[This Transcript is Unedited]

National Committee on Vital and Health Statistics

Subcommittee on Standards and Security

January 28, 2004

Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, SW
Washington , DC 20201

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 [8:55 a.m.]

Agenda Item: Call to Order - Dr. Cohn

DR. COHN: We're going to get started here in just a minute, would everyone please be seated? Okay, good morning, I want to call this meeting to order. This is the second day of two days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee is the main public advisory committee to the U.S. Department of Health and Human Services on national health information policy. Obviously I also want to mention for those of you in attendance that there is actually a full meeting of the committee scheduled for tomorrow, so you're obviously welcome for that also.

My name is Simon Cohn, I am the national director for health information policy for Kaiser Permanente and chair of the committee, and I apologize, I seem to have a frog in my throat here. I want to welcome fellow subcommittee members, HHS, and others here in person. I also want to welcome those listening in on the internet, and of course as always I want to remind everyone in the room to make sure to speak into the microphone and speak clearly so those on the internet can hear us in our deliberations today.

Obviously there's a lot to cover today. This morning we begin with a HIPAA update and we're pleased to have Karen Trudel here sort of telling us a little bit about implementation as well as recent developments for HIPAA. That will be followed by a discussion on the claims attachment work and sort of a discussion really of what should be the next steps for the committee, I think we had drafted a letter but really the question for the subcommittee is whether we're ready to move forward with a letter or whether we need to do further investigations and discussions with the industry and public before we move forward with a letter at this point.

Following that and after our morning break is a discussion with the dental community. The focus of that session is really on SNODENT and whether it is appropriate to recommend SNODENT as a clinical terminology for dentistry, an issue as you remember was sort of still open from our PMRI deliberations from last year. But having reviewed some of the testimony I think we're all aware that there are other issues that are going to be coming before the subcommittee in terms of just general discussions around coding issues and the dental community.

After lunch we will further discuss our role in investigating and recommending e-prescribing standards. As many of you know the recently approved Medicare Reform legislation, otherwise known as DIMA(?), calls on the Secretary to adopt standards for e-prescribing and the NCVHS has been directed to develop such standards recommendations. Jim Scanlon and Karen Trudel will update us on the department DIMA(?) work plan, and then we'll be discussing a draft work plan for our work, which I think we'll be reflecting on in our meetings with the full committee tomorrow. Obviously I want to thank Jeff Blair, our vice chair, for his work in terms of putting together I think an excellent draft work plan for us to use in discussion.

Obviously I want to emphasize that this is an open session, those in attendance are welcome to make brief remarks on topics, on issues pertinent to our discussions. We will also have time at the end of each session for brief comment by those in attendance. Finally, for those on the internet we welcome email and letter comments on issues coming before the subcommittee.

With that let's have introductions around the table and around the room. For those on the national committee I would ask if there are any issues coming before us today for which you need to publicly recuse yourself. Jeff?

MR. BLAIR: Jeff Blair, Medical Records Institute, vice chair of the subcommittee, a member of AMIA, ASTM, HL7, HIMSS, and there's nothing on the agenda for today that I'm aware of that I would need to recuse myself.

DR. HUFF: Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City. I would need to recuse myself if we talk about HL7, LOINC, or ICD-10-PCS.

MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services.

DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, member of the committee and subcommittee.

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

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

MS. SQUIRE: Marietta Squire, CDC, NCHS, and staff to the subcommittee.

DR. WARREN: Judith Warren, University of Kansas.

MR. ALFANO(?): Bill Alfano, Blue Cross/Blue Shield Association.

MS. ZIGMAN-LUKE(?): Marilyn Zigman-Luke, AAHP/HIAA.

MS. BLOGETT(?): Holly Blogett, Amisis(?) Center Tech.

MS. FRANK: Sheila Frank, Delta Dental Plans Association.

MS. O'SHINSKY(?): Janice O'Shinsky, Delta Dental Plans Association.

DR. SCHOOLEY: Dr. Ed Schooley, Delta Dental Plans Association.

DR. GUAY: Good morning, Dr. Al Guay, American Dental Association.

DR. KILE(?): Dr. Frank Kile, American Dental Association.

MR. ACORDY(?): Frank Acordy, American Dental Association.

MR. BROWN: Tim Brown, National Association of Dental Plans.

DR. ADAMS: Dr. Roger Adams, National Association of Dental Plans.

MS. IRELAND(?): Evelyn Ireland, National Association of Dental Plans.

MR. ROUDY: Dan Roudy, American Health Information Management Association.

DR. COHN: With that, Karen, welcome, Happy New Year, and thank you for coming to join us and talk about HIPAA and where we are.

Agenda Item: HIPAA Update - Ms. Trudel

MS. TRUDEL: Thank you. I'm going to take just a few minutes to do a brief update on compliance, complaints, regulations in general, and then spend the rest of the time doing a brief overview of the National Provider Identifier final rule, which was published on the 23rd of January. And I'm sorry, Pat Payton, who's the chief author of that document, was not able to come down and do the presentation because of some road conditions up in Baltimore, but I really kind of wanted her to hear some of those applause also.

Let's start with compliance and complaints. The Medicare compliance rate is slowly rising, it's just above 60 percent at this point, and what we're hearing from other health plans is again, that there is a slow but steady increase in the rate of compliance for claims.

In terms of complaints we've received much fewer then what OCR has at this point on their plate, we have a total of 46 complaints, only 35 of which turned out to relate to transactions and code sets, some of the others were privacy, which were forwarded to OCR, or others that were outside our legal scope.

Of the 35 actual transaction and code set complaints 27 of them had to do with complaints that a compliant claim had been rejected by a health plan. Two had to do with companion guide issues where there were allegations that companion guide requirements were in conflict with the implementation guides in the standards. We have five code set issues to resolve, and one issue that has to do with the NCPDP retail pharmacy format. About 48 percent of all of the complaints that do relate to transactions and code sets, the complainants indicated that there was some sort of a cash flow implication that caused them to file the complaint in the first place.

The vast majority of the complaints we received are from small providers filing complaints against health plans. And at this point we have taken in every complaint, we have sent a letter to the covered entity complained against asking them for information, have they fixed the problem, do they have a corrective action plan, and all of them have been responsive to date. We found that we are able to work out many of the issues, changes are being made, and at this point we have not had to go any further then exchanging information and working towards voluntary compliance, which is exactly what we had been hoping for.

So that is the status on our complaints.

Let me talk a little bit now about the National Provider Identifier. The final rule was published on January 23rd, the effective date is May 23rd, 2005. Let me explain why that is. We normally don't have an effective date that is that far out. The reason for that is that we want to make sure that providers who are covered entities can begin to apply for NPIs as of the effective date which gives them the full two years after that to do whatever implementation work they have and also the same for health plans. And we don't that the system for providing enumeration and the contractor who will handle that enumeration process would be in place until next May.

The compliance dates are May 23rd, 2007, for everyone except small health plans, and May 23rd, 2008, for small health plans. And by these dates covered entities must use only the NPI to identify providers in standard transactions.

There was a lot of discussion about what a National Provider Identifier should and should not do, and I apologize for those of you can see these, I'm almost reading the slides, but I'm sure you can't see them on the internet. The NPI will replace legacy provider identifiers, including the UPIN, any other provider IDs that health plans give out, and it will simply transactions, and save money in the long term because everyone will be able to identify a provider in the same way.

The possession of an NPI will not guarantee reimbursement by health plans to that provider, it will not enroll providers in health plans, it won't make a provider a covered entity if it isn't a covered entity. And it will not require providers to conduct electronic transactions.

It's important to note that a lot of the comments we received on the proposed rule had to do with making the NPI more robust in terms of collecting data. The feedback that we got was that an enumeration system could be bare bones in terms of data because health plans were still going to have enrollment processes, and those enrollment processes were going to be much more robust, they would require additional information, they would require additional assessment on behalf of the plan and therefore we didn't need to collect that data twice. Also simplifies keeping the data up to date.

So what does the NPI look like? We started out with an eight position alphanumeric, in the final rule we went to a ten position all numeric with nine, with the tenth being the check digit. It still does not convey any information about the provider and it is compatible with health insurance card issuer standards.

Who can have an NPI? The regulation says that any health care provider can have one, covered and non-covered, individuals, organizations, and indeed subparts of providers. The issue of subparts is a legal one because a provider by definition is a legal entity, sometimes a subpart is not a legal entity but it furnishes health care in a very separate way. For instance, a nursing home chain may be one legal entity but each of the nursing homes within it provide care and billing is done on an individual basis. Each one of those would need a provider ID but the chain itself would be the legal unit. The concept doesn't necessarily correlate to the hybrid entities in the privacy rule but it does allow us to assign provider IDs at a level that's consistent with business needs. This concept of a subpart obviously doesn't apply to individuals.

A covered provider is responsible for determining whether its subparts need NPIs, and the covered provider is responsible for either obtaining it or making sure that the subpart does so. And the covered provider is responsible for any subparts compliance with the final rule.

So how does a provider get an NPI? It's important to note, and I'll note it again, that providers are not going to have to do anything for quite a while, obviously the system won't even be available to provide the identifiers for another year plus. But when the system is available the provider would complete an application form, we will provide for electronic filing, the application would be processed, data would be edited, validated, we would be looking for potential duplicate applications. And then the provider would receive a notification of what their NPI is. We hope to do as much of this electronically as we possibly can.

The information that we will collect will be used to make sure that we are uniquely identifying the provider, that we are not providing a duplicate ID or mixing up two providers, and also will be collecting necessary information so that we can communicate with that provider. So we're asking for addresses, we're asking for birth date name, information that we will use to either check against the database to see if there's already one there, or to make sure that we can communicate back with the provider and say this is what your NPI is. We will be collecting somewhat different information obviously for individuals and organizations and we've categorized the information as being either required, situational, or optional.

Required information for individuals would be name, gender, address and telephone, the taxonomy code which is what their specialty is, date of birth, state/country of birth, contact person's name and telephone number. Situational would be state licensing numbers. Optional will be things like the Social Security Number or Tax ID, other names, credentials, other identifiers.

About organizations we will require similar information, the contact information, authorized officials name. For situational elements the employer identification number if the provider has one. Again, license numbers, if the provider is of a certain type, and optional again, other names or identifiers.

The system itself will be developed under contract with HHS/CMS. It will process the applications, assign the NPIs, it will store the information about enumerated providers. It will apply updates because providers are required to maintain their information and update it as it changes. It can generate reports and statistics, and we do have a system of records notice on file.

The enumerator, whatever organization will run this system and actually issue the identifiers, again will operate under one contract, it will receive the applications and the updates, resolve errors, help with problems, handle data requests, and it will use the national provider system as its tool to do that.

Again, important to note, providers don't have to do anything now. By May of 2005 covered providers will be able to begin to apply for NPIs, we expect extremely heavy initial demand. And the covered providers must begin using their NPIs in standard transactions within two years. Non-covered providers may also apply for NPIs as we said before, having one does not make you a covered entity. There's no requirement for non-covered providers to obtain them or use them, and it's perfect okay for NPIs to be used on paper transactions as well. And in fact we expect that health plans will do this as a matter of administrative simplicity.

In terms of disseminating data we've specified three levels of users, one of which is HHS and the enumerator, those entities would have access to all the data, the health industry, which need enough data to be able to match up the new NPIs with their existing provider base, and the general public. And the amount of data that we would be willing to disseminate to those groups is smaller. Again, we do expect that we will have an initial demand for data in addition to demand for identifiers, and we will protect confidentiality of that data based on our systems of records notice and an output strategy, a data publication strategy is still to be determined and published.

So what are some of the changes from the proposed rule? I think these will not surprise you and in fact I think the NCVHS made a lot of these recommendations. That the NCI be ten position all numeric instead of eight alphanumeric. That there be a single enumerator. That we distinguish between individuals and organizations but would no longer have a separate category for groups. The NPS is collecting less data about providers then initially proposed. And that there be three levels of data dissemination instead of two. Some of the data that fell away when we went to this leaner and meaner approach is race ethnicity, birth country name I believe that is, education information, certification number, all practice locations, membership in groups, and organization type control code.

Some new data is primarily administrative, contact person, a reactivation date if the NPI is closed and then reopened for some reason, maybe the person stops practicing and then starts again, very little additional data.

I'll skip over this, this is just where the different items can be found in the final rule.

The provider requirements are to obtain an NPI, to use it to identify the provider, to disclose it when requested, furnish updates to the national provider system within 30 days of a change, that if your address changes in a month while you're telling the post office you tell the NPS as well. We require business associates to use all NPIs appropriately, and to comply with the requirements for subparts.

Requirements for health plans and clearinghouses, the plans must use NPIs on transactions, may not require enumerated providers to obtain more NPIs. The health care clearinghouses must use NPIs to identify providers on standard transactions so that basically a health plan may crosswalk its existing provider identification scheme within its own walls and systems, but when it sends transactions and when it receives transactions they must use the NPI.

So what should covered entities be doing right now? Becoming informed is one of the few things that providers need to do right now. Health plans need to begin to look at their own processes and systems that are effected by provider identifiers. Hospitals, for instance, that need to report physician identifiers on claims need to begin to look at how they're going to crosswalk and update those identifiers. Develop implementation plans with trading partners and educate staff.

We talked about the effect on providers. The effect on health plans is definitely more significant then for providers, the provider will just view the one identifier. Legacy and health plan assigned provider identifiers will not be permitted, so that the plan will need to crosswalk those with the NPI. There's no information about the provider existing in the NPI, in other words there is no intelligence in the number, a number of plans have assigned provider identifiers so that if it has a first digit it means it's a hospital or it's in XY county, there needs to be some planning and some thought about how to crosswalk those to this new no intelligence rule. It should simplify coordination of benefits considerably and utilization review as well.

Health plans will not need to maintain existing provider enumeration systems but it still will need to maintain enrollment systems and processes, and will need to collect enrollment data, validate data, health plans will always have a need for more data for their business operations then the NPI will provide. And the effect on clearinghouses is similar.

The NPI rule is available on our HIPAA website, which is www.cms.hhs.gov/hipaa/hipaa2, it includes the final rule, frequently asked questions, and analysis of the public comments, and an overview of the NPRM. We will also be providing information via HIPAA roundtable audio conferences and partnering with professional organizations.

Thanks. Any questions?

DR. COHN: Karen, thank you very much for the informative update. I think there probably are a fair number of questions, I know Jeff has indicated that he had a couple and I'll follow on his footsteps.

MR. BLAIR: So we're up to 60 percent compliance with the health claims submissions, correct?

MS. TRUDEL: Right.

MR. BLAIR: Is that based on the volume or is that based on the number of entities?

MS. TRUDEL: For Medicare purposes that's based on a percentage of electronic claims coming in in a compliant format.

