[This Transcript is Unedited]

National Committee on Vital and Health Statistics

Subcommittee on Standards

Administrative Transactions Standards, Code Sets

And Operating Rules Industry Status of Planning, Transitioning and
Implementation

June 18, 2013

National Center for Health Statistics
3311 Toledo Road
Hyattsville, MD 20782

CONTENTS

P R O C E E
D I N G S

Agenda Item: Welcome and Introductions

DR. SUAREZ: Welcome everyone to our second day of the Standards Subcommittee
meeting. As I said yesterday at the beginning, this annual here is pretty much
a hearing we hold annually around this time of the year to take a pulse of
where things are in the industry with respect to implementation of the various
standards under HIPAA and the Affordable Care Act. So this really serves as an
advisory committee to the Secretary to take not on how things are evolving with
the standards and make recommendations back to the Secretary about existing
standards at certain points and into the future, certainly evaluate and
recommend changes in the standards, whether it is the next version of standards
or things like that.

So this is part of what has been what has been called for in the Affordable
Care Act, an ongoing review process, periodic review process of the evolution
of standards and adoption and implementation of those that they need to update.

So we are very pleased to start this second day with a couple of major
topics. We are really going to focus this morning on two topics. One is
development and implementation of operating rules, and the second topic is
ICD-10, both in term of preparation and implementation as well as some new
areas of opportunities and applications of ICD-10 in relationship to other
components of the many things that are happening in the industry with respect
to coding and vocabulary and terminology.

I don’t think we want to do a review of yesterdays many excellent points
that we heard in testimony. I think it was a really great way to set the stage.
We focused primarily of course on the status of 5010 and D.0 and regulatory
update. But across the board and perhaps one interesting point that we heard
yesterday was the importance of really for organizations, as they begin to
transition to ICD-10, to begin moving from the existing 4010 – some of the
organizations are still 4010 organizations – and they certainly rely on
their vendors to perform the transition, if you will, the translation of the
4010 to 5010, which is perfectly permitted in the regulation organizations.

That’s the main purpose of health care clearinghouses, but what we heard
yesterday was the reality when ICD-10 hits, that is really not going to be a
possibility, the reliance of an external vendor to perform any upcoding or
downcoding, as they refer to it, from ICD-9 to ICD-10 and backwards, is not
going to be really something that can be outsourced. It is something that has
to be done by the organizations and in order to do that the organizations have
to move really to 5010. So that was a very salient point I heard yesterday.

In any case, we are going to move ahead with the agenda for today and the
first thing we are going to do is introduce all of us here. We will start with
the members of the committee and then we will go to the public and invited
testifiers.

I will start — my name is Walter Suarez. I am a member of the National
Committee and co-chair of the Standards Subcommittee. I do not have any
conflicts.

PARTICIPANT: Good morning. I am Ob Soonthornsima, Blue Cross Blue Shield of
Louisiana, co-chair of the Standards Committee and member of the full
committee. No conflicts.

MS. KLOSS: Linda Kloss, member of the subcommittee, member of the full
committee and co-chair of the Privacy, Confidentiality, and Security
Subcommittee. No conflicts.

MS. GLOSS: Alexandra Goss. I am a member of the Standards Subcommittee, the
full committee and I have no conflicts.

DR. GREEN: Larry Green, University of Colorado, Denver. I am a member of the
full committee, not a member of any subcommittee, and no conflicts.

MR. SORACE: Jim Sorace, ASPE staff to the subcommittee. No conflicts.

MS. FARRAR: Good morning. I am Kamahanahokulani Farrar for Lorraine Doo. I
have no conflicts.

MS. WILLIAMSON: Michelle Williamson, CDC’s National Center for Health
Statistics and staff to the subcommittee.

MS. GREENBERG: Good morning. I am Marjorie Greenberg from the National
Center for Health Statistics, CDC and executive secretary to the committee.

MS. PICKETT: Good morning. Donna Pickett, National Center for Health
Statistics, CDC, staff to the subcommittee.

MS. BEBEE: Good morning. Susie Bebee Office of the Assistant Secretary for
Planning and Evaluation. I am staff to the subcommittee.

(Introductions around the room)

DR. SUAREZ: Thank you. I do not know if we have any people on the phone.

MS. HOLLAND: This is Priscilla Holland of NCAHO.

DR. SUAREZ: Thank you. Anybody else? Thank you again. We also are
broadcasting this on WebEx. For those that are listening and watching on the
WebEx, we will try to make sure that as people speak if they can identify
themselves for the benefit of those that are listening and we appreciate that.

We will start the first panel this morning on operating rules. We have
several testifiers. I think we are going to go in the order that is in the
agenda. We ask testifiers to limit their comments to about eight minutes or so
so that we have time at the end for questions from the committee members. I
think we have two signs here, three signs. One is a five-minute mark. You will
see the yield. At the one-minute mark, you will see this elegant person, and
then you will see the end at the end of the remarks.

Let’s start.

Agenda Item: State of Development and Implementation
of Operating Rules

MS. LOHSE: Good morning. Good morning and thank you for inviting us. We are
here to testify about the status of the operating rules and I am Gwen Lohse,
managing director of CAQH CORE. My presentation is detailed so I am just going
to go through the very highlights and then you can use the written testimony as
you see fit afterwards. We are obviously available for questions. Hopefully all
the detail is useful.

As you can see, the overview is going into the rules, the specific rules and
then industry wide and then some next steps for CAQH CORE based on lessons
learned, and then also the industry at large since we are all working together
on this.

Three things to kind of take away as you think about this. We spent a lot of
time in the last little while to support implementation. A lot of the findings
are around that support of implementation.

And then secondly there are a lot of other people at the table that are not
in the room. I think we all are more familiar than a lot of other people that
are not directly involved. How do we think about those that are not as directly
involved, because all their involvement is essential to the process. And then
what are the lessons learned that we actually act on to move the needle?

With that said, I had talked about – we had done a lot of work since
last time we testified – build awareness, support implementation, ongoing
maintenance and future operating rules development. So all of this is obviously
an integrated model and we put that in the back because without each of the
steps you really cannot get to the full adoption and the aims that we are
talking about here — convergence, efficiency, all of the things you’re
mentioning in your larger report.

There are a few slides on four and five. I am not going to go into these in
detail. These are just a reminder about what are actually the operating rules
that we have in the market, and they do data content as well as infrastructure.
So as you think about this, this is more data in the market and then also
infrastructure across all of the transactions.

As we think about this the alignment with the operating rule author and the
SDOs are essential, so we have been spending a lot of time on really working
with the SDOs, both with ANSI X12 and NACHA. You will see also for the second
set, the EFT and ERA, that NACHA, the EFT, is a new transaction. They have been
good partners, but we have a lot more work to do as the industry gets more
familiar with that standard.

So as we think about next steps, really the HIPAA-covered entities are going
through a set of steps to get to implementation, so what we are doing as the
author is looking at each of those steps to see how can we coordinate with
others, how can we also create implementation tools to assist, and how can we
track and see what value is each of the tools offering and each of the steps
offering?

So if you think about eligibility and claims status, more people are towards
the end of the arrow, or they have challenges so they are not at the end of the
arrow. And the deadline was obviously January, delayed until March.

EFT and ERA, people are right in the middle. So as I go through kind of
findings by rule specific we can think about where people are in that arrow.
Then alignment obviously, as we are working with the SDOs is critical, and you
will see, for instance, we have a public webinar on June 24th with
ANSI CAQH Core and ASC-X12.

So this is just a lot of detail, to give you a sense of where am I getting
my information, and across the board there has been a lot more interest. There
are 12,000 people who have attended all of the education sessions. There is
more participation, more coordination. So we are looking across the board how
to get more people involved.

For the first set of rules the resources are really tight, the technical
resources. Trading partner coordination is really critical. It is a challenge,
and you will hear about that more today. And some people are looking at the
enforcement and not the value, especially with the health plans that need to do
certification.

For the second set of rules you have different challenges by stakeholder and
some underlying knowledge with the standards, especially around the CARCs and
the RARCs that are challenging.

Also the enrollment rules – I think you will remember EFT/ERA they have
enrollment. People need to learn about each of the data elements within those
enrollment rules. So that is again learning – NPI, tax, how do you use
that? Then simultaneous priorities.

As we are thinking about the challenges this is what we are talking about.
This is a huge change. We are going from thousands of codes down to actual sets
of code combinations. This isn’t an easy job for those that are implementing or
the author. So this is going to take a little while, and that is why there is
so much maintenance going on. And there are code committee that are aligning
with the effort and also a task group that is co-chaired by four different CAQH
co-chairs that are multi-stakeholder.

So the same benefits and challenges are really the same rules. So it is no
pain, no gain. I think we have all heard that before. So those things that are
beneficial are also the most challenging.

What is going on at the industry level challenge? We have heard these things
before, but we have a challenge with those practice management systems that are
not HIPAA-covered entities. The providers need them. They don’t have an
incentive to adopt. We also have a need for a coordinated network in education,
and then additionally resources.

For instance, some of the Medicaid’s are having challenges, some of them
have adopted, so they have reached those who have resource challenges, and
Medicare has been great. They have actually been one of the first entities that
have come up with a deadline for the CARCs and the RARCs. So across the board
that is positive.

With regard to governance I think we had updated you that we were going to
update our governance. That has happened. The CIO for CHRISTUS is now the CORE
chair. And I apologize – I am going through this fast. We thought we had
12 minutes.

The third set of mandated operating rules. Those are on board. We have done
a lot of surveying. There is a lot more that needs to be done with regard to
education about what can actually be included in a regulation. There is
interest in putting rules on employers and practice management systems, and
obviously that can’t be part. And there is also a lot of interest in insuring
the language. The third set of rules allows for an ongoing maintenance, similar
to what the CARC and the RARC did in the EFT and ERA enrollment rules.

So what are the recommendations as we are moving forward? The next steps
– we are working a lot on further awareness. How do we work with other
entities? We are also aligning with the standards setting bodies. Some of the
rule requirements can actually move into the next version of the standards. And
how do we use tools – the web – to announce the groups to get more
involvement? CARC and RARC, the maintenance committee, has met 12 times.

For the NCVHS, we also hope that you all will seek a set of recommendations
from other authors about how to do their implementation and then look at things
like Medicare and Medicaid to have their adoptions highlighted.

So with that, just concluding, this is an essential part of health reform.
CAQH CORE has made some great progress about demonstrating that there can be
evolution with all these different steps and coordination. And we are looking
forward to applying those lessons learned into the third set of rules now that
we have so much feedback from the industry.

DR. SUAREZ: Thank you. The main goal is really to hear the base of your
testimony, but then have a lot of time for interaction. So thank you for that.

I think we go to Tammy.

MS. BANKS: Thank you for the opportunity to comment and we will be
submitting our testimony later and do other priorities at the time, not that
this isn’t the ultimate priority.

The question that is always raised is what about the rate of physicians
adoption for standards and operating rules? We went out and discussed with all
different sized practices, where they were at, and we got a mixed bag of
responses. So I could not even give you one clear-cut answer why there is not
physician adoption. But what we were able to confirm was that those who have an
automated solution that integrates the operating rules within their workflows,
they are receiving the value. While those who have stand alone solutions appear
not to be receiving value.

We also found that practice size really impacts technology use and thus the
likelihood of using operating rules. To give you a little example, we talked to
a vendor who specializes in helping smaller practices. They have a standalone
solution for eligibility verification. However, they are not getting adoption
and we are like, why? The reasons we received was, one, there is a cost
obviously for the additional module, because when you send an eligibility
transaction, again, think standalone module, you are going to pay six cents to
twenty-five cents for each transaction, or they are going to have a bulk rate,
because again you need to go through the different intermediaries to get from
point A to point B, and unfortunately there is a cost associated with that.

They are also not sure how to use the additional information. There really
has not been education to the physicians; much as we have we have tried to get
the education to the physician. How do you use the information? It is not
integrated in their workflow so they know where to use it and how to use it and
some payers prohibit the collection of anything but the co-pay, so that is kind
of a cursor not to adopt.

Some practice staff, especially the smaller practices, they are using the
web portals because it is at no cost. It is very inefficient, it is
time-consuming, but again it is the quickest, least costly way for smaller
practices to receive this information. Regrettably practices still feel
comfortable making phone calls. Obviously we know there needs to be a culture
change. We know we need to give them the ROI to understand why that is not a
viable avenue for eligibility verifications. But these are the reasons why.

Eligibility is not binding. I pick up the phone and I pay six cents or
twenty-five cents – that doesn’t mean I am going to get paid. I still
could get a denial. So the incentive is is the cost worth the outcome? It is a
practice-specific question. When a payer confirms a patient’s eligibility many
practices are still experiencing retroactive denials regardless if the
eligibility was informed. This is an important issue that will not be solved
with these transactions. Again I want to restate that it affects adoption.

The onus should be on the payer in our minds to cover services if
eligibility is established or an employer, if they fail to notify a payer of a
change in an employee’s employment status.

One practice indicated eligible patient at time of visit turns out to be not
eligible, either 48 hours or even more problematic 18 months later. That drives
up extreme costs on the back end of the system. And the priority to address
this issue has really been raised with the advent of the exchanges. Because in
those rules, in certain instances, when patients enrolled in exchanges plans
fail to pay premiums providers risk not being paid.

Under the federal regulations here it is a little bit different –
insurers offering these exchange plans must provide a three-month grace period
to individuals who have not paid their premiums, and during the first thirty
days insurers must pay the claims regardless if you do eligibility. But the
sixty days they are going to be holding them and it is going to be the provider
responsibility.

Now how are we going to get the information to the practices so they know
that it is in that interim term, interim period? So we can argue who should be
at risk and who should be at fault but the issue is what is the value of
eligibility if we don’t consider if there are operating rules or other ways to
resolve this issue that is going to be very problematic for exchanges?

Payers are required to notify providers of this information, and again I
just want to reiterate, I think it needs to be a top priority for operating
rules or for this committee to think about – how are we going to resolve
that conflict going forward?

Claims status, on the other hand, is a brighter picture. When we talked
again to this billing management vendor focused on small physician practices
they have an integrative module. More payers are using unsolicited 277s. I know
the solicitous was part of the operating rules, but I think it is a good
comparison here. What they are finding is they are getting more reports. They
are patient-specific, and have increased frequency so they are able to increase
the value of that workflow product.

So the physician practices are obviously using this information and all
stakeholders are getting value. But again, this is integrated within the work
flow. It is automatically used. This isn’t a standalone module, which now you
have to change your workflow to use, and there is no additional cost.

So again, we found that when the standards and operating rules are
integrated within a claims processing payment and auditing solution, or are
behind the scenes, this information is used at high frequency. The eligibility
rule really was created in order to help providers get the financially
responsible information for co-pay, deductible and co-insurance prior to or at
the point of care. And we commend CORE because that is what CORE did with the
eligibility transaction – understanding that is where a lot of the cost
is.

However, we as an industry need to support that effort and we need to look
at operating rules that meet business needs. I know that the Affordable Care
Act was set up per transaction because these are operating rules that are
companions to standards. But if we are going to look at operating rules as
companion to standards we cannot look at the business needs that encompass a
lot of different transactions.

So moving forward I think we really need to think about how are we going to
adopt operating rules. Is it going to be by standard? Or is it going to be to
solve a business need and get the industry to embrace it so that we can
actually get the cost savings for the business need?

You heard us talk about prior authorization – 278 authorizations,
great, that is the purpose of that transaction. But to get the efficiencies it
is not just the 278 that needs to be thought about. It needs to be how do you
let the provider know when authorization is needed? It could be the 270, 271.
If we put operating rules around around 278, is that going to solve that need?
And if they don’t have that information it doesn’t drive adoption and now we
are back where we are. Unless we look at the business need to try and figure
out how using the standards and operating rules, we can accommodate that
business need when it is not isolated to one transaction, we are not going to
get the biggest ROI across the industry. We really encourage the committee to
think about the adoption of operating rules moving forward from a business need
perspective instead of a per transaction need.

The other thing is we still had reports about where people would send, ask
for claim A. They would get information back for claim B. Obviously, there is
still an issue with getting the information you do need from a provider
perspective. Sometimes they are just getting pendant. That means they received
it, but they cannot respond to it, which is very problematic. Those are issues
that still need to be worked out in the industry.

One pediatric multi-practice in Stockton, California indicated payer
noncompliance with the eligibility and claims status operating rules that they
have not received patient financial information such as remaining deductible
coinsurance amounts necessary to calculate payments at the time of service.
They continue to make the phone calls and utilize manual workflows. We also
were very dismayed to find that the information was inaccurate so now they have
to refer to manual processing.

And just the last point I want to make in regard to EFT/ERA is many of the
smaller payers are using credit cards. They are mandating providers to get
credit cards as payment. They are not offering the check option or the EFT
option. We really need clarification to this industry that EFT is required if
you are a covered entity, and needs to be an option. Unfortunately, with credit
cards, they are very costly to the provider office because you do not have them
in your hand so they are the highest commercial rate that you have to pay a
processing fee rate. That obviously really affects the bottom line cost. I
encourage you guys to consider messaging around that point. Thank you for your
time.

DR. SUAREZ: Thank you very much. I think we are going to go to Mona.

MS. REIMERS: Good morning. Hi. I am Mona Reimers. I am here from Fort Wayne,
Indiana. Basically, I was invited today to present how it really is working in
the field, what is working, what is not working. I can echo Tammy particularly
from the AMA who did an awesome job of queuing up. It makes my presentation a
whole lot easier. Thank you, Tammy. 38 physician practice, 24 non-physician
practitioners, 14 CRNAs, 16 PTs. We are a good size practice. I would say we
are probably definitely bigger than many of the small practices that are out
there today. We are independent, not hospital owned, which I think also sets us
in a different place than a lot of our contemporaries today.

The infrastructure and the operating rules for eligibility and EFT/ERA are
starting to provide some benefit. I want to encourage you all to know that your
work up until now has been a good effort. We have some positive examples to
show you. I wanted to discuss some areas where we are struggling and some
responses to the questions in the invitation.

Using the eligibility data, basically the real time batch eligibility as
well — or the real time individual searching and the batch eligibility are
both very important to us. We need both to do it well.

In the current and prior processes required us right now with Indiana
Medicaid. We have to print a slip out of a machine that is similar to a credit
card machine, but it is separate. It is not the same machine. At a desk, you
are going to see two machines.

We have to print that copy of the day of the appointment. Then our processes
require us to scan a copy of that into our system because if the patient later
proves not to be eligible for Medicaid, the only way we can get paid is by
proving that we had that receipt. That is the kind of thing we are trying to
get away from. That is a lot of time wasted. They ought to know whether or not
they told us the patient was eligible. It seemed like to me they gave us the
data, they ought to know it. Just picking on Medicaid. There are other issues
with other situations, but this is just one to highlight.

And using eligibility data, the granularity of the data content is not
always consistent. For instance, in our practice, we need to know whether or
not you have physical therapy benefits and where you are in that round of care.
You may have 20 visits a year. You may have $2000, but what have you spent
today because patients expect us to tell us their benefits. Unfortunately, we
do not sell the insurance to the patient, but a lot of times we are the people
who are trying to decipher it for them.

It is unclear whether or not our PM vendor is required to make changes into
our system and how we can query out that information. I trialed something where
I sent an eligibility feedback report to one of the folks I know at United
Healthcare who was very helpful. They came back and said, well your
clearinghouse did not ask for it. In other words, we did not know we were not
sending out a request for the information that we wanted. All of this is
somewhat invisible to people in my chair.

And then we have no clear understanding of where the data will be stored. Is
our vendor going to store it? Is our PM system going to store it? If we need to
go back and query later what happened, we would like to know where that data is
going to be stored. Are we responsible for it? Is someone else responsible? If
so, for how long?

Our Medicaid payers right now are having down time days. We have nicknamed,
but I will not tell you what they are. But they are down typically around the
1st and the 15th of every month for a day or two. That means you cannot get
eligibility on those days period. It is just not available. It is kind of a
like a white vacuum.

Self-funded health plans are seeming to really struggle. We might have a
contract with a TPA who does self-funded and traditional health insurance. The
self-funded health plans are not on board with the TPA. You think you are
pinging out eligibility, but you are getting back information only on certain
patients. You are not getting a full report. Their eligibility data is just
simply missing.

What we really need is exception reporting. We do not necessarily need to
look at 700 patients a day and try to go through line by line.

Working with our particular IT department, we have developed some tools
though to take that automated eligibility pinging at the point of insurance and
also in the batches. That has been very good. But we are fortunate to have
talented IT staff on board being the size practice that we are. Not a lot of
practices will have that resource or could afford it even to hire it
independently. I would encourage the ongoing communication and development and
not just one set of rules forever and ever.

And the ability to use case by case and the batch with all the payers making
the same infrastructure will help us move forward.

The good news with eligibility is we are beginning to have predictive
analytics on top of these things. Here is where I am going to show you an
example of the good that is happening. By taking a batch eligibility folder or
file out for tomorrow, we can see at our North office how many patients have to
sit with registrar. This allows us to allocate our resources and our staffing
correctly. I cannot tell you how happy this makes my front desk manager. Being
able to know where she has to have her staff at what time of day, when she can
do lunches, when no one can go to the restroom. She just basically has this
really figured out.

On the claim status reports, I regret to tell you that nothing has changed
from our perspective. Maybe that is good because in some ways we were already
getting it. Maybe in some ways it is just not there yet for us with our
vendors. I cannot tell you because I am not deeply embedded in all the rules to
know whether or not we are getting it or we are behind. That is the trouble
with where we are today.

With EFTs and ERAs, we had previously had a history at my organization to
accept every ERA reasonably possible to accept. The problem with the ERAs and
we do accept 90 percent of what we are told is out there. The problem is that
we still have to sometimes go line by line to figure out what wasn’t paid and
why on a detail line by line. We might have a surgical claim with eight
transactions codes on it individual things line items and some of them are not
paid and they leave an open balance and we cannot tell why.

EFTs is the lowest cost. We are getting these requests to take payments on
credit cards. I imagine that the small practice does not have the sit up and
say no. We did it for a while. It was like what the heck is this. And then
after a while we said no. We are not going to do it anymore. But when we call
them and tell them we want an EFT, they are like quick to cut a check rather
than they do not want to do the EFT.

Some payers are saying that what we can pick up on an ERA off their website
is better than what we are getting back through our clearinghouse or that they
recommend we do both. That is just a really bad process altogether to do two.

Tracking numbers and re-associating the EFS and ERA will be tremendously
helpful. We have had months particularly over an accounting period where it may
be a tax year or we have our partner bonuses, which tend to be really a high
stress time. The three-day rule helps us close the books. Otherwise, we have
funds in the bank that we cannot attribute to where they go because we cannot
find the ERA that goes with it especially if the ERAs are being mailed in the
US postal service. It can be quite a difference in number of days between the
two transactions.

The CARCs and the RARCs. As a member of CAQH, our practice is thrilled and
cannot wait to get more information on how this is going to go. Right now, we
have to know every payer’s individual payment codes and map them to the work
process for the next to do. Just because the claim is paid, it does not mean we
are done with it on our end. By knowing what these things are and standardizing
it, it will tremendously help our industry.

Some questions that arose when we tried to implement. The clearinghouse and
the PM vendor working directly with physician practices do not really — the
boots on the ground do not know — the vendors for the clearinghouses, the
vendors for the payers. Those local people that we talk to day in and day out
do not know about these operating rules yet and they do not know how their
companies are going to bring it down to them. They have heard about it. Maybe
had some webinars or whatever, but they really do not know what is going on.

The solution is obviously to continue to deliver awareness. Speaking on
behalf of my contemporaries, I will tell you that there is a tremendous fear
that EFTs are going to mean that the payers will reach in and withdraw funds
from their checking account. We just need to stop that from being a fear
factor. Give providers dual eligibility of ERAs for a few months so that you
can gain trust. That really helped in our organization. CMS auto enrollment
will help and continue to educate the providers.

Tracking documents and discrete clinical data to obtain prior authorization
and pre-determination would be helpful. In our world, we would love to see —
if we sent you the data, if there is some sort of a code attacked to an opt
note or a therapy note that we sent you and it is going to stay in that system
and we can say go back and get the one, two, three, four, five that we sent you
on Tuesday that you affirmed that you have and now attach it to the claim.

Thank you very much. There is my contact information.

DR. SUAREZ: Thank you so much. I think we are going to go to Tim.

MR. MCMULLEN: Good morning everyone. My name is Tim McMullen. I am the
executive director of the Cooperative Exchange, which is the recognized
resource and representative of the clearinghouse industry. I want to thank
NCVHS for holding these important hearings and inviting us to participate.

Cooperative Exchange represents 26 member companies and organizations
including 19 clearinghouses many who are in the room today. Our position in
partnering with providers, vendors, and payers give clearinghouses a unique and
comprehensive perspective in the area of operating rules.

Today I am answering the question posed by the subcommittee regarding the
development and implementation of operating rules. As I sat here, a number of
my colleagues, Tammy and Mona and Gwen have already raised issues that I am
going to raise as well.

Under the development and maintenance of operating rules, clearinghouses are
noticing that providers are often unaware of any changes, mandates or benefits
as was said before. However, on the vendor side, they say that providers are
participating in the operating rules by evidence and a rise of eligibility and
claims status transactions. Again, take that for what you find.

We are finding sporadic content information in smaller providers and lack in
the use of service type codes instead relying upon generic codes.

With respect to the maintenance process, our members are finding the
maintenance to be restrictive and slow. There is no process or plan to update
or change existing operating rules and we recommend that a process be put in
place possibly administered by another organization for faster implementation
of changes and updates although Gwen and I spoke a little bit about that this
morning.

As Gwen had mentioned, the CARCs and RARCs maintenance process is also slow.
Recommendations come from ASC X12, but are implemented months later from CAQH
CORE. For example, CARC/RARC recommendations were made by ASC X12 in January,
and just adopted by CAQH CORE in May.

Now what effect does this have? The CORE operating rules state that the new
codes can be used immediately, but the delay in receiving the updated CORE
CARC/RARC combination document means that entities may implement the new codes
when available from the code committee meeting, but then have to go back and
make changes after the code combinations are produced, thus having to update
systems twice, and the providers receiving information in different ways after
the updates are done.

In regards to the operating rules on eligibility and Tammy sort of brought
this up earlier, we found smaller payers are not providing information on
patient responsibility. We also found that providers are not using electronic
eligibility, instead directing their patients to their websites or again going
back to the phone to confirm eligibility.

There were some technical issues that arose when clearinghouses implemented
the first set of operating rules. Payers’ transaction protocols were already
established. However, because of the safe harbor requirements, payers and
clearinghouses had to implement changes to support the safe harbor protocol.
The problematic business issue is that providers are not using the operating
rules on eligibility. While the safe harbor rule provides for a uniform method
of exchanging administrative transaction data between health plan and provider,
it also provides that any other method may be used. Consequently, very few
health plans are mandating that type of communication and very few providers
are asking for it.

For the operating rules for EFT/ERA adoption and implementation,
clearinghouses are actively involved currently in the testing process. We are
finding that there are smaller health plans that are doing virtual credit cards
and not the ERA. Because the 835 transaction does not support credit card
payments, they are accompanied by a paper remittance advice, which reduces the
ability to automate the provider. Mona briefly spoke about this. The question
arises on after the adoption data, what happens when they are asked for an EFT?
Health plans will have to support it.

There is also concern that the communication regarding the operating rules
on EFT/ERA coming out are not reaching all parts of the industry, which Mona
had alluded to as well. As with 5010, smaller providers are dealing with
limited funds and any reimbursement disruption will be felt hard by them.

I found this one interesting. Some of our members brought up that there is
an issue of providers who live close to a number of state lines and they divide
their accounts between different banks across those state lines. They do this
for cash flow and creditor maintenance. With EFTs, they will have to be at one
bank. And for smaller providers who rely heavily on Medicare payments, which
are going to be all EFT, they are struggling with this requirement.

Finally, there is the issue of the HIE’s premium payment grace period. CAQH
CORE will have to provide operating rules to take that into account.

PARTICIPANT: — health information or insurance — insurance in that case.

MR. MCMULLEN: Real quick. Earlier this month, the Cooperative Exchange held
a clearinghouse caucus at the ASC X12, with over 85 industry stakeholders. This
group also highlighted a number of issues with EFT/ERA. They are there.
Actually, Deb Strickland will actually go — her testimony goes into a little
bit deeper on some of these. I will just leave those for you to look at in a
second.

For the next round of operating rules, some of our members are working with
CAQH CORE on their development. That being said, we are going to recommend that
a better mechanism for submitting suggestions so that all stakeholders, not
just CAQH CORE member, can participate and can submit suggestions and recommend
that a vote or consensus method be instituted by CAQH CORE so all the
suggestions have equal weight.

I want to finally leave this with you. And Tammy — when she was talking
about the business solution, that is — clearinghouse is absolutely agree with
that point. But we want to leave you with this one thought. The implementation
of the operating rules does not follow the workflow process of the claim life
cycle, which has caused challenges in implementing and integrating into
existing workflows. Therefore, the Cooperative Exchange recommends that NCVHS
look at all the electronic transactions in more of a holistic approach rather
than a set timeline under the regulations, and then adopting that order of
process. We would recommend that you look at that going forward. Thank you.

DR. SUAREZ: Thank you very much.

MS. STRICKLAND: Good morning. My name is Deb Strickland and I am from Tibco.
I am happy to be here testifying on behalf of health plans, health plan being a
health plan vendor.

We were posed with a couple of questions from the committee. I took some
time to go out and research and talk to many different plans as well as
clearinghouses and providers to try to gather where we are and how things are
working and how things are not working. In a collaborative approach, I think
knowing the facts I think we can get this right going forward.

For the ERA phase III set, there are some issues that came about, one of
them being associated to the enrollment rule specifically, which did not
account for all of the various enrollment methods or models that are out there.
The predominant model is the payer has something on their website and the
provider comes on and enrolls. That was really, I think, the focus of what the
operating rule lends itself to. But it did not look into other things like
clearinghouses, some third parties, and some other outlier types of things that
are going on in the industry. When it came to implementation, plans were like
wait a minute. This goes totally against what I do in my current business and I
cannot really align properly. This is kind of disrupting to what I currently do
into what the processes and my providers know.

