on this computer.
We added, in a previous letter, we recommended the adoption of a standard
for a healthcare electronic fund transfer (EFT) to be used when a plan is
submitting an electronic message to a financial institution and that’s where
we’re going to put in the definition. We follow that then with, “we want
to take this opportunity to clarify that this recommendation applies only to
the EFT message between the health plan and its financial institution.”
The concern that we had from these banks that wrote us letters is EFT is a
standard used by the banking industry that is a fairly comprehensive standard
and we are only looking at one small segment. Only the message between the plan
and their bank is the only thing that is covered in what we’re doing. So we
want to be as explicit as we can in that statement. Any questions about that?
COMMITTEE MEMBER: Do you want to put in specifically this does not effect
credit card transactions?
DR. WARREN: We had a long discussion about that and as soon as we start
doing that we’re calling attention to all the other different transactions.
Then we’d have to get into a laundry list. We’d probably have to add about a
paragraph or a page of explanation, which takes away the intent of this letter.
We figure that if we re-emphasize that it’s only that one small segment of the
entire EFT standard then we’ll be okay. Leslie.
DR. FRANCIS: Just to be sure that I understand, there’s nothing practically
inconsistent with applying this to that one aspect and not to anything else. So
there isn’t anything that would make it difficult to do the credit card for
another transaction–
DR. WARREN: Except what we’re talking about is a healthcare plan sends a
message to their bank telling them to disperse things. As far as we know, that
plan doesn’t use a credit card to do that with. That’s what we’re talking
about. The whole EFT standard is an entire financial transaction standard.
We’re only looking at one segment and it is only when the plan contacts their
bank.
DR. FRANCIS: That wouldn’t constrain how the bank then contacts other
people?
DR. WARREN: No, it doesn’t constrain the bank from doing any of the other
part of that standard.
MS. GREENBERG: Would it be clearer if it said, “submitting an
electronic message to its financial institution” or is that too specific?
DR. SUAREZ: Only through the EFT message between the health plan and its
financial institution, that’s what it says at the bottom.
DR. WARREN: What I can do is pull this out and put in the definition from
our previous letter and that may make it a little clearer, but we thought we
had defined it pretty clearly because we didn’t want to get into this
misunderstanding. Lorraine.
MS. DOO: The other thing that we reminded ourselves of this morning is that
this is a recommendation letter and trying to be responsive to letters that
have been received, but they will have ample opportunity to respond to the
regulation and that’s really where it will count. That is the policy.
DR. SUAREZ: One more point, if you go back just a little bit above that
where we say that conditional on the authority to making certain revisions to
the proposed operating rules, that the actual recommendation– there seems to
be– it creates some disconnect between the certain revisions and the
recommendations that follow. When we read those, they will come way later. What
I was going to suggest was inserting at the end of that paragraph, in
parentheses, recommendation 1.1 and 1.2.
DR. WARREN: Do it right here?
DR. SUAREZ: The condition, exactly, inside parentheses there, recommendation
1.1 and 1.2. They come way down.
DR. WARREN: You want “will follow”?
DR. SUAREZ: I’ll just close before without “will follow” and just
close it recommendation 1.1 and 1.2 so it is clear that the certain revisions
to the proposed operating rules are what we’re making recommendation 1.1 and
1.2. Then if you go down below, I noticed that right after this paragraph that
we just finished, we start “elimination of reference”. That’s in bold
if my eyes still work. I know our traditional way of organizing the letters is
that we create some observations and then we make the recommendation. I don’t
know if it works to bring the recommendation 1.1 at the beginning here, and
then have this paragraph explain recommendation 1.1. This jumps into
elimination of reference to court certification–
DR. WARREN: I looked at that last night, and we’d have to almost rewrite the
letter in order to get them to line up with observations and everything else–
DR. SUAREZ: All I am suggesting is if you go down to where we say
recommendation 1.1, if moving that recommendation 1.1 paragraph above, just
above.
DR. WARREN: Then where do you want the paragraph before it that explains it?
DR. SUAREZ: Follow that. So we say recommendation 1.1, the secretary ensures
that all references, and then the paragraph that follows.
DR. WARREN: I see what you mean. Got it.
DR. SUAREZ: So move those, just that, up above, and we’ll move 1.2 where
this is. We can then eliminate that heading.
MS. GREENBERG: Above elimination, right, you want this–
DR. SUAREZ: No, you can eliminate that line, eliminate line number 156. You
can eliminate it.
DR. WARREN: So, eliminate the header here?
DR. SUAREZ: Right, just eliminate that one. Then we’ll just go down to
recommendation number two and 189. We’ll move it to line 189.
DR. WARREN: So, we’re just using the recommendations as the guidance instead
of the heading, okay, and do the same throughout then, or was it just those
two?
DR. CARR: Then we go down to other considerations, do you want to do the
same thing with this recommendation of putting it in place of the title?
DR. WARREN: No, because we have four headings: adoption of operating rules,
maintenance and change requests, and other considerations.
DR. SUAREZ: Not any more.
DR. CARR: So, again, the only edit in the recommendation in this part was to
bold it and replace we recommend that with recommendation 2.0.
DR. SUAREZ: I think recommendation 2.0 is referencing the other
considerations, right? I would move that recommendation 2.0 above that and then
eliminate the other considerations regarding operating rules.
MS. GREENBERG: I think right now the rest of us are kind of confused.
DR. SUAREZ: We’re just ordering this and then we’ll explain it.
DR. CARR: So in the letter on line 212 yesterday we had number two,
maintenance and change requests of operation rules. Is there a recommendation
that goes with that?
DR. SUAREZ: No, there’s not recommendation.
DR. WARREN: There’s no recommendation on that. It’s part of the first
section. It’s just telling the secretary that we are studying that and to
expect a report on it.
DR. SUAREZ: Maybe we should move that to the end of the letter after
recommendation two.
DR. FRANCIS: Judy, there is a typo at the end of the bold, after rules,
maintenance and change requests for operating rules, there is a typo.
DR. CARR: Take the apostrophe out of “rules” on line 226.
MS. GREENBERG: Obviously we’re going to have to read through the whole
thing.
DR. CARR: Okay, are there any other comments, suggestions? It was a great
effort and a great letter. Thank you very much. Now we have to take a vote.
Does anyone want to make a move to approve?
DR. SUAREZ: I move to approve the letter as edited.
DR. CARR: Second. Is there any discussion? Hearing none, all in favor? Any
apposed? Any abstentions? No abstentions, no opposition. Moved forward, thank
you very much. Great job.
(On motion duly made and seconded, the motion was unanimously approved.)
Agenda Item: Standards – HIPAA Report
ACTION
DR. CARR: Next topic, Bill let me ask you are we ready to look at that or do
we want to–
DR. SCANLON: Go ahead.
DR. CARR: Go ahead, okay, so we’ll need to put that up on the big screen, on
the jumbo-tron. The next topic is the HIPAA report. The work that followed from
yesterday’s discussion was a reconfiguration of essentially page one of the
executive summary.
DR. CARR: We took the discussion from yesterday and made some changes to
this and we’ll take you through it. The opening paragraph of the executive
summary is the same as yesterday, I think, Bill, so just scroll down. We can do
the fixing later. Actually, Bill, maybe you could speak and let Walter edit.
Walter, at this point, I would say let’s put this in the final format view
because there are so many changes. We can go back and find them, but I think
for the purposes of reading this–
DR. SCANLON: Now you understand why I do not bring a computer with me.
DR. WARREN: Are those the changes that you guys made last night?
DR. CARR: Actually, could we see them? I got really lost. Could you put them
back up?
DR. CARR: We can go back to that, but here’s what the issue is. We had three
authors editing each other’s work, so when you try to track this, it’s even
more confusing. I’d rather get agreement on the concepts and then we can show
the changes, but I think that we’ll get lost if we try to sort the green from
the light blue from the lavender.
DR. SCANLON: I think, with one exception, all the changes are basically in
the first page and a half of the executive summary. The exception is something
that we should note which is that it’s in the privacy section where we talk
about the number of complaints that have come in. It’s a sentence added to say
that we do not know out of the total number of potential problems there are
what those complaints comprise. We don’t have a sense of –.
DR. CARR: Let’s go back up then to the first paragraph which reads the same
as yesterday, setting the stage for the fact that roughly 10-15 percent of the
nation’s $2.5 trillion annual spending go to all administrative costs, that’s
all administrative costs. Then we go into the description of HIPAA. Here we
have an opening sentence that is new. HIPAA was expected to play a major role
in controlling administrative costs, so that links it to the opening paragraph.
DR. FRANCIS: Could we change controlling to reducing?
DR. WARREN: I don’t think it necessarily reduces —
MS. MILAM: Justine, we use the word confidentiality, but it goes further
than that domain. Would we want to say privacy and security?
DR. CARR: Yes, privacy and security. Change confidentiality to privacy in
line–
MS. MILAM: Actually, we should put both in because they’re different.
DR. CARR: Confidentiality comma privacy and security of health information–
got that? Line three that begins insurance. The remainder is exactly as we
described it yesterday.
MS. GREENBERG: I’m with Judy, frankly, that it would have been helpful to
see where you’ve changed and where you haven’t.
DR. CARR: You know what, we can flip back and forth. So Walter, do you want
to go back to just show the mark-up? Move it up so we can see that. Red is
today. Blue is last night. Purple is Bill.
DR. SUAREZ: I don’t think it’s very helpful to see it.
DR. CARR: We introduced the word “electronically”. We changed
“individual” to “individually”. We changed
“identifiable information” to “identifiable health
information”. Nothing major.
MS. GREENBERG: You can go back.
DR. CARR: Now go back, okay. Description of HIPAA, if you want to show how
much change was in the paragraph and then we can go back and do a read. Did we
see description of HIPAA?
DR. WARREN: Can I make one grammatical thing before Mike Fitzmaurice jumps
me on it? Just because there’s one thing I know that you haven’t pick up on
yet, Mike. I can’t find it now, but somewhere in there you have a
“which” and it should be a “that”.
DR. CARR: I’m going to put a moratorium on “whiches”,
“thats”, commas, and periods because the tenses are all inconsistent
throughout this. That is work that will need to be done, but we won’t get
lunch. The status of implementation–
DR. FRANCIS: Before you go there, take out “focuses on” and say a
main component of HIPAA is administrative simplification.
DR. CARR: Right, good point– any other suggestions on the description of
HIPAA? Hearing none, we will now go to status of implementation. Why don’t you
show what it used to look like, because this is significantly different? This
is all new.
DR. SUAREZ: This is a brand new paragraph.
DR. CARR: Walter, this was your– could you speak to this?
DR. SUAREZ: I think the idea was to start with a strong statement about what
has HIPAA really contributed to and it was important to mention these major
contributions to the transformation and modernization of the healthcare
industry in three important ways.
Number one, by laying the groundwork to move the industry from paper to
electronic format in administrative and clinical systems.
Number two, by moving the industry to a common set of standards from a
multiplicity of standards and formats.
Number three, by establishing a privacy and security framework to ensure
protection of health information. Today there is a much greater awareness of
the need to protect the privacy of personal health information and enhance
efforts to do so.
