[This Transcript is Unedited]

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Subcommittee on Standards and Security

March 3, 2004

Washington Terrace Hotel
1515 Rhode Island Avenue, N.W.
Washington, DC 20005

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway, suite 160
Fairfax, Virginia 22030
(703) 352-0091

TABLE OF CONTENTS

P R O C E E D I N G S [9:25 a.m.]

Agenda Item: Call to Order, Welcome and Introductions – Dr Cohn

DR. COHN: Good morning, everyone, would everyone please be seated? I want
to call this meeting to order, this is a single day hearing of the Subcommittee
on Standards and Security of the National Committee on Vital and Health
Statistics. I think as you all know the full committee will be meeting tomorrow
and on Friday at the HHS building and I actually want to thank all of you for
coming to a different site. For those on the internet we are actually at the
Washington Terrace Hotel.

I want to start by apologizing to those in attendance as well as on the
internet that we’re starting a little late, a combination of traffic in the
metropolitan area plus I think the fact that everyone is sort of used to going
to the HHS building for meetings I think contributed some to a delay in having
everyone here for the meeting.

Anyway, I am Simon Cohn, chairman of the Subcommittee on Standards and
Security and I’m the national director for health information policy for Kaiser
Permanente. Obviously I want to welcome everyone here, all of our subcommittee
members, staff, others here in attendance and welcome those listening in on the
internet. This is being broadcast on the internet and I do want to remind
everyone to speak clearly and into the microphone as I’m trying to do this
early morning.

Now we have a fair amount to cover today. This morning we begin with a
HIPAA update and I want to thank Stan Nachimson for coming to provide that
update. This is being followed by a discussion of claims attachments. As many
of you will remember the subcommittee in December was updated on the work of a
number of the standards development organizations related to the claims
attachment standard and we received some input from the health care industry on
this work. Now based on that hearing we decided that we needed to hear
additional testimony from others in the industry and other standards
development organizations. Obviously we want to thank our testifiers who will
be testifying to us today for coming forward with some additional insights and
thoughts on this proposed standards. Obviously we all recognize the importance
of computerized claims attachments to administrative simplification and
decreasing administrative costs in health care and obviously we look forward to
the comments and the discussion today.

This afternoon after the testimony is completed the subcommittee will
further discuss the issue and may decide to develop a letter of recommendations
to the Secretary. Now following that discussion will be a discussion of a
letter we received from the designated standards maintenance organizations
concerning standards for billing for supplies and I think subcommittee members
have received background documentation on all of that but we’ll be discussing
that and sort of seeing what we want to do and whether a letter is appropriate
at that time.

Finally we complete the afternoon with sort of an introduction to version
seven of our e-prescribing work plan. I really want to thank Jeff Blair, our
vice chair, for very hard work on this, albeit version seven, as well as all
the staff support to help bring us to this point. Obviously the point of the
discussion, and we’ll I think be starting it this afternoon, probably
continuing it during our breakout tomorrow, we’ll be making sure that we’re all
comfortable with the focus of the work as well as the overall plan for the
hearings recognizing that it’s a very aggressive plan, there’s going to be a
lot of sessions between now and November, at least in the current work plan so
we want everyone to reflect on it, sort of the view is at this point either
improve or approve. And at that point comes the issue of having us all begin to
look at our calendars and see if we can by the time we leave on Friday have
people’s availability so we can put together the actual hearing dates. Remember
how difficult that is sometimes to handle over the internet it might be useful
if we could actually be able to announce by Friday morning that hearing
schedule, at least for the next six month.

Now I want to emphasize that this is an open session. Those in attendance
are welcome to make brief remarks if you have information pertinent to the
subject being discussed. We will also have time at the end of the morning
session for basically an open mic and we invite anyone who has comments to make
to make them at that point regarding the claims attachment standards. Finally,
for those on the internet we welcome email and letter comments on issues coming
before the subcommittee.

Now with that let’s have introductions around the table and then around the
room. For those on the national committee I would ask if you have any conflicts
of interest related to any of the issues coming before us today that in your
introduction we would like you to so indicate those conflicts of interest. And
obviously let’s start with the introductions. Jeff?

MR. BLAIR: Thank you, Simon. Jeff Blair, Medical Records Institute, member
of AIMA, ASTM, HL7, HIMSS, not aware of anything which would be a conflict of
interest.

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention,
staff to the subcommittee and liaison to the full committee.

DR. HUFF: Stan Huff with Intermountain Health Care in Salt Lake City and
University of Utah. I have potential conflict if we discuss HL7 or ICD-10-PCS
or LOINC.

DR. WARREN: Judy Warren, University of Kansas, I also have potential
conflict if we discuss anything with HL7 or SNOMED.

MS. GRAHAM: Gail Graham, staff to the subcommittee from the Department of
Veterans Affairs.

DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for
information technology to the director of the Agency for Healthcare Research
and Quality, liaison to the national committee and staff to the subcommittee.

MS. AULD: Vivian Auld, National Library of Medicine, staff to the
subcommittee.

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

MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics,
CDC, and executive secretary to the committee.

MR. REYNOLDS: Harry Reynolds, vice president, Blue Cross and Blue Shield in
North Carolina, member of the committee.

MR. NACHIMSON: Stanley Nachimson from the Office of HIPAA Standards in the
Centers for Medicare and Medicaid Services.

MS. FRIEDMAN: Maria Friedman, CMS, staff to the subcommittee.

[Introductions around the room.]

DR. COHN: I think Jeff you wanted to make an additional disclaimer?

MR. BLAIR: Yes. My employer is personally involved with the development of
the CCR and if discussion comes up related to the Continuity of Care Record
then I would recuse myself.

DR. COHN: Before we move on to our first presentation I should comment that
even though I am generally conflicted I don’t think I actually have anything
that I am in conflict of interest on today, so this is the chair.

Now with this, Stan Nachimson we’re obviously pleased to have you come and
join us and brief us on sort of current HIPAA updates and issues, so thank you.

Agenda Item: HIPAA Update – Mr. Nachimson

MR. NACHIMSON: Good morning, thank you very much, I appreciate the
opportunity to bring the subcommittee up to date on what we’re doing in terms
of HIPAA, both implementation and policy, and enforcement. The October
16th 2003 compliance date for transactions and code sets was of
course a momentous date, at least for CMS and the Office of HIPAA Standards,
but I’m hear today to talk about some other compliance dates, regulatory dates,
and enforcement actions that we continue to be involved in.

Starting this year we begin a series of compliance dates with additional
standards regulations that have already been published. July 30, 2004 is the
compliance date for the National Employer Identifier, for all entities except
for small health plans who had an additional year. The next year, April 21,
2005, is the compliance date for security, plans with a security regulation. I
mention that particularly because in our discussions with entities there’s a
realization that security does take some advanced planning and work and covered
entities should be looking at least beginning their risk analysis and other
efforts so that they do meet the compliance date of April 21, 2005.

Recently we had the pleasure of publishing on January 23rd of
this year the National Provider Identifier, the second identifier standard to
be published under HIPAA. Compliance date is May 23rd, 2007, a
fairly lengthy period of time, longer then the two years that are generally
given for compliance. The reason for that is the time that CMS needs to take to
build the system to assign that provider identifier. Some of the work on that
system could not be started until the reg was actually published so we’re
taking the time to build the system and make sure that the two year period
starts when we will be able to assign National Provider Identifiers to those
providers that request it, so there will be two years from the date that the
first National Provider Identifier can be assigned to the compliance date. The
covered entities should have enough time to prepare for the use of that.

We have plans for some upcoming regulations during the rest of 2004. A
proposed rule on the National Plan Identifier is expected towards the latter
part of the summer and the rest of the year we should expect to see a
regulation on, proposed regulation on claims attachments, obviously it’s a
subject for discussion later today. And also later this year what we’re
affectionately calling the Modifications Two Notice of Proposed Rulemaking,
another regulation that deals with some changes to transactions and code sets
primarily in regards to some of the policy issues that have been particularly
problematic for the industry during the initial implementation of the
transactions and code sets.

Regarding our outreach activities, CMS, the Office of HIPAA Standards,
continues activities to work with industry and inform all necessary parties of
the requirements for all the HIPAA regulations, especially through our 866
number, it’s a toll free number, and our Ask HIPAA email box, and reminding
people that’s at HIPPA@CMS.HHS.gov where we will respond to individual
questions about all of the HIPAA standards and policy.

We continue to work on additional guidance papers for critical issues to
the industry, both in the transactions and code set areas and this year you
should expect to see a series of papers on security implementation, especially
for the smaller provider audience, there the feeling that the more
sophisticated entities have the opportunity for the review of documents from
the National Institute for Standards and Technology and other areas to really
understand what’s necessary to implement the security standards, however there
seems to be some concern that especially smaller providers are not as
technologically oriented as other entities, will be able to I think explain
what they need to do in order to comply with the security standards.

We also continue to monitor industry readiness in the implementation of the
transactions and code sets, there was last year of course the issuance in July
of contingency plan option for all covered entities where although the October
16th, 2003 date remained in effect covered entities were entitled to
implement contingency plans so that payments especially could continue to flow
in the health care industry in case one side or the other in a transaction was
not yet ready to handle the standard transactions.

We continue to monitor the readiness of the industry to move towards full
compliance with transaction and code set standards, participating in surveys
and hearings, a recent hearing by the Workgroup for Electronic Data Interchange
for example that basically had testimony, various segments of the industry as
to their readiness and certain problems that are getting in the way of full
compliance, we continue to work with those organizations to make sure that we
can resolve and remove some of the obstacles.

We believe that although most covered entities can exchange some of the
standard transactions I don’t believe that there are a large number that are
already exchanging all of the standard transactions. Medicare seems to be
leading the way in the claims, especially in, the claims transactions latest
figures show roughly 66, 67 percent of Medicare claims are coming in in the
HIPAA standard formats. Last Friday the Medicare program announced a slight
change to their contingency efforts where they are now saying that as of July
1st claims that come in the HIPAA standard format will continue to
be considered electronic claims if you paid using the 14 day floor, but those
claims that come in in non-HIPAA formats as well as the paper claims will be
paid with the 27 day floor, so in essence that’s sort of a slow down in payment
for non-HIPAA compliant claims in an attempt by the Medicare program to
encourage providers to submit claims in the compliant format. And I believe
also it shows their willingness to at least give the industry reasonable notice
that a change is coming. They announced this at the end of February, July
1st is when this policy goes into effect so there’s several months
providers have to move towards compliance.

Talk a little bit about the status of enforcement actions and complaints
for transactions and code sets. As folks might know our enforcement process for
transactions and code sets similar to that for privacy is a complaint based
effort where we’re not taking any action to go out and review covered entities
but are only responding to complaints of non-compliance from others. As of
February 25th CMS received 66 total complaints, 53 of those were
valid transaction and code set complaints, 13 of those were not transaction and
code set complaints, they were either privacy complaints that were forwarded to
the Office for Civil Rights or non-HIPAA complaints, was explained to the
complainer that this is not the place to send in those complaints.

But of the 53 total transactions and code sets complaints 16 were against
the Medicaid program, eight Medicare, 29 against the private sector. Of those
36 were because the complainant, or the complainer, felt that a compliant
transaction was rejected, one had to do with companion guides, 15 had to do
with code sets, and one had to do with a complaint about an NCPDP transaction.

CMS is currently investigating those complaints, 13 of the complaints have
been closed at the request of the complainant, 40 still remain open. So we
haven’t had a huge influx of complaints but of the ones that we’ve had we are
actively investigating those and hoping to resolve those. The idea is to
resolve those between the two covered entities, the entities that are involved
in the complaint rather then attempting to do any harsher enforcement, that’s
the tack that we’re trying to take.

So that’s pretty much where we are in CMS on the HIPAA standards, I’ll be
happy to answer any questions if there are any.

DR. COHN: Questions from the subcommittee? Any questions from the floor?
Okay, well, Stan thank you, I’m sure we’ll be having additional conversations
on this as we go through the day and into Thursday and Friday. I’m sorry, Stan?

DR. HUFF: What was the percent of compliant transactions that you’re
receiving now?

MR. NACHIMSON: The Medicare program looks like approximately two thirds of
the claims that are being submitted electronically are coming in as HIPAA
compliant claims.

MR. REYNOLDS: Stanley, could you define what Medicare finds a compliant
claim to be?

MR. NACHIMSON: No, I can’t. In terms of Medicare they have set up, what the
Medicare program considers a HIPAA claim they have set up a series of edits to
measure compliance with the standard and the implementation guide, they have
specific edits and should a claim pass those edits that’s considered a HIPAA
compliant claim. But CMS at this moment, the department at this moment has not
defined with a HIPAA compliant claim is.

DR. COHN: Michael?

DR. FITZMAURICE: Stan, is there any anticipation of changes in HIPAA policy
regarding electronic submission through email or through the web on a secure
basis?

MR. NACHIMSON: I think you’re asking for the Medicare program, and just for
the general audience let me explain a little bit of separation in CMS in my
hesitancy in answering certain questions. CMS has responsibility for operation
of the Medicare program, oversight of the Medicaid program, and HIPAA policy
regulations and enforcement, plus the fact that Medicare is a covered entity
the agency has erected what we might call a virtual fire wall between the
Office of HIPAA Standards and the folks in Medicare and Medicaid that operate
the program where we tend to keep some distance because we have some
enforcement authority over them. Their policies and a number of their policy
discussions are sort of their own and we don’t get involved in all of the
details nor do they necessarily get involved in all of the HIPAA policy
discussions, we keep some distance. So when I answer questions I have to be
careful that I’m answering either from the HIPAA policy, the OHS perspective,
or this is a Medicare or a Medicaid question.

So your question has to do I believe with the Medicare policy that several
years ago they issued directives out to the industry that they would not allow
individually identifiable Medicare information to flow to the Medicare program
to the Medicare contractors over the internet. My general understanding is
there is, there either are plans or there is something already in the words to
allow for some limited access over the internet but I’m not intimately familiar
with those, I can’t give you any details on that.

From a HIPAA policy perspective, put on the HIPAA hat, there’s nothing in
HIPAA that prevents claims or other information from being sent over the
internet via email, again assuming that it meets the appropriate standards.

DR. COHN: Any other questions or comments? I mean certainly I would sort of
comment that that issue around the internet and use by CMS and all of this is I
think a topic that we have on our issues list for a more thorough briefing from
CMS from somebody who actually wears the right hat there. I do appreciate your
comments, you’re clearly not responsible for that policy or the implementation
of it.

Yes, Harry.

MR. REYNOLDS: Locally many of us are seeing a consolidation of the industry,
the number of people that used to directly submit is going down quite
dramatically and appears to be consolidating into third party submitters, it’s
been dramatic at least in our environment. Are you seeing that nationally?

MR. NACHIMSON: I’ll just speak from some conversations that I’ve had with
different folks and I’ve heard a mix of plans saying that they’re getting more
and more of their claims from third party submitters, clearinghouses, or both,
and others that are saying that they’re actually seeing a lot more direct
submission from providers, I think that differs depending on the area of the
country and a particular plan that you’re in. I haven’t seen in some of the
Medicare statistics where they report the number of submitters, it seems to be
staying relatively stable. Then again that’s only the experience of the
Medicare program.

DR. COHN: Other questions or comments? Okay, well Stan thank you, we’ll be
asking additional questions as we go forward I’m sure.

With that why don’t we move t our first panel, I think we have Kepa
Zubeldia, Don Bechtel, and Gary Beatty, if you’d like to come and sit in the
front. I obviously want to take this occasion to welcome back one of our former
subcommittee member who has been I think absent from the subcommittee, it’s
been a month now? Kepa, we want to thank you for coming back and joining us.

DR. ZUBELDIA: Simon, I’m having withdrawals.

Agenda Item: Industry Perspective on Claims Attachment
– Dr. Zubeldia

DR. ZUBELDIA: Good morning, my name is Kepa Zubeldia and like Dr. Cohn said
I was a member of the subcommittee a month and a week ago. I’m bringing today a
summary of issues concerning the transaction known as the claims attachment.

It’s an overview and before I start I’d like to make it clear that I have no
stake in the game although I’m a member of X12 and HL7, but Claredi is not a
transactions processor such as a clearinghouse or provider or payer, so we will
not see these transactions flowing through our system other then in a test
environment.

I’m going to be talking about the need for attachments, the approaches for
attachments today, a little bit of historical background of where we are and
why we’re here, and then I’ll be talking about five different issues, and a
little bit of a summary of what we learned from the HIPAA experience.

The attachments are additional information that must be provided to the
payer in order to adjudicate a claim, that’s a claim attachment. There’s not
only a need for additional information to adjudicate a claim but sometimes
there’s a need for additional information for preauthorization or even for a
referral sometimes.

The needs for attachments vary among the different payers, they’re very
dependent on their specific claim reimbursement practices, on state law
requirements for certain attachments, and other kinds of requirements,
specifically for reimbursement and their fiduciary duty.

Attachments are the ugly duckling of the HIPAA transactions. Providers don’t
like attachments, they’re time consuming, they’re expensive to produce, they’re
difficult to understand what the payer really wants, you really don’t know what
to send sometimes, you just send everything, and they’re perceived by providers
as a payment delay tactic.

Payers don’t like attachments either because they’re time consuming, they’re
expensive to handle, they’re sometimes difficult to understand, especially
they’re just photocopies of the medical record, and increases the cost of
administration of the claims. Most payers will ask for attachments not to be
sent by the provider unless the payer request them, but there’s not a good
mechanism to request the attachment. The payer sends a letter and because the
providers receive this letter requesting the attachment maybe weeks after the
claim was filed and just delays the reimbursement cycle there is a tendency by
some providers to just send the attachment proactively to avoid delays. And the
send the attachment when in their past experience there’s a high probability
for the payer to request the attachment.

There is three types of approaches for the attachment, one is this
predictability factor, when it’s required by law or regulation or a business
practice of the payer then you send it immediately with the claim, there’s no
reason to wait. Certificates of medical necessity, prescriptions, consent
forms, remittance advice from the primary payer when you’re filing a secondary
claim.

Then there’s the other kind that is frequently required and these are
proactively sent with some of the claims. A provider will send what in his or
her past experience has proven to be useful for reimbursement. For instance
there are certain dental procedures that practically always need an x-ray, bite
wings or plenarex(?) or whatever, and they’ll send it automatically with the
dental claim. Anecdotally, somebody was telling me the other day about a
dentist that was sending x-rays to the insurance company and one day the
insurance company called him and said this x-ray doesn’t quite match the teeth
of this patient, and this is fraud. And the doctor said no, I’ve been sending
x-rays for ten years and this is the first time I have a problem, in fact I’ve
been sending the same x-ray for ten years. So they don’t always look at the
attachments.

And there are some attachments infrequently required, as a response to the
payers request for additional information then the provider will send the
attachment and typically this is a copy of part or all of the medical record.
If a provider cannot make sense of what the request is they’ll send the entire
medical record, if they can make sense they’ll only send part of it.

Let’s talk for a second about the transmission mechanism, because there are
two different topics here, one is the attachment content and the other is how
it’s sent. The most frequent transmission mechanism is paper. There’s some
attachment information that’s now part of the 837 implementation under HIPAA,
for instance adjudication information from the previous payer on secondary
claims, certificate of medical necessity for Medicare claims, ambulance,
oxygen, other certificates, they’re part of the standard 837, it doesn’t need
to be sent as a separate attachment. But of course most of the time this is
sent on paper.

There’s also electronic dental attachments that are increasing and these are
being sent today in a substantial number, I believe they’ll be another
testifier discussing this, and they’re being sent as x-rays, pictures,
periodontal chart, models, actually pictures of the models, reports, etc. But
also most of the time these are sent on paper.

There is no implementations currently of the proposed HIPAA standard
attachment using X12 and CDA as of yet and that kind of information is being
sent on paper. There’s no standard attachment in use today, there is no
standard content, no standard format, no standard method of transmission, and
the most frequent method of sending attachments is paper. The message here is
the attachments today are sent as paper.

Let me give you a little bit of the history of how we got where we are.
About ten years ago X12 was seeking ANSI accreditation as an SDO in the United
States. ANSI asked for X12, I’m sorry, HL7 was seeking an ANSI accreditation.
ANSI asked for X12 support of HL7’s accreditation request and ANSI essentially
wanted to have a memorandum of understanding between HL7 and X12 as part of the
HL7 accreditation. This was a time to draw some lines in the sand. The
memorandum of understanding says that the two SDOs would work together to avoid
overlaps and make things easier for the implementation of electronic
connectivity in health care. At last the way this was presented in X12 was that
X12 was for administrative transactions and HL7 was for clinical messages. X12
was for inter organization data transfers and HL7 was for intra organization
data transfers.

Now after the lines were drawn in the sand the sand has shift and HL7 is now
an international standard, not just a U.S. national standard. I remember in
that memorandum of understanding, at that time they were talking about HL7
meetings having somewhere between 150 and 200 attendees, that’s probably just
one of the war groups today. So as an international standard HL7 is responding
to the needs of all of its members, not just the U.S. members. For instance,
Australia is using some HL7 messages for administrative transactions. HL7
messages are being sent between institutions, that’s normal practice today. And
the international affiliates are really not all that concerned about ANSI, that
A in ANSI is American and they really don’t care much about that, HL7 responds
to international needs.

So that 275 ORU HL7 message was a shotgun wedding, it satisfied the HL7 X12
agreement because the clinical information was sent in an HL7 message, there
are no X12 standards for clinical information, clinical information standards
are the domain of HL7. And the message routing and administrative information
is sent in an X12 transaction. The 275 X12 transaction was created specifically
to send HL7 messages and other forwarding objects within the X12 transaction.

So the result of that was an HL7 message encapsulated inside a binary object
in the 275 X12 transaction. The syntax is inefficient, it’s difficult to
handle, it’s unproven, it’s not very clear that all the translator companies
out there can handle this, that’s one of the objectives of the pilot project.
But it’s politically correct according to the agreement between HL7 and X12.

So what are the issues of attachments as I understand them today? There are
several parts, the attachment needs a standard request for additional
information, the provider needs to know exactly what the payer is asking for.
The attachments use a standard attachment request, which is a 277 proposed
transaction, 277, and the content of the request would be as LOINC codes inside
a 277, so it would be clear and codified what is it that the payer is asking
for. In theory if the request is a standard the provider that receives the
request could build a system to automatically respond to the request, so if the
payer is requesting a specific lab test the provider’s system could
automatically without human intervention respond with the results of that lab
test. That’s a theory, we’ll see later that it’s not quite like that.

But there’s a little bit of an issue with this automated codified request,
must all attachment requests be codified, if they’re all codified the list will
probably never be complete, somebody is going to need something that is not on
the list, that’s going to happen. If they’re not codified and the requester is
free to request just about everything, whether it’s codified or not, then
what’s the value of a standard, what’s the value of a standard request, if
there is the freedom to use an un-standard request who will use the standard.
What did we learn from HIPAA in this area?

One a provider gets the request the provider is supposed to respond with a
standard response to a request for that additional information. Now some
attachments are easy to standardize, electronic remittance advice, certificates
of medical necessity, certifications and so on, they’re easy to codify. Other
standards are more, other attachments are more difficult to define and codify.
The HL7 and LOINC booklets for the proposed HIPAA attachments have done an
outstanding job in codifying those things that are difficult to codify, it’s
amazing the work they’ve done. Some of the attachments are practically
impossible to standardize as a response, free from text, well, you can tag the
text but it’s difficult to standardize free from text. Graphic lab reports, you
can include the graphic but it’s very difficult, pictures and so on.

So when the payer gets a non-standard response to a request, and the
non-standard attachment gets to the payer, what are the choices? Can the payer
ask again for that same attachment to be delivered in a different form, to be
delivered as a standard? Can the payer ask a different question to satisfy the
payers needs? What’s the value of a standard in this case if there is
difficulty or impossibility to codify some of the standard attachments? Again
the 80/20 rule applies, 80 percent of the cases may be possible to standardize,
20 percent not, there has to be a balance between the two.

The third issue is the issue of unsolicited attachments, unsolicited
attachments are sent along the 837 claim. There is an electronic staple
mechanism between the claim and the attachment, the 837 claim refers to the
attachment control number that is included in the 837, and the 275 attachment
is labeled with an attachment control number that links the two. These
unsolicited attachments are sent when the payer’s standard operating procedures
or the provider experience indicates that they should be sent. Like I said
before most payers discourage these unsolicited attachments.

One of the biggest questions in this area is what’s the impact of HIPAA
privacy in sending unsolicited attachments, does the minimum necessary apply to
unsolicited attachments or are they exempt from the minimum necessary and just
as the other X12 transactions are exempt from the minimum necessary. So that’s
something that I’d have done before I bring a lot of questions, I don’t bring
the answers.

Another issue is work flow automation, there’s multiple systems involved. I
explained earlier how the theory is that if the provider receives the standard
request for an attachment the provider could build a work flow to automatically
create a response to the standard request, in fact to create a standard
response to the standard request. This would involve multiple systems. The
claims are administrative transactions, most attachments are clinical, and
typically administrative and clinical systems don’t talk to each other. Now
there’s a possibility of an administrative and clinical system talking to each
other to create this automatic response to a standard attachment but I think
that possibility at least at this point is very remote.

There’s also the issue of multiple attachments per claim, there has to be a
strong linkage between the attachment request and the attachment response
because if there are multiple attachments to one claim it needs to be very
clearly understood what attachment belongs to each request.

How is the attachment handled by the payer once the payer gets the
attachment? Today they handle mountains of paper, there’s absolutely, there’s
no question about human intervention handling that paper. The ideal situation
would be that the standard attachment is electronically automatically processed
by the payer without human intervention. Is that attainable? Is that the goal
for the first round of HIPAA attachments? Are the payers willing and ready to
take the attachment automation step? Keep in mind that large payers are very
different from small payers. Are the vendors and clearinghouses ready to
provide these automation tools?

Finally, the fifth issue is telecommunication and formatting issues. There’s
multiple parts to an attachment standard. Putting aside the historical
reference to the MOU between HL7 and X12, we’ll talk about that, the data
content could be sent as LOINC codes and that’s very, in my opinion a very good
approach. But there’s different possibilities of saying data content using
different vocabularies, terminologies, images, plain text, there’s all kinds of
data content that could be sent in the attachment. I don’t think that
everything will fit into one standard form of data content.

The data format could be sent in multiple different ways, it could be sent
as an HL7 message without any X12 wrapper, either as a 2.X syntax or an XML
syntax. It could be sent as an HL7 message encapsulated inside X12. It could be
sent as free form text, free form text inside an HL7 message, free form text
inside X12, free from text inside HL7 encapsulated inside X12. it could be sent
as a scanned document as TIF or JPEG, that TIF or JPEG could be codified as a
DICOM image that could be then sent inside an HL7 message, it could then be
sent inside an X12 transaction. So there’s all kinds of options for sending the
attachment and the data format for the attachment.

Transmission mechanism, could be over the internet. Stanley just talked a
minute about CMS’s internet policy that doesn’t allow the Medicare contractors
to use the internet, that could be a problem for Medicare, they may want to
reconsider the policy. The would be some encryption and authentication issues
in sending attachments over the internet. And there could be a combination of
standard and non-standard components in the attachment that could be standard
format, standard codes, standard transmission mechanism, or a combination of
all of the above. And perhaps as moving one step at a time towards the
automation of the attachments, it may be wise for the subcommittee to recommend
certain standards or a variety of standards for different purposes. I don’t
know if they’ll be one attachment that suits everybody.

So HL7 is also recommending this incremental implementation and in their CDA
attachment documents they’re talking about how providers that don’t have a lot
of automation could be sending a scanned image of a document and they could
also send if they have the automation the ORU message that has everything
codified, so it’s kind of a step wise approach.

I bring a little bit of lessons learned from HIPAA, I don’t know if they
will be 100 percent applicable to this but it may be. Even with detailed
standards such as the X12 standards under HIPAA implementation vary greatly.
Each payer today has a different set of companion documents specifying their
particular requirements and making generic interpretability very difficult or
impossible. Rather then trying to fight it we probably ought to learn to live
with the differences. Interpretability is the biggest problem in implementing
the standards.

Process reengineering is also very, very difficult. Is the industry going to
automate the current attachment process, which is done on paper, or is it going
to switch to a more efficient process of automated request and responses to the
attachments? There’s a lot of value in taking one step at a time. Without a
clearly understood return on investment most implementations will focus just on
the minimum necessary for compliance, whatever that is, whatever I have to do
that’s what I’m going to do. Even the best designed standards will run into
problems during the implementation phase.

We’ve also learned that the big bang approach does not work, there has to be
an implementation plan. The implementers wait until the deadline, in the X12
case was the final rule or beyond, to implement. The NPRM for the transaction
and code sets didn’t have much impact on implementation. I would not expect an
NPRM on attachments to have a very significant impact on implementations and
attachments.

Early adopters are very few, I think at this point they’re pretty much a
myth, maybe two or three early adopters around the country but I haven’t found
any yet. Well, there are some, okay. The government must lead by example and
incentives. CMS is now applying an incentive to the implementation of X12 HIPAA
transactions. Smaller payers and smaller providers will feel left out of the
process no matter what, and no matter how much inclusion(?) you do smaller
payers and providers will always feel left out, so that’s something to keep in
mind.

And I think that’s the end, if you have some questions now or later I’ll be
available here the rest of the morning.

DR. COHN: Kepa, thank you very much. Are you passing out Prozac with your
presentation? Thank you for reminding us of the complexity, seriously. I think
our next presenter is Don Bechtel and today you’re representing AFECHT. Thank
you for joining us.

Agenda Item: Industry Perspective on Claims Attachment
– Mr. Bechtel

MR. BECHTEL: Mr. Chairman and members of this committee I am Don Bechtel, I
am the current chair of AFECHT. I’d like to make the opening comment that
AFECHT is in its mission dedicated to the implementation of standards and
transactions and their efficient use in an secure and open network. Some of the
testimony I’m about to make may not sound that way, but we truly are and the
reason we bring up the issues we bring up today is to make sure that we do have
a smooth transition to their implementation and avoid some of the pitfalls that
we’ve experienced in the past.

It would be fair also to say that AFECHT does not represent all the vendors
or the providers in the health care arena for plans or providers, but we do
represent a large number of more prominent organizations in the industry.