And also some of the answers were getting back from CACQ CORE is that they
can fill out the DEGs, all those data element groupings, and then maybe leave
that page if there is other information they need to gather or get or supply.
That is fine. Again, we are developing another process for the payers to
support to get those providers on.

And also some payers had one form that they had the providers submit to
them. But they picked what transactions they wanted. And now with this, they
now have to separate out ERA and EFT outside of that single all in one sort of
encompassing process and go to a different disjointed type of enrollment
process, which is also something that is causing some problems.

I would suggest that maybe we narrow the rule to apply to direct provider to
payer model rather than to say it is including all of them because we are
having a problem with mass enrollments and supporting all of them.

With the group codes CARCs and RARCs associated to scenarios, the work was
actually created before the maintenance process was developed, which became
slightly a different issue because as soon as they were out, they were actually
out of data. While the rule was predicated on the fact that these code lists do
not change very often, both code lists, the CARC code list as well as the RARC
code list had 32 different changes and adds associated with them, which is kind
of a big flux. And each one of them has to be reviewed and seeing how that
impacts the associated relationship between the CARC/RARC grouping as well as
the scenario.

And the infrastructure rule — the ERA is basically a batch transaction in
the industry and is typically done in that way. It does not really get
communicated via SOAP and MIME although I suppose it could. That is not
something that is typical. Although on the other side when the communication
rule was created and vetted, the 270, 271, 276, 277 that could have been a
thing that was used for communication. But when the development of the ERA and
EFT rules were created, then the 270 rule was also applied to it. What I am
hearing from plans, and I know specifically being a vendor, is that plans had
to because of their compliance office purchase certain software to allow them
to do SOAP and MIME even though it is highly unlikely that anyone would want to
do this. That becomes problematic because we do not want to add an undue burden
to the industry for things that are likely not going to be used, but because
the compliance officers try to take a strict line.

The question is are they working. I think that a public comment period with
responses is needed in this process as was alluded to. We do not have a lot of
interaction with anyone outside the CAQH membership and that becomes a problem.
People cannot comment in if they are not members and get a response out. There
is a number I am sure that CACQ CORE was blown up because I know myself and I
know different organizations that I am associated with have been pushing folks
who have questions to CACQ CORE, which is appropriate and I am sure they are
developing FAQs to answer those. But I think a public comment period before
people try to go to implement it would be a better way to go.

And the fact that these rules actually go out as law. The IFCs, which is a
problem because even though there is a comment period with that, there is no
response. You can comment, but then it is already a law. It is really not going
to go back and change. That becomes a problem.

Also I wanted to point out that we need to have more rigor around other
comments and a more implementation strategy or pilot as well as with the HIPAA
transactions with the operating rules because once you try to go implement it,
certain things come to light. For example, it is impossible in some ways to be
compliant with the operating rules, which is going to be a problem for the
industry. In this case, the names would have to be used without modification,
but those names have open and closed parentheses, slashes, dashes, and marks
that cannot be put in XML tags. Yet, they want the XML to be built off of those
tables, which is a big problem. You cannot do both. You cannot be appropriate
in XML language and use the tags that they are telling you to use. That is a
big problem.

Rule 360. The other thing that I think folks have pointed out is the
practice management systems are a big problem in the industry. They are not.
Their software is not aligning to the content of the 835, which is a little bit
disheartening for someone who has been developing 835 for about 20 years now to
know that the providers on the other side are getting content that somewhere
around 3050. They do not get all the data. They do not get remarks in a lot of
cases and they do not get provider level balancing figures. Even though we
apply this operating rule, we keep applying rules on top of the industry, but
the reality is that if people are not getting the data like we can put these
CARC and RARC combinations into scenarios, but the providers will not receive
them today. They will not receive them until we get the practice management
systems underneath at part of that umbrella that makes them have to comply
content-wise with what is being delivered in the 835.

And of course, as we go forward with additional operating rules, if we can
apply the 270 rule to transactions as appropriate and/or modify them as
appropriate for each individual transaction.

I want to offer suggestions, but they are just suggestions. I had a manager
many years ago that said don’t just drop bombs and run. Whenever you bring a
problem, try to bring at least three solutions to that problem. I offer some
suggestions. One is that we make sure that there is a public comment period
with responses before these things are put into law. It has to be fair to
everybody, not just people who are CAQH members, but everybody even outside
that umbrella so that we all have a voice and that people are being heard.

Take more time to vet these rules. I understand that there is an
anticipation of some rules coming in the list of questions that we had January
14. I hope not because that means another set has to be selected, written, and
vetted before they are handed. That is only six months. I do not find that to
be enough time personally. I do not want us to find ourselves in a situation
where we have the same type of problems that we have with ERA and EFT not so
much, but ERA and enrollment and all these different things. If we can vet
them, we will be much better off I know if we take our time. I have some
suggestions as to what we could do. We do need to leverage all of those folks
in the industry, get public comments, take some time, vet things out, and then
prepare them properly for the industry.

And then a documentation of the operating rules. We want to make sure that
they are as clear as possible. I know when they first came out that was a lot
of the questions that come to me just because of my role in the industry and
the fact that they were related to ERA and EFT. A lot of questions came to me
about what does this mean and trying to make me interpret what these things
were saying. There is a lot of good information in there, but we just need a
document. Maybe even at the end or something that just says these are just the
facts. These are the requirements. Boom, boom, boom. These are the things that
you are going to be held to. These are the things you are not going to be held
to. That would be a good thing because the industry could get right off the
ground and not have to sit around trying to interpret things before they even
start developing.

And then we want to make sure that there are no requirements or even aspect
of requirements in footnotes. In the documentation, there were large footnotes
and sometimes there were really key pieces of information that were in those
footnotes, which I think a lot of people ended up missing, but then we started
bringing up communications and awareness of that so people started to pay
attention to that.

As far as the maintenance process, this was another part of the question. I
will just finish up with this slide. The operating rules for other transactions
such as eligibility, things outside the CARCs and RARCs seem to be unknown to
people at this point. It just seems to be to send a note to CACQ CORE to answer
the inquiries. I believe they write FAQs to help people facilitate getting that
information out.

And there is no way for an outside person to ask for a change. If there is a
person who is not a CACQ member, they cannot just come in and ask for a change.
I would request that we have some sort of change request process where people
can feed into this and see the timelines and the structures and where those
suggestions are going, how they are actually going to be incorporated, are they
going to be incorporated. If not, why? Why would they not be incorporated if
there was enough need in the industry to do that?

I will end here. You can use my deck as necessary for your future
considerations.

DR. SUAREZ: Thanks, Deb. You will be sharing this with the committee. Now we
have Tim on the phone.

MR. KAJA: I am on the phone. Can you hear me okay?

DR. SUAREZ: Yes, we can. Thank you.

MR. KAJA: Great. Thank you. My name is Tim Kaja. I am with UnitedHealth
Group. We are pleased to offer our testimony here today on the operating rules
and the transactions. We submitted our testimony yesterday. I am going to give
some excerpts from that testimony specifically around what we have learned
around managing the change that we are all talking about here, what we did, and
what we have observed in the eligibility and claim status transactions and how
we are applying that forward.

Also, what we are seeing — I want to give the committee some numbers to
give you a sense on adoption and what we are seeing as a large payer in the
industry around claim status and eligibility and then I have about six or seven
observations that I will share based upon our experience.

Really the first area here around program structure. Everybody can put their
programs together around how to put these transactions in place and how to
ensure that we are compliant with the operating rules that need to sit on top
of the transactions. But one of the things that was extremely valuable to us is
hearing from — like the forum that you have right here even outside of the
testimony that has given folks like Tammy, Gwen, Tim, and others to stay close
to those constituents throughout the process to record their observations,
record where they are seeing their experiences because it is as though you can
build the ball stadium, but without the roads that are coming to it and the
cars that get you there, you really do not have any adoption. I want to give
hats off to the rest of the industry for freely sharing what their observations
are.

Let me give you a little bit on adoption. At UnitedHealth Group, we process
about 35 million claims per month. As it relates to eligibility, prior to the
5010 adoption back in June of last year, we were processing about 15 to 20
million transactions per month in the arena of eligibility. Since that time in
2013, that number has grown to an average of about 28 million transactions. I
think that should tell the committee something that the way the transactions
were put in place in 5010 and the operating rules that sit on top of it. We are
seeing considerable uptake in the usage of electronic transactions.

On the claim status side of the house, very similar. We processed about 4
million transactions prior to the change. And after the change in 2013, we are
seeing an average of 5.5 to 6 million transactions monthly in the first part of
2013. Again, eligibility and claims status from the first round of operating
rules that were put in place and transactions we are seeing adoption.

But if you take that on one hand and on the other side look at the manual
transactions that are coming through, the total volume of manual transactions
has really remained unchanged. Now that is a good thing and that is a bad thing
because what we are seeing — what I think where the industry is projecting
eligibility to be as approximately two transactions per claim and we are seeing
that trend continued to head in that direction. And if we had not had these
transactions in place, I do not think we could hire enough people to man the
phones to take these eligibility transactions in the way that we historically
have done now. While we are seeing great advancement in electronic
transactions, we are seeing stagnation in the total of — great advancement in
electronic transitions. We are seeing stagnation in the manual transactions
that are out there, which tells us we have to go back and look at the
transactions again and say how do we get rid of the rest of the manual
transactions that are out there.

So, really two things that come from that. One is physician practice
workflow. It has been our experience that and I think we heard Mona’s testimony
— I do not know if it is a majority, but somewhere in the neighborhood of 35
to 40 percent. If the practice cannot change the way they do business to that
degree, we do not necessarily see the adoption. We have gotten that feedback
from the MGMA. We have gotten that feedback from individual practices. We have
gotten that feedback also from the HBMA.

One of the things that is getting in the way there is some of the federal
and state agencies that are out there and their readiness for submitting
transactions in the 5010 and in the operating rule environment. One of the
suggestions we are going to have is how to ensure that particularly state
Medicaid agencies are ready and able to submit transactions.

Let me get to our observations here. The first observation is that a key
point for both eligibility and claim status transactions and their value is
that the non-covered entities are not incented or required to incorporate the
functionality provided in the operating rules. Today, only the payers as you
know are required to submit and be compliant or to reply and be compliant with
the transactions.

We would encourage practice management system vendors and other non-covered
entities to become compliant. As we think through this, we are a little bit on
the fence around whether or not that should be a mandate or it should be a
different type of discussion around how do you create the economic incentives
for them to become compliant in the environment that we all work in today. I
think that is a very key discussion going forward because I think there are
folks on both sides of the fence there.

The second observation is recommending a mandatory registration of readiness
by covered entities as we approach the deadline. It is very difficult to tell
whether or not an entity is going to be ready. As you know, during the 5010
process we had to figure out how to accept both types of transactions for a
period of time. Accepting both types of transactions is extremely expensive. We
are not talking about ICD-10 here, but when we get to ICD-10 if that is the way
the industry is going to go, the expense to the industry to accept both is
extremely expensive and the length of time that it goes on is extremely
expensive for the industry.

Relative to practice management systems and other non-covered entities. We
do need to, as I mentioned before, — I do not want to say require, but create
the right incentives to pass, receive, and post-standard ASC X12 transactions
with the mandated operating rules. Relative to readiness, another observation,
the state Medicaid agencies, we need to figure out how to get state Medicaid
agencies ready with that growing population via the need to have transactions
from state Medicaid agencies compliant is extremely important.

Regarding ERA and EFT, one of the things that we have observed and I have
not heard this yet in any of the testimony is in order to transmit a
transaction electronically particularly EFT it requires consent. Each of the
states out there requires that the individual receiving that transaction
consent to the fact that they are going to get that transaction electronically.
We are going to have to figure out how do we do that in an environment as big
as we all operate in or is there an ability to look at the state rules that are
out there regarding consent for electronic transactions in the arena of EFT.

The next observation is on the clearinghouse side. I think we heard Tim and
his testimony. But it is our understanding that the clearinghouses are still
getting some 4010 transactions. They are not just a smattering of them, but a
reasonable volume of 4010 transactions that are out there and converting them
up to 5010. While that is acceptable in today’s environment that becomes a real
problem next year as we get into ICD-10.

The last observation here is on the arena of EFT and ERA. Doing EFT and ERA
together is very important. If you separate the ERA from the EFT, there is
really little economic advantage to not just to the payer, but also the
provider from our observations in adopting the transactions.

Maybe in conclusion here what I would offer is if the first round of
implementation of eligibility and claims status and the adoption that we are
seeing in the industry is any indication of what is to come, we are very
positive on what we had seen. We are highly supportive of the core operating
rules that sit on top of the transactions. They enable the adoptions. They
enable providers and payers to work together in an environment where that
adoption can actually happen. We are, however, going to have to figure out how
do we economically incent all of the intermediary components of our health care
system to submit transactions and accept transactions in an electronic way.

Thank you for the opportunity to provide our testimony.

DR. SUAREZ: Thank you so much, Tim. I am hoping that you are going to stay
on the line for our Q&A. Thanks again. We are going to Priscilla now.
Priscilla, are you on the phone?

MS. HOLLAND: Yes, I am.

DR. SUAREZ: Okay. Go ahead please. Thank you.

MS. HOLLAND: Thank you. Good morning. My name is Priscilla Holland. I am
senior director of heath care payments for NACHA, the Electronic Payments
Association. I would like to thank you for the opportunity to testify. NACHA is
providing information on how NACHA is working with CAQH CORE, NACHA’s regional
payment associations and other health care associations to educate the health
care and financial services industry and assist in the implementation of the
operating rules for EFT and ERA. I am going to be taking this from a very
different perspective than some of the previous testifiers.

I did want to make a comment to Tim on his previous testimony. He had some
concerns about EFT consent and authorization. I did want to let him know that
that is one of the NACHA operating rules that the receiver has to authorize the
ability to receive those transactions. It is something that we would have to
look at within the NACHA operating rules as opposed to handling it outside of
the network.

NACHA is a not-for-profit association. We are responsible for the
development and administration and enforcement of the operating rules for the
ACH Network, the NACHA operating rules. Our rules support electronic payment
services and standards in the area of payroll, bill payment,
business-to-business payment, and international payments. We represent and
bring together over 10,000 member financial institutions of all sizes and types
throughout the United States, both directly and through our 17 regional payment
associations.

NACHA was identified by this committee to work with collaboration with CAQH
CORE as a candidate authoring entity on the development of the EFT and ERA
health care operating rules. NACHA has worked closely with CORE to develop the
operating rules. And we continue to work with them to educate both the health
care industry and the financial services industry participants on the features
and benefits of implementing the operating rules. NACHA is actively
participating in the CORE town halls, educational webinars, and presents at
many health care conferences on the EFT and ERA operating rules and the health
care EFT standards.

Recently, NACHA’s voting members, which are financial institutions, approved
changes to the NACHA operating rules to better support the healthcare EFT
standard and operating rules healthcare payment processing and the delivering
of the TRN Reassociation Trace number. These changes will be implemented by
September 20 of 2013 to better help the health care industry with their
implementation in January of 2014. Our new rules allow for the identification
of the health care EFT standard transaction, standardize the identification of
a health plan to make it easier for the providers to recognize the health plan
sending the payment and require financial institutions to have the secure
electronic delivery option available to deliver the TRN Reassociation Trace
number to the provider, and formatting changes that reinforce provisions of the
health care EFT standard and operating rules including the TRN Reassociation
Trace number as defined by ASC X12 835 TR3 version 5010 report.

Financial institutions, the ACH operators, and financial services technology
vendors are working diligently to implement the NACHA operating rule changes to
better support the health care industry by being able to appropriately identify
the health care CCD plus Addenda transactions and to deliver the TRN
Reassociation Trace number to the providers, if it is requested. Through our
work with these organizations, NACHA believes that the financial services
industry will be ready to support their health care customers’ use of the
health care EFT standard and the EFT and ERA operating rules by January 1,
2014.

Additionally, NASHA and our 17 Regional Payment Associations are working to
educate the financial services industry on the health care EFT and ERA
operating rules, health care EFT standard, the changes to the NACHA operating
rules made to support health care, and ways that financial institutions can
help their health care provider customers improve their back office processing
through automation, risk management, and electronic payment processing. NACHA
developed train-the-trainer materials for our regional association members, who
will in turn train financial institution staff on how to assist providers in
implementing the health care EFT standard and automation of the back office
functions.

NACHA has also developed a variety of resources to assist the health care
and financial services industries in understanding the health care operating
rules and the health care EFT standards. Some of the key resources we have are
health care payment resource website that contains separate sections for health
plans, health care providers, and financial institutions. Each section contains
information pertinent to the audience on the operating rules and standards,
features and benefits, challenges and opportunities, publications, links to the
CAQH CORE EFT and ERA operating rules, and other resources.

There is an additional section on the website on the health care EFT
standard, which includes frequently asked questions on the CCD plus Addenda
format and rules along with a link to the NACHA publication, which is the
Healthcare EFT Standard Implementation Guide.

We also are working with other health care organizations to develop
educational materials on the benefits of using health care EFT standards and
the EFT and ERA operating rules.

As a member of WEDI, NACHA staff participates on the EFT and ERA work groups
developing educational materials on the EFT and ERA operating rules and the
health care EFT standards. NACHA staff worked closely with the AMA on the
development of their EFT toolkit. We previously presented an on demand webinar
for the AMA on the benefits of EFT. We have two webinars scheduled in 2013. We
provide quarterly articles for the AMA publications and the PM alerts. And we
worked with X12 on questions with regards to the TRN Reassociation Trace
number.

NACHA continues to work closely with CORE on education of both the health
care and financial services industries on the implementation of the health care
EFT standard, the EFT and ERA health care operating rules and the NACHA
operating rules. As with all changes, some organizations adapt to changes
better than others. The operating rules were developed to assist in the
implementation of the HIPAA standards and seem to be achieving their designated
purpose. NACHA looks forward to continuing to work with the health care
industry to implement the health care EFT and ERA operating rules and the
health care EFT standards.

From NACHA’s perspective in looking back over our almost 40 years of
developing health care — sorry, financial services operating rules, it takes
time to work out some of the kinks. But the operating rules do assist in the
standards development and implementation.

I thank you for you the opportunity to testify and will be on the line if
you have questions.

DR. SUAREZ: Thank you, Priscilla. I think we go to Cathy now.

MS. CARTER: Thank you. The agenda what I was going to cover were the
questions that were asked that we respond to. We will go through each of these.
In terms of Medicare’s fee for service and again let me just start by saying
that I am responding really for Medicare fee for service. You cannot just use
CMS or even Medicare because there are lots of different aspects of Medicare. I
am actually talking just about Medicare fee for service. We are compliant with
phase I of the operating rules including the Internet connectivity. We actually
have our system. We began that capability in May. Lots of effort went into
that. We have one submitter that is currently using that and we have four that
are currently attempting to get connected, but not a long line of people
waiting to use this transaction.

The concerns that we had about that were it was difficult to do. It took a
lot of back and forth, a lot of hand holding. I do not know that it will get
easier even as we move forward because each entity still has to be brought
through that specific process.

In terms of phase II with claims status, we are working toward compliance
with these operating rules. We are hoping to have our batch claim status
transaction offered via Internet by January 1. I am hoping that we are not
going to experience the same challenges that we did getting HETS up and running
by Internet because if so, that date could possibly be in jeopardy. But that is
currently our plan.

In terms of the real time, Medicare does not offer, has never offered a
real-time claim status transaction. We are working on a strategy for being able
to offer that. We do not have a date at this point.

The concerns on this are related to real time and that is the funding, which
we are extremely short of even more so than our normal shortages of funding
this year, and then the level of effort and time to be able to do it.

For phase III, we are working toward compliance by January 2014. We believe
that we are going to meet that date. I think you have heard a lot of discussion
about the CARCs and the RARCs. Medicare is a big believer in the whole process.
No problem there. But we are finding it to be challenging with the CARC
process, the RARC process, and then the combination thereof. We end up being
out of compliance automatically when things are first published.

We also experienced an issue where the PQRS system, the Physician Quality
Reporting System. When we tried to get compliant with these rules, we lost all
the functionality we had there. I think we are going to have to go back and put
their piece in while we figure out a way to do it correctly some months down
the road. There is an awful lot of things connected as you all know. When you
try to comply with one thing, it ends up a problem someplace else.

In terms of the development of the next phase of operating rules, we are
planning some real active participation in this. The sessions that are being
planned. We are attempting to get the folks from CMS together. Actually, not
even just fee for service, but if anybody else wants to participate, we are
going to try to orchestrate some sessions that really did not happen the first
time. We were very busy implementing 5010 and we did not really spend the time
or have the time or the energy or the effort to actually participate.

The concern here is that payer issues and we are a pretty big payer that
they are not being necessarily taken into consideration during the development
process. We are trying to work through the surveys in providing input. But it
does seem to us at least the way folks are explaining it to me that a solution
is then brought to the meetings as opposed to working collaboratively to
develop a solution that would then be voted on. I think there have been some
concerns expressed today about that as well.

We do participate in X12. We have for years. We suggest and I think you have
heard that today as well that there be more interaction. And maybe there are
things going on that I am not aware of or that our folks are not aware of, but
there were meetings at X12 in June where it did not seem like all the right
people were there and maybe other things were going on again that we were not
aware of.

We also concerned that it seemed like some of the operating rules seemed to
be getting into things that should be in the standard and there is just two
examples up there that seem to be the case as far as we understand.

Issues with the process. Payers only have one vote at least that was my
understanding. Although I did hear that if you are a member of CORE then you
get more votes. I do not know. We have not confirmed that. If that is the case,
I think we want to get to be a member. We only have one vote on surveys and one
on the rules themselves and that is a problem for Medicare. We have a lot of
different views, a lot of different programs within Medicare. I am not quite
sure how to square that with where we need to go.

Lack of a formalized change management process. I think you guys have heard
a whole bunch about that today and we share those concerns as well.

And then the CARC/RARC process. We would like to suggest that at least it be
considered that we just have one process and just one process to do all three
of those. If you can only use them in combination, why have one to develop one,
one for the other and then one for the combination? That does not really seem
to make sense.

In terms of the time frame, the next phase. We think it is problematic.
January does not seem doable. I think others have said that as well. We think
this is a major effort for Medicare and other payers as well, not just us.

The first two phases were developed before the legislation. At least that
was my understanding before the legislation existed. The third was rushed in
order to meet the dates and the law. And this one now for claims I think is
going to be very much more difficult to get to, more problematic, more
argument, and more discussion needed. I think that is going to take more time
than there is available in the current time frame if all parties are engaged in
the process.

Thank you.

DR. SUAREZ: Thank you so much. I think we go now to Mary.

MS. HYLAND: Thank you. I do want to thank the committee for being able to
provide testimony on behalf of Healthcare Billing and Management Association. I
am Mary Hyland. My day job is actually vice president of Regulatory Affairs for
the SSI group and also the chief privacy officer. I am bringing many of these
comments based on our complex base of payers as well as providers as a revenue
cycle software vendor and data analytics vendor as well. We are seeing a
complex situation that is being uniquely stated from many perspectives here
today. We want to give you the overall perspective of what we are seeing from a
customer base that has revenue cycle software as well as participating with our
clearinghouse. Our numbers are slightly different from some of the previous
responses.

We have worked for CAQH CORE. We actually were the first clearinghouse to be
CORE certified on phase I. We have certified on phase II. We are a vendor that
is an authorized testing vendor for eligibility and claims status. Now we are
engaged in the CORE 3 phase III of TNERA operating rules.

Based on our clearinghouse connections, we have over 2400 connections with
payers. Eligibility is certainly the most widely implemented transaction
associated with any of the CORE operating rules to date. But where we see some
of the deficiencies is in the lack of compliance with adding co-pays and
deductibles. Medicare and Medicaid plans are struggling to meet the CORE
requirements for compliance. We have also identified Medicare contractors and
commercial payers who have implemented eligibility may not consistently provide
the detailed information or deductibles that are necessary for providers. A
good example is psychiatric coverage days and deductibles. Some payers provide
more information via their websites as we have heard in previous testimony
versus in the transaction. While this may be seen as a violation of the
regulatory rules, providers see it as a necessity in terms of obtaining crucial
information on deductibles and payments as well.

Mona also brought out the fact that the real time status of those coverages
are not available. That is also a huge impact on the providers.

We have not really seen a clear reason though why this occurs. Why can they
not provide the complete information? Why do you have to go to the website as
well as receiving the transaction? We definitely encourage more research in
this area so that we can actually determine why this is occurring and help
assist the organizations and the industry to become compliant on that.

Also, as we develop new operating rules to accommodate health information
exchanges, we definitely need to provide guidance in HIEs that did not exist as
the eligibility guides were created prior to their existence. Claim status
operating rules also are not being implemented by MACs at this time. The
estimated time of completion for the implementation that has been given to us
is October 2013.

Commercial payers are inconsistent with their progress to implement claim
status transactions and MACs currently provide batch transactions, but not real
time. It is an important element for the MACs to put this in place as well as a
HTTPS secure connection for real time 276 transactions.

Also, commercial payers are inconsistent with their development and their
use of the claim status transactions in real time connectivity, planning and
preparation for the implementation of the CORE operating rules for EFT and ERAs
are ongoing.

One of the statements that I would like to also reiterate is the CARCs and
RARCs. Our standards, but they are definitely provided inconsistently based on
the payers. For example, medical necessity for an uncovered service requires an
additional call to identify what the specific information is regarding that
code and also there are — because the most specific RARC is not included.
There needs to be further development in that area as well.

Health plan identifiers definitely posed as significant challenges for
payers and trading partners like enumeration into health plans and sub-health
plans is challenging. We not only have to look for the enumeration of NPIs to
see some of the issues that were occurring in the industry. Also, providers,
clearinghouses, and billing agencies are going to be impacted should the
enumeration not be fully tested within the payer environment prior to
implementation. And also, no organization models for each payer are unique.
Therefore, the payers are the entities that make such determinations.
Clearinghouses utilize existing payer provider IDs and sub-IDs. But with HPID
comes significant infrastructure changes within their environment and may delay
further reimbursements based on complexities that have not been fully thought
out and not fully tested. We need to keep this in mind as we move forward.

Clearinghouses already exist in the existing regulation. The other entity
identifier is requested by payers for most of the clearinghouses. We are
already going to obtain an OEID in case that is an issue that we receive a
request so that we will have that proactively.

Also, there is information to keep in mind that CPT codes are a primary
driver behind the professional physician reimbursement. But ICD-10 also helps
in terms of the reimbursement. Those physician practice management groups are a
part of the large hospital organizations are being included in that perspective
and also defined in giving them templates and guidance in terms of coding and
education and training. I would like to emphasize the MACs in Medicare are the
most challenges payers in the environment with their restrictions on budgeting
and lack of programming. Programmers need for compliance with all of these
initiatives is very impactful for single organizations much less the complexity
of the Medicare and Medicaid environment as well.

But we are your trading partners. We want to assist you in your efforts.
Please reach out to us for assistance. I would like to thank the members of the
subcommittee for the opportunity of testifying today. Thank you very much.

DR. SUAREZ: Thank you so much. Thank you very much. This was incredible.
Thank you so much. Thank you especially for your straightforward testimony. I
think it was very valuable to hear all the many points about the value, but
also some of the challenges of implementing operating rules. I know that we are
in a journey, as we always like to say. To start it really a couple of years
ago with the implementation of the initial set of operating rules. There is
going to be a lot of adjustment in the process as we all go along. That is one
of the main purposes of having us here today is to begin to understand how and
where and we can help in adjusting that process to make it better.

We are going to open it now for questions from the committee members. Are
there questions? Linda, we will start with you.

Agenda Item: Discussion

MS. KLOSS: I thank everyone. This was an amazing amount of information. I
thought one of the themes that came across in many of your comments was how do
we update the operating rules. Perhaps it would be useful to hear a little more
discussion on what your thoughts are about an update process that will be
appropriately inclusive, but yet as you said move things along at the speed
that we really require.

MS. LOHSE: I will absolutely make a comment and after we are done, I have a
few comments of clarification too just to make sure I address some of the
things that came up. With regard to maintenance, one of the things I think as
an industry we want to be thinking about, is what is maintenance. Is
maintenance more requirements? Is maintenance taking what we have and refining
it? Like I said, I think we have received 1300 requests. And those have turned
into I think — we have 500 FAQs. Seventy percent of them are from non-CORE
participants and this is an unfunded mandate remember. There is no funding.
Ninety percent of all that work is getting done by the few people that decide
to join. But 70 percent of the lift — all the surveys are public. The CARC and
RARC outreach is public. The question in my mind is when we talk about
maintenance, are we talking about refining or are we talking about adding. If
we are talking about adding, are we at that point? Do you have a critical mass
that then you push along to the next requirement? If we are talking about
refining, is it a substantive change or is it a non-substantive change? I think
those are key questions in my mind.

And then I think we need to all anticipate to — there are a lot of other
entities that are not going to be direct contributors to the maintenance
process. How do we take their input and consider it knowing they are not going
to be direct person? One person mentioned one vote per entity. It is absolutely
no one from CAQH gets a special vote. It is one vote per entity. A WellPoint
has the same exact vote as Ortho. They are a CORE member. We are talking about
individual practices with one vote to one vote. Maintenance is part of that
process. How do you get the people that are not directly involved in their
input and how do you also maintain that one vote to have the stakeholders? I
think the CARCs and the RARCs are probably a prime example. That process. They
have had 10, 12 calls. They have done two straw polls. They have put up two
compliance reviews. They have four multi-stakeholders. There is lots of
opportunity to participate in that. And yet not everyone is. How do we continue
to encourage participation?