DR. CARR: That was in response to the comments yesterday. We want to make
sure that we don’t fail to recognize the great accomplishments.
MS. GREENBERG: Since there is that summary sentence and first you talk about
paper to electronic then you say common set of standards– I think this is very
good, by the way, I like this– and then establishing a framework, yet the
summary statement is only about privacy. I would do one of two things. I would
either put a semicolon after information or I would expand that to say that
today there is a much greater awareness of the importance of standards and of
the need to protect the privacy, or something like that.
DR. FRANCIS: Take out the “a” before much greater, though.
DR. CARR: No, we will get that on the rewrite. Anything else? Now, to the
next paragraph, Walter. It starts with “however, the completeness”.
DR. SUAREZ: However, the completeness of these efforts is not known, as the
department has not systematically tracked implementation. Moreover, the speed
of adoption across industry has been disappointing, though in part
understandably, given the starting point for implementation. The lack of full
implementation of all HIPAA components now threatens the nation’s progress
towards reform in the healthcare system and providing access to quality
healthcare in a timely manner.
DR. CARR: Bill, do you want to speak to that?
DR. SCANLON: We’re trying to bring in a number of different concepts. One is
that there was in the original executive summary the idea that the department
has not been tracking implementation, so we can’t say exactly where we are in
that. It relates also to what I said earlier about the privacy section. The
second idea was what came up yesterday, which is that there really has been
progress. While we’re expressing dissatisfaction with where we are, we’re not
trying to be totally critical in terms that we haven’t moved at all. That’s
what the second sentence is about.
The third sentence is actually an issue that I think, as a data committee,
that we need to recognize. The key to healthcare reform, true reform of the
delivery system, is data. People are talking about all kinds of mechanisms like
ACOs and bundle payment and things like that, but if we don’t have data that
support the development and the operation of those kinds of reforms, they are
not going to work. I think that’s why that third sentence is there.
MS. GREENBERG: Could I just suggest that in that first sentence, though I
don’t want to be an apologist for the department, but to say however the
completeness of these efforts is not known as the department has not
systematically tracked implementation throughout the healthcare industry.
Obviously, we have a very good idea of implementation in Medicare. I think the
point is that throughout the healthcare industry it hasn’t.
MR. SCANLON: Can I– a friendly amendment, I would say neither the
department nor the industry has systematically tracked it.
DR. SCANLON: I didn’t hear that, Jim.
MR. SCANLON: Neither the department nor the industry has. It’s not that
nothing is being tracked. There is considerable information on where things are
and there is considerable information in some sectors on the percentage of
people complying and the percentage of records. I wish there were a way to
differentiate a little bit more. It’s not that there are no metrics; it’s sort
of– detailed metrics or comprehensive metrics. Even if we had it, it wouldn’t
solve much in terms of the goal.
DR. SCANLON: I think comprehensive and systematically was also trying to get
at the idea. It’s not that we know nothing. It’s that we don’t know enough.
MS. GREENBERG: I think you can get rid of healthcare in the second
healthcare industry then it won’t be so redundant.
DR. CARR: Next sentence, are we okay with disappointing?
DR. FRANCIS: I would get rid of for implementation, though. I would say
given the starting point– the reason I’m pushing some of this, which may seem
almost grammatical is that I want them to be really punchy sentences
DR. CARR: Given starting point– is that clear to everybody? What we mean
there is that it was passed in 1996 and work was begun, how many years later?
MS. GREENBERG: The first transactions and code sets rule was 2000, which
ended up not being implemented until 2003.
DR. CARR: Is that what we’re referring to here?
DR. SUAREZ: This is the argument. We tend to think that HIPAA is 15 years
old, and it is as a law, but in terms of implementation it is only seven years
old at best. It’s truly less than seven years old, so in the context of times
the disappointment is less disappointing.
DR. WARREN: Shouldn’t we put that in there? That implementation starts in
2000.
DR. CARR: I think we need to expand that.
MS. KLOSS: We talked yesterday about the rule-making process. It’s not just
implementation. It’s the whole process. I think we’ve lost that a little bit.
Understandable, given the starting point and the process of implementation, or
something, I think we need to lay the groundwork for that later discussion.
DR. SCANLON: It is more the 15-year period that does matter. There is the
issue of why it took until 2000 before we did this. There was a provision that
Congress was going to act and the department wasn’t supposed to act, so they
didn’t act. There was that delay, which was built in, but beyond that, there is
the issue of why it took until 2000, why it was delayed until 2003, et cetera.
A longer time frame is involved with multiple parties being responsible for
different pieces.
DR. CARR: So Linda, you had a recommendation that comes after–
MS. KLOSS: Given the starting point and the process for implementation,
which covers a lot.
DR. CHANDERRAJ: Should we add the regulated process of implementation?
MS. GREENBERG: Adoption is good, too, because–
DR. CARR: Raj, you said, given the regulatory process? Is that correct to
say regulatory process?
DR. SCANLON: I think we have to be a little bit cautious here, because we’ve
had the discussion about the regulatory process a number of times. It’s both an
issue of how it doesn’t need to take as long as it does, and secondly there
have also been proposals, including legislative proposals, that try and change
things. It’s a somewhat delicate area.
DR. WARREN: All those details are in the report. If this just refers to that
then they can read the report.
DR. CARR: The lack of implementation of all HIPAA components now threatens–
DR. SUAREZ: Let me just ask one thing. Is it lack of full implementation of
all HIPAA components by all parties involved?
DR. CARR: Right.
MR. SCANLON: It is a how much question.
DR. CARR: Now threatens the nation’s progress toward reforming the
healthcare system and providing access to quality healthcare in a timely manner
MS. KLOSS: Would impede be better than threatens?
DR. CARR: Threatens or impedes? I know Bill is favoring threatens. Paul is
trying to say something.
DR. TANG: I think it’s threatens. It’s really an essential part of being
able to reform the health system as Bill was saying. I think threatens is much
closer to what’s going on.
DR. CARR: We can hear you really clearly today. We’ve moved the speaker
right in front of us. Thank you, Paul. That was your language so that was very
helpful. Any other changes on this paragraph?
DR. FRANCIS: I would take out in a timely manner, because it sounds like
what it’s doing is making my seeing the doctor slower, and that’s not what we
mean.
DR. CARR: Okay, providing access to quality healthcare period. All right,
moving right along. We’ve called out a section that still needs work. It’s
called challenges to implementation. We have two flavors of this. The first
five bullets speak to the ongoing challenges to implementation. We had also
outlined– we had a number of other bullets that may be redundant in here.
Maybe you took them out?
DR. SCANLON: Actually, they have now been parked elsewhere. I think that in
terms of this first page and a half we want to stick to these. These are the
issues that were impediments in the past and they remain impediments for the
future. What we’re trying to do is highlight them so that if you’re reading
this as a congressional staffer, these in some respects are implicit
recommendations. These are things you need to deal with.
DR. CARR: Let’s go up to the beginning of that, Walter.
DR. SUAREZ: Sorry. Let’s read it for people on the phone. This is the
heading: challenges to implementation. The first paragraph reads: the
achievement of the vision of seamless electronic flow of information in a
confidential and secure manner has been slow with result and unnecessary waste
of resources. Continued and more rapid progress in achieving the full benefits
of administration simplification and strong privacy protection will be hampered
by the following issues that have also impeded past progress.
DR. FRANCIS: Before we go on, can we break up some of those sentences and
say, put a period after “slow” and say the result has been
unnecessary waste of resources.
DR. CARR: What was wrong with the way it was before?
DR. FRANCIS: I think it’s punchier if we have very short sentences. I would
also figure out how to have both– then I would get out the “which”
phrase and I would say, progress in achieving the full benefits of
administrative simplification has been and will continue to be hampered by.
MS. GREENBERG: What does the result refer to?
DR. CARR: The consequences.
DR. TANG: Speaking of which, do we have a title for this yet? Just talking
about punch, I think the theme of this is really the lack of administrative
simplification threatens health reform. If we have some kind of punchy title
that has a call for action built into it, we might get more visibility and
readership.
DR. CARR: As an alternative to challenges to implementation, what would you
recommend?
DR. TANG: I don’t know if that’s a section heading or a title of the letter.
Mostly because our main theme is that there were a lot of good reasons to have
HIPAA, but actually now there is a renewed reason, the lack of interoperability
of data and protection of privacy, confidentiality threatens health reform.
It’s that kind of big picture headline. Our words now are saying this, but
these are the words– they’re going to read these words we’re editing because
of our big picture headline.
DR. CARR: You’re recommending that we think of a new title, which may be, if
as you’re listening to this, anybody who has a recommendation along those
lines. But back to the actual heading of this line, it’s very vanilla I guess,
challenges to implementation, but that’s what it is.
DR. SCANLON: It might be something like challenges to achieving the
objectives, fulfilling the vision, something along those lines. I think you
need a verb in there.
DR. TANG: Say what the outcome of not meeting these challenges is. Is this a
heading title or a letter title?
DR. CARR: No, this is a heading title, so the opening begins with the
introductory sentence, then definition of HIPAA, then progress to date, then
challenges to fulfilling the vision is what it now says.
DR. TANG: As it stands, I don’t have a motivation to read this thing. What
I’m hearing about the edits sounds so good, that I first need to get somebody
to figure out why I should read this thing. I’m hearing all the good words that
would fulfill my —
DR. CARR: How about broken dreams? Or heartbreak?
DR. TANG: Want me to try to work on the title?
DR. CARR: Please, that would be great.
MS. GREENBERG: Judy and I are having a little problem with the second
sentence. Actually as is sometimes our solution, I would get rid of it. This
has resulted in a lot more than unnecessary waste of resources. We already said
above that it impacts reforming the healthcare system and providing access to
quality healthcare. This sentence is– that’s a problem, but you either have to
say it all or just get rid of it. I would.
DR. CARR: All right, I was trying to link it to the money picture. The
achievement of the vision of seamless electronic flow of information in a
confidential, secure manner has been slow. Progress in achieving the full
benefits of administrative simplification and strong privacy protection will be
hampered by the following issues that have also impeded past progress. We might
reword that.
MS. GREENBERG: I thought we had progress in achieving the full benefits of
administrative simplification, strong privacy protection has been and will
continue to be hampered by the following issues.
DR. CARR: Right, has been and will continue to be. Thank you.
DR. CHANDERRAJ: Do we think the first sentence is necessary there?
DR. CARR: I want to make sure we get through the concept and we can do a
second look as we go through, but I want to make sure we have the points in the
right place. There are five issues and these are the issues that are past,
present, and future. One, the law failed to mandate adoption by all parties,
parenthesis, the law requires adoption for all health plans, all health care
clearing houses, and only healthcare providers that choose to conduct
transactions electronically. I think we need this present tense.
Second, strong incentives for adoption, such as Medicare’s requirements for
healthcare providers to submit electronic claims, are absent from many
participants. Third, compelling evidence about the potential benefits of
full-scale and more rapid adoption is lacking given the department has not
measured the impact of the law. We’ll have to fix that. Fourth, the original
standards were compromised by the level of optionality and variability allowed
in the implementation of the standards. Last, the HIPAA mandated patient
identifier has not been implemented because the department as been prohibited
by law from spending appropriated funds to finalize a standard for it.