MR. BLAIR: But is that individual claims --

MS. TRUDEL: It's volume, volume of claims, not volume of submitters.

MR. BLAIR: Okay. Do we have any numbers of compliance for any of the other HIPAA transactions besides claims submission?

MS. TRUDEL: Medicare is collecting information on claim, the remittance advice, and the COB at this time, and I have to apologize, I neglected to memorize the remittance advice and the COB numbers.

MR. BLAIR: No problem, next question. Congratulations again on having the final rule out for the National Provider Identifier, and it's less then 1,000 pages. And the question I have is one of the comments you made in describing what was included and not included was that it wasn't required to include the educational background of the provider and what I'd like to know, since we're heading down a path where we're going to be dealing with national standards for e-prescriptions and more and more looking at electronic signatures, if the National Provider Identifier provided some degree of certification, somebody is who they say they are, then it might begin to offer some type of opportunity for authentication. But from what you were saying I was starting to get the feeling that it really isn't a certification that someone is who they say they are. Could you please help me understand whether it is or it isn't and do we need to supplement it or --

MS. TRUDEL: I think that there are several issues here, one is that it's a lot easier in some ways to assure who an individual is then who an organizational provider is because then you get into the additional complexity of not only is the person requesting the identifier who they say they are, do they have the authority from that organization to ask for the identifier in the first place. That was a level of complexity that we did not feel that we could get into at this point.

So no, the NPI does not convey any sort of notion of yes, this person is definitely who they say they are, whether it's an individual or an organization.

MR. BLAIR: Or more explicitly whether they're board certified in surgery or not?

MS. TRUDEL: Exactly, exactly.

MR. BLAIR: That is not there.

MS. TRUDEL: No. And again, that was consistent with what we thought the scaled down approach should be.

MR. BLAIR: Okay, thanks.

DR. COHN: Karen, I guess I'll ask some of my questions, which, and I will apologize, I've not yet read through the final rule so I'm sure that probably it's in the final rule or in the FAQs. I was just sitting here listening to what you were describing and clearly I think we all get that this is not a credentialing number and indeed as we all know health plans, Medicare, everyone does a much more exhaustive credentialing process but this is an important piece of the whole thing. But having said that I found myself, I mean I'm both happy to see that we're not using location codes on top of things to identify locations and I'm understanding in how you're identifying organizations that I think an organization has the flexibility to get identifiers for, I mean literally almost any address that they deem is important just because of that flexibility. But explain to me if you're an individual provider and you have a couple of different locations of practice, how exactly does that work? I didn't hear that you wind up with three NPIs, do you wind up with one NPI and then three different address with that NPI?

MS. TRUDEL: That's correct. One NPI, three addresses, and we're only collecting one of those three addresses, any which one that they want to provide as the location of the practice in addition to a mailing address.

DR. COHN: And so you're talking about the change request for addresses --

DR. ZUBELDIA: Can I help you with that?

DR. COHN: Oh, please, thank you.

DR. ZUBELDIA: The expert transactions have a secondary identifier called the site code, so you have the primary identifier which would be the provider, and the secondary identifier which would be the site. And the provider assigns their own site codes, typically traditionally the industry has been using a four position alphanumeric site code created and designated by the provider. For instance a university may designate as a different site each one of the departments, so when they get the remittance advice the site code comes back in the remittance advice and they know how to post the payment. Same thing happens with multi-location providers, physicians, that typically have been designated their own site code.

DR. COHN: Well, but I was also hearing within the NPI that there's actually the capability to get separate identifiers so that locations can have different NPIs for each site, so I guess there's two ways of handling this. You can have one code and then how many possibilities are there, how many different location codes can you have if you're a complex provider?

DR. ZUBELDIA: Four position alphanumeric --

MS. TRUDEL: 999.

DR. ZUBELDIA: No, no, it's four to the power of 26, so it's a big number.

DR. COHN: I'll look up that number off line. Okay, that's helpful, so it sounds like there's basically two approaches for organizations. Obviously I was just trying to think of how an individual goes around billing, recognizing that sometimes geographic location does have an impact on billing and payment and all of that.

MS. TRUDEL: right, from our perspective, from the NPI, NPS's perspective, the individual gets the one identifier.

DR. COHN: Okay. Now the second question, and one thing I'm sure this is another FAQ piece which as I said have not reviewed, I know earlier on there had been some discussion that there would be some, at some point that currently existing databases would be sort of transformed, and by that I mean not necessarily completely transformed but for example physicians with UPINs, and obviously that's a relatively frequent number that many if not most physicians have, that that database and those numbers would just, they would suddenly receive NPIs. Is that going to happen or do people have to apply for new ones?

MS. TRUDEL: We've left that open at this time. We got a number of comments in the proposed rule that that would be a really great idea because it would simplify life for people who already have identifiers. We also got comments saying if the data is not good you are just perpetuating bad data in a new database. And so there's still some assessment of the accuracy of data that we have in terms of Medicare files before we'll make a decision as to whether we're going to do that or not and to what extent.

DR. COHN: Well, okay. I guess the final question about that is is that just as health plans have, I mean our commercial health plans have their own credentialing process will this be an opportunity to, I mean you will obviously still require the additional data within Medicare that's resident in a UPIN, and so that will continue to be a separate credentialing process and probably this will be an occasion for you to sort of reflect the quality of your data and databases is what it sounds like.

MS. TRUDEL: Right, for instance the Medicare Physician Enrollment form, the 855, will continue to be required and it will link up, the system that carries that data will link up with the NPS, so that the identifier that's issues is an NPI.

DR. COHN: Well, okay, great. Other questions? Marjorie?

MS. GREENBERG: Congratulations as well. Maybe you said this and I just didn't catch it but if an organization allows its subparts to have NPIs will there be something in the database that will indicate what organizations those subparts are associated with?

MS. TRUDEL: I believe so, I'm not absolutely positive, I'm pretty sure that there's a hierarchy but I'll have to check.

DR. COHN: Kepa?

DR. ZUBELDIA: Karen, congratulations for getting this out, it's great news. You know how when you send an email sometimes you get that feeling, oops I forgot something right after you press the send key? I think there was a typesetting error in the list of the database elements, somebody forgot to put in the provider's city, the provider address is required, and the state and zip, but the city was missing. So you may want to relay that to Pat Peyton, they may have to correct that.

MS. TRUDEL: Thank you.

DR. ZUBELDIA: I have a couple of questions on the taxonomy code, it's a required element, are the taxonomy codes going to be reflecting taxonomies for institutional providers or for non-person providers, entity providers? Because right now the taxonomy codes don't get into a lot of granularity there. I mean they have to --

MS. TRUDEL: Yes, if there's a need for additional codes we can, that's an externally maintained code set.

DR. ZUBELDIA: And then you mentioned the three levels of data dissemination and in the NPRM there was an indication in the database as to what level dissemination each level corresponded to. In the final rule there is not that indication. Is that something that was part of some other rule or somewhere else or can we use the same level of dissemination that was in the NPRM?

MS. TRUDEL: That will be part of the data dissemination strategy that I said would be forthcoming. Basically we're looking at the data that we have now, we will be storing in the database, looking at the privacy act and other constraints and trying to figure out what can be in public use files, what can be in files if someone signs a data use agreement with us, and essentially crafting a strategy based on the data that we have and the rules and regulations that are already in place.

DR. COHN: Anything else? No? Other questions? Michael.

DR. FITZMAURICE: Again, congratulations on the large volume of claims coming in electronically. But let me ask, is that 60 percent of the claims coming in from Medicare providers, are they completely HIPAA compliant? Are they sufficient for Medicare payment?

MS. TRUDEL: They're completely HIPAA compliant.

DR. FITZMAURICE: Wow, that is impressive. Secondly, in one of your slides NPIs effect on providers, you note that COB payments will come sooner. Is that they may come sooner, is there anything in the law that says that they actually will come sooner or is it just logical that if it's more efficient people wouldn't want to hold on to the money, they'd want to pay it out faster?

MS. TRUDEL: There's no requirement on the timing for COB payments but it does kind of stand to reason that if everybody identifies the provider the same way it's going to make it a lot easier to link up files and communicate and do all the things necessary for payment of a COB claim.

DR. FITZMAURICE: I agree, it does stand to reason.

MS. TRUDEL: We probably shouldn't have been quite so bold about that statement, though, point well taken.

DR. FITZMAURICE: Third, what should the covered entities be doing at this time? One of the things probably is that they should be preparing for a national health plan identifiers since that's coming down the road and it's one of the HIPAA requirements, and I guess one of the first questions they should say is how many digits should we prepare for. If they prepared for a ten digit national health provider identifier code do you expect that to be sufficient? Because if they're going in for a provider identifier, if they're going in for a health plan identifier, can they make both of them ten digits and save the programming time at this point? I realize it's not official because it's not out as a --

MS. TRUDEL: I can't even comment on it.

DR. MCDONALD: Sorry, I didn't hear the whole presentation, but would you expect providers to have only, I mean physicians or practitioners, to have only one identifier?

MS. TRUDEL: Yes.

DR. MCDONALD: And what will outsiders be able to get of this database? I'm asking more specifically, we're trying to connect a lot of hospitals in our city, could we get the database under some arrangement?

MS. TRUDEL: Again, that leads back to the dissemination strategy that I mentioned to Kepa, we're still working on, so the levels, aside from the enumerator and HHS are what can we release to the general community under the privacy act and what data can we release that contains privacy act data but that could be released under a data user agreement.

DR. COHN: Public questions? Dan, do you want to come up and introduce yourself and ask your question?

MR. ROUDY: Dan Roudy, American Health Information Management Association, just a couple operations questions, Karen. We have a gap of one year between large and small providers, so that means, health plans, so that would mean that providers would have to continue to carry multiple numbers until we get through the second phase of the implementation and is there any way that they'll be able to identify which payers are considered large versus small?

MS. TRUDEL: The definition of a small health plan is in the transaction and code set regulation and again, this is an issue that's going to come up with every single HIPAA standard and actually would have been an issue with the transactions and code sets had we not had the year extension. So there is that one year where there's potential confusion and I think we have plenty of time for plans to state their expectations about what they think they are. For the most part Blue Cross/Blue Shield plans, etc., they're not small, it's the small ARISA(?) plans, the funded ARISA plans that are likely to be that.

MR. ROUDY: The department wouldn't have a problem however if a small plan came forward and got involved in the system early.

MS. TRUDEL: Absolutely not, there's no, there's absolutely no bar to any covered entity implementing any HIPAA standard earlier then they need to.

DR. COHN: Mike?

DR. FITZMAURICE: -- on a contingency basis, do you anticipate that 12 months from today that no contingency acceptances will be accepted? That all of them must be fully HIPAA compliant? Is 12 months a long enough time period as a rough guess, not as a firm statement?

MS. TRUDEL: Well, first of all I can't speak for the industry as a whole because we're talking about plans that are in a variety of places in terms of percentage of compliance that they're working with. And as I think I said before Medicare is continuing to monitor our progress and at a point in time where we feel that we've got a high enough percentage of compliance we'll then begin to make plans to take down the contingency and to do outreach to our provider community. We aren't in that place yet and I can't even tell you when we are going to be in that place.

DR. COHN: Other questions? Clem and then John Paul.

DR. MCDONALD: Given the optional fields how would you be able to avoid having duplicates? I mean I can imagine someone practicing two sites and the practice manager is submitting these forms and a Social Security Number is not required, birth date is probably not enough, disambiguate --

MS. TRUDEL: First of all birth date, gender, state license, number --

DR. MCDONALD: Is that required?

MS. TRUDEL: It's optional, it's required for some provider types, so I would say for physicians it's going to be required. And when we did, we did do de-duplication exercises a number of years ago on our own data, we found that the state license number was the one where we caught the most dupes because the names were slightly different, you're right, the birth date alone is not enough but state license number is an enormous help.

DR. COHN: John Paul?

MR. HOUSTON: This may be a stupid question but is there any allowance, I know the NPI is national, for dealing with cross border like Canadian and out of country providers who might be billing insurance in the United States? Was that intended with this?

MS. TRUDEL: That's a really good question. I don't think that entities that are outside the U.S. would be considered a covered entity under HIPAA but I would have to check with the lawyers.

MR. HOUSTON: Well, I don't think they'd be covered necessarily under HIPAA but it would be interesting, if we're trying to set up a national identifier for simplicity I was just wondering whether you had a Canadian physician, or physician office, who would be billing a U.S. insurer, whether they would be able to get an identifier in order to streamline the insurers' operation.

MS. TRUDEL: I'm sure if my NPI expert were here she could answer you but I will at least take the issue back and make sure that we thought it through.

DR. ZUBELDIA: Looking at the rule, the mailing address has a field called country code. I don't know if that will be allowed or not but there's a place here to say --

MS. TRUDEL: I defer to the alternate expert.

DR. ZUBELDIA: -- send my mailings to Canada.

MR. HOUSTON: Kepa can be after tomorrow, right, officially after today.

DR. COHN: Any final questions for Karen? Well, Karen thank you both for updating us on where we are with implementation of codes and code sets and financial transactions as well as this very exciting new rule that's come out. I think they'll be lots more questions and I suspect you'll be updating the full committee tomorrow on some of this stuff. Am I correct on that?

MS. TRUDEL: Right.

DR. COHN: But I think you have obviously, I want to congratulate you, I mean I think it's very good work, we've obviously been waiting I think a long for these and it's nice to see them step by step coming out. So obviously I think it's good for the industry now to know exactly what the format and information required so it can move forward to begin to do the implementation, so thank you.

MS. TRUDEL: Thank you.

Agenda Item: Draft Letter to Secretary Concerning Claims Attachment - Dr. Cohn

DR. COHN: The next item, and this is really more of a short discussion then a long discussion, on the agenda it says draft letter to the Secretary concerning claims attachments. I think you'll all notice that there's not a draft letter in front of you for consideration. I think after much wordsmithing and attempts to get a letter right I think we've, or at least I've come to the conclusion and I want to just discuss it with everybody to make sure we're on the same page, I think there's a sense that we need to do some additional hearings and further investigation into the world of claims attachments.

We heard obviously from some of the providers and from some of the standards organizations in December, I think from my view I think one of the most important things or ideas that came out of that session was the idea of demonstration projects to help I think encourage, refine whatever standard is brought forward with an NPRM or otherwise. But I think that there's also a need for us to sort of listen a little more widely to the industry to hear about alternative approaches that appear to be being implemented around claims attachments just to get a sense of that. And obviously we're also beginning to receive letters and questions regarding actually concepts of both administrative simplification, exactly how claims attachments relate to privacy concerns and others, that probably we should take a little time to hear before we come forward with a letter.