DR. SUAREZ: Just very quickly because I think it is an important point.
Maintenance in the context of the standards whether it is standards, operating
rules, code sets, it includes everything that you mentioned. It includes
refinement. It includes addition. It includes retiring. It includes that
process. The question is really — I think we have a good level of
understanding of the maintenance process of standards like X12 and HL7 and
those that are being adopted for administrative transactions. What I think the
question was is really how does that work in the operating rule world where we
have a defined set of operating rules in place and required to be used as of
January 1, 2012 for two transactions: eligibility and claims status. What
happened to those operating rules that are being implemented since 2012 in
terms of maintenance? That includes refinement, addition, retirement,
everything else. How is that process being done?

MS. LOHSE: With the additions, we are not at this point putting resources
towards adding things. The industry is still implementing and we have limited
resources. We are not adding bottom line. We do not feel right now — there are
early adopters that would love to add. They are a minority and we are talking
about a very small minority. No adds.

For refinements, there is substantive and non-substantive. Substantive — to
date, we have not gotten any substantive changes. Deb mentioned mass enrollment
for the FTE and ERA, but you cannot do it. There were actually 100 forms
collected during the rule writing. There were several entities that do mass
enrollment that participated. I can name three vendors that have already
executed the enrollment. There are a few requests. We have three of them to
change certain data elements. The volume is not up at this point to go in and
make that revision. There is a process. There is a version process for the CORE
rules. We do seek outside public comment. I think we can absolutely do a better
job of that. There is no doubt about it. This whole process needs a better job.

For the CARCs and the RARCs that is even more challenging as an example. The
CARCs and RARCs — there are three code committees. Think about pre-CORE. Say
CORE did not exist. No operating rule on having code combinations or business
scenarios. You had one code committee over here, another code committee over
here and another code committee over here. Everyone picked their own codes. We
have done an analysis of five years. The last five years of when the codes came
out from the maintenance committees to see every code has a different effective
date. We are talking about thousands of codes coming out with a different
effective date.

And then additionally, was there compliance with those codes? There was a
maintenance process. Was there compliance? We collected — CMS gave us over
three months of data. It was all blinded of course. The compliant and so did
payers, so did vendors. Compliance was not there on the majority. We are going
through a major scrubbing in some of these instances where the rules and the
standards both have to be scrubbed.

That is part of what — no doubt, as we take on these operating rules, that
is a process and a challenge that existed way before the rules. We have taken
on a massive undertaking by the industry. This is not a small piece. I think
that rule especially requires massive focus on the maintenance.

Some of the other ones. The rules will roll into the standards. I think you
know with the content we have said always to ANSI X12 the content that we are
supporting for the rules of the use of the ANSI X12 co-pay, co-insurance, all
of that, those financials that the providers want. Those should all roll into
the next version of the standard. We have said that consistently. That is part
of the maintenance too and the update is, when will the next standard come out.
Those will roll in. I think first there is a process. Absolutely it can be
improved. Some of the rules are more challenging than others because of the
various different groups involved.

And long-term. Do you want to consolidate that? I think Cathy brought up a
point. Is there an entity that wants to take the responsibility to have the
code combinations, the business scenarios and own all the definitions? That is
the bigger question in my mind is with regard to maintenance around that
particular rule.

DR. SUAREZ: Let me bring in some more questions from the committee.

MS. GOSS: My first question is for Cathy. On your slide three, there was a
footnote of the concern that the effort it took to get the first submitter
properly set up to use their certificate. Can you speak to a little more of
your public key infrastructure dynamics and what Medicare is doing in regards
to knowing who is who in the zoo and using certificates?

MS. CARTER: Unfortunately, I cannot speak to the technical part of it. I
could get somebody to send you the specifics. But according to the way we —
and I am not sure how much of this was our choice versus what was driven by
when you go down the road of doing Internet transactions. Then we have rules
that we have to follow for our security. We were using public/private key. And
there was some confusion on the part of the folks that got connected about
which end they were on and we went back and forth a bunch of times. But in
terms of the exact specifics of that, I do not have that —

MS. GOSS: I would propose for subcommittee considerations in the future that
we have of a focused conversation about X509 certificates, how that tracks with
individual identity issues using web services in a federated environment. There
are a lot of aspects to that that is going to enable us to move forward in
helping meeting consumer payer and provider needs. But there are some big
looming issues.

I will move on from that hot juicy topic to my other question, which is for
Tim. You had a comment in your testimony regarding governance enabling
effective dialog and moving forward sort of in a holistic view and that
possibly there could be another organization being proposed. Could you expand
upon some of your comments there please?

MR. MCMULLEN: Those were actually two separate thoughts. The other
organization had to do around the maintenance aspect of it. Maybe another
organization who might that be. I do not have a solution for that.

For my last slide when talking about the holistic approach to have NCVHS
look more of a holistic approach on what is coming down the pike for the
operating rules, the next set of operating rules. I was in that dominion.

As those words were coming out of my life, I realized I probably should have
had a diagram to go with that to explain the steps. I can either do that over
the break and get it back to you or I can rely upon Mary Hyland to talk about
that. But the Cooperative Exchange certainly could assist in advising you on
the claims process. If you wanted to look at what our recommendations of how
the next set of operating rules in order should be looked at, that would be
happy I would be happy to discuss with you. Does that answer your question?

MS. GOSS: Not quite, but I am not sure I asked a really good question. We
can move on because I am sure there are other members of the committee who
would like to ask —

MS. LOHSE: I wanted to comment Alex. I think it is a great question. And one
of the things — Tim had brought about that holistic view and I brought up
about the codes. Again, pre-CORE, you still had that need. We are driving. That
is a funding piece. One of our recommendations was how to get more funding
because this is a big effort and this is analytics reporting. All of that to
really make it worthwhile. I think the funding for that type of effort is
absolutely critical to consider.

MS. GOSS: Can I do a follow up to that? Deb Strickland, back in the X12 days
and maybe Margaret Weiker in the audience can address this as well at some
point. I think there was some talk about trying to look at the workflow of
health care and how standards were developed, how they were released, how they
were synched with one another. And if my memory serves, that process sort of
broke down because of the needs to adopt things in a regulatory framework with
the Administrative Procedures Act so we were not able to do the holistic view.
I am having flashbacks to a decade ago. Can somebody from X12 fill in the dots
on that? There is a really good point about the need for us to look at what is
happening from the electronic health record data with the provider/patient
interactions and then how does that data get reused because it is the same
data. We are just making it look different.

MS. WEIKER: I would like to respond to that question. I am Margaret Weiker,
chair of the Insurance Subcommittee at ASC X12. As part of the restructure for
those that were in attendance yesterday when I talked about the timeline for
the next version, I mentioned about the restructure. And what we are doing as
part of the restructure is we are moving away from transaction specifics and we
are looking at it from a function. What is the business function? You have a
business function of benefits. What are the benefits? What are the data
elements associated with benefits?

Once I have the benefits, how do I get them? You go to enrollment first. You
have to enroll. What are the benefits? Then the benefits go down and they flow.
Part of the restructure is, one, we are moving away from that is the 837 or
that is the 274 or the 278 or the 277CA or RFA, whatever and looking more at
the business function. And also part of the business task group and the work
groups is the flow of the data amongst the transaction and having it flow and
be consistent throughout all of the transactions.

I have a group looking at entity. How to identify a person through all of
the transactions. That includes IDs, names, demographics, et cetera as well as
then harmonizing all of that data because some is directly, some is indirect.
We are looking at the harmonization as well of that data across.

MS. GOSS: It is really good to hear this focus. My question secondary to
that is how is that work then coordinating with HL7 and NCPDP since we have
different standards bodies who are all playing with the same kind of data
content.

MS. WEIKER: Now, you are talking a little bit different level in regard to
harmonizing data amongst the standards. There have been many attempts to do
that. You check with Michael Fitzmaurice. That is still in play and you can go
out and look at the data. We tried to feed that in — anyway, there is that out
there as well.

And then on the data elements where let’s say the NCPDP pharmacy industry
uses the 835 transaction. We have liaisons that go back and forth between the
two organizations. In NCPDP, there is a work group that is specific to looking
at external standards and other things to where if it impacts them directly or
indirectly, they are looking at — they are looking at that data as well.

MR. KAJA: In addition, I think to all the conversation that is going on
regarding the holistic view, if you take the business aspect and put it over
the top if our objective is to get adoption around this and we are talking
about maintenance understanding the enormous cost to the industry, to
providers, to payers, to achieve compliance here in all of the things that are
on everybody’s plate today. When we look at the holistic view, the holistic
view of end to end around how the transactions work, but the adoption nature
and the ability to adopt into the numbers.

And what I mean by that is if you took a Pareto chart and said here is the
top three bars on the Pareto chart around what is preventing us from adoption
and attack that with the appropriate maintenance of the transaction and the
operating rules, I would encourage the committee to think about when we look at
the holistic view that we look at the holistic view from the purpose that we
are all trying to achieve here, which is adoption and not take the lowest bar,
not that we would do this purposefully, but just intently looking at the
analytics that support the adoption. That if we did this component of
maintenance, we could get another .5 percent adoption in the industry or it
would remove a roadblock on the practice management side in order to allow
certain transactions to flow and the way we need them to flow.

I think that holistic view is extremely important as we consider the next
round in these transactions.

MR. SOONTHORNSIMA: I was going to make that observation, but I think we
already talked about that because I heard several of you talk about all these
transactions and you look at these things independently. I think you just
covered what I was going to ask.

But I do want to follow up with Gwen a little bit. You are talk about this
as a non-funded mandate. And the question I have is right now this is — it is
really a comment. The funding is done by your membership. The funding is
provided by your members.

MS. LOHSE: The core effort is multi-million dollar effort. It started as a
voluntary effort. It now was adopted to be mandated. The core participating
fees — we keep them very low so anyone can come in. It is $500 for Mona’s
group to be a member. It is free to Medicaids. Less than 10 percent of CORE’s
cost is covered by the CORE participation fees. We have heard from multiple
entities that have reserves or they have billion-dollar spreadsheets that they
do not have the money to join. That is on the provider side as well as on the
health plan side.

CAQH CORE — this new board governance is multi-stakeholder. All the voting
in CORE is multi-stakeholder. Every entity has one vote. CAQH is not treated
any differently, but it is funding 90 percent of the cost. I just want to make
sure because it is complicated.

MR. SOONTHORNSIMA: Here is a follow up. Cover 10 percent of that.

MS. LOHSE: It is actually less than 10 percent.

MS. GOSS: CAQH funds 90 percent. Membership fees cover 10 percent.

MS. LOHSE: Less than 10 percent.

MR. SOONTHORNSIMA: Less than 10 percent. Considering the complexity now that
we are talking about, end to end looking at the transactions as business
process not individual transactions. I do not know. Order of magnitude.
Normally, we just speed up, but unsure adoption. I think that is really the
goal. The rules can be really complex. Have you thought of what it would take
as an entity and then holistically? Is there a model that you are looking at
that could help?

MS. LOHSE: We have actually spent a lot of time about analytics especially
because of the CARC and the RARC need. We are talking about — and also which
of the financials are most important. Tim’s comment I thought was very good.
This goes back to Linda’s comment about where you do maintenance that is going
to have the biggest bang. We have actually done a research analysis with each
of the rules. What analytics we need and what it cost to do those analytics
because you need — we have seen from the index. We have an efficiency index
that is tracking each of the transactions. We are using 1.3 billion claims for
each of the transactions to see where the biggest bang is. Is it the
infrastructure? Is it the data content? We can give you some numbers. They are
not promising because it cost dollars to do the data analysis. And also, you
have to have the people that are willing to provide the data. And then you also
need the process to look at the data and make decisions from it. I hope that
answers your question, does it? I am not sure if I did.

MR. SOONTHORNSIMA: So you need money to analyze.

MS. LOHSE: And collect.

MR. SOONTHORNSIMA: That is the still big question in terms of what it would
take to really move this forward more holistically.

MS. LOHSE: Yes, more holistically. We are probably talking about four times
the amount of funding we have right now for CAQH CORE and maybe three times the
amount of funding. Probably in the four categories from the initial research
that we have done.

MR. SOONTHORNSIMA: Maybe a follow up just for the group. What I have heard
is a handful of themes. One is many entities particularly smaller payers,
smaller practices are struggling and they are not really using the capabilities
that come with all these transactions. And two, there are also other options to
get to eligibility claims status. Information that is incomplete on the
electronic transaction. They might go on the website.

It sounds like there are a lot of options that exist today that prevent
people from leveraging this. How would you balance? How do you stop people from
going to the website? You prevent people from making these websites available
to smaller practices. How do you harmonize those different venues? Any thoughts
on that. This is quite in the practice today and in the industry today. Some of
these practices are actually quite entrenched. People are just not going to
move away over night from the website or otherwise.

MS. HYLAND: I was just going to make a comment from our perspective. We see
that we do not want to limit the capabilities of the providers in obtaining
their reimbursements. I originally worked in the provider sector. I was a
registered nurse. I worked in the hospital settings. I see it from the
provider’s perspective as well as the payer’s perspective having worked for
them and now the vendor clearinghouse perspective. While we have the standards
and rules in our regulatory environment, we also have overlapping standards and
rules. Where do we draw the line to limit providers from obtaining the
information that they need to obtain reimbursement? I think we also have to
consider that as a major portion of this, not to just focus on standards and
rules, but to look at ultimately and providing health care. And to do so, the
providers need their reimbursements to continue to provide health care. I think
that is an important factor in this that has not been discussed, but certainly
needs to be on the table.

MS. REIMERS: If I could chime in as well and I think Tammy had her hand up
too. I would suggest that providers have a place to go where someone will check
on their issue whether it is CAQH, MGMA, AMA, NCVHS, a hotline where they can
say I do not understand why this did not work. And someone would go out, reach
out to the payer or the clearinghouse or the PM system vendor or whoever and
help them with their issues. I know that sounds daunting with the thousands and
thousands of providers and thousands and thousands of transaction code sets.
Maybe if everybody got five golden tickets or something where they could call
in and try to get responses that were intelligent, were problem solving and
educational at the same time. And then you pull those things together and you
share them as lessons learned. There are always a few bad apples, but there are
mostly people who really are trying to make the systems work. I know I do not
know where to go if I did not feel like going was my personal helper or people
like Tammy or MGMA. I honestly do not know where I would go if I did not have
help with some of these things. I think the problem is there is no help that
you can trust to be your single source.

MS. BANKS: Just quick comments. I think these discussions are ones that we
started with the advent of the ACA and incorporation of the operating rules. We
have been asking for the administrative simplification roadmap. What is the
roadmap? What are the priorities in relationship to the standards, to the
operating rules, to the convergence of clinical and administrative data? I know
WEDI is doing a wide scale effort to look at this. I am not sure where they are
at. This is important. CAQH obviously — we have to think about funding. We
have to think about funding for X12. We have to think about funding for — all
of this is voluntary effort guys and we are putting what — how much money into
the system. We are asking people to volunteer their time above and beyond their
day job to get there. There is so much ROI that we have to find a better way to
do that. Obviously, everybody always says CMS funded. But in all seriously, are
we going to really take onus and make change or not? If we are, we have to get
funding to do this.

The second point is about functionality. And realize that one of the key
drivers to bring in solution to physicians is not a covered entity and has no
onus to be in the game. And unless we can get practice management systems in as
covered either as business associates that are required to comply with these
requirements, we are not going to get the wonderful investment that payers are
making to the providers. It has to be incorporated within the workflow. It just
has to happen. It has to be behind the scenes. No one should have to adopt a
270, 271, or even know what it is. Again, I just want to clearly articulate.
Removing options is not going to help, but providing interoperable solutions to
the provider will.

MS. LOHSE: I just want to add two things. One is we feel that certification
is essential. You have a number of hops here. We do not have one network. How
do you hop from one and certify each? We have had a voluntary CORE
certification program. In the appendix of my testimony, you will see some
entities. The majority of them are actually non-CORE participants again using
the CORE developed test suites, test script by stakeholder to see have they met
the rules.

The CORE board has been encouraging certification from the different
practice management systems. I know, for instance, the new board chair has been
encouraging the vendor that Christus uses. It is a $3 or $4 billion health
system to get CORE certified. They also have an EHR system. I think
certification plays a big role in this because it is testing the adoption
afterwards.

The second point is maybe not options, but the question is how do we take
advantage of one of the things that the rules do is encouraging real time
connectivity. There are other methods to connect. We are going to see a need
for that even more in the third set of rules.

Attachments. We had testified about a roadmap in the fall to say we are
going from sending paper by US postal, sending PDF by electronic and then
structure data and structure exchange. We need to allow for that roadmap within
the operating rules. I think some of the real-time, the electronic enrollment,
all of those things encourage people in the right direction. They may not get
to the standard immediately, but it is on the path to the right way. Those
would be the two adds that I would have to your question.

MR. SOONTHORNSIMA: Thank you. One more thing I failed to mention as a theme
is — thank you for bringing that up again, Tammy. The ACA with the health
insurance exchanges and with the 90-day rule. Do you see this as an opportunity
then because after the 30-day period when they start pending the claims?
Obviously, on this eligibility information is already being made available to
the providers whether on the website or electronic means. Is this an
opportunity then to get the providers to be educated with this 90-day period?
And perhaps there is an effort that we can do together to make sure that you
start using electronic transactions. Possibly, there will be more clarity
before you deliver more care. Whatever. The sooner they know the better. What
are your thoughts on that? I see this as an opportunity, but I know there are
also challenges as you all have said of the adoption today.

MS. BANKS: Obviously, I see it as a huge challenge, however, an opportunity
as you said. We really have to look at to make sure the information is provided
and it gets to physicians. Again, we do have a lot of hurdles. As an industry,
we have to agree that we are going to get to the solutions. We have to get
practice management systems or we are going to pass that information to the
provider. I know I am being redundant here, but that is a big key message.

We also need to have education. I do not mean to be disparaging here, but
take a look at the CORE rule in order to help providers collect at time of
service. How much education came out from CMS saying you now have these
numbers? This is what can happen. There is a huge workflow change that has to
happen in the provider office. I talked to vendors. No vendor went out and said
you are going to get more information. You can be more efficient. Here, this is
what you can do. Here is your ROI. I know we have been messaging it. It is not
enough. That is why we get back to the roadmap, which is even more important
than any single issue that if we do not agree on the priorities and we do not
agree on the messaging points and we do not go out like Banshees to every
stakeholder to make sure we play our part, we all suffer. Unfortunately, we do
not have all the stakeholders in line to make this happen. But the exchanges —
we have to figure out a way to get that information in a clear concise manner
that can be used.

DR. SUAREZ: Well thank you. With that, thank you so very much everyone for
this panel. I know we are running a little behind. I did not want to let the
discussion be cut short. I think we had a number of very important large-scale
messages that we heard and some also very important more specific issues and
points about the current and the next round of operating rules. Again, thank
you so much for the testimony. We will certainly be following up with many of
you to get some more clarifications and opportunities to find ways to improve
the process.

Thank you very much. We are going to take a ten-minute break. We are going
to come back at 10:50. We will reconvene the last panel.

(Break)

DR. SUAREZ: We are going to reconvene the hearing. We are going to go to our
second panel this morning. We have divided this into two parts. The first part
is really focusing on the plans and the status of preparation for achieving
ICD-10 compliance. We are going to hear from several perspectives.

We are going to change a little bit the order. We are going to begin with
the testing pilot discussion and testimony and then we will move to the other
testifiers.

And then we are going to have a second part that is focusing the new users
for ICD-10 data and opportunities around new uses, new applications, and new
relationships between ICD-10 and other vocabulary and terminology.

I think the idea is we are going to start with part one, go through the
testimony and then leave time for questions at that point and then move to part
two, hear the testimony and then open up for the discussion at that point.

We are really going to try to keep things in time and we are asking
testifiers to limit their testimony to about six or seven minutes. We are going
to be giving you a first warning, which is the yield sign when you have three
minutes to go. The yield sign means you have three more minutes to go. And then
the gentleman, the police person here will be a one-minute warning. That is the
way we are going to be going.

Let’s start with testimony from — I think, Kari, you want to do —

Agenda Item: ICD-10 Planning, Testing, and
Implementation

Part I – Preparing for Implementation

MS. GAARE: We appreciate you all moving us around. Good morning. I am Kari
Gaare of the Office of E-health Standards and Services. Thank you for having us
here today to give an overview of the end-to-end testing pilot. I am joined by
Dean Cook of National Government Services. He is going to go into a bit more
detail, but I just wanted to begin with a little bit of background about the
project.

In September of 2012, we awarded a contract to National Government Services.
And the purpose of the project is to develop a process and methodology for
end-to-end testing that could be used for all of the administrative
simplification requirements. We decided to test this framework using ICD-10 as
the pilot case. As we have heard from NCVHS recommendations and also from
industry testimony, end-to-end testing is very critical for implementation.
What we have heard is that there really is not a common understanding of what
end-to-end testing is and what needs to be accomplished prior to implementation
for that.

Really the purpose of our contract was to begin to explore the concept of
end-to-end testing. We wanted to develop a framework and we really wanted to
focus on getting industry input when we were doing the framework development.
And then finally we wanted to pilot it.

With that, I will turn it over to Dean. He will talk a little bit more in
depth about what we have done to date so far in the pilot and then where we are
headed.

MR. COOK: Thank you, Kari. Good morning everyone. I would like to thank you
for the opportunity to present our pilot for end-to-end testing and talk a
little bit about the importance of it throughout the different industry
segments.

One of the things that is important to know about the pilot was that it was
a non-industry specific pilot. We were looking for a solution to work for all
industry segments. Even though when we were awarded the contract, I was working
as Medicare contractor. I was pretty sure that I needed to take my Medicare hat
off. We had to look at something that worked for commercial, for blues, for
Aetnas, for Medicares, Medicaids. We were looking at solutions that meet the
needs of the entire industry. And over my 34 years in IT and health care, I had
a lot to bring to the table. My role in this project is to serve as a subject
matter expert.

What we are going to talk about today a little bit is I am going to give you
an overview of our goals, our intended outcomes, kind of a pilot overview of
what we have done, the three phases that we have, what we have completed to
date, talk a little bit about our webinars and the listening sessions.

One of the things that was important was we wanted this to be built by
collaborations. One of the things that this pilot had to do was prove that we
can all get in the room and get along. That was one of the first hurdles. And
to do it virtually was another hurdle, which you folks have overcome here. You
have already adapted to that and we had to get 17 companies that brought a one
to many relationship with all of their constituents together and get us to
agree on some things that we could work forward for the industry. Those were
some of the things and then we will talk a little bit about our checklist and
how to get a hold of us.

Our goals were more than just what we started with. We needed to develop and
implement a process and a methodology, not a system, but we also needed to come
up with some tools that would work for each industry segment to guide them and
the process of being able to adopt transaction standards, operating rules, code
sets, identifiers, and any type of administrative simplification type change.
That end effect of ICD-10 — ICD-10 is really a subset of administrative
simplification. We used that as a pilot of proof of concept.

Our second goal was to make this become an industry-wide best practice. And
in order to do that, we have been partnering with WEDI and with HIMSS and some
of the other entities that are out there that had already started work taking
the approach that we did not want to recreate a tire. Tires already exist. They
roll and they get shipped from point A to point B. It is just a matter of how
long they last. We wanted to look at what they had already done and kind of
leverage some of that.

Our intended outcomes were basically to provide documents and artifacts or
what we call tools that can work with the other tools that you already have
available because we found that as we looked at this many of the industry
segments already had project plans. They had business plans. They had other
tools with their translator companies and things that were already in place. We
needed to provide some tools that could supplement some of that that it would
help them identify the key checkpoints.

Another outcome that we hope to have was to make it become something that
would be a universal process. One of the things that we have lacked in the
industry since HIPAA and even before that was a common repeatable way to test
things. We were trying to come up with some tools that would help us if we
could dust it off when HIPAA NICS comes out. Maybe the tasks that need to be
done are a little bit different because of HIPAA NICS, but the process, the
methodology, and the checklist could be reused over and over again. That way we
do not have to reinvent that wheel every time we pick it up, dust it off, and
move forward.

And then we had to start with the universal framework or a common
understanding.

We devised our project into three phases. The first phase was our gap
analysis identifying our industry collaboration partners. The second phase was
the actual detailed work of building the checklist. What we did was we started
with a base document. We built documents for the five industry segments to
start with. Then we presented them to our industry collaboration partners and
get feedback from them. And then we began to hold listening sessions with those
different industry segments. We will show you some statistics from that.

And we are on track the end of this month as of June 27 to actually release
our next version, which will be the excel version of the document to go out in
the final three months to be used for testing to where those industry segments
can use it and start to work through it.

What we have completed to date was we recruited our ICPs as we have talked
about. They were a varied group. We defined the industry segments that we had
and there are five of those and we will talk about those a little bit later. We
had to define what our levels are at one, two, and three, one being internal
readiness assessment, two being some external testing, and three being ready
for full production.

We had to come up with baseline definitions. We had 17 ICPs and we had about
100 definitions for end-to-end testing when we started. We had to work through
that to come to a common definition for that. We came to a definition for
readiness and a definition for compliance. These definitions have been reviewed
by OESS legal. Now, they approved them tentatively with the understanding that
there is no regulation or legislation written up for them at this point, but
they said that it looked okay as a starting or a base point.

We met 31 times with our ICPs with an average attendance of 67 percent,
which isn’t too bad considering that we ask these to be volunteers. They are
volunteering their time.

We have also held listening sessions and these were with the various
industry segments that we will talk about. We started those back in February
and we did it with a herculean effort. We started out with the first listening
session with six hours, not hours continuously with one topic, but a general
session that was an hour and a half, two hours. Then we had a session for an
hour on each of the industry segments. That way if you were a small provider,
you came back to that. If you were a large provider, you came to that. If you
were a payer, you came to that. If you were a vendor, you would come to one of
those and work through those. We have also met with some other groups like
PAHCOM, with Cooperative Exchange, with HBMA, and we have been working with
Walgreens to address NCPDP issues.

Some of the statistics. We have held 50 listening sessions thus far, as of
May 31, and we have had 3922 entities. I say entities because that is people
that actually connected. We sometimes have more than one person on the line at
any given time.

Our industry segments and we have five checklists at this point. One for
small providers. One for large providers. One for payer. And then when we
thought of vendor, we realized there are differences if you are a provider with
products. You have practice management and EHR as well as your analytic
products. But if you are a payer, you also have vendors that are involved. We
have two flavors of that checklist.

We divided our documents into two. We have a high-level end-to-end testing
document. You can think of that as an executive summary. It contains the
levels. It also contains what we call elements. And we defined our elements as
six different types of elements that are not necessarily applicable for all of
the checklist. There is a planning where you have to know what the legislation
says. There is an assessment. Then there is a design where you go right to
specs. Then there is a development. Then there is a testing and there is an
implementation.

We also provide suggested timelines on the ICD-10 and the administrative
simplification version of these of how far out from the regulation date you
need to start doing those and those are provided at each level.

Then we get into our detailed end-to-end checklist. And on there, we have an
instructions tab and that is basically because we have an excel document with
lots of formulas. If you have ever played with excel, it is real easy to mess
things up. We put in detailed instructions on how to add rows and how to do
different things to make it usable and how to make it work for everyone that is
going to need to use it.

We have definitions. And on that tab, we have the definition for end-to-end
testing, for readiness, for compliance. We have a definition for what each
element means as well as definitions for some of the industry groups that we
have worked with and kind of a guidance with our links. It has hot links to the
websites to help you get to those places.

We also included an initial assessment that allows you to identify the
transactions that you use and also allows you to identify trading partners, a
total number, and then some other questions. Then we get into the detailed part
of the checklist that has an element with all of the tasks. They vary in size
from about 100 lines to which takes up to about 16 pages to some of them are a
little bit smaller in the 10 to 16 pages when you look at all of the tasks that
are out there. And then we show the link that is up there.

We have a mailbox set up, which is ngs.compliancetesting@wellpoint.com and
it provides a source for people to give us questions and we respond to those
questions within one business day. It is also how people sign up for the
listening sessions that are going on.

We are currently on a hiatus in the month of June because we had about 20
sessions in May and now we are taking all of that under advisement and working
it back into that next version of the checklist that is scheduled to come out
on June 21.

Hopefully, that gives you an idea of what we have done so far and then we
will be glad to take questions at this point.

DR. SUAREZ: Thank you very much. We are going to go next to Michigan.
Dennis.

MR. WINKLER: Good afternoon or good morning still. My name is Dennis
Winkler. I am technical director of Blue Cross Blue Shield of Michigan. And on
behalf of the association Blue Cross Blue Shield of Michigan and the other
Blues’ plans, thank you for the opportunity to talk about what we are doing
really in the testing space.

I think what you are going to hear today is a tad different than a lot of
the traditional activities going on in testing, but hopefully we will explain
why. Everyone knows testing is critical. The bottom line is it is not until the
payers have the opportunity to actually test with the providers that we
actually will know what information will or will not be coming across when
ICD-10 goes live. That is what makes it very important that we figure out how
to do an effective end-to-end testing with the provider constituents.

There are a lot of different concepts and testings going on. But as you have
heard on the CMS pilot, really they are scenario based and include end-to-end
testing. Blue Cross Blue Shield of Michigan is participating in as many of the
pilots as possible because we strongly believe that medical scenarios,
well-defined medical scenarios are key to effective testing. But we truly
believe that there is a much more cost effective way to do testing with our
providers for ICD-10 than end-to-end testing. We call that content-based
testing.

Why is testing an issue? If you think about it, end-to-end testing is and
always has been an issue associated with its difficulty in implementing. It is
expensive and it is time consuming. Because you oftentimes are focused within
specific issues or situations that you want to test, its results are really
limited.

As it relates to ICD-10 and we still view ICD-10 as a business-based
initiative. It is not a technology initiative. And therefore we believe that
any testing for ICD-10 with our providers need to be accessible to all
providers, not those with deep pockets that can test with us. It needs to be
very easy to understand and execute and must be cost effective. But most of all
the information that we test with between the provider and the payer must be in
a manner in which we both learn something and position ourselves to be better
off for the transition to ICD-10. That is when we feel content-based testing
occurs.