Let’s take them one at a time. Number one, the law failed to mandate
adoption by all parties. Any comments on that?
DR. FRANCIS: Can we pick a different word than parties? It’s not clear– the
idea would be participants in the healthcare system, right? Something like
that?
DR. SCANLON: I am a little nervous about either participants or stakeholders
because we’ve been trying to expand the concept of stakeholder to include the
patient. We’re not thinking about improving requirements on patients.
DR. CARR: By all entities?
DR. SCANLON: Everybody likes parties.
DR. CARR: Parties– let’s go back to parties.
DR. SUAREZ: Parties instead of entities?
DR. CARR: Do we have a better word than party?
DR. FRANCIS: I would put it in the positive and just say, the law only
required adoption for health plans, healthcare clearing houses, and healthcare
providers that chose to collect —
DR. CARR: I think we’ve had that. Again, this is back to your approach,
we’re trying to punch out there was a failure. I think this was really stating
it, using the words failure to mandate had this result.
MS. MILAM: I’m thinking back to some of the older privacy letters. Would we
want to go as far as to say all organizations with health information?
DR. FRANCIS: I like that.
DR. CARR: All organizations using health information?
DR. SUAREZ: Health care organizations.
MS. DOO: I’m not sure what you all were trying to get at, but I’m presuming
that one of the missing entities are the vendors that provide the practice
management systems and software for the providers. It’s the parties to the
transactions, right? That’s what we govern.
DR. CARR: By adoption by all parties to healthcare transactions?
MS. DOO: Is that what you feel is missing? Who are you saying is not–?
DR. SCANLON: This came up in a phone call earlier and I think that to me the
issue was that we still have a very significant volume of paper claims which
are completely outside of–
DR. SUAREZ: At first, it was every provider not only providers that chose to
adopt. That was first, and then there is a whole host of others such as vendors
and practice management systems.
MS. DOO: You may then want to then give those examples. In other words,
providers should not have been given an out, is what you’re saying. If they’re
still using paper claims, it’s because they are still allowed and enabled to.
DR. SCANLON: That goes to the third bullet about compelling evidence. I
think it’s very difficult to consider whether or not the congress would enact
something that said if you want to submit a healthcare claim, you are going to
have to submit it electronically. That’s a bold step. The issue is that there
are two ways to give incentives. One is to provide a very positive incentive
the way Medicare was done. The second one is to show people that it is really
in their interest to do this and to get them to comply voluntarily.
MR. SCANLON: The other thing is that I think we have to be careful for each
one of these. Some of these apply to privacy differently than they apply– and
you don’t want to–
DR. SUAREZ: This is what is so interesting about HIPAA that not a lot of
people understand. The law requires applicability of HIPAA to these entities.
If I am a healthcare provider not conducting transactions electronically, I’m
not subject to privacy. The only way I’m subject to privacy is if I send the
claim electronically.
DR. CARR: But what is subject to privacy is not limited to the electronic
claim. It’s all PHI.
DR. SUAREZ: Once I’m in privacy, I’m in privacy for everything, but if I
don’t do electronic transactions, I’m not subject to anything with privacy or
security. I bet not a lot of people know about that.
MS. KLOSS: I think that we have to look at how the law was constructed in
the context of 1996, where we were, and keep driving forward that perhaps it
failed at that time, but now it’s time to close those gaps.
DR. SCANLON: Maybe the context of that is what Judy was talking about
yesterday. One of the things to think about for next year is to take a
committee-wide view of HIPAA, where we are and where we may need to be. That’s
the kind of potential recommendation that comes out, but I think where we are
in terms of this report is too big of a leap.
DR. CARR: It is a true statement to say the law failed to mandate adoption
by all healthcare organizations, except–
DR. SUAREZ: That is the number one issue with HIPAA.
DR. CARR: Is organizations the right word? That includes providers. I don’t
know how Larry feels about that.
DR. FRANCIS: I’d say entities.
MS. GREENBERG: I hate entities.
DR. CARR: Parties. Actually, it would be healthcare parties. It’s
physicians; it’s clearinghouses and all that. It’s not the best word, but it’s
closer than anything else that has been suggested. Okay, we’re leaving that
first bullet and going to the second one. Strong incentives for adoption, such
as Medicare’s requirement for healthcare providers to submit electronic claims
are absent for many participants. Okay, so absent for many participants, are
they–
MR. BURKE: I was going to suggest, do you want to establish a pattern, you
starting the law failed, the second one might be, at no incentives to keep a
poetry about each entry being the same format.
DR. CARR: Exactly, so what did you recommend Jay?
MR. BURKE: The lack of strong incentives for adoption, then it follows in
the same pattern.
DR. CARR: A lack of strong incentives for adoption are absent. It’s the
negatives. So a lack of strong incentives for adoption such as Medicare– are
absent for many participants.
DR. SUAREZ: The participants are really only any other healthcare providers.
Every health plan is required. Every clearinghouse is required.
MS. DOO: The incentives or penalties are coming from the plan. So Medicare
says thou shalt submit electronic claims.
DR. CARR: Yes, so it is lack of strong incentives from non-Medicare
providers or plans. Lack of strong incentives for adoption were absent.
MS. GREENBERG: With the exception of Medicare’s requirement for healthcare
providers to submit electronic claims, strong incentives for adoption are
absent.
DR. CARR: That is excellent.
MR. SCANLON: Subsequent to HIPAA, several states have adopted regulations,
which require rapid payment, distinguish between electronic submission or
paper.
MS. GREENBERG: So maybe it wasn’t just Medicare.
DR. SCANLON: The issue is that it’s such as Medicare. The idea was that that
is the example, not the universal. A plan that is dominant in a community could
say if you don’t submit electronically, you’re not going to be in my network.
That’s a strong incentive.
MS. GREENBERG: Maybe such as was better.
DR. SCANLON: It was meant to be an example not a–
DR. CARR: Lack of strong incentives for adoption–
DR. FITZMAURICE: Excuse me, Justine? Except that lack of strong incentives
are absent, the lack are absent.
DR. CARR: Strong incentives for adoption by providers are absent. Strong
incentives by healthcare providers were not uniformly implemented or something
like that.
MS. KLOSS: I thought it read better to have the such as, have the clause
come after adoption.
DR. CARR: Yes, strong incentives for healthcare adoption by healthcare
providers, such as Medicare’s, maybe parenthesis, such as Medicare’s
requirement for all providers to submit electronic claims are absent.
MS. GREENBERG: Universal– are not widespread.
DR. CARR: Are we saying that HIPAA should have created strong incentives?
MS. GREENBERG: We are saying that other plans didn’t follow.
DR. SCANLON: I think what we are doing is that we’re setting up a future
recommendation. The idea is that we may not have anticipated this end because
remember the Medicare incentives came in 2001. They didn’t come with HIPAA. The
issue is that this is a continuing impediment. Unless we give an incentive for
the future, we’re not going to–
DR. SUAREZ: Here’s another example that might actually give a different
perspective, or states that mandated all healthcare parties to conduct
transactions electronically.
DR. CARR: Let me go back to the beginning. Strong incentives for adoption by
healthcare providers, we need to continue to say to submit electronic claims
are absent with the–
MS. MILAM: How about Marjorie’s language, are not universal?
DR. CARR: Such as Medicare’s requirement, close parentheses.
MS. GREENBERG: Yes, such as Medicare’s requirements.
DR. CARR: Is that it? Strong incentives for adoption by healthcare providers
to conduct transactions electronically, such as Medicare’s requirement, are
absent.
MS. GREENBERG: The problem is that they’re not absent because Medicare and
states have made requirements, so are not widespread.
DR. CARR: Are often absent. We’re going to have to figure out the tense. I
know this goes back and forth. Are we done with bullet number two? Moving on to
bullet number three. Compelling evidence about the potential benefits of
full-scale and more rapid adoption is lacking given the department has not
mandated the impact of the law–
MS. GREENBERG: Let’s go back to where we were before. Given the uneven
tracking or something, because we said we’re not just talking about the
department, but we’re also talking about the industry.
DR. CARR: The absence of metrics to demonstrate benefit has hampered– the
absence of tracking or measurement to demonstrate benefit and compliance of
measurement, measures, to document compliance and benefit.
DR. SCANLON: This is really about incentives, but it’s only the benefit part
that we’re really worried about mentioning.
DR. CARR: Document benefit, take out compliance, to document benefits has–
DR. SCANLON: A full-scale and more rapid adoption?
DR. CARR: Has undermined full-scale and more rapid adoption. Absence of
measures to document benefits has undermined full-scale and more rapid
adoption, period. Is that good?
DR. SCANLON: Very punchy.
DR. CARR: The next bullet, the original standards were compromised by the
levels of optionality and variability allowed in the implementation of the
standard.
MR. SCANLON: Could we substitute variation for the phrase of optionality and
variability? The original standards were compromised by variation allowed in
the implementation of the standard?
DR. CARR: Variation permitted, yes. By variation–
DR. SCANLON: Except, we have been using the word optionality in a number of
letters, so I think we want to put it in.
DR. CARR: By the levels of optionality permitted in the implementation of
the standard.
MS. GREENBERG: The elephant in the room, it seems, and maybe it’s just
obvious, except I wouldn’t want the committee to look too naive, is that these
were all political compromises, obviously. They have had consequences.
DR. SCANLON: The role of an advisory committee is to tell you what–
MS. GREENBERG: And that’s fine.
DR. CARR: At the time, it seemed like a good idea, but–
MS. GREENBERG: I think people even realized they were less than ideal, but
this is what it took to get it through at the time. Now, we’re paying the
piper, in a sense.
MS. KLOSS: I think it is important to go back to the framing sentence for
this list. That’s not critiquing the original HIPAA; it’s talking about these
issues as impeding process going forward.
MR. SCANLON: I think people are more interested in what do you do next,
without a full-blown new regulatory program. I don’t think that would be
helpful. Can I suggest that the original standard were really industry
standards? The department and the committee were left with trying to make them
work, but they were industry standards. I’d like to get the industry’s
responsibility for selling this, at least part of it. The original industry
standards–
DR. CARR: –were compromised by the levels of optionality and variability
permitted in the implementation of the standards. Is standards the right word
there? Standards compromised by standards?
DR. FRANCIS: I don’t think that makes sense because I think the point was
that because industry wanted optionality and variability, implementation was
compromised.
DR. CARR: The decision to permit optionality and variability–
DR. FITZMAURICE: How about they were inefficient because of–
MR. SCANLON: They were not ready. They basically urged congress to mandate
standards that when we looked at them, they were, for various reasons, not
ready. It took two years, among other things, to straighten that out.
DR. CARR: The standards were not compromised. They were not–
DR. SCANLON: It’s the benefits from the standards were compromised by the
fact that there was optionality and variability.
DR. CARR: The benefit from the original industry standards was compromised
by–
DR. WARREN: But it’s the interpretation of the implementation was
compromised by the interpretation of the standards.