Over the last two weeks, we had short notice of this meeting, but over the
last two weeks or so we’ve been trying to assemble among our members some
answers to some questions that were posed to us. Those questions were what is
the readiness of the vendor community to implement the standard, what are the
issues we anticipate may impede the successful implementation, and what
recommendations could we offer to ensure successful roll out of the next wave
of transaction standards, in particular claim attachment.

Again, as a general remark AFECHT does support the standards under HIPAA and
we believe the claim attachment will significantly improve the efficiency and
the processing of our systems for claims adjudication and payment. We believe
that when the standard is integrated into the provider and health plan systems
it will increase the efficiency and improve the overall quality of health
information being exchanged. However, having learned from the previous HIPAA
transactions we realize that there may be many unknown and untried processes
and system enhancements to implement before we can realize this objective. We
believe the claim attachment was originally put in second phase because quite
simply it’s harder and it’s going to take a lot of work.

The implementation planning we perform now should follow or allow enough
time for both, for all organizations to understand and resolve the issues that
are certain to be found prior to imposing deadlines for completion. And due to
the complexity of the problems we’ve experienced during the first round of
HIPAA AFECHT strongly recommends that the industry establish a project plan to
coordinate the validation and implementation schedule of all covered entities
and the key players, namely vendors. AFECHT and many of its members and other
organization associations that we worked with over the years stand ready to
help the industry discover and document what these issues are that lie ahead.
We are committed to assist in the identification and the resolution of these
problems and to conduct trial implementation with other interested members in
the industry from each effected health care segment to complete this work.

Speaking to the question of readiness, some of the clearinghouses and
vendors within our organization have begun to make the necessary enhancements
to implement the claim attachment for certain attachments, namely the DMEs and
home health forms. Some of have participated in small pilots with earlier
versions of the standards and some have developed prototypes which were
recently demonstrated at the February HIMSS. But most of this work has been
preliminary and very basic, and to our knowledge now of it has attempted to
implement all the various functions that will need to be supported to fully
support claim attachments.

In general most vendors, payers, providers have been fully occupied trying
to implement the first round of HIPAA, this has where most of our attention has
been and we still have a long way to go. There’s still some transactions that
have seen very little progress at all. And it is fair to say that the vendor
community is apprehensive about the implementation of claims attachment
standard, there is uncertainty about the potential problems that will be
encountered and a desire to have some level of industry study and education on
the transaction before we begin to develop our solutions.

Some of the issues and concerns that our members have shared with us, and
we’ll share with you, begin with a very simple statement that this is going to
be a very complex transaction to implement and that there will be a number of
issues and problems to deal with and we’ve kind of outlines in the next few
pages what we believe some of the major issues are going to be. We’ve ordered
this list by the way in what we believe are kind of the priority or the major
issues, the major issues to the less major issues, they’re all major but some
are more important then others.

Work flows are probably the most serious concern for us. When a request for
additional information is received what will happen? And Kepa shared with us a
number of scenarios and I think he outlined that very nicely. But the point
being when a transaction comes into a provider’s application it’s most likely
going to hit a billing application, not the clinical applications. And so some
sort of decision mechanism is going to be required to determine where the
transaction needs to be directed, what kind of system interface exists if any,
some sort of routing table for where to direct various requests of various
types. This work can be quite complicated in more sophisticated environments
and I believe there’s going to be a lot of work necessary to make that happen.

Of course both the request and the response transactions must be captured
and the provider must maintain these together with the claims in some sort of
status indicator to indicate what work has been completed or what work is still
pending, so that they can properly manage their claims and billing process.
These requests will not only require application logic but also databases to
store these requests and the information together with the statuses for audit
purposes and for the billing departments to use in terms of managing their
process. Policies and procedures within the institutions will need to be
modified to account for these new work flows.

The work flows just described would imply that there are interfaces between
financials and clinical systems but generally these don’t exist today. We have
lots of interfaces in an enterprise system that are between the financials and
the clinicals but these interfaces are not request response in nature, they’re
mostly communicating among the clinical systems the clinical data that they
need or among the financial systems that the financial systems need. Clinical
systems are generally pushing charges and information for the financial world
but they’re not normally pushing the clinical data that’s needed for an
attachment. This is all new work for us. So these are mostly push transactions,
not such much request and pull, and this is what we will be experiencing with
claims attachments.

Developing these work flows and the associated interfaces will be
complicated which may require additional standards. As noted above each vendor
will have to agree on some sort of protocol as to how to handle these and the
point that I failed to make above is although these systems may be contained in
one institution sometimes they’re on different systems, sometimes using
different technologies, different protocols, different methods of storing data,
different coding systems, different data structures, all these make for
complications to be dealt with in some sort of normalizing standard to be able
to interface between the two. Additionally some of these systems aren’t even
located in the same enterprise, and we’ll talk about that under data flows.

Locating the data within the health enterprise has potential problems, in
some cases where the data will be contained in one system while in other cases
it’s located in multiple systems, especially with clinical and financial
applications operating usually on different machines and potentially different
technology platforms, both the clinical and the financial systems could
potentially even be outsourced in certain enterprises. So laboratories and
billing systems could be operated on totally different systems from the
organization that’s using that data.

Beyond the challenge of knowing where to find the data and how to use it
there could be other problems, and an example of this would be establishing
user or system access controls for security and privacy reasons, and once
you’re in the data store knowing exactly how to acquire it because of the
technology issues that I just described.

We believe that for these interfaces between the various systems to actually
work you’re going to need to have, develop as vendors, some sort of application
interface program, some sort of remote procedure calls that will allow data to
be requested and retrieved, to be able to work in a truly ubiquitous
environment among disparate systems such as we have.

We believe health care setting issues are a potential problem as indicated
above, billing systems, labs, could be in separate enterprises —

MR. BLAIR: I’m sorry, what did you say was a potential problem?

MR. BECHTEL: Health care settings, organizations, large hospital
environments versus maybe larger systems that are all self contained or smaller
practice management systems, small laboratory systems, home health
organizations and so on. The settings themselves have issues that may make the
exchange of this data more complicated.

Interoperability as Kepa has mentioned we also believe is going to be a key
issue between the financial and clinical systems, to establish the connectivity
in the exchange of data that’s needed to conduct these business transactions
that have traditionally not been automated. Most interfaces between billing and
clinical systems today are just done manually, establishing the standard
protocols for these interfaces within the health enterprise will require in our
opinion additional collaboration among the vendor community.

We also think coordination with EHR would be beneficial to the
implementation of claim attachments and we suggest that this be considered as
well.

The standards point is really to the point of interoperability within the
enterprise that I’ve already described.

There’s also a concern about LOINC codes, outside of clinical systems these
are not widely implemented as a code set today and interfaces between this and
other code sets such as SNOMED will need to be further defined in ways that
include documentation for the consistent use and interpretation for mapping
purposes to be used by all providers and all health plans consistently.

Identifiers is another concern we have, as a new standard we’re all trying
to get this implemented, it becomes a distracter from the work that needs to be
done with claim attachments.

At minimum necessary we have a number of issues surrounding minimum
necessary considerations and I think Kepa did a nice job of describing that,
I’m not going to outline what he’s pretty much already said.

Infrastructure changes may be required as many of the systems that we have
today are not fully utilizing XML or using XML at all, and to handle the CDA
standard this will become a requirement.

Competing standards is also an issue that confronts us, as we saw with other
standards in the first round when we implement portal solutions, this begins to
distract from the quality of the standard that could be implemented. It also
creates more confusion on how to implement these standards if we’re trying to
do portals and trying to do the standards too. And although we appreciate the
portal being used in some setting, we see the value of it, we’re just saying
it’s a distracter.

We have some number of recommendations based on the issues described above.
AFECHT does recommend that the NPRM for claim attachments be issued soon but we
say that with some caution. We would request that consideration be given to the
work that’s already in progress and that we time the release of the NPRM in
such a way that the work that we’re trying to get done for round one gets
closer to get completion so that we can focus on this new NPRM. We also
recognize that without the NPRM the industry is not going to move forward very
fast so this is an issue that we need to begin to try to find the right answer
for.

AFECHT recommends that the industry develop a project plan as I’ve noted
before with realistic timetables being established for the claim attachment,
which should consider a number of aspects to allow, to have time allowed for. A
without going through any detail there’s on the next page, we’ve outline what a
plan should consider. In quick summary there needs to be time for analysis,
time for the development of the application codes, time to validate that
development. We believe there needs to be time included in any project plan for
the trial implementation to be conducted, and for that trial implementation to
be able to create documentation on the issues and underlying problems that may
need resolution before we try to implement this nationally with a mandated
timeframe.

We recommend that those findings be considered by the SDOs and CMS for
correction prior to a final rule being issued, and that the national
implementation plan that might be developed for the pilot work with some
modification after finding out what the real issues are could be adjusted to be
a better timetable for full implementation by the industry.

Obviously this plan needs more vetting and needs more input but we believe
it contains most of the important elements that should be considered and we
feel it is extremely important to industry to have such a plan. And AFECHT and
a number of other organizations, HL7, HIMSS, WEDI-SNIP, are currently working
together now to try to start an implementation trial process with some
interested vendors, providers and payers and we think if that work can actually
get executed we would hope NCVHS would look to that effort for some input.

AFECHT recommends that the final rule should not be issued before the input
from the beta trial is done. AFECHT recommends that NCVHS consider recommended
a phased deployment of the claim attachment. And AFECHT also recommends that
NCVHS consider finding a means to help fund a pilot or trial implementation,
especially for some of the provider settings that probably won’t be able to
participate unless there’s some funding available and without their
participation the trial really can’t be successful.

This would conclude my prepared remarks, I welcome any questions, and I
again thank the committee for the opportunity to speak with you today.

DR. COHN: Don, thank you very much. A final presenter is Gary Beatty,
welcome, and thank you for joining us, and I believe you’re representing X12
today.

Agenda Item: Industry Perspective on Claims Attachment –
Mr. Beatty

MR. BEATTY: I will be representing X12, thank you and good morning. I
apologize for not getting copies of the testimony prior to the session today as
we were working on it yet this morning and ran into logistical problems with
copy centers this morning, so I don’t even have a paper copy, so I’m running in
a virtual world this morning if you will.

On behalf of X12 I’d like to thank you for the opportunity to testify today
regarding health care claim attachments requirements for HIPAA, the Health
Insurance Portability Accountability Act. X12, just a little background,
consists of approximately 370 member organizations, we are represented by
organizations not individuals. Within X12 develop standards that are both based
upon X12 as well as XML formats for cross industry standards, so we’re not
focused solely on just the health care industry, we develop standards for doing
business electronically across a broad spectrum of industries within North
America.

Within X12N the insurance subcommittee, which I currently chair, there are
approximately 140 member organizations as well as over 95 non-members of X12
organizations that represent payers, providers, software vendors,
clearinghouses, value added networks, sponsor organizations, and consulting
organizations. Unfortunately you can’t see it but I do have a model that
highlights the transactions that are mandated under HIPAA and I believe you’ve
seen several very similar models to this one at your prior December hearing
dealing with attachments.

X12 as you’ve heard from Kepa has been working on health care claims
attachments actually since the early 1990’s when we developed the 837 health
care claim transaction. As Kepa mentioned contained within the 837 transaction
set we have data content to support different types of attachments such as
durable medical certification, ambulance certification, chiropractic
certification, home health care information, home oxygen therapy, the ability
to link to external documents as Kepa related, I think he referred to it as the
electronic stapling which has been a term we’ve used and batted around within
the standards community a long time, that can refer to either paper or
electronic transactions. This attachment information is still contained with
the 837 transaction and is currently part of the mandated 837 that is required
of the industry under HIPAA today.

Since 1997 X12 has been working with HL7 and we have been working together
to develop a national standard for health care claim attachments to meet the
attachment requirements under HIPAA. By working together we’re better able to
meet the needs of the health care industry as we can incorporate both financial
administrative data content along with the clinical data content into a single
standard. This combined standard can take advantage of the same routing that
the health care industry is establishing as it goes through the current
implementation of the other administrative transactions.

As a result of X12 and HL7’s attachment special group coordination X12 has
developed several attachments supporting health care claim attachments
including the 275, additional information to support a health care claim or
encounter. In the X12 world we have an implementation guide for it which has
reference of 004050X151 so it’s based upon what we refer to as our 4050 version
release of the standard with a guide ID of 151, which can be used as either
unsolicited attachment to the 837 health care claims submission, which Kepa
referred to as the early front end submission of attachments unsolicited with
the claim, as well as the response to the 277 health care claim request for
additional information, again based upon version 4050 with a guide ID of 150.
Both of these transactions had their respected implemented guides approved for
publication at the recent X12 trimester meeting this past February and will be
publicly available the second quarter of 2004, so even though it is approved
for publication it’s still not publicly available today but will be soon.

Within the 275 transaction is a binary segment as Kepa had referred to,
which will contain the HL7 CDA document representing the clinical data needed
for health care claim adjudication. The HL7 CDA document can be structured,
codified, or it can be unstructured, imaged, and it may be a complete document
or a portion of a document. Originally HL7 developed six attachments based upon
their version 2.4, which has a similar syntactical structure as the X12
standards. In 1998 the 277 transaction requesting attachments was pilot tested
in coordination with HCFA, then HCFA, which did involve both payers and
providers. The pilot however did not include the 275 HL7 version 2.4. Another
pilot test was conducted in 2000 by Empire Blue Cross and Blue Shield and HGSA
administrators along with CMS which did provide limited proof of concept of
these transactions, and I’d also like to refer you to your December testimony
as well where you did receive comments relative to the year 2000 pilot.

Given the capabilities of the health care industry and varied success, the
length of time since the pilot, and the emergency of internet technologies HL7
has evolved its standards to the clinical document architecture which is based
upon extensible markup language XML. HL7 has already provided testimony to this
committee on their CDA approach on December 10th, 2003. X12 is also
looking to use a similar process for moving clinical data content to support
the 278 transaction for pretreatment authorizations and referrals, and that’s
in its initial stages and evaluation.

In April 2003 X12 and HL7 jointly sent a letter to the Secretary of Health
and Human Services expressing concern over the length of time that has elapsed
since the original recommendations for attachments based upon HL7 version 2.4
and the need to provide HL7 enough time to complete the CDA and pilot test the
277, the 275 with CDA, CDA, prior to the issuance of the NPRM for these
transactions to ensure completeness, accuracy, and business proof of concept.
To date the CDA development has been completed however the industry still needs
to conduct pilot testing to verify the industry business needs will be met
through the usage of the CDA and the flexibility it affords the health care
industry for both structured and unstructured content for the health care claim
attachments. This pilot testing must be completed prior to the issuance of the
health care claim attachments NPRM.

Some recommendations, obviously we need pilot testing, we’ve learned that
from our experience with the other transactions that are mandated under HIPAA.
X12, HL7, CMS, again have gained valuable insights relative to these
transactions as part of the first two pilot tests. The need for pilot testing
was emphasized again recently at the WEDI hearing on implementation of
transactions and code sets January 27th down in Tampa. They stated
that if testing early business and data content uses can be addressed prior to
the actual mandate under HIPAA. X12 supports the need for pilot testing the
attachment transactions however this requires broad volunteer participation
from representatives of the health care industry user community including the
payers at varying levels including commercial, governmental, governmental can
be broken down all the way from the federal government all the way down to
state and county governments, ERISA(?) health plans, including the
representative organizations and TPAs, TPOs, ASOs, and the rest of the alphabet
soup in the ERISA world. HMOs, PPOs need to be able to participate in this
project.

Health care providers, and again from varying levels, hospitals, clinics of
different sizes, individual physicians and practices, clearinghouses, value
added network software vendors for both payers and providers. In addition these
pilot tests will require time, funding, to be successful. We and AFECHT are in
the early stages to facilitate pilot testing and X12 workgroup members have
participated in these early discussions.

Transition from the X12 837, as we mentioned the 837 currently does support
some of the attachments even today currently mandated under HIPAA. X12 and HL7
need to develop a joint recommendation for the transition process and timeline
to move the data content from the health care claim that will be contained
within the attachments. In 1999 across workgroup team within X12 identified
specific data elements that need to be migrated from the 837 health care claim
to an attachment standard. Discussions are underway between X12 and HL7 on how
we should move forward with the decisions from 1999 ensuring a current day plan
is defined and agreed to and the appropriate communications and education is
made available to the health care industry relative to these decisions and
plans.

Usage of health care claim attachments, we also recommend that the NCVHS
work with the Office of HIPAA Standards and the health care industry
representatives to ensure the attachments provide policy guidance to the health
care industry on the appropriate usage of health care claim attachments. This
includes but not limited to appropriate business situations where attachments
should or should not be required, frequency of usage, and amount of clinical
data required to satisfy health care adjudication.

Education, X12 and HL7 is currently developed an education program for our
June 2004 X12 trimester meeting in Chicago, which will cover business process
and usage of the health care claim attachment, including the 277, the 275, and
the CDA documents, and perhaps time permitting the prospective work flow and
best practices. This education program will be evaluated and presented in
subsequent X12 trimester meetings depending upon industry needs. X12 believes
that such education is crucial to the industry’s success of implementation of
claims attachment standards.

Electronic claims attachments and specifically the combination of X12 and
HL7 standards are new to the health care industry, as such awe believe there
needs to be a concerted effort to educate the health care industry on the issue
as quickly as possible. At this stage only education will provide an adequate
preparation for the publication of the claim attachment NPRM and ensuring
implementation of the proposed standards. X12 will support such education
efforts where possible. X12 welcomes the information sharing during this
hearing as well as ongoing input to make the best EDI standards we can for the
health care industry.

Thank you.

DR. COHN: Thank you very much, and I presume we’ll be getting a paper copy
of your testimony. And actually Kepa I presume we’ll get a copy of your
overheads —

DR. ZUBELDIA: yes.

DR. COHN: Okay, great. Well, questions from the subcommittee, I guess maybe
I’ll start out with just a question and I’m sort of listening to all of you and
am once again reminded of the complexity of successful implementation of almost
any of the standards and I think in many ways we need to congratulate ourselves
on how far we’ve gotten with the transaction and code set standards at this
point, but obviously we’re learning more. Now I think I’m hearing as I listen
to everyone, I think I’ve heard sort of the need for pilots and I think
everybody is sort of nodding their heads, I want to make sure I did hear that
right. As we look at models for this going forward I find myself sort of
looking at the recent Medicare Modernization Act and the description of how
they framed sort of the comments around pilot testing, in this case for
e-prescribing as an idea of coming up with provisional standards, piloting, and
then having the results of those pilots feed into a final standard. Is that the
model that you’re all thinking about or is it a different model for pilot
testing? Kepa?

DR. ZUBELDIA: It’s important that the result of the pilot be fed back to the
government before there is a final rule. I’m a little bit concerned about the
flexibility of the government process to do that. Ideally what I would like to
see is have some sort of NPRM or Notice of Intent that triggers some pilots and
that then can be fed as, perhaps a Notice of Intent that triggers some pilots
that that can be fed as an NPRM so there can be feedback once the industry
knows what is it that the government is going to propose because if you start
with an NPRM and then the pilot there is no way for the industry to feed back
into the government the recommendations or the intention of the government
after the pilot.

Let me explain this. When we went through the NPRM and final rule for the
HIPAA transactions as a result of the NPRM there were a number of comments that
were adopted by new implementation guides and part of those was the expression
of the type of service code. When the final rule came out a lot of people were
surprised by the type of service code had been suppressed and if there had been
something from the government saying this is what is going to come out there
would have been less of a shock. I guess a lot of people did not watch the
implementation guides and the standards setting process close enough to know
what was going to happen and they only look at what the government says in the
Federal Register. So if there is an NPRM and then a pilot and the result of the
pilot is fed back into the final rule they don’t get the time or the
opportunity to comment until the final rule hits and it’s too late. And perhaps
there would be, another cycle may be helpful to have that feedback and say this
is the intent, let’s get the pilot started, then the feedback of the pilot will
appear as an NPRM and people will have the opportunity comment on the NPRM
before the final rule. I know it’s a lengthy process but it may give a lot more
opportunity for feedback and less people would feel disenfranchised.

MR. BECHTEL: I would agree with what Kepa just said, I think though from my
own way of thinking, I was not anticipating creating a step before the NPRM, I
was looking more for a step between the NPRM and the final rule to occur,
accomplishes the same thing. But I think Kepa’s absolutely right in what he
says, we need to be sure that what we put into the process from a trial is
actually what we expected to get out. So I think that’s important.

DR. COHN: Gary, and then Jeff has a question.

MR. BEATTY: I guess two things. I came up through the e-business world from
outside the health care industry many, many years ago and when I first got
involved with doing business electronically it was through the strong armed
tactics, do it or else, or it just simply made good business sense in the early
days working with companies like Sears and Wal-Mart, some of those folks. As I
got into the health care industry I learned this industry doesn’t do anything
unless it absolutely positively has to, doesn’t matter how much good business
sense it makes.

I think a Notice of Intent is good but I think if we, without some muscle
behind it people just simply won’t do it within this industry. I think things
that will encourage the pilot to happen will again be we need education, we
need volunteerism, we need to some extent funding to make this happen because
it is going to take a concentrated effort to do a pilot and people won’t do the
pilot unless they have to, or unless there’s significant motivation and as we
heard from Kepa, I mean attachments are kind of the ugly duckling of the
industry, it’s sort of the thing we have to do.

But we have to get through this, I think we need to get through this before
or during, as closely to the time of the comment period as we possibly can so
that the industry can make informed comments through the proposed rule process
before we get to a final rule, because otherwise we’re going to get a point
where we’re mandating some of the industry and they don’t know what they’re
being mandated to do and that’s going to cause a lot of frustrations and we
need to limit, those are the problems that we’re running into now, that the
industry did not pay attention as much as they should have during the initial
development of the phase one parts of HIPAA and now they’re running into the
wall of we should have paid attention earlier. And we need to make sure we do
that the right way this time.

DR. COHN: Okay, Jeff?

MR. BLAIR: First of all let me just indicate that I found the testimony this
morning very helpful to me, it really clarified a lot of issues, and it does
appear as if both Kepa and Don are agreeing on advice to the subcommittee in
that we would wind up posing a Notice of Intent followed by pilot tests
followed by the NPRM —

DR. COHN: I don’t know that I heard, I think we need to stay away from, I
think what we heard from them is they want to an opportunity to have evidence
of government direction, pilots, input from those pilots, and a final rule, is
that —

DR. ZUBELDIA: Let me clarify, what I think needs to happen is the input from
the pilot, the feedback from the pilot needs to be fed into a process that
provides the opportunity for public review and comment before a final rule. I
don’t know if Notice of Intent is the process, two NPRMs is the process, I
don’t know what the process is but there has to be opportunity for public
feedback and comment on the proposed rule from the government after the pilot.

MR. BLAIR: This was sort of a set up for my question in a sense that
sometimes I hear folks say we need a demonstration, and then I hear people say
we need demonstration projects plural, and it appears to me, and maybe you
could give me some guidance on this, that it doesn’t sound like one
demonstration project would be appropriate even for the six different claim
attachments that were being looked at by X12 and HL7 even some years back,
including ambulance, durable medical equipment, home health. Could you give us
some guidance, not only on which particular claim attachments would be
appropriate for the first set of demonstration projects but also the
stakeholders and players that need to be part of that? Because it sounds like
we’re looking at a series of parallel demonstration projects.

MR. BEATTY: I would agree and when you see the handwritten testimony that I
have, I mean we broke it down into various type of organizations that are going
to be exchanging the information and it won’t be one big type of project, we
need to be able to gain experience from varying levels and varying parties
within the industry. Certainly the dental industry will have its own unique
requirements, the institutional venues, hospitals, inpatient/outpatient types
of situations, hospice, home health care and so forth, home oxygen therapies,
it needs to be a concerted effort of many efforts to test the various business
scenarios within the industry. Because when you look at the current transaction
we have now, I mean some of the transactions are having limited amount of
success because some segments of the industry did not participate in the
process, behavioral health care, to some extent the anesthesia parts of the
industry and some other verticals within industry did not participate in the
early development and review process and are stuck now. We want to make sure
that we can get as broad of input as these pilots go forward so that when it
does come time to have a final rule everybody is represented at the table.

DR. COHN: Let me ask a question and then Michael and Stan. This has to do
with the business case for all of this and I think it had something to do with
pilots and sort of general industry adoption. Now I’m actually reminded of
actually one of, a couple of years ago one of our now members of the
subcommittee testified before us, and you probably have to recuse yourself from
any knowledge of this, but he at that point sort of indicated well, they were
already pretty much doing the basic HIPAA style transactions, obviously in the
old format, but they were doing most of them, and that they saw the real value
of the whole thing to be around claims attachments, that there was really going
to be industry savings and all of this.

Now I guess my question is is as you’ve all talked about the complexity and
the issues and all of this I’m left sort of wondering, I mean is there a strong
business case that if people are given sort of the benefit of some federal
direction of we’re going to go, likely going to go this way, that there would
likely be spontaneous people beginning to implement and driving business value
in advance of a mandate on this one? Or is there some other, is there something
I’m missing here, and Gary it sounds like you wanted to comment.

MR. BEATTY: Are you asking is there a value proposition to doing
attachments?

DR. COHN: Yes.

MR. BEATTY: And I would suggest there is, it gets to the whole revenue
cycle, we live with attachments and it’s part of why I had the one statement
that we have to evaluate when do we really require attachments. When I was on
the payer side the payer I was involved with required attachments all the time
whether they used them or not, and it was kind of one of those situations I
think Kepa had alluded to. And as we evaluated that process very quickly we
learned, once I started getting involved with it that you really didn’t need
them all the time. But we have to look at the requirements to figure out what
are the values and when you look at revenue cycles and so forth, because I also
have experience from the provider side implementing a lot of these
transactions, a lot of providers measure everything by how long revenue is
outstanding or days revenue outstanding, however you’d like to refer to it.
When I look at the attachments process today when a payer has a nice letter
writing system, they create a letter, they send it to the provider, provider
goes out, does the research, collects the information, sends the attachments
usually on paper back to the payer and they start processing it, that process
delays the remittance by usually an average of about four to six weeks is what
usually I’m finding. And what we’re trying to do is reduce that and eliminate
much of that four to six week delay timeframe. At the same time we’re trying to
standardize the information that we’re exchanging, which is also going to
provide some benefit.

In the past when payers would ask for information generally providers would
send sometimes the entire medical record even though the payer was only really
looking for one isolated piece of information, instead they get a stack of
paper two inches thick. And this afford us the opportunity to ask very specific
focused questions from a payer to provider on what exactly are they looking for
to be able to move the process forward. So there’s a lot of value propositions
to that. But at the same time as Don and as Kepa pointed out there’s a lot of
complexities to make that all work together.

MR. BECHTEL: I guess I’d like to also add to this a little bit, I would
agree with what Gary just shared with you. I think the other element of is it
required is there are a lot of state requirements today to provide certain
information that can only be obtained through an attachment, so I think there
is current need to be able to do attachments aside from just payers saying they
want it. There is also infrastructure issues, which I described to you and I
think the infrastructure being built is a positive thing, it’s just going to
take time and it’s complicated but it’s positive in many ways as it will
improve other functions that we’re trying to do in our information systems in
the clinical side as well as exchanging data between health plans and entities
that are looking to understand outcomes and other kinds of things of this sort.

Clearly having those capabilities will be a benefit, and maybe not just from
the claim attachment perspective but maybe from broader perspectives as well.
And there’s also when you look at managed care the claim attachment is not just
associated to the claim, it’s also associated to the authorizations and
referrals, and in that environment where we see a growth of need to know why
certain things are being prescribed or ordered, therapies, etc., with some
medical being provided through an attachment, so I think even if we took away
the claim we’d still see a growing need on the managed care side telling us
that we would need to do this.

DR. ZUBELDIA: There’s different ROI to the different components of this
puzzle. The standard request for additional information sent electronically has
a very high ROI, instead of the provider getting a letter in the mail which
takes time that is hard to interpret the provider will be getting a
standardized code that says this is what I want and would get it
electronically, which is immediately, very high ROI. The ability to send the
attachment electronically, whatever the attachment is, the ability to send it
electronically rather then paper as ROI for both ends, for payer and provider,
because the payer doesn’t have to handle the paper and can get it right away.

Now the ability to codify the attachment as a particular RU message inside a
275, I would say that has a more long term ROI and perhaps in the long term
very high ROI because it allows for the whole process to be automated, it is
not a short term ROI, so I don’t think you can look at the whole attachment
puzzle and try to identify the ROI for the whole puzzle because it depends on
how you look at the different pieces. For instance the dental industry is using
very effectively very simple mechanism that I think you’re going to hear about
today of sending x-rays and images electronically, very simple, it doesn’t have
all of these information that we have in the attachment proposed with a 275,
and I don’t think it would work for all attachments but for some attachments
that very high ROI is causing the dental industry to use it today. So you need
to look at the different pieces, different components.

Let me also comment on the pilot project. There’s a risk with the pilot
project, the pilot projects need to be very focused on what is it that they’re
going to do, the risk is that if the pilot projects start exploring things just
for the sake of exploring them they may diffuse their value and they need to be
focused on what is it they’re looking for. There is all kinds of things that
could be done and as an industry we need to know what needs to be done and how,
and there’s an opportunity there to just do pilots on the umbrella of
attachments to do pilots on EKI(?), pilots on security, pilots on sending
x-rays, pilots on this and that and at the end perhaps not have a good
conclusion.

So it’s important to do the pilots, get different parties involved, large
payers, small payers, direct submitters, clearinghouse submitters, with a
vendor, with more then one vendor, with small provider, with large provider,
different specialties, but they need to be focused on the task at hand and
that’s going to be a challenge.

DR. COHN: Mike and then Stan.

DR. FITZMAURICE: In response to Jeff’s question Gary raised the idea of
different scenarios and that certainly I think that NCVHS can supply a forum
for determining, or for getting suggestions for individual scenarios and
communicate that to the Secretary. But in mentioning pilots I wonder, you want
to develop standards, you want to make them work in a laboratory, then put them
out into pilot testing, I suppose you want industry input to different
scenarios tested in a pilot, who funds the pilot, should this be an entirely
government funded pilot, should it be a cooperative venture with the industry
for somebody volunteers and says I’ll do it in my health plan for these claims,
let’s give it a try, how would that work, what would you recommend that it
work?