Now, what we have basically done is the premise that we know that providers
and all the way through the payers can run 5010 today. If you think back very
simply, the only difference that is occurring with ICD-10 from a technology
standpoint is we have a flag that says it is an ICD-10 code and one could
question why we need the flag and the actual ICD-10 value itself, which is
going to be validated against based on a valid table of codes for a given
effective date. Basically, knowing that as a premise, we basically said let’s
get rid of all the infrastructure and figure out a mechanism in which we
actually communicate with the providers. This is very simple and it is very
inexpensive. View this as online testing. The providers are taking an online
test. And everything you are going to hear about is just based on that.

On the professional side, we basically started with our key set of claims,
our production claims that are of interest to us whether that is high priority,
high dollar, and high risk. Those codes that are of interest from a payer
standpoint and we create medical scenarios. And basically, we have the
physicians sit down in a web environment and those scenarios are exposed to
them and they take an online test. All they have to do is tell us what ICD-10
codes in order starting with the primary diagnostic code all the way through
the other ICD-10 codes they would send for that scenario. They would then send
that over to us. We would still, as a payer, have to run those because their
medical scenarios are predefined. We have the test environment set up. All that
we are doing is receiving the ICD-10s. We are appending the ICD-10s onto the
claim, running that through our test environment, and then we basically send
back to the provider not only the results of the information they sent, but the
baseline that we had relative to those production claims in nine and any
discrepancies.

We also send back to them what their constituents have selected as primary
ICD-10 codes. That is the feedback loop. They sit down. Take an online test. We
run it through the test environment and we send back through an email
notifications the results of their test.

Now on the facility side, it is a tad different. We were hopeful that on the
facilities we could do the same thing. But we found in discussions with our
facilities is that the groups that actually do the coding for the facilities
are so entwined with how they actually store medical records in their current
environment that we could not come up with generic scenarios. At least for
ICD-10, we are actually finding again those high volume, high dollar, high
impact claims in production sitting down with the facilities. And when we agree
that those are the scenarios they want to test, they go pull the record. Then
they recode it again through the online test mechanism. They basically code
that ten, send the tens over and we receive it, process it, but there we go
through the DRG and we show the DRG mismatch. Very simple process.

Benefits to this approach. Provides examples, real life examples based on
history as to what actual ICD-10 codes for a given medical scenario providers
will be sending to us and will be processing.

Therefore, it allows the providers to determine if their clinical
documentation supports ICD-10 coding. That is one of the key values that we
believe we will get out of content-based testing with our providers. It is very
easy for providers to participate the traditional testing. All they have to do
is enroll, tell us what specialty for a medical professional provider, and they
are in. There is no cost to the provider other than taking the test. The full
cost is on the payer.

Therefore, we believe it will increase the possibility of provider
engagement. Properly defined medical scenarios should stand the test of time.
Medical scenarios if done right are not ICD-10 centric. They are defined
situations that occur in the medical community. If we in fact define those
properly, they should be able to be reused, which is consistent with I think
what you heard earlier about reusability.

Avoids risk associated with PHI. All we are doing is sending back ICD-10
codes and results. There is no information associated with the actual PHI so we
do not have any risks there. It minimizes the resources required to provide the
testing.

Challenges to the approach. Developing scenarios is resource intensive. Very
resource intensive if done right. Scenarios must be clinically airtight so that
you do not have any interpretation.

I am told that I am done except one thing. I have to do this and that is
with any testimony we have to have an ask. Let get to the ask. This is a great
document. Feel free to read it and ask me any questions. However, request for
help. For us to finish our testing, we as a Medicare provider also or payer, we
actually have to finish our testing associated with the risk scores both with
ourselves internally as well as with our provider community. It is very
important that we have the updated ICD-10-based version of the hierarchical
condition codes for us to complete that testing. To date, we have not received
any date or notification as when that information would be available. We are
asking for some assistance in being able to get a date so we can plan
accordingly to complete our testing.

Similarly, we have a lot of the pilot groups are going around creating
medical scenarios. We firmly believe that there should be an ability to reuse
these scenarios so we are asking for consideration to create a national-based
repository of medical scenarios that can be used over the course of time.

Thank you very much for the six minutes and my quick presentation.

DR. SUAREZ: Thank you so much. I think we go next to Tim.

MR. MCMULLEN: Once again, I am still Tim McMullen, executive director of the
Cooperative Exchange. We are still the recognized resource and representative
of the clearinghouse industry. And we currently still have 26-member companies
and organizations including 19 clearinghouses.

Our position in partnering with both providers, vendors, and payers give
clearinghouses a unique and comprehensive perspective. And today I am answering
the questions posed by the subcommittee regarding the planning, testing, and
implementation of ICD-10.

First, I think it is important for everyone to realize what a clearinghouse
can and cannot do. In the role of ICD-10, our role is not to provide the code
on the claim, but to pass it through from the provider to the payer. We can
provide mechanisms to edit codes against payer guidelines, but we cannot
crosswalk codes based on medical record content. However, that being said, we
all know that clearinghouses will be the first people you call when something
goes wrong.

I want to at this moment just really quick — it is not on the slide there.
I just want to speak briefly to say that the Medicare decision to not to
end-to-end testing without sufficient reasoning. They came out with a statement
last week. We just felt it was a bad signal to the industry because providers
who have substantial business with Medicare may be at a great disadvantage
because of this decision. I did speak with Cathy Carter yesterday on this. She
explained the reasoning, but I think that reasoning needs to be brought forth
to the public to have better understanding of why they made that decision.
Again, I think it sends a bad signal to say that.

In the end when I say we are going to get the call, providers need to
determine if the reimbursement is the same, different based upon the DRG codes.
And again with testing, larger payers are end-to-end testing with their largest
providers and at least a beta population of end-to-end testing would help. That
was my Medicare statement response.

Another question asked was about milestones. And to ensure a successful
transition, we recommend these critical industry milestones to achieve between
now and the proposed new compliance deadline. These are sort of in order of how
they need to happen. These are still the issues that are still outstanding.
Payers need to publicly release their testing dates and testing plans. We have
not heard from all payers.

Vendors need to get their systems to providers. I heard just last week or a
couple of weeks ago that a very large vendor is nowhere near ready with some of
their clients. They need to get their systems out to the providers.

Next, the payers really need to release edits as soon as possible. We saw
this problem in 5010 when it was — I think they released theirs in April
before it went live. And providers transfer their systems to the new software.
Some folks still have difficulty with that.

We heard this yesterday as well. To maintain industry momentum on
transitioning to ICD-10, we strongly urge OESS not to change the date or
provide a grace period. This will only further delay industry preparations. We
heard some of this this morning as well.

To better facilitate end-to-end testing during the remaining transition
period, the Cooperative Exchange urges all stakeholders in terms of
collaborating. Collaboration is key here. Consider the HIMSS ICD-10 National
Testing Program going on or a state collaborative, and especially participate
with your clearinghouses.

As we saw with 5010, the biggest risk for health plans and providers are
cash flow, i.e. the delay in payments because of coding issues. For the
provider not getting paid at all or getting underpaid will require providers to
look at their reports on a daily basis. Obtaining those reports will mean they
have a reporting system in place. Again, some of the vendor software is not
capable of doing that. The clearinghouses can provide this information as well
as historical payment information.

For the payers, the cash flow issue is just as important. Their cash flow
must be within the range of their estimates, or else their reserves and medical
loss ratio measures are at risk. That is it.

DR. SUAREZ: Thank you very much. We are going to go to Rob now.

MR. TENNANT: On behalf of our more than 22,000 members, I would like to
thank the subcommittee for the opportunity to testify. As we all know, there is
a lot of steps that practices need to take to get ready for ICD-10. I am going
to focus really on just a couple. One is of course the software changes that
are necessary both on the practice management system side and on the EHR side.
But also and what we are focusing on here is external testing with their
clearinghouses and health plans.

One thing that is relevant. We just concluded some research, which finished
up last week. We got almost 1200 respondents to our survey in groups where
about 55,000 physicians practice. Group size range from 1 to 700 with the vast
majority being in physician practices of 20 or less. Forty-four medical
practices, specialties were included. The interesting results start here, which
is the vast majority of practices need a software upgrade. I think that is
expected, but very few are saying that their system currently is able to
generate the I-10 codes.

Also very interesting is the cost. We have seen some studies in the past
that look at cost. This is the most up to date numbers that we have seen. About
33 percent say that their vendor will cover the cost for both PM and EHR
upgrades or replacements. But for those again the majority that will have to
pay for it for again a small practice, 10 physicians, they are looking at a
cost of over $200,000 just for the software, not including staff training and
other costs associated with ICD-10.

One thing we are finding is that the majority of vendors have not even
communicated with the practices. I think that is the most startling revelation
from our survey. It echoes a lot of what we have heard in the last two days is
that communication is simply not happening. The same with in terms of testing
dates. We are simply not hearing from the vendors of when the upgrade will take
place, when we will be able to conduct internal testing in the practices. And
that leads of course to external testing.

And what is interesting here is on the clearinghouse side, about 60 percent
of practices say they have not heard anything from their clearinghouse in terms
of testing. And more than 70 percent say they have not heard from any of their
major health plans regarding testing dates.

Obviously, they are concerned about a lot of things when it comes to ICD-10.
Most importantly, the loss of productivity following the implementation dates.
Seventy percent are very concerned about it. We have seen various statistics
floating around. There were some released in the last HIMMS meeting suggesting
that a clinician is going to spend an extra five minutes for a patient
encounter. You say five minutes is not very long. But if you are a physician
seeing 25 or 30 patients a day, five extra minutes probably translates to 20
percent less money coming in the door. A huge potential loss in revenue for the
practice.

Of course, the ability to select the right code is also a huge concern for
practices. And, again, these are multi-specialty groups. There are single
specialty groups. Very concerning.

To get to Tim’s point, why should we worry about the clearinghouse? As you
can see here, a lot of practices use a lot of clearinghouse services. The vast
majority have between 80 and 100 percent of their claims flowing through a
clearinghouse. If the clearinghouses are not ready, are not able to test, it
certainly going to be a problem for us.

And then you add the issue of unspecified. You can see here that a pretty
significant percentage of practices say they use unspecified codes on a regular
basis. As we know, the clearinghouse cannot solve that particular problem for
the practice. They can help, but they cannot solve the problem. You have these
factors. We learned earlier that between 10 and 20 percent of practices are
still on 4010, a huge issue as well.

Just to echo Tim’s comment about the very unsettling news from Medicare that
they will not be conducting end-to-end testing, I do not think the irony is
lost on us that the good folks at NGS have been working with us and others to
create an end-to-end checklist for payers and Medicare itself will not be
employing that checklist.

In conclusion, I wanted to say that there are a lot of issues with
collaboration or the lack thereof, a lack of communication between practices
and their key trading partners.

In terms of recommendations, we have a few. Obviously, we need to reverse
the policy not to test. That is ridiculous. You cannot have a turnkey situation
in October and expect the payments to simply begin flowing. We have to release
the payment policies for both Medicare and Medicaid. We are recommending a
registry that would allow practices to go to a single location on the CMS site
and learn all they need to know about readiness and where to go to test. We
need to fully engage with the HIMMS, WEDI national testing pilot.

We have to obviously ramp up education. Dr. Mostashari yesterday mentioned
the RECs as a potential vehicle to educate small providers. They are working
with over 140,000 primary care doctors, yet, he claims there is no money. That
has to change. We have to reach the most vulnerable providers in the industry
and the RECs are an outstanding way to go about that.

And of course, as we have said many times, there has to be a practice
management system certification process. We have heard that alluded to here in
the last couple of panels. It is critical that the market have a way to
differentiate between products and practices need to know if they will be able
to take advantage, not only of ICD-10, but also operating rules and the other
transactions.

Thank you very much.

DR. SUAREZ: Thank you so much Rob. Thank you. That was terrific. We are
going to go to Holly.

MS. LOUIE: Good morning everyone. My name is Holly Louie and I am the chair
of the ICD-10 committee for the Healthcare Billing and Management Association.
For those of you who may not be familiar with that organization, it represents
more than 700 professional billing companies that employ more than 30,000
people and submit an average of 350 million initial claims annually.

HBMA has been providing information, education, and resources to our members
since 2009. We believed Denise every time she says we are not going to delay it
again. We keep telling them that and we believe it is really going to be next
year.

The other thing that I think sometimes gets lost in the shuffle is this is
not just a coding change. It is completely changing the payment model. It has
the potential to be extremely disruptive to the health care system at large if
it is not done well.

When we last testified here last year, we raised some key points and I would
like to take just a moment to point those out again because I do not think they
have changed. The definition of ready did not have an agreed upon definition so
it meant whatever anybody wanted it to mean. I think we need to learn from that
and have one definition of ready this time.

We learned with 5010 that payer testing to Rob’s point was extremely
limited. It tended to only test syntax, not full adjudication. It did not cover
the edits that surprised us later. And it did not complete the process so to
speak. It was certainly opaque, not transparent. I think one of the earlier
committees today talked about getting surprises that you did not even know were
in the process.

We also had asked this committee to encourage the secretary and CMS to
establish benchmark dates for testing that could not be ignored and we still
support that strongly.

What did our industry scan show? We still have quite a few payers that are
using 4010 predominately in the Medicaid and Medicaid HMO programs. Confidence
that they will be ready is questionable.

The recent studies that confirmed that physician documentation is still
deficient somewhere in the vicinity of 40 to 50 percent of the time to choose
the most specific code currently much less under ICD-10.

Our survey this month has shown that currently we do not have any member who
can test end to end with any known payer.

Testing dates are payers have provided to us and our vendors and our
practice management vendors range from now until my personal favorite. They
plan to test October 1, 2014.

The industry has also shown that a lot of people have not made noticeable
progress.

And payers are widely convergent in their coverage policies. Some have said
they will not process unspecified. Some have said business as usual. And one
commercial plan said to ask CMS or AMA what their policy should be.

I think payers struggle every single year just updating ICD-9, CPT and the
NCCI edits quarterly. They cannot meet those deadlines. This is concerning.
ICD-10 is exponentially bigger than 5010. I think we still need to remember
that.

I echo everybody else. The CMS announcement that they would not test
externally is extremely concerning. If commercial payers follow that and there
is no external testing, there will be no way to know if it is successful until
it is too late and we are sacrificing reimbursement to the providers.

And lastly, very quickly because I saw some — I think for the doctors in
the group most of us have heard or nurses have heard of distracting injuries.
In emergency medicine, it just means you focus on the fact somebody has a bone
sticking out of their foot and in the meantime they are dying of something that
was really serious that you overlooked. I think there are a lot of distractions
in our industry right now. This new policy from CMS. We have already heard
people say that means they are not going to go on October 14 because they do
not need to check. I think that is a concern and it is a credibility issue.

Next, I think repeated announcements by some influential people that ICD-10
will be delayed tends to lead to apathy and we can wait attitude, which will be
problematic as we move forward to the go live date.

I think ridiculing some of the ICD-10 codes — really, burn due to water
skis on fire subsequent encounter. How many times are we going to need that
code? I would submit maybe never. But it distracts from the true codes that do
matter in getting the data we need and the quality care we need that are in the
ICD-10. I think the focus needs to be on that and what that provides.

And there is no miracle cure. There will be no software clearinghouse or
anything else that is going to solve this. We need to work directly with our
providers.

With that, I see my shut up sign. I am going to conclude here very quickly.

We really encourage this committee in the strongest terms possible to
recommend that both Medicare and Medicaid must engage in end-to-end testing and
meaningful testing with their major stakeholder groups and their critical size
partners. We are not asking that they test with every single one man physician
in the country. But critical trading partners do need to be able to test to
know what is going to happen.

I saw a cartoon this morning that the first door said lessons learned. The
second door said lessons relearned. And the third door said, oh, for crying out
loud. We want to avoid those last two doors if we can. Thank you very much.

DR. SUAREZ: Thank you. Thank you very much. Joe, I think is next.

MR. MILLER: Good morning. My name is Joe Miller. I am a director of
e-Business at AmeriHealth, but this morning I am speaking out on behalf of
HIMSS where I have been a co-leader along with Jim Daley from WEDI of the HIMSS
WEDI ICD-10 National Pilot Program Collaborative.

Let me say that the collaborative started really in April of 2012 a couple
of months after the date was reset for the implementation. HIMSS convened a
group of industry leaders, many of them sitting here in the room to look at
what could we do to ensure that there was not another reset of the date and how
could we work together as an industry to ensure that payers, providers,
clearinghouses, and vendors could collaborate together to be a more efficient
and effective implementation of ICD-10. Out of that came the ICD-10 national
pilot program, which is a collaboration of HIMSS and WEDI.

There are many challenges. I do not have time to go through all of these. I
think probably the committee understands many of them. But part of these
challenges around testing involve creating a test bed of data is a time
consuming — a reliable useful test bed of data is a very time consuming and
expensive process and not everyone needs to do it individually. We can leverage
and utilize what others are doing here.

Timing of testing is very challenging effort. And testing — making sure
that all the participants are in the same place at that point in time and able
then to share their information is a challenge.

And finally, any kind of synchronous end-to-end testing across all of those
involved is challenging. Not everyone has their system in the same place at the
same time. How do we move forward?

We suggested that we wanted to try to create a new process for end-to-end
testing that would enable us to really advocate for testing that could begin
now as opposed to a process where folks could use it now as oppose to as they
got closer to the implementation date that reduced any trial and error. It
avoided the problem of synchronous testing.

The pilot program enables a base level of testing. It helps to establish a
minimal testing threshold. It applies common threshold values and uses
de-identified data.

Today we have a pilot test going on that has over 34 providers, 19 payers, a
number of clearinghouses as well as vendors involved in the testing process.

The test is being done with clinical scenarios that use real data, data that
was contributed by a number of facilities that has been coded by AHIMA-trained
coders, a whole group of coders. And they have completed 67 — coding on 67
percent of those scenarios. We are up to about 200 scenarios at this point.

As I said, the groups are coders. They are multiply coded by multiple groups
of coders. And the steering committee for this effort — about half of the
scenarios are coded by the steering committee.

What we have here is a very valuable set of test scenarios that are being
used today by providers who are going through the process now and — first
pilot test of this to actually go through and code those clinical scenarios.

They bring their results back to the team of original coders and then
getting feedback on their coding process. Payers and clearinghouses are also
looking at this data through an asynchronous process that allows everybody to
work on the same set of testing scenarios at the same time.

I will skip quickly to the end because I know that I have probably a minute
yet. But a key point that we found was real life testing scenarios are key. We
learned so much more from those. I would echo Dennis’ comment that one of the
things we need to take out of this is not that I think we have developed just a
good process for testing ICD-10, but we have developed a rich set of clinical
scenarios that we should be advocating for our industry to use.

If I were a CIO or a CFO in a practice, wouldn’t it be great if I could ask
have we tested with the national set of scenarios? If I were a practiced
manager in a practice, wouldn’t it be great if I could ask a vendor have you
tested with a national set of core scenarios? The next time WEDI does its
survey, wouldn’t it be a great measure of industry progress we could ask
people? Have you finished initial testing with the base set of core scenarios?
This is a key objective for us. The roadmaps for each group will be varied and
so forth. But if we can ask that question, I think we can both measure where we
are in the process and ensure greater success. Thank you.

DR. SUAREZ: Great. Thank you so much. I think that concludes our first part.
We are going to open it up for some questions from the committee. While people
are raising their cards, it looks like they are moving quickly. I guess I
wanted to ask the CMS representatives about the decision that was announced to
not do end-to-end testing. I think it is important to hear and to understand
that give the impact and the effect that it could have into the future. Would
that be something that you want to talk about?

MR. TAGALICOD: Actually a few comments that I would like to make based on
what we have already heard. I just want to clarify. There are several hats that
CMS wears. One is programmatic. Clearly, I want to address — I am glad Cathy
is here. The hat I am currently wearing and then Cathy can talk about the
programmatic piece is from a policy and regulatory side. I want to reiterate
that the date has not changed and will not change. I want to clearly emphasize
that.

Two, we believe that testing is important whether that is end-to-end testing
or content-based testing or other forms of testing. We do say that we want to
leverage what exists or what will be coming down the pike, the best practices,
and the things that we have been talking about. Yes, it should be data driven
and it should be real or the other word was airtight clinical scenarios. Those
are the kinds of things.

And, yes, I would like to validate that when talk about whatever testing the
definitions should be consistent across industry. Those are the kinds of things
that we are looking at.

Then I am going to turn it over in terms of the programmatic piece and the
decision that was made, a business decision that was made on the programmatic
side.

DR. SUAREZ: Cathy, do you mind identifying yourself for the record?

MS. CARTER: Cathy Carter from CMS, really speaking on behalf of fee for
service Medicare again. And this decision — I think there has been maybe some
a little bit of confusion. We have had the same plan in mind ever since the
very beginning of all the work for these many years we have been working on
ICD-10. I do not believe there was ever a plan to test in fact with providers
all the way through and be able to give back a remittance advice that says here
is the exact amount of money that you would get for this. That was not planned.

The announcement that people were talking about really was not an
announcement. What it was is the MACs were telling us they were getting
questions and they were asking what they should say. The answer is the honest
answer. No, that is not what we are planning on doing. There is nothing set up
to do that in the Medicare environment.

We have heard today and previous days loud and clear folks are not happy
with that. I guess in part I can understand the concern. I think that in order
for us to do — I think there is a lot of difference in interpretation about
what testing is and some ideas here today about how one could go about doing
things I think are interesting things maybe to think about.

And what we have agreed informally I must tell you in the agency is that we
would talk about this. That is all we have agreed to. There really has been no
money or process or time set aside to do this kind of testing. Our plan is to
have all of our changes made, all of our system changes made in October of this
year. That is the plan. And then we would have a year to do our testing of all
of the pieces that have been done throughout that next year. We think we have a
very rigorous testing process for all of the changes we make. We make really
big changes, have done that for years. Things do not always go perfectly
clearly, but we believe that our testing process really is sufficient. We think
that this is a different sort of change than what we had for 5010, for example,
the ability to get a file. We could test whether or not you can send us an
ICD-10. That would be easy. I do not think that would tell you anything. That
is not going to tell you anything at all. We will all have the files of codes,
the nines and the tens for the different dates of service.

All I can say at this point is we will go back and have some discussion. But
I do not believe it is an easy — there is no easy answer to this. I fear that
whatever it is we could potentially come up with is probably going to still
have many people unhappy. We are in this place that is probably not a very
happy place. We are not trying to say we don’t want to go by the rules. We are
not trying to be better than other payers or anything like that. We are trying
to be realistic about what is possible given the environment that we operate
in. As I said, we do have an extensive testing process. We think it is
sufficient to make sure things will happen correctly.

It is interesting that the majority of the concern seems to be on the
physician side as opposed to the institutional side. At least that is what we
have been hearing. And on the physician side the payment process does not
really — it is really not as nearly as much driven on diagnosis codes as it is
on HCPCS codes. It is an interesting dynamic. I hope that at least addresses —

DR. SUAREZ: Thanks Cathy for that and Rob for those comments. I really
appreciate those. We are going to go to questions from the committee.

DR. SOLACE: I was curious. We have heard a lot about testing especially with
common scenarios and common use cases. One thing we have been looking at and
that is that the cumulative prevalence of less common diseases is actually
pretty high. A lot of significant patients have rarer to less prevalent
diseases. How might you start to look at — and basically any code set when you
change it is really going to be a continuous improvement process iteratively
for hopefully and it is a good thing for many years. How might we work this so
that we address the needs of these smaller communities?

MR. MILLER: I think if I understand your question there are — let me
approach it this way. When we began with our course, we would call a core set
of test case scenarios. It was really with the idea in mind that payers and
providers would develop other scenarios to supplement this core set with. And
that the core set over time could expand.

But our concern again was getting everybody on the bus and the reality being
that many of those providers to get in the bus might not even test at all. But
if we gave them some basic scenarios to test with, they had something in their
hands that they could work with. It was not to limit it to that by any means,
but rather to create a starter set of scenarios to work with.

MS. KLOSS: Thank you all for your testimony. I have two questions, but first
I will say that compared to a year ago, I guess I am a glass half-full person.
Progress has been made. Last year we talked about it would be good if there
were some models for end-to-end testing. Here we are. We have them. And we also
have scenarios being developed.

Now it seems to me that we are going to need a step-by-step guideline for
all of the parties as to how to use these new tools because if there is
anything we have learned about the ICD-10 transition process no matter how
finely you break down the set of instructions, you have to make it more
explicit. I would think the end-to-end plus the scenario — they are not
mutually exclusive. They are very complementary. But I would think a next step
and I do not know if you agree or if this is in the works of putting this
together into a very simple explanation for people as to what is going to be —
what is going to allow them to sleep at night because I think that is the level
at which a lot of organizations are working. Maybe we could have a little
discussion on that.

My second question goes back to the testimony we heard yesterday from WEDI,
which seems to be the glass half-empty part of this story is that despite the
good progress being made, the data coming in in terms of substantial readiness
is bleak. Whatever your suggestions might be as kind of the shock and wake up
call. Whatever collectively all of the stakeholders can do to raise the decibel
on this. I know many of your organizations are doing that, but is there
anything else. Two questions. One, the practice. How do we make these testing
breakthroughs really usable on the ground? And then a higher-level question.
How do we really raise the noise on this and the urgency?

MR. TENNANT: Maybe I will start. I think in some ways we can combine the
questions from Jim and Linda. I think one of the problems with the testing
scenarios and frankly it is the only game in town so we do not have much to
complain about. There are thousands and thousands, tens of thousands of
scenarios. Even if there is a clinical scenario that has been developed, that
is not a guarantee that every payer is going to pay that claim based on that.
This is why we need all of this plus the ability of the practice to test
directly with their health plans.

I mentioned the RECs. The most vulnerable folks here are the smallest
providers. Why not utilize a process that is already in place that is a trusted
voice within the practice community and push the testing scenarios out through
that vehicle? Not perfect.

MS. GOSS: Wouldn’t that take funding extending the funding VRECs because a
lot of the RECs are closing up shop this year and a lot of them do not have
support for business models. How can it be boots on the ground if they are not
supported?

MR. TENNANT: Absolutely. I have talked to probably a dozen of them. They all
want to get into this area.

MS. GOSS: I am with you. But I think the issue is that ONC funding is
drawing up for the RECs. Without that, we do not have boots on the ground that
is cost effective compared to large-scale consulting groups.

MR. TENNANT: Again, it all gets back to the investment. We have been told
through the regulations that there is tremendous ROI available through ICD-10.
Wonderful. Well, let’s invest in that if it is going to create a lot of ROI.
Let’s put some money up in the front end to make sure the transition goes well.
We seemed to be very interested in supporting meaningful use with billions and
billions of dollars. There is nothing out there for ICD-10. We are expecting a
miracle to happen and frankly I do not think it is going to.

MR. WINKLER: To answer the two questions. One of the things as it relates to
sharing Blue Cross Blue Shield of Michigan relative to its scenarios and we are
not speaking relative to the other pilots. But we are making our scenarios plus
a for lack of a better word a cheat sheet that says how do you go about taking
these scenarios, finding the respective claim from the payer’s environment
because it has to be grounded on something that actually happened. We are
making that available to any plans that are interested in taking them. Right
now, the other blues plans have taken that up, but we are making that available
across the board. Again, it is very limited. We have 400 medical scenarios in
the professional side. That is what we have targeted as our high-risk,
high-volume, high-dollar type scenarios. I am sure some of them will align with
the HIMSS and the WEDI scenarios, but I am sure they have a broader much richer
set. That is a step towards trying to jump start making the initial investment
reusable.

As it relates to the second part of the question though, one of the things
that we have found is we have a pretty robust communication strategy where we
find medical practices, medical societies in the state. We target a
presentation that is generic to ICD-10, but we target some of the questions to
the specialties associated with ICD-10. So far and we have only done this
really at three actually two and we are having the third one later this week.
We are trying to encourage the debate within the specialties. By asking the
question and then inevitably someone says wait a minute. That means I have to
do this. And then the discussion starts within the group. We are finding that
as extremely beneficial to get the awareness, because if you are speaking
ICD-10, nobody is listening. If you speak specifically to some situation that
is unique to that specialty, it catches and then it starts going on its own.

MS. LOUIE: Just a quick comment on that. I think one of the reasons and to
get people more involved especially the physician provider community in
particular is an ICD-10 code is an ICD-10 code, but what we are contending with
is literally thousands of payer policies that drive payment the decision to pay
or not pay off of that code. If they have no way to test the fact that Medicare
may adjudicate it one way does not mean anybody else is going to. I think that
is one of the sources of concern. I think it will get physicians more engaged
if they know they can test because truthfully their bottom line and everybody I
have talked to is am I going to get paid. Here we sit today and I am sure Rob
is in the same boat. The answer is I have no idea. I think that will really get
physicians interested and active in participating if we can give them some
answers.

MR. MILLER: I would just add that around the codes or the clinical scenarios
the ones that HIMSS and WEDI worked with would be published on HIMSS ICD-10
playbook site and available to everybody. I think there is a lot of great
information out there. But even the RECs are probably not prepared today to be
able to support ICD-10. They are going to require some training and support to
get them up to speed on doing it although I totally agree. They are the right
people to do it. They have their feet on the ground. They know the provider
community and they have the trust of the provider community.

MR. TAGOLICOD: I just want to validate a couple of things. One is to
someone’s question regarding communications. It is not only CMS, but working
clearly with the partners around the table that are already here is the simple
explanation to have targeted communications. And the communications are based
on the cohorts that we are looking at. And we are working through societies and
associations and specialty groups, et cetera. Those are the kind of things that
we need to do.

But I think the curricula, if you will, has to be in terms of focusing.
Someone used the phrase codes that matter. Maybe it is the scenarios that
matter to focus on. And another person used high volume, high dollars. Those
are the priorities that I think we need to focus on, but yet not ignore the
other scenarios that we are looking at.