Now I'm making all of these statements, I'm sort of curious about thoughts from the subcommittee if this is indeed more then just my own sense of the matter. I think my hope would be is that in March we may be able to find some time knowing that we obviously already have a whole lot of things on our agenda. But the idea might be to spend a little time hearing more from the industry on these topics and sort of getting a better sense of how all this should go forward.

Thoughts, comments? Stan?

DR. HUFF: I think that's a prudent course, I mean I haven't seen any of the questions that don't necessarily have answers but I think they certainly deserve careful consideration. So I think it would be prudent to have some more hearings and talk about it and make sure that all of the issues are known and understood.

DR. COHN: Thoughts or comments? Kepa?

DR. ZUBELDIA: I won't be here in March.

DR. COHN: You might be, you might be testifying, Kepa. Other comments on this? I think certainly, Jeff, did you have a comment?

MR. BLAIR: I just wanted to share, actually in the cab from the hotel to the meeting this morning you and I talked about this a little bit and for the benefit of the rest of the subcommittee I just wanted to share the feeling that I had about this because it's kind of mixed. On the one hand I feel like we don't want any delay going forward with an NPRM. Does that mean we need to write a letter to support that? And I think that's a matter where I feel that we should leave that to the chair totally to determine whether a letter is needed to support an NPRM. The other thoughts that I had were that I do think that the testimony that Wes Rischel gave us was outstanding and that it's going down the right path, but it's so early and the demonstration projects have not occurred yet, and apparently there's other entities and organizations, by the way, do we all have copies of the letters we've received from the other folks that are beginning to raise questions? Okay. And they're raising valid issues and questions. So Stan, I would just agree with your word, is that it just would be prudent for us to take the additional time to listen before we actually write a recommendation letter.

DR. COHN: I guess the other piece and the one thing that I think will say in public session, unfortunately it isn't in the letter, or any letter, but we may want to actually expedite this aspect depending on what we conclude after hearing a little more, is that I think it's absolutely critical almost no matter what happens that there needs to be demonstration projects. And I think that that to me is the one item, now I don't necessarily think a demonstration project has to occur or be completed before an NPRM is produced but I think our thought is that it is something that would be very useful in the process of coming to a final rule to sort of help refine it, give us real life experience with a standard for claims attachment. And certainly I think we need to do whatever we can to help encourage the Secretary to move forward with whatever help he can provide in terms of enabling demonstration projects on this. I think we all think there's an important business case that if done right this would help enable, but I think that's something we need to get out in the field and test.

Anyway, other comments on this one? It sounds to me like everybody is sort of comfortable with the current status of all of this and we will just reflect it towards the end of the day on how we put all this together with everything else that we have to do, and I think I've heard at least from some of you, I reflected yesterday about whether we just start having four day, excuse me, three day sessions of the subcommittee on hearings versus more hearings for the remainder of the year and I've at least heard some comments that a number of you think that more frequent two day hearings may be the way to go. But as we put more on our plate for the year obviously it does sort of beg the question of how we on a timely basis address all of these things. And not just in a timely basis but in a way that is up to our standards for having been thorough and authoritative in our judgments on these things. So, anyway, yet another to do for the year.

DR. ZUBELDIA: How are you going to promote the demonstration projects without the letter? Somehow I'm concerned that by not sending the letter the demonstration projects may be set back waiting for something else to happen. And I think the demonstration project needs to move on.

DR. COHN: Well, without making a comment there, other thoughts?

DR. MCDONALD: I would be concerned the same way because all the way along we know that everything gets delayed until there's some sort of trigger in any of these things and I don't know that we've had demonstration projects for most of the things that we proposed. I think it's a good idea, I think we should, but I think the same thing, unless it looks like there's some really action going on people are busy enough that they stay busy with the other things.

DR. COHN: I agree with you and that was sort of the quandary that I was having. I think we're going to have to mull over this one a little bit, I mean certainly one obvious solution to this one, or at least a way to expedite a letter as well as hear more from the industry, would be to have a session soon, in March, to consider this and basically put it on a fast track consideration, hearing more from the industry and then coming out with a letter. And recognizing that there's another full meeting of the full committee as early as early March, I mean the reason I'm hesitating on this one is because it moves us back into a three day session of the full committee, I mean with us having a day and then two days of the full committee in early March. If we wait until late March we're coming up with a letter for June, which does seem a long time from now. So I've been, based on what I was hearing I've been a little reluctant to start suggesting to the subcommittee that we do a hearing for a half day or whatever in early March. But let's reflect on that as we talk about other items, such as e-prescribing, and look at the overall work plan for the year.

Steve, did you have a comment?

DR. STEINDEL: Just a comment on meeting schedule. Many of us might be here on February 18th with the NHII, and if we tack a day on that.

MS. GREENBERG: I think Privacy and Confidentiality is meeting the 18th and 19th.

DR. STEINDEL: And NHII is the 18th.

MS. GREENBERG: And NHII is meeting the 18th.

DR. STEINDEL: And there's a good overlap between this subcommittee and the NHII Workgroup.

DR. COHN: I think that that's a thought, I mean obviously that's a little fast for putting together a hearing, which I think is the --

DR. STEINDEL: But I think that there's a lot of interest.

DR. COHN: Yeah, I think there is a lot of interest. We'll take it offline for the moment, I think we'll reflect on it as the day goes on. I'm just, as I said, like Kepa, like everyone else, it's sort of, the part that I'm concerned about is obviously getting demonstration projects to begin to show proof of concept, to begin to show that it really gives us the value and administrative simplification that we're seeking. But I think we do need to hear a little more from the industry in all of this. So probably by the end of today we will hopefully be making some plans, obviously this is also complicated by the fact that we are doing a transition on committee members and all of this.

DR. ZUBELDIA: My preference would be to send the letter perhaps changing in the letter, removing whatever you want to remove as far as recommendations but strongly recommending that there be demonstration projects. And then perhaps send another letter after the February 18, 19 meeting. The demonstration project needs to be kicked in gear an they're not going to do anything until they see the NCVHS saying yes, this is the direction we're going to go, they're just going to wait.

DR. COHN: Well, I don't know, I think that's an open question but certainly I think we might be able to help move them forward. Marjorie?

MS. GREENBERG: And certainly if you want to focus some attention on this having two letters several months apart is not a bad thing.

DR. COHN: Okay, well let us, I don't think I have an answer here but I think we'll reflect on it as we go along, and obviously we have a number of options and as I said certainly there's a need for a session to talk more with the industry about all of this. I think what would be best is if we could talk to the industry and then hopefully come out with a letter that isn't, as commented, the complete evaluation of claims attachments but at least moves us to the next stage of demonstrations assuming that we come to that conclusion after a little more from the industry. But let's see if we can make all that happen in a, what I think I'm hearing is a timely fashion, and I think we are in some ways helped by the fact that for a variety of reasons we have NCVHS meetings occurring at really sort of a torrid pace over the next six weeks, so I mean there should be some way for us to leverage that. And I think that's what I'm sort of hearing is it's fine to not have a letter today but let's move forward with this in an expeditious fashion.

Okay. Now with that I think it's time for our break, we will take a 15 minute break and come back at 11:10.

[Brief break.]

DR. COHN: Will everyone pleased be seated, we're going to get started with our next session. Would everyone please be seated we're going to get started with our next session.

Agenda Item: Dental Standards Issues - Dr. Cohn

DR. COHN: Okay. Well, I want to welcome our distinguished guests for a discussion of what's been described as dental standards issues. I obviously want to thank you for coming and joining us today. I'm going to ask each of you to introduce yourselves and your positions, and then obviously we'll start with Dr. Albert --

DR. GUAY: Guay.

DR. COHN: I'm sorry, that's what I thought it was but the u --

DR. GUAY: It's spelled correctly, that's very good, a good start.

DR. COHN: Okay, well that's a good start. Anyway, would you like to start by just introducing yourselves?

DR. GUAY: I'm Dr. Al Guay, I'm the chief policy advisor at the American Dental Association.

DR. ADAMS: And they didn't spell my name right, I have to say that, I'm not a Rodger, I am a Roger, Roger Adams, and I'm the immediate past chairman of the board of the National Association of Dental Plans and a current foundation board chair.

DR. SCHOOLEY: I'm Dr. Ed Schooley, I'm the vice president dental director for the Delta Dental Plan of Iowa, but I also play a role with the National Policy Committee for Delta Dental Plans and represent all the Delta Dental Plans on the Coder Vision Committee.

DR. COHN: Great. Thank you all for joining us, and Dr. Guay we'll take your testimony first.

Agenda Item: Dental Standards Issues - Dr. Guay

DR. GUAY: Thank you. Well, Dr. Cohn, subcommittee members, good morning and I already introduced myself, I haven't been authorized to do this but on behalf of the senior citizens on this morning's panel I think you for having the testimony late enough so we could wake up and early enough so we don't nod off in the middle of the testimony.

On behalf of the American Dental Association I really want to thank the committee for their interest in dental standards and I have to say and for your patience in the past year or so in this process. I was interested in hearing what Dr. Cohn said about why we're here today because I just wrote a couple scribbled notes about that. What's our main business here today? And we think, and he agrees and the subcommittee agrees I hope, is talking about a diagnostic code terminology for the individual patient health record, the PMRI standards. And if we think about a diagnostic coding system it's almost intuitively known that it has to include all the possible diagnoses a dentist may encounter during interaction with patients. I don't think that's a hard concept to understand. So we have to have a diagnostic coding system that allows dentists to put in their patient record all diagnoses that they discover or that they deduce from their interaction with the patient, not just those codes that are related to insurance claims processing, unless you have a code that says something like diagnosis not recorded because not relevant to claims processing, I think that's a little bit short of the standard for a good health care records, although it certainly would be more simple.

We've heard criticisms of the SNODENT system that it's too complicated and there are too many codes, and that's hard for us to understand when we have to cover all diagnoses, you need a code for each of the diagnoses. We're also interested, see I read the testimony that Delta has submitted to you about their new interest in diagnostic codes and claims adjudication adding to them the claims process, it's interesting to us because there have been diagnostic coding systems with dental items for 30 years and they've never been utilized in the claims adjudication process. Up until this date there's been no interest in diagnostic codes and we certainly are interested in that. And we're also aware that there's going to be some opportunities to use modifiers to do diagnoses, a number so small that it's certainly, the event is a name for a diagnostic coding system wouldn't accrue to the small number of codes that they're talking about.

SNODENT, you know about it, we've been talking about it for a while, it's not available to anybody, the Library of Medicine on their website, you have to have an agreement with the Library of Medicine. We sent a copy to Delta to look at and they returned it without looking at it, so kind of a confusing system.

So basically today I have two items of business. One is I'd like to provide you with an update on SNODENT and try to answer some of the content questions that you've posed to us about SNODENT in your consideration for it being recommended to the Secretary as a standard. And then as a separate item we'll try and describe some of the other questions that have been posed to you, or to us, about our dental procedure codes, a totally different system. I think it's important to separate those two things so I'm going to in my discussion talk about the diagnostic coding system, electronic patient health record, and then we'll answer questions about the procedure code system related to claims adjudication, the two different things we're going to be talking about.

We certainly appreciate the opportunity to talk to you about SNODENT again, we've had several discussions, and we understand you're looking for additional information about the relationship between SNODENT and SNOMED CT, the medical system, coding system that you have proposed to go forward to the Secretary already. Well, just to briefly review historically, in '98 the ADA was desirous of formulating a system for diagnostic coding terminology taxonomy and we wanted a system that would serve the needs of the profession and after looking around at existing coding systems we thought about starting new, we determined that the architecture and the form and the structure of the SNOMED coding system owned by the College of American Pathologists fit our needs perfectly and fit the needs of the profession perfectly as opposed to those that we had already seen. And so we made an agreement with them to develop SNODENT using the architecture, hierarchical architecture of SNOMED, and with their cooperation we developed SNODENT and they assigned SNOMED codes and it's now totally integrated into the SNOMED system. So if you look at the SNOMED system, which you've already looked at in great detail, in that system is SNODENT. Not identified specifically as SNODENT but intermixed in the terminology, the different systems, are the codes that make up SNODENT when they're abstracted. So SNODENT is sort of a subset of the SNOMED coding system, maintained by the ADA with the cooperation of the editorial board of SNOMED.

SNOMED has taken some changes over those years, the version 3.5 has transformed into the current SNOMED CT structure, primarily by addition of some codes that the British had been using, coding V3(?) in the British coding system has been integrated into SNOMED and that has some dental terms into it also, and so that has now evolved to the current SNOMED configuration of SNOMED CT. ADA maintains a relationship with the editorial board of SNOMED.

For the maintenance process, which you had some question about for SNODENT, is very similar to that for SNOMED. We have an advisory committee on dental electronic nomenclature indexing and classification and we affectionately call it the Code NIC. And this committee is the primary source of input and recommendation to our Council activity concerning SNODENT. And this committee is made up of representatives from all the recognized dental specialties, and representatives from the American Dental Association and those councils that are concerned with the dental commerce so to speak.

The ADA is working now on a system to include payer representation on that so that's our, clinical structure requires we go through a system that's already been started and that should be completed in April of this year and it's my guess that there will be then an invitation to certain payer organizations to become members of the Code NIC and have a voting voice in that committee.

I kind of looked first at this when I was thinking about this, about here's a system that no payer, dental payer uses at all in their claims adjudication process, and here's a system that we've developed and we have a maintenance process for that, and the payer reps want to be a part of that system, and it's sort of, I live in Chicago, and it's sort of like me asking to vote in Indiana because some day I might move there, so it was a kind of a novelty situation but the ADA has accommodated that and we will be recommending that there be payer membership and input into that committee.

Our executive direction and I here at the last meeting promised an open process for maintenance to the SNODENT coding system, and we'll do that. The Code NIC committee takes testimony from any interested party, including testimony through the internet through our website, so anyone who has an interest in the diagnostic coding system can put input into this committee, changes and modifications, whatever, and we'll continue that. The Coding Committee then passes judgment on these recommendations, much like you to do move up forward to the Secretary, this will move up to our council which will then determine which recommendations are chosen, what changes will be made, those recommendations then will go to the SNOMED International Editorial Panel for their consideration for including into the SNOMED.

The ADA developed SNOMED and we're proposing as a standard that it become an integral component of the electronic health record for dentistry, for dental patients. And we think that the adoption of an electronic health record depends really on the codified system that's accepted by practitioners, so we urge, and this sort of was developed by practitioners, we urge that your committee designate SNODENT as a core terminology for dentistry, the patient medical record, for reasons we've already enumerated and we would encourage its use by the profession. For those reasons in summary SNODENT's a complete system, it's contemporary, it's not filled with archaic non-used terms as some codes are. Its hierarchical architecture is ideal as we've seen and I think you probably agree with that, and it's ease of expansion in a logical manner is really easy to do.

We're grateful for your consideration and we look forward to your further consideration of SNODENT and recommend it move forward to the Secretary. Let's close that book, the discussion of SNODENT in my presentation is finished.