DR. CARR: Permitted in the interpretation of the standards, not the
implementation? Good, this is great. Anything else on that bullet number four?
MR. SCANLON: That’s good
DR. CARR: Anything else on that bullet number four?
DR. FRANCIS: That just doesn’t make sense to a naive reader.
DR. SCANLON: I think we want to go back to the idea that benefits were
compromised. Benefits from the original industry standards–
DR. CARR: The benefits of standards–
DR. SCANLON: –were compromised by the levels of optionality and variability
in the original industry standards.
MS. GREENBERG: Through the benefits of standardization it was compromised.
DR. CHANDERRAJ: Benefits of standards and compliance were ended by
optionality and variability. Permitted in the interpretation of these standards
I think is redundant again.
DR. SCANLON: In the interpretation, permitted in the interpretation of the
original industry standards.
DR. CARR: Yes, so the anticipated benefits of standards– of
standardization, is that right? The benefit of standardization was compromised
by the levels of optionality and variability permitted in the interpretation of
the original industry standards. The benefit, single–
MS. GREENBERG: I think that says it.
MR. SCANLON: In fact, this committee spent two years trying to–
DR. CARR: “Were” to “was”.
DR. SUAREZ: Are we saying singular? I think it’s plural, the benefits of
standardization.
DR. CARR: Great, any other comments? No. Moving on, the HIPAA mandated
patient identifier has not been implemented because the department has been
prohibited by law from spending appropriated funds to finalize a standard for
it.
MS. GREENBERG: Isn’t the prohibition broader than that? It’s not just to
finalize. It seems they pretty much shut down the whole investigation.
MR. SCANLON: Could we turn this around like the others and say Congress has
prohibited?
DR. CARR: Congress has prohibited by law–
MR. SCANLON: –the development and implementation–
MS. GREENBERG: –the development and adoption of the HIPAA mandated patient
identifier. Then I think we should say, which–
DR. SCANLON: Since we were talking about GAO yesterday, we would never tell
the Congress, you screwed up.
MS. GREENBERG: Either way you say it–
MR. SCANLON: Don’t blame the department for not doing it.
MS. GREENBERG: How about just saying the prohibition to develop and adopt
the originally and mandated patient–
DR. CARR: The law was passed.
DR. SCANLON: The other way was not blaming the department. The department
was prohibited. It was stating the fact first. I’m fine. I’m just telling you
about the GAO style.
DR. FRANCIS: We’ve been really careful to say exactly what Congress did and
did not prohibit. I think we should be careful here, too. What I think we
should say is, legislative prohibition–
MS. GREENBERG: –to develop and adopt–
DR. FRANCIS: No, but that’s not what they’ve prohibited. What they’ve
prohibited is spending appropriated funds to finalize a standard.
DR. SCANLON: Well, promulgate or adopt, but we have the exactly wording
here.
MS. GREENBERG: It says, Congress prohibited DHHS from using the authority
under HIPAA to promulgate a final rule or standard.
DR. FRANCIS: Right, let’s just say that.
DR. NICHOLS: I like that a lot. Bill, the purpose of an advisory committee
is to tell Congress when they got it wrong.
DR. CARR: We can go cut and paste into that. We don’t have to dictate it
right now.
MS. GREENBERG: You want to know what it is? Congress prohibited, you could
say the department or DHHS, from using the authority under HIPAA to promulgate
a final rule or standard for a unique patient identifier. Do you want to say
anything about why that’s a problem, or do you say it later?
DR. CARR: I think that’s okay. Then the lack of implementation of all HIPAA
components now threatens the nation’s progress toward reforming healthcare
system–
MS. GREENBERG: Wait, we already said that above.
DR. CARR: I know. This was a lot of cutting and pasting. Do we want to say
it again or take it out? We already said it.
MS. GREENBERG: That last sentence, before the bullets.
DR. CARR: We’ve completed the part on challenges. Now we’ve gone to
necessary next steps. That was challenges to fulfilling the vision, necessary
next steps.
MS. GREENBERG: How was that changed?
DR. CARR: I think that’s all new.
DR. SUAREZ: It is all-new.
DR. CARR: The idea being we identify the things we want in the first page to
identify what we need them to do. HIPAA’s goals remain highly relevant with the
ever-growing need to converge financial, administrative, clinical, and quality
data to promote greater quality and efficiency in the healthcare sector while
ensuring the privacy and security of such data. Their achievement is contingent
on a strong commitment by the department and stakeholders to develop as rapidly
as possible a comprehensive set of standards that achieve genuine
administrative simplification and privacy protection involving the integration
of data from a multiplicity of sources in ways never envisioned when the law
was passed.
DR. SUAREZ: Let’s stop there for a second. This is like saying we should
scratch and start anew. This is saying we need to rapidly develop a new set of
comprehensive standards. That’s not what we are looking at. I don’t think we
need this whole sentence.
MR. SCANLON: We could say complete the original standards
DR. SCANLON: What are we doing in all these standards committee meetings
that I come to? We’re talking about revising standards. That’s not the same as
starting from scratch. The issue is– we’ve been raising in our letters the
issue of optionality, which is one of the key impediments that we talked about
earlier. I think this is what we’ve been engaged in.
DR. SUAREZ: No, I think what we’ve been through is to make sure that people
comply with the full set of comprehensive standards that have been adopted
already. The part that is lacking is not the development, it’s compliance.
That’s why it says here, stakeholders to develop as rapid as possible a
comprehensive set of standards. We don’t need to develop a comprehensive set of
standards. We need to make sure that the department and stakeholders ensures
the compliance of all the standards.
DR. SCANLON: No, it doesn’t just say a comprehensive set of standards. It
says a comprehensive set of standards that achieve genuine administrative
simplification and privacy protection, and I don’t think we have that today. We
have a set of standards that do not achieve–
DR. SUAREZ: They’re not achieving it because there is no compliance. They do
not achieve it not because–
DR. SCANLON: Then why are we engaged in the revisions?
DR. SUAREZ: The standards are not bad. The problem is compliance.
DR. SCANLON: Then we don’t need to have all this discussion of revisions if
the issue is compliance. What we should be talking about is how do we do
enforcement. We should simply be making recommendations about enforcement.
We’ve been having hearings about the different standards and different things
related to the standards and the revisions to those. The ACA sets out a very
ambitious agenda there. I think this is very consistent with what we’ve been
doing.
DR. CARR: So we have a couple of comments. I believe Leslie, then Jim, then
Judy, and then Mike.
DR. FRANCIS: I think the problem is that develop suggests starting over or
starting from the beginning, so how about complete and either encourage or
implement compliance as rapidly as possible, something like that. To complete
and monitor compliance.
MR. SCANLON: That was, I think, my point, too. It’s a matter of, number one,
complete the adoption of the remaining standards, however we want to phrase
that. Then, two, to secure or promote accelerated options, something like that,
of the standards.
DR. WARREN: I guess it’s a comment about where the dialogue is going about
standards. Standards are a living thing. They evolve over time depending on how
technology improves and grows, how business changes. We’re always going to be
in a world where standards are evolving. There’s never going to be a final set
that is good for everything. I think we need to keep that in the back of our
heads. With that, the issue then is people’s adoption and compliance with these
sets of standards.
We know we got into trouble, although Congress has continued to do it, when
we specify a version of a standard in either regulation or in law because then
you must undo those things in order to keep up with where today’s world is.
That happened to us early on in HIPAA. The version was specified in regulation
and that’s why we’re in the issue between 40-10 and 50-10 and we’ll have it
again when we go to 60-10, and as we go into various versions of Health Level 7
(HL7) as it evolves as well. I want to be careful that we don’t say that the
problem is the lack of well-done standards. They are there. They evolve. We
need to support that.
DR. CARR: Do you have a recommendation?
DR. WARREN: If we just not address that because I think the issue is the
adoption and compliance of the standards themselves.
MR. SCANLON: I think you can say streamline the adoption process. I think
the streamlining issue–
DR. SCANLON: There is also the issue of optionality, which we’ve been
raising in other contexts. If you talk to providers, that’s the thing you hear
most about.
DR. SUAREZ: With 40-10, not with 50-10.
DR. WARREN: So various things have happened. When we create a standard we
need to have implementation guides. We’ve tried those. We’ve tried operating
rules. The issue is there are certain areas where there is– you can’t put in
the standard all the different specifications of how the world works.
DR. CARR: Let’s get a couple of other comments and then go back to the
word-smithing. Mike?
DR. FITZMAURICE: I think both Bill and Walter are right. I see it as a
matter of continuing to develop the standards. I might insert testing, because
I’ve heard it has talked about testing, and then encourage the implementation
of the standards as they’re written and then check the compliance. Are they
implementing it the right way? It’s development, testing, implementation, and
compliance.
DR. WARREN: I agree with that. Instead of using develop the standards, you
use evolve the standards.
MS. GREENBERG: The first sentence, particularly when you added quality,
makes me think, what about public health? Actually, public health is very
impacted by HIPAA, too. If you just say financial, administrative, clinical,
but then once you start adding quality, to me the absence of mentioning public
health is apparent.
MS. MILAM: I thought that, too, Marjorie, but then when you look at the
specific context, I don’t think that connection to public health data is a goal
of HIPAA, is it?
MS. GREENBERG: The thing is that public health uses administrative data and
clinical data, and sometimes financial. Quality of care also uses all of those.
I would just get rid of quality. What other data is quality data using other
than financial, administrative, and clinical? Maybe it’s using– that’s a
problem when you start specifying things.
DR. CARR: Do we have a recommendation of–
MS. GREENBERG: I don’t want to put public health in there, so I would say to
get rid of quality.
MR. SCANLON: I would just delete quality, because we mention quality in the
next phrase anyway.
MS. KLOSS: Do we need this sentence? Could this be punchier if it starts–?
MS. GREENBERG: How about financial, administrative, clinical, and other– I
don’t know, because there are so many other kinds of data, too, that we need to
converge.
DR. CARR: So HIPAA’s goal remains highly relevant with an ever-growing need
to convert financial, administrative, clinical, and other data to provide
greater quality and efficiency in the health sector while assuring privacy and
security of such data.
DR. SUAREZ: I think dropping quality is enough. We really need to move on.
DR. CARR: We’ve got ten minutes to finish this. They’re achievements– now,
who is they, who are we talking about?
MS. GREENBERG: The achievement of the goals.
DR. CARR: The achievement of the goals is contingent upon, I would say, a
strong commitment by the department and stakeholders to develop as rapidly as
possible–
MS. GREENBERG: –and other stakeholders. We’re stakeholders. By the
department and other stakeholders.
DR. CARR: To develop as rapidly as possible a comprehensive set of standards
that achieve genuine administrative simplification, privacy protection,
involving the integration of data from a multiplicity of sources in ways never
envisioned when the law was passed.
DR. SCANLON: Could we, to solve some of the problem here, could we get to
Judy’s point about things beyond standards are also important? Maybe eliminate
everything– say, commitment by the department and stakeholders to achieve
genuine administration simplification and privacy protection involving the
integration of– I mean, we don’t know exactly what it’s going to take, but we
give them the objective here.