I would simply offer in our discussions with the departments IT domain
steering committee. We are looking at — CMS has a responsibility of working
with all the other federal partners. We have been talking to the IHSs, the
HRSAs, the CDCs, the education training centers that are focused on providers
to leverage those feet on the ground because it is not only the RECs we
recognize the economic reality of the funding reality. What realities do we
have to work with? We are looking at the particular whether they are FQHCs,
whether they are the tribal facilities, whatever we need to do in order to
leverage those in order to get the biggest bang for the buck.

I want to expand the discussion to say it is not just the RECs because that
would be putting everything on them. There are other ways of addressing this.

DR. SUAREZ: We are going to go to Larry and then Susie and Alex.

DR. GREEN: I want to direct my question toward Joseph and Dennis and maybe
you — I will tell you the question and then I will explain it. How do you
select scenarios when a diagnosis is not possible? Here is the explanation for
it. The largest platform of health care delivery we know based from the
population’s perspective. It is the primary care platform. That is where a lot
of these small providers are. It is a select majority of the face-to-face
transactions between clinicians and patients every single day, month after
month, decade after decade. From those countries or those systems that are
capable of doing classification and the labeling to create episode
epidemiology, we know that approximately —

First of all, we know that disease actually has a beginning, middle, and an
end. It does not just have an end. And that throughout that episode at the
front end of it a slight majority of the time an accurate diagnosis is
something not possible. No amount of testing. No amount of time will lead to an
accurate, precise diagnosis. That is because disease is vague when it begins. I
am tired. I am tired in a way I didn’t used to be tired. That sort of stuff.
That is the situation now. That will be a select majority. That scenario is
going to be playing on in primary care settings all over the country. What are
the scenarios that are going to allow us to learn how to code those in ICD-10?

MS. BOWMAN: I can answer that if Don isn’t chomping at the bit down there.
One of the advantages of ICD-10 is there are many more actual symptom and
clinical findings kinds of codes than there are in ICD-9. There has been
somewhat of a misperception that unspecified code or symptom codes or anything
that is in that vague or not a definitive clinical diagnosis kind of code will
not be acceptable in the ICD-10 environment. That is simply not true. And even
payers are telling us there might be certain situations where they are looking
for more specific code, but they recognize that there are times when the
symptom level, the clinical finding level, abnormal test is all you know. There
are codes for those things. And as a matter of fact, the cooperating parties
have just come out with a statement saying those are the codes you should use.

DR. GREEN: I understand that. That is not my point. My point is the
scenarios that are going to be used for testing. How many of those cannot lead
to a precise diagnosis? Are you doing that?

MS. BOWMAN: I won’t step on Joe’s toes, but I am actually one of the coding
experts involved in the HIMSS project. I have actually looked at a lot of and
coded a lot of the scenarios in that project. There are some in that category
that do not have definitive diagnoses that are coded to a symptom or clinical
finding type of level.

DR. GREEN: That is true for you, Dennis?

MR. WINKLER: As it relates to what we are doing at Michigan, no. We are not
looking at it in that vein. It is not because of the desire or the intent. It
is because of resources. We have to in a very short period of time figure out
what are the most important codes or scenarios to go after, that satisfy the
masses within our professional and our facilities. We are going off of things
that happen. But if we do migrate to an environment where we expand and have a
repository that grows and is shared through time, I believe we can get to that
environment and I think that is critical for the overall well being of the
environment.

DR. SUAREZ: I think we are going to go to Susie and we are going to need to
wrap up quickly.

MS. BURKE-BEBEE: My question is along that line probably to you Dennis and
maybe to you Joe. In those real case scenarios, the clinical scenarios that you
are talking about, you mentioned, Dennis, about the nine to the ten. To me,
that is a golden nugget for the provider. As a provider when I am coding
something in my office and I am going to have to use a more detailed coding
system like ten, what are you finding going from that nine to the ten? Is it in
these case scenarios helpful to those providers so that they can see in a real
case scenario that this is what I need to do going forward?

MR. WINKLER: Unfortunately, we are just starting our pilot. We do not have
the actual feedback from our providers yet. I can tell you though that when we
were using our trained coders also to do the initial coding in 10 to do our
neutrality testing, there was a tremendous amount of learning associated with
their understanding ICD-10. It is one thing to be trained. It is another thing
to take a look at a record and then determine what ICD-10 codes. And one of the
things we found is when we were doing that coding, not to have the 9’s in front
of them. Actually, look at the record and then compare afterwards and say wow
because that is the learning that occurs.

MS. BURKE-BEBEE: Is that part of the educational material that would be
going forward?

MR. WINKLER: The feedback loop that we have on our professional side is we
basically say on the professional it is obviously what is your co-pay, your
deductible, did it pay. We have the baseline as to what it was in 9, what you
sent and its results, and then at the bottom we show what your peer group has
basically applied relative to the 10’s. We are trying to give them both pieces
of information to show the deltas between the net impact, not necessarily what
9 code they use, but what is the impact to their at risk.

DR. SUAREZ: We are just about time to transition to our next part in this
panel. Thank you everyone for this terrific session. I think we learn a lot. As
Linda said, I am also half glass full person. I see a lot of progress. I see a
lot of challenges coming up. I think a number of opportunities to make
recommendations to move forward and to increase the coordination and the
communication strategy. I think that is going to be critical. Thank you again
for the testimony.

We are going to go to part 2. We have three testifiers, three speakers. We
are going to invite them to join us here at the table. I know Benjamin Miller
is going to join us via phone. Benjamin, are you on the phone?

MR. MILLER: I am here.

DR. SUAREZ: Thank you. Great. We are going to start with Sue and then go to
John and then go to Benjamin. We will have time for Q&A. For this, I think
we are still going to try to ask our testifiers to focus on about six, seven
minutes of testimony and then give us an opportunity to have a lot of
interaction with the members of the committee.

Agenda Item: Part 2 – New uses for the ICD-10
Data

MS. BOWMAN: Thank you. I am Sue Bowman, senior director of Coding Policy and
Compliance for the American Health Information Management Association or AHIMA.
On behalf of our more than 67,000 members working in the health information
management or HIM field. Thank you for the opportunity to testify today.

I have been asked to comment on a slightly different topic today on new uses
for the ICD-10 data. This presentation will be particularly of interest to
those of you in the half-full category I think.

Before considering new uses of ICD-10, we should keep in mind that many of
the original uses that we envisioned when adoption of ICD-10-CM/PCS were first
discussed in the 1990s are still relevant and anticipated once these code sets
are in use. At that time, AHIMA and others recognize that the ICD-9-CM
classification could not keep up with an accelerating body of knowledge
regarding diseases and medical advances as well as the growing need for more
detailed knowledge for research community health improvement and existing
reimbursement models.

Since then, adoption, implementation, and use of EHRs, growth of health
information exchange, changes in reimbursement models, incentive programs such
as meaningful use, and health care reform have only emphasized the widening gap
between the health care data we have and the health care data we need.

ICD-10-CM and PCS are communication tools with many uses beyond the most
well known one of a reimbursement. The use of ICD codes in the medical hospital
in-patient perspective payment system has led to a widespread misperception I
think that the ICD classification system is in fact a reimbursement system.
Although ICD has been used for its original intended purposes of data storage,
retrieval, analysis, and interpretation and long before it became part of the
Medicare hospital in-patient system and despite the fact that its uses have
expanded dramatically in the last 30 years, this misperception of ICD as a
reimbursement system still seems to persist.

The fact that new ICD-9-CM diagnosis and procedure codes are announced each
in the Medicare hospital in-patient PPS rule may help contribute to this
misperception. NCVHS might consider suggesting that the Department of Health
and Human Services contemplate using a different mechanism for publicizing
changes to the ICD code sets.

Before I began discussing some of the anticipated uses of ICD-10 data, I
would like to point out that ensuring the accuracy and integrity of coded data
has never been more important and both depend on the quality of the underlying
medical record documentation and the application of standard rules and ethical
coding standards.

The use of ICD-10-CM and PCS also lends itself to the process of
computer-assisted coding such that its EHR systems become more standardized and
use terminologies such as SNOMED-CT or LOINC, the ability to automatically
generate codes from the EHRs will change the process of coding, as we know it
today.

As attention to improving quality of care has grown so has the role of ICD
codes and the production of better data on quality. ICD codes are currently
playing a key role in quality measurement programs and comparisons of providers
and the additional detail in the ICD-10 code sets makes this practice even
better.

Health care providers have the opportunity to ICD codes to determine the
progress of an individual over time, measure the effectiveness of various
treatment modalities, monitor patient safety, and identify complications. All
of these areas have much more detail in the ICD-10 code sets.

Treatment protocols customized for each patient can be designed. Aggregating
data for multiple patients using single or multiple ICD-10 codes can also
provide information on best practices and other means of improving quality.

On a community basis, these same collections of data in the form of ICD
codes can provide for a larger analysis of treatment protocols and provider
quality. Strategies for preventing diseases and injuries and reducing disease
burden can be identified. And better more sophisticated quality measurement
models are likely to emerge with the availability of more detailed data.

Improved data will allow the refinement of existing reimbursement systems by
providing more detail in which to determine payment policies and set
reimbursement rates. It could also help with new reimbursement models such as
value-based purchasing or other models based on quality measurements and
outcomes.

The ICD-10 information could also affect programs such as ECOs and bundled
payments. The use of ICD-10 also has the potential to reduce the opportunities
for fraud and improve fraud detection capabilities with updated terminology,
increased specificity and standard definitions reducing coding ambiguity and
misinterpretation and improving coding accuracy and the ability to effectively
audit claims. The improved logic and increased specificity in ICD-10 will
facilitate the development of sophisticated tools for detection of questionable
patterns and suspected fraud.

The more detailed coding system will also lend itself to better internal or
external auditing. And providers who take active steps to implement internal
audit programs should see a decrease in request for external auditing as
internal claims processing improves with the use of ICD-10.

I have already mentioned a few uses of ICD-10 related to the provision of
clinical care including improved clinical management, patient safety, and
internal quality measurement. Improved ICD data will permit improved
identification of patients for disease management programs and more effective
tailoring of these programs to meet individual patient needs thus improving
patient outcomes and patient satisfaction and lowering health care costs.

The use of ICD-10 data has great promise for enhanced public health
surveillance including detection of bioterrorism events. Imagine the potential
for public health agencies to track disease outbreaks to alert the public and
access collective data worldwide. This can be accomplished by flagging specific
ICD-10 codes or combination of codes that can be sent electronically from
providers to the public health agency.

While the use of ICD codes for research is not new, ICD promises to provide
a rich source of clinical information with much less reliance on the arduous
and time-consuming review of medical records. Interoperable data across
organizations will be available for systematic reporting. And better
understanding of diseases and injuries will lead to improved prevention or
mitigation strategies.

The design of clinically robust algorithms will be facilitated both to treat
chronic diseases and track outcomes of care. And researchers will be able to
share data with international colleagues in a much more efficient manner.

Administrative efficiencies will also occur, better data supporting clinical
care that will result in cost savings, and more detailed codes will result in a
reduced need to provide additional information to support claims and audits.
Organizations will be able to conduct more accurate and detailed trend and cost
analysis and more effectively monitor resource and service utilization.

And, finally, in the area of consumers, as we move toward a more
consumer-centric health care system, access to better data will mean consumers
will be better equipped to use this data to compare providers on the basis of
cost and quality of care. The adoption of consumer-friendly interpretations of
medical terminology including coded data is also underway.

With better data will come an expanded ability to educate consumers on cause
and outcomes of treatment options and ultimately increase patient understanding
and involvement and their health care will improve the population’s health and
decrease the cost of health care.

In conclusion, the ICD-10 code sets are tools that when combined with better
medical record documentation and other parallel developments occurring in the
health care industry such as EHRs and incentive programs such as meaningful use
can produce a rich source of health information at the level of detail and
quality needed to support existing uses of coded data as well as numerous
opportunities for new uses.

With the ICD-10-CM and PCS code sets set to be in use in 15 months, it is
time for a broader perspective on these uses and AHIMA wishes to thank the
subcommittee for beginning the education today. AHIMA looks forward to working
with the NCVHS and the Department of Health and Human Services to further the
understanding of the potential uses and benefits of ICD-10-CM and PCS
information. I will be happy to answer any questions the members of the
subcommittee might have.

DR. SUAREZ: Thank you. Thanks so much Sue. We are going to go to John next.

MR. QUINN: I am going to bring up the topic of what is happening in
meaningful use right now as it relates to SNOMED and the relationship to ICD.
The US is going to adopt ICD-10 in place of longstanding ICD-9. Meaningful use
stage 2 is now starting to see implementation guides. That is what we call
Draft Standards for Trial Use, DSTUs, that are going out now to first adopters
who are primarily in two areas. First is the expansion of the continuity of
care documents for meaningful use stage 1 to now include about six additional
document types based on clinical document architecture, which this is all
structured data. And what it does is it fills the obvious gaps. Transition of
care from a patient discharge hospital back to the referring physician. A
patient being asked to get a clinical specialist to review their case and the
information passed from the referring physician to the referred physician.
These all involve the use of SNOMED.

Similarly, in the area of laboratory results, we are looking at the
beginning of the use of a common standard across all the reference labs and
hospital labs on the reporting of laboratory results with coded clinical data
including quantities as well as normal ranges and out of normal range triggers
to go with those.

I am going to encourage you to get a copy of the slides and to look at this
stuff because there is about three times as much as I can possibly talk in the
seven minutes or so we have.

HL7 represents patient data by using reference terminologies, classification
taxonomies and here is a list of some of them. In general, HL7 does not make up
its own terminologies except to describe itself. I will talk about that in a
second. That is called meta-data. Since all of us have been listening to the
news over the last few weeks now, everybody knows what meta-data knows so I do
not need to spend any more time talking to you about it. But it is actually the
same thing, maybe not about national security, but it is instead about this is
how we described the data that comes along in the CDA documents so it can be
properly interpreted in the context by the receiving computer system.

The HL7 relies on terminology standards developed by other organizations.
The predominant one we are looking at when we talk about SNOMEDs is IHTSDO,
International Health Terminology Standards Development Organization. And when
we talk about ICD, we are talking about the World Health Organization.

I want to skip way ahead now to slide 11. It is one thing to talk about
ICD-9 to ICD-10 mappings and there is a lot of research out there that has been
done on that as to how does that look in a SNOMED environment. How can I use
SNOMED to possibly facilitate that? There have been some studies done. To be
honest with you, the results that you get when you look at the percentages of
accurate translations is not real comfortable if it is your life or your loved
ones life that is in charge. We got as high as 84 percent and that might have
been okay in grammar school, but it is probably not okay for a visit to the
doctor’s office and that was the high number. The rest got a lot worse.

Meaningful use. We are on the edge where if you take something like an
ICD-10 code with all the structured information that is going to be available
in the medical record and the electronic medical record being passed around in
consolidated CDA documents, it would be hard to bypass the temptation that says
I am going to use more detailed information that is available in SNOMED. Either
ICD is going to have to grow very rapidly — SNOMED at this point, for
instance, has 19 classification sub-trees that go across everything including
what you would effectively call medical knowledge as well as things like
anatomy and physiological processes that are associated with any observation as
well as expected treatments.

One of the specific things we were asked about is big data. I know in
conversations that I have had with ONC, big data is, A, highly desired for
analysis. This is the same thing we are talking to the NSA doing. Only we are
talking about doing it for looking at patterns and medical conditions and
medical care. If we are going to do that, we need structured data capture. FDA,
CDC, National Institute of Health in general are all very interested in being
able to get on this. ONC is very interested in moving it forward faster rather
than later. I am sure they are at this point looking for provider organizations
to facilitate that. But pretty much the structured data capture into SNOMED at
the point of care is pretty much a requirement for us to get to that point,
yet, it is one of the fastest ways right now for ONC and Congress to see ORI on
the investment in high tech that they have made at this point too. It gets more
complicated. We have to actually deal with moving how do you translate and map
from SNOMED into ICD-10 and ICD-10 into SNOMED.

There is another set of studies and I have referenced them here in the slide
that has been done at the National Library of Medicine by two physicians. The
one I am familiar with is Jim Campbell at the University of Nebraska Medical
Center who has been working with HL7 and IHTSDO for all the years I have been
working. That is going on 26, 27 right now for me.

Semi-automatic generation of ICD-10 classification codes from SNOMED. Would
this be a way of doing it? Well, they have done some work on it. They seem some
hope. I think if you read the study and I have downloaded a copy. It is in my
suitcase. It is a little thick. It is just the technical specifications of the
release notices right now. If I dig around in the NLM website, I am sure I will
find a lot more, but it was all I could handle in the time I had to prepare
this presentation. It is probably worthwhile taking a look at.

It does start to address some of the questions out of the end of the last
session that talked about how do I marry the data available in the medical
record to not just the coding system, but what I should be doing next or other
things I might be doing.

This is pretty much personal experience. When we start talking about where
is it working at this point and especially in the area of primary care, the
best example would be the United Kingdom, specifically England, where they have
been doing — their GPs have been using SNOMED now for somewhere in the range
of 10 to 15 years even before the more current programs that started up. And in
fact, the GPs are actually paid for either on a capitated contract basis or a
per head basis. They are not NHS employees. They are not getting a paycheck
regardless of what they do. The ICD code that is generates is just as important
to them as it is to primary care physicians in the US especially those in small
and medium-sized group practices.

There is also more reference about exactly what they found in here. I
encourage you to take a look at it. That is a set of countries right now that
are using SNOMED. Anybody who is using SNOMED too is using ICD as well, but
they are using it more for classification epidemiology reports to the World
Health Organization for public health whereas in this country we have more dual
use to ICD.

That is it. I strongly encourage you to take a look at the slides. If you
feel like you have any questions, give me a call, and send me an email.

DR. SUAREZ: Thank you. Thanks John. We are going to go to Benjamin on the
phone.

MR. MILLER: Thank you and good afternoon everyone. My name is Ben Miller. I
am an assistant professor in the Department of Family Medicine at the
University of Colorado. I am a clinical psychologist by training. I am pretty
honored to be asked to testify today regarding the DSM-V and ICD-10. Thank you
for this opportunity.

I know you have my slides so I am just going to mention the slides in
passing as I go through the testimony. You can move to the first slide please.
The separation of the mental health system from the physical health system has
a history rife with fragmentation, poor quality and higher cost. If having two
separate systems to treat the singular construct of health was sufficient, it
should have worked by now. Scientific evidence just won’t allow us to proceed
as if the brain and behavior are separate from the body. Treating one condition
at a time, whether it is a mental health condition or a physical health
condition without taking into account their inseparability results in poorer
outcomes and higher costs, rather than the achievement of what seems to be a
promising value proposition for health care.

However, in the face of what we know and these indisputable facts, we still
have fragmentation at almost all levels in health care. Consider how we train
our health care providers. Consider how we pay for our providers. Consider how
our providers deliver care. Consider the various ways our providers are asked
to document the services they have provided.

I have been asked today to testify regarding the DSM-V and the connection to
ICD-10. You may ask, why start off with a discussion about mental health and
physical health integration. And the answer to that is at the heart of my
testimony.

However, I want to begin my testimony with the caveat that I am not an
expert in the DSM-V and ICD-10. I am, however, a health services and health
policy researcher who has practical experience on the ground and across the
country with helping communities better integrate mental health within health
care. Said differently, I am an advocate for health care integration and do
everything I can to help our communities address fragmentation at the clinical,
operational, and financial level.

Let’s start today by outlining some of the components of the DSM-V and
ICD-10. Currently, mental health professionals have two classification systems
to use for coding mental disorders. Number one, the International
Classification of Diseases and number two, the Diagnostic and Statistical
Manual of Mental Disorders. Almost all mental health professionals in the US
use the DSM-IV-TR, which was developed by the American Psychiatric Association.
The DSM-IV provides diagnostic codes solely for mental disorders; whereas the
ICD-1- has codes for both physical and mental disorders. Of note, in my own
clinical training, we were never taught about the ICD, but just the DMS. I do
not think that I am alone as a mental health professional in this regard. While
the ICD-10-CM has codes for mental disorders, mental health professionals in
the US still primarily use the DSM for diagnoses and diagnostic codes. As many
of you know, no other specialty in medicine has a separate codebook for its
disorders. All physicians from all specialty areas use the ICD with the
exception of psychiatry.

The fifth edition of DSM has been in process for almost a decade. The
previous version of DSM, the DSM-IV, was completed nearly 20 years ago. The new
DSM-V has several updates from the DSM-IV, many of which have been highly
publicized and written about.

Mental health professionals like psychologists are often licensed
independently to assess and diagnose individuals who seek care for a variety of
health conditions, primarily mental health. Most mental health professionals
have been trained using the DSM for this purpose and apply this manual in their
day-to-day professional lives. Because mental health diagnoses must be conveyed
in terms of ICD codes, psychologists and other mental health professionals
should have a working familiarity with ICD or use some type of crosswalk from
another system such as DSM to ICD in order to identify the appropriate codes to
be paid for their services.

The Center for Medicare and Medicaid Services has addressed the DSM
previously with regard to ICD. Specifically, CMS responded in FAQ1817 stating:
“The introduction to the DSM-IV indicates that the DSM-IV is fully
compatible with the ICD-9-CM. The reason for this compatibility is that each
diagnosis listed in the DSM-IV is crosswalked to the appropriate ICD-9-CM code.
The DSM-IV is not a HIPAA compliant adopted code set and may not be used in
HIPAA standard transactions. It is expected that clinicians may continue to
base their diagnostic decisions on the DSM-IV criteria, and, if so, to
crosswalk those decisions to the appropriate ICD-9-CM codes. In addition, it is
still perfectly permissible for providers and others to use the DSM-IV codes,
descriptors and diagnostic criteria for other purposes, including medical
records, quality assessment, medical review, consultation and patient
communications.” And it appears that this same commentary is true with the
DSM-V as it is for the DSM-IV.

Let’s take a deeper look into the differences in the DSM and ICD as it
relates to mental health. For example, the DSM-V lists several symptoms of the
disease and then requires that a specific number of criteria are met within a
specified timeframe for the diagnosis to be given. Depression is offered here
as an example. On the left, you can see that there are criteria for depression
within the DSM. Please note the highlighted words specifying number of criteria
that needs to be met as well as the duration of symptomatology.

On the right, you can see a comparison of the ICD-10 for depression. If one
looks a little bit deeper, which I did not have room on the slide to put, you
will find that beyond these initial criteria you can see a narrative format
within the ICD-10 that describes much more about the symptoms and the disease.
In short, if someone spends time comparing the two, the DSM applies more
specific criteria and time periods to the diagnosis while the ICD offers up
more general criteria.

The DSM-V has a full listing of ICD-9/10 codes in it, both numerical and
alphabetical in its appendix. Meaning, any mental health provider using the
DSM-V as a diagnostic manual can have access to the appropriate ICD-9 and 10
codes. This is important as there has often been great confusion in the mental
health field about the crosswalk and what was required for ICD from the DSM.

Interestingly enough, mental health providers are not required to use the
DSM as HIPAA initially endorsed the ICD-9-CM as its formal code set for mental
disorders. Again, as you all well know, HIPAA was enacted in 1996 to tackle the
need for a consistent framework for electronic transactions. On August 17,
2000, HIPAA adopted specific code sets for diagnosis and procedures to be used
in all transactions. The HIPAA official codebook for diagnosing mental
disorders is the ICD-9-CM. All mental health care providers and health
insurance companies must use these codes for all data collection and billing
purposes.

According to an expert in the field, Dr. Dayle Jones from University of
Central Florida, “When HIPAA first announced that the ICD-9-CM was its
official code book for mental disorders, mental health professionals questioned
whether they should continue using the DSM-IV.” She stated that
“Counselors can use the DSM-IV for diagnosis because the diagnostic codes
appearing in the DSM-IV are derived from the ICD-9-CM. Thus, the DSM-IV codes
automatically meet coding and reporting requirements under HIPAA.”

It is important to note that there are other differences between the DSM-V
and ICD-10. For example, the DSM was produced by a single national professional
association for psychiatrists (the American Psychiatric Association) while the
ICD was produced by a global health agency with a public health mission to help
countries reduce the disease burden including mental disorders. The DSM
generates revenue for the American Psychiatric Association while the ICD is
free through the internet. The DSM was developed primarily by psychiatrists
with the ICD’s development being multidisciplinary. And the DSM as a manual is
approved by the American Psychiatric Association while the ICD is approved by
the World Health Assembly.

As mentioned, health insurance companies must follow HIPAA, and since ICD is
the HIPAA-compliant code set, this begs the question. What role does the DSM
play in health care?

The answer to the question appears to primarily fall on the clinical
relevance of diagnostic manuals for mental health providers. Since most of the
half a million mental health providers have received training on solely the
DSM, this manual continues to have a profound influence on the provision of
clinical services as well as the perception of its need in the mental health
community. As state previously, it does not appear to ever have been formally
stated that the DSM has to be used by mental health providers unless an agency
determines it, state law dictates it, or a professional societies or ethical
guidelines include it.

Where does this leave us? If one of the needs for the US health care system
is to better defragment, we must understand what continues to make us
disintegrated. Since the majority of US mental health professionals whether
psychologists, counselors, social workers or others have been trained
predominately using only the DSM for diagnosis, are we inadvertently creating a
workforce that perpetuates fragmented care? Rather than help unit our health
care workforce write large with a common system for diagnosis and
classification, we continue to appear to have a separate piece of that pie for
mental health. Since most mental health providers have little knowledge about
the ICD or the fact that the DSM diagnostic codes, which are required for
billing and recording purposes come from the ICD, it seems there is a
substantial disconnect between some of our training programs and the reality of
health care.

And while there is still much to be learned from the DSM-V and the impact it
will have on mental health and in health care, the fact that ICD-9 and 10 codes
are included within the DSM-V do help mental health providers at least have a
connection to the ICD.

In preparation for this testimony, I talked to several mental health
trainees, including my own, and asked them about the DSM. One person I spoke to
mentioned that their hospital did not require them to use the DSM at all, while
another reported not using the DSM either but also admitting to not being
educated enough on the ICD to speak competently about it. Regardless of the
level of the trainee, there appeared to be confusion or outright
misunderstanding in the mental health field around the DSM and ICD. During my
research for this testimony, I was continually amazed at the confusion that
exists in the field around the DSM for mental health providers. There are
countless forums, countless frequently asked question sections on websites
solely devoted to help educate providers around the DSM-V and ICD-10 and yet
confusion still exists.

Within the context of DSM-V’s arrival and ICD-10’s proliferation, there
appears to be yet another opportunity to address fragmentation in health care
and how our coding and classification systems, payment structures,
administrative entities, and training program offer us a chance to better
integrate whole person health care.

Thank you.

DR. SUAREZ: Thank you so much, Benjamin. Great testimony. I appreciate it.

I think we are going to go to questions now from the committee members. Who
wants to start? Linda.

Agenda Item: Discussion

MS. KLOSS: Thank you. Thank you all. As Walter said, we really were anxious
to start looking to October 2, 2014 and issues in terms of use of new data.
Yesterday as we heard from the sobering WEDI results on preparation for ICD-10,
one of the sidebar conversations Ob and I had was, what are the set of metrics
that the industry will use to judge where we are, what the progress is in
implementation. I was just really wondering and this goes to those who spoke to
us about testing also, the earlier panel. Do we have any sense? Do we have any
idea of whether there is a need for us to have some sort of measures that we
judge progress on so that we do have more robust numeric data on progress on
this very complex implementation from day 1 and not sort of wait a year to
begin to gather that data?

I think of this because I am aware that in Canada and in Australia and other
countries when they transition from 9 to 10, they had some baseline data on
coding accuracy that they went into the transition with and had perhaps a
better collective national sense of when they got back to their baseline or
exceeded their baseline. Just throw that out as something because I think that
may be an area that the committee could pursue some kind of measures of
progress in this very complex implementation.

Sue, what have been your thoughts on that or John?

MS. BOWMAN: I heard two parts of your questions. One is getting back to just
standards for accuracy, productivity, and those kinds of issues. And then
another question I am asked frequently that I think is also part of your
question is are there any studies in other countries that prove the data was
better after they implemented ICD-10. I have not actually — if anybody knows
of any, I would love to see one. In my discussions with the international
community, they did not really look at it that way where they had to prove the
return on investment of ICD-10. It was seen more like moving to the next better
version. There were a lot of research projects that maybe they could not have
done or have done as well if they hadn’t had ICD-10. But the project did not
look at was ICD-10 the reason we were able to analyze this particular question.

MS. KLOSS: I was not asking that question as much as sort of what are the
metrics of this change. For example, operational effectiveness, the relevance
of the data, which I guess is —

MR. QUINN: Remember ICD-10 was adopted by the rest of the world a long time
ago. Getting current information or even people who were part of the transition
is probably somewhat difficult. On top of it all, the fact that we use it as a
catalyst for justifying reimbursement or for documenting care giving for
reimbursement puts us in an isolated spot as well. It would be easier at this
point to figure out what the adoption rate is going to be for ICD-11 from WHO
starting next year than it would be to figure out what happened 15, 20 years
ago.

MS. KLOSS: I am not suggesting we go back. I am raising the question of
whether it would be useful to have any metrics going into this transition that
we all agreed on.

MS. BOWMAN: I think it would be useful.

DR. SOONTHORNSIMA: Maybe just to dovetail on what Sue — and in your
testimony, I think you clearly outlined some of the benefits, all the benefits
that you can think of today and how other countries are currently using those
things so not necessarily metrics, but guidelines as to how we can begin to —
once we implement. I think there were two-part questions. The first question
was how to get over this hump and what are the metrics for us to get there. And
the second part is pretty much in your testimony where once you get there here
are the usage of the — perhaps a guidance once we get over the hump. That way
we can begin to — I do not think we would have to prove ROI at this point. It
is what it is when you do it.

MR. QUINN: And you are working in a slightly different environment where
your concern is there is no enough money for investment. We are basically
saying they have to do it. Why or how are they going to do it outside of a fear
of not being reimbursed, which I guess is even stronger than the one that is
being used in meaningful use, which is we will give you a 1 percent bonus on
your reimbursement if you attest to having a system that, A, is capable of
supporting meaningful use, and B, is being used in that way. Of course, the
downfall with that one is now somebody has to go out and police it. They
started to try to do that and make some examples so people realize that it
really is not just a blank check. You have to actually do what you said you
were going to do.