We'll move on to the other issues that have come forward that have come to the surface. Unlike diagnostic codes, which have never been a part of dental transactions the ADA procedure code is a long standing mechanism for dentistry for the dental treatment that they provided to patients to payers. It's make in the system is accomplishment by a legally binding court approved settlement agreement between the American Dental Association and the Delta Dental Plans Association of America, and this agreement clearly spells out exactly how changes in the code can be made. The ADA modified its code and maintenance procedure to accommodate this agreement and has rigorously abided by those terms since the terms were decided upon or agreed upon.

The settlement requires that a code revision committee be established, which is an entity with representation of both dentists and third payers, third party payers, and a national purchaser of dental benefits to consider changes to the code. Any changes to this mechanism had to be agreed upon by all the signatories to that agreement. As the nature of the dental benefits industry has changed, much like the medical/surgical/ hospital industry has changed over the year, new market forces have emerged. A relatively new organization has emerged that represents a substantial portion of the dental benefits industry, the NADP, and you'll hear from their representative shortly. Recognizing this change to dental benefits environment the ADA has recommended that the code revision committee, dental strategic code revision committee, be expanded to include a representative from NADP, and another representative from the ADA to maintain its balanced representation as determined by the settling agreement. To this date the proposal has not been accepted by our partners to the settlement agreement, DDPA, we're hoping we can agree on this change relatively quickly.

Recently some players have recommended that several modifiers be added to the procedure code and that are in fact diagnoses. This expansion of the procedure code into the area of diagnosis by the inclusion of a relatively limited number of diagnosis in the form of procedure modifiers was considered by a special ad hoc committee workgroup of the code division committee. They recommend that the CDC defer action on this request in light of the emergence of SNODENT and the committee will monitor further development in this area.

There's been some discussion about modifiers to procedures and I think our language is pretty clear that a modifier to a procedure should be talking about things that modify the procedure, not their diagnosis that results in the need to the procedure. So it's sort of a jumbling of things by putting diagnoses into procedure codes, there's a mechanism for keeping them separate and clear and clean and we think that should be abided by.

We think that putting diagnostic information in procedure codes, to replace local codes and specific needs in individual dental benefit plans, it would not result in a net administrative saving, and would probably thwart the HIPAA goal of standardization and transactions and code set regulations. And we think this would delay or maybe even prevent a great number of dentists migrating from paper claims to electronic claims.

Let me conclude the discussion of the procedure code by expressing our appreciation to this subcommittee for its interest in learning how the ADA is working to bring the various dental communities together, involving and resolving dental transaction concerns. We really believe that those involved in dental transactions on a day to day basis are best equipped to resolve problems as they present themselves at that level of day to day business.

Finally, addressing the main business at hand, that is the dental diagnostic taxonomy for electronic health record, thanks again to the subcommittee for the time and effort you've spent in considering SNODENT as a core dental terminology and express again our desire that the ADA, that you recommend SNODENT as a core terminology and make the recommendation to the Secretary.

And I'd be happy to answer any questions or expand upon anything I've talked about. Thanks.

DR. COHN: Dr. Guay, thanks, and we'll take questions and discussion after everyone's had a chance to testify.

Agenda Item: Dental Standards Issues - Dr. Adams

DR. ADAMS: I don't know who arranged the seats but I feel like the last couple of years where I've been actively involved in trying to resolve between the settlement agreement of DDPA and ADA, I think whoever did this did this on purpose because, in fact I was talking with Al about this, I've been talking with the senior leadership of the ADA almost on a daily basis to hopefully come in today and share with you a resolution and so I think they'll rename me the negotiator rather then the chairman of the board.

I'm delighted to be here on behalf of NADP, or the National Association of Dental Plans. I'm going to review with the subcommittee briefly kind of an update of where we are in the improved communications between NADP, the ADA, and Delta Dental Plans Association, particularly addressing the Code Revision Committee and our statement from the last testimony of this committee, some brief comments on the licensing of CDT codes, and then I will make some comments on SNODENT relative to NADP.

Most of my comments in the verbal part of this testimony is going to be a high level review of what was in the written, I'm not going to go through that in detail, you have that to reference. I really find myself in an interesting position here because I have blood that flows through me from all three associations. I graduated from dental school in 1974 but I completed three different specialty programs in dentistry. I'm an oral and maxillofacial surgeon by training, I've completed a residency in oral pathology, I've been featured on the cover of the Journal of the American Dental Association, I've been on the Medicaid Advisory Panel for the American Association of Oral and Maxillofacial Surgeons, been an active member of the Utah Dental Association on their board of Directors.

I've been a participating dentist with Delta Dental Plans for 23 years and right now am very active with the Delta Dental Plans Association on other initiatives that are very exciting, and so I've worked very closely with them and obviously I've been on what many of my colleagues call the dark side, for the last eight years, with the National Association of Dental Plans.

And I get asked frequently why do I belong to the National Association of Dental Plans or why do I belong to the ADA or DDPA. I'll tell you the whole reason I belong to these three association is the whole reason I went through and got three different specialty degrees, and that is ultimately what we're all here about with the HIPAA and everything else is bottom line we want to improve the health of the people we serve. Simplification is to get us to that point. Unfortunately we all get so relegated to our little silos that we sometimes forget the overall purpose of what we're trying to achieve and that is ultimately providing a benefit that will improve the health of our patients. To that end I certainly hope my testimony today will have some effect.

Just briefly, NADP, and did we hand out that, you all have this little pie graph and this is updated as of just really the data here is fairly accurate. And this is just a pie graph that kind of demonstrates what Al introduced. The National Association of Dental Plans is a new association, but it represents now a significant block of the dental benefit companies. We have dental HMO, PPO, indemnity discounts plans. Our members include major carriers as well as regional and state, single state companies. We provide more then 70 percent of all networked based dental benefits and one third of the indemnity benefits in the United States. As you can see this adds up to about 56 percent of unduplicated market share as compared to the other trade association members. If you boil all of this down National Association of Dental Plan members provide benefits to approximately 95 million of the 155 million Americans that have dental benefits.

So we appreciate that the American Dental Association and certainly Delta Dental Association, many of their plans are members of our association, that the ADA has recognized us as a legitimate representative within the dental benefits industry. In fact to our knowledge, and we're fairly accurate with this, there's no other trade association, health or dental, that can claim this breadth of representation in the dental benefits industry.

Now in February of 2002 we appeared before this committee and voiced our support of the electronic transactions and our commitment to compliance with HIPAA. We also voiced our concerns with the HIPAA dental code set development and maintenance primarily surrounding the exclusion of NADP on the CRC and licensing requirement, including the CDT usage fees being imposed on the dental benefits plans. Our objectives at this initial testimony before this committee was to ensure an open process of maintenance of these standardized code sets, and equitable representation of all parties directly impacted by the dental code sets to govern and process as mandated by HIPAA, and a fair licensing of the CDT code sets.

And as Al introduced we are just delighted to be here today and state the process and the influence of this subcommittee has worked in this particular arena. And I would like to acknowledge our appreciation and leadership to the American Dental Association for facilitating a tremendous improvement. Not only has the ADA been responsive to our requests for meetings, notices, and agendas but they have been instrumental in facilitating changes that have dramatically improved our access to code revision and maintenance process. Our written testimony that you have documents several examples. The ADA has also recognized NADP's thorough, we have a complete process of code evaluation through our what is called CDT technical advisory committee. This is a committee made up primarily of dentists that are members of our, that are plan members, and they all have clinical experience, and this committee works in an open and predictable procedural mechanism by which they can comment on code set development and maintenance. The ADA saw this at the last round of the CRC and acknowledged the thoroughness that we did, in fact Frank was here and acknowledged that.

NADP also appreciates and would like to acknowledge the ADA and Delta Dental Plan Association for their effort this past year to expand their authority so everything stays in balance. DDPA has recommended that the seat, and they support the initiative to have NADP at the CRC table, so both associations are in agreement but because of the settlement agreement are held hostage by that settlement agreement. They both agree, DDPA has made a recommendation, and we have that referenced in your testimony that NADP replace the purchaser representative on the CRC.

Our position remains the same, and namely that all payer groups with unduplicated representation in the dental benefits industry should have a seat at the table. We feel this supports the intent of HIPAA and meets the higher standard, and that is taking away all the silos and all the profiling and all the turf wars, it serves our people better and it will help facilitate improving the health of our members if we all can come to an agreement. And we're delighted, I think we're just literally days away from having this agreement finalized, so I'm going to put an end to that chapter in our testimony, we're just delighted that both the ADA and DDPA are working aggressively to resolve that.

I would like to address very briefly, because we brought this up in our last testimony, the licensing of CDT code sets. As we testified previously we agree that the ADA has a legal right to license its copyrighted material. Our written testimony outlines to the committee the difficulties that we have in understanding exactly how the licensing fees would be applied, particularly when we look at it from our larger regional and national member companies. I again am very pleased to state that we are in active communications with the ADA and very confident that a plausible and equitable resolution to the licensing fees will be achieved. So I'm going to put an end to that chapter as well. I will reserve the right if we can't resolve this, I don't see any reason we can't, but we have it on record that these matters are still open.

Now I'd like to go ahead and issue some comments if I could on the SNODENT. And I'm going to refer here to this more to the written testimony, I'm going to quote a portion out of that. But we've communicated to this committee this last year via written letter our concerns with a privately developed unreleased system of dental diagnostic codes. While the ICD-9 is indeed limited with regard to dental diagnostic codes SNODENT is totally unknown except for the fact that it includes what we hear, we've not seen it yet, some 6,000 codes. While I agree, and I can't agree anymore, if you're an oral and maxillofacial surgeon you need to understand all of the ICD-9, all the CDT, and you need to be able to integrate them. So I do understand and certain understand the complexities of diagnosis. That's not the issue.

We're the largest representative dental payer community, we believe that if SNODENT is designated as a national code set under HIPAA the maintenance of SNODENT must be accomplished in an open process established by HIPAA, and Al has stated that will be done. But since the development of the process was not open to payer participation and there have been no payer evaluation of this system, significant time must be allowed for evaluation before any implementation can reasonably occur. So we're not arguing the fact that it shouldn't go in, we believe that it should. But there's been no participation by a community that represents a significant constituency and believe me, when this hits the table from the third party payers it's going to be a significant cost to reprogram our systems to processing. We know that it needs to be done but we have to have significant time and participation because I've definitely seen from the clinical end, now understanding the third party payer end, when you can get the communication together all of a sudden things make a lot more sense and changes can occur.

So we just, we support, we agree, we want to be involved before it rolls up to the next level. That's what our recommendation is to be.

I'd like to just conclude and just state on behalf of the entire NADP membership and all of the 95 million members that are insured under our plans, I want to express our appreciation to this subcommittee and share with you, that I've had the opportunity to share with you. We've had tremendous progress, the communication barriers have dropped and we are resolving some critical issues. And if it hadn't been for your oversight I firmly believe this would not have occurred this last year. And it's the willingness I feel of three excellent associations, Delta Dental Plans Association, the American Dental Association, and the National Association of Dental Plans are excellent, excellent association and it's been my great privilege to be part of this meaningful dialogue.

Thank you.

DR. COHN: Thank you. Ed?

Agenda Item: Dental Standards Issues - Dr. Schooley

DR. SCHOOLEY: Thank you and I would say the main point to perhaps take away from my testimony today is kind of rooted in the current EDI rate for dental claims, which kind of hovers in that 30, 35 percent range and kind of has been there for quite some time now, whereas you kind of look on the medical side we're up in the 60 to 70 range. So in partial answer to one of Dr. Guay's questions, really DDPA's renewed interest in diagnostic or modifier or some kind of a clinical reason code is to really kind of facilitate the improvement of dental EDI rate. Because we feel in many respects this is really kind of part of the solution to increasing that rate. And I think also it's borne of the fact that there's been, due to the fact that increased dental coverage and many, many more Americans are now covered with some form of dental coverage.

My testimony today will basically be broken into two parts, and one is just to provide you with an update on CRC matters from the previous testimony. And the second part really is to address some SNODENT matters. I'm going to kind of try to follow pretty much the written testimony here just so you can kind of follow closely.

First an update on the continued improvements to the process, and I would like to follow up on our past testimony and correspondence to update the committee on the status of dental code set revision and the maintenance process. If you recall it was at the last February 6th meeting and requested, we requested the subcommittee's guidance on the development of an open code set revision and maintenance process. Subsequent to that hearing the dental payer groups reached an agreement on very key areas of reform. As a result of the subcommittee's attention to the matter the ADA and the payer groups did meet, developed changes to the CRC structure and overall process, created a timeline, and put a lot of protocols in place. And as you know the CRC is really the established mechanism for the review and revision of CDT, current dental terminology procedure code set.

And in summary, these changes were adopted by unanimous vote by the CRC then in August of 2002. I would note these changes probably would not have occurred but for the interest of this subcommittee. We do see progress being made towards achieving the overall goal of an open code revision and maintenance process but we do feel there are some opportunities for improvement as we go forward.

And briefly just a couple of follow-ups on some of those opportunities, the first one having to do with the nature of ongoing changes to the CDT code set. As we previously stated in the February 6th testimony in connection with CDT we made the point that changes must be carefully designed to achieve administrative simplification. When possible changes should be minimal and objectively science based. At the upcoming February meeting of the CRC there's over, there's roughly 186 new submissions for either new codes or code revision, and again this is 186 to a code set that only currently encompasses 500 or less procedure codes. When you kind of look at those 186 code submissions, really less then 10 percent purely kind of represent either new science or technology.

In judging from past experience we expect 50 percent of these changes to be adopted and often these changes represent forms of code splitting or unbundling of procedures. We do believe billing code changes should not be designed to necessarily enhance provider payment opportunities without increased services to patients.

The other concern kind of has to do with the timing of changes. As you know the current process does occur on a two year cycle but the point should be made that frequent and pervasive changes to the code set, such as what are kind of suggested with the 186 upcoming submissions, are rather disruptive and time consuming to implement. Updates should be limited to make the process truly more manageable. In the case of Delta Plans for most product what does this involve, it means changes must be filed and approved by the state departments of insurance, new benefit booklets, new fee schedules, update the websites, reprogramming costs, and this should not be lightly looked at since Delta Dental Plans collectively contract with three out of four dentists in the entire country, that's roughly 108,000 dentists. So all these expenses do add up to the cost of dental benefit plan administration, in some cases serve only to increase the cost of care, thereby making dental care, dental benefits less affordable and really less available in the United States.