MR. BECHTEL: My feeling on this subject is it’s a combination of all those
things. I think the vendors will want to participate because these are products
they’re going to have to build and roll out, they’re going to want the
opportunity to do it right. I think there are some forward thinking
organizations that would want to be involved in that.

I think the same would be true of payers, there are some who won’t have the
resources to do it but there are others who will and I’m sure you will be able
to find payers that want to participate, in fact there are payers who have
participated in prior beta runs. So I think from those organizations they may
do this because it’s the right thing to do.

From the provider perspective I think you’re going to have more issues
because the resources aren’t available for this kind of work and they are going
to need funding to be able to pay for it. So I think there is going to be a
need for some funding for some segments of the industry to participate in a
pilot.

MR. BEATTY: I would agree, and it’s not restricted just to the provider
side, I think there’s also certain segments of the payer side that also need,
will need some funding to make it really work, especially you start getting
smaller risk based worlds where you have small TPAs, TPOs and so forth that
really don’t have the funding to be able to do a pilot project as well.

DR. ZUBELDIA: The government normally doesn’t give money away that easy. I
think that a realistic approach to the funding could be, if I want to explore
being realistic myself, it’s difficult, but it could be perhaps allowing or
funding some Medicare contractors or Medicaid contractors to participate in the
pilot, perhaps reimbursing some of the small physicians that send electronic
attachments and passing at least during the pilot project some of the savings
along to those physicians that send the attachments, because there are
substantial savings for the payer when the payer gets an electronic attachment
rather then paper. So perhaps that’s a mechanism of semi direct funding or
indirect funding or whatever you want that can get to the small physicians that
participate in the pilot, and if then Medicare/Medicaid contractors, if two or
three in the country participate in the pilot because in the end Medicare and
Medicaid are the largest payers in the country they can essentially pull the
rest of the industry behind them.

DR. FITZMAURICE: I think one of the lessons that we’re learning a little bit
from what Kepa said is that many times in the health care system somebody does
something that improves the working of the system but doesn’t get paid for it,
and so Kepa suggested that if the health plan is a major beneficiary of
something is there a mechanism that a pilot under the Medicare program or the
Medicaid program could do to maybe estimate the savings and pass some of the
savings back to those who do attachment in some fashion. I gather that was your
suggestion

DR. ZUBELDIA: And I think there is some precedent to that, some of the
quality improvement organizations in a different state have demonstration
project where hospitals that improve the quality through perhaps electronic
medical records, perhaps some quality measures, get additional funding or
reimbursement from Medicare. So this could be part of the same kind of project.

DR. COHN: Stan?

DR. HUFF: Again, I would like to thank the presenters for a nice, I think
bringing to the forefront the important issues that are surrounding this. A
couple of thoughts that came to mind, some of these are just comments and maybe
you could reflect on them. A lot of the issues that I think you brought up Don
reflect the complexity of doing business regardless of whether you’re doing it
electronically or not, that is the separation of the billing department from
the clinical systems, I mean even if you think of this as a manual system
somebody in the billing office has to walk over and find the medical chart or
ask a physician or a nurse about this information and so part of it is just a
complexity of how we have silos within institutions relative to these things.

But the other thing that came to mind is it seems to me that we want to if
we can allow a spectrum of automation that could slowly build, that is at the
one end sort of building from what Kepa said, everything is paper and so at one
end somebody sends a paper request and somebody does a bunch of manual work and
they send a paper response, and then you could build to a situation where your
electronically at least making the request and maybe in the middle ground
you’ve got an electronic request and you end up with an image that’s sent
electronically and then ultimately you have this end to end where you send it
electronically this system can ask another system in an automated way for that
information, bundle it up and you fully automate it.

But it seems like to the extent that we can we ought to try and support sort
of increasing sophistication through the pilots and then through implementation
so that in fact the flexibility for instance that’s offered by the CDA to
either contain an image or to contain structured data is actually an important
characteristic because it allows that kind of phasing along with it.

MR. BEATTY: Just like with other transactions, the staging is extremely
important and I think the model you presented is a very viable model, but at
the same time having the mandates but also having the volunteer implementation
of the others as you progress forward. So if somebody does have the ability to
move forward with CDA in a codified fashion they can do it even though it
hasn’t been yet mandated upon the industry. So we can have early adopters if
you will of the requirements.

DR. ZUBELDIA: The risk of that is that people may stop after the first step
and say I’ve done it, I’m sending scanned images of my medical records back, I
don’t need to do anymore. And most of the ROI, long term ROI is in the
automated process with real codified attachments that can be automated, that’s
the long term ROI. And sometimes, we’ve learned from the PCS implementation
that people are very concerned about compliance and they’ll do whatever it
takes to be compliant without really benefiting from the real ROI, so there has
to be a clear indication in this area.

DR. HUFF: I would see that danger and I guess the oppose danger is then
instead of making a stairway you make a high jump that nobody can get over the
bar.

MR. BECHTEL: I would agree, I think we could build a plan that takes us in
steps to where we’re trying to get to that would take into account the kinds of
things you described, and would have some mandate to get to the end point so
that we don’t have the issue that Kepa’s describing, because I agree, that
could happen if we don’t force an end point.

MR. BEATTY: In some ways CMS is doing that stepping point now and we’ve
gotten the contingency plans, we now have incentive to move forward by setting
the dates for adjudication of payment, so in some ways we’re stepping
transactions forward in a similar fashion.

DR. HUFF: One last quick comment.

DR. COHN: And then I have one final question and then we will take a break.

DR. HUFF: I just wanted to challenge a little bit the, I can’t get the image
out of my mind of the shotgun marriage, and I guess my characterization would
have been that actually it was a marriage that was built on strengths of two,
that is X12 has an established pipeline between the business partners that have
the most interest in this and HL7 really has the knowledge and appropriate
formatting for clinical data and is the most used clinical format. And so I
actually saw it as a thoughtful careful union of two strengths rather then a
forced political solution, but that’s just a comment.

DR. COHN: You have to recuse yourself from that whole comment since you’re
with HL7.

MR. BEATTY: That’s right, I have to retract —

DR. COHN: Now I have a final question and I want to give everybody at least
a ten minute break, but I think we’ve been talking about around it but I just
wanted to get you on record. Obviously there was a proposal made in December
related to the HL7 X12 claims attachment and obviously it’s not, I don’t think
it’s fully formed, I think we’ve all been talking about it needs to be piloted
and all of this stuff. But are you all generally comfortable with that
approach, I mean we’ve talked about the idea of flexibility, low technology,
high technology, all things that this seems to have, but fundamentally are you
supportive of that approach and that particular standard at this point? And
Gary I think I heard you in your testimony saying yes since you co-developed
it, is that right?

MR. BEATTY: Right.

DR. COHN: Don, representing AFECHT?

MR. BECHTEL: Yes, I believe we support that as well.

DR. COHN: Kepa?

DR. ZUBELDIA: Sure.

DR. COHN: I wanted to ask.

DR. ZUBELDIA: I see some benefits and some problems with it, I’ll explain
what I see. The scanned image which is probably going to be the first step in
deployment of the attachments, the thing that a lot of people are willing to
implement first. The scanned image included inside an XML structured, included
an X12 bin segment, it’s a triple layering of a document that is potentially
problematic to manipulate today with the existing tools. There are some, most
of the translators around that can translate X12 can also translate HL7 and can
also translate XML, but not necessary when they’re imbedded inside each other.
So the fact that a translator can process XML, HL7, and X12 doesn’t necessarily
mean that that same translator can process HL7 inside an X12 bin segment and an
image inside the HL7 message. So that’s something that needs to be explored so
that’s my hesitancy. Other then that I think it’s an excellent approach because
it gets the structures in place for the migration to the end goal, so once
people understand the structures the migration to the end goal, which is the
completely automated codified attachment, will be much easier. So if we can
resolve the technical issue of the nested syntax I think it’s an excellent
approach.

MR. BECHTEL: I would also just add one additional thought to that. Kepa
mentioned scanned documents as sort of the starting point and that is a logical
place to begin, but I think we also want to consider the EHR and the impact
that that will have to allow us to really do the segmented discreet data
elements that we’re looking for ultimately. And when we get to EHR I think we
can do attachments better and it may be part of the stepping process as we do
the things we can easily and then we get EHR in place and then we go and do the
things that are maybe more complicated.

DR. COHN: Well, great. Thank you all, it’s been a great beginning panel on
this discussion today. We’ll take a ten minute break and come back at 11:25.

[Brief break.]

DR. COHN: Okay, we have two presenters for this which is further discussion
industry perspectives on claims attachments. I want to thank David Schinderle
for joining us as well as Michael Icenhower, okay, Mitch, apologies. David, I
think you you’re to start off the testimony please.

Agenda Item: Industry Perspective on Claims
Attachment- Mr. Schinderle

MR. SCHINDERLE: Thank you, Mr. Chairman. I’d like to thank you for the
opportunity to be here today and to explain what started out originally as an
advocacy effort in Southern California, it has now led into a business
enterprise owned and operated by the Hospital Association of Southern
California in concert with its technology partner, Health Logic Systems
Corporation in Atlanta, Georgia.

One of the things that I’d like to give you a little background on myself as
well, I come out of the provider community over 30 some years, the last 18 or
so I was the vice president of finance and treasurer of the St. Joseph Health
System, about a 4,400 bed 14 hospital system headquartered in Southern
California. And at that facility I was responsible for revenue cycle which
included managed care during much of my tenure there, as well as responsibility
for accounts receivable and cash flow. And as such I participated actively in
the X12 process since 1989 and used to co-chair the 835 workgroup for
remittance advices and I’m now actively working on the attachment standard
workgroup as well. So I also sit on the Electronic Health Care Network
Accreditation Commission so I’m very familiar with the clearinghouse side of
the business from an accreditation perspective, so I appreciate again the
opportunity to be here and to share with you some of our experiences in a
working environment.

Four years ago we came together as a hospital association with some of our
largest payers in Southern California to begin to address back office issues.
We had a lot of outstanding issues and when we got folks in a room and we
started prioritizing all the places that we could potentially put our energies
the number one issue that sort of came out of those discussions was the need to
address claims attachments. At that time we were four years ago thinking that
we were going to have an attachment NPRM come out within a few months and so
this was fairly high on folks’ radar screen at the time and right about,
actually within a couple months of our committee being formed to work on this
the HCFA at that time had issued a white paper actually outlining what their
approach and goals were to the approach of electronic attachments. So we were
pretty well focused with a footprint of what we were expecting both from an X12
standard perspective as well as the outline that had been provided to us by the
Health Care Financing Administration, now CMS, to focus on this particular
issue.

And we ran into as we began our research all of the problems and then some
that you have heard today from the other speakers, I won’t elaborate on those
but to say that there are many and they are an extremely costly proposition for
the industry, both on the payer and provider side and I’ll talk more about that
here in a second.

Hospitals are currently spending between $20 and $30 dollars, one of our
major medical centers in California just completed a study last summer where
they discovered that they are spending on average $33 dollars per request to
respond to attachments, and they have 35 million electronic records sitting in
their electronic medical records system, so this is a very costly business
proposition on the hospital side. And as Gary Beatty mentioned earlier the
processing cycle time is 30 to 40 plus days as this moves through the cycle,
it’s a very disjointed process. Generally speaking the requests from the payers
go to a lock box because the only address the payers can support in their
system today generally is the address where they send the remittance money. And
so it goes to the lock box and then the lock box vendor doesn’t know what to do
with it because it’s not a check or remittance advice and so it gets lost and
it gets routed, it becomes a difficult process as it goes through this cycle.
The cost to the payers as we have worked with the payer group appears to exceed
and is approaching $20 plus dollars per transaction for them, fully loaded
cost. So it is costly on both sides of the equation and it takes up
considerable amount of time.

The other thing that we found is that one of the major limitation on the
payer’s goal of 100 percent electronic submission of claims is claims
attachments. In California we are stuck at around 60 percent electronic
submission. That last 40 percent is very much tied up with the attachment
problem and is one that the payers are very focused on trying to fix at least
in our market because they are attempting to see if they can’t get more claims
to auto adjudicate, eliminate all the key punch costs of all these paper claims
that are coming in with attachments.

Coordination of benefit claims is another major portion of that problem
because the 837 COB transaction today is not working very well and it’s very
early in its adoption phase, we’re probably a few years away before that
becomes heavily utilized by the industry, and we just got some consolidation
regulations that were published here in the last week or two indicating that
the Medicare program is going to consolidate some of its coordination of
benefit activities which is probably going to further delay adoption as people
sort out these new regulations and how those guidelines are going to work.

Payers are also incurring significant interest and other costs that are not
in the cost numbers I previously gave you. Because of all the delays that are
going on here under prompt pay laws a significant portion of the problem is
related to interest cost and also we have the problem of misdirected claims in
California where we have heavy delegation to provider organizations who have
taken managed care risk and our actually paying claims on behalf of the payers.
And so providers have difficulty sorting out who should get the claim and
because of what they call division of financial responsibility issues and that
leads to further attachment problems and shotgunning of claims that adds up to
delays and higher interest cost.

So our objectives as a community of users was to try to find a new way to do
business. How could we expand this and create at least a starting place for a
single way to do business that would work, lower the cost of doing business
with fewer touches per claim, improve the business process, and finally deal
with the IT platform that was in place today, which was primarily Microsoft
based products on desktops so users both at the payers and at the providers and
to not bring new software in that had to be installed or had to be integrated,
that it was basically IT light, it had to be so simple the business manager in
a medical group could implement this without IT support, that a business office
in a hospital could implement this without IT support. Because if we had to
involve the IT department this wasn’t going to happen. And the health plans
wanted it that simple as well because they had 500 other projects that were in
front of this one. And so getting IT resources to pay attention to this was a
mission that drove our goal, it just became very important to us.

So we developed what we call the Claims Attachment Document Exchange, that
was primarily an ASP type web based service where the provider, I’m sorry,
where the payer could request and then scan and upload those documents in
response to that request. We found that many of the provider’s documents were
already in some electronic repository, like transcribed dictation, the
statement of charges or itemization of charges, the ER face sheets for example,
and these documents tend to be the core of a very high percentage of what
people are asking for routinely. And that research that we did suggested that
those documents if they could be uploaded easily like an email attachment would
be very attractive to the providers and so we built it around that and we also
built around the concept of scanning for those other documents that were
generally handwritten, where were not available in electronic form so that
those could be uploaded as well.

We supported thinking that it would work, at the time we decided to support
the 837 claims transaction set relative to the attachment piece but as we’ve
since learned that is not a fully, is not been fully adopted by many people in
the communication chain from the provider all the way through to the health
plans. In many cases the health plan is receiving the information but they have
not updated their claims adjudication system such that their claims examiners
can see that there isn’t an attachment control number that’s been sent to them
so that they can go look for the attachment, whether it’s been mailed into
them, faxed in, or electronically transmitted.

The providers wanted fax capability because we had payers that couldn’t
support electronic but yet very much wanted to receive those attachments, and
we found that many payers, their preferred way of receiving attachments today
is fax, which is challenging at best. The payer reviews the submitted documents
and then completes the adjudication process so that’s basically what we did. We
set up a simple attachment document request form which basically follows the
275 and 277 transaction sets as they’re currently being composed in terms of
data content. We set up a relatively simple check off list, at least we thought
it was relatively simple at first. One of the things we discovered very early
on was a nomenclature problem in that the definition of simple things like a
complete chart, we have seven, eight people around the table and we have seven
or eight different definitions of what is a complete chart and what hospitals
were sending in in response to the payer’s request. And so we have worked very
diligently to try to define among our user community what is meant by all of
these different document types that we have come up with that our frequently
requested.

We also provided work lists then for the provider to receive those requests,
to sort and filter them in order to respond to the business need, and then set
up a way for them to go into a detailed request and have a scan or an upload
capability to send the records back to the payers. When we first started this
we thought the easiest way to do this is just send an entire document and put
everything into one envelope and that doesn’t work very well for the payers
because we found that the payers would then print everything out in order to
review it because it wasn’t indexed for them, so we found out that it was very
necessary to index the documents by document type so that they weren’t looking
at a 300 page medical record to try and find a history and physical, all they
had to do was click on the history and physical or the discharge summary or the
statement of charges and then go directly to that document.

We have built this to try to be HIPAA compatible for all known requirements
that we know of today. We’ve been active as I mentioned earlier in the
standards process and we’re committed to supporting the HIPAA standard as it
moves through the approval process. We currently are installed in two early
adopter health plans, PacifiCare who’s been installed the longest with us now
across their entire product line. I guess we’ve been installed there 20 some
months. Health Net came up last fall, Aetna is planning to implement a pilot
with us in the spring for their California operations, and we are moving
forward with the California Medicaid program with EDS to begin an operational
pilot there. We also have been selected by the Utah Health Information Network
to begin a process of rolling this out across their various provider types this
summer of ’04 and we are currently faxing attachments to a number of other
payer partners.

We also did participate in a very limited pilot with the approval of the
Kansas City Regional Office with Mutual of Omaha to explore at a nursing level
could the nurses deal with images and could they reach the same clinical
conclusion on a very small sample of records. And that study only involved
about 20 patient records that had previously been adjudicated, the team at
Mutual of Omaha sort of pre looked at those, then they had us, they requested
the attachments through our system, we responded through the system, they
re-reviewed them to see if they could reach the same results, and in fact they
did and as we understand it it was fairly well received, but a very small study
of the viability of that as a proof of concept. Additional Medicare pilots have
been under discussion for some time with the CMS Office of Program Integrity,
but that is moving very slowly. And we would obviously encourage pilots as
folks had discussed earlier.

We do have 76 hospitals that are either live or committed to go live with us
so far in California, we are planning to expand to other provider types like
large medical groups, medical management companies, who are managing like
emergency room physician claims and things like that as we tend to move out and
across. And we are beginning to work in some other states and explore
relationships with those hospital associations, try to get more experience and
to better understand what’s happening.

So what have been our results that we’ve seen out of this project so far?
We’ve seen a decrease in the days in accounts receivable for the providers,
that’s been primarily driven by a substantial reduction in cycle time ranging
from six to 18 days depending on how fast some of our providers have been
responding to the cycle time process in general. Most requests that are made by
a payer across our system are responded to within three or four days and some
are processed on the day they’re requested and are closed out by the health
plan in the same day, so it’s amazing to see those kinds of things occur. And
we’ve seen at least at a theoretical level a cost reduction of about $21
dollars per transaction so far. I say theoretical because until you have a much
larger number of payers participating you’re not really going to realize those
dollars, so in a limited number of payers you’re not laying staff off and
taking Social Security numbers off the payroll, so as a result of that today
that’s a theoretical opportunity of savings that we believe is achievable if we
had broader participation across a larger number of payers.

What we’ve basically learned is that this is a lot less about technology and
it’s a lot more about standardized process and nomenclature. The technology
that we built is all off the shelf, we went with cheap and inexpensive
scanners, although some institutions have installed multi thousand dollar
scanners, most people have under $500 dollars scanners in place, and some have
under $100 dollar scanners in place. It is about developing trust, if a
provider changes his process will they get paid timely and efficiently by the
payer, it’s all about the work flow and making sure that if they bet the farm
and change their business process that the payer is going to support that
change in business process and pay them in a timely and efficient manner.

The providers need simple clear guidelines on when and what type of
attachments are needed. We’ve been working with our community of payers to do
that and they have graciously come forward and are providing that kind of
information and the additional guidelines that are sort of needed as to when
they’re going to need certain types of documents, what are those thresholds so
that we avoid this process of providers trying to second guess when documents
are going to be needed or getting the trust factor high enough that they’re
willing to wait after submitting an electronic claim for the payer to ask for
those attachments, knowing that they’ll be processed and turned around quickly.

LOINC codes seem to have little appeal out there right now, it’s not how
folks do their work today and it will require significant training and at some
point it becomes a work force issue. The folks that do this type of work do not
have the skill set necessarily to deal with the coding complexities if this is
done manually. If it can be fully automated, and we support that long term, we
believe that that’s a good thing. But we have to move as many of the other
folks have spoken to in baby steps and we’re not sure that folks are ready for
this yet. Payers and providers generally work at the document level related to
attachments today, they’re not dealing with the data elements within documents
typically. Payers typically based off the information they see on a UB92 or
HCFA 1500 do not have sufficient information to really drill down and ask data
element type questions typically, unless it was a missing data element on the
UB. They’re typically looking for a document to determine a pattern of care, a
preexisting condition, things that they need to have answered under the type of
insurance contract that was sold to that beneficiary or member. And we do
believe the clinical documentation architecture using XML is a step in the
right direction, but it will still be very challenging for smaller providers
and payers we think for many years.

Providers still prefer to submit attachments at the time of billing today if
they know what’s needed. They think it’s just faster and more efficient and
they’re reluctant to separate that claim from those attachments because they’re
still fearful of reassociation problems. I mean one of our health plans that
we’ve been working with for some time has 100 people in a dead letter office
where they try to match this stuff up, this is not an insignificant problem, we
have had situations that we’ve uncovered where the mailroom receives the
attachments and they separate the claim from the attachments and they scan it,
they index it, they do all those wonderful things, then somebody checks to see
if anybody had asked for the attachments and if they said no they trashed it
and through the file away. And then two weeks later when the claim finally got
around to be examiner they discovered oh, we need the attachments, and then
they request it. And then of course the provider is sitting there with a FedEx
receipt signed for that they sent the attachments and can’t understand where
their attachments went. So you have these kind of provider and payer type
stories that come out.

We had one very large institution in California we went into and we were
working with them and just to give you another little horror story, but they
made two copies of every request for attachments and they kept a bank of file
cabinets in the business office and because 90 percent of the time the payer
lost the first one, and of course when the second request came in they made
another copy and then put it in the file cabinet. And once the claim was paid
they would always wait six months after the claim was paid and then they would
finally destroy and shred the document. Because it was cheaper then annoying
the medical records department that many times asking for the attachments and
incurring the copy service costs or the scanning service costs or whatever to
go get their documents another time. So there’s lots of industry stories out
there that I won’t bore the committee with but just to give you a couple of
those example as a baseline.

The paperwork segment as I mentioned earlier, there’s many communications
problems, right now the biggest one being that the vendors who supply the
adjudication software or the in-house teams that wrote that software and
maintain it have not updated their software in many cases to allow for that
information to be seen, so that’s problematic at the moment. The 837 COB
transaction set, again tends to be very problematic at the moment. We are
optimistic that that problem will get solved but in the short term we think it
may make some sense to look at some exceptions for moving that data possibly
through the attachment transaction.

Providers and payers need simple tools that work with what they have today
as we mentioned, and electronic medical record systems generally don’t easily
support electronic claims today. We have many situations where it works
wonderfully in-house in the medical center but when you try to export one
document from the medical record set, you can print it, yes, you can attach it,
no, you can send the entire file but you frequently can’t send just the one
document and so there are workarounds and some of the vendors are now starting
to move forward to modify their software to permit those kinds of things but in
the past for security reasons in many cases the EMR vendors didn’t permit those
kinds of activities because they were afraid someone would go in and steal
record and do things that way and so they put barriers to some of the things
that we’re trying to do today with the attachment standard and hopefully
they’ll address those in the near term.

So what’s our recommendations based on our sort of experiences in California
and other places? In order to achieve the fiscal goals of the transaction and
code set we believe the attachment rule should be published soon. We need to
get the industry on notice, get this process moving. We do believe that payers
should provide clear guidelines on when and what attachments and why the
documents are needed so that the providers have a better understanding of what
they’re doing and why they’re doing it.

The proposed rule should support multiple approaches, we believe the changes
recently at the HL7 level is a very good step in the right direction and we
think the final rule should, and proposed rule should support those approaches.

LOINC codes should be used I think initially at the document level for
claims attachments to support the claims adjudication and be broad enough to do
that and allow for folks to phase in to the deeper adoption for greater
clinical integration of systems as we develop that sophistication and as we get
through enough pilots to be able to understand how all that plugs together.
Because work flow and process flow as Don Bechtel indicated and Kepa indicated
are not going to be easy and it’s going to take a lot of effort to work all
those things out.

We think the attachment rule should permit alternate submission modes for
the coordination of benefit transaction in order to allow for more of this to
move electronically and to address some of the concerns we’re hearing from the
payers in trying to get to their goal.

And finally we support and endorse the comments that the American Hospital
Association has submitted previously to the subcommittee, we think they made
some very good points in their letter to you and we would support those as
well.

I think the committee and would welcome any comments you have at the
appropriate time.

DR. COHN: Okay, David, thank you very much. And Mitch Icenhower, thank you
also for joining us.

Agenda Item: Industry Perspective on Claims
Attachment – Mr. Icenhower

MR. ICENHOWER: Mr. Chairman and members of the committee I’m pleased to have
this opportunity to talk to you. I am the product line manager for Health Care
Data Exchange, it’s the EDI’s subsidiary of Siemens Health Services. We’ve been
very involved in the HIPAA efforts up to date, migration to the existing TCS
transactions, and Siemens provides the revenue cycle solution for approximately
1,000 of the acute or institutional customers that we have in the United
States. That’s roughly about 25 percent of the acute care facilities out there.
So my comments today will reflect a little bit on what we think the background
is here, what our status is, some of the issues that we see, a couple things
that we think are positive trends that we can hit, and then just some specific
recommendations.

As I said, represent about 25 percent of acute care provider market, really
some of the slant that I’m going to talk about today is really about those
acute or institutional customers. Some of the solutions that are, David, you
got some great stuff that’s going on, will work at certain levels better then
others. One of the biggest challenges that we see is that the institutional
customers have an internal challenge of corralling their information and using
that correctly, and a lot of the comments and suggestions that we’ll make will
kind of try to reflect that that’s some of the complications that we’re going
to face.

As far as where we are in the scope of claims attachments, we’ve worked with
all the TCS transaction, that really wasn’t that big of a stretch for us, like
a lot of vendors we’ve been doing electronic filings and claims type
transactions since 1980. It seems to funny to say that now but compared to the
effort that we’re going to have with the claims attachments, the other HIPAA
transactions are actually the low hanging fruit and I know that Stanley will
laugh when I say that because we haven’t actually really implemented of his
industry yet, but the ROI, the focus on the administrative simplification, that
was sweet spot stuff that we really did know what we wanted to do it was just a
question of how we were going to implement it. With claims attachments we think
we have more of a situation where there’s still a lot of debate as to the what
and as to the how and we think that it’s going to really require industry
collaboration such as these kind of forums and a collaborative plan to really
be successful.

As far as where Siemens is and its status with claims attachments, we have
been heavily involved in the analysis pieces, working with different SDOs, HL7,
and have gotten to that point, but like a lot of other software vendors the
actual development work isn’t going to happen until an NPRM is published. We
obviously have laid some of the groundwork, we’ve started incorporating things
like the LOINC codes into our common vocabulary engine, but we really need to
have that opportunity to get the feedback, get the final rule before we would
start having development in one area or another and it’s really because our
lessons learned from the previous HIPAA implementation, it really gets down to
you can actually destroy the momentum for our customers if we take them in the
wrong direction. That’s why I think the suggestions that I’ve heard today about
this trial period, a pilot period with feedback that has input to the NPRM,
really it could take more time to do but in the long run it’s going to increase
the quality and the communication of the expectation of what that final rule is
with the providers.

We’ve talked a lot about how health care, and especially the providers, will
not do something until they have to do it, well part of that is that there was
a lot of conversation and noise before the final rule got in place, and they
screamed that out until they know what they really have to work on. And a
process that’s iterative, that takes a pilot and gives that feedback and really
winnows it down so that we have a shorter gap between that NPRM and the rule
and what we really want to implement is going to get their attention a lot
more. And the credibility of having that feedback is going to make a big
difference to the adoption rate.

Industry organizations such as WEDI, AFECHT, the AMA, all the organizations
that are represented here today can work with the vendors in a more effective
way then we did on the first round of the HIPAA implementation to help spread
that message of credibility and how we’re doing, get the feedback and to reach
out to the provider. I think more collaboration between those organizations to
get that provider education piece is going to be critical.

As far as our participation in a test pilot, Siemens would be happy to
participate in an initiative like that, I’m sure that other major vendors would
express the same type interest. We have to represent the industry in the plans
and the pilots we do here and it’s a challenge as we said, even the six types
of attachments we’ve identified really does bring a variety of scenarios that
we could be doing, so the pilot as you said could be multiple pilots at
multiple sites, but again, a structured test system that we get the results
back on a structured pilot and bring that into the NPRM, it’s going to just
cover so many scenarios where we got caught up after the final rule this last
time.

As far as the challenges that we see, really one of the ones that’s going to
effect institutional customers the most and I’ll probably expand a little more
then my previous presenters is the data collection, storage, and access. In a
typical acute care provider today the billing system, the clinical system, the
departmental systems, are all separate, they don’t contain information, there’s
usually a patient type index that pulls these things in an index way so that
you can pull the information together. But as far as when that request comes in
from a payer to get those things, it’s not only a question of it might be
different data and it might be different formats, but it’s going to be
different systems, different vendors, and different access control. The billing
people are not going to have the access control that they need to get to to get
to all these different systems. And while some of the things that we’ve looked
at like quartile solutions do a great job of dealing with the request and
response workflow, and the UI and presentation of those things, there’s still a
problem we need to address which is that provider, how they turn around and how
they handle the data internally, and that really puts vendors like Siemens
right in the middle of that solution because we’re the ones who can help them
pull this together. We think that the way to pull it together is in sync with
the industry and in complement with the movement towards an electronic health
record.

The other key areas for problems, standards deployment, of course we’re big
supports of HL7 and been involved in HL7 for some time, and again we’re
particularly supportive of the recent initiative that support the vocabulary
and definitions that are going to be used in electronic health record. But some
of the other things that have happened like LOINC, we think LOINC has great
value. As you said it’s not a great adoption rate and the vendors have not done
a great job or just haven’t fully supported the LOINC codes yet. Again, we have
them loaded in our common vocabulary engine, we’re ready to go, but we don’t
have widespread implementation of them in our customers. Using it in a manual
UI type approach, it’s cumbersome and there’s an education issue. But if you’re
going to try to automate some of this to go out to an electronic health record
and to be able to get to this data, the LOINC codes are key and they do provide
the mechanism to be able to do that mapping and be able to have those requests
relate to the individual systems that are out there. So I agree that LOINC as
implemented for the manual interface can be burden, I think that where it
really gets its value is when we go to those automated solutions and we’re
tapping into an electronic health record instead of a million disparate systems
in each provider.