DR. GREEN: I want to go back to a population perspective again and ask
anyone that just testified or anyone that is still left in the room a question
about education. I am struck from the last day and a half, Walter, about how
often the word educate, the verb educate has come up over and over and over
again. It seems to be a really big deal and a really big need. This last half
of the morning’s presentation were outright scary.

MR. QUINN: They did ask us to talk about the future. That does kind of limit
the group of people that are working in that area. My reaction is — it used to
be when I started working in this domain 25 some years ago that I could on one
hand tell folks do you know anybody who is an informatician or do you know a
physician who has been trained in informatics. Of course, I get this blank
look. I came to the realization that there were probably five or so maybe ten
universities I could name off the top of my head that actually had a formal,
defined informatics program and people who were getting programs. Typically,
MDs are ending up getting essentially co-training computer science and working
in some level of specialization of medicine associated with it.

The Beacon grant aspect of HITECH distributed funds for the creation of
formal informatics programs now. It is hard for me to actually pick up or go to
visit a website for any university in the country especially if they have any
sort of medical school whether it is nursing or physician trained that does not
now have an informatics program. How good the quality is and how long is it
going to take until that knowledge infects the working population and we all
work off of that base is still to be seen. I personally probably will retire
before then, but I am darn close to that whereas nevertheless it is something
that certainly has increased the base of what is available in universities
across the country for training in this area.

DR. GREEN: That is definitely on the target. I was thinking about a
different set of clinicians. Like in your comment, you said physicians and
nurses. Given the population prevalence in mental health disorders and there is
45, 50 people here. That means ten people in this room this year will have
diagnosable mental health behavioral problems. I just heard testimony that says
that half a million clinicians basically do not get any training at all in ICD.
I am not talking about informatics experts. I am talking about people who are
trying to take care of folks with things that are highly prevalent. Is there
any plan anywhere to educate proper use of ICD-10 to anybody other than
physicians who want to get paid?

MR. QUINN: As long as it is viewed as that, this is how you get paid, then
it is going to be relegated to professional coders whether they are part time
or full time.

DR. GREEN: I think the answer is no.

MR. QUINN: Probably.

MS. BOWMAN: I would see some improvement and expansion of education. Maybe
not down to every single clinical provider, but there is education both
face-to-face, webinars, on not just the use of ICD-10 the way coders use it,
but the value of the data.

In one area where I have seen a lot of progress is at AHIMA. We have had an
ICD-10 summit every year since the rule was published in 2009. There has been a
very clear progression in the sophistication of thinking. The first year
everybody was ringing their hands. What is an ICD-10 code even look like? And
this year there was much more presentations on data analytics and how to use
the codes to analyze in some very sophisticated ways. There are people thinking
about that. There is education going on where both are at the payer and
provider level. People are being more educated on ICD-10, but there is still
the group that are not coming to those kinds of events that have not done
anything as you have heard from some of the surveys that have presented here.
You do have both camps. But I think there is a gradual trend upwards where
people are starting to understand the data if they need to.

DR. GREEN: In your opinion, does that maturation include the mental health
community?

MS. BOWMAN: Yes.

DR. LAZARUS: Since Larry asked for anybody in the room. Steve Lazarus,
Boundary Information Group. I will take you back to 1979. When we moved from
ICD-8 and many other coding systems, there was not one to ICD-10. We moved from
8 to 9. Medicare forced it for hospitals and physicians and it was not codes.
It was narratives, standard narrative nomenclature. All of a sudden out of the
woodwork, the last 90 days before we went live vendors came out with computer
systems to help coders in hospitals. It never existed before. The same thing
will happen again. Companies, AHIMA chapters, medical societies in a local area
started giving training programs to physicians in the community how to do
coding just before they had to do use it. It will happen again.

The government does not have to solve every problem. Yes, we have to push a
prod so people know it is important. Sometimes the private sector has to step
up and the professional associations with their own resources who are in the
business of communicating with their entities have to step up. They will
probably do it just like they did in 1979.

DR. SUAREZ: Thanks Steve. We are going to go to Jim, Donna, and then Alex
and I think we are going to wrap up.

DR. SORACE: John, I was just curious, going back to your talk where you are
discussing the issues involving crosswalking like ICD-10 to SNOMED and ICD-9.
Basically, from what I have heard, there is no solution that is 100 percent
accurate and the best is about 84 and many were somewhat less. Hold that
thought for a moment.

My understanding is that the algorithms that run the internet scale log end
or end log end. Do we know how the maintenance of complex crosswalks and
oncology scale?

MR. QUINN: I am sure there are some that might, but they would be — you are
not talking to one of them. I know a couple who I would ask.

DR. SORACE: — speaks to the feasibility of maintenance.

MR. QUINN: Correct. It does. And in fact, I will be honest with you. I was
looking at the results from what I have seen in the studies on ICD-9 and ICD-10
crosswalks in SNOMED to ICD-10 to SNOMED. It is a little surprising to me at
how human intensive the intervention need to be just to get a single crosswalk
to work.

DR. SORACE: I have pulled some of the literature on these issues. I think it
is one of these —

MS. PICKETT: Two parents. Larry, to your concern about mental health
providers. CDC has been working with multiple providers in terms of outreach
and education. Last year we were scheduled to do an ICD-10-CM presentation
during one of their annual meetings. But because of the timing of the notice of
proposed rulemaking proposing a delay in the implementation, the leadership
felt it was more prudent not to have the presentation last year because it
would have been time before the final rule. However, we have continued dialogue
with many of these providers to provider presentation and materials for
subsequent meetings, some of them to occur later this year. I did want to let
you know that. And the American Psychological Association was one of those
groups that we had talked to. It is on their radar screen.

To the other point that was made during the presentation on DSM-V and the
relationship to ICD-10, I did want to point out that one of the slides was
actually showing a comparison of the DSM-V to the WHO version ICD-10, which
does contain a mental health glossary. However, in ICD-10-CM, we have removed
that glossary. Several years ago, that glossary was taken down, not only out of
ICD-10-CM, but also out of ICD-9-CM as it relates to discussions that occurred
here at the national committee when we were having discussions about HIPAA code
sets. I did want to make that clarification.

DR. GREEN: Can you explain the implications of that? I think I followed you,
but I am not sure. That means what?

MS. PICKETT: During the discussion several years ago, there was concern that
the mental health glossary within ICD-9-CM and in ICD-10-CM at that time really
was not consistent with mental health practice in the US. WHO always includes a
glossary. However, the US has never updated that glossary because WHO does not
update the glossary between major revisions. To avoid the confusion that people
were having between the definitions and glossary that was in 9-CM and 10-CM and
to point to — well, not necessarily point to, but to recognize the fact that
as in the FAQ that was described that the diagnostic criteria contained in
DSM-IV that clinicians could still use that within their clinical practices. We
took it down in ICD-9-CM and I forget the year. But it was also taken down out
of ICD-10-CM at the same time. The glossary is no longer part of ICD for the
clinical modification for use in the US. It still does exist in the WHO
version.

MS. GREENBERG: The bottom line there is that there aren’t contradictory
diagnostic criteria in 10-CM to either DSM-IV or DSM-V because there aren’t
diagnostic criteria in 10-CM.

DR. SUAREZ: Before we go to Alex, one interesting point though is DSM-IV or
V were not named on the meaningful use as a code. Now we have mental health
providers doing SNOMED, DSM, and ICD. Correct? That is ultimately what a mental
health provider has to do in their medical — mental health providers as has
been presented. I do remember being trained on DSM. Mental health providers are
trained and use and very familiar with and code basically used at DSM’s
structure to codify clinical documentation. In reality, there are three
different types of coding schemas that are used in a mental health record at
this point. I think that is a reality in my mind.

DR. GREEN: Forgive me for being overly simplistic, but this is a screw up.

DR. SUAREZ: It is a difficulty. It is a complete difficulty. Yes, we are
required to use SNOMED and their meaningful use or codification of —

DR. GREEN: How are we going to get over this? If we are going to do the
triple aim, I know of no one that can argue the case that we can get to the
triple aim if we cut out behavioral health, mental health problems. The
prevention and the care of chronic diseases.

DR. SUAREZ: I think that is one of the things that we as a committee can
provide as guidance and recommendation to try to align and try to —

PARTICIPANT: Let’s get that on the agenda.

DR. SUAREZ: I think we were going to go to Alex.

MS. GOSS: I have one comment, not for discussion. How about that Walter? My
comment is that there have been a lot of themes here today that really
necessitates the subcommittee having discussions about educational-level
programs for medical schools and training initiatives that really help set a
framework and leverages all the work that we are doing to standardize,
harmonize and advance the community. But if we do not go all the way back to
the basic beginnings of where people get trained in their professions, we are
doing a disservice moving forward especially because it is the young
whippersnappers that are going to help solve our problems long term with the
technology.

DR. SUAERZ: Thank you. It is interesting. I was just looking at the agenda
of the HIMSS ICD-10 forum. It is a two-day or three-day I guess — agenda that
includes a lot of the same issues that we heard here. Many of our testifiers
are actually going there or coming back from there. But there is a lot of
discussion also around the other topic that we just concluded, which is the use
of ICD-10 beyond just billing as a tool for other things. I think that is very
encouraging. I think we are beginning to see the path point beyond are we going
to do ICD-10 to really how do we do best ICD-10. I am very glad. Thank you so
much for the testimony that was provided.

We are going to public comment. But before we go to public comment — we are
going to open it up for public comment. Anyone in the public who wants to make
a comment. If you could identify yourself.

Agenda Item: Public Comment

DR. REGIER: I am Darrel Regier and I am the director of research at the
American Psychiatric Association and also served as the vice-chair for the
DSM-V taskforce. I worked on the DSM-V for the last 13 years. Prior to that
time, I was at the National Institute of Mental Health for 25 years and worked
on the DSM-III, the DSM-IV, and working close with Marjorie and Don and so
forth on all of the DSM versions.

Now, there was some I think lack of appreciation of what the DSM-V actually
does that is different than what the ICD-10 does. As Donna pointed out, the
ICD-10 is an important classification, the international classification system
for all disorders including mental disorders.

One of the problems that we have had in mental disorders with the absence of
biological markers and some of the other validators that are present and the
rest of medicine, is that we found that there were vast differences in the
rates of hospital admissions for schizophrenia and bipolar disorders in
different countries. This was a major US/UK study that was identified in the
late ’60s, early ’70s.

Following that, there was the agreement that we needed to have very explicit
diagnostic criteria for mental disorders more so than we did for other medical
surgical conditions. As a result, DSM-III came out in 1980 that basically was a
new approach to mental disorders that included explicit diagnostic criteria.
This was then discussed with WHO by the Alcohol, Drug Abuse, and Mental Health
Administration at the time under Gerry Klerman. The World Health Organization
then actually agreed after a series of conferences and a major international
conference in ’82 to adopt the DSM-III approach to mental disorder
classification for the ICD and that we worked for ten years to get the ICD-10
to be able to have roughly comparable data and in fact the APA really waived
copyright protections in order to allow the WHO to be able to use these similar
kinds of criteria.

What has happened though is that — it has been as Ben mentioned before, it
has been 20 years since the last version of ICD-10. There has been an enormous
amount of work that has taken place since that time.

We started working with WHO back in 2000 when I left the NIMH and we have
just published now as was mentioned the DSM-V. What the DSM-V does is it
includes both the ICD-9-CM and the ICD-10-CM codes in parentheses with a
clearer recommendation that all you have to do is switch from one code to the
other code. It is an automatic crosswalk. This is an automatic training guide
for ICD-10-CM for the entire mental health community that is now going out.

At the annual meeting of the APA in May on the 19th and 20th of May, we
actually included trainers from the American Psychological Association, from
the Mental Health Counselors Association, from the National Association of
Social Work, from the Marriage and Family Therapists Association, and from the
Mental Health Nurses Association. All of them have had their own trainers there
so that they can train their own communities on this. As was said before, this
— what this does that is not done by the ICD-10 is that it provides explicit
diagnostic criteria so you don’t have confusion about what the codes mean.

In order to do the types of things that Sue talked about in terms of using
ICD-10 for quality assessment, for looking at audits, for fraud and abuse, all
of the Medicare vendors actually use the DSM-IV at the present time in order to
assure that they have the requisite diagnostic criteria entered into their
charts to make sure that there isn’t fraud and abuse. That is one of the uses
of this. And you would not have that kind of capability without the kind of
explicit diagnostic criteria and the explicit information that is in here.

Our association understands the responsibility it has. It is not unlike the
American Dental Association. It is not unlike what the International Sleep
Disorders Group does, the dermatologists do in their area as many of the cancer
folks do in order to provide additional information beyond what the ICD can do
with a simple coding system in order to educate the clinical population, not
just physicians, but all the ancillary health professionals as well in order to
advance our understanding of mental disorders. That is just additional
background.

If you were going to be talking about the mental health issue at a future
meeting, we would love to join you. Through the CMS and through Donna’s office,
we have been able to update the FAQ on the CMS website to mention that the
DSM-V is now available. Also, that it does code directly to the ICD-9-CM and it
will code directly to the ICD-10-CM and we had all the — we spent a lot of
time making sure the codes were right so that in fact that transition can take
place.

DR. SUAREZ: Thank you very much for that comment. Thank you. We appreciate
it. Any other public comment? Okay. Hearing none, we are going to adjourn our
meeting. We are going to reconvene in an hour at 2 p.m. We will start our
subcommittee meeting at 2 p.m. Everybody is welcome to join us as well.

(Whereupon, a luncheon recess was taken.)

A F T E R N O O N S E S S I O N (2:00 p.m.)

Agenda Item: Subcommittee Discussion

DR. SUAREZ: We are going to reconvene the Subcommittee on Standards. I think
we want to spend the remaining of the afternoon on three or four main topics.
First of all, we want to do some debriefing of the hearing and some of the
themes that we heard from the hearing. It is always good to do it this fresh as
soon as we finish a hearing to just summarize a little bit and highlight again
some of the themes that we heard throughout. It was a terrific hearing in the
richness of details and in the topics and the findings of surveys. I think it
is worth going through that. I think for that we are probably going to go
through roughly the agenda that we follow in the hearing.

The other topic we want to talk about is actually one of the notes during
the hearing and something that we have received communication directly is a
need to submit a letter — NCVHS submit a letter to the secretary to confirm
basically our consensus, our agreement with the recommended changes that are
made or being made to the pharmacy claim. You heard about the comment during
the testimony from NCPDP of the change of what is needed. We will talk about it
in more detail. We have drafted a very short letter that documents this and
basically reconfirms our support for the change. That is something that we
would probably need to introduce tomorrow during the full committee of the
discretion of the chair.

The third topic we want to talk about is we want to highlight a few of the
comments that we have received on the attachment letter. One of the first times
that we are able to do this. We published the draft letter on attachments last
week. The community, the industry could take a look. We received a few
important comments that we wanted to share with the group. In general, all of
them very positive. There is a lot of strong support certainly and recognition
of the work that was done by the subcommittee in drafting this letter. But
there were some minor suggestions that were offered by the industry so I wanted
to share those with you all. We can discuss what we might want to do about
them. Some of them are relatively small clarification points and some others
are a little larger talk points.

And then I the last item I wanted to just bring up is we did receive also in
advance of the hearing a letter regarding another topic. It is somewhat related
of course and all that, but it is about the use of the uniform device
identifier that is soon to be named UDI by the FDA. The use of that in the
health care claim. There is already a process under way to consider this for
inclusion in meaningful use stage three as a requirement to have EHRs document
or have the capability to document the UDI, the identifier of a device and
primarily in this case are class one device, implantable type device is our
most significant device. Primarily certainly for post-marketing surveillance
and for being able to identify potential issues with the devices and
communicate with the patients. Documenting that unique device identifier on the
electronic health record is something that is valuable and well supported.

Similarly, there is a recommendation being presented to include the UDI in
the next version of the health care claim and the transactions. I wanted to
just bring that up. I will mention it at the end of this meeting in the form of
a letter that we received. Those are basically the four major agenda items that
we wanted to cover.

Are there any other things that people wanted to bring up at this point? We
do have actually another meeting of the full subcommittee on Thursday from 8:30
to 10. And at that point we are going to primarily do two things. One is make
any final revisions of the letter based on the presentation that we will make
tomorrow to the full committee and any comments that we receive from the full
committee to make modifications of the letter. We will do those.

And then we want to focus our attention on the work plan of the subcommittee
for the remaining part of the year and next year. We want to discuss that at
the Standards Subcommittee meeting on Thursday from 8:30 to 10. But today we
wanted to do the debriefing and cover these other items.

Anything that people want to consider covering today?

MS. GREENBERG: I just have my card up here because I want to say something
during the debriefing.

DR. SUAREZ: You already want to talk about the debriefing.

MS. GREENBERG: I do not have to say it right now.

DR. SUAREZ: No other agenda items for the meeting. Then we can go ahead and
start with the debriefing.

MS. GREENBERG: I did have one other item. Have you decided of what you are
going to do about the next HIPAA report?

DR. SUAREZ: That is part of what we will be talking about on Thursday during
the work plan discussion, the subcommittee work plan. That is one of the items.
We have several items. The HIPAA report, potential hearings later this year,
and some topics. We will have a discussion of that. Thank you.

DR. SOONTHORNSIMA: Thank you, Walter. Just to tee up the conversation. I
thought maybe we could frame the themes a little bit. That way people have a
chance to react to these or add to. One, what we heard consistently is the idea
of let’s begin to look at these transactions more realistically instead of
looking at them one transaction at a time and make them fit sort of the
business practices that exist today and the variations.

Two, consistently we heard small practices and small payers are challenged,
challenged by a couple of issues mainly the vendors that they rely on to make
these changes happen and also the cost of doing this.

Third, we also heard about education. You mentioned earlier education,
education, education, Larry. But I think what I heard was slightly different.
You have to be really more focused perhaps. Awareness, education, and even
focused handholding.

Fourth, we heard again the roadmap, but this time around, I would like to
change the context of the roadmap. In our context as we have been talking
about, the roadmap has a lot to do today with all the changes that are
happening and when they happen.

But today I would like to add you also have to think about the tail of each
implementation because clearly what we heard this morning just a 40/10, 50/10
change alone there is a tail that exists already with regards to how lots of
practices why they might be compliant, but they are relying on 40/10 so that it
is a dose of reality. I would like to coin that as some of these tails and
every implementation.

And what happens, as you all know, the tail also impacts the next milestone.
For example, in this case specifically I wonder with practices clearinghouses
and even payers that are upcoding — upconvert I should say, not upcoding —
upconvert 40/10 to 50/10. What are the implications then of the financial risks
when you start applying ICD-10. Those are the areas that I am trying to frame
up at high level. I will pause right there.

DR. SUAREZ: Let me add a few more. Great summary. I am going to go from the
beginning of our hearing. I think one of the big messages we heard today and it
is very important and I am going to try to say it correctly. I am sure there
are people here that will be able to correct me. What we heard yesterday was
that NCVHS is not likely to hear a recommendation to move to the next version
of the HIPAA transactions until sometime in 2015 or potentially even into 2016.
That is a big important message. The extra transaction standards, which
represent — we did not hear yet anything from — actually we heard from NCPDP
for the pharmacy transactions that they are not even working yet on any version
of them.

MS. GOSS: I want to just clarify with Margaret. Is that 2015 they will have
something to bring forward?

DR. SUAREZ: That is the important part. My understanding is that the process
laid out by X12 including — to be determining was the window of testing before
a formal recommendation can go through DSMO and come to us. We are talking
about 2015 or potentially early 2016. That means the recommendation to us
saying we recommend to move the industry to the next version and so NCVHS can
send a letter to the secretary who recommended that. That is not going to
happen until 2016 or sometime around that.

That has another big important implication because what he means is that
looking at the timeframe for generating proposed rules because there is not
really — final rule authority for this. This is probably going to go through a
propose rule making process and all that. And then after that the adoption
window for a new version of a standard according to HIPAA says 180 days so 6
months. But it is probably given the potential significant impact. Again, by
then I might not even be a member of this committee. It is possible that this
will be two years after the rules come out because of a very large or a year
and a half. Who knows?

In any case, the point I want to make is that we are going to be staying
with 5010 until at least if I am estimating this correctly 2018. Potentially
maybe 2017, but more likely 2018. That is a big important message I heard
yesterday. I think it is important to highlight that because I think it is
important to tell industry and informed that this now the expectation. We
should remain and continue to work and refine and make sure that we do well
5010 and continue to move there because that is going to stay with us for the
next four or five years. That was one important message I heard yesterday. I am
sure there are going to be press releases and more details coming up later on.

DR. SOONTHORNSIMA: That is not a theme. That is a fact.

DR. SUAREZ: That is a fact.

The other theme I heard was very positive is the fact that with 5010, with
the version 5010 D.0, 3.0, the industry is actually in a very good position
through surveys, through reports, the payers, Medicare, CMS. The report was in
many cases were in the high 90s, in some cases 99 plus in terms of people using
5010.

We also heard though that there are still organizations that are from the
organization to a clearinghouse still using 4010 and in some cases up to 20
percent or more, which means the organization is not doing 5010. It is doing
4010 and sending that data to the clearinghouse for the clearinghouse to do
5010 on their behalf. That is again mentioned earlier perfectly legal and
permitted except when it comes to do ICD-10 because with ICD-10 that type of
reliance on a clearinghouse or an external entity for upcoding from ICD-9 to
ICD-10 since 4010 does not support ICD-10 transmission is not going to be
workable. What he means is that all the 80/20 rule, the 20 percent of people
that are still on 4010 need to begin to get the message that they must move to
5010 in order to be able to comply not just with ICD-10, but be able to
continue in business I am sure. That was another important message.

I think 5010 D.0 struggled a little bit in the transition. We heard about
the impact of having to do this delay, 90-day delays a couple of times and some
of the effects of that. But in general, I think we are in a very good position
with 5010. That was an important message also to note because I think it is
valuable to always recognize the move that the industry has had. Those were two
important messages I heard yesterday in the testimony.

I also heard an important message I think from CMS in terms of regulatory
activity. This deals with another transaction that we have been recommending
periodically and that is acknowledgments. We heard yesterday and it is a very
valid point that the reality that we have recommended the adoption of
acknowledgements of the standard transaction in the industry, but there is
certainly a balance to be played here in terms of the timing and the
overloading of requirements and acknowledgment could be a significant one over
the next two or three years given all the things that are going to happen in
industry.

And then this is the two-part situation. We heard that acknowledgment is
important. We have heard consistently that people want acknowledgments, that
acknowledgments are critical through the industry. That it is something that
even for implementing 5010 and other transactions. Part of the challenge was
the agreements to do acknowledgements and the differences in between payers and
providers in that. The benefit of adopting a standard for acknowledgements is
there. But we also heard the concern about the timing and when it can happen.
In general, we heard it is probably not going to be something that is a top
order priority in CMS’ regulatory agenda at least for this year and potentially
for next year. That is another important message that I think is important to
recognize.

I think I am going to stop there and then turn it to other people. Marjorie
and then Linda.

MS. GREENBERG: Thank you. I congratulate those of you in CMS and the
co-chairs and the subcommittee on putting together very interesting I guess
full day with a half day yesterday, half day today. I think Walter and Ob, you
picked up on obviously a lot of the themes and main themes. I think mine sort
of fit into two things that really struck me although those of you who have
been around for while will say particularly on the first one that is nothing
new. You have been saying that for a long time. I just keep quoting Bill
Scanlon who said about health policy and it is the same thing about health data
policy. If you are in this field for a long time, the good thing is that the
issues never change. As I am cleaning out my office now after 40 years of being
in this field, I can only agree with them.

The thing that really struck me though it was different this time than the
last time, but was something that I think I remember mentioning I think it was
a year ago, but it might have been two years ago. It was in June when you had
the annual update on what was happening with ICD-10 code sets. That hearing and
I am sure you remember it well or at least Walter. There was a lot of concern
expressed about people — all the mandates. Certainly this roadmap thing. I
think we have to stop talking about it. We need to really start working on it.
I do not know to the extent to which what WEDI is doing will help in that
regard, but I do not think it is really the same thing. Some of us are involved
with that too. It is a piece of it, but it is not the whole thing. I think it
is going to be really embarrassing and I will be retired, but I will still be
around. If a year from now you hear people saying what we really need is a
roadmap. I think we need to get on with this. When I say we, I do not mean just
the national committee, but I mean the department and really start scoping this
all out.

PARTICIPANT: We will call it something else.

DR. SUAREZ: To that point, we have on the agenda for Thursday that as a
specific item to discuss. The plans for how to execute, how to stop talking,
and how to do it.

MS. GREENBERG: But one of the things we heard at that previous hearing and
as I said, I cannot remember if it one year ago or two years ago was how come
we implement these ICD-10 code sets when we are having to do meaningful use.
And then in the same breath, ICD-10 is too complicated and we are going to do
meaningful use and adopt SNOMED. We do not have the documentation for ICD-10,
but we need to be focusing on SNOMED. I am really saying that there is a
disconnect. I questioned. I said if people do not even have the documentation
or are not capable of creating the documentation for ICD-10 code sets, which
are classifications, high-level classifications compared to vocabularies. What
is going on here? There is a complete disconnect here.

I sort of heard that again today. On the one hand, ICD-10 has too much
detail. It is too complicated and it is particularly hard for the small
providers and that is where I get to my second point. But then I heard John —
we will give him an assignment. He is not here. But talking honestly about — I
do not think people are really going to be using ICD. They are going to be
using the SNOMED categories. I will tell you that the whole reason that the
World Health Organization and the International Health Terminology Standards
Development Organization made a really important milestone agreement was
because IHTSDO did not want WHO to come up with a ghost terminology, which they
were nibbling at the edges. And WHO did not want SNOMED or IHTSDO to come up
with a ghost classification. We have two international standards here. Let’s
make them work together. It is a long subject I will not belabor. We obviously
need both. We need vocabularies and we need classifications. Of course, 22
countries, many of them are very small and the main ones are English speaking.
At this point, SNOMED is a long way from being an international terminology in
the way that ICD is an international classification.

But nonetheless, we acknowledge that there is a continuum. But there are two
real problems here. One is something has to be done to improve documentation of
health care if you are going to have data that is going to be useful. If the
solution is always to go to unspecified, where we know the least, et cetera, it
is not — you have to have that option. You have to because as Larry said,
certainly in primary care encounters, you may never know. It may never rise to
the level of a diagnosis. That is okay. Symptoms need to be treated too.

We keep hearing that, but nobody seems — I know AHIMA is certainly — I am
singing your song. That brings me to this issue of the small practices and the
lack of infrastructure for a lot of the health care system. I do not think — I
have been thinking about this and I cannot say although some would say the
solution is everybody has to be in an accountable care organization and you can
make a good case for that. I have heard Bill Braithwaite say you cannot
practice medicine with paper records or without all of the technology, health
information technology that is needed or that is available. Well, I think there
are some people who are probably practicing medicine very well without that,
but it is in certain areas.

It seems to me maybe we need to think outside of the box about what kind of
infrastructure can be developed to support all these small practices out there
that are not going to do what my primary care doctor did, which after telling
me he could not afford electronic health records because he was a small
practice, he joined Johns Hopkins primary care network. But there are a lot of
places in the country where that is not even an option. There is something to
be said for more personal smaller practices. There has to be some solution.

This may sound like it is out of the scope of this committee, but I am
thinking of some solution that deals with the information aspects here, the
data aspects because it just — it is a burden on these small practices. I do
not know how many small payers there are, but I guess there are still some of
those. There needs to be some solutions certainly in the shorter term to allow
them to continue practicing medicine and treating patients and treating
patients with high quality, but not maybe just being absorbed by some larger
group. And maybe it is a different kind of clearinghouse. I do not know.

There has been some talk in the area of mortality data because you have all
these little islands. We have 200 countries in this world and some of them are
very small. They cannot even accommodate one person to just code death
certificates. Maybe there is some way you can do this in a regional way.

It is the same kind of idea that we need to be thinking outside of the box
here I think. I do not have the solutions. But I think these two issues of
improving data documentation and yet recognizing how far we are from it. I just
downloaded at lunch this health IT smart brief, which WEDI puts out weekly. I
am sure many of you see it. It says stakeholders are not prepared for stage 2’s
SNOMED criteria expert says. Dave Delano of the Massachusetts eHealth
Collaborative has expressed concern that many in the industry may not be able
to meet the clinical quality measures for using SNOMED under stage 2 because
the codes are too complex and are not widely used by providers and EHR vendors.
You get problems on that side as well. A lot of people have signed up for
meaningful use stage 2. Everybody has to sign up for ICD-10. That was one good
thing. I actually did not hear anybody ask for a delay. I did not even hear
anybody suggested a delay would be a good idea. That was encouraging.

Those are my two big issues. It relates to the education issue because how
are we going to get and that is something Alex said before lunch. How are we
going to really get this information revolution into if not practice of
medicine, but the health care system? I am not sure that anyone is really
focusing on that.

DR. SUAREZ: Thanks. I think we have Linda and then Rob and then Jim and then
Alex.

MS. KLOSS: I have one additional item as a big theme to add to the list and
that is about update processes. We heard it in two contexts, but I think it
really applies to all three topics we have discussed. The DSMO. That
understanding of the rapidity with which we can actually keep standards current
and take full use of technologies to simplify processes. We heard it with
regard to operating rules. I think if we had had more time to probe, we would
hear it with regard to code sets because this is a big opportunity as it
relates to code sets and vocabularies when you think about those two together.
And supporting a digital health care environment, we ought to be able to update
these systems through web technologies virtually real time. We are so far from
being able to do that. I think that is one of those visions that we need to
articulate and work toward over the next five to ten years. Perhaps that could
be a code set issue. I think updates are an issue across all of these data
management issues.

DR. SUAREZ: When you say update, you mean the maintenance process.

MS. KLOSS: I mean maintenance and dissemination is a better way to state it.