DR. CARR: Walter, are you okay with this? Is this– a strong commitment by
the department–
DR. SUAREZ: That sounds great. That sounds fine.
DR. CARR: The achievement of goals is contingent upon a strong commitment by
the department and other stakeholders to realize genuine administrative
complications and privacy protection. So we are good with that.
Next sentence, while the timeframe for achieving these goals should be
ambitious, recognition of other challenges impacting healthcare entities, such
as implementation of EHRs in meaningful use, and adoption of ICD-10 code sets,
et cetera, is critical so that a realistic timeframe can be established.
DR. SUAREZ: The adoption of ICD-10 is part of HIPAA. This should not be
there, I don’t think, because we’re all talking about HIPAA.
DR. SCANLON: It’s in part responding to the public perception that this is a
huge thing, even though it’s part of HIPAA. It’s a huge thing that is a
one-time occurrence. It’s not going to be every year or so. That’s why it was
included in the list.
MS. GREENBERG: Well, true, but it’s all part of HIPAA though. It’s not
outside of it.
DR. WARREN: Isn’t the issue here instead of talking about implementation of
EHRs, it’s the ensuing legislation that has been passed rapidly when we have
the high-tech legislation, followed by ACA, all of them with very aggressive
timelines mandated by Congress. That’s the problem.
MS. KLOSS: I question whether we want this sentence here.
MS. GREENBERG: It worries me. If you don’t mention ICD-10 it sounds like it
gives strength to the argument that we can’t do EHRs and meaningful use and
also ICD-10. I’d just get rid of the sentence.
DR. CARR: The point is a good one that there needs to be harmonization of
these omissions. While the timeline for achieving goals should be ambitious,
recognition of other challenges impacting–
MS. GREENBERG: Just make the harmonization point. Once you start qualifying
it –
DR. CARR: Achieving it should be ambitious. It should also be harmonized
with competing, with simultaneous–
MS. GREENBERG: Can you say, in ways never envisioned when the law was passed
and then–
DR. CARR: We have two concepts going on.
MS. GREENBERG: Do you want to say something about how it is also important
that the new requirements such as those for EHRs and meaningful use are
harmonized with the HIPAA–
DR. CARR: Expectations should be harmonized with–
MS. GREENBERG: I wouldn’t mention timeframe here and ambitious. I don’t even
understand what– we’ve already said to stick with the timeframes you’ve got. I
don’t know what you’re referring to there.
DR. GREEN: Justine, I think this isn’t going to work, but isn’t our point
that the timeframe needs to be ambitious? Why don’t we just say that?
DR. CARR: I’m finding a contradiction, because we’re saying it should be
ambitious and then saying except for–
MS. KLOSS: That is why I am saying take it out or reposition this sentence
to reinforce that administrative simplification is part of the overall
transformation.
DR. CARR: The timeframe should remain ambitious as we pursue a multiplicity
of initiatives.
DR. SUAREZ: I think the next paragraph already talks about the pressing
need.
DR. CARR: Hold that sentence then. To realize the vision of HIPAA and
adequately address the pressing health needs of an aging America, we need to
move boldly and vigorously to complete the standardization needed to
effectively and efficiently deliver quality care. Among the most important
steps moving forward, we need to– I think it’s forward singular, is it not?
Here are the things we need to do: develop meaningful metrics to measure
progress, align appropriate incentives to ensure full adoption, ensure adoption
and implementation of all standards by all entities subject to them, accelerate
the pace to adopt and implement the new standards, implement more aggressive
enforcement, synchronize timelines in the adoption and implementation of
standards, and evaluate unintended consequences such as the effect of new
standards on public health. Is that random?
MS. DOO: And get funding for all that.
DR. COHEN: Well, the unintended consequences had to do with the issue around
IRB issues–
DR. CARR: Yes, but we have a multiplicity of unintended consequences, so I’m
not sure– I’d just evaluate unintended consequences.
MR. SCANLON: The other bullet, possibly, but I think the committee has
debated this, was to streamline the adoption process. Was that not– or should
we stay away from–?
DR. CARR: Accelerate the pace to adopt and implement new standards, but
you’re saying streamline the process?
MS. GREENBERG: Should you say, by streamlining the process?
DR. SCANLON: There are multiple ways of accomplishing that goal. I would
take that as a license, Jim, to streamline the process.
MR. SCANLON: Whatever you do preparatory, you’re still in for three years of
rule making.
DR. WARREN: I have a question because I really don’t understand some of
this. The second bullet, a line of appropriate incentives to ensure adoption.
So HIPAA did not allow for any incentives, so where are these incentives coming
from?
MS. GREENBERG: I wondered myself.
DR. CARR: The consequence is that Medicare found a great incentive that you
won’t get paid if you don’t electronically submit.
DR. WARREN: That is the only incentive that HIPAA allows. There are no other
incentives. It’s different then what we have currently with ACA where there are
financial incentives.
DR. CARR: When you adopt ICD-10, you will have a greater model of your
clinical care or your p for p.
MS. KLOSS: I read this incentive as broad. Incentive might be cost saving,
the $80 billion that can be saved if we really achieve administrative
simplification.
DR. SUAREZ: It might also mean prompt payment or faster payment.
DR. CARR: Let’s leave the door open for future incentives.
DR. WARREN: To me, when we align incentives, it means we already know what
those are and that they are specified some–
MS. GREENBERG: Maybe encourage appropriate incentives to ensure–
DR. WARREN: –or identify.
DR. CARR: Identify appropriate incentives. So ensure adoption– Jim, your
point again was–
MR. SCANLON: Well, I thought it wouldn’t be worth getting the word
streamlining, but I see in the fourth bullet accelerate the overall pace, and I
guess that would cover it.
DR. CARR: We had a question on unintended consequences. We’re on our last
minute. Do we want to say anticipate unintended consequences, as opposed to
evaluate unintended consequences?
MR. SCANLON: Assess and innovate or something like that.
DR. CARR: Anticipate and minimize?
DR. COHEN: Would this be the place to add the bullet from the previous we
were trying to incorporate about aligning HIPAA with other ongoing activities?
DR. CARR: Yes, that’s right. We were going to come down here and say it
better here. We do say synchronize time lines in the adoption implementation of
standards. Do we want to also say–?
DR. SUAREZ: Align, I was going to say align. That’s the right framing. Align
the implementation time frames with–
DR. CARR: Harmonize major initiatives requiring the same resources,
something like that. Harmonize implementation of major initiatives– but it
could be the major initiatives that are on the same group. To Raj’s point, if
the physicians are required to manage five simultaneous initiatives, that’s not
harmonized. One is harmonizing it, but think about the implementer, related
to– I wouldn’t say related to health IT because in two years it’s going to be
something else. Harmonizing implementation of major healthcare initiatives– of
the impacted group on a single group of implementers.
MS. GREENBERG: I don’t know that we talk about that anywhere in the report.
DR. CARR: Well, we talk about ICD-10 and the challenges and the resources,
right?
DR. COHEN: Why not keep it more broad, just harmonize the implementation of
major healthcare initiatives?
DR. CARR: Yes, of major initiatives.
DR. SUAREZ: Including, we can give examples.
MS. GREENBERG: ICD-10?
DR. SUAREZ: To HIPAA such as meaningful use, I need a charge(?).
DR. CARR: No, I wouldn’t do that. If we’re not going to name it, we’re just
going to say harmonize the implementation of major initiatives.
DR. WARREN: When we’re through with this one, I want to go back to bullet
three.
DR. CARR: Okay, we’re going to go back to bullet three, and then we’re going
to ask for a motion to approve this with the editorial finding of the executive
subcommittee.
DR. WARREN: So, currently HIPAA adoption has already occurred for all
entities that are subject to them, which means that anybody who is doing
Medicare reimbursement.
DR. CARR: So is it implementation?
DR. WARREN: No, the problem is that no other part of the industry has
adopted them. It has only been mandated for when you apply for Medicare. That’s
the problem. I would say, by all entities, period, and get rid of, subject to
them.
DR. CARR: Is everybody okay with that? There is clearly some past tense-
present tense issues here, singulars and plurals, commas and periods,
apostrophes, which we will address. Is there any other major issue in this
pre-amble to the executive summary that–
MS. GREENBERG: And then the whole executive summary as we knew and loved it
is continuing?
MS. DOO: I had one last question which was, who is the “we”?
DR. FRANCIS: The United States.
DR. CARR: To realize the vision, we need to move boldly.
DR. MAYS: It is needed. Do we need to specify– I didn’t understand–
DR. CARR: Vigorous and bold action is needed.
DR. SCANLON: It can’t be the department. We’re not thinking that the public
sector is going to all of this by itself.
DR. CARR: Well, we’re giving it to Congress. It’s everybody, but if your
Congress–
DR. WARREN: I would say Congress. Congress needs to move boldly.
DR. SUAREZ: Is it Congress, the Department, or the healthcare industry? Or
all of it?
DR. SCANLON: I don’t think we want the public sector to do this. There is
too much intervention involved here. I think what we want is for the various
stakeholders including all the people in the private sector in healthcare to
recognize that it is in their interest to do a number of these things.
DR. CARR: Stakeholders need to move forward.
DR. FRANCIS: Why don’t we say of an aging population, the United States
needs, and that’s the broadest.
DR. CARR: Do we want to say stakeholders or do we want to leave it general,
the United States needs?
Ms. GREENBERG: I’d just say the US, the United States.
DR. CARR: Okay, a show of hands: how many people want stakeholders? Eight.
And how many people want to say the United States? Six. I think stakeholders
has prevailed.
MS. GREENBERG: I don’t like that at all. I’m sorry. I don’t know that I like
the US–
DR. CARR: Let’s leave that to the executive committee and underscore it as
an important point.
MS. GREENBERG: I would just say it’s necessary to move boldly and
vigorously, and leave it to question that this has to do with it.
MS. DOO: It is necessary. That works.
DR. SUAREZ: It is necessary to–
DR. TANG: I submitted my homework. I offered to come up with a title for
that first section about challenges. I’m just trying to create one with a
little bit more punch, and I suggested Incomplete Implementation of HIPAA Has
Threatened Reform of the Health System as the section title.
DR. CARR: So instead of saying challenges, we’re saying Incomplete
Implementation of HIPAA Threatens Reform of the Health System? I like that.
DR. TANG: It starts out with– it gives our proposition. A seamless, secure
exchange of health information is essential to improving the health of all
Americans and to reforming the system through which care is delivered, period.
Both the incomplete implementation of data standards contained in HIPAA and its
non-universal applicability to all participants threatens the success of health
reform, and then continue to explain that.
DR. CARR: So you’re suggesting that as the opening sentence. We currently
have, the achievement of the vision of seamless, electronic flow of information
in a confidential, secure manner has been slow.
DR. TANG: I’m just punching it up a bit. We’re trying to call– in this
pre-amble to our pre-amble we’re trying to– why is our commentary in 2011
important to moving forward? I’m just trying put that point out in front.
DR. CARR: Great, I have this language and I will give it to Walter and we
will finalize it in the executive subcommittee. I would like to now entertain a
motion to approve this report to Congress.