I'm going to kind of transition now to the discussion around diagnostic code sets and SNODENT if you will. Dental payers often look to the medical claims world for really models of improvement. Professional claims as you know utilize two current procedure code sets, CPT and HCPCS. And this dual system really serves as a checks and balances system for both providers and payer. The AMA maintains the CPT code while collaboration of public and private payers maintain the HCPCS codes. Dental claims, on the other hand, only utilize one CDT dental procedure code, which as I have previously noted is maintained in a collaborative effort through the CRC. So for the dental world really our only checks and balances system is really through the CRC level at this point.

The medical system uses an interaction of procedure and diagnostic codes for billing and for transaction purposes and as you know ICD-9 is maintained by the government in an open process. The ADA has proposed SNODENT for diagnostic information if required on dental claims. I will discuss our opinion about its suitability in a minute, but I'd like to point out now that SNODENT code set is maintained solely by the ADA, however we kind of heard some updates that at least the ADA intends on including in some form some other groups, including payers. But we would kind of make the argument there is really no system of checks and balances or impartial party for maintenance of this important dental diagnostic code set as there is currently in the medical world.

Our rationale is as follows. There's been a great deal of discussion about designated standard maintenance organizations regarding the adoption of dental procedure code modifiers or diagnostic codes to provide a reason for the specific treatment. And I kind of have to say that, just think about that, all we receive on dental claims is a treatment code and so and very often it's just not evident by a particular procedure is really being done or even under what circumstances the service is being rendered. Therefore in the dental world text notes and attachments kind of take on more of a critical role because we really don't know why a service is being done or under what circumstances. The dental payer groups find that diagnostic information is critical in order to adjudicate many claims automatically and to manage our programs.

We should also note, too, that even the IRS kind of stipulates that dental benefits really should not go towards services that are cosmetic in nature, and the Department of Labor further stipulates that emergency oriented dental claims should be handled in a very expedited type manner. And neither of these cases is that often indicated on the claim when you do not know, again, you don't have a diagnostic code or a clinical reason factored to it.

I kind of go on to list some of the advantages regarding diagnostic codes in terms of efficiency, that it certainly would improve accuracy of claims, lower administrative costs, decrease the claim turnaround time by 2.2, and actually reduce administrative costs because certainly a paper claim just costs more to adjudicate then an electronic one. As many as three percent of 77 million claims, about 2.3, have missing information that may lend themselves to be codified if you had a diagnostic type code set. Another application would be for fraud and disease management purposes, as well as for benefit design. That sponsors of dental benefit plans would now have information to help construct more quality and cost effective type plans for group purchasers.

The research community is interested as it would facilitate more effective outcomes research, and truly identify those procedures that do work, that are efficacious and those that are not for a given clinical condition.

We heard a little bit about claims attachments, diagnostic codes will reduce or eliminate the need for claims attachments in many respects that currently discourage dentists from submitting claims electronically. Again, as many as six percent of 77 million claims undergo professional review and another 2.3 again kind of have missing information. If you just kind of do a little bit of math up to six percent of 77 million claims, some 4.6 million may be impacted if you could kind of codify some of this missing information. And then again if you just kind of extrapolate that to the entire dental benefits world using Delta Dental Plan numbers over 18 million claims could be efficiently adjudicated with appropriate diagnostic coding improvements. So again, our main concern is really trying to adjudicate claims more efficiently, more accurately, and increase the EDI rate.

The ADA has acknowledged the importance of diagnostic codes to providers and payers in previous testimony, testified for example that SNODENT could provide the mans for diagnostic coding, reliable diagnostic treatment outcomes data, and for third party payers to eliminate the need for narrative descriptions in attachment, and I've kind of noted that previous testimony.

When you look at SNODENT it's very analogous to SNOMED in terms of its granularity, in fact SNODENT was included in the National Library of Medicine licensing of SNOMED for its use in the electronic health record. So I kind of come back now to this issue of process and how it impacts this important dental coding subset and how in this particular role in the success of administrative simplification.

The ADA has expressed strong support for using the 6,000 SNODENT codes as the proper diagnostic code set for dental procedures. However, the ADA has also indicated the development and maintenance of these diagnostic codes would be solely and entirely the purview of the ADA without substantive payer representation or participation, however again we kind of heard a little bit of update on that today. So they have also declared that it falls outside of the current purview of the coder vision committee.

The 6,000 SNODENT codes raises concerns about achieving the goal of really truly administrative simplification. The 6,000 really may not be appropriate for that particular purpose, and it really appeared to at least Delta Dental more suited for use by the research community and dental informatics then by payers. For billing and transaction purposes we don't really need 6,000, that appears very, very complex, we feel they would really confuse the provider world. And according to most payers when you talk to them, roughly 30 to 40 diagnostic type codes is really that's all that's truly kind of needed to really again achieve the goals of administrative simplification.

Our urgent message to the committee today is that administrative simplification can be advanced for dental claims with the efficient diagnostic code set. Again, only 35 or 40 would be needed. Important debate must occur among the dental payers and providers before SNODENT or any other diagnostic code set or set of modifiers is adopted.

ICD-9 and ICD-10 codes are much more efficient in our perspective then SNODENT, and either would be preferable for the purposes of claim transactions. Although as a plan we have not completed our full assessment, ICD-9 diagnostic codes are somewhat limited and outdated, and DDPA does believe that ICD-10 with some changes is a needed improvement for medical and dental claims. Currently dental payers have no diagnostic codes in use in claim transactions, and so in our preliminary assessment we view the cost differential between implementing ICD-9 or ICD-10 to really be actually the same, and currently we are undergoing a process of developing a package of ICD change requests.

Because HIPAA includes statutory definition of a code set that includes diagnostic codes DDPA strongly believes that the diagnostic code is part of the national standard code set and any proposal to adopt diagnostic codes, such as SNODENT, must be accomplished in an open process established under HIPAA. I would note at this time that our primary objective or objection to the adoption of SNODENT for medical record core technology is really rooted in cost and availability concerns and it's not that we wanted necessarily representation on the maintenance committee. Our request for participation on that committee is really a result of the ADA initiative to add SNODENT to the electronic claim format.

In summary conclusion, the adoption of diagnostic codes would be an important step forward in simplifying electronic transactions for dental procedures. DDPA supports ICD-10 for dental claim transactions. And just as CDT dental code system is now a national standard in the dental industry and maintained through a balanced process, the adoption of any dental diagnostic code as part of this national standard must be accomplished through the open process required under HIPAA, and DDPA respectfully requests the committee's support in this matter.

Thank you very much for your attention.

DR. COHN: Well, I actually want to thank the testifiers for really fascinating testimony, very enlightening and I think very interesting for us all. I guess I would ask that perhaps, given that at least two of the three discussion items that we've had, one was obviously the CRC process and licensing fees, seem to be at least I'm hearing sort of on the edge of being resolved, I think two years after they were first brought up to the subcommittee. I don't know that we need to take time to discuss it but I think we would all look forward to a letter, assuming the successful resolution of those issues, just to indeed inform us that indeed that issue has been resolved so that we can sort of take it off of our to do activities and issues to watch. So I guess we would hope for that and we'll obviously keep our fingers crossed on that.

Now obviously I think everyone has a number of questions about SNODENT and I'll sort of defer to our other subcommittee members to sort of begin to delve into that, and staff. I would observe that I'm hearing sort of an interesting tangle of discussion here, and indeed I think obviously sort of reflecting on this when we put this together, which was that I think when we were originally talking about SNODENT we were sort of thinking about a clinical terminology that would be used primarily within the context of a dental electronic health record. And I've got to tell you I was informed in this conversation that I always presumed that SNODENT, like SNOMED, handled really all aspects of expression in dentistry as opposed to being just a diagnostic code, so I've actually learned something from this presentation. But obviously what's coming forward is the issue really that, in this conversation, that there really is no diagnostic code for dentistry and is it just used for an electronic health record, or should it be part of a claims transactions, I mean where do all these things fit together and so this is all sort of tightly bundled together in the conversation. So I'm just observing that we're hearing about three or four things sort of simultaneously without trying to unwrap them all and disambiguate them all, but hopefully we'll have a chance to talk about that in the questions.

Now Steve did you have a few questions to start off with them, and then Jeff, and I see Clem also in line and then Stan, oh, and Marjorie.

DR. STEINDEL: Yes, I have some specific questions regarding SNODENT and its legal relationship with the College of American Pathologists, the ADA relationship with the college, and its inclusion in SNOMED. And I'm coming at this from my position as CDC liaison to the SNOMED editorial board and I have been in that position for probably on the order of six plus years and second, as part of the key government negotiating team on the SNOMED license from its inception, in both of those positions the college has always presented the dental terminology content as integral to SNOMED, that it was provided to the ADA and they have an agreement with the ADA to use it. Consequently it was our assumption when we entered into the negotiations that this terminology, the SNODENT terminology, would be part of the SNOMED package that was transmitted to the government, and indeed it is and should be appearing for public availability in the UMLS in the neat future.

With that as a preamble there are two things that arise from your testimony. The first is you note that you have a ten year agreement with the college on this. What happens with the dental content at the end of that ten year agreement?

DR. GUAY: I would anticipate that it would be extended, and the ADA generally does not enter into ten year agreements with anybody, our agreements are usually one year or two years or three years, but we have such confidence in the CAP relationship the initial contract was for ten years so we anticipate it being renewed, the Lord only knows that. But I'll tell you the ADA and the CAP are going forward on an international basis with SNODENT code as part of the SNOMED code besides in the United States. So our relationship with SNOMED and of the CAP is growing rather then shrinking.

DR. STEINDEL: Okay, I'm encouraged to hear that, thank you. The second part of that is that if for some reason, and there's absolutely no intention on anybody's part, the college's part, the government's part, or anyone else's part, but the agreement was specifically written to protect the investment of the government that in case for some reason this agreement should be terminated by either party, the last version of SNOMED would turn over to the government to be used as it is now, and that would include the SNODENT terms, and you are comfortable with that portion of the agreement.

DR. GUAY: This is my first knowledge of that but on, and I read quite a bit about it, my guess is that there, it's fine. What is happening now is happening now. There's an agreement to perpetuate today's situation in the future, I think that that's okay. I really don't, I don't really foresee any friction between the two organizations.

DR. STEINDEL: Okay, thank you for clearing that up. I think there are some other questions as Dr. Cohn just alluded to concerning SNOMED, SNODENT, and HIPAA code sets and diagnostic purposes, etc., which I think other committee members will address but I wanted to clear up the specific thing with regard to the federal license. Thank you.

DR. GUAY: And maybe add one more thing because this sort of fills out the picture, there's been a discussion with CAP and in CAP about the availability of the SNOMED, including SNODENT, through the National Library of Medicine at no cost to use in the United States. And when we first saw that we were a little bit distressed by that but we're no longer distressed by that because what, if you look at SNOMED as a total code, as I said earlier, the SNODENT terms are not in a chapter called SNODENT, they're dispersed through any one of the systems where the codes are derived. And there are a number of codes from SNOMED into SNODENT, a number of dental codes from SNODENT into SNOMED, so the service that the ADA will perform will be to extract the subset of the SNOMED code called SNODENT and that will be the product in the marketplace.

DR. STEINDEL: Thank you.

DR. COHN: Okay, Jeff next then Clem.

MR. BLAIR: Up until the availability of SNODENT what codes were payers using to reflect diagnosis?

DR. GUAY: The answer is none, there's never been a request or a requirement for dental claims transactions for a diagnosis or diagnostic code. To this day there's not either.

DR. ADAMS: They're not being used now either, SNODENT is not being used by the third party payers --

MR. BLAIR: So you haven't used diagnostic codes at all.

DR. ADAMS: No.

MR. BLAIR: When the NCVHS went through the process of trying to select a core set of clinical data terminology standards or PMRI standards the process that we used, not necessarily saying that it's right or wrong, but the process that we used was to gather information from the code set developers, and to hear from the users of the code sets and I don't really recall, when we heard from users we just assumed that all of the users of these code sets were either vendors of electronic health record systems or health care providers. I don't recall that we ever checked with payers because we were inferring that the clinical data terminologies that we're looking at would be mapped to existing diagnosis and procedure code sets that were previously defined under HIPAA. So one of the things that I'm thinking of here is that the use of SNODENT I'm thinking of as primarily being a use for patient care, for clinical research, and that it would have a secondary use in feeding into the reimbursement process. And Ed, you mentioned that all you really need is maybe a roll-up into about 30 codes and maybe that makes more sense for the reimbursement process, doesn't need the 6,000 SNODENT codes, but the other uses of SNODENT require the 6,000 uses. So maybe there has to be a bridge, an intermediate step as there is with acute care and ambulatory care in medicine, to a billing code set, which apparently doesn't exist, and maybe part of the problem here is to infer that SNODENT would be a billing code set and maybe if you could wind up looking at it instead as a clinical code set and still consider that there is a lack of a billing code set for diagnosis that needs to be created, and then have SNODENT mapped to that billing code set, maybe that could help resolve the issue.

DR. COHN: Dr. Guay?

DR. GUAY: We have a, first of all, as happens in this conversation historically the two systems are intermingled, they're two separate systems. You've identified clearly that there are different needs maybe for codes but in talking about the SNODENT diagnostic coding system in the context of the clinical patient record, electronic individual patient record, and that's what the ADA is seeking, is to us clear, now on a practical basis with our procedure codes. Now with our procedure codes there are 600 procedure codes or so. We have a condensation that we publish with our manual, and this is one of the services of the manual, of the most frequently used codes so that in dentistry particularly I would have to guess in my clinical experience there probably are less then ten diagnostic codes that are used every single day in the dentist office, carries(?), periodontal disease, whatever, because the scope is ordinary daily general practice dentistry is limited to a small number. And so we publish with our entire procedure codes a summation of the most frequently used codes so that office administrators don't have to go through the book every day looking for those few codes that are used on a repetitive basis.

Now electronically that's simple to do, and we're talking about moving to an electronic environment, and it's a simple thing to identify those codes that are used most frequently. On the other hand most frequently for reimbursement purposes is different then most frequently for diagnostic purposes. So I think it would be not too difficult and it would seem to follow logically that were diagnostic codes ever to be required or asked for in health care transactions that the ADA in their process that they followed that they did for the procedure codes would publish a small number of frequently used diagnostic codes in every day dentistry. So it's a practical solution to a problem that would be more complex then it is.

DR. COHN: Other comments? Did you want to make a comment on this one?

MS. GREENBERG: Well, I just wasn't sure that people, everyone was aware of the process that's been going on starting with the December meeting of the ICD-9-CM Coordination and Maintenance Committee, and continuing for the next meeting, and I believe it's in April or May, and actually I've been emailing here with Donna Pickett who due to the weather was unable to get to the, she helped, she may have spoken with several of you, I think she helped set up this part of the agenda. She is listening in on the internet --

DR. COHN: Well, give her our regards.