MS. GREENBERG: Are you suggesting that it would be good to update
classifications on a continuous basis? Actually, WHO has suggested that with
ICD-11, not that you would necessarily — you would have a foundation layer
where you are updating it. I do not think you would want it to change every
day.

MS. KLOSS: Several years ago, AHIMA did an analysis working with AMIA on all
the code sets and the development update, dissemination processes. It is all
over the map because CPT has updated one cycle and DSM on another cycle. When
you look across the industry, all of that cost a lot of money and creates
confusion. There is an opportunity to think out of the box about maintenance
and dissemination. We are fully leveraging the technology.

With regard to roadmap, I had the same thought. Let’s stop talking about it
and do it. I think there is an opportunity to join the discussion we had about
a holistic view. For instance, we would not necessarily have to pivot from
transition to business process standards if it were articulated on the roadmap
that here is the business process and these are the component standards and
they are going to be addressed in this sequence. Does that make sense? To your
point earlier, Alex, that it seems to me we have talked about this before.
There is a way to probably do both.

And then I think the third thought I had that gets added to the theme list
is we have an opportunity to capture maybe a little more formally than through
this hearing process. I am actually thinking of even the committee
commissioning a report or something that describes this kind of large — the
lessons from this large-scale change that we are about so these lessons do not
get lost in five years from now and not learning them all over again. There
were just some rich lessons learned in all of that testimony. It seems to me
that somebody could research that and pull that together because we are dealing
with large scale systems change.

When we think about that kind of change management, there are some things we
should be doing like celebrating the successes. We heard some good things here
that it would be great to send out press releases on the amount — where we
have come in 5010 in one year. It was so bleak a year ago. Well, we have some
clean up to do, but we have essentially done it. But that is part of the change
process. I think there may be something here that we could create some real
value.

MR. TAGALICOD: Actually, that is a good segue into because I usually do not
play cheerleader. I am going here is the dire. We need to go forward and we
need this and we need that. I am going to play a little of cheerleading.

Actually, Marjorie, it was a year ago. I remember we were at that meeting
and we were talking about a roadmap and we are going to yes. That is like —
what do we need to do next. It was almost a year ago.

MS. GREENBERG: It was the subcommittee a year ago and it was at a hotel.

MR. TAGALICOD: We were in the proverbial hallway talking about it. We need
to move there.

What has happened was and we were still in stage 2. We were still meeting
with the secretary. That still did not get — it did not pan out just yet until
later into the fall and we were talking about the question was on the table.
Should we include any kind of reference to ICD-10? That was still a debate. But
now there is at least a reference in terms of certification regarding ICD-10
and then looking forward as a basis of using stage 2 looking to stage 3 and
saying maybe we need to have a specific reference to ICD-10 as part of and
again I do not want to get ahead of any rule making or any agency, but a
question out there is do we make an explicit part of certification and then
some. We have moved the conversation.

In terms of alignment, one of the things — this is almost in place of a
roadmap because we think we know what a roadmap is, but we are operating out of
certain assumptions. One of the conversations that we also had was about look
at all the quality measures. They are all over the place. We have different
measures. It does not seem as standardized as we need to have them. Only to
find in HIMSS 13 in New Orleans, our colleagues at Center for Clinical
Standards and Quality saying we are getting to a point where you come in where
this PQRS, IQR or whatever the quality programs are, meaningful use, ACOs. You
come in once and that is all. I think they are moving towards that. I think
there are kinks to be worked out. But that was just a dream a year ago.

I think we have moved to a place where we are aligning at least the quality
reporting and saying this is what we mean by quality. This is what we mean by
numerator and denominator for a given particular quality metric. I think we are
getting there. Is it perfect? Not just yet because we are still also learning
how to use the technologies in order to do the real time.

Actually, this is related to the updating whether it is ICD-10 or anything
else using the technologies in order to get there. I think we are experimenting
through piloting how we can do that kind of updating acknowledging the myriad
data sources. But if you have the same data, it should go in and it should give
comparable data so you can compare. It is only a year ago we could say the
state of affairs was it is the same data. But because of some algorithm of some
system whether it is an EHR system or whatever, it was not comparable data. In
fact, they were so far apart that we are going it is actually useless in terms
of whether it is paying for quality or for research or for whatever. Again, as
part of where we have gone, I think we are farther down than I think we
acknowledge.

I think the other thing too and this is where again I try to be reticent
about my role at CMS. This is where I am going to say CMS now has a strategy
that incorporates the triple aim or however we are calling it. And then part of
the roadmap at least for CMS is the eHealth roadmap. I think part of the
discussion is with NCVHS and with WEDI to making sure that they themselves are
aligned that they self reference each other so that we know what are some of
the timeframes as well as the milestones and the objectives that we are all
trying to drive towards. Are we there yet? No. But I think we are getting
there.

I would argue that WEDI may have a different plan, but I think there are
several of us around the table that sit in those work groups that can inform
the process so that we ensure that they are not divergent processes.

The other piece to this is I know Marilyn Tavenner specifically said about
ICD-10 and eHealth in general was I want to develop a kind of toolkit, but it
is not really a toolkit. The phrase eHealth university is coming up. That is
taking place at least amongst our federal partners. And, again, it is about
educating a particular cohort or target audiences because as we have heard in
listening sessions from smaller providers, please do not lump me even with the
medium-sized providers because our needs are so vastly differently not only
from them, but from the larger organizations. You need to address our
particular needs. Are we being sensitive to it? Yes. Are we trying to develop
in partnership with other folks around the table? Yes. But I think we are still
getting there. But I think it is within the horizon. Again, my cheerleading
role.

And then the last piece too which I was kind of mentioning about the code
sets and updating. I think we have technologies. I think we just need to do
some piloting around it because I see small pilots. And to do that kind of
updating on an ongoing basis, I think it is there. I think we just need to test
some assumptions. How do you leverage CMS or ONC or the industry that are doing
these kinds of pilots? I think we are going to learn a couple of things and
then we should unfold those insights into a roadmap. I am done.

DR. SUAREZ: Thanks Rob. Great points. I think we have Jim and then Alex.

DR. SORACE: Just in full disclosure, I am a pathologist. One of the things
that was mentioned is that the diagnosis of an illness evolves over time and
over encounters with the health care system. People do not rush in and they are
not labeled instantly. And also, the overall success of the health care system
in delivering quality depends on meeting individual diagnostic needs very well
across the entire population. This can be very complicated because you have
many different types of diseases.

The reason why I mentioned I am a pathologist is that a lot of times it
begins with a loose disease categorization, fever of unknown origin, fatigue,
depression. You cannot design a more granular code. It would be a mistake if
you did and frankly you will make mistakes if you force people to do it. But
when those happen is there is an interaction over time between the patient and
the provider. And there are interactions between the provider and labs and
radiology services. An awful lot of the action specific — and also pharmacy
services as they try different therapies and what not. An awful lot of the data
that helps you ultimately understand what is happening in that patient is in
these other systems. And it is in a pack system or a lab system or a pharmacy
system.

You can try and you should make it interoperable with an EHR. But the other
thing you will notice is that technology will change over time and these
individual systems will have better imaging and they can reanalyze. You never
entirely disengage in it. Rather than trying to support very granular codes.
Another way of looking at this is you can just stay with a more — disease —
that is less specific. But you can cluster it with finer and finer observables
and other types of opinion over time and — more specific diagnoses. And we can
debate at what point you want to recode or not.

But the point is is that it is in diagnostic systems and in some of these
other systems like pharmacy systems. We are putting effort into the granularity
of codes, but some of this actually might be put into these other systems and
how those codes are then rolled up and clustered for patients. And then
nationally in a population health level, you are monitoring how many different
clusters occur and are these patients really like one another. I am just giving
a differing — more of a diagnostician’s view having done labs as to what some
of the other alternatives might be.

MS. GOSS: Lots of really good comments here this afternoon. I have a very
short list of things I would like to offer. All the prior comments. Need for
robust processes around testing before adopting standards and to do this in the
context of various actors in the health care continuum was a theme I heard that
we need to address and that is one of the lessons learned I think to a couple
of the earlier comments that I had seen in adopting 4010 and then A1 and then
5010 to the point of promulgation was that we consistently had a problem with
wanting to adopt transactions that had not been road tested and road tested
hard and to do that in an environment where it is not the usual suspects coming
to the table to provide the kind of good testing that they do, but it is such a
small sample of the real world out there and that we continue to have a
disconnect from main street and that is very troublesome to me. I think that
needs to be a part of our discussions of our roadmap. I think that we have a
lot of good testimony and experiences that we can leverage in informing that
discussion.

In order for us to really effectively move forward, I continue to be
concerned by a theme related to the support of the providers. I do not want my
provider worrying about health care transactions. I want my provider to worry
about my health care, who I am as a person, and how my world around me
influences my quality of life and my long-term health care. We should be highly
transparent in the work we produce. But my point here is more about how do we
help the providers get to the point where the technology pipeline is
transparent to them by helping them really be successful and that this should
be a short-term hurdle as we adopt this 21st century revolution and that we
really prepare those coming out of technology schools and medical schools and
universities to really just continue to improve that system as we move forward
and keep it behind the curtain.

One of the things that is very troublesome to me because I think it is
another flashback of my prior life that does not seem to have been addressed
which is a comment that was made in one of the testimonies today about the
standards overlap if it is still happening. Who is on first to do what and how
we coordinate it across the standards community. I think the conversation in
general has gotten better, but I am not sure where the standards charter
organizations fit in versus what SNI framework is going to be doing and what
happens when the money dries out or dries up. And how do we move forward with
effectively coordinating because the overarching ANSI groups like the Health
Informatics Standards Board was disbanded when HTSI came about.

And then when things still really were not working too well, we put together
the standards charter organization and that is when I left this world in 2008.
It sounds like SNI really has been carrying that water and really trying to
coordinate things. But at some point, that may not be the solution. We need to
be letting the industry drive this. Once we get mature and get a solidified
digital base in use in health care then who is really governing moving forward
in effectively developing and maintaining not only our standards, our code
sets, our operating rules, coordinating with academic institutions, et cetera.
I think that is a long-term issue that needs to be part of our roadmap.

I also am not convinced that the level of kumbaya that we have seen in the
standards community and the data content committees is necessarily as effective
as they would like us to believe.

DR. SUAREZ: Thank you. Susie.

MS. BURKE-BEBEE: I am not sure I heard these themes. The non-covered
entities. That was mentioned. That has a big impact on providers. Alex, you
touched on this a little bit. But I think very significant is funding. HITECH
is not going to come around again, the ACA for the next ten years and the
sequestration environment. How was committee, subcommittee address funding in
roadmap. I think we heard that not loud and clear. And finally, minimizing
change. Very important.

DR. SUAREZ: Could you say a little bit more about minimizing things?

MS. BURKE-BEBEE: What I heard today was that the roadmap would be very
helpful so that we do not duplicate efforts and that we are able to cross
coordinate so that the changing would be minimized.

DR. SUAREZ: Minimizing the change.

MS. GOSS: And building on Susie’s comment, I would say that not only to
minimize the change, but to become much more effective at how we coordinate
that across national organizations to the point where people can use their
resources wisely and be a part of the process as opposed to having to cover a
multitude of environments and when they realistically cannot do it and it does
not fit into a natural business strategy.

MS. BURKE-BEBEE: An example I would say that Rob mentioned was reporting it
once across many different ACO, meaningful use, the quality programs. Of
course, what came to my mind was of course, there are different numerators and
denominators. You may have the same data, but then the business purpose may be
not the same. The problems that we are trying to solve and our solutions may
create other problems, but we still need to follow with that report once across
many different programs.

DR. SUAREZ: Before going to Ob, I wanted to add —

MS. KLOSS: I just had one very short comment that kind of summarizes what
you said. One of my favorite quotes about change is from David Lawrence from
Kaiser. He said that those who are most successful understand that sequencing
and pacing of change are critical. I think about that so much in everything,
but it clearly is illustrated by what is going on now in health care.

MS. GREENBERG: There was just one other thing and particularly since Rob is
still here. It seems there needs to be some clarification or further
conversation about this whole issue of end-to-end testing. We heard four or
five people wringing their hands that basically felt that CMS was undercutting
the whole agenda by whatever this pronouncement was that was made. And then we
heard from CMS that it was not a pronouncement or it was not an announcement. I
do not know whether this is semantics or what. But it is not a good situation
to be in like 15 months out. Can you help us with that at all? I am not
suggesting that CMS should change what it is doing because I do not know enough
about it.

DR. SUAREZ: If I may say just one quick point. This committee has the
ability to take specific recommendations. The point was made about the fact
that CMS is not going to do ICD-10 end-to-end testing with individual
providers. That is the main issue that CMS is doing all the types of testing of
ICD-10, but not the end-to-end testing with individual providers, which is what
everybody is looking for to do with everybody else — we heard from Michigan
Blue Cross Blue Shield how they are actually doing end-to-end testing with
individual providers saying you go here, do this, test this, see what you get.
That kind of an end-to-end testing. That is the main issue.

It is important to note that Rob mentioned it at the beginning. There is a
difference between CMS, the regulatory, and Medicare, the operator of a
Medicare plan. And it is Medicare that wanted us not doing that. The
recommendation that we can certainly advance is a strong point to the secretary
that this needs to be considered because entire industry is looking at doing
this and they need to this type of end-to-end testing to be successful with
ICD-10.

MS. GREENBERG: Do you feel that this committee understands fully why CMS has
made that decision?

DR. SUAREZ: Medicare.

MS. GREENBERG: Well, Medicare is pretty big. Also known as the 800-pound
gorilla.

MS. GOSS: But Medicare fee for service never said they would do that
testing. I think what they envisioned was that if they had done 5010 testing
and then they were going to be having focused testing with ICD-10 more in the
context perspective that that was probably going to be enough. They do not have
the strategy nor do I think they have the funding or the bandwidth to do it. I
am not in the Medicare world anymore, but that is what I have gleaned.

MS. GREENBERG: That is why I would be a little reluctant for this to go
ahead and say do it if it is not practical or reasonable.

MR. TAGALICOD: Here is another way of looking at because someone had said
and I do not know if it was the blues. It is given the resources that we have
and the risks that we have to manage, but we know that we need to pay. At the
end of the day, we need to pay and we need to pay accurately, et cetera. Given
those and the timeframes, people have different ways of looking at testing. I
understand. I can tell you what my personal bias is because I come from that
world. I like to know clearly what end-to-end testing and yes, is that the most
rigorous? Yes. If I had a certain amount of funds and timeframes and not
managing my other businesses.

The blues made a business decision based on the resources they have and
their sensitivity to certain kinds of risks. For others, it will include
end-to-end testing. At the end of the day, it has to be testing. But if you are
going to do end-to-end testing. In fact, I had a conversation at lunch. I am
going if you are going to do end-to-end testing, let’s make sure that we have
the same definitions and the same things that we are all driving toward. But if
you are going to choose different testing, then let’s make sure that it gets to
the end of the day payment and, again, to the accuracy based on the assessment
of risk. Everyone has to make a business decision large and small.

MS. KLOSS: We did talk about doing some education or some guidance or I
think I suggested doing some kind of guidance to help organizations decide
where they would line up.

DR. SUAREZ: One other importance point that I have not heard and it was
somewhat troublesome for me was the entire session on operating rules. I think
we heard a number of important points there and basically I wanted to summarize
them briefly here in a couple of things. Number one, we are struggling to
complete the transition of operating rules. We are still adjusting to the
change. It is not an easy process. Health plans seem to be and particularly the
larger ones seem to be getting better and getting ready to comply with the
operating rules, but many providers are still not even aware of what operating
rules mean whether they are compliant or not or how they are doing it. Maybe
they are relying on clearinghouses to meet those requirements. That is a — we
are struggling because it is a new thing and we are still adjusting.

Number two, there are some process questions about maintenance and about how
changes happen and particularly how input is received. We have the example, of
course, of the DSMO process, the change request process, open process for
anyone to submit to a specific website, a particular request and the analysis
is done and the responses are done. There were some questions about how the
current process for operating rules with respect to receiving or viewing
changes is working.

And here is the context for this whole discussion of the next round of
operating rules, which we should be thinking about them in terms of a
transaction-specific set or whether there should be some just overarching kind
of more holistic as had been said. But in the context of operating rules, there
should be some — operating rules that apply to everything. And maybe there is
only a few or maybe it is hard to find some of those. Or maybe it is not about
applying to everything. It may be operating rules conceptually based on this
function and not the transactions.

And that is, I think, a significant message that I got out of that
discussion and the context or the reference that was made about the new way of
thinking is really transactions are a reflection the need to communicate
information. That information need is the reflection of a business need. We do
not really need to go to the source, the business need, and the business
process and start to look at those that holistically rather than transactionize
each of them just to create the transactions and say this is the way to do it.
I think that is a clear opportunity that we have in terms of this concept of
the roadmap and the concept of looking at this in a different way.

I also heard questions from the providers particularly. We heard a few
providers reflect on the value of some of the processes that are being put in
place. Eligibility is a good example. And some examples came up about how
providers perform eligibility or, for example, EFT and some of the limitations
that exist in how EFT is supposed to be done.

We heard about the credit card issue that some payers only accept credit
cards or accept credit cards to do payments and is not an EFT option perhaps.
There are several of those kinds of situations that are creating a struggle in
terms of being able to implement operating rules. I think it is going to be
important to reflect that. It is something that we need to consider.

The most important message of all I heard is don’t try to force operating
rules by January 1 on this next round. We are starting to look at as an
industry what are the operating rules for all these other transactions. There
are five major transactions. Three of them are really huge. But all of them are
important. Five major transactions for which operating rules are to be defined.
And, again, this is using the same verbiage of the law that is transaction
directed or centered. There are claims. There is a major transaction and
operating rules about claims. There is prior authorization. Talk about a
complex transaction and operating rules is going to be huge. There is
enrollment and premium payment and then there are attachments, yet, another
very big one.

I know those five are supposed to be adopted by January of this next year.
That is not possible. We need to communicate that to the secretary that this is
not going to be possible to meet this deadline that we need to really on this
measured transaction need to work with as an industry to define them, to test
them, to look at the value of implementing them and then come back with the
recommendations.

DR. SOONTHORNSIMA: Can I add onto that? Another thing that we heard, I think
this came out a few times, has to do with health insurance exchange eligibility
and delinquency that we are moving from — I forgot — 45 days typically to now
90-day period. And that will cost quite a bit of havoc. Forget about the
operating rules for a second. That starts 11/14. There is a concern in terms of
disruption and the bad debt.

I think we have to look at this as a big issue and challenge and look at how
eligibilities/claim status come into play and help the providers use that
information more effectively because they have to manage some potential bad
debt. That is, I think, a big implication there too. That is another major
change that is right around the corner.

MR. TAGALICOD: And kind of tying up about the conversation on several
things. I remember it was not a lie. But before I go there, I think what we did
not know about in terms of a roadmap and what I think we need to figure in is
the influence of the health insurance market place, but it is not called the
market place instead of the exchanges. As we realize that we are using some of
the rules for these transactions and we did not contemplate that a year ago and
then we were saying by the way, shouldn’t we be using this? It is anywhere from
the transactions to issues like privacy and information security. We need to
see those all intend them and then say what are our priorities individually and
then as an industry. I am including the federal partners in that.

PARTICIPANT: The rules were not written a year ago. That is the point.

DR. TAGALICOD: Exactly. I think we have moved —

PARTICIPANT: Even the 45 to 90-day rule came out very late.

DR. TAGALICOD: But I think now that are still developing — I think we are
poised to do the roadmap. I think now we need to have — we have enough
information in order to that.

The questions about funding have come up over and over again. It came up in
the different context. It was how do we fund intraoperability in
vis-à-vis HIEs, not the insurance exchanges, the information exchanges.
The question that is on the table and I do not want to lead too much because it
has program and financial implications in terms of federal priorities. It is a
question. Then I think we have to answer it as we go along. How do we leverage
ACA or current funding or our payment policies whether it is Medicare or
Medicaid or the innovations in terms of ensuring the kind of interoperability?
Again, I think interoperability to the business need, it is not a technical
thing. I am not talking about it as a technical thing.

Again, I think I shared this story ten years ago. I was living in
California. I am a Kaiser baby. I was visiting my brother who was about to be
married. It was in Upper Chesapeake in Maryland. They thought I had — I had a
temperature of 103. Wouldn’t it had been great if all the information that
Kaiser had over the last 40 years of my life over at Chesapeake in order to do
whatever they needed to do. I am using that as an example of the kind of
interoperability vis-à-vis the kind of care information I needed at the
time of care at Upper Chesapeake.

Again, what are the policies, Medicare, Medicaid, and then some and the
dollars that are attached to it to leverage? I am going to leave that as a
broad question because it does have implications about what our priorities are
that he may or may not like.

MS. GOSS: Your big question mark dovetails with a thought that I have about
being able to have a roadmap conversation that really looks at leveraging the
workflow discussions that we have been hearing today. If you start to look at
the workflows of patient care, you start to naturally touch upon meaningful
use, the HITECH, the HIPAA, all the different kinds of aspects that you are
talking about and you can start to shake out from that workflow level
conversation the communications for the actors, the work for the standards, the
operating rules, the insurance exchanges. You can let those transactions and
the techy stuff be behind the scenes. If you look at it from a layman’s term
about what happens in the process and start to take basic simple workflows and
then extend them over time to more complex ones as you get to a process, you
can start to pull all of the stuff together. But that is going to take oodles
of money because you have to get work groups to get in the conversations
because it is so complex and we all have such different views. How can we
leverage his funding conversation with our make it around the workflow
discussions to get us to the roadmap that starts to solidify the foundation
that has been invested in over the last ten years.

DR. SOONTHORNSIMA: In fact, there is some really good tough work that folks
at CSIO are doing right now. They are mapping some of these things out as they
are solidifying their rules in the workflow. If you want to start with that,
that is a start.

MS. GOSS: I would not reinvent the wheel because a lot of these workflow
discussions have —

DR. SOONTHORNSIMA: They are learning this by the way. They are learning this
from the industry. That is only side one unfortunately. That is only for health
insurance. They are not even mapping out what it means to the providers, but
that is an example.

DR. GREEN: I wanted to announce that everyone has run my entire list of
themes. I would like to offer three types of comments. One is interpretative
and another is about — I am going to pretend that I am looking across all the
subcommittees of NCVHS and comment. As many of you know, I love personal
quotes. I want to share my two favorite quotes from the last 30 hours. One is
from Alex and one is from Mona. The interpretative remarks — these cannot be
wrong because it is the way I am looking at this. A lot of this came out of the
operating rules discussion. Personally, I thought of the different sessions.
That was the most potent one in terms of really getting to meaty stuff and
being a good driver for the committee.

The first one is it is obvious that it is too complicated and it is
unnecessarily too complicated. And that it stays complicated because advantages
are created by retaining the unnecessary complexity. And that we are not agreed
about the purpose of the whole enterprise and that we simply keep messing
around with the wealth care enterprise. We are making a secondary objective,
the health care enterprise. That was on display. There is just no way to avoid
it. It is hiding in plain sight.

I want to remind everyone that I cannot think about what a trillion is. Some
of you have heard me say this before. You can wonder how long ago a trillion
seconds were and begin to get some idea about why this is hard and so
intractable is we are — US wealth care is the fifth largest economy on the
planet. That $3 trillion enterprise if those were dollars were seconds would
create 85,000 years. That is an incredible amount of money. I am convinced,
again, by this hearing, this meeting that part of the reason it is so hard is
there is just so blooming much money at stake.

DR. SUAREZ: I thought California was the fifth largest economy in the world,
but maybe health care is bigger.

DR. GREEN: Does California have a $3 trillion economy? I do not think so.

DR. SUAREZ: Close to that.

DR. GREEN: Actually, California does not show up in the CIA website as a
country.

The other thing is you keep this seeing this tension about engagement is
voluntary, but everything has to be coordinated and integrated. These are non
sequiturs. They missed all moving concert, but we missed all — have the
authority to move when we want to, the way we want to at the pace and when we
want to.

PARTICIPANT: It is the American way.

DR. GREEN: The American way. This ties back to another thing that I would
interpret is we are watching what happens when a complex adaptive problem is
approached with linear strategies. This is nontrivial because if we are going
to be serious about the suggestion that we had for a roadmap and we are going
to hear Linda’s suggestion. Part of the operating definition of roadmap has to
do with sequence and pace. Did I hear you right about that?

That begs the question about can you solve a complex adaptive problem by
sequencing things at the proper pace or not. I suspect that we have no choice,
but to try to do that. And it looks like it would be at least be an axiolytic.
And if not, provides some actually useful guidance for work. But I think we
should be cognizant of the fact that that strategy may be futile.

It is also clear from the last day’s meeting that many of us still do not
accept the IOM’s conclusion in ’99 and 2000 that it is so screwed up, it cannot
be fixed. We are still trying to fix it. I find all that humbling and
intimidating.

Second bundle of comments here, Walter, is it seems to me from a
committee-wide point of view — what I have been mostly doing for the last day
and a half is listening for the convergence theme. How does this committee’s
work connect back up with the other committee’s work and how do we manage to do
something that is in our space that is useful? That convergence theme is I find
really challenging. But I thought I heard in this discussion here a couple of
things that look really promising to me.

One is this notion of assistance over and over again. If someone would just
help, if someone would just teach. What we are hearing is it is no one’s job.
For our meeting tomorrow, Susan, again, has done this wonderful report based on
the population’s committee stuff. At the community level, which is the action
point, it is already widely acknowledge. It is the action point for actually
elevating population health closing the disparities. The communities are saying
help me. One of the big things they will not help with is data and how to use
it and how to use it properly, how to use it correctly and avoid making
mistakes and not do harm and that sort of stuff. I think hiding in plain sight
is an opportunity that is already in the ACA. It is often forgotten about.

It was mentioned very briefly by one presenter. They referred to it. The
Senate says — AHRQ started putting some money into an extension agency sort of
thing. In the ACA, it is called a primary care extension service. It takes
almost no imagination to see how that could just be the nidus of a new,
national resource. It does not have to be federally owned. It does not have to
be state owned. It does not have to be privately owned. We can think of all
sorts of ways to finance that and organize it. But there is a desperate need
for assistance in managing the pace and rate of change that is afflicting the
health care world. We are not getting it. I think we hide behind the big
organizations like Kaiser and the ACO idealized sorts of folks that say we can
form capital and we can provide the assistance. I get to do sight visits in
those systems. Forget that I just named one or two. This will be generic
complaint or criticism. They are nowhere near as integrated and effective at
exchanging and using information as they want to appear to be.

My point here is everybody needs help. It is just really hard what we are
trying to get done and we have not decided that we could use a little help. But
we keep hearing from people that come to our — we heard at the populations
hearing in spades, and we are hearing it again now.

I think this idea about an educational aid and abetment service that AHRQ
has — I think they have funded four states. Each of those four states had to
get three associated states. They are now making grants to 16 states that have
all tried to do something to start launching a statewide assistance theme to
help clinicians and practices of all sorts change. It includes data management
and adoption of VHRs and that sort of stuff. These grants are gigantic. The
three states that allow this — they are 60,000-dollar grants for two years,
each year for two years to work on this problem.

My point is that we are prepared to spend $3 trillion a year. What I want to
call attention to is there is a convergent opportunity across our subcommittees
to jump on this idea that communities, the providers, payers, basically
everybody could use some sort of generic assistance organization. I beat that
death, didn’t I, Walter.

The last thing I want to say comes back to something that I heard Linda say
that was not on my theme’s list. There really are recurrent lessons that we
keep being shown again and again about the nature of change. For me, one of the
most important things I would like to call out is we continue to operate as if
changes are temporary period of time in which we get to new normal. But in
actual fact, the transformative change for health care is to go from a health
care system in which doctor graduate, get an MD, and then they are able to
practice medicine for as long as they want to and do whatever they wish to
continuous maintenance of certification from doing an audit every ten years to
continuous quality improvement.

Change in health care now must become a way of life. It needs to be positive
change. It needs to be change that has improved. This is a huge titanic
geologic size shift. All these deadlines. We cannot even agree if a deadline is
great because it makes us do stuff or it is horrible because it is top-down or
it cannot be done. But we have to figure out how we are going to approach
health care as changing it as a way of life. Classifications do not just change
every 10 or 12 years. They actually change month to month, year to year. And
why this is not a fool’s errand is the information age has arrived. This is now
technologically plausible, but we keep behaving as if we are in the industrial
age.

My two favorite quotes, which I will — you guys with is — they are not
necessarily all that funny or anything. Mona said — did you hear her say we
did not know we were not requesting the data we wanted. You were talking about
your themes. You went by this again. I love Alex’s question about who’s who in
the zoo?

MS. GOSS: I said it in regards to our digital certificate, and I should give
Lili Koch(?) and my team the credit for that because who’s who in the zoo is a
favorite phrase that we have been using in regards to a public key
infrastructure and whether it was called an authoritative participant’s
services directory. In a health information exchange world, you know who is
asking you for stuff, who that person is, in what context they fit in to a
larger scheme of things and the services that they have. If you do not know
who’s who in the zoo, you do not know how to manage your indices and support
query-based exchange of clinical information for patient outcomes.

DR. SUAREZ: All right. If there are no other comments and it is already 3:30
so it is a good time to do a transition to the other items. I wanted to suggest
the following next steps basically. As always, we try to basically summarize
the themes and the discussions today were very useful in helping us take notes
of the various themes that we heard. We will run some magic and make it look —
and read nice and certainly highlight the themes.

Along the way, we always put together observations. In addition to the
higher-level themes, we identify specific observations that we want to make and
there are a number of things that we heard today, but are probably very
important observations to make.

And then we will have to look into whether we have a specific recommendation
to make. There are potentially a few areas where I heard recommendations. One,
of course, was this discussion about CMS or Medicare and end-to-end testing
concern. And there are potentially a few others.

I think what we will do is probably take the next few weeks to bring all
these together in terms of themes, observations, and recommendations and
convene a conference call, our subcommittee conference call to begin to process
that with the goal basically of I think by September coming back if not sooner,
but by September for sure coming back with a formal letter to the full
committee. How does that sound for next steps?