DR. FRANCIS: Could I see one thing? I gather there was a major addition in
the privacy section and I would like to quickly see that.
DR. SCANLON: Walter, could you scroll down to the privacy section?
DR. FRANCIS: I just want to be sure. I’m sorry, Justine.
DR. SCANLON: It’s the third bullet. At the same time, no assessment of how
this volume of complaints compares to the overall number of instances where
privacy may have been compromised has been made.
DR. FRANCIS: That’s fine.
DR. CARR: I’d like to entertain a motion to move this report forward.
DR. CHANDERRAJ: I make the motion to approve it.
DR. CARR: Thank you, Raj. And seconded by Mark. Any discussion? All in
favor? Any opposition? Abstentions?
(On motion duly made and seconded, the motion was unanimously approved.)
DR. CARR: Next up is the community health data initiative report.
Agenda Item: Community Health Data
Report
DR. GREEN: I move it be accepted. The report of the last 18 hours is that
with your robust participation yesterday, there were over a dozen improvements
proposed. They have been further sculpted a highly participatory subcommittee
meeting jointly with privacy and population. Susan, as of about 15 minutes ago,
has them all in their locations in the document. To my knowledge, there were no
requests for deletions. These are all improvements and additions to the report.
At the subcommittee meeting there were no objections to including them all,
so what you proposed yesterday basically has been done. There is continuing
work that we are delegating to Susan and deputizing her to do. I don’t believe
any dissent surfaced at the subcommittee meetings about something that we need
to bring back to adjudicate. Dr. Nichols was not here yesterday for good
reason. He studied the report also, and I would like to invite him to raise a
further issue.
DR. NICHOLS: Thank you, Larry. Let me just say, first of all, I apologize
for not being here yesterday. What essentially happened was a rather unique
opportunity. There were 4,000 clergy and a group of community organizing
think-tankers, who wanted me to come talk about how to talk about health reform
in various contexts. Some of you know this, that I have a riff from Leviticus
to covering all Americans that is kind of interesting to some people, so that’s
what was going on. Anyway, I apologize for missing.
I love the report. I think in general it does an incredible job of capturing
the energy coming from the communities and I love the theme of empowering them
in the recommendations. I also must say that I have never in my whole life
encountered a heading that has mathematics in it, which I love. Stewardship
plus privacy protection plus engagement plus governance equals trust. I think
we should note that somewhere as the first equational sub-title.
What struck me was in the spirit of empowering communities, I worried that
some of the language in explicitly three places might scare them out of doing
anything going forward. Let me point to, if you go to page four, at least what
was page four in what was mailed to us where it begins with the heading I love,
the last sentence. Significantly, an expert workshop participant reported his
findings that technical protections such as de-identification are inadequate to
assure the public that health data are being used appropriately. I wondered if
here and in two other places we might insert the phrase, in some cases, because
I worry that a newcomer or stranger or community thinking about this will read
this and say that they can’t move forward without getting what is recommended
on page 17, which is more– further efforts in leadership are needed. The real
kicker is on page 25 where the language reads; overarching finding of that
workshop was that approaches are not sufficient. I would like to insert in some
cases before each of those three so that people don’t conclude that there is no
safety in moving forward.
DR. GREEN: This strikes me as an excellent suggestion.
DR. FRANCIS: I would prefer “may not be sufficient”.
MS. GREENBERG: Isn’t it the technical protections alone, the technical
protections alone such as the identification are inadequate. It means you can’t
just rely on these technical protections. I thought that was really what they
were saying. You need to do other things within the community as well by
engaging them and having to assure people–
DR. HORNBROOK: Have we defined the identification somewhere before this so
people know what we’re talking about? If we mean just removal of the 18 PHI
elements then we should put that in.
DR. GREEN: The point that Dr. Nichols is asking us to accommodate is that
when he reads the whole report and takes it overall, his concern is that we
need to modify our assertions about these risks to say that this is important
in some cases, but it is not universal.
His point is that we have overreached in what we have stated a little bit in
a way that could actually damage the report. With your permission, since he’s
been able to be so specific about where he wants to make that point, I think we
give it back to Susan again. She can write the language that makes that point
but protects what is already there. Let’s approve that as a concept. He’s not
asking for a new paragraph or to redefine anything, he’s actually asking to
change one or two words or maybe insert those three words he proposed in a
couple of places that just make the point that it is not universal, to mitigate
that. Can we do that?
DR. FRANCIS: I actually have some trouble with thinking about it that way.
What that suggests is that there are going to be a limited set of contexts. We
did want to say something broader, which is that the current approach divides
the world into de-indentified HIPAA standard and non. We wanted to question
that. We got a lot of questioning of that. I’m fine with softening it, but what
I don’t want to do is come away with the suggestion by softening it that we
shouldn’t be rethinking the de-identification strategy. If we were to say, may
not be sufficient, I would be happy with that. Or, something like its
sufficiency or its adequacy depends on the context. I’d be fine with that. It’s
just that I do want to have the more general critique idea there.
DR. NICHOLS: I would certainly concur that I am not trying to elevate the
edification as a strategy that should be presumed to be sufficient. What I’m
reacting to is, and I think Larry described it adequately– I read the whole
thing on a plane, and in one sitting to someone who is modestly informed about
what communities are doing, it reads as if it may not be possible to do
anything because we have insufficient standards at the moment. I want to make
it clear that there are lots of cases in which you can use all fair claims
data, the community health data initiative kind of stuff. That’s quite
different. That’s really the empowerment that we’re trying to engender. The
specific granularity of getting down to a world in which you try to have
individual clinical data that had been de-identified in addition to other
layers of protection is on a separate, second-order thing.
DR. COHEN: I agree and I think there are two distinct points. I think Susan
can incorporate them both. One lends general concern about how strident we come
across in certain cases. That needs to be tempered. I think the point Leslie
makes, specifically with respect to the comment on page four around
de-identification, I think that needs to be put in context or toned down. I
think both of those things need to happen.
DR. HORNBROOK: I think the key issue here is whether you want to be teaching
as well as making recommendations. The issue here is that essentially we’re
getting privacy by herd privacy, that in any data set there are at least six
people that look identically like you on every single variable in that data
set. Even that, of course, is only a certain amount of privacy, because, of
course, if there’s enough known about you in public domain databases, they can
cross-reference and eventually figure out some way to identify the six people
you are.
As a data-holder, we’re very concerned at Kaiser about giving out data that
could be re-identified. The only way we do that is under IRB approval, privacy
board approval, and a contractual agreement with the data recipient that they
will use it only for the purposes for which they’re approved and then destroy
it. There isn’t free-floating data at the patient level out of Kaiser
Permanente because that’s not something that we have enough confidence that
doesn’t give us any business risk as well as risk to our patients.
DR. GREEN: Mark, I don’t hear Len’s suggestion disagreeing with that.
DR. HORNBROOK: I know. The question is when you talk about de-identification
and re-identification, are you comfortable that anybody who reads this will
know what in the world you are talking about? Or do you not care about it?
DR. MAYS: My point is, and I think that the way Bruce put it is exactly the
issue, it’s kind of like two different issues. The first one is the one where–
I think you have to have a lot more background as a community-person to really
appreciate the way in which it is written. I think what you need to do is maybe
a couple of more sentences so that it is clearer as to the complexity of what
you’re saying.
I think in terms of the other issues– you just don’t want this unintended
consequence. The community will walk away with thinking, I think, in terms of
the other two instances, that this is terrible. They will actually highlight
that and talk about that in the community meeting in ways in which you don’t
want. I think the first one can just be modified with just a couple of words
because I think it is a little technical.
DR. GREEN: Susan is nodding that she gets it. I would like to incorporate
this and just pretend that that discussion happened yesterday. I would
entertain a motion– a reminder, our plan for next steps with this that if the
committee will approve this today, Susan is then on a very short timeline to
actually rewrite the report and incorporating all of the input in the next
10-14 days at which point it will be taken to the executive subcommittee for a
review to see if it has been faithful to the discussion. It will then be
published. That is our plan. Is anyone prepared to move that we adopt this?
DR. CARR: Discussion? All in favor? Any opposed? Any abstentions?
(On motion duly made and seconded, the motion was unanimously approved.)
DR. CARR: I would actually like to bring up something that Linda began a
conversation about last night, which is our dissemination of our work products.
I just want to review, Linda, some of the ways that we might begin to think
about new ways to think about our dissemination.
MS. KLOSS: I think that we’ve certainly finalized some important work this
morning and thought that a process the committee might want to follow as we
move these projects along is to think through a communication plan or a
dissemination plan a little more formally and tie it, certainly, to the subject
of the document using all the vehicles, electronic dissemination, press
release, even in certain instances a press conference. I think that these
documents are worthy of that, and we all know how much noise it takes to get
attention paid to work product. A process might begin to be designed to work
through this very deliberately for each document.
DR. GREEN: I just want to say that if we think about the future work plans
where we’re about to go to next, the population subcommittee would be very
pleased to use this report, if you will, as a sort of case example. We would
make this a priority for our subcommittee to focus on dissemination of the
report in the immediate future as a next step for us. We’d welcome this and
would like to do it.
DR. TANG: I think what Linda proposes is an excellent thought. I’m thinking
of an accompanying proposal. In a sense, what you’re saying is that we need to
find ways, mechanisms, to get this more visible, to have a greater impact. One
way is to make it more publicly acceptable. Certainly, I don’t know that all of
our reports are acceptable to everyone who reads it. The other is to make sure,
or at least to look out for ways that dovetails with trains that are already
moving. If we are more deliberate about where the linkages are and what the
timeline requirements of those linkages are, I think that would also increase
our impact factor.
MS. KLOSS: A specific action suggestion I made is that we develop a template
for a communication plan that each of the subcommittees can be developing as
they are developing a work product. I said I would take a first cut at
preparing that. I do believe that the report to Congress also should go through
this process. I think there is so much insightful meat in that report that
needs to get out.
DR. CARR: For those of us who were at the 60th anniversary, John Lumpkin,
one of our former chairs made this very point. Our work is not out there in the
way– for example the FACAs at ONC. ONC has really been able to push
information out there. I think Paul and Walter your experience there would be
helpful for us to get it out there. I do think these two reports are very, very
important. You mentioned, I don’t know if you were serious or not, a press
conference. Is that ever anything that we would do?
MR. SCANLON: Well, we better check. That is not something that most advisory
committees do on their own.
DR. TANG: But in a sense, part of it is– just given title, it’s amazing.
It’s part of this release that the IOM report on EHR safety, and the titles go
over the place, but I just saw that it’s on the front page of Modern
Healthcare. The cover story I think is called Computers Kill. That wasn’t
really the intent.
MR. SCANLON: It is a double-edged sword. There are people who worry about
these health IT initiatives in medical records moving around. Let us see what
we can do.
DR. CARR: There is a lot that we can do with identifying the stakeholder
groups who need to be hearing about this. We were kind of shocked to here that
many people at NAHDO knew nothing about what the committee does. That should
not be.
MS. GREENBERG: It’s indicated what the committee does do once they heard
about it is very helpful to them, or could be.
DR. GREEN: One detail, do we have a date we’re working towards to post the
report on our own website?