MS. GREENBERG: Hi Donna. I haven't gotten a response, she sent me an email saying, and I was of the same impression, that didn't sound like people were necessarily aware of the work that's going on to expand ICD-9-CM for dental diagnoses. I was actually at the December Coordination and Maintenance Committee meeting and a number of recommendations came forward for updating and expanding those codes for administrative reimbursement and related purposes, obviously not for the clinical record. And I believe most of those are being incorporated into the addendum for the 2004 for ICD-9-CM and also there are additional requests that I think will be favorably entertained at the next meeting. And of course anything that goes into 9-CM would go into 10-CM if it isn't already there. So I think the process is what I had asked Donna and haven't been able to get a response yet, is who was leading that effort because I'm not quite sure though it sounds like Delta has been involved with it somewhat. So I think the process is underway to get dental codes into the current code set that is used for diagnoses under HIPAA administrative transactions.

MR. BLAIR: Well, the other piece of the puzzle then would be if SNODENT as part of SNOMED is being mapped by the NLM to this expansion of ICD-9, then the mapping is there, to the billing codes.

MS. GREENBERG: It would be.

DR. COHN: And maybe I should just ask almost a more fundamental question because I think that there's, once again, there's three or four undercurrents going on. One of them is what to use for a clinical terminology, and obviously is trying to make what you do exactly how we've conceptualized how the rest of the health care world we have perceived it, and it may or may not work for dentistry. But I guess I'm sort of wondering, I'm sort of hearing and maybe this is an undercurrent with ICD and with your testimony, is the intent of dentistry to start requiring dental codes, diagnostic codes on dental claims? That's seem to me what you're all dancing around with because I'm hearing that you don't have one, it sounds like at least some of you perceive that there's a need for one, you're wondering whether SNODENT is that or whether it's something else, and you're sort of talking about it, there's going to be a modifier to a CRC code, I mean to a CPT code or is it going to be something else, is there general agreement by all of you that the industry would work better and the billing and claims and administrative simplification pieces would work well? Is that really what we're talking about at least on one level? Ed, do you have a comment?

DR. SCHOOLEY: I would not go to the point and say that there's general consensus across the industry any way in terms of the need to have a diagnostic code, but I will tell you that in our initial work investigating modifier codes or having a clinical reason for a treatment code there is a lot of interest by plans, by many major plans, to have the availability of a diagnostic code set for some of the reasons I kind of mentioned. Right now they have none, right now they cannot even choose to use a diagnostic code set to improve the adjudication of claims, so our premise is trying to get a standardized diagnostic code set out there at least available for plans to use who want, so choose to use them for their business needs.

DR. COHN: Roger?

DR. ADAMS: Yes, I think there are a couple of things to realize the difference between health and dental. Many of the plans and many of our members are independent dental plans only, they don't use a medical processing system to process their claims, so they don't even have the capability for putting in the diagnostic code in their claims processing system. So if you implement and mandate a diagnostic code there's going to be a tremendous cost associated by many plans to implement just to be able to process the code. So HIPAA was a tremendous impact for a lot of these companies to start becoming HIPAA compliant, but now you throw on and what we're getting in feedback is a tremendous concern with the cost of implementing a diagnostic code.

The second comment I'd like to make is I'm hearing Al talking about electronic patient record, which is a totally, fine, I can understand that from the complexity of that many codes if you're really getting in, I mean if I start going to my pathology and you want to have diagnostic codes, I'll come up with 6,000 different variations of a fiberosteous(?) lesion within the mandible, I mean depending on how you want to split the hair on diagnosis. But when we start talking about clinical diagnosis for paying claims you can take the most highly utilized codes, that's one way of looking at it, but that's still not a diagnosis, that's just the utilization of code. I think what I would submit is that there is the possibility that the electronic claim piece is a total separate animal from the actual processing piece, much more like Jeff has talked about, and that we need to have an industry coalition put together to recommend the diagnostic code proposal to where we then can make certain that that fits from a payer perspective and from a clinical perspective so that we don't overwhelm a payer's system and cost, and that we also come up with a legitimate, and I agree with Ed, as I'm just sitting here grinding through my head, probably 35 diagnostic codes would be reasonable in dental, it might be 40, it might be 20, whatever, a small number, but I think that that has to be developed with the significant input of the payer community for what, if we get mandated that it's going to shut down many companies just with the cost of trying to do that in a short period of time. But if there's enough time and they see this coming down then there's not going to be an interruption of care and it will keep every plan in a competitive market. Does that make sense?

DR. COHN: Well, I think you've said two things that are sort of opposed, one is that you're afraid of diagnoses but it sounds to me like you're basically in favor of a small amount of diagnoses --

DR. ADAMS: We're not afraid of it, we just don't want to see it come down in a sudden, and I think from a payer community, putting my NADP hat on it, we definitely need via the table because we understand the complexities of implementing that type of a system in a processing modality that doesn't exist.

DR. COHN: Okay, before we move on Dr. McDonald, Dr. Guay, what do you think we're talking about here?

DR. GUAY: Well, I'm going to ask you the same question. Are we off now, my speculation is that you really love SNODENT as a clinical descriptor in the patient health record.

DR. COHN: That's what you think we like.

DR. GUAY: I'm hoping that's what you like.

DR. COHN: Well, what is it that you want --

DR. GUAY: If we can close that book again and say now we're talking about a dental transaction piece apart from the patient record that would be usable if the industry ever asks for diagnoses and it's not in our power to do that. You've heard them say that's so so. So what I'm saying and I said earlier, the American Dental Association has absolutely no power to tell industry what they need for the adjudication of claims. If they say they need this or that that's their business, I mean we're not in that business. We're in the business --

DR. ADAMS: [Comment off microphone.]

DR. GUAY: -- CDT is not a diagnostic --

DR. ADAMS: No, but what we hear from the payer community is that the evolution of SNOMED all of a sudden becomes a beast that we are now obligated to pay claims to just like CDT came in and evolved in that sense. So that's an environment that makes us highly nervous. Now if it's just purely an electronic patient record that is not going to be impacted and mandated to be used in the payment of claims, we don't have any problem with that.

DR. GUAY: Who would mandate that you had to have diagnostic codes in the claims procedure payment transactions, who would mandate that?

DR. COHN: Probably the Secretary of HHS, I mean if anybody was going to mandate it, through rule making I mean --

DR. GUAY: Would the Secretary of HHS say in order to pay dental claims you've got to have a diagnostic code?

DR. COHN: I'm actually asking the industry what you want. Obviously dentistry, and then I'll let Dr. McDonald because he's been very patient, but clearly dentistry is a different beast then medicine in the sense that medicine is typically has had diagnostic codes that have been used for billing and used for administrative transactions, and the clinical diagnostic work that we've been doing has been to a degree of granularity for clinical care. Dentistry seems to be in the position where you don't really have much in any way of diagnoses in your area and so I think it leaves open the question of if you have a diagnostic code system how it will be used, which I think is what you're sort of asking, is it just clinical, is it administrative, is it both, and I think that's sort of what you're bringing to the table. So I think I'm hearing that at least all of you are sort of, might be more comfortable with SNODENT if it were just used in electronic health records but it does leave open the question of what do you do on a claim or do you even put a diagnosis on a claim, and that's really a question for the industry.

MR. BLAIR: Just in case it wasn't, Ed, in case you were not aware, when the NCVHS recommended SNOMED as part of a core set of PMRI terminologies, it did not recommend it for payment, it recommended it for clinical use.

DR. COHN: Well, Jeff, I'm not trying to answer that question, I'm just sort of observing the landscape. Now Dr. McDonald has been very patient.

DR. GUAY: I got interrupted in answering my question, can I finish my question?

DR. COHN: Oh, I'm sorry, please.

DR. GUAY: Trying to get my train of thought back. I think the last thing I said was that the need for including diagnostic information in the dental transaction is solely within the power of the payer industry, not the power of the profession. The track record has been for 30 some years they've gone along probably relatively well never asking that question. So it sort of raises in my mind what is the deal now, but that's not our business as I said earlier. You'd asked about ICD-9 and the procedure process for maintenance of ICD-9, I've seen ICD-9, I've seen the recommendations going forward, and there's a couple terms in there that I'm, I've been a dentist for a long time and I think a good dentist. There was terminology that I had no idea what they were talking about. I went to all the existing dictionaries in our library, terms not included anywhere on the medical dictionaries in our library. The only way I got to figure out what they were talking about was they had an explainer, explanation of what the terminology was, so that is not a user friendly contemporary coding system. It has archaic terms, it's not hierarchical, it misses things, it is very difficult. So that's why the ADA when they were looking to do a coding system our first inclination was why don't we just build upon an existing coding system, why start from scratch. And the first place we went was the ICD series and we found it unacceptable, and so this is a whole genesis of the development of the SNODENT as part of the SNOMED hierarchical logical system.

DR. COHN: Marjorie, please.

MS. GREENBERG: My emails are coming in fast and furiously here, I guess it's the blessing and the curse --

Okay, apparently it was the University of Illinois School of Dentistry that brought forward the request for new codes to ICD-9-CM, but there were supporting letters received from others in the dental community, and I'm trying to find out who those were, but in any event there were 76 new dental codes that were proposed for October 2003 and more being proposed, which would be implemented in 2005 at some time. I think she means October 2004.

The point is that this process is going on right now and it needs your participation, these three groups, as well as others in the dental community. We have had some input obviously but it appears not sufficient maybe. And I believe that the addenda is either posted on the NCHS website or will be posted very shortly, and so we really need, there's another short comment period because there's a whole process by which we have to get new codes into ICD-9-CM that will then be part of the 2004 addenda and then are used in the DRGs and everything else. I realize that these dental codes would not be used for that purpose but before we add these codes I would want to make sure that we have had full, I mean these are open meetings as you know about but it snowed the day the 76 codes were presented.

So anyway, I hope you don't mind if I use this opportunity to encourage people to go to the NCHS, www.cdc.gov/nchs classifications website and see what has been proposed and let us know whether you support this or not. And I also was just going to say, we were having a little bar here, that I'm old enough that I remember when diagnostic codes were not required for outpatient and physician claims, and of course that decision then was changed by Medicare. As we know Medicare does not cover dental but Medicaid does and I understand that they've been using local codes so some type of a movement towards a national code set does sound like it would be desirable and obviously all the interested stakeholders need to be involved.

DR. COHN: No, I think the fact that I'm looking at three presenters, who I think are key to this sort of activity, who at least to my understanding don't seem to be aware of it, obviously tells me there needs to be better communication and interaction, but certainly we would hope that you would all participate and review these codes. Dr. Schooley, I'd actually like to allow Dr. McDonald to ask a question.

DR. MCDONALD: Thank you. Some of the questions kind of got answered but it was just clarification and then I wanted to ask a real question. But originally, the 40 codes you were talking about were diagnostic codes, not procedure codes, correct?

DR. ADAMS: Correct.

DR. MCDONALD: And the procedure codes now are the dental procedure codes and there's 600 of them or something like that, right? And when you're talking about ICD-10 which version, ICD-10-CM, the diagnostic codes, or PCS, the procedure codes? You said ICD-10 might work for us and I wasn't sure in which context that statement was made.

DR. SCHOOLEY: Within the Delta organization we have developed actually a task force to assess ICD-9 and ICD-10, and we did use the CM version --

DR. MCDONALD: For diagnostic codes.

DR. SCHOOLEY: -- started to look at and started to identify business needs and then gaps in the current diagnostic coding system, and what would kind of be needed, and we're going to be putting together kind of a package of additional items.

DR. MCDONALD: Then having kind of got oriented clearly, the question really related to how harmonious the decision really was, the one that Simon thought we didn't have to ask. And I think it isn't from what I heard from the succeeding discussion. Let me interpret what I think I hear, I think I hear that sort of the larger industry would like to have, they may like to have some diagnostic codes because it might help adjudication, but they'd like to have a modest set and then with various participants in the development, is what I heard, and so in that context I think the word about the SNODENT being sort of the tail under the tent or something like that. Is that fair? So the economic issues are still prevalent or is it just really can we get what we need instead of something else? You don't have to answer me directly I guess but that's really what I --

DR. SCHOOLEY: I would just like to comment that DDPA's main concern is really the open process aspect of it and we really don't know exactly what that truly meant before coming here today, whether that meant just merely attending a meeting, whether it just meant providing some input, or whether it really meant more of a direct participation, being at the table, having a vote, and whether there is a good, again balanced, and check system if you will that you have on the medical side.

DR. ADAMS: And I would, our feeling is exactly the same.

DR. MCDONALD: So tomorrow a document is not going to come out that's going to go well, it's all pretty sweet and roses time.

DR. COHN: Stan, I think you're next. We'll just try to keep it in line here.

DR. HUFF: I'm just trying to make sure I understand the history and then sort of the current governance of SNOMED, or SNODENT terminology. SNODENT existed as an independent corpus before you started collaborating with SNOMED?

DR. GUAY: SNODENT was in a developmental process, and we developed SNODENT in conjunction with SNOMED, in other words the exact process is the Code NIC committee I talked to you about, was made up of representatives from each of the specialties of dentistry plus general dentistry and some ADA people, they drafted up in each of the areas of dentistry the conditions, the diagnoses, submitted them to the SNOMED people, who then added some additions and put SNOMED codes onto the list that the ADA had supplied to them of dental diagnoses. And when that was done that was SNODENT, the combination of terminology developed by the ADA, some added by SNOMED people, and SNOMED codes, that became SNODENT.

DR. HUFF: Okay. And what, I mean was discussion about CRC and maintenance of CDT, what is your process going forward for maintenance of SNODENT?

DR. GUAY: The process, first of all SNODENT has, as I testified earlier, has been on the shelf since '99 and it was brought off the shelf with the Secretary's request for submission of codes for designation as a core terminology. And so from the initial development of SNODENT, when it was finished in '99, there's been no work on that at all. Now the ADA is saying now that the code the committee has been going on all these years, the proposal is that there will be payers put on the Code NIC committee, which will meet and discuss all recommendations for changes to SNODENT from any interested party. That will then go on to our council for their approval, and then will go on to the SNOMED editorial board for inclusion in the overall SNOMED, which includes the SNODENT.

DR. HUFF: So, just summarize for me again, who's on the committee that you're proposing? Is that the same committee as the code committee that manages CDT or is it --

DR. GUAY: Two different worlds.

DR. HUFF: -- entirely different.

DR. GUAY: North hemisphere, south hemisphere, the crossing over, somehow we got to the equator thicker. The two are totally different --

DR. HUFF: And who are the people who would be on the SNODENT committee then?

DR. GUAY: SNODENT committee is comprised right now, is composed of representatives from each of the recognized specialties of dentistry, eight, from the Academy of General Dentistry representative, and representatives from the councils that manage practices in the ADA, dental practice, dental benefit programs. We've proposed to add to that committee representatives from payer organizations. We'll still be called the Code NIC, it will be expanded by adding payers to that. We'll have the same vote on that committee as anybody else has, one vote each.