There has been, just a quick moment on the clinical document architecture,
again, we think that is a worthwhile initiative but in the U.S. implementation
just the adoption isn’t there yet. We think it’s got great potential, we’d like
to see it addressed as part of the pilot transition in the pilot periods that
we do, but at this point we’re not seeing the widespread adoption and we think
that it’s critical that we pull it into the pilot process if it’s going to be
successful.

Finally, just a quick comment that there have been a lot of suggestions that
ICD-10 would eliminate the need for some of the stuff that we’re talking about
here because their ability to define down to a greater and more granular level,
haven’t heard much of those comments here today, I think that’s because the
people here understand that ICD-10 can help to be a filter to reduce the amount
of claims attachments requests that you see by giving that more granular
definition, but it’s not going to eliminate the need to do it. And I think it’s
just one of those clarification things, there’s some folks who feel strongly
the other way but we feel it’s just, adoption of ICD-10 gives us better
opportunity to reduce the amount of requests that go but we’re still going to
have requests, it’s still going to be the ugly duckling that we’re going to
have to deal with.

The last challenge we see is really that workflow that Mr. Bechtel and Kepa
have referred to. There really is a workflow issue that vendors like ourselves
can help resolve and it really is those two major workflows that you talked
about. One is the proactive, they’re sending it out with it every time because
that’s what their experience tells them to do, and the other one is the ad hoc
request that comes back from the payer for those things. That’s where we really
see the opportunity that if an EHR was in place that really, you look at those
workflows and you define them, today they’re very difficult to automate because
of where we are but if we have a transaction standard, if we have the LOINC
codes, if we have those pieces, and an EHR where we can pull that data together
instead of having it be in disparate systems, that is really where the
automation opportunity is and that’s where we can really tackle the workflow
problem.

We feel pretty strongly that the initiatives that are going on right now
with the electronic health record, AHIMA’s recommendation to have something
implemented by 2010 for the provider base, those things have a lot of value. I
know we need to do interim steps and we need to do things that will provide
interim value and the test pilots, the rules, all those things. But alignment
with the EHR initiatives really gives the providers more incentive to get into
an adoption mode, gives their organizations more incentive to fund these
things, and helps us bring all things forces, whether it’s HIMSS, AMA, the
MPMA, all these organizations together in a common goal. So I think that when
you look at the long term range goals of what we’re trying to do alignment of
that E HR initiative and the claims attachment initiative is really where
you’re going to deliver a true ROI savings and a true workflow savings to the
providers. And when they see that vision they will be more likely to adopt the
claims attachment steps that they need to do.

The final thing that we think could be helpful is a national implementation
plan. It goes under what Kepa said, lessons learned from HIPAA. In HIPAA we did
a lot of things right, we did a lot of things that we could learn from, I think
one of the things that was right but we could still learn from is a Strategic
National Implementation Process, SNIP, we probably got into that game too late
and because of the tight timeframes for implementation did not have the
opportunity to effect provider implementation the way we have. We know big bang
is not a good way to go at it after the first time around, we know that
universal feedback coming back through organizations like WEDI and AFECHT is
that a staged implementation, and one that is not dictated by the government
but really helped developed by the industry itself, is what’s going to be
successful in walking us through to get to that end goal. And that end goal
still can be that EHR claims attachment alignment but the important thing is to
involve the industry in developing a stage plan that we can work through
together.

I’d just like to end with a couple of specific recommendations that we had
talked about and I think they’ll flow right into the general tone of what we’re
talking about today. We definitely recommend a required trial implementation
and the opportunity to get that feedback before the final rule is developed.
Absolutely have, look at the in time of the final rule implementation and have
a realistic implementation of what the industry is going to take to implement
it.

We need to permit adequate time for each market segment to adopt it and I
think we’ve done an okay job with HIPAA, certain segments were able to react
faster, sooner, better then others.

The deployment plan really should be developed amongst the industry players
and maximized in the organizations that are involved and represented here
today. The individual providers will not get the message unless those
organizations not only bring their needs forward here but help us on the out
push of the information back to them.

If I could summarize everything in a general philosophy of claims
attachments and what we think is for a plan here be aggressive but also focus
on being achievable, we want to have something that mandates their behavior but
if we don’t have the buy in in the creation of the timeframes we get to the
point where we are. The last thing we want to do is have contingency plan after
contingency plan, we want to get a realistic approach the first time, have a
step wise improvement that may have interim phases, and ends up with us in the
timeframes of having achieved both goals, a claims attachments process that
saves the industry money and an electronic health record initiative that has
decreased costs and increased quality in health care.

DR. COHN: Thank you both for some very interesting testimony. Are there
questions from the subcommittee? Harry?

MR. REYNOLDS: I would also like to thank the excellent information. Talking
about CADX for a minute again, you have a comment in here that it was built to
meet on the HIPAA requirement. We have a continuing argument going on in the
HIPAA world, which is direct data entry versus actual records and what’s in the
records, that they’re the same. Can you help me understand if you in the CADX,
you’re actually capturing, entering and transmitting all the same data that
would be in an attachment?

MR. SCHINDERLE: That’s a good question. The way we’re doing it today is
we’re trying to follow the data content, we have not incorporated fully like
LOINC codes for example behind the scenes, or are we translating it in note to
an X12 envelope today because we’re doing predominantly HTML type based
transactions. What we are finding is that some of our health plan partners are
treating us as a clearinghouse, which we admittedly say we are, and that we as
their business associate they are looking to us to basically put these
documents into their format such that it’s ready to go into their document
workflow. If they have like a file net system for document management and
workflow they want us to flow our documents right into their workflow as if
those documents had come into their mailroom, had been scanned, indexed, key
punched, whatever, we’re just feeding right into that workflow so that they’re
not having to change their workflow.

Other smaller organizations very much want to have a web based interface for
their staff, they don’t have a place to store the images, they want to have
sort of that interactive web based experience with the product. What we’re
trying to focus on is staying as close as possible to the data content, to the
definitions that are in the X12 standard.

MR. REYNOLDS: A follow up question. If you stayed with the HTML and as you
have it now how does that play when we actually go to a standard? You made an
earlier comment which also lay in an IS world, you don’t want to include IS.
But as soon as you step into that actually X12 and the other things you’re
entering the IS world again aren’t you?

MR. SCHINDERLE: To some extent, I mean we can code things behind the scene,
we can deliver that information and if someone requires the transaction, for
example if someone out bounds a 277 request for attachments to us we can
convert that and render it HTML to a provider who can’t deal with the
complexity of a 277 request. We can then turn that around and feed it back to
the health plan when they submit the attachments and put it back into the X12
standard and batch it into them. So we can act as that sort of clearinghouse if
you will to move the transaction both ways. So yeah, we’re going to have to
deal with it but we’d rather do the heavy lifting then have to force the
provider to do it or potentially the payer if it’s a small self funded health
plan or some other organization that doesn’t have the expertise to deal with
that. If they have the expertise, fine, we can just deliver in the X12
standard. Right now we don’t have any takers, nobody seems to want to deal with
it at the standard level although we’ve offered it several times.

MR. ICENHOWER: I’m taking off my clearinghouse hat and putting on my vendor
hat, obviously what I would look as a vendor if I’m going to develop the
workflow automation that the providers need to pull this together and
interface, that’s where the standard transaction delivers a lot of value. As
accommodating as any HTML feed to me could be I need the standard to be able to
code something that’s going to be used across the industry.

DR. COHN: I have a question and then Jeff and then Gail. I think you both
have in one way or another sort of referenced I believe LOINC, and this may be
a piece of ignorance on my own part but I was, I think we all I think have
appreciated the value added that LOINC provides in the more robust claims
attachment scenarios as we described. I guess I’m having, I’m sitting here my
own self sort of trying to figure out A, whether even in the most basic
implementation, the scanned document, etc., etc., both whether LOINC is
required or is being suggested and the value added and the complexity, and I
guess I’m, once again I know in the end stage it has great value but can you
comment about that, somebody just trying to scan and get images up through
whatever standard may be approached.

MR. ICENHOWER: Basically, and I do not claim to be an expert on LOINC, I
defer to Mr. Bechtel as more, but the idea, where we see it is that if there’s
a manual intervention just like you talked about here then requiring the using
to understand the codes and its in their heads to be able to utilize those
things, I really don’t even think that’s why if I’m one of the folks who
primarily design it, they wanted vendors like me to be able to take that and
map so that the code values as well as the format could be mapped and could be
a pass between those so that I can, basically the reason that’s there is so
that I can automate these solutions for providers and if you’re not, if that
link from the request is a UI to a human then that really isn’t adding that
much value at that point. We think that long term the LOINC codes are going to
be a critical part in allowing us to really interface back and understand the
request and pull the right data from what might be a myriad of vendor systems
that we’re fronting into an EHR.

DR. COHN: So I think you’re saying that in the very basic scenario you
question the value added of LOINC in that one.

MR. ICENHOWER: It would seem to have reduced value in that scenario, yes.

MR. SCHINDERLE: In a human interface environment it probably has limited
value today, assuming we have standardized nomenclature for what people are
requesting. Now LOINC is a way to get to that standardized nomenclature if
there are good definitions behind that and the industry is working pretty hard
to try to do that. But in the absence of having all that pulled together what
we’ve attempted to do when we started this thing, we continued and we keep
watching what’s going on with the development of the LOINCs is to attempt to
have our own sort of glossary of definitions that our user base has sort of
agreed on at the payer and the provider level that this is what we mean by
pertinent chart information, this is what we mean by an emergency room record,
whether it includes the physicians notes or not, those kinds of things so that
there’s some commonality because we found there was no commonality among the
medical directors and the nurse reviewers and the hospital business office and
HIM people, and it varied from different parts of the country. As we’ve moved
around different terminology means the same thing and so nomenclature tends to
be a problem in the industry and one that is going to continue to plagues us
for a while.

DR. COHN: Well said. Jeff.

MR. BLAIR: Thank you, Mitch and David. Could you help me understand a little
bit better the environment we’re dealing with, and let me tell you the intent
of where I’m trying to go with this question before I ask it. I’m hearing
everyone indicate that there’s really a business case once we’re able to
automate health claim attachments with the standards, the HL7, the X12, LOINC
and all, that that’s where we want to go. On the other hand I’m also hearing
that there’s a lot of workflow issues, a lot of environmental issues, and lack
of infrastructure, so that there’s a lot of problems to be worked out. So now
that I’ve indicated those two different things I’m wondering whether it would
be helpful if we didn’t look at this as one entire issue but if we could
understand the pieces a little bit better because maybe there’s certain pieces
that could move forward faster and others that we need to be more sensitive to
and more accepting to. So I’m going to ask this in two ways because I’m not
sure the best way to answer it or analyze it, so one of the ways would be when
you’re dealing with health claim attachments are you getting the majority from
the ambulatory sector, from home health, from hospitals, maybe that’s one way
to look at it, from the source that it’s coming from. The other is that we have
the six different health claim attachments that have been defined, the
ambulance, the durable medical equipment, the home health areas, maybe if you
could kind of give us a picture that way as to which ones have the great volume
or which ones have the greatest opportunity to be moved forward more quickly
then others and which ones we need to maybe not impose a sophisticated
technical solution on very quickly. So help me understand the health claim
attachment environment by pieces and which pieces could be moved forward faster
and which ones may need to take more time.

MR. SCHINDERLE: I have two responses I guess to that question. I guess my
accounting training is coming into the forefront here but if you follow the
dollars and use that as a barometer the initial sweet spot here that we’ve
uncovered in our projects in California has been in the automating of the
request and the automating of the delivery of the response, and those two areas
slice a huge component of the cost that we have uncovered out of the equation.
If you did that first you’re dropping $20 some dollars off the cost. If the
next slide of that, now you’re down to a cost of $6, $7 dollars, how do you get
that next slice cost. Well that’s going to be harder to get to because it’s
going to require a lot more automation inside the health care organization and
inside the health plan and this is where Siemens and other vendors like that
are going to come into play because they’re going to have to develop all of
that infrastructure to get that next slide of cost. But that big first layer is
the transport layer in my opinion and that could be a win first phase if you
will.

MR. JEFF: Which portions of the environment that we’re looking at, okay
you’re saying all portions on the first phase.

MR. SCHINDERLE: Well, no, if you’re talking about, that’s the second part of
my sort of response. You were saying if we looked at just the six document
types or if you looked a the 18 or 19 different provider types where’s sort of
the sweet spot, that’s a very difficult question. We’ve asked like the state
Medicaid program who had pretty good analytical data on their data to sort of
answer that question for us, they’re very rules based. The largest single group
of attachments that they receive from providers in California tends to come
from hospital institutional providers, the next layer is like DME, and then it
drops down into all the other provider types as they go down the list. But
their organizational list is a little different then the next payer we talked
to, who is a different sort of volume mix depending on how their rules are
driven. So I don’t have a global industry standard that I could really respond
to this to because as we go out to payers and to providers and we ask for
metrics we find they don’t have any. And part of the reason why this hasn’t
been managed is because you can’t manage something you can’t measure and so one
of the things we’ve been attempting to do with our product is build in
reporting, tracking, and metrics because you can’t figure out where you’re
going to go or where you need to go if you don’t have solid metrics and
statistical counts of what’s being asked for and how often and how when, and
how long is it taking people to respond and so on and so forth. So we’re trying
to build all that in in an effort to try to get to the answer to the question
you’ve raised, but I would say it’s too early for us with our limited data that
we’ve collected so far to have a solid answer for you.

MR. ICENHOWER: And I would say the same thing for a slightly different
reason. As I noted our customer base is slanted toward the institutional
customers, which actually are some of the prime candidates for the improvement
here, and the long story short is it depends on who you ask. When I talk to our
customer base it really depends on the provider, the payer, and the rules that
are implementation in those regions as to where they think the biggest savings
are. From our surveys and the things in our research we’ve done with our
customers there’s been a great variance on it. That’s why we think the pilot
programs should be looking at it, not just a usability but the cost savings
that are associated and really try to gage that back into the plan that we have
for roll out. Anecdotally I’ve heard things that they feel the savings might
not be exactly as David has allocated the amount of $20 on the transport, but
closer to the half and half savings that you might expect. So it really has
been a pretty varied answer and we’ve done sampling on our customer base but I
think you need to do it across the different provider segments to really get an
accurate representation. I’m sorry I can’t give you a more direct answer then
that.

DR. COHN: Okay, great. We have I think one or two more questions, one more
question, we are running seriously behind and I’m going to try to —

MS. GRAHAM: This will be fairly brief, this is for David. In your estimated
initial cost of $33 dollars versus the $21 dollars, is that taking into
consideration all three, what sounds like three parts of it, the payer, the
provider, and the clearinghouse?

MR. SCHINDERLE: The provider cost numbers that we gave you there that were
between $20 and $30 dollars with sort of a high end being the $33 at this one
medical center is sort of a range, they sort of fall in the middle, that would
be sort of a bell shaped curve if you will if you sort of took the middle of
that and said it was around $25 dollars, if we’re getting a savings of $21
you’re sort of falling into that, you see what the delta is, about $4 to $5
dollars is the net cost. So there is a sweet spot in there that we’re finding
but in order to achieve that as I mentioned earlier you need broad adoption.
This isn’t something that, at least in California it would take the top ten or
15 payers in order to achieve those kind of economics, to get full adoption.
Where we are today with three, four payers coming in, we need much broader
adoption in order to drive that number and to have that opportunity for savings
to be realized because otherwise people aren’t going to take people off the
payroll then you’re not really achieving that, it’s really just paper savings.

DR. COHN: Well, I want to thank our panelists, it’s been a very interesting
conversation and it will obviously be continuing with yet another panel after
lunch. Now we do have on the agenda an opportunity for brief comments, really
an open microphone from the floor, would anybody like to make any statements or
otherwise? Would you like to go to a microphone and introduce yourself.

Agenda Item: Open Microphone – Ms. Doyle

MS. DOYLE: Teresa Doyle. We forwarded to everyone a copy of a letter and we
would just like it to be considered as part of your deliberations, and I’d like
to just highlight a couple of the points. One is is that we think that the
pilot program really should be done before the NPRM, we think that it will
actually create better information and that that information will be very
helpful for the comment period and also understanding what the implementation
process. I think we found HIPAA transactions and code sets many people even
after the final rule came out really didn’t understand what it required in
terms of systems changes and business processes and so we think it’s very
helpful before the NPRM to know that not only it’s workable but what it takes
to be compliant and then we would have a comment period and then ultimately a
final rule.

Secondly we think that in terms of process, right now many of our plans are
still between 25 and 50 percent receiving HIPAA compliant transactions, 25 and
50 percent, and so we still have a long way to go. And I guess we’re somewhat
concerned that if we don’t have full compliance with what’s currently on our
agenda and then to add yet another standard could be detrimental ultimately to
achieving a successful implementation.

And the final point really is that as we look at any of these issues going
forward we want to keep in mind what our ultimate goal is and again, trying to
create some coordination and a national strategy in moving forward and when you
look at the claim attachment standard that’s before us does that fit with where
we want to go ultimately with the electronic health record and I know that some
of our presenters this morning certainly did address that issues, they believe
that it was compatible and timely. I can tell you that sometimes I hear other
comments that they believe maybe it’s not the only way to go, that there are
alternatives. And I’m not saying that one way is right and one way is wrong but
I think it’s important as NCVHS moves forward that it constantly sort of
reconciles that, the standard that you’re talking about today to the ultimate
goal. And yes, if we’re going to invest our resources it is still in line with
ultimately perhaps an electronic health record and more importantly one in
which there’s a shared electronic health record.

Thank you.

Agenda Item: Open Microphone – Ms. Ward

MS. WARD: My name is Maria Ward, I am one of the co-chairs of the Attachment
Special Interest Group in Health Level Seven, I have been working on this
project for nine years now. As I’ve been listening to discussion this morning
I’ve just sort of been making a list of things that I think will be relevant to
your discussions and your consideration and I know we’re pushing the lunch hour
so I’m not going to go through that right now, hopefully I’ll have an
opportunity to do that before I leave.

But to one of the very last question I think you asked Jeff I think it’s
important for you all to know, for years we have tried to figure out what is
the low hanging fruit and that’s how we came up with what we came up with, six
or seven or eight years ago. You should know that several activities are
underway which I can talk about the others later but one of them is a survey
that HL7 approached WEDI, probably two months or so ago, maybe in December, and
WEDI is actually leading and working with us and with X12 on conducting a
national survey through WEDI that’s going to ask those very questions, Jeff and
Simon, what are your attachment needs, who are you, when do you need them, why
do you need them, what happens if you don’t do them. We haven’t come up with a
complete list of questions yet and we have to define our scope and so forth but
we hope that we would actually have some substantive information that comes out
of that that could be useful to you, it probably won’t be for at least several
months but we recognize the need —

MR. BLAIR: Will that include more then the hospital community, will that
include ambulatory and home health?

MS. WARD: That will hopefully include everybody, it will go out and be
advertised through HL7, through X12, through WEDI, through this committee if
you choose to, through CMS, through whoever will broadcast it, and people will
have an opportunity just to log on to the WEDI-SNIP website and use the tool to
respond right there and then we’ll be able to analyze and kind of come up with
some trends and get some really hopefully some good ideas, broad based diverse
ideas about that.

Agenda Item: Open Microphone – Mr. Tennent

MR. TENNENT: Two really quick notes, I’m Robert Tennent with the Medical
Group Management Association. One, I support the idea of pilots and it will be
wonderful to have some of those pilots conducted before the NPRM to identify
obviously data content issues but also to built momentum going forward and if I
can add a new term for the claim attachment standards it’s the Rolls Royce of
the transactions, it’s only going to effect the highest level of providers
right away and I think what we need to do is build ROI throughout the industry
and if we’ve learned anything from transactions and code sets it’s that
providers have to rely on their software vendors and so we have to build ROI
with the vendors. They have to start developing these systems before the short
16 month window.

The last thing is there’s also an ROI for the vast majority of providers
that are paper based that has not been discussed and that is when a payer sends
an electronic request for attachments that speeds up the process. Maybe the
provider has to send on paper through the mail the response to that but if they
can get it quickly it will lower their AR and that’s going to be a huge
improvement for providers.

Agenda Item: Open Microphone – Mr. Kay

MR. KAY: Good afternoon, thank you, my name is Brett Kay, I’m the director
of government affairs with the National Health Council, which is a private
non-profit umbrella organization, more then 110 national health related
organizations are our members and what we really work to do is bring quality
health care to people and give a patient voice and patient perspective to this
issue which is the comments I want to present today.

We do represent, our core membership is more then 50 of the nation’s leading
patient based organization groups such as the American Heart Association,
American Cancer Society, Epilepsy Foundation, Easter Seals, and others with
chronic diseases and disabilities. But our members do cover the major
stakeholders sort of that run the gambit from providers to patients, and really
want to voice our strong support for protecting patient privacy and the
confidentiality of medical records.

We’ve heard a lot here about technical standards and things but I think we
want to take a step back and really take a look at it from what is the ultimate
impact and goal on patients and as you all know the medical records really
contain information that patients would prefer not to share in some cases, with
insurers and others out there who have access to them, patients pay out of
pocket in order to keep information off of medical records and do other things
as well so that they don’t want to assume that their insurers will have access
to that. And many times people pay out of pocket they assume that this cost
will not go there.

What we are concerned about is if XML or any other type of standard that
allow really, that is adopted that permits an entire document or the entire
medical record containing all the patient’s information to go to, to transfer
across when that is not necessary really made an issue of concern involving the
patient provider information.

The approach we think really does undermine protections afforded in the
minimum necessary standard for the privacy rule by giving health plans the
access to information which they may or may not really need as necessary for
the current payment. And it does easily expose information related to treatment
for which patients have paid out of pocket with an expectation that it would
not be shared with their health plans and so what in sum we really urge is that
you strongly consider the consequences of allowing such a standard to be
adopted.

When HIPAA was put into place it was put into place precisely to protect
patient confidentiality and shield sensitive medical records from insurers and
others who were in a position to use it in a discriminatory manner and so we
really hope that allowing the providers to send the patients entire medical
record under this protection of the minimum necessary standard, it’s in direct
conflict really with the spirit of the rule and so we urge you to consider
that. Thank you for this opportunity.

DR. COHN: Thank you.

DR. HUFF: Will you accept a question? Aren’t there times when sending the
entire record is required?

MR. KAY: If it’s required yes, but I think that this where it would be a
wholesale —

DR. HUFF: Well, I want to make the distinction I guess between, technically
we should be able to send the whole record, if you want to have policies and
procedures to prevent that that’s a separate issue of how you want to protect
privacy and confidentiality. But you’re not saying we should make it impossible
technically to send the whole record —

MR. KAY: No, where it is necessary, where it is required by law, certainly
we want that to happen. What we’re saying is there should be policies and
procedures in place so that it’s not just every single time a whole record is
going through for no reason rather then just to send it.

DR. COHN: Thank you for the testimony, and thank you all, our testifiers
during the open mic. Any final comments before we break for lunch? Well, I do
want to apologize to everyone, we are running late. However I would remind
everyone that we weren’t scheduled for lunch until 12:15 anyway and we did
start about a half an hour late because of late arrivals, so on our new
timeframe we are now at 12:50, we will adjourn until 1:50 and we will do our
best to make up time as we can during the afternoon, so thank you all.

[Whereupon at 12:50 p.m. the meeting was recessed, to reconvene at 2:05 p.m.
the same afternoon, March 3, 2004.]

A F T E R N
O O N S E S S I
O N [2:04 p.m.]

DR. COHN: Well, welcome everyone back, I realize we are running even a
little later then expected. This afternoon we’re continuing our testimony with
other stakeholder perspectives on claims attachments. I want to thank our panel
for joining us, I think our first speaker replacing Dr. Guay is Frank Kile, and
then we have Penny Sanchez and Tom Hughes, so please lead off.

Agenda Item: Other Stakeholder Perspectives – Dr.
Kile

DR. KILE: Thank you, Dr. Cohn, members of the subcommittee. As you mentioned
I’m not Dr. Al Guay, I’m Dr. Frank Kile, I work for the ADA here in Washington,
D.C. Dr. Guay was unable to make it to Washington for testimony today so sort
of at the last minute I agreed to step in and try to provide the information
that he would have if he’d been here. This also allows the association all
plausible deniability about anything I say.

On behalf of the association I would like to express are appreciation to the
NCVHS for their interest in dental attachments. I’d like to discuss the ADA’s
policy on attachment, the current methods for providing attachments, and
finally how attachments could promote administrative simplification.

The ADA’s policy on attachment is that they’re not necessary in the vast
majority of cases, and in those cases all the information necessary for claims
adjudication could be included in the dental claim form itself. The ADA has
worked with the payers, the dental providers, and vendors to develop claim
forms, both electronic and paper, which meet the needs of all interested
parties. This has been quite successful as many payers have reduced the
requirements for attachment when dental claims are submitted electronically.
Unfortunately there is no agreement on situations for which attachments are
required. Consequently most dental offices submit far more attachments then are
required in an effort to avoid payment delays, and I think this was echoed
earlier today with other testimony that you heard about over doing the
attachment process in order to expedite the possible payment.

Most dental attachments are already graphs but increasingly periodontal
chartings or operative reports are being requested for specialized treatment.
Most dental attachments are submitted in the same envelope with the paper
claim, however when a dentist submits an electronic claim and the attachments
are mailed separately there has been significant difficulty in matching the
claim to the attachment and again, I think this was echoed this morning in some
of the earlier testimony. This often requires a duplication of the attachment
and delays the payment. Scanned attachments may be submitted to a repository
for reviewing by dental consultant but the current technology is proprietary
and image quality lacks clinical quality. This may also require resubmission of
the attachment and again delays payment.

The ADA does not currently support this approach because it is not standards
based. The ADA has supported the use of DICOM images for image transfer but the
dental plans apparently currently do not accept those images.

In the interest of administrative simplification the ADA proposes that the
data content of a dental claim be reduced from a maximum data set to a minimum
data set. This data set would be consistent with the information on the ADA
paper claim that is sufficient for adjudication of most claims by most third
party payers. Additional information may be required in certain specific
situations by payers under contract would be provided in a supplemental
attachment. This would prevent about 90 percent of the claims to be processed
expeditiously with only the essential information. The remaining ten percent of
dental claims would be subject to be exception processes with the dentist
providing the additional information upon request and as required for payment.

This approach has been successfully used in the pharmacy industry where the
median pharmacy claim amount is comparable to the median dental claim amount.
Further simplification would result if all payers were to agree on the criteria
for attachments. The dentist would know in advance what additional information
might be required for prompt adjudication. Clear and unambiguous criteria for
submission of attachments can be support successful implementation of a
national standard. The ADA is proposing to work with the National Association
of Dental Plans and the Delta Dental Plans Association on this effort.

I want to thank you for this opportunity to share the association’s ideas
with you, I’d be pleased to answer any questions if I’m able and if not I will
certainly bring them back to Dr. Guay and he will provide further information.
Thank you very much.

DR. COHN: Thank you. Penny?

Agenda Item: Other Stakeholder Perspectives – Ms.
Sanchez

MS. SANCHEZ: Hi, thank you, my name is Penny Sanchez with Electronic Data
Systems, who is currently the fiscal intermediary for California Medicaid where
I’ve been working for I hate to admit about the last 20 years. I’m also as some
of you may know a co-chair of HL7’s Attachment Special Interest Group, however
today I’m here representing the National Medicaid EDI HIPAA Workgroup, which I
think many of you have heard of at this point, we’re more commonly known as the
NMEH, and that’s NMEH, not NEMH, which most people want to say.

The NMEH is subdivided up into many separate sub-workgroups and we focus on
specific issues within those workgroups, one of which of course is claims
attachments. And I’m one of two co-chairs within that workgroup, the other one
is Linda Louise Bush of Pennsylvania Medicaid. We also have two other
sub-workgroups that actually are focusing on claims attachment development
content for Medicaid, and that is the Dental Sub-Workgroup, is working on
periodontal charting and then the Prior Authorization Sub-Workgroup is working
on attachments specific to prior authorization. We would like to thank you for
the opportunity to share our perceptions of the impending proposal for
electronic claims attachment.

I’d like to first give you a little bit of background on NMEH so you
understand where we’re coming from. The NMEH was formed under the sponsorship
of the Systems Technical Advisory Group of the National Association of State
Medicaid Directors back in November of 1999, which was about when most of the
Medicaids were really starting to focus in on HIPAA, before then there were
wasn’t a lot of attention from the Medicaid agencies on HIPAA. So in 1999 we
formed, we started out with only ten states, and most people believed we would
never get all 50 states to play in the same sandbox, and within six months we
had representatives from all 50 states, the District of Columbia, and some of
the other U.S. territories. So it’s been a very successful group in
accomplishing some wonderful tasks that we’ve done.

NMEH members are very active participants in all of the standards
development organizations related to HIPAA, X12, HL7 and NCPDP, they’ve had
very long standing relationships with NCPDP and have really focused a lot of
effort in the last four years on X12 and on HL7. We are also members and
actively participate in WEDI-SNIP committees and AFECHT whenever we can. We
also have seats on the National Uniform Claim Committee and the National
Uniform Billing Committee as representatives of NASMED(?), so we try to stay
very focused and make sure that we represent the needs of the Medicaid
organizations.

Our main goal is to identify HIPAA related issues that are common to
Medicaid agencies to find resolutions to those issues, represent Medicaid on a
national and state level, and one of the things that I think is more important
is to share ideas and common processes. We seek to find processes and develop
processes that meet the needs of our provider community who serve an at risk
beneficiary population, at the same time we have to make sure we maintain the
integrity and the policies of the Medicaid program which is not always an easy
balance to create.

How does Medicaid use attachments? Obviously we use it for claims
adjudication and to meet some specific state and federal requirements that
require us to get attachments. However we see the potential for uses of
electronic attachments and other ways and other business purposes and I think
Kepa mentioned one of them which is prior authorization and I think somebody
else mentioned managed care as well. Those are some of the uses that we see as
well to adequately assess prior authorization requests, to assess the
effectiveness of some of our state programs and some of the special programs
that we have so that we can validate that the program standards are met. To
support case management clinical data collection, which is pretty important in
many states. To perform post payment review and to probably most importantly is
to mitigate fraud and abuse within the Medicaid program.