DR. CARR: I would say two weeks for both of these.
DR. GREEN: Once it’s in the public domain on the website, then people can do
with it whatever they want to do with it.
MS. GREENBERG: We’ve got to get them finalized with the executive
subcommittee. Then we will send it to the appropriate parties. I think we don’t
feel it is appropriate to put it on the website before the people that it is
going to receive it.
MR. SCANLON: We give them the courtesy– these are the chairmen of the
various committees in Congress that receive the report. We give them the
courtesy of–
MS. GREENBERG: We could be fine if they were finalized today, but given some
of the–
DR. CARR: But the community health initiative report, we talked about two
weeks until Susan’s done.
DR. SUAREZ: If the committee has an issue to report, who is it going to? Is
it to the secretary? The HIPAA report is going to the chairs, to Congress.
MR. SCANLON: It goes to Congress. That’s a report to Congress. We’ll
probably send them around to HHS as well. I think the community data report is
probably– the committee could post it just as a– I think it would be–
MS. GREENBERG: Except for the HIPAA report to Congress, everything goes to
the secretary. We’ll send it to you–
MR. SCANLON: Just courtesy that we allow the recipient– we don’t make them
public at the same time, otherwise the secretary gets calls and she hasn’t even
seen it. But not much time.
MS. GREENBERG: Certainly before Christmas we want these out.
DR. FRANCIS: I was just going to say there is a very important date thing
here. You really don’t want it out December 22. You want it out either December
8-15 or January.
MS. GREENBERG: I don’t think we want to hold it until after the first of the
year. We’ll do our best to get these finalized and then to get them out. I
welcome Linda’s offer to work on this dissemination. Tout ça change,
tout le même chose. This of course has been a continuing issue, as it is
for any organization that produces things.
DR. CARR: This will be a standing part of our meetings when we have the
report out from the committees, the dissemination.
MS. GREENBERG: We actually have a subcommittee?
DR. CARR: A work group. A dissemination work group.
MS. GREENBERG: Also, I think I can probably offer some of Susan’s time to
work with you. You have prepared things in the past about dissemination
strategies. Could you, Susan, send Linda whatever you’ve done and also Susan
could put a little time into this, too, because it’s certainly something she
has–
DR. CARR: We’ll work on the details offline. I want to hear from Vickie and
Leslie and then I want to hear the report outs from the committees.
DR. MAYS: One of the things I was going to suggest is two individuals who I
think once this is going to the secretary would want to carry this would be the
Surgeon General, Regina Benjamin, for the community one. Then if you can find
Howard Koh, I think once it gets in their hands once it’s at secretary, they
will–
MR. SCANLON: We’ll take care of it within HHS once you send it. We’ll get it
to those people and the agency heads and we’ll distribute it generally.
MS. GREENBERG: If you have people or organizations, send them all to Linda
or Debbie.
DR. CARR: Linda, closing? I think I wrote Linda and said Leslie. Did you
have a– you’re done? Now, I’d like to hear report outs from each committee.
Let’s start with Quality.
Agenda Item: Subcommittee Report outs, Strategic
Plans & Next Steps
DR. MIDDLETON: Well, we had a productive meeting of the Quality Committee
and welcome to the new members again. Paul was on the phone, so it was nice to
have him as well. Basically what we did is to review the NAHDO presentation
summarizing the quality activities over the past decade and used that as a
springboard to talk about the next decade or future work of interest.
We generated a wide ranging discussion a number of issues impacting quality
assessment and measurement and thought hard about how to predict where the puck
needs to be with respect to quality work and make sure our efforts, in that
regard, fit into a quality measurement and policy development opportunity. Paul
Tang outlined the upcoming meaningful use policy development and the impending
notice for proposed rule-making in 2013 and suggested that in the fall of 2012,
if we had output from the Quality Committee, that would be the most opportune
time to deliver it.
We talked about the million hearts campaign idea for cardiovascular quality
assessment and the measurement lifecycle development. We talked also a lot
about preference sensitive and patient-derived or person-derived measures of
quality and decided actually to go in a slightly different direction than what
had been written up in the million hearts measurement lifecycle idea. We are
going to pursue hearings around the topic of preference based individualization
of quality of measurement, thinking that that is the most relevant thing to
impending preference based quality and meaningful use incentives and whatnot as
well as the movement of quality assessment much more towards the individual and
builds upon our last letter which called out the person centered measures as
really the way to go.
There are lots of ideas around what this hearing might cover in terms of
preference-weighted health status measures, functional status assessments, the
notion of a health or quality credit score, how to use these measures in
assessing health value and production and the like. Provocative members of the
committee including Mark Hornbrook and Larry agreed to write up some draft
questions we would ask of presenters and we will meet on Tuesday via phone to
try to finalize our plan and direction here and then begin in earnest, planning
for late February hearings or hopefully in that timeframe.
This obviously dovetails and builds upon population committee work and we
didn’t talk through enough of whether or not these could even potentially be
joint hearings or whether or not we wanted to proceed just as Quality
Subcommittee hearings. We were ably assisted by John White who filled in for
Matt Quinn who was not available. Let me ask any members of the committee if I
forgot or misrepresented anything.
DR. CARR: The title of the hearing then is?
DR. MIDDLETON: This is a working title, but it is called preference-based
individualization of quality measurement.
DR. TANG: If I might tease that out just a bit. The individualized is
looking at– part of the issues what we talked about were the disparities, part
of it was just how you align the intrinsic incentives for a position to work on
each person not just worry about the population averages and just the measures
that matter to patients. The concept of individualized means that the position
or the person gets quote, credit, for making improvements for each person
whether you have an A1C of 8 or an A1C of 10, both of them can improve and
improving those two individuals is what we’re after and what we want to align
the clinicians to do.
That’s some of the thoughts behind that, and then also it works on
disparities. The other one was the preference, and that’s the preference of the
individual patient. We’re focusing a lot more on individuals and the things
that matter to them like functional status. We realize that these are concepts
that are being talked about in other quality circles, but we weren’t aware that
people were actually moving it forward. There is a contract out from HHS to
have people work on these, but in terms of one of the things that we thought
would be helpful is a commissioned paper if we knew the appropriate experts to
build our knowledge about these individualized quality measures.
DR. CARR: Vickie, did you have a question?
DR. MAYS: It’s like behavioral economics. It’s really great.
DR. MIDDLETON: We did also talk about ICD-10 and I think that’s an important
and interesting area for us to deliberate upon, but we thought this was more
opportunity for this next phase.
DR. CARR: So Marjorie, we’ll have a presentation on ICD-10, or Lorraine,
particularly with regard to the impact on quality measures and who is working
on it and what should we be thinking about. Mark?
DR. HORNBROOK: Just an editorial question, we often shorten ICD-10CM,
ICD-9CM to ICD-9 and ICD-10. We’ve already implemented ICD-10 for death coding.
Let’s keep that in mind. When you say ICD-10 being implemented, somebody is
going to say aren’t we doing death coding. Yes, we are. The CM is the critical
distinction, to me at least.
MS. GREENBERG: That’s why I always refer to them as ICD-10 code sets because
it’s CM, and then PCS which has nothing to do with ICD-10 except that it is
coming along with it. It has no international basis.
DR. HORNBROOK: It is the procedural codes that go with hospital services.
MS. GREENBERG: I have notes from yesterday that are as broad as wanting to
potentially hear from every stakeholder whom ICD-10 code sets will impact to
now this more– which, of course had to be narrowed– but now to this specific
focus related to quality. We’re talking about the March 1-2 meeting. I thought
you wanted to hear more generally about some of the transition issues related
to data use, but we can– again, it’s going to focus on quality of care. That
would be more CMS, AHRQ–
DR. CARR: We talked about MQF and the role they are potentially going to
play.
MS. GREENBERG: –those organizations. Mark raised some issues. It was an
email going between the three of us, I think, that went beyond that also. We
will put together whatever you want, but I want to know whether the focus is
specifically quality or something broader.
DR. CARR: I think that it will inform as Blackford said, that may be
something that the quality subcommittee wants to pursue. I think that when we
understand this it will go a little bit in depth as opposed to the overview.
That would be my recommendation. I see two people raising hands, Judy?
DR. WARREN: I just need clarity on what is meant by ICD-10 and quality. When
we’re looking at quality, are we looking at ICD-10?
MS. GREENBERG: How the transition to the ICD-10 code sets will affect the
data available for quality assessment.
DR. WARREN: The question then is, are we looking at the impact of the change
in the organization to go to this, and that is the issue, or are we looking at
it as a code set to capture the data for quality? To me, those are two very
different–
DR. CARR: What I say might be a third thing, but today, we have lots of
trended data of how individual hospitals or organizations or nationally, how
we’re performing. Take for example how the patient safety indicators or the
IQI–
DR. WARREN: So it is the bridging between ICD-9 and 10–
DR. CARR: Right, so those codes will not map– they will map, but they’ll be
different. The trended data may change because of code usage or specificity.
One question is how does that mapping go, so that when IQI or patient safety
indicators are reported, which has been part of the value-based purchasing with
the IQI, what will happen? How will we navigate through that? Who’s thinking
about it? What are the gaps? What needs to be done? Who is doing the mapping? I
would say that, and then add that it has many children and grandchildren. All
of that is used in an array of performance–
DR. WARREN: I think we muddy the waters when we say who’s doing the mapping
because you’re going from a code set that has these characteristics to a code
set that has these characteristics. What we need to do is manage the transition
between the reporting periods. You’re going to have a disconnect there. It’s
not a mapping issue. It’s a moving from one to the other. Am I getting that
right, Linda?
MS. KLOSS: Well, I heard a broader discussion yesterday also. What I wrote
down was that planning for the use of ICD-10 coded data as a starting point,
and perhaps CMS has done work in this area, but beginning to get some thinking
going about making use of the opportunities. I did not see it as looking at
mapping or some of the mechanicals. It’s planning for use.
DR. CARR: I agree. Those are both important. Are there other suggestions?
Bruce.
DR. COHEN: I see two pieces of this. With the new depth of the codes, are
there things we can do that we haven’t been able to do in the past? The other
piece is when ICD-10 was adopted for mortality, there were comparability ratios
developed that allowed for trends. The second piece, is there ongoing work
around CM that will allow us to continue to think about how to do trend data,
and if not, should there be and how would that work? It’s a historical look at
the use of clinical information over time as well as potential new applications
because of philosophical and conceptual change in how codes should be recorded.
Both of those are important.
DR. CARR: I don’t know if this is what you meant, but aggregators of data
who have risk-adjustment methodologies also incorporate all of these. That
would be impacted as well.
DR. SUAREZ: My question is really– this is a hearing I suppose.
DR. CARR: No, an update–
MS. GREENBERG: Which could lead to–
DR. SUAREZ: An update being done by the committee or an update being
presented to the committee?
DR. CARR: No, we’ll get a report from CMS–
MS. GREENBERG: And NCHS.
DR. CARR: — and NCHS and HIQ. I guess what I am wondering is, are we
planning for this?
MS. GREENBERG: We’re trying.
DR. SUAREZ: This is an update to the full committee, and update to the– not
the quality committee, but the full committee?