DR. HUFF: And it's been asserted that “SNODENT is unreleased” --

DR. GUAY: That's true, it's available from the National Library of Medicine for anybody in the United States that wants to --

DR. HUFF: How would I recognize it within the UMLS metathesaurus?

DR. GUAY: It's as I said earlier, there's not a section called SNODENT, the codes are imbedded in each of the sections by systems, that when pulled together would become, and what the ADA would do is combine those, or sort them out and list them as a subset of --

DR. HUFF: But right now that pulled together set doesn't exist.

DR. GUAY: It does exist, we have that.

DR. HUFF: You have it?

DR. GUAY: We do. We made it available to Delta, they didn't look at it. We have probably five or six or seven sites now using this, mostly our universities, using this SNODENT systems in a couple years.

DR. MCDONALD: Will that be free?

DR. GUAY: Pardon me?

DR. MCDONALD: Will that be free?

DR. GUAY: The SNODENT part extracted will not be free. If you wanted the plastic surgery set from SNOMED, that's not free either. You can extract it, the subset. This has all been a long discussion with CAP about what is the relationship between us and the freely available code at the National Library of Medicine and that's been resolved because they were doing the same thing with their own people about what could they do with the SNOMED code now that it's available at the National Library of Medicine, can they have sub-products that they can sell and the answer is, in their summation is yes.

DR. COHN: Stan have we addressed --

DR. HUFF: Final question. Is the content of SNODENT restricted to diagnoses, or does it have finding information? The distinction I'm making is finding information would be, I mean I'm not smart about dentistry but teeth color or descriptive properties of teeth, and the wear and how much your gums bleed, that's sort of stuff is in there?

DR. GUAY: It has some findings but mostly are diagnoses, sometimes the findings in diagnoses, there's not a clear line between them, they are primarily diagnoses symptoms and some findings, mostly diagnoses.

DR. HUFF: Thank you.

DR. COHN: Okay, thank you. Michael and then Steve.

DR. FITZMAURICE: As with a lot of hearings this has been really informative and it's like looking at a microcosm of the economy. I see some people talking maybe subtly about premiums, giving health plans a fair opportunity for profit, and we're talking about the tools they use. I hear people subtly talking about payment to providers and fair opportunities for income, but consumers would say they want services, that is a fair opportunity to choose providers, provider services with payer health plan premiums. There's a lot of desirable characteristics we probably could agree on, maybe not all of them, we want efficiency in the process, we want open representation of those with direct and material interests. We want an accurate description of the services and the patient outcomes. It gets involved in technology, diagnoses, procedures, because we want to advance medical knowledge for the benefit of the patients.

A lot of this the marketplace is going to determine, it's not going to be a Secretary decision, the marketplace determines payment schedules, dental health plans, benefit coverage decisions, adjudication, this is essentially the weighing of the benefits and costs to all parties. Within our framework there's a National Health Information Infrastructure which is a vision, we have to deal in the world of reality, so we push for greater efficiency, greater advancement of medical and dental knowledge and technology, and we want the application of this knowledge and associated techniques for the benefit of the patient.

What I see you going through, and it's a very good process you have, you're talking with each other, you're expressing the incentives that you have in trying to work it out. Nothing every comes to us perfectly but we can see where you're going and I think the process you have so far has been a very good process with a lot of good will on both sides. It's kind of privilege to see this microcosm at work, and I wish you luck.

DR. COHN: So that's a comment.

DR. FITZMAURICE: That's a comment.

DR. COHN: Steve and then Clem and then I'm going to try to put things together here.

DR. STEINDEL: I have a for information question of you. We've mentioned a lot of committees and groups but there is a dental DSMO, and what is the constituency of that group?

DR. GUAY: I can't answer that question, maybe Frank, he participates in the day to day operations, if that's okay.

DR. ACORDY: Frank Acordy from the American Dental Association. I believe you're referring to the ADA's Dental Content Committee. The constituency of the Dental Content Committee, and if my memory fails I beg forgiveness, it's comprised of representatives from the National Uniform Billing Committee, the National Uniform Claim Committee, the Delta Dental Plans Association, the Workgroup for Electronic Data Interchange, AAHP/HIAA, the Blue Cross and Blue Shield Association, and four representatives from the American Dental Association, excuse me, five representatives from the American Dental Association. I think that should, excuse me, and the Centers for Medicare and Medicaid Services. I believe that total is 13, if not please correct me.

DR. STEINDEL: Thank you, I was curious about that because of course that's one way to get input into the HIPAA process and I just wanted to see how broadly constituted the group was.

DR. COHN: Kepa.

DR. ZUBELDIA: Thank you. Let me express some reservations from this meeting, I've been kind of on the sideline listening in. It seems like SNODENT is a clinical terminology, it's more then diagnostics, it's a clinical terminology, of which some of the terms are diagnostics. It also seems that nobody wants to have a requirement for a diagnosis code on every dental claims, at least I think that's coming out pretty clear, it has been expressed both by payers and the ADA, that it's not necessary, it's worked like that for 30 years and the payers are concerned that they may be overwhelmed with a diagnosis code on every claim.

But it also, I've heard that the payers may need additional codes, additional codes to identify whether a claim is the result of a cosmetic procedure or it's an accident or a prophylactic, and some of those codes may be diagnosis codes, but some of them may be different from diagnosis codes, maybe a code that says this is a cosmetic procedure independent of a diagnosis.

On the other hand the claim itself, the 837 claim as we know it today, the dental claim, even though it has room for diagnosis codes, the implementation guide has specifically removed those elements and marked them as not used. And I checked that out, and also there's a section right next to the procedure code for four modifiers that were initially opened as modifiers and in the addenda were restricted to modifiers issued by the American Dental Association Code Content Committee, I think the modifiers must be part of the CDT modifiers, those are the only modifiers available. And as of today there are no modifiers issued like the CDT, so you can only use certain modifiers that by the way don't exist.

It seems to me that adding diagnosis codes, even adding diagnosis codes to the claim, whether they are ICD-9, ICD-10, or SNODENT, one satisfied the problem if there is a problem. It seems like what I've heard expressed by the Delta Dental Plans is that perhaps you need some codes but I suspect that adding diagnosis wouldn't tell you whether it was an accident or whether it was a cosmetic procedure or a prophylactic procedure, or what the diagnosis was.

So perhaps this dialogue that you've started and that is going on perhaps needs to look at the possibility of having some codes that could be useful by the payers to satisfy their needs that they may have and perhaps even legal needs in certain states to identify something for certain dental claims, that are not necessarily just diagnosis codes, and perhaps you need to look at something, I don't know what, that could fit within the existing claims structure and for a moment I'm going to call them modifiers. Because that fits into the structure as we know it today and I'm not saying that they would be equivalent to the modifiers that we use for the CPTs and HCPCS codes but it could be a modifier for billing purposes only. And for billing purposes you may want to give additional information in addition to the procedure code.

And if we look through the 837 claim telescope view, the thing that comes is that there is a place for up to four modifiers that would modify a procedure for billing purposes and leave the SNODENT terminology separate from this battle that I think is very separate and distinct. It's just my observations on this.

DR. COHN: Yeah, and maybe I'm maybe speaking for some of the testifiers but my understanding in the testimony was at least some discussion that those sorts of modifiers had at least at one point been under consideration by your CRC --

PARTICIPANT: There was an ad hoc --

DR. COHN: -- and it may be either on the table or off the table depending on the workings of that group, that is correct isn't it?

DR. GUAY: There's several organizations, just two come to mind, that proposed the modifiers to the procedure codes, and almost universally the modifiers were diagnoses, didn't deal with cosmetics or emergency or patient circumstances or procedure circumstances, they were diagnosis. And so the discussions with the committee is that a modifier to a procedure, we don't think so, it's a diagnosis, nothing to do with the procedure per se.

DR. COHN: Sure, and I guess I would defer to the workings of the dental community to figure out what they want to do with modifiers, though I think that Kepa has his reasonable suggestion.

I wanted to sort of try to put things together because I think there's a number of to do's for the people who have testified before us, and I'll start out and I think Clem may have an additional --

DR. MCDONALD A question, that's what I have is a question.

DR. COHN: Oh, I'm sorry, please.

DR. MCDONALD: In terms of the subset I just wanted to understand how, I guess ADA assumes that the big set is not going to be very conveniently used, so most dentists or systems would want to have the subset. Is that an assumption?

DR. GUAY: That's my guess.

DR. MCDONALD: And then a question, could anyone else make such a subset or would that be, the subset be copyright by the ADA?

DR. GUAY: I don't know the answer to that question except that if it were a piece of SNODENT, that's copyrighted, and I think the agreement with the Library respects copyrights.

DR. MCDONALD: Well, the challenge is is I think what the agreement says is you must get it delivered as the whole UMLS, and the question is is it the net, people will still have to pay for it to get it in a practical form, that would be a disadvantage.

DR. COHN: Carol, do you have a question? Then I will try to put things together and give everybody a lunch break. Please, go for it.

DR. BICKFORD: Carol Bickford, American Nurses Association. In this discussion there are two groups that I haven't heard as part of the discussion and that is the educators, how are we preparing our dental practitioners and how does the faculty in the schools of dentistry help them learn about dental codes and standards in relation to that? And the second group are research, because if we're looking at outcomes, that's based on evidence based practice in research and so how are they able to put all this stuff together and aggregate it and count it and do the checks and balances. So I'm raising those as folks that I haven't heard in this discussion as being partners in the decision making and the development process.

DR. COHN: Thank you.

DR. GUAY: Well we have, I think there's five, don't hold me to that number, schools using SNODENT in their clinics, and there's one school, I'm sorry, I can't remember who is going to totally electronic records in their clinics and they're using SNODENT. We're in discussion with the CDC about CDC using SNODENT as an epidemiological --

DR. COHN: Well, thank you, I think Steve has hopefully a final follow-up to Dr. McDonald's question and then maybe we can once again try to put this together and figure out the next steps.

DR. STEINDEL: Yes, this gets back to the first question that I asked concerning the federal license. The federal government did not license SNODENT, it licensed SNOMED, and SNODENT is part of the content, an unrecognizable part of the content of SNOMED as far as we receive it. And consequently the federal license governs what we can do with the SNODENT content within the, as put into the UMLS and as we would use it from the UMLS. And since we can't distinguish it as a product of the ADA we would be able to use it for subsetting, etc., as we would be able to use any other part of SNOMED. And that's what I was trying to clarify earlier in part. And that's why I was curious about did the National, the agreement between the College of American Pathologists and the National Library of Medicine, from the ADA's point of view, properly represent the intellectual property rights of SNODENT. Was the college free to do what they did with it? And if they are not then I think we have some problems that we need to discuss, both with the ADA and with the college because it's the government's assumption that we can use it as we would any other portion of SNOMED.

DR. GUAY: My legal training was at Tuft's Dental School, so I'm sort of speaking away from my sort of expertise. We've had discussions with CAP about that because we had the same question that you pose, and we were told that we under the arrangements were free to do what I said that we would consider doing. And apparently, I'm not speaking for them but apparently they feel the same opportunities, that providing materials that make the utility of the code more user friendly, that they're free to do that --

DR. STEINDEL: Yes.

DR. GUAY: That's the assumption that we're going under. And if we're wrong that will be another battle going on between --

DR. STEINDEL: I mean my position at CDC would be that the group at CDC who was thinking about using SNODENT, if they're thinking about entering into any type of payment relationship for just the codes, now not anything peripheral to that to make it easier to use, etc., I would say we can get those codes for free through the UMLS license agreement, which is what we're planning to do with all other forms of SNOMED.

DR. COHN: Okay, let's try to put this together, I think that this may not be as easy as I thought a couple of minutes ago because clearly there's a number of different currents going on, and I think a number of to do's really for our esteemed presenters. I really want to thank you all for really what's been a fascinating set of discussions, some of them sort of hard to pull apart because they're so tightly intertwined.

Obviously I start off the conversation by sort of asking, knowing that the CRC membership and the license fee issue is sort of sounds like is close to some sort of conclusion. Obviously you have the subcommittee informed of when that was resolved and obviously we would still very much like that.

I'm obviously hearing that there's needs in dentistry for at least for some undefined purpose some limited set of administrative codes for diagnoses, I think I'm sort of hearing that and it will be determined obviously by the dental community exactly how they would be used. Now as we talk about that it certainly sounds like there's an independent activity going on that it sounds to me like you may not have been aware of relating to the world of ICD-9 in terms of additions to ICD-9 and that should certainly be something that you're all evaluating.

Now we do obviously understand that obviously on one hand the ICD-9 Coordination and Maintenance Committee is an open process. On the other hand probably it's not something that you all follow really closely because generally it probably doesn't have a lot to do with dentistry, or at least that you don't perceive that it does but it certainly recognizing the work going on, it's something that it sounds like you all need to be reviewing and seeing how it might in some way meet your needs.

MS. GREENBERG: I'm giving each of them the website so they can --

DR. COHN: Okay, the website and maybe Donna Pickett's phone number so they can call her to ask about it. So that's certainly something that you all ought to be doing, recognizing that you seem to have dual needs.

Now I'm also hearing issues about SNODENT and its applicability, and it sounds like there's a number of issues still outstanding relating to contracts and specific uses that probably need to be dealt with with the federal government I think before we can start making any comments about its applicability and usefulness as a national standard in a clinical domain for the purposes of an electronic dental record or something like that but we'll be looking forward to getting some of those clarified and hopefully we can make some further statements.

Now as part of that obviously I think it's very refreshing actually to hear the payer community engaged in these conversations. I'm actually sort of looking at this and sort of thinking back to our PMRI discussions and the truth is is that the payer community in health care, though I represent sort of both in the world of managed care, has probably not been as engaged as they ought to be, and you're actually showing us a very interesting model where the payer community really does, is aware of the importance of clinical diagnoses, and so we obviously, from my view the idea of a more open process where the payers and providers are working together around the concept of clinical diagnoses and findings are, it's obviously refreshing and something that we obviously encourage.

Now we would look forward to hearing from you exactly how that works out and whether as you continue discussion whether it's as open a process as you would like, because I think openness is probably, and it's openness and inclusiveness in terms of the conversation, so we would look forward to future communication from you all about how well that's working.

I think beyond that, I'm not sure, I probably am missing some other key areas but I mean Kepa obviously brings up the issue of how the electronic implementation guides work in with any of your future visions, and certainly I think you're hearing that there are clearly constraints based on what implementation guides look like on how any of these pieces fit into electronic transactions, which is one of the things that you're all speaking as being in favor of, wanting to have work easier so that you can do less claims attachments. And certainly the choices that you all have are to talk with the X-12 clinical, dental, Kepa, help me with this one, is there a separate X-12 group that deals with this one? Okay, well basically to have future changes made in the implementation guides to enable at least on a situational basis diagnoses in a way that might be helpful to the industry, or perceive something that you could do now which is a modifier, but that's really something that the industry needs to decide and it's really part of your near term and longer term strategy.