One of the major gaps for Medicaid agencies in implementing the initial
transactions and code sets rule was the absence of a standard way to
electronically receive the required supporting documentation needed for claims
and prior authorization. The current process to receive additional information
is I think as you probably know very manual and labor intensive since we still
continue to get them on mostly paper and fax. This is obviously very
inefficient for both providers and the Medicaid agencies. We see the move
towards electronic standard attachments as a definite improvement on efficiency
in processing both claims and prior authorization requests.

Although prior authorization requests don’t fall under the HIPAA regulation
we mention it here because Medicaid agencies such as California and Minnesota,
North Carolina to name a few may voluntarily implement electronic attachments
in support of that business function, so we’re hoping that happens. In addition
the Medicaid, the National Medicaid Information Technology Architecture
Framework, MITA(?), which is currently under development by CMS, will strongly
encourage states to adopt common national IT standards to facilitate
interoperability, improve data exchanges between trading partners and make
better use of the internet and emerging technology. MITA’s mission is to
establish a national framework of enabling technologies and processes that are
specifically designed to support improved program performance for today’s
patient centered Medicaid enterprise. A critically important piece of that
strategy is the development of standard claims attachments and prior approval
attachments that can be uniformly utilized and understood by everyone.

We eagerly anticipate the release of a claims attachment NPRM and eventual
final rule and urge the department to release this as soon as possible so that
gap between the electronic claim and the remaining supporting documentation can
be closed.

Members of the NMEH actively participate in the workgroup at X12 and HL7
that have been developing a solution for claims and prior approval attachments.
The NMEH fully supports definition of a standard to electronically transmit
claims attachment data and what we mean by a standard is a definitive data set,
minimum and maximum, defined by a standard organization. By defining standard
content for attachments both providers and payers know what data content is
required at the time of the encounter allowing providers to capture the
appropriate data.

The NMEH supports the current claims attachment approach defined by HL7 and
X12, we are really pleased with HL7’s recent decision to move away from the
fully codified HL7 traditional messaging structure to the more flexible XML
based HL7 clinical document architecture, the CDA. Since the CDA offers
different levels of implementation we see it as a definitive benefit for both
providers and health plans including Medicaid agencies. Many Medicaid agencies
felt that the initial approach using only structured codified data would have
posed challenges for both providers and Medicaid agencies. The fully codified
model poses several operational and business challenges, some of those are cost
to implement this model is expensive, an analysis needs to be performed to
ensure that the appropriate return on investment can be achieved. And then some
provider organizations maintain their clinical and attachment data in imaged
medical record systems and discreet codified data is not easily available to
their administrative systems, and we’ve heard this in several cases.

The CDA’s capability to capture either image documents, text data, or fully
structured codified data allows both the provider and the Medicaid agency the
flexibility to determine which business model best meets their needs. We see
this flexibility in the CDA as a means to greater participation in electronic
attachments. Most Medicaid agencies anticipate that the initial implementation
phase for claims attachment will be limited to image documents and/or text data
due to state budget limitations and systems staff resource availability. As
states are able to complete cost/benefit analysis on various attachment types
they may choose to integrate into their processing systems fully codified
capabilities in order to realize the full benefit of the structured content and
that is auto adjudication of claims.

I think many state Medicaid agencies would like to get to that point but I
see that they would actually do a cost benefit analysis first on various
attachment types to determine which of those types would be best suited for
fully codified data. I don’t envision they would actually do it for all
attachment types. As with the transactions and code set standards Medicaid
agencies need to work through the issues and operationalizing the claims
attachment solution and integrating it into their current infrastructure.

The models defined by X12 and HL7 allow providers to send attachments in an
unsolicited manner if the health plan or Medicaid agency has instructed the
provider that the additional information will always be needed at the time the
claim is transmitted. Health plans or Medicaid agencies can also request the
additional information in a solicited manner using the X12 277 request with the
appropriate LOINC value. We agree that both of these models should be available
but are concerned that the unsolicited model may result in the receipt of
attachments not necessary for processing the claim. This will likely result in
the need for both the Medicaid agencies and the providers to be mindful of the
minimum necessary provision under the HIPAA privacy legislation. Medicaid
agencies and health plans need to be cognizant of this provision when
requesting additional information under the solicited model and providers need
to ensure that the data provided under both the solicited and unsolicited model
adheres to the minimum necessary principle.

Some of the issues and concerns that we had I’d like to address now. First
off, are we ready for XML? Some Medicaid agencies have already begun
development of web portals and applications using XML while others have
expressed concern about the ability to forge into a new application language
and technology where they have no familiarity. Most of these concerns seem to
be centered around whether Medicaid agencies will have the knowledge base,
system staff, and funding necessary to support XML based applications and to
make the appropriate business changes.

Issue number two is can we constrain file sizes? It is our expectation that
many of the attachments we receive will be image documents. Image files can be
quite large even when captured in a compressed format. In order to maximize our
efficiency in receiving batch transmissions we believe that health plans,
including Medicaid agencies, should be able to define file size limitations for
each transmission. This allows these covered entities the ability to better
handle capacity planning within their own network.

The adoption of new attachment types. The NMEH sees a great deal of value in
the six attachment types that have already been developed and published by
HL7’s Attachment Special Interest Group and we do expect that these attachment
types will cover many of the attachment needs under Medicaid. However in
addition NMEH has been working very hard over the past several years to define
data content to the attachment types that meet specific Medicaid needs beyond
those of the six attachments already published by HL7.

We have been actively participating with the HL7 Attachment Special Interest
Group to perform the requisite industry outreach and draft the data
requirements into HL7’s additional information specifications booklets. These
attachment types include children’s preventative health services, periodontal
charting, durable medical equipment, and consent forms which cover the
federally required abortion, hysterectomy and sterilization consents. HL7 has
also defined data content for home health attachments which several Medicaid
agencies plan to use. Medicaid has identified several other types of important
attachments that still require content definition, a few of these are
non-emergency transportation, proof of timeliness, third party liability,
eligibility, vision and x-rays.

The changing face of Medicaid medicine requires that we adopt quickly and
efficiently. In the past many Medicaid agencies have used quickly adopted local
codes to accommodate changes in policy or to accommodate new medical
technologies. Under HIPAA use of local codes is not an option and one
alternative to capture this additional information may be through the use of
attachments. The NMEH recognizes that the legislative rulemaking process takes
a considerable amount of time. We encourage the department to develop a process
to adopt future attachment types for use under HIPAA in a more timely manner or
to look at alternatives other then the time intensive NPRM process to adopt
additional attachment types while still allowing for the appropriate level of
scrutiny and public comment on the attachment content. In the interim Medicaid
agencies may choose to use the published attachment specifications voluntarily,
however until there is a rule mandating the use of those attachments it may not
be possible that we will get trading partners to actually work with us.

Consent attachments. One of the more onerous attachment types for both
providers and payers and Medicaid agencies is the federal requirement for
physical consent documents for abortion, hysterectomy and sterilization, and in
the testimony I’ve provided the exact code of regulation. Medicaid agencies
must obtain a physical paper copy of the consent form in order to receive
federal matching funds. This documentation can contain several signatures
validating that specific federal requirements are met.

The NMEH has worked hard to define these exact requirements in an electronic
attachment format so that an HL7 additional information specification standard
can be published. This attachment type would allow Medicaid agencies to capture
the federally mandated validation requirements electronically, however we
continue to find barriers to completing this attachment definition. According
to the Medicaid division at CMS the wet signature of the entities defined on
the consent form must be obtained in their appropriate context before the claim
can be processed and federal matching funds receives. In the past this has
required Medicaid agencies to obtain paper copies of these forms.

In 2001 we submitted a white paper which is attached to the testimony to CMS
proposing several options to improve efficiency of this process. The preferred
options are allow the providers to retain the documentation in the office.
Allow a scanned image of the paper documentation to be submitted with the
electronic attachment. And allow structured codified data with an indicator for
signature on file at the physician’s office. We also explored several other
alternatives, such as digital signatures, using public key infrastructure,
point of service swipe cards, smart card technology and biometrics. None of
these methods were recommended due to cost and implementation difficulty.

Unofficially CMS has stated that they will allow an image of the entire
consent form showing the wet signatures with the electronic attachment, however
we are still waiting for a formal response on this issue. We need to send in
this data in paper format, the need to send in this data in a paper format is
both a burden to the provider and the Medicaid payer. The NMEH continues to
develop this electronic attachment and hopes that it may be able to use it
voluntarily or as a HIPAA standard in the future.

Medicaid involvement in attachment pilots. Medicaid payers are an integral
part of the health care industry, we believe that pilots should be conducted as
new transaction types are adopted under HIPAA. However, the release of an NPRM
or a final rule should not be contingent of completion of pilot. The reason we
say that is we, there are many states eagerly anticipating the use of
attachments in their process and they believe waiting for an NPRM or a final
rule until after pilots are completed would delay that process even further,
something they actually see a return in investment on. Most states are not in
the position to participate in pilots at this time, however a couple of states
have expressed some level of interest in participating. While one state has
expressed they would be willing to participate with or without funding others
are concerned with the level of effort and costs associated with such an
endeavor. Some questions they have are is enhanced funding available, what
technical support is available during the pilot project, and who would
coordinate trading partners and vending support.

In closing the NMEH believes that the implementation of a standard
electronic claim attachment would improve efficiency for the provider process
as well as efficiency for the Medicaid agencies claims adjudication process. It
is our hope that as the industry moves towards more technical sophistication
the ability to use the CDA to its fullest potential will be realized so that
claims can be auto adjudicated providing lower processing costs for providers
and payers and allowing faster payment for providers.

I want to thank you for this opportunity to share our views of the National
Medicaid EDI HIPAA Workgroup and we look forward to seeing a future NPRM for
attachments. Thank you.

DR. COHN: Sandy, thank you. Tom Hughes, welcome.

Agenda Item: Other Stakeholder Perspectives – Mr.
Hughes

MR. HUGHES: Thank you. My name is Tom Hughes and I’m with a company called
National Electronic Attachment. Let me thank this body for giving me the
opportunity to speak to you today. First let me say a word about my background
and my company. I’ve been in the insurance transaction business for 14 years
and previously owned what is now today the dental division of WebMD, so that
you know that we have experience in that area of the business.

When I sold this company in 1995 I took back a contract to run it, had a
three year contract and at the end of that contract was when we started
National Electronic Attachment. And we built it, until today it has contracts
with 93 commercial payers, including the Delta’s, and 25 Medicaid payers to
process electronic attachments over the web. While we process millions of
attachments or images each year we generally store the most recent six million
images on line at any given moment in time. I tell you this not to brag about
our company but to give credence to the fact that this is just not a good idea,
that this is a business, but rather a live active business solely in electronic
attachments.

Let me speak for a moment about what I mean by electronic attachments. I
look at attachments as anything that’s needed to send in support of an
electronic claim is an electronic attachment. This could be an x-ray, a
narrative, a perio chart, and EOB, a student verification, a lab test, a
certificate of medical necessity, an EKG, or anything else that the payer might
request. These are non-coded, non-imbedded, not in another transaction such as
an X12, but in most cases are scanned images of paper documents with the
exception of x-rays which are scanned images of film.

Now my prepared remarks are broken down into several areas, number one the
internet and electronic attachments, the attachment regulations, the cost
benefits, the provider to provider services, what I call the magic and the
potential attachment specifications.

In the internet and electronic attachments first and foremost the prevailing
rule, law, prohibitions from the federal government that does not allow
attachments or claims to be transmitted over the internet is in itself
ridiculous. Medicare has this prohibition. The FDIC insures banks that allow
transfer in and out of bank accounts to pass information. If a patient is
insured on the commercial side with Blue Cross and Blue Shield of Georgia for
example, Well Point, which is one of our clients, the attachments for a claim
can be transmitted to that organization over the internet. If that same patient
changes coverage to Medicare federal requirements state that the claim must be
sent electronically whereas the attachments must be sent on paper through the
mail. This is not logical.

In areas where there is Medicare fraud or Medicaid fraud investigation is
dramatically enhanced when given the ability to service attachments by doctor
ID number, and any time a list of attachments will show what the doctor is
doing and a total structure of that doctor’s work. On the provider side the
ability to transmit information by the internet means millions of dollars in
administrative savings. It does now appear that the CMS Medicare may be getting
closer to using the internet. We have recently received an enterprise
architecture approach and a request for comments on this. Our initial request
for a CMS pilot, and I’ll just share that with you, in regards to doing durable
medical equipment claims, was well received and two of the four durable medical
equipment payers instantly gave their desire to participate. Just to be safe
and to share with this group, this is being done working with the program
integrity group and not with the HIPAA people, so I just need to clarify that.
I’m certainly not here to beat up on CMS but to share with this group that we
simply concur with statements that this body has already received relative to
using the internet, I’m just adding my weight to it.

Under the attachment regulations, a central question is do attachments as
transmitted today now meet federal guidelines. Attachments through the
attachment’s network now in use in the country meet the contemplated regs
approach that support an imbedded scanned image into the X12 XML document. Thus
providers and payers that have begun using scanned attachment products will be
on a migration pat and not on a dead end.

I also am aware that there is much discussion within CMS, NCVHS, and other
agencies regarding HIPAA standards and contemplated HIPAA claims attachment
regulations. I have communicated along with my contemporaries directly to CMS,
OHS, about my concerns relating to the complexity, the cost, and the ability of
providers, let along payers, to technically implement and deploy the systems
essential to comply with the approach that may be proposed using X12.

My biggest concerns relative to this is cost, the impact to the way business
is being conducted today and major changes to the work flow. I’m aware that
these concerns have reached the chair of this committee and at this point I
would not be placing any bets on the viability of the contemplated NPRM should
it be promulgated late summer as predicted. Also as we know even after the NPRM
comes out there’s 60 days of comments followed by months of preparing the
responses followed by the final rule. Finally, which means it will be possibly
another year before the final reg is published. In my opinion we are years away
from final regulations for HIPAA claims attachments.

Additionally it’s highly unlikely that major clearinghouses such as WebMD,
PayerPath(?), ProxyMed(?), Infotech Global, Global HealthNet(?) or others will
spend the millions of dollars necessary and invest two to four yeas of
development time to support the contemplated X12 277 275 HL7 approach. These
vendors will not invest as the ROI on change is necessary to be able to process
these attachments are measured in light years while these companies are looking
for the ROI to be measured in months. Also as far as I understand WebMD,
PayerPath and Global HealthNet have already made a conscious decision to
recommend the systems they already have in place to their providers who want to
send attachments, meaning images and texts electronically now.

In the meantime providers and payers simply must take advantage of already
in place robust scalable and functioning secure services for sending electronic
attachments to get out of the fax, snail mail attachment business. If providers
could leverage the capability today to make attachments quickly, reliably and
securely available to payers the positive impact to cash flow and productivity
would be huge. Most payers currently provide for us today the attachments that
are necessary to match up to specific procedure codes.

I’ll digress a moment from my remarks here to say that in the dental arena
with only one exception the payer must tell the provider for this procedure
code this is what’s required. In our case in our company we’ve got 112, 113
different payers, I have 112, 113 different schedules. But a provider in their
office knows that when they do a procedure code number something this is what’s
required or nothing is required. If nothing is required they send the claim
electronically and the claim gets paid, there’s no further attachment
necessary.

In some cases the attachment comes back, if you send the claim
electronically the attachment request comes back electronically. If you send
the claim in the mail, needless to say the attachment request comes back in the
mail.

Let me share if you would some comments in regards to dental electronic
claims. First, it’s been interesting in the last few years in signing up payers
to accept these electronic attachments. Electronic attachment companies, which
would be my competitors, my other companies, provider payer software and the
ability through job aminoapolation(?) to see an x-ray, to lighten it, to darken
it, to contrast it, to zoom in, to zoom out, and to get the best x-ray possible
without changing it. Then the provider can see on their own system what it was
that they send to the payer before it actually leaves. Currently some of the
major dental payers in the country run attachment entry stations in their
mailrooms so that their people who adjudicate claims never see anything in the
way of a piece of paper, every claim and every attachment is put in in the mail
room prior to it going to the floor.

For other payers who don’t already do imaging most of the electronic
attachment companies recommend to those payers that they scan in every claim
and every attachment where they’re either doing the work, to a change to the
work or where they’re denying the work to be done. This way if you go to peer
review the payer is not put in the position of requiring the provider to send
back to the payer the attachments and more importantly receiving back different
attachments then they originally received.

We are very pleased to have the American Association of Dental Consultants,
these would be the people who review electronic claims and attachments at the
various insurance companies in the country, decide to use the electronic
attachment systems on a national basis for their members to use in the area of
education. Also the American Academy of Periodontology(?), the AAP, the
Association of Oral Surgeons, the AAOMS, two of the eight groups of specialty
dentists recognized by the ADA and some of the largest senders of attachments
in the country have now both endorsed electronic attachments for their members
to use when sending electronic claims.

In the cost benefit, in order for a provider to send attachments
electronically they need a simple $100 dollar scanner. In the case of x-rays
they probably need a $200 dollar scanner because it must have a transparency
adapter, and they need a monthly fee of either $20 to $25 dollars to be
connected to the network to send all the attachments that they want
electronically from their office. Included is all the training, the technical
support, and the customer service. Programs are available in some office where
the registration fee and the scanners are paid for by the payers who recognize
the savings to them in having the claims come electronically, and the
attachments coming electronically.

Dental attachments are sent from providers in every state in the country
today. Our research through other attachment companies who are members of
NDEDIC, the National Dental EDI Council, found that for each attachment that is
sent electronically in the area of dental, which is scanned in attachments over
the internet the saving to the provider is about $1.27 an attachment, quite a
bit different from the numbers I saw up here for medical. And the savings to
the payer is approximately $1.46.

The question can always be asked as to why wouldn’t a provider desire to
spend the bucks to go to the contemplated X12 277 275 HL7 approach. Simple
answer, the cost. You must remember that the use of any electronic capability
is not going to happen at the provider end without the input of the practice
management companies and the software vendors. In the dental arena you’re
looking at roughly six major players, although there are more then 100
different dental softwares in the field. My thought is that only these six
could afford to make the changes necessary.

I’ll stop one second and say that HIPAA alone ran probably 100 people out of
the market who were dental practice management vendors who have systems in the
field and can’t support them in terms of doing things.

Today Renaissance Clearinghouse, which services dental claims and is owned
by Delta Dental Plan of Michigan will process all dental claims for providers
in the United States at no charge, and yet we struggle to get more then 50
percent of the dental claims to go electronically.

After the 16th of October last year everyone thought that any
payer who accepts and pays claims would be required to accept the claims
electronically, yet thousands of claims will be almost 100,000 at the end of
this month, will be printed and mailed daily to payers by clearinghouses where
the payer cannot or will not accept the claim electronically.

While I may appear to be rambling, dentists in America whose job it is to
make teeth healthy, white, and provide painless treatment are not programmers
and are not going to get rid of their current computer systems and buy another
one to send a set of X12 based attachments to a payer when they already have a
simple inexpensive off the shelf approach and products from the companies
approaching electronic attachments now.

When we first started at NEA, talk about myself for a moment, I presumed the
payers would do attachments in the same way they do claims, claims basically go
from the provider to the clearinghouse to the payer and it’s gone. In the case
of attachments it goes from the provider to the clearinghouse repository, and
that attachment sits. And the main reason is because in the area of medical
claims payers have humungous amounts of money to throw at programming and in
the area of dental they have basically none.

I am happy to report to you today after talking with some of the electronic
attachment companies that the first group of worker’s compensation payers are
coming on this week, which means the acceptance of electronically scanned
images. Every new claim in the worker’s comp area requires an attachment for
adjudication.

In provider to provider services, which we see as one of the major focuses
of attachments, providers can also use the provider to provider electronic
medical record exchange capability, which means scanned images sent scanner to
computer, even if they don’t initially plan to use the provider to payer
service for claims attachment. The benefits here for the providers are
enormous, no more faxing medical records by referring physicians to specialists
or consulting physicians. No more handing medical records to the patient to
take with them. No more special courier costs to deliver medical records. No
more will a patient show up for an appointment with a specialist only to find
that the medical records from the primary physician have not arrived.

DR. COHN: Tom, I don’t mean to break in, are you getting close to finishing?

MR. HUGHES: Yes.

DR. COHN: Okay, thank you.

MR. HUGHES: Let’s talk about the specific attachment specs that might be put
in the proposed rule for HIPAA, the ambulance, the emergency department,
rehabilitation services, clinical reports, laboratory reports, and medical
records. We are absolutely not critical of those people who spent hundreds of
hours working on this to make this happen. The electronic attachment industry
could have built these specs for probably less then $10,000 bucks a spec.
Complete implementation of these we certainly hope will happen. But having read
the previous testimony from people who have spoken before this group my
consensus is is that the payers aren’t going to spend the money to build
in-house attachment receiving software until they can see the utilization will
be there to justify the cost.

Again, I want to thank this body for asking me to come.

DR. COHN: Questions from the subcommittee? Michael.

DR. FITZMAURICE: A quick one, I wasn’t sure, this is for Frank Kile, that
you were for or against claims attachment.

DR. KILE: Again, I think the basic policy of the ADA is that we would prefer
not to have attachments if at all possible —

DR. FITZMAURICE: You prefer the health plans not ask you —

DR. KILE: Right, exactly. But I think we also recognize that there is going
to be a requirement in a selected percentage of all claims, dental claims, so
we’d rather not have to do them but we understand we have to.

DR. FITZMAURICE: And if you have them you’d rather have them structured —

DR. KILE: We’d rather have them structured, simplified so that we don’t have
to try to figure out which exact format, which exact plan goes with which exact
kind of procedure.

DR. FITZMAURICE: And is that the same for you Penny Sanchez?

MS. SANCHEZ? Yeah, the NMEH supports standardized claims attachments, I mean
we’ve been focusing, definitely been focusing our efforts over the last three
years on developing content for those specific state Medicaid attachments we
still need, so we definitely are on board with getting standards
electronically.

DR. FITZMAURICE: You would like to see even additional attachments —

MS. SANCHEZ: We want additional attachments that are very specific to
Medicaid needs and we’re trying to get them out there for the requisite
industry outreach so they can be used by the whole industry. It’s important
because Medicaid is unique in many ways, I think most people realize and we
have some very unique needs.

DR. FITZMAURICE: And Tom, I didn’t sense the overall enthusiasm from your
microphone that you wanted attachments and you wanted them structured, but
maybe I’m wrong, maybe I wasn’t listening correctly.

MR. HUGHES: The ones that they have recommended, I don’t have any problem
with those being structured certainly because we don’t do those but we could
very easily do those. I think that attachments need to go, in the meantime I
think attachments should go electronically whether structured or not structured
while this group works on the structure.

DR. FITZMAURICE: Very good, thank you.

DR. COHN: Penny, I actually have a question for you and obviously I’m always
concerned about the state Medicaid agencies just because you typically have not
real flexible IT infrastructures at least historically and I know at least
there was a period of time when you were having trouble actually implementing
the basic HIPAA standards that were coming forward.

It sounds like in contradistinction that claims attachments there seems to
be sort of a ground swell from state Medicaid and they are going, are they
already doing things out there —

MS. SANCHEZ: There aren’t any states, there’s one state that I know of
that’s exchanging electronic attachments at this point but not in obviously the
standard way. You’re right, in the past Medicaid have had funding difficulties
within their own states in getting the basic and transactions and code sets
rule up and running. What I see though is the attachment, the people that have
been coming to the table at our conference calls which is not every state, I’m
going to have to admit that, there’s about, we average about 23 states
represented in our calls so we really we have stakeholders of about 23
different states who see a definite return on investment by implementing
attachments, and specifically even though they see the six that are already
developed as important, some of the bigger ones for them are the ones that are
not developed, DME is another one that’s a very big deal to them, we’ve had a
lot of interest from the Medicaid and the children’s preventative health
services one because it helps them gather information they need for assessment
of their EPSDT programs. So there are still attachments out there that are
probably very critical to Medicaid agencies that are not developed fully yet.
So we’re working as quickly as we can to get those developed.

DR. COHN: Actually Penny one final question, this actually relates to some
of the things Tom was saying. Obviously I think one of the things that we’ve
been trying to explore knowing that the X12 HL7 standard has sort of very basic
functionality to very sophisticated functionality, which I think Tom was
alluding to. From your view is the basic functionality basic enough that it
would be able to be easily implemented by the Medicaid groups?

MS. SANCHEZ: I haven’t seen any resistance from specifically the imaged
version with the human decision variament that uses images. I think most of the
Medicaid agencies that I’ve spoken to that have attended the calls see that as
a definite way that they can implement claims attachments. There are those also
that want to do the fully codified for only specific attachments and some of
those that come to mind, clinical reports I’m not sure ever, we will ever
implement the fully codified, it doesn’t make a whole lot of sense. But
ambulance probably yes, rehabilitation probably yes, because there’s some
return on investment, and DME definitely once it finally comes down. So, yeah.

MR. HUGHES: We work totally with 28 different Medicaid states, some of the
problems are really, the latest one we brought on which was Denatel(?), which
is this from California, there was no money in the budget from the state level
to be able to do that. Medicaid a lot of time get the short shrift of what
takes place which is totally different then payers and other people.

DR. COHN: I think that’s been all of our observations about that. Other
questions or comments? Okay, well I want to thank everyone, I think we’re going
to take like a ten minute break and then come, actually, I’m sorry, before we
do that, open mic, Maria did you want to make a comment? This would be a good
time for you to make a comment and then we will take a ten minute break.

MS. WARD: I’ve got my list. My name is Maria Ward, I’m a co-chair of the HL7
Attachment Special Interest Group and I’ve been listening very carefully to a
lot of the discussion this morning and I shared some thoughts with you earlier.
But I also have a number of things that I think are important so therefore they
are of course for you all to consider as you go forward and talk through your
position on this whole claim attachment standards stuff.

The first thing, there was a mention this morning, I think it was in Gary’s
testimony, about the motivation of HL7 for moving from what we had previously
developed really in 1998 to last year when we kind of took a turn and we went
forward with developing a CDA approach to attachments. Yes, that was about
technology and that was about timing and that was about it had been a really
long time and we knew it would be yet several years before a final rule came
out. But most importantly it was about feedback that we got as a standards
developer from the industry. We were being responsive, we were listening, and
we were trying in our new approach to accommodate as we’ve all, Simon, you just
talked about, the lower end and the higher end in terms of trading partners and
sophistication. So we think it’s important for you all to know that it wasn’t
just because it had taken so long, it was because we were trying to be
responsive to in fact things that we heard through WEDI presentations, through
HIPAA summit presentations, through national presentations on our proposed,
prior proposed approach.

And then to that point about presentations, one of my soap boxes right now
is about education. Education on what this recommendation really is and what it
really does and what it really doesn’t do and there aren’t a whole lot of folks
who know that and that’s because you can’t reach the whole world when you’re
just talking about it within a committee or two committees or three committees.
So we in HL7 have reached out to WEDI-SNIP in conjunction with X12 and I think
that you all should know that there’s a couple of things going on, concurrent
efforts right now, many of them through SNIP, some through AFECHT, we talked a
lot about the vendor, the sort of joint collaborative vendor, traction that
we’re trying to get with pilots, that’s one of them.

In an education front we have within HL7 we now do several times a year what
they call educational summits and we are on the agenda as teaching about half a
day, even a full day in November, teaching about HIPAA, teaching about claims
attachments, I’ll be doing that at the end of this month in Chicago, three
hours to whoever wants to come and listen about what this is all about. So
through HL7 we’re starting to try and get some outreach going with education,
through WEDI-SNIP we have a series of web casts planned, national web casts
where we’re going to have panel kind of presentations.

The first one is going to be I think April 19th, Wes Rischel and
I from HL7 are going to spend an hour or whatever doing a talk at the most
fundamental level about this and then allowing for Q&A and then the next
one will take it down a layer and get a little more detailed and then we’ll get
into business issues and the business processes in terms of the payer side and
in terms of the provider side, so through WEDI-SNIP we’re trying to do
education there, through AFECHT, with HIMSS, and WEDI and HL7 and X12, we’re
trying to get some traction on the vendor side in terms of pilots and also in
terms of education on the vendor side, focused vendor education sometime
probably in May I think we’ve been speculating via web casts and then a focused
full day of bringing vendors in and having just the long day of education with
the vendors, letting them take it all in, digest it a little bit, and get their
thoughts and their feedback once they’re better informed versus just kind of
trying to figure out from stuff they’ve been reading and not having had the
opportunity to get that more formal education.

Just a couple of comments on the pilot. It’s funny, I fall on both sides of
this argument. I think, I believe, that we have to do this, I believe that we
have to get some people going on this and we have to flesh it out and we have
to figure out what works and what doesn’t work. We’re kind of forging new
ground here, we all know that but at the same time my experience has shown me
without a regulation there’s not a lot of motivation for anybody to do anything
so I don’t know what the answer is. I don’t think a Notice of Intent, which was
some of the discussion this morning, is going to motivate anybody to do a
pilot.

I’ve had an interesting last couple of weeks as part of a project I’m
working on reaching out to payers, talking to payers about their current status
of the HIPAA implementation of transactions and one of the transactions we put,
my client put on that survey was for attachments because they just wanted to
see, do people even know, do people even know it’s in HIPAA, is it on anyone’s
radar, and unilaterally every response from every payer has been the same
response I would give if somebody asked me, which is well, yeah, we know it’s
there but we’re not going to do anything with that until we see a proposed
rule, why would they really invest in that until they had some reason both on
the payer and the provider side to believe that it was actually real and
actually really going to happen. So I don’t have the answer to that, I think
it’s important to test, I think it’s important to try and get folks motivated
to do that, I’m not sure how to do that short of regulation.

I talked to you earlier about the WEDI survey which I think the results of
which will prove to be very informative for yourselves and for us as a
standards developer as well in terms of where the industry seems to be falling
right now on some of the more important questions around claims attachments.