MS. GREENBERG: It is an update to the full committee, which could raise
issues that one subcommittee or another might want to pursue more, but it is,
right, an update to the full committee?
DR. CARR: If you want to broaden it, that’s okay. We are changing languages
and we have different words and different things, and at the end of the day
there is a story that needs to get out about what gets better–
DR. SUAREZ: My question is really whether the department has enough
information to provide an update on the challenges of using the new codes in
data analysis. In other words, there are researchers, there are centers for
research, there are data organizations that– the ones that have to use the
code set and do all of the transitioning and all that– to what extent there is
information ready from them about all the challenges and issues around this? Is
the department going to talk about those challenges, about the status of the
ICD-10 transition, or– I’m just trying to understand what–
DR. CARR: Let her speak, go ahead Mark and then Paul.
DR. HORNBROOK: I mean the developers of ICD-10 and then the CM part of it,
had certain decisions they made to classify, create a taxonomy of disease they
thought was important to recognize. They are breaking diseases apart. They are
introducing brand new disease entities and they may be obsoleting some diseases
that have now been redefined as something else, or recombined. This whole
diagnostic space is inherent framework for defining health problems and
defining how we frame medical interventions. Physicians should work off of a
diagnostic hypothesis, not just random assessment of the patients.
To me, it’s integral to quality assurance. If the taxonomy gets better, more
accurate, more modern with what science knows about disease and about health
problems and about the interactions between behavior and body functions and
physiology structures, we ought to know that. It ought to be in our quality
assurance algorithms. There is something about ICD-10 that has really high
priorities. There are some disease domains that they’ve really made some
dramatic changes with and I’d like to know what those are.
DR. SUAREZ: Those are already known. 70 percent of the changes were in
orthopedics, for example, and laterology. There is already a comprehensive
description of the changes done to the ICD-10 and the areas most impacted by
the change and all of those things are already– so I’m just trying to
understand–
DR. CARR: So, are you–
DR. HORNBROOK: So there is a downstream implication for that. We’re
responsible for making sure that it happens.
DR. CARR: Paul, last comment, and then we need to get onto the
subcommittees.
DR. TANG: I have a question. What about the use of SNOMED in quality
reporting?
DR. CARR: I’m hearing a number of important concepts, and I think the
executive subcommittee at our next meeting will decide how to incorporate this.
Paul, thank you for bringing that up, as well. I want to move now to the next
subcommittee report. Leslie?
DR. FRANCIS: So this is for Linda and myself. We had a first joint meeting
with populations. Then we heard from Maya an absolutely wonderful where have we
come from and where might we go slide deck, which if the full committee would
like we can actually send around. Based on that and on the earlier committee
discussions, we had put together a somewhat longer list of issues categorized
by issues raised by the HIPAA report of unfinished business there that is
particularly related to our subcommittee, issues raised in the community health
data initiative report that are uniquely related to our committee, and issues
raised by Jim’s presentation yesterday from the department.
Just to give you examples of those, from the HIPAA report, consider the
question of data and compliance and enforcement. From the community health
data, consider the question of privacy standards for aggregate data rather than
just individual data. From your report, consider the release of small area data
and the kinds of privacy questions raised there. We went around the committee
and we all called out issues that were of most importance to us. We have a list
that Linda and Maya and I are going to prioritize based on timeliness,
doability, and punch importance. We will send that around.
DR. CARR: Excellent, thank you. Populations?
MS. MILAM: Like Privacy, we met in a joint meeting and we also had not quite
a separate meeting. I think we remained together pretty much for the afternoon,
which is terrific. I’ll start first with some remarks about the hearing that we
think we’re going to be holding at the end of January. The current week that we
have slated for the socioeconomic status and position hearing isn’t working for
all of the schedules. We’re going to look at some additional dates, either
earlier in January or perhaps a little bit later in February.
Vickie Mays has agreed to chair the hearing and she is going to work closely
with Susan Queen and others. We define the scope of the hearing, some work to
do ahead of time. After getting the hearing scheduled our next steps pretty
quickly are going to be to line up the panel, figure out exactly who we need to
hear from and get those people locked in. We anticipate giving feedback to
Vickie through email and working through the issues around the panel that way.
Vickie recommended a teleconference of populations the first week after
Thanksgiving. We thought we could go ahead and get some help in getting that
scheduled so we can get that on our books. That call will focus on the content
in terms of the questions of the hearing, so that we can get those questions
out to the participants. Vickie, Larry, did I miss anything?
Also, we focused on the CHIP Report with privacy and I want to first start
with thanking Susan Kanaan. Let’s give Susan a round of applause. The report,
as you all know, is beautifully written. It brings to life the excitement and
energy and good work of those committees, but that’s not all that Susan did.
Susan helped shape the workshops. She wrote the questions. She interviewed
everyone ahead of time. She helped us figure out what was important. Susan
really did everything from start to finish and let us just give some input
along the way. It has been a fabulous project from start to finish, and I want
to thank you, Susan. You’ve really made it for us.
Now, we’d like to talk about next steps. An idea that came from both
Marjorie and Walter, due to the crosscutting nature of the recommendations in
CHIP that impact populations, standards, privacy, and maybe quality. It would
be to have a retreat. Because we have so many issues coming out of it, Walter
and Marjorie recommended that we actually prioritize where do we start, what
should our next steps be. I wanted to throw this out to the group for
discussion. Should there be a full committee retreat around the CHIP report to
discuss next steps and to figure out where we go next?
DR. SUAREZ: On the last point, I think we have been trying to plan a
committee retreat for several months. I think it would be worth to actually
have a retreat that goes beyond the CHIP report and basically talk about all
the things that we’ve been talking about today, HIPAA and the future, all these
aspects. I think it’s a great opportunity. We have now full membership in the
committee. I think it’s a great opportunity to do it.
DR. CARR: Excellent idea. We’ll take that up also at the Executive
Subcommittee. Walter and Judy.
DR. SUAREZ: You know our story. Our future of the subcommittees on page 31
of our HIPAA report. We certainly went through the planning and development of
the HIPAA report and all the other activities. We have certainly discussed a
line-up of all the things that we need to do coming up, and I have a list here.
We didn’t have a chance to discuss it during this morning’s meeting of the
subcommittee, but it’s basically our standard set of activities that we have.
Starting with the implementation-monitoring role that we have, so next year
is going to start 50-10, D.0, 3.0,. The new transaction standards are going to
start. There is going to be continued rumblings and continued talk about ICD-10
and the preparation toward ICD-10.
One of the activities that we will need to do, as we regularly do it, is a
monitoring of implementation of those. Probably some time in mid to next year a
hearing around how the implementation of ICD-10 D.0 3.0 going, and how are we
going with respect to planning for ICD-10. That’s one core activity that we
usually have.
There is also, along the line of preparation, there is also the preparation
of what would be the implementation of the health plan ID, which is scheduled
based on the pending rules sometime next year, and the operating rules for
eligibility and claim status, which start January of 2013. There are a number
of things that are coming up and we want to hear from the industry how things
are evolving with respect the transactions that are implemented next year and
the upcoming ones the following year.
The 2012 fiscal report is another big activity that we always receive. A lot
of discussion about the improvement process and all the improvements that we
need to work on with respect to the maintenance of the standards, so that is
going to continue to be a topic for us certainly through the report from the
fiscal as well as the additional work that we will be doing. We will continue
to make progress on that arena. I hate to say it, but we will need to prepare
for the 11th HIPAA report on Congress, so we’ll start tomorrow on that.
We’ll continue to identify and recommend, these are a couple of other areas,
we need to identify and make recommendations probably sometime next year on the
authoring entities for the operating rules for the remaining transactions,
claim, enrollment, premium payment, so that there is a better timing for the
development of those operating rules. We were so short in time in terms of
recommending an authoring entity and then having the authoring entity come back
with recommended operating rules. This time we want to work in better timing.
One major area that we have been discussing and we haven’t fleshed out all
the details is the whole area of public health data standards. We mentioned
that yesterday, but this is sort of thinking beyond HIPAA and thinking beyond
the Affordable Care Act and the new priority. It’s really– we’re NCVHS, we’re
the national committee advising on public health in some respects, and public
health data standards are a major component. I think that’s what we hope will
be one new major area of activity for our committee.
Then there are new areas of standardization beyond section 10109 that we
highlighted, actually, in our HIPAA report to Congress. For example, the first
report of injury, a transaction that was named under HIPAA, we haven’t yet
taken any action on. We mentioned electronic signature standards, meta-data
standards. Work with the other subcommittees, for example, Privacy and
Security, on e-consent and the whole meta-data standards as well, standards
around personal health records that we mentioned yesterday, and then standards
for things like socioeconomic and demographic data to support analyses and
studies, including things relating to health disparity, this in partnership,
for example, with population health.
There is an array of topics that we haven’t really finished up sorting out,
but we will be doing that, and probably by the time we get to the retreat, we
hope to have a better alignment of that. Judy and Lorraine?
DR. HORNBROOK: One of the things we talked about last night at dinner is
meta tagging. As we get into more sophisticated data sharing, other pressures
of giving communities more information on the health of their members, you are
going to want to know who’s using the data for what purpose and if it shows up
in an unapproved way. As Judy told us, you can put meta-tags on so it
identifies where that data came from and when it shows up in a place that it
shouldn’t show up, you’ve got proof that something happened that was not
approved. I don’t know whether you want to begin to think about these kinds of
balancing forces of improving access, giving communities more power to use
data, at the same time recognizing that they need privacy protection for their
own individuals inside their community, especially the vulnerable people. You
can only go so far in having community good will protect an individual from
having social shunning, bad jokes, or bullying going on inside their websites
or Facebook or whatever.
DR. SUAREZ: You pointed out that we all know that ONC published an advance
notice on meta-data as a proposed rule. There is the expectation of course that
there will be an actual notice of a proposed rule coming out that incorporates
a lot of the comments made even though some of the comments were to withhold
the issuance of an operating open notice of proposed rule on meta-data because
the industry might not be ready. Regardless of that, there is probably going to
be something coming out on meta-data sometime next year, maybe even late this
year, as proposed regulations. There will certainly be another opportunity to
look at this topic.
DR. HORNBROOK: The movie industry knows how to turn off your access when you
borrow something for a week and then all of the sudden it expires and you can’t
watch it anymore. If you have a year’s expiration date on your data set it then
goes away after a year.
DR. CARR: Vickie, final comment.
DR. MAYS: One of the things that we talked about last night was also this
issue of making data available to the community and realized that many of us
have the responsibility to do this but don’t have any guidance, and I’m
wondering if we can begin to talk about that. The kinds of ways in which there
is software in the domain, to incentivize the software makers, to try to figure
out ways in which we can do this without a lot of costs.
As I pointed out, all of us that have NIH grants over half a million dollars
have to put our data out for the public to use and we don’t have any guidance.
DR. CARR: Excellent point. I think, given our time constraints, it is time
to adjourn. I want to thank everybody for yet another incredibly productive
session, so safe travels and good luck on the standards hearings.
(Whereupon, at 12:05, the meeting was adjourned)