DR. GREEN: Do you expect that letter to be ready by September?

DR. SUAREZ: Yes. That is a goal. With that, we can probably proceed to the
next couple of items. I do not know how long this would take. It could be a
short process. We will see. If it takes too long, we can take a break at some
point.

The next item I think we wanted to bring up is this need to prepare and
present a letter based on the priority item that we heard in the hearing here.
We have prepared a one-page short letter that I will be reading here very
briefly. And the context of this is basically as it was mentioned during the
testimony from NCPDP. NCPDP had to do a modification, a correction to the
transaction that is used to do pharmacy claims to basically accommodate for
capturing something that is called the actual quantity prescribed by a
provider. This is a field actually in the telecommunication standard for
pharmacy and in D.0 that is in place right now. But that field that is called
quantity prescribed is not in use right now. Nobody is using it.

What the recommendation was to change that from not used to conditional use.
And the conditional use will allow the capturing of that information. And the
purpose of capturing that information is so that the information can be used to
validate whether or not there were inappropriate fields in excess of the
quantity prescribed, which is apparently an issue that was identified in a
report in September last year of the Office of the Inspector General of the
Department of Health and Human Services. That is the genesis of this. They
raised the concern that there were some inappropriate feeling of prescribed
quantities and there was no way to capture that because a transaction does not
allow to capture it. The recommendation was to change that.

The NCPDP wrote to us a letter in November of last year communicating to us
that they were proceeding to send that recommendation to all ESS to Rob’s
office. And in March of this year, Rob’s office responded to NCPDP saying that
they approved the change to the transaction standard. And the plan laid out by
NCPDP, which consisted basically in addition to republishing the transaction
implementation guide notifying the industry, publishing some FAQs, modifying
somewhat they call the version — doctrine which is an educational document
basically. All those were the elements that were put in motion. CMS in March
approved that.

But it appears that they are expecting — HHS a letter from the national
community confirming and agreeing with that change that that change is needed
so that it can take effect basically because the national committee is the one
that recommends the adoption of these standards and any modifications to the
standards. That is the genesis of the letter. Basically, the letter — I am
going to read it very quickly.

November 15 of 2012 the national committee received a letter from NCPDP
notifying as part of the recommendation that NCPDP was submitting to CMS
regarding the enhancement of the telecommunication standard for pharmacy
claims. The recommendation was to allow the standard to specify the conditional
use of the field quantity prescribed, which is field code 460-ET, which is
currently classified as not used or not in use to be able to be conditional use
to communicate the actual quantity prescribed by the provider. This data will
be available to validate whether or not there are inappropriate fields in
excess of the quantity prescribed, a concern raised in the September 2012
report from the Office of the Inspector General. I cited the report in the
letter.

CMS approval in March 2013. The NCPDP recommendation and action plan, which
included republishing of the telecommunication standard implementation guide
with an explanation in the editorial corrections section. Publication of the
change in the version editorial document and notification of the — to the
industry. Those were the plans.

The final statement is we want to take this opportunity to inform the
Secretary that NCVHS is in agreement with the recommended correction to the
adopted standard for pharmacy claims and the actual plan as recommended by
NCPDP and support CMS decision to approve this change. Basically, we are just
communicating to the secretary that we are in agreement with the recommendation
and support CMS’ decision to approve that change.

MS. GREENBERG: Just clarify. Is this something that requires the committee
to take this action?

DR. SUAREZ: We need tomorrow to present this to the full committee to
approve it and then have Larry sign the letter.

MS. WEIKER: Make is the DSMO process because this is part of the whole DSMO
process.

PARTICIPANT: This is a change to the adopted standard so it is just like the
DSMO. It is just coming through a slightly different —

MS. GREENBERG: We are bringing this forward as part of the DSMO report.

DR. SUAREZ: I forgot to mention that. That was part of the DSMO report. One
of the approved changes by the DSMO was change request 1182 I believe.

MS. GREENBERG: We do not have to do a letter like that for every DSMO
change.

MS. GOSS: I think there is a dynamic because they cannot do the business
function now and this is the only way they can change it. But what I am not
clear about is there is no federal rule promulgation. It is just — is there a
federal rule that needs to happen?

MS. WEIKER: It is still being discussed.

MS. GOSS: This is the trigger mechanism to get OESS to take the actions they
need to get it out to the industry. It is not just an editorial code set
change. It is underlining data element usage.

DR. SUAREZ: All the other DSMO changes apply to the future transaction.

MS. GREENBERG: Which are not mandated in any event.

DR. SUAREZ: They are not so they are processing and they are being
incorporated into the future standards. It needs to be recommended by the
national committee.

MS. GREENBERG: That clarifies it.

DR. GREEN: What would happen if we didn’t?

MS. GOSS: They would be some really unhappy people and they would not be
able to do business and we would keep hearing about it.

DR. SUAREZ: What happens if this does not take effect?

MS. GREENBERG: If it were to become part of rule making, they would require
a recommendation from the national committee.

DR. SUAREZ: If we do not recommend this then CMS when they publish a
proposed rule, they cannot say and NCVHS the advisory to the secretary
recommended that we adopt this change.

DR. GREEN: Who would care?

PARTICIPANT: I think we would care.

MS. GREENBERG: We want them to care.

DR. SUAREZ: We care. I care.

MS. GREENBERG: Even the committee has a role or it does not. Please expunge
that from the record.

DR. SUAREZ: Thank you for that.

DR. SOONTHORNSIMA: Is that why he is not on the subcommittee?

PARTICIPANT: This letter would have to go to the committee tomorrow —
Thursday with an explanation.

DR. SUAREZ: We will have to introduce it tomorrow. It is a short message. It
is not an easy thing to explain that field 460-ET, which is — is several pages
long.

MS. GREENBERG: If you tell the full committee that the standards
subcommittee looked into this and it recommends this, they will be grateful as
opposed to really trying to explain it.

DR. SUAREZ: I will focus on the bottom line there. That is the letter. I do
not know if there are any comments from the committee members.

MS. GREENBERG: Do you want to email that to Marietta so she can have it
printed out for people?

DR. SUAREZ: We should.

MS. GOSS: And was the letter developed in orchestration with the DSMO
representatives in attendance?

DR. SUAREZ: Yes. We worked with — Lynn and Margaret sent us the
information, the background, the details, the request, and then there was the
testimony that was noted. This is almost quoting it.

DR. GREEN: Whom is this letter addressed to?

DR. SUAREZ: To the secretary.

PARTICIPANT: From the full committee.

DR. GREEN: No, the one that you got — NCVHS.

PARTICIPANT: The subcommittee.

DR. SUAREZ: Which letter?

MS. GOSS: I think he is asking about how did we get in November that was
addressed to the subcommittee.

DR. SUAREZ: The OID report was published. There was a need to change. NCPDP
wrote a letter and sent it to OESS and sent us a letter to the two of us
communicating that there was this change and that apparently we did not need to
take any action. That is why we did not take any action. Now we heard from CMS
they want to have the national committee take action on this otherwise they
might not be able to actually fully implement this.

MS. BURKE-BEBEE: And this is standard practice from the DSMO perspective. We
just have not done it a lot because as you said Walter, I believe, this stuff
folds into the next version. This is addressing the current version. It is a
little bit new or it has been a while since we have done this before, but it is
all part of the DSMO process.

MS. GREENBERG: Once you explained that, I was okay.

DR. SUAREZ: I think that is the way to start it clearly and I missed that
part so I thank you for that. I will mention that.

Any other comments on this letter? I will send it to Marietta and we will
distribute copies and discuss it.

The other topic I think we wanted to bring up is as I mentioned we had the
opportunity this time around to publish our draft letter of recommendations on
attachments on the website. Several industry leaders really took the
opportunity to read the letter, review it, and began to send comments. Again,
most of the comments were very positive. They really appreciated the work the
subcommittee had done in assembling all these set of recommendations. They did
have a couple of points that I wanted to bring. Some of them will potentially
imply some adjustments to the letter or changes. That is why I wanted to bring
them because I think tomorrow during the discussion we can also mention them to
the full committee. There are 18 recommendations. I know you know them by
heart. I am going to repeat a few of them just the ones that were referenced
and noted in these comments.

Just to give you a sense. Everybody was very much in agreement with the
various set of recommendations. As you recall, the first recommendation was
really about conducting an overarching review of the adoption of standards.
This is a concept of the roadmap again kind of going back and looking at that.
Everybody was very much in support of that so much so that some of them
recommended maybe moving one of the recommendations up forward to align it with
this. I think that probably would be okay.

PARTICIPANT: To change to recommendation.

DR. SUAREZ: No, to just move up. They bring up recommendation 14 and
recommendation 14 is — we can go to that. Depending on the timing of the
attachment rule, the Office of National Coordinator makes every effort to align
their rules. This is ONC and CMS — align the two rules, which we heard
actually. They are already going to be looking at that stage 3 meaningful use
and the attachments and recommendations. That is recommendation 14. It could be
moved up as recommendation two to align.

PARTICIPANT: But not to combine it.

DR. SUAREZ: Not to combine it.

MS. GOSS: Walter, can I ask a structure process question here? For tomorrow,
we have a letter that we have already crafted.

MS. GREENBERG: It has gone through the Executive Subcommittee.

MS. GOSS: I hearing there being some thoughts about we might want to propose
a modification to that. I think what we are trying to do here is discuss those.
But then how does this conversation translate into an effective discussion at
the full committee tomorrow. Would that possibly be that you would want to swap
something out and give a new letter or just —

DR. SUAREZ: No.

MS. GREENBERG: The letter that has to be discussed tomorrow — that has been
posted and that is in the E agenda book, et cetera. Now, you can always bring
it forward to changes if the subcommittee wants to. You have to really consider
do you want to do that. How much do you want to open it up? Of course, you are
opening it to the full committee. But I must say the executive subcommittee
review — we actually got only accolades I think, no changes. Sometimes you
start moving things around and then people — I do not know. I am not saying
ignore these comments that you have, but certainly the letter that has to be
brought forward tomorrow is the one that has already been posted.

DR. SUAREZ: That is definitely the intent.

DR. SOONTHORNSIMA: We just want to hear what those feedback.

MS. KLOSS: I would consider moving a recommendation from page seven to page
two as an editorial change. It is not —

DR. SUAREZ: Which one? 14? That will be fine. But those are the things we
would mention tomorrow. We are not going to change the letter —

MS. GREENBERG: Everybody may be fine with that. What are the others?

DR. SUAREZ: The other one was our recommendation three says that the
definition of attachments is very generic, which is good, but it also creates
some concern. Supplemental documentation needed to support a specific health
care related event. We put in parenthesis such as claim, eligibility, prior
authorization, and others using a standardized format. It is a very generic
definition. That is good. But it certainly creates a question I guess as to
which transaction is expected to be required to use this standard that we
recommended because in recommendation number six we are detailing the actual
standard that we are recommending. We are recommending the adoption of HL7, of
LOINC, of X12, 275, all those things. It creates a potential for saying this
standard should be required for all these transactions that fall under the
definition of attachment, which includes anything that is supplemental
documentation needed to support specific health care-related event. That is
probably the biggest area where people were commenting. Some people were
suggesting we should specify which are the transactions that should be started
with let’s say as a requirement. We did say that we recommended that these be
phased in progressively that this is not something that should be required all
in one. But we were probably not as clear as maybe we wanted to be in terms of
that sequencing. We really did not say the first transaction that you should
adopt standard for it should be claimed. And then study and look out how the
other transactions would be applied to.

It leaves it open to interpretations to whether we are recommending that the
standards be adopted for all possible instances that meet the definition of
what we are recommending be attached.

MS. KLOSS: Would it be possible to read what the comment was that came in on
that verbatim?

DR. SUAREZ: We are concerned with recommendation six, which may be taking us
overarching in light of recommendation four. Recommendation three is the
definition. Recommendation four says the areas to which attachments related
transactions should be applied include claims, eligibility, prior
authorization, referrals, care management, post-payment audits, and any other
administrative profits for which supplemental medical information is needed. We
are saying in effect this is how we define attachments. The standards should be
applied to all these areas and these are the standards. The comment is raising
a concern because it lists all these possible areas where these standards were.

MS. GREENBERG: Could you just finish reading what the comment was?

DR. SUAREZ: Sure. A recommendation for list claims, eligibility, and prior
authorization. It is important to note that these functions have been named in
HIPAA as using in this case is NCPDP standards for the pharmacy sector listing
the X12 transaction in recommendation six that does not support the full range
of standards. This is raising the concern that this might spill into the NCPDP
processes that might imply that there is a requirement for NCPDP to now use
this.

In addition, perhaps recommendation six should state that the HL7
attachments must align with the ones being named in meaningful use. To be more
specific, I think we made a connection in recommendation 14. Also, it is noted
that X12 representatives were included in the review to date version 620 or any
next version of this transaction had not come forward. It is suggested that the
reference to 620 be removed to not cause confusion. And just to reference, the
X12 transaction that we are recommended were actually recommending a version.
We are recommending version 620. But we put in parentheses a little footnote
that says for X12 transactions the secretary should consider to adopt a same
version that may be adopted for other HIPAA-related transactions by the time of
compliance. Assuming that there is going to be 70X then instead of 620 it
should really be 70X, the same transaction. That is what we are trying to
align.

MS. GREENBERG: The ACA requires — what is their requirement about claim
attachments?

DR. SUAREZ: That final rules be adopted by January 1, 2014 and compliance be
started by January 1, 2016.

MS. GREENBERG: Is the committee suggesting that CMS do that following these
guidelines or that instead of issuing a final rule for claim attachment it just
issues a rule for attachments?

MS. GOSS: I think we are proposing that we just issue a rule for attachments
that spans multiple transactions, but that they were actually in recommendation
17 proposing and NPRM be done rather than a final rule in attachments. I think
that that could possibly cover a couple of things in these comments. I think
the first point where we were at Linda requested the full comment to be read
had to do with the large scope of recommendation three and maybe we take
recommendation three and we tie it with recommendation 17 to say solicit input
from the industry to get the consensus on certainly how these should be
sequenced or handled.

DR. SUAREZ: We are in the letter recommending that attachments be adopted,
the standards for attachments for adopted. We are trying to be open and allow
the regulator — we are recommending also in the letter that there be a
transitional process, but we might not be too clear. But the idea is that adopt
the standard for attachments. For attachments, these are the standards. But
then the actual when do you have to do claim attachments is January 1, 2016.
When do you have to do prior authorization attachments is something later.
Sequence that, but we are not clear in the letter of that idea of sequencing
rather than — it gives an impression that we are recommending that all the
transactions be adopted — all the transactions and the timeline be the same
for —

MS. GREENBERG: It is not just the timing, but I think I heard you say that
NCPDP also says that they have some other standard for their —

DR. SUAREZ: They made that clarification for NCPDP that —

PARTICIPANT: They are not included in number six recommendation.

MS. GREENBERG: Is that clear? I do not have the letter with me.

DR. SUAREZ: Recommendation number six includes HL7 and X12.

MS. KLOSS: Just a matter of process, these sound more substantive these
comments. Do we make these modifications now or make some of them and expect
other comments to come out through the NPRM process?

DR. SUAREZ: If CMS decides that NPRM is what they are going to do. We are
recommending NPRM. I read all the recommendations. I think the changes are good
and not that substantial in the sense of they are not changing the direction or
overall goal that we had. I think it is more clarification that it is helpful.
What I suggest — I probably should have done that today. I can certainly do a
red line edit of the changes and bring that tomorrow. When we present the
letter, we present the official letter that we distributed and then say we have
additional changes we want to recommend to the letter some edits that are
helpful for clarification and introduce them more during the meeting.

DR. SOONTHORNSIMA: Let’s be specific. NCPDP has one — issue —

DR. SUAREZ: There is one on recommendation six. Actually, there are two
changes recommended on recommendation six. One is X12 is recommended that when
we name the routing emblem, we say X12 275 additional information to support
health care claim and health care service review. They recommend that we do two
bullets because there are two separate transactions. That is some minor
clarifications.

On recommendation ten, which I will read to you, recommendation ten is the
one that says data other than identifying information that are already supposed
to be included in the originating transaction for which an attachment is being
requested, say a claim, must not be permitted to be requested again in the
attachment. And then they are saying but the recommendations that — the
regulations should clearly remind covered entities to follow the implementation
of specifications and/or the operating rules of the transaction. They are
suggesting some addition to that as a minor clarification on ten.

On recommendation 11, it is a very short one. Chained attachment requests.
That is, the continuous follow up request of attachments after the first
attachment should not be permitted. There is some question or point about
clarification, the many hours of analysis and the prior authorization
exchanges. It was recognized that there are situations where information is
still missing and may need a follow up exchange to provide missing information.
It is unclear how without further analysis and guidance that would state it as
a chaining. There is a good point. There are some instances where they are
missing.

I think the point is the first submission had missing data in the first
place apparently. They need to resend. It is not really a chain in that sense.
It is a clarification of the definition of chaining there.

MS. GOSS: And shouldn’t it also be that if you are going to ask somebody to
send you something after you got it a trigger mechanism that you should do all
your homework before you go ask for something of somebody again? If you are
going to make it ask, make it once because you have done your homework.

DR. SUAREZ: That is recommendation 11. Recommendation 12 is a minor thing.
Make sense to re-inform the use of existing transport currently used. This is
more a suggestion or more an agreement. I agree this is not supposed to be —
recommendation 12 where relation should not define specific standards or
methods for transport. This is a transport agnostic concept. I think the
comment here is agreeing with that.

And then the last item is recommendation 18. It is recommending simplifying
as much as possible. Recommendation 18 is when regulation should take into
account the difference in how attachments apply to the pharmacy industry.
Simplifying the word by saying the regulation should take into account the
specialized needs of the pharmacy industry where attachments are used for prior
authorization, but not used for claim attachments. Something that is a shorter
description. Those were all the changes. Four or five —

DR. GREEN: Who did these come from?

DR. SUAREZ: This came from X12, NCPDP, and HL7. Each organization sent them.

MS. GREENBERG: I think if you can do what you said, put a red line version
that you can then put up after you introduce it, don’t you think that will be
all right, Larry?

DR. GREEN: I do. A clarification. We are not going to change our definition
of attachment at this point.

DR. SUAREZ: No.

MS. GREENBERG: I would recommend against that because then you really open
the whole thing up.

DR. GREEN: We are three bullet points away from a ten-page long process and
I do not want to go back.

DR. SUAREZ: This will be short. I tried to make it very short and simple.
And certainly, during the discussion, there might be people that might have
additional changes. Our hope is really to wrap up this and then be able to
finish.

DR. GREEN: Let’s do this tomorrow. Trying to practice our improving behavior
as a Full Committee. We want to invite important changes in the findings and we
want to invite important changes in the recommendations. We wish to extinguish
comments about I would rather it said this way and that way.

DR. SUAREZ: Okay. You can say that. I will call you on that.

MS. GOSS: If you are going to do a red line, maybe what can happen is if you
do that tonight and maybe hold those recommendations until after the other
committee members discuss it. And then maybe what happens is that because I
know how good you are, Walter, as the conversations are happening and you see
consensus around a few of those recommendations or content changes that maybe
you could add them and then you could reflect in one document the full scope of
changes.

DR. GREEN: Walter, if you are okay with that, I really like that. Let’s show
the full committee the letter that we show the world including them assume that
they have read it and studied it and that they are coming prepared to talk
about and let’s not open up with a different letter.

MS. GREENBERG: I agree completely.

DR. GREEN: And then let’s start with them. And then when that has happened
then you guys say we also heard from these three people.

MS. GREENBERG: Should anybody bring up these things, which is unlikely, you
could refer to it. I agree with you.

DR. SUAREZ: That is excellent.

MS. KLOSS: I actually think it is great that you take the time to read it
carefully, communicate it, and get it to us before.

MS. GREENBERG: We do not want to get it wrong.

DR. SUAREZ: This is a standard operating procedure now for the committee. I
think we need to publish this a week in advance and inform the industry that
they have this. Please review. See if we missed something.

MS. GREENBERG: Normally, we do not post it a whole week in advance.

DR. SUAREZ: We almost did actually. We posted this on Wednesday evening.

MS. GREENBERG: It seems that it worked to advantage that we did this time.

DR. SUAREZ: This letter was posted I think Wednesday evening.

MS. GREENBERG: It is much better than if these folks had to then come to the
meeting and try to —

MS. KLOSS: Or see it after.

DR. SUAREZ: I am very pleased. Like Alex was saying. I really acknowledge
the industry, Margaret and Lynn and Jim and everybody that commented. I think
it was very helpful. I will do that. I will insert those minor changes, red
line.

I think the very last item we have in the agenda if there are no more
comments on this one. I just wanted to mention again this is a communication
that we received from an organization called the Pew Charitable Trust. The Pew
Charitable Trust has a health care division. And at that program, they have
been really emphasizing focusing a lot on the UDI, the universal device
identifier. They have been convening together with the Brookings Institution, a
series of meetings. One of them actually was hosted by Brookings Institution to
discuss specifically the incorporation of the UDI into the X12 transaction
standards.

They sent us a letter informing us of their perspectives and their position,
their interest in having this be part of the next version of the standard. The
process that they are also going through with respect to incorporating this
into the meaningful use stage three for EHRs to be capable of documenting the
UDI. All of this of course the biggest purpose and the main reason is to be
able to do a lot more close to real time of course post-market surveillance and
communication with patients that might have defective devices or things like
that.

We received that letter. There is no action to be taken. I know that the
group — I think the group was able to enter this into the DSMO process, I
believe. Do you want to tell us a little bit about what —

MS. WEIKER: The UDI. The Pew entered a change request into the X12 change
request process. Someone as a placeholder at this point in time. It would be
included in the next version of the guides we hope to adopt for HIPAA. But they
did not have the business requirements at this point in time to fulfill those.

In a call held last week between Pew, WEDI, X12, and the FDA were looking
and trying to see if we cannot get a bigger joint project kicked off around the
UDI to gather those business requirements. They keep saying they want it in the
claim, but it is like what is the requirement. What is the situation? In some
instances, the provider when they bill, won’t even know what the UDI number is.
It may be in a total different system than the billing system type of thing.
All of those kinds of things have to be flushed out before it is added to a
claim or a prior — wherever it may be added. That is basically what that
discussion was. We need to get the industry together and figure out what is the
requirement. Yes. Devices need a number that can be tracked for recall. And
there are things like that that make sense. But then you are like if I submit
it on a claim, what is the payer going to do? I need to store this number. And
if I store the number, for what purpose? Are you going to expect me to do
product recalls now and go through my history and pick a number? Those types of
things. That would be a good idea. No, I am not saying we must do that. But
what is the requirement? You keep saying it has to be in the claim. Why? What
for? What is the purpose? There are those kinds of discussions that really have
to happen before we just throw the UDI in a claim and say here it is.

DR. SUAREZ: There was an instance at least in the Medicaid program in which
— the Medi-Cal.

MS. WEIKER: Yes. But it was not the UDI really. It was a predecessor. It was
the UPN. It was the GS1 number that you used in the supply chain because there
is the supply chain aspect of all of this too that has to be taken into account
that does not impact a health care claim per se. It was successful in Medi-Cal.
I think Medi-Cal testified to this committee about the UDI and so did the FDA.
And the FDA has put in a DSMO change request, but we rejected it because there
was no business requirements. Plus they could not give us the business
requirements. They are just the authoritative body to have a number and what is
the number and where it is housed and those types of things. More to come
whether this bigger group gets together and decides that or not.

DR. SUAREZ: It is important to know that the final rules — been published.
The FDA has not published those.

MS. WEIKER: Except OMB and clearance.

DR. SUAREZ: It is moving along. What we heard in the proposed rule anyway
was that the UDI would have two options I think in terms of possible numbers.
The DS1 or the industry —

MS. WEIKER: I did not get any insight on what the number would be, but they
are still going to do it in phases, because if you remember in the NPRM they do
it in phases. They let it slip in that call that would still be what they were
—

DR. SUAREZ: And really going back to the question of the purpose, part of
the challenge is this — the simple way of thinking of devices of course is
implantable devices and the recall need and the importance of being very aware
of that. But UDIs will apply to different classes. It could go all the way to a
glucometer. If there is an expectation that a UDI be included in a claim then
every glucometer, everything would have to be if it is prescribed and included
— has to be coded. There is a risk or expanding this. It is a challenge there.
That is a main update basically on the UDI. I just wanted to inform the
subcommittee that we received that letter and it is something that we will
probably hear more about as Margaret had said.

I think that is all we had for the agenda for the afternoon. Any comments?
Any additional comments from the committee members?

DR. GREEN: I have one. Alex being added to the committee has just been
fantastic. She drives us back and forth. She feeds us. She brings us water. She
is just marvelous.

DR. SUAREZ: I echo that.

MS. GOSS: You just want a ride back to the hotel at the end of the day.

MS. GREENBERG: It was a motion that got her on the committee. We will accept
that endorsement. And those who recruited her onto the subcommittee can also
bask in that glory.

DR. SUAREZ: Thank you for that. Any final comments? We have public comment
also. If anybody from the public wants to come and provide us some more
thoughts.

Agenda Item: Public Comment

MS. HYLAND: Thank you, Walter. I am Mary Hyland with the SSI group and
representing HBMA. The comments I wanted to make was regarding end-to-end
testing. Although I did not comment on that section of the review today, there
are extensive extenuating circumstances that were not provided to the committee
today that you need to consider before you make any type of recommendations. I
firmly support CMS in their announcement that they made whether it be that the
industry receives that information appropriately or not. It was actually first
step for CMS in terms of defining what type of testing they can and cannot do.
The industry is also challenged by the same situation that exists in CMS. The
commercial payers are also finding the same challenges in terms of end-to-end
testing. That is why there are different approaches to end-to-end testing this
time.

Also, the fact remains that in the past we have created this situation that
occurs today that the providers are requesting testing with everyone. They want
to test with all of their payers. They are demanding that. And the fact remains
that we in the industry created that situation. We told them. You have to test.
It is imperant that you test as a provider with your trading partners.

Now, we have a completely different situation with ICD-10. With ICD-10, the
providers have internally had to update many of their internal systems.
Anything that touched ICD-9 must be updated to ICD-10. Some of our providers
have well over a thousand pieces of software to implement and test before they
can actually conduct external testing with any of the trading partners. Their
timelines are short. Their delays have been many in the industry based on all
of the back-to-back implementation they are experiencing. The providers do not
even know the extent of end-to-end testing and what entails end-to-end testing
or even what the definition of end-to-end testing is. Many of us in the
industry have varying definitions of end-to-end testing. That is the first
issue in the industry is that my interpretation of end-to-end testing may
differ from your interpretation of end-to-end testing.

If the consensus in the industry is that everyone is going to be allowed to
test with their trading partners and there is going to be a demand for testing
with their trading partners, we are going to experience the same situation that
occurred during 5010 initiatives. With all of the implementation of software
internally in the provider systems, that is going to also impact their
capabilities of even conducting end-to-end testing. They do not even know the
complexity of trying to engage in end-to-end testing. It takes a dedicated team
of individuals internally. They have to have IT involved. They have to have
programmers. They have to have coders. They have to have other financial
systems, engineers involved in this process if they want to conduct an actual
end-to-end test with their payers.

The other problem is the payers’ systems along with CMS will not allow a
complete process of end-to-end testing. Even trying to create an 835 remittance
advice in a production environment is very limited. There are only a handful of
payers that are actually capable of doing this in this type of environment for
testing. It is not just a matter that one should embrace testing in the
industry. The type of testing that is also being looked at by the industry is
out of the box testing.

For the complexity of this particular situation and also moving forward with
our regulatory initiatives that we have coming up, we have the capability of
actually creating business models, business-type testing models for each
provider for each trading partner and their associated products and services
that they engage in. We should not embrace the concept that everyone has to
test. Not everyone does have to test.

We have the 5010 that has been in existence and have been traded in the
industry to date. We have certainly 20 percent by some standards of the
industry still is not conducting their transactions on the 5010. But they have
trading partners who are doing that for them. In essence, those very same
trading partners will also assist them in providing the ICD-10 codes on those
5010 converted transactions. There is not going to be an actual limitation of
those providers who do not convert to 5010 because their trading partners have
the capability as long as they provide them with ICD-10 codes. They have the
capability of being compliant based on our standards. That is not a limitation
of those providers.

If you look at the costs involved of those providers in updating their
systems, as I believe Rob mentioned today, it was over $200,000. Those of us in
the industry have the capabilities of doing that for them and will do that for
them based on our relationships that exist today. That is also another
contention that we need to consider. They are alternatives. And with the
capabilities of testing differently and testing based on the needs of the
industry, what is going to provide the most value to those providers in terms
of testing.

I had to leave the conference yesterday to present at the HIMSS conference
regarding this very topic. It has to be a decision internally with the
resources available that the provider has as well as what their goal is in
testing. What will bring them the most value? Once they understand that, they
technically do not have to test, but if a provider sector is created by their
payers and they also have the opportunities of submitting through various
portals to test individually with their transactions that is another capability
that we did not have during the 5010 process that now exists. I would recommend
that we do not limit the out-of-the-box thinking on these topics, but embrace
them and move forward with new types of testing and new elements that we can
provide the industry.

I believe that many of us in the industry already have on our roadmaps
further definitions to create not only the medical-based scenarios that were
discussed today, but also different types of scenarios, different types of test
beds that we can create for different processes that exist currently that we
can then utilize to our benefit in terms of moving forward with testing.

DR. SUAREZ: Thank you. Thanks for that comment. I think there are a number
of ideas that we heard today about testing. I was very impressed with Blue
Cross Blue Shield Michigan. Certainly the national HIMSS, WEDI pilot project
and the many scenarios. This is all about scenarios, risk management, and
offering different options as you pointed out.

Any other comments from anyone else? I think we are adjourned. Thank you
very much. By the way, I do want to thank our staff. I think this was a
terrific job again in performing, identifying, confirming the speakers. Thank
you to our host here, our NCHS team.

(Whereupon, at 4:24 p.m., the meeting adjourned.)