I have a cryptic note here that I’m not sure what the relevance was, there
was a discussion about business case this morning and it’s actually funny,
those of you who know me, know me well enough, I’ve spent the last seven or
eight years doing this and I spent the last two years in physical therapy
following two shoulder surgeries and after every clear last year, I have a
national plan, a national payer, every claim was denied for five months, it’s
started totally about $6,000 dollars before I got angry enough to be aggressive
about it when I got billed, balance billed because they weren’t paying it and
the wind up was it wasn’t because they weren’t, I truly believe it wasn’t
because they were trying to delay payment, it was because they’re such a big
organization they had paper in medical review for me, they had paper in appeals
from me, they had paper in the claims adjudication part of the department from
me, and so to take a step towards eliminating all of those pockets and all of
that paper and being able to centralize this a little bit and automate this a
little bit would have made me the patient a whole lot happier because I ended
up having to take that on actually with my insurance company instead of my
provider because it ended up becoming my bill that had to get resolved, so I
think just the sheer volume and the sheer manual process involved in the paper
world today is motivation enough to really try and get this moving forward.

A comment about pilots and limiting, nobody I don’t think wants to limit it
because we’ve heard Kepa and we heard all the folks this morning talk about the
need for a really diverse broad based industry input into these pilots. There
was some discussion about if we could get supplemental funding from
Medicare/Medicaid sector which might be easier from CMS.

I would make the observation and caution that just a Medicare or just a
Medicaid pilot probably isn’t going to give us a really good idea of the world
of attachments, especially when you have a single payer Medicare kind of
situation. Their policy on physical therapy for example, $1500 dollars a year
and that’s it. My policy with a private insurance company is I have no cap but
I have to prove justification every six weeks. So to do a pilot that just sort
of has similar generic across a Medicare contractor kinds of rule versus the
diverse payer where you have negotiated contracts based on employer groups and
so forth, I think you really need to test that and I think you really need to
shake that out because that’s where you’re going to see a lot of variability
from private payers, so I think that’s important that private payers
participate in that.

A comment about the X12 HL7 XML, and I’m not going to try and step too far
out of my area of knowledge here but this morning we were talking about the
ability, I think Kepa had made a comment about the ability to have an XML
document, a CDA inside a binary segment of an X12 transaction so that you know
there has been limited work already done toward that, it’s not completely gee
we wonder if it’s going to work. In April of last year Microsoft and a vendor
called Gorilla Logic pulled something together in less then a month to do
demonstrations at HL7 for us that demonstrated putting the CDA inside a bin
inside an X12 segment. And just recently at HIMSS Epic and I’m at a loss for
the other vendor that participated in this but there was a CDA claims
attachment part of the HL7 IHE interoperability demo at HIMSS, so they did
demonstrate creating a CDA, putting it where it belongs and sending it along.

So we’ve had a little, yeah, it’s all demonstration kind of stuff, it’s not
real provider/payer exchange, but we have had vendors do it. I couldn’t even
tell you about the success of it but it has started at least to be looked at.

I have to say this because I think you all have to know this, I know Stan
knows this, about LOINC, there’s a lot of concern and I think that’s because
it’s new and it’s different and there are some expectation not knowing any
different that all of a sudden implementers of claims attachments are going to
have to support this 35,000 or 40,000 code set for attachments. Not the case,
not even close to being the case.

What we’re doing with the majority of attachments with LOINC is literally
tagging a question, identifying a question, what is the patient’s weight,
that’s the LOINC code, that’s the question. The answer is the value, 120
pounds, 180 pounds, it’s not a LOINC code value that existed in LOINC for its
truest sense of use in the clinical and laboratory environment, it’s sort of
LOINC for attachments. And so back to the education, no, why would anybody know
that unless they learned about it but it’s important to understand that we all
think at least in the HL7 side that some of the fear about LOINC is the fear of
the unknown not necessarily consistent with what folks are thinking in terms of
LOINC.

Let’s see, there was a comment, and I’m wrapping up, there was a comment
right before lunch about concern expressed that with the development and
perhaps the promulgation of this rule and development of this standard that the
entire medical record, the entire chart would be required to be sent by a
provider in every situation. I just want to be on record with HL7 saying that
isn’t even close to the case, there’s no requirement for anything. The
transmission vehicle, the standard allows, if the payer were to request from
the provider, as my payer did for my PT provider, came one year they said give
me her entire, I want to see her entire chart, all of her progress notes. They
asked for it, could they send it in this solution? Yes. Is there a requirement
for a provider to do that each and every time they submit a bill? Never the
intent, not even close, why would the payer want that, why would the provider
want to do that, and furthermore one would think that again, references made
earlier as well, the minimum necessary provisions of privacy would prohibit
that. The provider would be inappropriate in doing that, so can it support it,
sure, but don’t anybody be misunderstood to say that this thing will now start
requiring that because that couldn’t be farther from the truth.

I think I’m done, those were my points. Thank you.

DR. COHN: Maria, you’ve been very patient all day with us, so thank you.
Other comments from the open mic before we —

DR. BICKFORD: Carol Bickford, American Nurses Association. Throughout
today’s sessions I’ve been bothered by the thought that we are just automating
a mess and getting it worse and worse and worse. I’m inquiring about what we’re
doing to evaluate exactly what it is we’re trying to move or talk about the
data components, can some of that be resolved by doing it right at the front
end so we don’t have to deal with attachments? What is the purpose of the
attachments?

There’s a second thought and that is we’ve been focusing on the financial
components, how are we looking at it from the further use of the data that are
being transmitted in the attachments and those reporting structures to help us
to dour evidence based practice and understanding of outcomes in the diagnosis
and interventions pieces. Are we setting up the structure so that we’re able to
do the research that needs to be accomplished?

So I guess my biggest concern is we’re automating a mess so we’re doing it
faster.

DR. COHN: Thank you. Sheila?

MS. FRANK: Sheila Frank from Delta Dental Plans Association. A little bit on
the same vein but not quite, DDPA understands that the whole industry would
like to simplify the claims process to the point where attachments are not
required, but at what cost? HIPAA doesn’t mandate the standardization of health
insurance plan design, payment models, or payer operations.

Some plans are dependent on the data in the attachments to operate their
plans according to contractual obligations, government reporting requirements
such as Medicaid expressed today, and sound business practices. And also the
concern for the health of our beneficiaries, this data is used for evidence
based practice research and improvement of payment models. This is the state of
the art of our business today. The type of data found in attachment is now
collected almost exclusively in hard copy.

To resist finding a solution for today’s immediate dilemma eliminating the
transfer of paper and x-ray films in my industry will not move us rapidly
toward anybody’s broader goal, or the ADA’s goal of simpler dental care models,
or dental care payments models. DDPA is not willing to say that the solution
proposed by HL7 is the best one for conveying attachment information but it’s
the only one being given serious consideration as a HIPAA sanctioned national
standard right this minute.

For that reason we’re supporting it like the Medicaid agencies, and are
looking forward to the balloting of a periodontal attachment standard that can
be adopted uniformly across the dental industry as a maximum dataset when and
if such information is needed in support of claims. We think that building the
standards absent any HIPAA regulations will at least get us in the right
direction of defining our maximum datasets for these attachments. And I’m sure
that view is shared by the NMEH, being a member of the NMEH also myself.

DR. COHN: Thank you. Any final comments? Okay, well I want to thank
everyone, I want to thank our panelists as well as those on the open mic and
we’ll take a ten minute break.

[Brief break.]

Agenda Item: Subcommittee Discussion and Development of
a Draft Recommendation Letter to the Secretary – Dr. Cohn

DR. COHN: Now before we start sort of discussing a letter and what we ought
to do, etc., I think Stan Nachimson wanted to just reflect a little bit on what
he’d been hearing as well as I think some thoughts that CMS has had about all
of this as they draft various documents, is that a nice way to describe that?

MR. NACHIMSON: Thank you, Simon. In some ways I feel actually very good
about the testimony, so I really appreciate the time the testifiers took to
think about these issues around claims attachments and present them to the
subcommittee. What I feel good about is that we’ve been able to address a
number of them in the development of the NPRM and in some of the things that
we’re doing and I just wanted to bring those to the subcommittee’s attention.

I think the NPRM will address some of the critical issues that were raised
today, certainly will make some proposals and ask for further public comment on
things like unsolicited attachments and the concern that the payers have
expressed to us that if we allow unsolicited attachments then providers are
just going to send lots and lots of not paper, but they’ll be electronic
attachments and what are payers supposed to do with all that information.

We will look at the incremental approach, staged approach that several
people have mentioned and ask for public comments on things like that. I think
it’s critical, it was mentioned in the WEDI testimony, that the rest of the
transactions appears to be a major industry concern about implementation.
They’ll be a discussion about minimum necessary concerns as people have already
addressed.

There was a lot of mention about the role of vendors and clearinghouses and
whether they will or they won’t be ready, whether they will or they won’t be
willing to adopt this particular standard. We’re working through AFECHT and a
number of other committees to sit down and really had mentioned this in our
testimony to work with the vendor community, both expose them to the standard
and actually get input even before we come out with the NPRM as to the
appropriate, how they feel about the standard, what the timing is, what the
cost involved and the effort involved in building these systems and whether
these kind of a standard makes sense for their systems.

The concern about whether or not plans will implement this, the simple
answer is that if we were to publish a regulation adopting these standards
there’s a requirement that plans have to be able to support the standard, I
think that’s why it’s critical to get their input as to what, as to the cost
and timing involved in that.

We do continue to look for pilot tests, not a whole lot of government
funding available at this point, we are researching different possible places
to get some funding for pilots. Anyone, any groups that have already expressed
interest we’d be happy to work with them in setting up a pilot test and trying
to define what some of the parameters are.

The mention of the NPRM and the Notice of Intent, I just want to make sure
that people understand that should we publish an NPRM and there be a pilot test
and should the pilot test say that you were completely wrong in the proposed
approach in the NPRM we actually would go out then and publish another NPRM, we
would not move immediately to a final rule and say oh, made a mistake, we’re
going to go this way.

DR. COHN: Say again what you just said.

MR. NACHIMSON: Should we publish an NPRM that proposes an approach and
through pilot tests and other public comments the response is their approach is
not correct we would not say oh, we’ll change the approach and then publish
that in a final rule without giving the industry enough opportunity to comment,
we would in all probability publish another Notice of Proposed Rule Making and
allow the industry to comment on the major change of approach. I think that’s
an important consideration, under the APA if there’s a major change from what
you’re proposing to what you’d like to have as a final you do need to publish a
Notice of Proposed Rule Making.

DR. COHN: We were trying to figure out how all that would work in the world
of the regulatory environments, actually it’s reassuring to hear that there’s
provisions for that sort of flexibility. Other questions for Stan before we —

MR. REYNOLDS: Has that ever been done before?

MR. NACHIMSON: Published additional NPRMs? I’m certain it has, I’m not aware
of particular items but that discussion takes place all the time so I would
guess very much that —

MR. REYNOLDS: Just a question on theory versus practicality.

DR. COHN: I guess the other piece would be this issue —

DR. STEINDEL: Simon, I can directly answer that question. In the area of
HIPAA probably not but in the area of CLEA(?) that has happened.

DR. COHN: Well good. And I was going to say another option obviously would
be an extended public comment period that would include the actual pilot period
themselves. I think we need to somehow reflect support of that idea because I
think that was one of the things we were hearing that if you’re going to do
pilots you want to make sure the pilots, results of the pilots get put into a
final reg and probably it isn’t just the pilots but it’s everybody’s comments
about the pilots.

MR. NACHIMSON: And for HIPAA regs there is no deadline by which we have to
publish a final rule after the Notice of Proposed Rule Making is published so
some of the comments, should we publish a Notice of Proposed Rule Making
comments could come in that say do not publish a final rule until the results
of pilots tests are known and we could take that into account.

DR. COHN: Yes, Jeff, I’m sorry.

MR. BLAIR: Stan, is there a mechanism to accommodate the request that we
heard from a few folks that we’re saying that there should be an opportunity
for industry comment on the success, limitations, or failures of the pilot test
that would be reflected in the NPRM, not saying that the NPRM wouldn’t begin
until after that’s all done but what I was, I’m thinking that if there would be
a mechanism, this is what some folks were saying, they wanted there to be
public comment on the output of the pilot tests and that that would be
reflected in the NPRM and I thought maybe if there was an extended comment
period for the NPRM that they would have an opportunity to somehow get that
reflected in, or if there’s some mechanism, maybe some, whether it is a
publication of the results of the pilot test so people could respond and react
to them. Is there anything like that that could be done?

MR. NACHIMSON: I don’t know the answer to that question, I can think of
several possibilities and it would depend on perhaps who’s sponsoring the pilot
test given that the department has to rely on the advice of several outside
organizations under HIPAA, the NUBC, the NUCC, ADA, and WEDI for example,
before publishing and finally adopting standards. I would think it might be
possible that should one of those organizations sponsor the pilot test and
gather comments we could rely on that. I don’t know how far we could actually
extend the public comment process.

DR. COHN: It sounds like rather then trying to decide the exact mechanism
here we need to stay at a high enough level where we’re sort of, I mean
whatever we come forward with needs to sort of reflect that view that, assuming
we decide we want to start with an NPRM we also want pilots, we also want sort
of the results of the pilots, and I think Jeff you’re commenting about comments
about the pilots as well as the results of the pilots to be reflected in
whatever process leads to a final rule. And I think that that’s sort of what
we’re saying and I think we’ve heard a couple of different methods to do that.
I guess I would suggest that we might, rather then trying to micromanage this
particular process, that we leave to the Secretary and the department how to
ensure that’s actually worked out and we try to focus to make sure that the
sort of the process pieces are in place where the input is as we sort of would
like to see it. Does that make sense?

Any other questions for Stan before we take a look at this letter? Okay.

Well, now there’s a letter, for those on the internet there’s a letter on
the screen that we’re going to start reading through, this was a draft letter
that we began to prepare after the December 10th hearings and then
realized as we were writing it that we really didn’t feel that we had enough
input perspective from the industry for us to really go forward with it, which
is of course the reason for the session today.

As I’ve reflected on it as I’m listening and of course we all know that we
hear through sort of a filtering process, but I think that a lot of the letter
actually still stands even after the hearings today though I think we all need
to reflect on them and certainly I think it remains a good starting point for
us to either begin to wordsmith or accept or otherwise. I think in the
interest, recognizing that others around the room probably don’t have copies of
it, I’m sure those on the internet haven’t seen it, how about if I just start
reading through it from paragraph to paragraph and we’ll see if we sort of
agree with it, and then we’ll move to the next paragraph, after we’re sort of
done with whatever changes to a paragraph we can reflect on are there more
things that need to be in here that we’ve somehow missed. Is that an acceptable
process for everyone?

Let me start with the first paragraph. Dear Secretary Thompson, as part of
its responsibilities under HIPAA the NCVHS is responsible for studying,
selecting, and recommending standards for health care claim attachments. To
fulfill these responsibilities NCVHS’s Subcommittee on Standards and Security
recently held hearings on standards for electronic claims attachments, and
probably I would at this point say held a set of hearings on electronic claims
attachments, this is wordsmithing, or we could say held hearings on standards
for electronic claim attachments on X and Y date, dates, okay, why don’t we do
dates.

MS. GRAHAM: Does it matter if the language, I mean in one part we refer to
them as health claim attachment and then we refer to them as electronic claims
attachments, does that need to be consistent?

MR. BLAIR: I think it’s health claims attachments —

DR. COHN: I guess it’s electronic health claims attachments, right? And
probably the same changes needs to be like electronic health claims attachments
two lines above. Okay, are we comfortable with those changes? Should we move
on? Did you have a comment? Okay. And obviously we can do minor word tweaking
and wordsmithing even post this session if great additional words or we somehow
mis-described some of the concepts here.

Next paragraph. The subcommittee heard testimony about the need for both
basic and advanced functionality in a claims attachment standard. For example,
such a standard should be flexible so that physician offices and others with
minimal infrastructure can electronic transfer claims attachment information to
health plans and clearinghouses. At the same time the standards should possess
the flexibility to permit users with more sophisticated infrastructures, such
as hospitals and payers using electronic health records, to fully leverage
their investments in electronic technology. HL7, X12, and it says and others, I
don’t know that we’ve heard about any others, I think it’s just HL7 and X12
have been working to develop a claims attachment standard that can meet these
requirements. And I guess I would just ask you to correct me if I’m wrong,
somebody in an edit had put others, I don’t think despite our investigation
we’ve heard of any others working on the claims attachment standard. I’m sorry,
what?

PARTICIPANT: [Comment off microphone.]

MR. BLAIR: Were you thinking like DICOM as an image or XML or what were you
thinking of when you said other standards?

PARTICIPANT: [Comment off microphone.]

DR. HUFF: But it’s not an attachment standard, it’s an image transmission
standard. I agree with you but I don’t, I would strike and others.

DR. COHN: I think we heard testimony today about other approaches to
electronic claims attachments but I didn’t hear anybody coming forward with a
standard in this area.

DR. FITZMAURICE: You could qualify this by saying the HIPAA claim
attachment, I think X12 and HL7 are the only ones working on the HIPAA claims
attachment standard.

DR. COHN: Okay, that sounds good.

PARTICIPANT: [Comment off microphone.]

DR. COHN: We’re only going to advise on the HIPAA piece. Now a minor change
up here which is an earlier sentence, talked about permit users with more
sophisticated infrastructures, such as hospitals and payers using electronic
health records, I don’t know about payers using electronic health records, I
mean it seems like that really relates to hospitals.

MR. REYNOLDS: Interfacing might be a word.

DR. COHN: I guess the question, what should we do with that sentence to make
it sound reasonable, I’m open, we’re talking about the idea of a more
sophisticated infrastructures, maybe such as some hospitals and payers?

PARTICIPANT: [Comment off microphone.]

DR. COHN: Okay, we’re comfortable Harry?

MR. REYNOLDS: I have a question before we move on. The second sentence in
that paragraph, are we saying that the minimal infrastructure is base
compliance philosophically and then you can go from there? We’re setting that,
once we decide what that minimum requirement would be that is the minimum
requirement, people go up from there as they choose.

DR. COHN: That was my understanding, I mean if it says something different
we need to —

MR. REYNOLDS: Well, that’s what I’m trying to understand, it can sound like
two standards the way it reads right now.

DR. FITZMAURICE: Is there one standard and it has many component, or are
there many standards?

MR. REYNOLDS: Well, if it has multiple levels, again, you can, it’s the idea
of minimum infrastructure is one way of looking at it, might be a lower cost
way of doing it also, versus going the other way possibly in some kind of a
transition period, so just making sure that are we saying for the small it’s
this and the larger it’s this or is this —

DR. COHN: Well, no, actually we aren’t saying that, we were saying that
people have minimal infrastructures regardless of whether you’re small or
large.

MR. REYNOLDS: I just want to make sure.

DR. COHN: Can start with the basics and be in compliance, and I guess the
belief is is that there’s business value in moving to greater functionality.
And I guess the other question is in this last paragraph, is this HIPAA claims
attachment standards, or is, I think it’s a standard —

DR. FITZMAURICE: It’s a standard with many components I would guess.

DR. COHN: Yeah, that what’s I, okay, good. We sort of talk about standards
and standard, Maria, it looks like you have —

MS. WARD: [Comment off microphone.]

DR. FITZMAURICE: But when you combine them you have a HIPAA standard right?
You don’t combine them you don’t have a HIPAA standard.

MS. WARD: [Comment off microphone.]

DR. FITZMAURICE: The HIPAA standard has several ANSI components, several
ANSI accredited standard —

DR. COHN: I think leaving it singular makes more sense because I think it’s,
I think we’re just talking about our two components of a complete package that
would likely be, if it were going to go forward would have to be specified by
the Secretary or else it wouldn’t work. Okay, Michael. I’m sorry, I apologize,
I’ve been having back problems and I’m not turning real well. Carol, would you
like to comment and then Michael and then Stan.

DR. BICKFORD: In the second sentence you have physician offices, that needs
to be provider or practitioner to allow those of us who are not physicians to
be included.

PARTICIPANT: Just make it practitioners or providers?

DR. COHN: Why don’t we say physician and other practitioners offices? The
problem we get provider is in the outside world, at least in CMS provider also
relates to institutions which provides no end to confusion here. Michael.

DR. FITZMAURICE: We’ve gotten down now to the third paragraph and we haven’t
told the Secretary from whom we heard testimony. I would offer a suggestion of
moving the testimony from payers and providers up to the top of the second
paragraph.

MS. FRIEDMAN: Should I move all that?

DR. COHN: We haven’t gotten to the third paragraph yet, heard testimony from
vendors, payers, associations, and providers further emphasizing —

MS. FRIEDMAN: Move all that up, heard testimony from —

DR. COHN: Okay, sure. Okay, other comments on this? I’m sorry, Judy?

DR. WARREN: Back on the change we made, physician and other practitioner
offices, we got rid of the others, I thought the others was important, I mean
that could be small community hospitals, rural hospitals, or other kinds of
places, not necessarily practitioner offices.

DR. COHN: And other providers.

MS. FRIEDMAN: So physicians, other practitioner —

MR. BLAIR: No, physicians, practitioners, and other providers.

DR. COHN: This needs to have some wordsmithing, no, it still doesn’t make
any sense here.

DR. WARREN: Or it could be physician and other practitioners, to me the
problem wordsmithing providers because we never know what providers means,
whether it’s somebody can do a bill or whether it’s someone who gives care.

DR. COHN: No, I agree with you —

DR. WARREN: It’s the organization that I’m trying to get at, small
organizations, back to where we have a continuum of standards.

DR. COHN: So we might say physicians, other practitioners, and small
hospitals?

DR. STEINDEL: I was going to suggest then a diversity of providers, so we
get rid of the two others.

DR. WARREN: Or maybe it’s provider organizations.

DR. COHN: Well, I think we’re getting into terms that no one even
understands, and this is an example, so let’s see, how exhaustive do we want
this example.

MS. FRIEDMAN: How about provider, provider something such as small physician
practices and rural hospitals?

DR. FITZMAURICE: Or just say providers.

MR. BLAIR: Just health care providers.

DR. COHN: That sounds fine. We’ve really taken this down to the basics,
okay, sounds good. Michael?

DR. FITZMAURICE: We said a whole paragraph about making it useful for
everybody but we haven’t mentioned the payers and we did have such as hospitals
and payers using electronic health records, and we got hung up on records, we
could say hospitals and payers using electronic health information.

MR. REYNOLDS: That’s not a key word, I agree with you, that’s not a key
phrase. Electronic health records has its own world right now.

DR. FITZMAURICE: And I would take out the large provider practices and
replace that with and payers so we have something for everybody, there’s
something for providers, there’s something for payers.

MS. GRAHAM: You’re saying the payers that the ability to receive electronic
—

DR. FITZMAURICE: Not only receive but they use electronic health information
for myriad purposes.

DR. COHN: Okay, at the same time the standard should possess the flexibility
to permit users with more sophisticated infrastructures, such as hospitals and
payers using electronic health information to fully —

MR. NACHIMSON: I was going to say just to stock to the HIPAA vocabulary we
use health plans rather then payers.

DR. COHN: Okay, let’s change it to health plans, to fully leverage their
investment in electronic technology. It’s probably information technology
rather then electronic technology at the end there, but I guess I’m trying to
think of how we’re differentiating the provider with minimal infrastructure
from the fact that we’re saying hospitals here with, you see what I’m sort of
saying here, what sort of hospital, using electronic health —

MR. NACHIMSON: Is there a need for you to give that example or can you take
that entire phrase out and just have it read standards should possess the
flexibility to permit users with more sophisticated infrastructure to fully
leverage investment.

DR. COHN: Is that better? Okay. Sounds good. Now are we leaving the
hospitals and health plans or are we getting rid of those?

PARTICIPANT: The software’s not taking that.

DR. COHN: Oh, interesting. Okay.

DR. WARREN: So on the first line do we need to change payers up there to
health plans?

DR. COHN: Yes. Now associations is important in this, okay everybody I think
we’re almost done with this, I’m just sort of looking at the first sentence
where it says the subcommittee heard testimony from health plans, vendors,
associations, and providers, it seems like sort of an odd group and I’m trying
to think of how better —

PARTICIPANT: [Comment off microphone.]

DR. COHN: And standards, thank you. I don’t know that we should, this is one
maybe we want to look at previous letters that we’ve written because we
usually, I think we’ve used these terms before somehow and maybe it’s the
vendors and associations, I mean usually providers are number two and,
something about the wording here seems a little, Maria, is that something I
could have you take a look at off line?

MS. FRIEDMAN: Yes.

DR. COHN: Okay, great. Okay, should we go on to the next paragraph? Yes.

PARTICIPANT: [Comment off microphone.]

DR. COHN: Okay. I guess we should call this Accredited Standards Committee
X12 —

MR. BLAIR: Accredited Standards Committee X12N.

DR. HUFF: That first number seven should be spelled out.

DR. COHN: Okay, should we go on to the next paragraph and let some of this
cleaned up, we’ll put parenthesis after Accredited Standards Committee X12N,
we’ll call it ASC X12N. Okay, move on to the next paragraph? Everybody okay?

The next paragraph is said the committee heard testimony further emphasizing
the need for demonstration projects and pilot studies to identify problems and
quantify benefits and costs associated with the implementation of the new HL7
and ANSI X12 claims attachment study. Should be standards, stop there and fix
that.

DR. FITZMAURICE: I would strike out the new HL7 because the Secretary, it
says old from new, and we haven’t explained that difference to him.

MR. BLAIR: I don’t even think you need the last part of that sentence
because we just wound up saying what the standards are so I think you could
just say we need the demonstration projects to identify the issues and
problems.

MR. REYNOLDS: I would also add in there by identifying problems also process
impacts, one of the things I don’t think we heard enough about today possibly
Simon was what’s it actually going to do to people’s processes to have to get
ready for this, I think that’s one of the big deliveries that the pilot studies
will give.

MR. BLAIR: Is this the sentence where, I don’t want to stick a whole lot of
stuff in but maybe we could just add just a few things and then this lists our
concerns, like for example we’ve got the workflow issues, the business case
issues, and the privacy issues, and if that’s in this sentence then maybe we’ve
taken care of it and don’t have to have a separate list of concerns.

PARTICIPANT: How long do you want the laundry list to be?

MR. REYNOLDS: You could replace my word process with impacts with workflow,
I think workflow impacts is probably a better way to say it.

DR. COHN: I’m just trying to think of where it should be and whether it
should be here or —

PARTICIPANT: Workflow impacts, privacy concerns and —

DR. COHN: I guess that part of the issue is as I’m looking at identify
workflow impacts, I’m not necessarily expecting a pilot study necessarily to
identify workflow impacts as opposed to —

MR. BLAIR: What if we listed as issues —

DR. WARREN: Workflow impacts is in the wrong place, it should be after the
other one, let the pilots identify them.

MR. BLAIR: Right.

MR. WATCHKINS(?): I’m Larry Watchkins, co-chair of WEDI-SNIP, as we’ve been
working through these same types of issues, obviously not in a pilot which
would have been nice for the regular HIPAA transactions or the ten, the three I
would list it as workflow impacts, implementation obstacles, and probably
privacy concerns fits in there as well but I think implementation obstacles is
another item that’s not necessarily about workflow, it’s just what are the
realities that the industry is dealing with both cost wise and implementation
wise that might cause issues, and that we need to identify through a pilot.

MR. BLAIR: I can’t see how far along you are because I don’t want to
interrupt what you’re doing but I have a different word there that I’d like to
suggest when you’re ready, Maria.

MS. FRIEDMAN: Okay, let me read this as it is, and I have a suggestion to
take off the back end of this. The subcommittee heard testimony further
emphasizing the need for demonstration projects and pilot studies to identify
issues and problems as well as quantify benefits, costs, workflow impacts,
implementation obstacles and privacy concerns associated with implementation of
the claim attachment standards. And I just think we should end it at privacy
concerns.

DR. COHN: I agree, I think the first part of the sentence needs some clean
up too.

DR. STEINDEL: Take out say heard the need, we don’t usually say —

MS. FRIEDMAN: Heard some testimony —

DR. STEINDEL: Heard the need, take out the clause testimony for, we don’t
usually, when we introduce that we’ve heard testimony in the first paragraph we
usually don’t repeat that we heard testimony again, we just say we heard the
need or something like that.

DR. COHN: Jeff, you were going to make a suggestion and then I’ll make a
suggestion.

MR. BLAIR: After workflow the word impacts has a negative connotation, I
think we need a more neutral word, either workflow changes, accommodations, or
issues, whatever everyone feels comfortable with, workflow changes.

MS. GRAHAM: Is that meant to encompass the issues brought up by numerous
people about the process being a little broken, as far as even the carriers, so
that’s meant to encompass that?

DR. COHN: I hope so, it’s obviously a high level, beyond obviously,
hopefully it will include that. Judy?

DR. WARREN: Yeah, I was just responding to Jeff’s thing for a neutral term,
implementation obstacles bothers me, could we say implementation challenges?

DR. COHN: Sounds good.

PARTICIPANT: You like that better then barriers?

DR. WARREN: Yes.

DR. COHN: Let’s take a look at the beginning, we started talking about to
identify issues and problems as well as quantify benefits, costs, workflow
changes, implementation challenges, and privacy concerns. I don’t know what the
issues and problems, those seems like we’re already specifying issues and
problems that we, I think basically to, I think we want to have studies to
quantify benefits, costs, needed workflow changes, identify implementation
challenges, I think we can sort of get rid of that first part.

DR. HUFF: Standard should just be singular at the very end of the sentence,
right, the claim attachment.

DR. COHN: I think we’re going to get rid of the, do you want me to read
this as it is right now? The subcommittee heard the need for demonstration
projects and pilot studies to quantify benefits, costs, workflow changes,
implementation challenges, and privacy concerns associated with the
implementation of the claims attachment standards. Probably there’s too may
implementations but we talked about maybe removing that last part. It sounds
like we need an end to all of that. Jack, it sounds like you have a
wordsmithing —

PARTICIPANT: No, actually this makes the sentence a little bit longer. You
had heard testimony and I thought there was some committee interest in the idea
of multiple pilots across a variety of public and private payers rather then
just — if that’s in fact the committee or subcommittee feels worthwhile
putting in the fact that it ought to be public and private, not just Medicare
—

PARTICIPANT: I think that’s down a couple of sentences, maybe address that
when we get to there.

DR. FITZMAURICE: Should standards be singular?

PARTICIPANT: They should be singular but the question is do we even want to
keep that part.

DR. COHN: Why don’t we get rid of the s there, why don’t we get rid of
implementation in the sentence above —

PARTICIPANT: And just end it at privacy concerns.

DR. WARREN: There’s also a problem with the word quantify, are we
quantifying costs or quantifying workflow changes and quantifying
implementation challenges and quantifying privacy, to identify?

DR. COHN: To investigate?

DR. FITZMAURICE: In case we don’t do it we can say that we investigated it.

DR. HUFF: You could put the quantify right ahead of cost because I think —

DR. WARREN: Isn’t investigate meant to apply to that whole string?

MR. BLAIR: I think she was replacing quantify because we don’t know that we
could quantify all of that but we could investigate it?

DR. HUFF: No, I was just trying to put quantify right ahead of, inside a
comma, benefits, quantify costs —

DR. WARREN: You still have investigate all the rest.

DR. COHN: Well, I think it’s really a question here about whether or not
we’re putting verbs in front of each of those that relate to them because I
guess the point to my view of a project and pilot study is not just to
investigate something but it’s also to come up with strategies to overcome
obstacles is what I tend to think of the point of these things, or recommend
best practices around so I don’t know that we, if all we want to do is
investigate implementation challenges —

MS. GRAHAM: — do want to just add and recommend options or solutions or
strategies, I though all part we don’t know, we know what some the privacy
concerns are but there might be more then what we’ve heard, roll out —

MS. FRIEDMAN: [Comment off microphone.]

DR. COHN: Maybe it’s potential privacy concerns, okay —

DR. WARREN: We’ve taken the negative out of everything else but that.

DR. COHN: My question is is that I think I was just sort of making a comment
here, basically we have investigate the benefits, cots, workflow changes, I
think it may be challenges, implementation challenges, and potential privacy
concerns as well as best practices —

DR. STEINDEL: I don’t like the word potential in front of privacy concerns,
just privacy concerns, there may be none that were identified.

DR. COHN: Yeah, you’re probably right.

MS. GRAHAM: With really privacy requirements, can this solution address
privacy requirements —

MS. FRIEDMAN: [Comment off microphone.]

MR. BLAIR: I don’t think it hurts anything for us to list it as privacy
concerns. There’s many people that have concerns about privacy and will
investigate that as it applies to these standards, what will come out in terms
of, what comes out comes out, but those concerns already exist.

MR. REYNOLDS: I think a key thing is not to confuse, we want the pilots to
truly do what they need to do and then we need to decide whether it’s a concern
or not a concern afterwards in each of those categories.

PARTICIPANT: [Comment off microphone.]

MR. REYNOLDS: Simon, I’m with you, I think investigate, I’d like a stronger
word, document, whatever but investigate says I can look at it and I don’t have
to, if I was doing a pilot I could investigate it, it’s not a problem, I
wouldn’t have to document it coming forward to say this is what the impact is.

DR. COHN: Probably it messes up the first, middle part, we almost want to
demonstrate the benefits, costs, and all of that which is what a pilot study
typically does but it sort of falls apart as you go through all the comments
here.

DR. WARREN: Maybe the last comment after privacy concerns, as you were
saying demonstrate best practices, kind of changes the members of the list a
little bit.

DR. COHN: Jeff, what were you thinking?

MR. BLAIR: I’m not sure this is right but the purpose of the demonstration
projects is to try to provide additional information on all of these issues,
and then Health and Human Services and the general public will wind up either,
the general public I’m assuming is going to make comments on those and Health
and Human Services will try to put that forth into an appropriate guidance for
regulations, so I don’t necessarily see that the demonstration projects are
going to solve what they surface as issues in all cases. So I think that if we
just indicate that the purpose of the demonstration projects is to, I’m not
sure what I’m saying is entirely correct because hopefully we’re going to wind
up showing that the demonstration projects will also prove the feasibility and
appropriateness of the standard, so I guess I’m going to withdraw my comment.

DR. COHN: And maybe it isn’t demonstrate, maybe it’s identify best
practices, let me read this because it still doesn’t quite hang together, we
actually need to sort of somehow come to enough agreement that we can do some
more wordsmithing on the side. But basically we have the subcommittee heard the
need for demonstration projects and pilot studies to, right now we have
investigate the benefits, costs, workflow changes, implementation challenges
and privacy concerns as well as identify best practices associated with the
claims attachment standard. Yes, Jeff, well it’s bad now but you can certainly
add more.

MR. BLAIR: Finish what you’re working on because I have a different part
related to this and I don’t want to interrupt.

DR. COHN: Well, it’s not together but maybe —

MR. BLAIR: A thousand years ago when we were dealing with the HIPAA
transaction standards one of the major issues was the readiness of the
standards and we don’t have that in here, and I think that since we’re in such
an early stage here that that’s an important issue that shouldn’t be left out,
is the demonstration projects should also be demonstrating the readiness of the
standards.

PARTICIPANT: Readiness for adoption —

MR. BLAIR: Readiness for implementation, implementation, adoption, either
word.

DR. STEINDEL: Could that be covered under implementation challenges, Jeff?

MR. BLAIR: Well, the implementation challenge, maybe it should replace
implementation challenge, maybe it should be readiness for adoption or
readiness for implementation instead of the challenges.

DR. STEINDEL: No, I don’t think so, I think implementation challenges
includes the ability to express the standard as well as other technical issues
associated within the organization.

MR. REYNOLDS: I want to go back to investigate one more time, the reason I
say that is if people are going to consider stepping up to help fund this it’s
much harder to fund an investigation then it is to fund something that is going
to be documented and can be used in further deliberations. And when you’re
starting to talk about this kind of money and this kind of effort and
everything that clean documentation of what the findings are out of that puts
it in a context that people might be more willing up front to put money in
because they know there’s going to be a documented occurrence coming up.

DR. COHN: So what are we talking about, to identify —

MR. REYNOLDS: Instead of investigate —

DR. STEINDEL: Can I suggest enumerate?

MR. REYNOLDS: Put document. Funding is much, when you’re looking in the
funding world I think it’s much more palatable of a word.

DR. COHN: Sounds fine, okay, document the benefits, costs, workflow changes,
implementation challenges and privacy concerns as well as identify best
practices, as well as the best practices.

PARTICIPANT: Want me to get rid of that whole clause?

MR. BLAIR: Or just and best practices.

DR. COHN: Okay, so and best practices associated with claims attachment
standard. Yes?

PARTICIPANT: [Comment off microphone.]

DR. COHN: I’d be fine with that, further requirements, what do you think?
Everybody comfortable with that? I think it all sort of means the same thing.
Okay, are we okay with that sentence? We’ll go on to the next one and we’ll
come back and reread the paragraph since it’s gone through some changes. Okay.

A pilot proposed by the Empire Blue Cross and Blue Shield, and then in
parenthesis which is under consideration by CMS, is an example of the kind of
projects that should be encouraged, supported and encouraged. Actually I think
getting rid of which is under consideration by CMS, let’s get rid of that. For
example the kind of project —

PARTICIPANT: [Comment off microphone.]

MS. FRIEDMAN: What’s the best way to describe it, just the way it is?

PARTICIPANT: Yeah, that’s fine.

DR. COHN: Are we okay there then? NCVHS urges the department to support
several different claims attachments, excuse me, it’s claims attachment
demonstration projects and pilots that would include institutional providers,
physicians, dentists, pharmacies, multiple payers, clearinghouses, and software
vendors. I’m not sure what multiple payers means, I think it’s maybe payers.

MS. FRIEDMAN: Multiple payers at multiple sites. It’s the whole cast of
characters in different combinations.

DR. STEINDEL: Well first it could be health plans, I would just say health
plans.

DR. COHN: I think we just change that to health plans, get rid of multiple.

PARTICIPANT: [Comment off microphone.]

DR. COHN: Exactly, you want multiple pharmacies, you’d want multiple
dentists, we’d want multiple physicians.

DR. STEINDEL: Now getting back to the issue of the first paragraph when we
had physicians and other providers, do we want to repeat that?

MS. FRIEDMAN: You’re trying to cover home health —

MR. BLAIR: Home health is not in there, we need to add that don’t you think?

DR. COHN: I don’t know.

MR. BLAIR: Isn’t it one of the very first high priorities of Medicaid and it
was one of the first six —

PARTICIPANT: [Comment off microphone.]

MR. BLAIR: It’s not? Durable medical equipment —

PARTICIPANT: [Comment off microphone.]

DR. COHN: Does it even make sense with those six to include pharmacies?

PARTICIPANT: [Comment off microphone.]

MR. BLAIR: Could you reread the six for us again?

PARTICIPANT: [Comment off microphone.]

DR. STEINDEL: Would dentists come in that group?

PARTICIPANT: [Comment off microphone.]

MS. FRIEDMAN: I think the idea of putting dentists in there is because the
dental world as we’ve heard is fairly proactive in doing some of this already.

DR. STEINDEL: Yeah, but they may not be part of the first set of six claims
attachments that are out there.

MS. FRIEDMAN: I understand that, the question is do you want to limit this,
do you want to prescribe the set of studies to only stuff that’s on the list
but exclude people who are out there doing it already? That’s the question.

DR. STEINDEL: That’s a good question to raise because my personal feeling is
that we probably should extend this list, in which case home health would be
appropriate. I don’t think we’re going to be able to do another set of pilots,
we’ll be lucky if we can do this set of pilots.

MR. BLAIR: Maybe if we had an other at the end then it leaves it open
because yes, dental is doing it now but they’re not necessarily doing it with
the HIPAA, HL7, X12N standard and we’re thinking about —

MS. FRIEDMAN: That might be one of the things that a pilot would look at.

MR. BLAIR: Yeah, exactly, is there an ability to accommodate the standard
we’re talking about or the degree to which they’re doing it now could be
accepted.

DR. COHN: So help me with where we’re going here, we’ve obviously got the
claims attachment standard that has six attachments right now and so do we
identify people for the pilots that have no relationship to those
demonstration, I mean to those claims attachments and if so how would we
involve them in this pilot, exactly what are we doing here?

MR. BLAIR: If we list it as e.g., such as, and then we’re giving examples,
then it leaves it to HHS to make it as broad or as narrow as, as broad as they
can but it doesn’t constrain them, we’re not being descriptive we’re giving
examples.

MS. FRIEDMAN: You could say have a different claim attachment demonstration
project and pilots that would include a wide range of stakeholders or some
other word such as institutional providers, etc.

DR. COHN: Okay, maybe a wide variety —

MS. FRIEDMAN: Or a variety?

MR. BLAIR: Let’s use the words our testifiers gave us, they said it should
be broad, a broad set —

DR. FITZMAURICE: Broad representation of.

MS. FRIEDMAN: Representation of stakeholders.

MR. BLAIR: Yes, such as and then you could list them and end it with others.

MS. FREIDMAN: You really want and others at the end?

MR. BLAIR: You don’t have it, we have such as.

MS. FRIEDMAN: Okay, the way the sentence now reads is NCVHS urges the
department towards several different claims attachment demonstration projects
and pilots that would include a broad representation of stakeholders, such as
institutional providers, physicians, dentists, pharmacies, health plans,
clearinghouses, and software vendors. Or that would broadly, we could say that
would broadly represent.

DR. COHN: I guess the question is whether, I mean an alternative way to
describe this would be a broad representation of providers, health plans,
clearinghouses, and software vendors, and leave it at that and use the wider
concept of provider.

MS. FRIEDMAN: So you take out dentists and pharmacies?

DR. COHN: Well, I would take out institutional providers, I’d take out
physicians, I’d take out dentists, pharmacists, I guess it still begs the
question of how are dentists and pharmacists going to participate in this
particular pilot.

DR. HUFF: Well, the dentists, the one thing that occurred to me is that they
did mention that there could be applicability for oral surgeons, the op reports
from oral surgeons.

DR. COHN: That’s true, but that’s not coming forward as one of the claims
attachments.

DR. HUFF: If I submit a claim for payment for oral surgery they may want the
op report from oral surgery.

MR. REYNOLDS: You could shorten it even more just by saying a broad
representation of effected stakeholders, period. In other words, I agree with
what somebody said a minute ago, home health is not up there, there’s all kind
of players that aren’t up there. We either have to list 25 or almost nobody.

DR. COHN: I think it’s one I’d be willing to get rid of because we’re having
trouble identifying appropriately, everybody okay with that? Going. Okay, let
me bring up another issue here as we have, we basically have a sentence where
it says a pilot proposed should be Empire Blue Cross/Blue Shield is an example
of the kind, kinds of projects, I mean it’s actually the example of the kind of
project, which should be supported and encouraged. NCVHS urges the department
to support several different claims attachment demonstration projects and
pilots that would include a broad representation of effected stakeholders. Now
my question is are we supporting or are we having them support and encourage,
is our recommendation here is that HHS fund these, are we using support in the
broad —

PARTICIPANT: To encourage, I mean there’s different kinds of support beyond
funding.

DR. COHN: Well, maybe encourages the department to encourage and support, I
mean clearly we’ve got support and encourage, I don’t know, I’m not sure I have
a strong feeling on this one, do we want to leave it support for the moment?

Okay, last sentence is NCVHS recommends that these demonstration projects,
I’m sorry?

DR. STEINDEL: Simon, do you think considering how we reworded the sentence,
do you think we should put the Empire Blue Cross/Blue Shield example after?

DR. COHN: That’s probably better. Okay, that looks good. Should I read the
last sentence now? NCVHS recommends that these demonstration projects and
pilots occur expeditiously so that the results and findings may feed directly
into the development of the claims attachment rule.

PARTICIPANT: The final rule?

DR. FITZMAURICE: If you leave it like that then they can do it however they
want, unless you feel strongly that it should come before the NPRM.

MR. BLAIR: This is I think where the testimony we were hearing today, I
think people wanted the opportunity to comment on the results of these
demonstration projects before there was a final rule, so maybe if we left it
open ended without being too prescriptive that the results just simply would be
reflected in the final rule or the rulemaking process, one of the two. But if
it goes directly then people don’t have a chance to comment.

DR. COHN: So are you agreeing with this sentence or not, Jeff, I’m sorry.

MR. BLAIR: No, I’m not agreeing with it because it says it goes directly
into the final rule and people were saying that they wanted a chance to make
comments as a results of the findings from the pilot tests before it went into
a final rule.

DR. FITZMAURICE: Do you want to read it again so that Jeff can see what the
sentence says? Because it doesn’t say final rule —

DR. STEINDEL: It doesn’t say final rule, the claims attachment rule.

PARTICIPANT: I think you need to take may out of there.

DR. COHN: Jeff, do you want to me to read this back to you? NCVHS recommends
that these demonstration projects and pilots occur expeditiously so that the
results and findings will feed into the development of the claims attachments
rule. Okay? Okay everybody? Next paragraph?

PARTICIPANT: [Comment off microphone.]

MS. FRIEDMAN: You could put it here and say pilots proposed by Empire Blue
Cross/Blue Shield and our examples —

DR. COHN: I guess I’m confused because I didn’t hear that as a pilot, I
thought that was a survey.

PARTICIPANT: That is both a survey and a pilot.

DR. COHN: Okay, because I only heard about the survey.

PARTICIPANT: It might be pilots, not just one pilot —

DR. COHN: Okay, having heard testimony on this one I guess I feel
uncomfortable —

PARTICIPANT: I did mention this —

DR. COHN: No, what we heard from you was the survey.

PARTICIPANT: No, I said education survey and AFECHT [off microphone] —

DR. COHN: Well, that isn’t a pilot though.

PARTICIPANT: [Comment off microphone.]

MS. FRIEDMAN: But you don’t have a pilot yet, you don’t have one in hand
yet, well this one is in hand. This is in hand.

DR. COHN: We’re obviously fully supportive but I’m just trying to think,
we’ve obviously encouraged them to support and encourage a broad, several
different claims attachment demonstration projects and pilots, I think that at
this point that has to sort of reflect what you are all trying to do.

PARTICIPANT: [Comment off microphone.]

DR. COHN: No, no, once you guys get it together maybe we need to hear about
it and we can just send a follow-up. Okay, are we okay there? Obviously we’ll
reflect on this tonight, I’m sure we’ll have a chance tomorrow to also further
wordsmith.

Finally NCVHS recommends that the rulemaking process begin without delay. We
understand that an NPRM concerning electronic claims attachments currently is
under development and we urge the department to issue this NPRM as soon as
possible.

The NCVHS wishes to thank you for the opportunity to submit these
recommendations.

MR. NACHIMSON: Simon, the first sentence of that paragraph, the rulemaking
process has already begun, we’ve already begun to develop the proposed rules,
I’m not sure what your first sentence —

MS. FRIEDMAN: How about continue without delay?

DR. COHN: How about finally we understand that a Notice of Proposed Rule
Making concerning electronic claims attachments currently is under development
and we urge the department to issue this NPRM as soon as possible.

PARTICIPANT: [Comment off microphone.]

DR. COHN: Is that okay? Now the question is are we missing anything here?
This is not one of our greatest letters ever —

PARTICIPANT: [Comment off microphone.]

DR. COHN: You mean about the actual contents of the NPRM, or are you
referring to about whether it should come out?

PARTICIPANT: [Comment off microphone.]

DR. FITZMAURICE: We heard a testimony that without an NPRM people won’t even
take anything seriously, they probably won’t even volunteer for a pilot, so I
think we do want to go ahead advocating an NPRM as soon as possible.

MR. BLAIR: The thought that I would have on this, and this is where I tend
to feel a little awkward and uncomfortable, is we heard testimony on the one
hand that people are not going to make investments in a demonstration project
or implementing the standards into their vendor systems until they see some
indication that an NPRM is underway and the federal government is serious about
going down this track, so that’s the reason that we’re saying move forward and
do this as fast as possible. On the other hand I think all of us, well, I can’t
say all of us but I certainly would feel very uncomfortable issuing a HIPAA
rule when we haven’t had demonstration projects to check all the issues that
we’ve talked about above, so I think it’s a balance between the two, we want to
move forward, we want to encourage things, but I think those demonstration
projects are critical.

DR. COHN: Vivian, do you have a comment?

MS. AULD: The second to the last paragraph, why don’t you end it by saying
we urge the department to issue this NPRM as soon as possible so pilot studies
can be initiated or something to that effect, so you’re implying at that point
specifically that the pilot studies are waiting for the NPRM.

DR. FITZMAURICE: That’s a good point because the NPRM would inform the pilot
studies.

MR. BLAIR: There were a lot of testifiers that didn’t want the NPRM to be
released before the pilot studies concluded, so that’s why we were kind of
leaving that ambiguous so that HHS could —

DR. FITZMAURICE: I don’t think they minded so much, Jeff, except that they
wanted to be able to have comments in there before the final rule came out and
if there were changes they would like to see another NPRM following the first
NPRM, they just wanted to have a chance to see what the results of the pilots
are and then to comment before they get hit with a final rule.

DR. STEINDEL: Mike, in regard to that do you think we, since Stanley has
briefed us that actually under the Administrative Procedures Act they’re
required to do that, either in response to the comment or response to drastic
changes in the NPRM that they originally released. Do you think we should
explicitly state that to make people who are reading this letter feel more
comfortable? Because the people won’t know it —

DR. FITZMAURICE: But that’s an administrative judgment.

PARTICIPANT: [Comment off microphone.]

DR. STEINDEL: No, that’s exactly right.

MS. FRIEDMAN: Why would you want to even bring that up?

DR. STEINDEL: I was just reacting to Mike’s comment, I personally do not see
the need for it, I was —

DR. FITZMAURICE: I agree with you.

PARTICIPANT: [Comment off microphone.]

MS. FRIEDMAN: Why don’t you reverse the order? Just move this last paragraph
up and say we understand that an NPRM is underway, we urge that the department
issues the NPRM as soon as possible, and then say we heard the need for all
this and those results will feed into the development of the claims attachment
—

DR. COHN: Come to the microphone please.

PARTICIPANT: Based on what you were all saying about people saying that they
didn’t really, that it’s a double edged sword, people want to see pilots before
they want the NPRM but they want the NPRM so that people will believe that
there is going to be a reason to do the pilots, so why not consider with that
sentence you just moved saying in order to encourage the development of these
pilots so that people do believe that there will be a value add to this
investment, come out with the rule so that people will take it seriously.

DR. COHN: Putting it back at the end here.

PARTICIPANT: Either that or say in order to ensure that people understand
the government is committed to this rule NCVHS encourages the promulgation of
this NPRM because it will help people feel that we are serious. And then the
committee heard the need for the demonstration projects, so you can still leave
it there but put in what one of the members was talking about in terms of that
need for understanding that there is an investment or a commitment.

DR. COHN: I guess I first of all say that I sort of agree with the idea that
we need to link it but I think it needs to be the last part back where it was
because it makes absolutely no sense with the information we have above because
we’re just talking about well they’re all working together and they’re doing
something, and there’s sort of, I think we do and I think Jeff made probably
the right comment, that we need to link, part of the value of getting the NPRM
out was to really give the industry something to be able to do demonstrations
and pilots around —

MR. BLAIR: And maybe we could use the words in order to be willing to invest
in demonstration projects and software development.

MS. FRIEDMAN: So that the pilot projects —

MR. BLAIR: So that the industry is willing to invest in pilot projects and
software development.

MS. FRIEDMAN: Willing to participate and, wait a minute, participate in
pilot projects and invest in the needed infrastructure.

DR. COHN: Stan?

PARTICIPANT: I’m a little uncomfortable with the fact that from the previous
conversation that we don’t mention the fact that there’s a desire to comment on
this post the pilot, if we have a letter that says put out a Notice of Proposed
Rule Making, do the pilots, and there’s no reflection of the concern to then be
able to comment on those pilots, we can essentially have something still go
through that does not allow the public to comment on it.

DR. COHN: I actually agree with you, how about, up above, NCVHS understands
that an NPRM concerning electronic claims attachments currently is under
development. We urge the department to issue this NPRM as soon as possible so
that the industry is willing to participate in the pilot projects and invest in
the needed, willing to participate in pilot projects and invest in the needed
infrastructure. We also encourage the department to provide for public comment
on the results of the demonstrations and pilot before a final rule is
promulgated.

The second sentence here is a little weird, I think the final sentence has
gotten the view that we’ve all been trying to deal with, it says we urge the
department to issue this NPRM as soon as possible so that the industry is
willing to participate in pilot projects and invest in the needed
infrastructure, maybe willing is, there’s a couple wrong words there.

MS. FRIEDMAN: Be motivated.

DR. COHN: Motivated, okay.

PARTICIPANT: We urge them to do it as soon as possible, period, and then
something like this will motivate the industry, but I think it’s two thoughts,
I don’t think the only reason that you want it to move forward is so people
will participate in a pilot, which is what you’re saying.

DR. COHN: Thank you. Are we comfortable? Have we missed anything?

PARTICIPANT: The last sentence, you’re thanking them for the opportunity to
make a recommendation, actually they didn’t give you that opportunity, that was
given to you by legislation, so I would say you thank them for considering
these recommendations or taking these recommendations, doing it, so that’s just
a comment from Larry.

DR. COHN: Okay. Now I’m actually expecting that there will be a couple more
wordsmithing because I think that probably as we look at this, as Maria reviews
it a little further there probably will be slightly, this will be slightly
changed tomorrow, but barring wordsmithing changes are people comfortable with
the contents and all this? I do apologize to everybody for the pain of this,
that’s why we keep our letters short usually because otherwise we’d never get
through them. But is everyone comfortable with this? Do we have a motion to
bring to the full committee tomorrow morning?

DR. HUFF: I move that we bring it to the full committee —

DR. COHN: With possible wordsmithing changes between now and then.

MR. BLAIR: I’ll second that.

DR. COHN: Discussion? All in favor? Opposed? Abstentions? Okay, this letter
is passed. Okay, Maria I’ll let you do wordsmithing on it as you think about it
and all of that. Should we move to the next issue?

Agenda Item: Subcommittee Discussion of Letter from DSMOs
Concerning Standards for Billing for Supplies – Dr. Cohn

DR. COHN: I do want you to know that I had my yearly review in my regular
job, the one I actually get paid for generally, and people thought that I was
wonderful except that they just wished I would end meetings on time, they
actually weren’t even, they didn’t even ask you to comment. So I do want to
apologize that this is unfortunately running a little beyond where we thought
it was going to end.

Now I did want to bring up this next issue and ask for your input and
otherwise, there’s a letter that we received recently from the DSMOs related to
the billing of supplies for the pharmaceutical world basically and at issue is
a request or ERISA recommendations brought to us back in I think it was 2002
related to a request from the DSMOs that the NCPDP standard could be utilized
by pharmacies for supplies, for billable supplies. Now we hadn’t actually given
them a formal response and I was actually, one of the great things about taking
long plane flights is I get to review all of the issues related to all of this
stuff and so looked back to 2001, 2002 and see what was going on. Now there are
a couple of things going on here and I actually need help from the subcommittee
to see what sort of response, as well as what additional investigation we might
need to do around all of this.

There are sort of two issues, one is should supplies be able to be billed
using an NCPDP transaction, and that’s one particular issue. There’s also the
issue which was really part of the original request from NCPDP, which is really
what made the whole thing so problematic, at least as I remember looking at it
from a couple of years ago, that they were describing the use of a couple of
different code sets for the actual billing of those supplies, and these were
code sets that we were not familiar with, did not do additional hearings on
because of the press of events otherwise, and really have no knowledge of the
quality of those code sets, I mean by our acceptance of the original
recommendation we’re obviously not only just approving the transaction and its
use but also what at least appear to me to be effectively accepting two other
medical code sets under HIPAA.

And so I guess the question number one is what sort of letter might we want
to respond to them about, and then the other question is is do we need a
briefing or dig in a little deeper around this issue of these code sets that
NCPDP was recommending for supplies. Now that’s the question, should we take a
look at this letter and then we can reflect on that issue.

Maria, you’re looking pained, is that, this is the advantage of having long
plane flights on the way to NCVHS.

So our letter that we have sort of put together is thank you for your
February 16th letter concerning the recommended use of NCPDP 5.1 for
billing for supplies as a standard under the provisions of HIPAA. The NCVHS did
not act on the recommendation, however we understand that the Department of
Health and Human Services is aware of your request and the issues underlying
it. We further understand that the department is taking these consideration
into account in its rulemaking deliberations. We look forward to continuing
collaboration with the DSMOs as HIPAA implementation moves ahead.

A relatively vanilla response but then bringing up these other issues about
whether or not we need to pursue a little more around all of this. Maria? Tom?

MR. LOUDER: Thank you, my name is Tom Louder and I’m with AAHP/HIAA and I’m
here today not only on behalf of our member companies but also on behalf of a
coalition that includes the Academy of Managed Care Pharmacy, the American
Pharmacists Association, the Pharmaceutical Care and Management Association,
the National Association of Chain Drug Stores, and the National Council for
Prescription Drug Programs, and we very strongly urge that you give favorable
consideration to the NCPDP request and if not that you put this issue on your
agenda for discussion and resolution at the earliest possible moment.

Just to give you a little bit of background, and we did send a letter and a
white paper to this subcommittee supporting our request, currently most retail
pharmacies use the NCPDP standard to bill both prescription drugs and supplies,
it’s a real time standard and it permits the retail pharmacy to get an almost
instantaneous response back from the payer whether or not this is a covered
benefit and whether or not there is any kind of a co-payment or co-insurance
requirement involved. As it came time for the final HIPAA addendum to be issued
I think people took another look at this and had one of those kind of oh my
experiences where if you looked at the way the standard came out it appeared as
if you would continue billing the prescription drug using the NCPDP standard
but you would have to use the 837 to bill the supply, and the problem with that
is the 837 professional claims standard is not real time, it’s a batch
transaction, and so you would have a situation, just as an example where
someone would go into the pharmacy and they would have this prescription for,
let’s say they’re a diabetic and so they’ve got a scrip for insulin and four
syringes and the pharmacist would say to them okay, that’s fine, I can go ahead
and clear the prescription for the insulin but because I’ve got to use the 837
for the supply I’ve got to wait to clear that to give you the supply or in the
alternative I’m going to go ahead and give it to you but I’m kind of on the
hook here for the supply.

Just to give you an example, one of our member companies bills over a
million dollars a month in supply claims right now using the NCPDP standards,
so last August on behalf of this coalition we wrote to CMS and we went and
talked to them, I know Stanley was there at that meeting, and kind of laid out
the issue and at the time we were saying to CMS that we thought that the
standard was actually somewhat unclear, that as long as the payer and the
pharmacy worked out what standard they wanted to use it was okay for them to
continue using the NCPDP because that’s what they’re using now, most of them,
and CMS response to us was no, that they felt like it was pretty clear and that
you had to use the 837. But they also pointed out to us there is of course this
kind of interim period where you can use a contingency plan, which is what most
of the members of the coalition are continuing to use as under this contingency
idea there continuing to use the NCPDP standard for both supplies and for
prescription drug claims. But I can tell you for the members of this coalition
it’s a huge issue and it needs to get resolved sooner rather then later.

DR. COHN: Tom, can I ask you a question because I actually reviewed, and I
think many of you, I will apologize if not everybody received your letter, but
I think I sent it out to everybody, you sent it to a number of us, okay, I did,
there are obviously a couple of new members that didn’t receive it. The letter
that I received from you obviously spoke very strongly in support of the NCPDP
5.1, and I think the reasons you’ve given are good reasons, real time response
and all of this. I didn’t see anything in that letter that in any way dealt
with the other issue that I was reflecting on, which was the use of the UPC or
HRI for the billing of supplies within the NCPDP standard. Was there a position
that your coalition was taking on that? Is that something that you’ve all
investigated and have an opinion about?

MR. LOUDER: I don’t know that we’ve investigated and have an opinion, I will
just say, because this is actually the first time it’s kind of presented itself
in that context, I’ll just say right now that our members are very successfully
using the NCPDP standard, whatever that may mean in terms of these codes.

DR. HUFF: Are they using consistent codes, or are they all using, do they
have bilateral agreements about what codes they’ll put in this?

MR. LOUDER: That’s a good question and that’s something we can dig down
into.

DR. COHN: I guess, Harry?

MR. REYNOLDS: NCPDP I think is a good thing, the two code sets when we’re
dealing with a regulation that’s already got a lot of code sets, understanding
that, I would like to know more about it, personally I would like to know a lot
more about that before I’d vote it yes or no.

DR. COHN: Okay, I guess the question is, I mean this letter obviously
doesn’t address that piece but we can obviously go forward with this letter and
we can also just tell, since we’re expecting to see the DSMOs and I expect that
Lynn Gilbertson would be there actually at the meeting where we have this sort
of yearly discussion, we could at that point have a session where we sort of
get some briefing and I know that Stan had offered to tell us more about these
code sets and we might get others to tell us whether or not this is good or the
right way to go or not. But once again, I guess in my own view it doesn’t take
a lot of brain power to figure that geez, if you’re a pharmacy and you’re
billing supplies you probably want to use a real time transaction and so to me
that’s not an issue and I was once again reflecting that that was not what
caused us to not address this issue a couple years ago, it was really the code
set issue and I know as little now as I did two years ago about that so it
sounds like we need to dig into that further and I’d obviously love it if you
would talk to your coalition because we may ask you to come and give us your
thoughts at that point.

DR. HUFF: I guess depending on how long we think that might take to
investigate, because it seems like we’re unanimously saying that we support
NCPDP as the format standard, and could we make that statement with another
sentence that said we need to investigate further what code sets should be used
in that transaction.

MR. NACHIMSON: When this issue came up a couple of years ago during sort of
the addenda process it came out after the proposed rule was published, which
was one reason why we couldn’t put it in the final rule, but there was also I’d
call it dissention within the industry, there was not, after the final rule
came out that said you use X12 for supplies, NCPDP for retail drugs if you’re a
pharmacy, there was not unanimous consent or even consensus in the industry
about which to go to make the change and in fact some of the letters that we
got even to this day say that some health plans ask for supplies to be billed
on NCPDP, some health plans ask for supplies to be billed on X12, some health
plans ask for prescriptions to be billed on X12 if it’s considered a medical
benefit. Some health plans call for drugs to be billed on NCPDP. Realizing that
there’s not consensus in the industry was one reason why we didn’t make a
change at that time but also why this is one of the issues that will be
considered in the upcoming NPRM and allow for public comment. Although your
coalition may have a different interpretation of the current reg then we do we
at least recognize that it is clearly an issue that should be reopened and we
intend that issue be reopened in this upcoming regulation, whether the
subcommittee wants to discuss the details now or when we get closer or after
the proposed rule is published is certainly a decision that is up to you but
the department is clearly aware of this issue and willing to deal with it.

DR. COHN: Okay, well I guess we have some options about what we do with this
letter, I mean we could say based on this conversation that we add a sentence,
maybe we don’t try to do the NCPDP sentence like we support this but we want to
know more about code sets, we could just say to them expect to be discussing
aspects of this further at our March 31st hearing assuming people
are willing. We’ve got like a really full plate coming up next year so I’m
afraid to sort of start overwhelming everybody.

MR. BLAIR: Simon if that’s the case and we’re going to hear more about this
on March 31st why do we even need to actually send a letter?

PARTICIPANT: This is really just because there wasn’t a full resolution to
it so the DSMO is just coming back to the committee and saying where do you
stand on this. There is a sense of urgency from NCPDP and that was expressed to
us. There is a white paper, a great white paper that NCPDP put together on the
billing for supplies and that may answer your questions if you don’t want to
wait until March 31st or whatever, it may answer your questions
about current practices and using those code sets. I don’t know, others may
know better then I if that’s available on their website, if not you certainly
can get it, I could get it to you tomorrow if you want to distribute that, so
that’s the first thing, I really think you might find answers in that. And the
second thing is Lynn Gilbertson at least at this point is not planning on
coming here to talk about this unless you’ve expressly not in the context of
DSMO, so if you think you want to add an agenda item you need to reach out and
let them know that because the plan the right now was for Gary to come, Lynn
doesn’t typically come, for Gary to come and just talk about the DSMO annual
report but Lynn wouldn’t necessarily be here unless you invite her for this.

DR. COHN: I guess since she has been the one writing the letter I’d presumed
we’d be seeing her. Maria?

MS. FRIEDMAN: Do we really even want to have an agenda item knowing that
this issue is under consideration and will be addressed in the modifications
reg? Wait and have those conversations after, or will they even be needed
depended on how it’s written?

MR. BLAIR: When does the modifications reg come out?

MR. NACHIMSON: Later this year, it is planned for 2004.

MR. REYNOLDS: Devoid of any recommendation from this committee, there is no
other hearing, is that correct Stanley? Where the industry could give further
testimony?

MR. NACHIMSON: Not a public hearing but certainly the public comment
process, NPRM is the opportunity for an open —

DR. COHN: And if we’re going to talk about this we need to talk about it
soon because once an NPRM comes out, I mean we can comment on the NPRM but we
don’t hold hearings on topics that are being brought up in an NPRM during a
comment period, it’s way too confusing for everybody.

DR. FITZMAURICE: Stan, when this comes out will it come out as an NPRM or
will it come out as a final rule, these changes?

MR. NACHIMSON: It’s NPRM.

DR. COHN: As I said I personally think that the code issue is still an
outstanding, it will likely be something we’d want to look at —

DR. FITZMAURICE: That does give us some time, if it’s going to be an NPRM,
even if we don’t address it comments can come back saying please address this.
If we act sooner they’ll address it in the NPRM.

MR. BLAIR: For whatever it’s worth Lynn is planning on being here to testify
to us on e-prescribing on the 30th, which is the day before the
31st, so if there’s any convenience in the fact that her trip would
be here.

DR. COHN: Let’s do this, what I think I’m hearing A, is that we ought to for
example look at this letter, what I’d like to be able to do is to read it to
the full committee tomorrow and it’s pretty non-offensive, it shouldn’t hurt
anybody’s feelings. I guess what I’m thinking is is that we should, I mean
assuming that you’re all willing we could A, approve this letter so that it
could be read tomorrow as a hey, we’d like you to act on it. B, I’m hearing
that Maria will be handing us a white paper that I sort of dimly remember from
the old days but I’ve seen a number of white papers but this is a different
white paper that NCPDP produced. My memory is that it still didn’t address the
code set issue but I’d be happy to be wrong, I mean this is getting to the
limits of my space between my ears. So I mean we may, if we could have some
copies of it we could all review it and then make a decision at our breakout
tomorrow about whether we want to spend one session sort of getting briefed on
these code sets, seeing how we feel about them, hearing a little about it and
seeing if we feel comfortable going forward with anything around that or
whether we still come away feeling it’s too confusing and don’t want to deal
with it.

DR. FITZMAURICE: I agree with that plan, it sounds like a good plan. I
wanted to draw attention that earlier we said that NCVHS understands about the
claims attachment but I think the claims attachment rule is in a public notice
that says this is on our standards plate for the coming year. Here we’re
talking about the we understand the department is aware of your request and we
further understand, we don’t say how we understand, it’s not public knowledge
—

DR. COHN: So?

DR. FITZMAURICE: So do we say rumor has it —

DR. COHN: Michael, I’m a special government employee.

MR. BLAIR: Could I ask a question? The letter isn’t a problem, it’s kind of
non-committal and so I wonder if the letter has value to NCPDP and the
representatives that use NCPDP that testified then I’d say okay, let’s go ahead
with the letter. But does it even have value because if it doesn’t then we
could use our time on other things until the 31st.

MS. FRIEDMAN: They had asked basically for closure on this and so this is
the closure —

MR. BLAIR: But the letter doesn’t give closure from what I could see, it
basically —

MS. FRIEDMAN: It said we didn’t act on this recommendation and that was the
request, did you act on it or didn’t you and we never heard back.

DR. FITZMAURICE: Let me address the other point, Simon, and that is as a
special government employee we can’t make comments about pre-decisional
material, if we don’t know this publicly then it’s pre-decisional material that
the department is aware of that request.

MS. FRIEDMAN: Didn’t Stanley just say —

DR. FITZMAURICE: Oh, if he said it then let’s say CMS. But otherwise it
looks like rumor has it —

MS. FRIEDMAN: — so does it really matter?

DR. FITZMAURICE: Well, if I’m reading the letter and it’s a public letter
well, how do they understand this, how do they understand it, the rumor mills
say that, how do we act on the basis of a rumor.

DR. COHN: Should we say the department, how about this, how about if we say
rather then we understand we say, get rid of that first part of the sentence
and we say the Department of Health and Human Services is aware of your request
and the issues underlying it.

PARTICIPANT: That makes it worse because that’s even more —

DR. STEINDEL: I think we should just say Stanley is aware of your request —

PARTICIPANT: And he’s on it.

DR. FITZMAURICE: Stanley while you were out we raised the issue of can we
say that since there are special employees around here saying something about
that maybe pre-decisional, that there’s no public knowledge of —

MS. FRIEDMAN: He just said it and he’s a real employee.

DR. FITZMAURICE: I don’t think we want to pin Stanley to —

PARTICIPANT: I say put his name in there, and his phone number, for
additional questions —

DR. FITZMAURICE: But does it say we’re taking into account what Lynn
Gilbertson wrote? I don’t think the agenda is that specific.

DR. STEINDEL: I was actually rereading the letter because I did have a
suggestion in that Stanley did say they were working on a modification rule for
2004 but this is very specific concerning something that might be in the
modification rule.

MS. FRIEDMAN: And unfortunately we can’t discuss content, it’s about as far
as we can go to say that we’re aware of the request and issues underlying it
and we’re taking it into account.

MR. REYNOLDS: Simon one way of thinking about it since this has come in
front of us again and there are new code sets involved wouldn’t it be prudent
for us to understand what that might effect? So that if we have a
recommendation at this point to make it, so that the next letter back to the
DSMOs —

DR. COHN: Well, we could have the next letter back to the DSMOs being a
physician or we could say something like we expect to further discuss this
issue on March 31st.

DR. FITZMAURICE: I like that better.

DR. STEINDEL: If the whole purpose of this letter is to just close the issue
with the DSMOs then we should say that the national committee did not act on
this recommendation however we do plan to discuss it on —

PARTICIPANT: [Comment off microphone.]

DR. COHN: So what I hear that I’m getting buy-in from the rest of the
committee, subcommittee, to add this to our list of items, okay. As I said at
this point don’t want to make any further commitments of the subcommittee time
until we’ve had, I mean we want to get buy-in as we go forward here as you
begin to look at the agenda for the year you’ll appreciate my comments.

MS. FRIEDMAN: Do you want me to then take out all the stuff about DHHS?

DR. COHN: Yeah. So is this letter okay?

MS. FRIEDMAN: I don’t want to put a date on the hearing because we don’t
know about people’s availability and the agenda.

DR. COHN: Are people comfortable with this letter?

MR. BLAIR: I move that we approve the letter.

DR. HUFF: Second.

DR. COHN: Comments and discussion? All in favor?

SUBCOMMITTEE: Aye.

DR. COHN: Against? Abstentions? Okay, got this one passed. Boy, for a
vanilla letter this took a lot of discussion. Basically I think the
conversations around the code sets were actually very helpful.

Agenda Item: Subcommittee Discussion of
E-prescribing Work Plan – Dr. Cohn and Mr. Blair

DR. COHN: Now I think our last issue for the day and I’m sure we’ll continue
discussing this tomorrow is our e-prescribing. I should ask everybody you okay
with another half an hour, discuss more work, you may regret having already
agreed to work on this other standards issue.

This is actually, I mean this probably is a good introduction to it all
because this is going to be our light for the next eight to ten months where
we’re going to be sort of juggling priorities and we’re going to be dealing
with this issues of e-prescribing as well as all the rest of our HIPAA agenda,
so just keep that in mind as we talk about all this. Now Jeff I think you
wanted to start talking a little bit about the e-prescribing work plan and all
of this. I guess I’m hoping that we’ll, I mean we’ll talk about the work plan
today and if we’re sort of comfortable with the timelines we’re talking about
we’ll get down to the actual physical acts assuming we’re comfortable with that
of trying to figure out how to schedule the time tomorrow that we need. Jeff,
please go forward.

MR. BLAIR: Do you all have copies of the work plan in front of you? Okay,
then we’re dismissed.

Alright, you probably have noticed that this is version seven and there will
be more, this is ongoing work. Now we have some new members here who may not
have heard our discussions about this in December so let me go through this as
quickly as I can and what we’re driving towards to be honest with you is for
you to understand the scope of the commitment we’ll have to be making as Simon
said.

Okay, the Medicare Prescription Drug Improvement and Modernization Act had a
section in there asking the NCVHS to come up with recommendations for
e-prescribing standards. It was a little bit unusual in that it was especially
directive to us, outlining not only the stakeholders we should listen to but
also a number of the issues related to e-prescribing that we should consider
for standardization. In the work plan if you can flip to the stakeholders that
are there, I don’t remember the section number so I can’t tell you by number,
but there’s a list of stakeholders. Well, the law wound up indicating quite a
long list of folks, everything from pharmacists, pharmacies, physicians,
hospitals, PBMs, state boards of pharmacy, state boards of medicine, federal
agencies, they listed all these things and that was plenty, but when we took a
look at it we realized that it didn’t include the current demonstration
projects for e-prescribing, it didn’t include the existing implementations of
e-prescribing, the networks that are being developed, and it didn’t include the
vendors and it didn’t include the SDOs, so we added those and that wound up
being a very healthy list, and there may be more as we go through this process
so this may not be entirely completely but at least I think we’re maybe
starting to get close to all of those folks that we need to listen to either by
law or what we deem to be really pretty important stakeholders that we should
be considering their testimony.

Now the other piece that was interesting in the law was that it wound up
indicating a pretty interesting list of areas that we should consider. It
included not only eligibility issues like patient eligibility for a
prescription but also whether or not the formulary would, whether they’re
eligible based on the formulary for that particular prescription. Obviously the
message format or transaction standard for communicating the prescription, the
code sets and terminologies that might be part of that. But it went on to list
a number of other considerations including drug to drug checking, drug to
allergy, drug to history, and it does turn out that they’re referring to the
history of medications that the patient is taking, and did I say drug to lab,
and dosage forms I believe was also in there. So it had a pretty interesting
list but it also included electronic signatures as well.

Now as Maria and Karen Trudel and Simon and Steve and I wound up trying to
make some of the first cuts at this work plan it became apparent that there’s
quite a bit of sense of urgency to try to produce interim recommendations as
soon as possible. Before I go into the interim recommendations let me just put
in perspective that our recommendations to the Secretary are part of a series
of major events that would be leading to e-prescribing standards in some form
nationwide.

The Secretary is supposed to report to Congress by September of 2005 the
initial standards recommendations. We feel like in order to give the Secretary
and Health and Human Services enough time to take a look at our recommendations
and turn them into whatever that recommendation would be we feel like we really
need to have our recommendations, our final recommendations by June of 2005,
and the interim recommendations, which I’ll get to in the work plan, by the
November full committee meeting of 2004. Following the Secretary’s report to
Congress in September 2005 e-prescribing demonstration projects are scheduled
for 2006. The results of those would then be reported by I think it’s April
2007 and the Secretary is to propose, or rather I think the word is promulgate,
final e-prescribing standards by April on or before April 2008, and I think
that there’s many people who would like to see that happen prior to April 2008.
You may notice that there is about, there’s quite a bit of time after the
demonstration projects are done so there is a possibility there that an NPRM
might be done but it’s not determined at this time whether it will be or not.

Well I think that that gives you an overall perspective. Maria, correct me
if I’ve misstated anything.

MS. FRIEDMAN: No, it all sounds —

MR. BLAIR: I didn’t lie? Not so far. Okay, now lets get back to trying to
see what it would take for us to get interim recommendations to Health and
Human Services by November of 2004 and that’s what Simon was saying when he
said the next eight to ten months looked pretty heavy.

What we did was we try to see how could we carve this up, how could we
divide this up, what would be appropriate for the interim recommendations. And
it was very hard to divide a lot of this out so there’s a list of priorities
there which you probably notice, which is the terminology, excuse me, the
transaction standards, the terminology standards, the things that I listed as
decision support which is drug to drug, drug to allergy, drug to lab, all of
those pieces, and also the requirements of state and federal agencies as well.
We had a hard time dividing those out either into near term or long term, we
had a pretty much group those together. The only thing that we felt we could
really carve off as a separate piece was the electronic signatures area. So if
we are to go forward with that mindset, I just came back from four days at
NCPDP and there’s a lot to e-prescribing that I think many of us really need to
learn in terms of a foundation, some of my preconceptions were not quite right,
there’s a lot of interesting differences from the world of electronic health
records and acute care.

So Maria is taking the lead in pulling together for us a day of education on
March the 30th —

MS. FRIEDMAN: That’s tentatively outlined there just to give you a feel for
what our current thinking is, it may change a little bit but it will give you a
flavor of what we thought the day would look like.

MR. BLAIR: Yes. And please observe that, and I don’t know what this
particular one says, if it does say NCPDP on the item list there, we’re looking
for more then just NCPDP representing the scrip standard, we’re looking for
them to represent the industry with respect to the different models of how
prescriptions are conveyed, the different information requirements, the
different constraints, the market overall as well as how the scrip standard
addresses and deals with these different models. And similarly with the
e-health initiative and Simon had pointed out in one of our discussions that it
is our hope that we could wind up having some overlap where we could get
somewhat different perspectives from each of the folks that testified to us.
Maria, did you have anything else that you wanted to indicate about?

MS. FRIEDMAN: No, we were talking about maybe a list of structured questions
that we could get everybody to address or at least topics that we would like
them to touch on as well as you’ll notice that there’s a group of feds there as
well, federal perspective, VA, us, FDA, kind of an overview of where those
agencies are again try to get them to touch on similar kinds of —

MS. GRAHAM: We’re not listed here but you’ve asked me, the other thing I’d
like to ask that DOD be added because we are Congressionally mandated to be
able to do many of these things by 2005.

DR. BICKFORD: You also need to consider DEA don’t you?

MS. FRIEDMAN: DEA will be handled later because the e-prescribing piece, if
you look through the agenda it’s going to be handled separately much later.

MR. BLAIR: Please understand this is just an introduction day.

MS. FRIEDMAN: So that’s why DEA is not on the list but I will certainly add
—

MR. BLAIR: Now if you look down to the schedule section in the work plan
what we did was we tried to lay out the first four priorities after the
introduction day, the first four of our five priorities would be part of the
interim recommendations. And when we looked at all the stakeholders and started
laying them out on a calendar, and this one is incomplete, I think Maria has an
update that we will probably develop after today and tomorrow with additional
discussions on schedule, but we were looking at between five and six days of
testimony laid out probably a couple days in May, and although it shows I think
here, if this is the right one, three days somewhere in July or August, that
will probably become four days with maybe two days in July, maybe two days in
August, that’s something we can discuss. Maria, did you have any other —

MS. FRIEDMAN: No, I think the idea was not to overload people and there’s
availability issues, but on the other hand we really need to make sure that all
the effected stakeholders have sufficient time and opportunity to come in and
tell us what they need to tell us. And so we’re looking, I would consider two
days in July, two days in August.

MR. BLAIR: No the mindset on this, this May, July and August timeframe, this
is where we would be hearing from all of the different users of the
information, either users that are prescribing or filling or providing
formulary information or DUR information, drug utilization review information,
into the system or regulating it or accrediting it. So in a sense after that
overview, which will be March 30th where we’ll get a feeling for
what’s there, all of these will be the folks that will wind up indicating how
they use the standards, what standards they need that are not there, what are
the gaps, what are the other considerations, what are their recommendations,
and then at the end of the August session we would take all of these issues,
needs, gaps, and pull them together into a questionnaire, not a big
questionnaire but a list of issues and questions, go back to NCPDP and other
major terminology developers, and they would come back in September and
indicate either that they have plans in place to address those additional
requirements or how they would be addressing the gaps, or what other
recommendations they have for us at that time. So that’s when they return to us
to indicate how they can meet all the requirements and needs that have been
identified in May, July, and August.

And then following that September session we would then wind up going
through our traditional three drafts, in this case of an interim recommendation
letter, which we hope and trust would be approved by acclamation by the whole
NCVHS committee in November. Simon and Maria do you have any comments on this
portion of the schedule that I’ve left out?

DR. COHN: Well, you already know my comments, every time I look at this
schedule I turn almost green just because of the number of days and yet I’m not
sure I see much of an option. I mean we can look at everybody’s schedule and
I’m sure there’s the ability to do some wiggling around of schedules one way or
another, one option might, we are sort of stuck with full committee meetings
the very beginning of September and then at the very beginning of November.
This would be one year where I had wished they had decided to leave the
November schedule late in November and give us a little bit of additional time.
But there may be some ways, if we can’t do four days in summer that we do some
days in summer, some days in early September, and then in October. But I’m not
sure that I see that there’s ways to curtail the number of days that we’re
going to hold hearings, in fact as I’ve looked at some of the, for
presentations, for example on day, one day you have physicians for an hour and
a half, hospitals for an hour —

MR. BLAIR: We’ll probably need more time.

DR. COHN: Well, I’m not terribly certainly that we’re going to be able to
hold it to that level nor should we —

MR. BLAIR: Can we ask people to speak fast?

DR. COHN: It leads me to believe for example when Jeff talks about a half
day in October, he said one of the reasons in an email, I sent it to everybody,
we probably ought to try to schedule two days in October because my belief is
that all this could shift back and be a lot closer to November, so I do think
we need to try to get the interims out in November but it may require, as I
said I think that’s a little bit optimistic.

Having said that you all may have a better idea then I do, as you know I’m
not happy about this one but I’ve also sort of resigned myself that we’re going
to have to do something like this. Judy?

MR. BLAIR: Would you mind if I just sort of stepped through the rest of the
schedule and then we can —

DR. WARREN: The five priorities that were here, were those specified in the
law or were these priorities that the subcommittee came up with?

MR. BLAIR: We derived those priorities right out of the things that were
indicated in the law, they wanted eligibility, they wanted electronic
signature, they wanted all of —

DR. WARREN: My next question is in priority number one can we change
physician to provider?

DR. COHN: Sure.

MR. BLAIR: Good. The other piece that I would add is we put e-prescribing,
which will probably take more then one day, not e-prescribing, electronic
signatures, probably in that January, February, March timeframe, we probably
have at least two days I imagine, but at the same time it gives us a little bit
of room if we decide that there’s an ambiguous issue that we couldn’t get
resolved for the interim recommendations then we could follow-up with maybe
additional clarifications during that first quarter of 2005 and then the second
quarter of 2005 we would go into the phase of first, second, and third drafts
of our final recommendations with the expectation that that would be approved
by the full NCVHS committee in the June 2005 full committee meeting.

So that was our take at laying this thing out, any ideas, questions?

MR. REYNOLDS: In trying to think through how to think about this
e-prescribing, I try to go down to the basis, and the basis to me is the
physician in the office, the pharmacy that they send it to, and the PBM that
answers it.

MR. BLAIR: And the vendors —

MR. REYNOLDS: Yeah, but I’m saying initially. But I would like to see if we
couldn’t move those three entities up earlier in the testimony so that as you
listen to vendors, as you listen to people talking about codes, as you listen
to everything else we’re keeping in mind that the only way this can be
ultimately successful in my opinion is if the general practitioner or the one
doctor in an office can make it work and we at least take them into
consideration. And listening that way, because a lot of times if you listen to
vendors first or you listen to anybody else first you get molded in your
thinking as to what they’re delivering, that may not be what the end
constituency is looking for.

MR. BLAIR: So let me try to capture this. You’re saying that the first
groups we should hear from are —

MR. REYNOLDS: After the education.

MR. BLAIR: After the education would be physician, PBMs, and pharmacists,
that group.

MR. REYNOLDS: That’s just a recommendation, I think it sets the stage for
who are we dealing with.

DR. COHN: Do you think health plans are part of that universe or you think
—

MR. REYNOLDS: Not initially, no, because most of them use PBMs.

DR. COHN: Well, no, the reason I’m asking is because the health plans
typically do the formulary management.

MR. REYNOLDS: But the PBM has to have that, okay, you’re going to get the
eligibility, you’re going to get the formulary, and you’re going to get all
that from the PBMs, so that’s why, it was a direct track right to the end, who
did it, who do I go to as a patient to get if filled, and did the PBM, yes,
there’s plenty other ways around that but that gives you a basic very clear
track as to what the issues are.

MR. BLAIR: Could I ask you one —

DR. COHN: I think Harry is using the physician as described under Medicare,
Judy.

MR. BLAIR: One of the thoughts was is that there’s a number of networks that
are moving very rapidly forward with implementations now in demonstration
projects. And as you probably notice you put those up early because we figured
we get real world feedback in terms of what they are doing, what they are not
doing, and they’re in Massachusetts and Ohio and Rhode Island, other areas, do
you want them to wait until after you’ve heard from the other three?

MR. REYNOLDS: I would put them right afterwards because again, we hear from
the constituency, then we hear what people are doing, and see if that’s
actually matching what we heard from the constituency. Again, a lot of people
do pilots and they do pilots based on the local environment, they do pilots
based on lots of other things, that’s the only reason I said it, Jeff, I
personally don’t want to be tainted by what’s already going on —

MR. BLAIR: Does the rest of the subcommittee agree with those priorities?

DR. COHN: I think Mike had his hand up, were you agreeing or further
commenting?

DR. FITZMAURICE: I’m agreeing because I can hear what Harry is saying, let’s
find out what functions the three major users want, what are the principles
that a system has to meet for them and then as we hear from the others we can
see is it possible to meet what they want. It gives us something to shoot at,
how close can we come to that target of things that they said they need. And
maybe you have a list of here are the absolutes that won’t work unless you have
this and we’d like to have these from the physicians, the PBMs, and the
pharmacists.

MR. BLAIR: Now I only have one thought because I’m willing to accept that,
but the only thought that I had was that I was a little concerned that in terms
of the physicians and hospitals that we’re mandated to listen to and that we
want to listen to, I’m a little concerned that many of them may not have that
much experience yet so I was trying to go for the experience first. Do you feel
like that’s —

DR. COHN: I don’t think we’re talking about hospitals.

MR. BLAIR: They listed hospitals as well.

DR. COHN: Well no, talking to them, but I don’t know they’re a prescriber of
Part D medications I don’t think.

MR. BLAIR: They’re not but they were there.

DR. COHN: No, a lot of stakeholders.

MR. REYNOLDS: I wasn’t eliminating any stakeholders, Jeff, I was taking
those three and putting them up at the top.

DR. STEINDEL: Actually I have a concern about shifting the order and it’s
because of what our charge specifically is. The charge to the NCVHS is to make
recommendations to the Secretary concerning standards for e-prescribing, not
necessarily to make recommendations to the Secretary for the e-prescribing
system. Now if we were going to do that I would agree with your order, I’d want
to hear from the people who were using it first to see what we need to
recommend. But what the Secretary has asked us to do is take an inventory of
standards that are out there and then report back to him what areas are covered
and what areas do we need coverage. So I think we need to first find out what
is really being covered by standards, what standards people are really using,
which is the way Jeff’s plan is laid out, and then look at the groups and ask
them, well, we heard there are standards for this, do you really use it,
probably we’re going to hear no, what other types of standards might you need,
well, we might need this. So we’re actually hearing it from the necessary
background when we talk to the actual users. That’s the way I viewed the work
plan.

DR. COHN: Harry, I’m actually looking at session two, day one, May
27th, and I’m wondering, I’m sort of seeing there we have people
doing things, I also see PBMs and physicians, and obviously I don’t see
pharmacies there which I think is maybe the issue. I’m just sort of wondering
does this begin to —

MR. REYNOLDS: That’s fine, I just was recommending an order because a lot of
times we forget, in many of these things we do we forget the people who
actually do it. But we’re going to include them, I understand, if you don’t
change it it doesn’t bother me at all, just threw it out as an example.

DR. COHN: I’m just sort of wondering if there’s some way to insinuate it
around only because otherwise, I mean the way we have them is sort of moved
around here, we have pharmacies off on during the summer for two hours, you’re
absolutely right what you’re saying. I guess I’m wondering if maybe we need to
hold your thought and sort of think about, and maybe the answer here is we have
a whole day orientation and maybe at the end of that day we’ll say geez, we
really have a better sense of physicians, PBMs, and whatever, and we can sort
of reconsider —

DR. STEINDEL: I think Simon capturing that thought, I think after the first
day and after the second day we’ll probably going to be making changes in this
work plan —

DR. COHN: Other thoughts or comments about all of this stuff? I mean does
anybody have any ideas about how we can do this so efficiently that we can get
down to two days during the summer for example?

DR. STEINDEL: I have put a request into the department for an NCVHS house
for this project in Georgetown, with tennis course and swimming pool.

MR. BLAIR: Did we accomplish Simon what you had hoped today and then —

DR. COHN: I think this is sort of an orientation to sort of what the work
plan does. Tomorrow obviously we’ll expect people to bring sort of calendars,
we’re not going to sit, I don’t think we’re going to start negotiate out dates
but we might. I’m hoping that if I can find a couple spare moments that were
sort of ranges of dates that we had been looking at moving out into the year
and we’ll be asking is having people sort of put X’s on dates that they’re
available and we’ll take that and if there’s some clear dates we’ll sort of say
on Friday hey, these are the dates you should hold.

MS. GRAHAM: I have a question about the questions, especially for the March
30th, the committee is actually writing questions or is it going to
be more like we’ll hire a pharmacy consultant like we did for the
terminologies?

DR. COHN: Well, we are going to get a consultant but I think we have to
agree on the work plan first so that we know what we’re hiring a consultant to
help us with. They do typically sort of charge on the basis of all of that
stuff. And I think that once we agree to the work plan then I think Maria
begins to write up a work order, or Mike or somebody around the table here
begins to follow that. In terms of actually questions for the 30th I
think we need to be, I mean realistically I don’t think we’re going to have a
consultant on tomorrow so if you have questions that you think need to be
addressed —

MS. GRAHAM: We’ve got our pharmacy people looking at it, certainly if they
have things that they would say this is the kind of thing you should ask we’ll
just send those to the committee —

MR. FRIEDMAN: Send them to me.

MS. GRAHAM: Okay.

MS. FRIEDMAN: And if anybody has burning issues that you think need to be
covered we can put them on the list and we may have to winnow them down because
obviously it’s going to be a very packed agenda as it is but still we would
like to get everybody to try and cover the same territory.

DR. COHN: Now it’s 5:49 now. Are they any other issues coming before us
today? Okay, once again my apologies. Okay, we will adjourn, we have a one hour
breakout tomorrow, full committee is meeting at 9:00 a.m. at HHS, Hubert
Humphrey Building, I look forward to seeing you then.

[Whereupon at 5:52 p.m. the meeting was adjourned.]