Now have I missed anything? Is there any other to do's that we're asking from this group? Clearly you've got a lot of work to do, I think it's wonderful that we're all talking about it. Do you have any final thoughts? I mean we've obviously been hitting you pretty hard with questions and really appreciate your openness in terms of the discussion. Dr. Guay, any final comments?

DR. GUAY: I spoke to Kepa earlier this morning about the attachments situation and made him aware of some of the things that are going on in dentistry already, and I told him I would write to you and give you a description of what is occurring in dentistry now with ready graphic transmission, peri-information(?) transmission electronically, and our relationship with the DICOM standards, our support of that standard, we'll write to you, the ADA will write to you and tell you what's happening in that area so you have some basis for looking at this. I know that your, the medical world apparently is behind the dental world, I won't make a smart remark, I'll just leave it at that. Don't undo what's already being done, that's being done successfully, in devising a system that you may ask the medical people --

DR. COHN: And we appreciate that, obviously as you know we are talking about a hearing on claims attachment that hopefully we can get some representation from dentistry because it sounds like you've got a lot of experience.

DR. GUAY: I told Frank to track that and when that invitation comes out we'd be happy to talk about our experiences in that area.

DR. COHN: Thank you. Dr. Adams?

DR. ADAMS: I'd just like to thank the subcommittee for supporting these initiatives and comments, we're looking forward to a resolution of those two issues as well.

DR. COHN: Okay, great. Dr. Schooley?

DR. SCHOOLEY: I would just like again to echo the focus on dental, it's really refreshing to spend a little bit of time on dental from time to time and I appreciate the subcommittee's attention to that. Thank you.

DR. COHN: I would just say personally, obviously I'm not a dentist nor do I play one on TV, my history is in medicine, but it's actually very refreshing and I think we've all learned a lot from this session. So thank you very much.

Now with that we will take a lunch break, we'll take an hour, we'll come back at 1:15.

[Whereupon at 12:15 p.m. the meeting was recessed, to reconvene at 1:15 p.m. the same afternoon, January 28, 2004.]


A F T E R N O O N S E S S I O N [1:15 p.m.]

DR. COHN: Okay, would everyone please be seated, we're going to get started here in a second.

Well, welcome back to the afternoon session. Just a bit of, I guess an update as well as a couple of comments before we move into the afternoon session. Now first of all I think we talked during the morning session about needing a special session to talk about claims attachments in more detail and I wanted to announce that we've identified a date for a special hearing on that, for March 3rd, which is the day right before the next full meeting of the national committee, so if you'll mark that down on your calendars, please reserve the date, obviously those on the internet be aware that we will be broadcasting this over the internet. The session will include obviously discussions about the claims attachment standard and other topics to be determined based on the number of testifiers on claims attachments. So that's item number one.

Number two is I just wanted to take an opportunity, and obviously this is a, we're in the process of transition at the subcommittee, I wanted to actually to welcome some of our new members, Judy Warren who is an associate professor of nursing at the University of Kansas. And I obviously want to thank you for joining us today, we know that you've not been sworn in officially but I think that will be happening obviously over the next day or two. Thank you for coming and joining us even before that happens.

The other new member in attendance is Harry Reynolds, and you're vice president for Blue Cross/Blue Shield in North Carolina, I have those credentials correct, and obviously we're delighted that you could come and join us. And obviously we're looking forward to having you both joining the subcommittee and the activities and are obviously happy that you're going to be available for those March hearings.

Now we'll be talking more about our department members but obviously I just want to thank Kepa Zubeldia and Clem McDonald, and Clem isn't even here to hear this but obviously we've really appreciated your participation and involvement in the subcommittee, I mean we'll be talking about the full committee obviously tomorrow, but I know I speak just for myself but I found both of your councils to be really critical to the success of our process and you will both be missed. Kepa, thank you very much.

Now with that we're going to be moving into discussions this afternoon on the e-prescribing issues as well as DIMA, and the department work plan related to that. We're obviously delighted to have both Jim Scanlon here as well as Kelly Cronan. I think Jim is going to do some introductions for Kelly so I will turn it over to you.

Agenda Item: Update on DHHS Work Plan for P.L. 108-173, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 - Mr. Scanlon and Ms. Cronan

MR. SCANLON: Thank you, Simon, and I too would like to welcome Judy and Harry to the committee. If looks like you're already recruiting Simon for members of the subcommittee, and we're going to give them an orientation to the NCVHS, both Judy and Harry later today I think at 4:00, so we'll go into more detail, and tomorrow I think you'll actually be official.

But today we've asked Kelly Cronan, who's the executive director of our Council on the Applications of Health Information Technology here at HHS to give a briefing on particularly the e-prescribing provisions on the Medicare Modernization Act. The department is very busy going through the provisions and addressing looking at how to address these, but we wanted to focus specifically I think this afternoon on the e-prescribing provision. The statute as Kelly will bring you through it actually contains a very specific and fairly rigorous timeline from the point where the NCVHS makes recommendations relating to preliminary standards, it takes us through as Kelly will point out some stages, leading ultimately to the adoption standards for e-prescribing.

So I think I'll turn it over to Kelly and then I think later the subcommittee, Jeff and others, will actually talk about the NCVHS work plan. Kelly?

MS. CRONAN: I guess I should start off by saying that we actually have not finalized any type of timeline in terms of our implementation activities but for the purposes of having everybody work off the same level of understanding I think it would be useful just to highlight some of the provisions that you should be most concerned about from your perspective.

The first date that's most applicable is in reference to the initial standards that the Secretary is obligated to develop, adopt, recognize, or modify, and that has to happen by September 1st, 2005, so while that seems like a ways off in fact the work is actually quite ambitious and there's going to be a lot to accomplish leading up to that. So working off that date the NCVHS will have to provide recommendations to the Secretary and have enough lead time for people to sort of process that information and figure out in what way are they going to recognize, develop, or adopt these initial standards. So that's probably the most important thing to be aware of in terms of timing.

In the statute it does actually specify that NCVHS should consult with ANSI accredited standards setting organizations, practicing physicians, hospitals, pharmacies, PBMs(?), state boards of pharmacy and medicine, and other experts on electronic prescribing. You should probably also be aware that there are some activities in the private sector right now that are focusing specifically on trying to get experts organized in working groups to address some issues related to implementation and in part they are looking at standards and one of the key people from NCPDP is involved with that effort. So perhaps in your planning you may want to keep in mind that there are some ongoing activities in this area and they might be able to inform your recommendations.

There is a series of other deadlines that we'll be considering when we start with the process of planning for a demonstration project around these standards and then they'll be a rulemaking process that will be going on in parallel over the next few years. But I think it's premature to comment on any of that as we have not really determined how we're going to be working with that and it's really not all that relevant to what NCVHS has to do.

What I think is important to point out is some of the design criteria for these standards, that need to be considered as you put together your recommendations. The standards are supposed to not impose an undue administrative burden on prescribing health care professionals and dispensing pharmacies and pharmacists. They must be compatible with what's already been promulgated with HIPAA, and they also must be designed in such a way so that they enable the exchange of electronic drug labeling and the listing, which I think in previous meetings and other activities you've been briefed on, this really gets back to the terminologies around medications going to enable structure product label, which will be disseminate through NLM.

The other important provisions to be mindful of relate to the information that's supposed to be going to health care prescribing professionals and pharmacies and pharmacists, and that information includes information on eligibility and benefits, which means information on drugs that are on any given formulary, any tiered formulary structure or any requirements for prior authorization. This also includes information on the drug itself that's been described or dispensed, as well as medication history for a given patient, which could include information on drug/drug interactions, warning cautions and when necessary dosage adjustments. Information on the availability of lower cost alternatives or therapeutically equivalent alternatives must be made available as well as requested.

Then there's another specific provision on medical history information, and again the date has not been specified in terms of when standards would have to be available or observed, but the Secretary has discretion here to set that date. But what's important here is that again, pharmacists and pharmacies and physicians or prescribing clinicians will have the ability to request for medical information as needed, but it must relate to the patient that they're prescribing for and it must also relate to the drug or drugs that are being considered.

A couple of things that we have been talking about internally and thinking through some of the needs for implementation, we recognize that there's already some standards that are already out there, particularly NCPDP messaging standards that are enabling electronic prescribing right now. We don't really understand the gaps, what are they currently covering and what more would be needed as we think about implementing this program. We also need some guidance on what would be necessary for the exchange of medication and other relevant medical history information. And we also need to know what exists in terms of evidence or standards that are already being developed or adopted in the area of knowledge representation, that's sort of one entire universe of standards that really hasn't been dealt with that much, at least internally here. So we really would like to know more about that area, how it interacts with what we need to be doing and I know that to a certain extent this was addressed in the recent IOM report so that would perhaps be one point of reference in starting to trying to get our arms around this.

So I think those are the most important considerations that we've thought about so far, I don't know if Karen Trudel has anything to add to that, who's also working on this.

DR. COHN: I think we'll open it up for questions and discussion. Kelly, maybe I'll start off just because I was obviously looking through the legislation and I think you've done a great job summarizing it. I actually appreciated some of your comments about the application to medical history information, which is I think the area that we in many ways had the most question about, about exactly how this all interplays because on one hand it's clearly critical, the scope could be literally equivalent to an electronic health record if one isn't careful, and then of course you're sort of comment, which I think I'm hearing, is that you're not sure whether the timeline is necessarily the same as for the other pieces, and I guess that may be is the question I have for you. I guess I had read through this and been assuming that the timeline for that medical history information dependency was literally the same as everything else. I mean what is your counsel on that?

MS. CRONAN: Well, that's a good question and we really haven't gotten general counsel to advise us in this matter yet, so it's premature to say anything definitively. But my current interpretation of the language is that it does say effective on or after such a date as the Secretary specifies, and it could allow for some flexibility. But I think in terms of the NCVHS perspective it would be preferable to have some guidance or recommendations from you so that when the initial standards are developed or adopted or recommended that that information could be taken into consideration earlier on.

DR. COHN: So as much as we can do in other words. Just to make sure I understood.

MR. SCANLON: Simon, I might again, because of the complexity here, I think whatever plans we lay out, or the subcommittee, I think we're just going to have to be in a mode of being able to change and expand and adapt as we get into the area, much as we did with HIPAA and other initiatives like that where you sort of, you started out with the scope of investigation, you look at what exists and what are promising candidates for standards, and what's their use and so on. But I think other issues inevitably arise that are related in how these all come together, and so I think the mode for the NCVHS particularly in this first year or so would be just to be fairly flexible about, we can start with the standards that are clearly the main focus but just to kind of keep open I think as well as we move along.

MS. CRONAN: Yeah, and it's important to stay in contact, HL7 might be taking on some additional work related to data exchange with EHRs that could end up being done in parallel with this effort and be relevant to the exchange of medical history.

DR. COHN: I would say the scope on this one is a, I mean the first piece is you can get your arms around, the second one, as you know it could take many different directions. Kepa?

DR. ZUBELDIA: Is it the intention here that there would be several standards adopted and perhaps some may have to be delayed? I'm looking at this list where it's not just the prescription, the electronic label for instance has to be transmitted, eligibility, DUR, drug history, medical history, is the intention to adopt standards for everything on the same date or whatever is available and then wait for the industry to develop the new ones? Or is the Secretary going to create standards for the gaps so that everything can be done at the same time?

MS. CRONAN: Well, I think that we're hoping that initially over the next year or so we're going to have a good idea of what currently exists, where the gaps are, and where development activities need to start ASAP. And then to the extent feasible whatever is available in terms of messaging standards, terminologies, so that would also incorporate drug labeling, and standards for knowledge representation, we would then, or the Secretary would then be in a position to adopt what is available or recognized as available come September 5th.

DR. ZUBELDIA: So what's the intention with the things that are not available? To wait for the industry to develop the standard or to create a standard like was done for privacy or security?

MS. CRONAN: I think that the language is intended to be flexible so that for example if the NCPDP scrip standard is working and it's been widely used to date then there's no reason not to adopt that, so it's something that is mature and been tested and tried and true, there's no need to reinvent the wheel there, but for areas that are much lesser developed that development activity would have to be recognized and encouraged and hopefully they'll be enough time as we go in the next couple years to allow for completion. So it will be a mix of adopting what's already out there in addition to encouraging new activities where they're necessary.

DR. COHN: Michael?

DR. FITZMAURICE: Two questions, the first one is you mentioned a gap analysis of what is needed between what is needed and what the scrip standard and other standards have, and also you mentioned looking at what standards already exist in the area of knowledge representation. Will the department be able to share those reports with the national committee?

MS. CRONAN: I was actually meaning that we need that type of guidance from NCVHS, to the extent that it's feasible we will probably be doing our own informal analysis.

DR. FITZMAURICE: And secondly, in the claims process, it's not only ordering the drug but there's going to have to be a claims process as well and imagine look at the 837 and at the NCPDP claim form, but the vocabularies probably have to fit together. Will you be looking at what vocabularies to use for both the claims process and the e-prescribing? We're certainly going to be looking at the vocabulary for the e-prescribing and there's got to be this harmonization between the two.

MS. CRONAN: That's something that has been considered but if it could be interpreted as a part of the entire program then perhaps it should be.

DR. COHN: Well, Michael, are you talking about beyond the HIPAA standards already for drug payment?

DR. FITZMAURICE: We'll probably have to go beyond the standards for the drugs in order to do e-prescribing.

DR. COHN: Oh, definitely, but I think the other --

DR. FITZMAURICE: I'm talking about the compatibility between the definitions of those variables in the terminology and what we recommend for e-prescribing.

DR. COHN: Okay, I'm sorry, Karen?

MS. TRUDEL: I think there's a need to make sure that three different things are compatible, one is any e-prescribing standard, another is a standard that's elsewhere in the legislation where the Secretary adopts standards for a drug card, not the drug card provision but an actual card that can be used under Part D, and also any of the administrative transactions that would be used from pharmacy to prescription drug plans to actually handle the eligibility, the payment, the remittance advice. And we will need, we, amorphous we, will need to make sure that they all do harmonize.

DR. COHN: Very good point. Jeff?

MR. BLAIR: Thank you for the guidance that you've given us to the extent that you could give it at this time, but things are obviously in flux and we've been struggling at the same point, we've developed two versions of the work plan where we've tried to identify all of the requirements that you have mentioned and try to see how we could set up a schedule to educate ourselves and receive testimony from terminology developers, standards developers, providers, payers, PBMs, and all of the other stakeholders that were specified in the law. We will be after this session reviewing our second draft of that work plan in terms of how we will be trying to look at all that with applying priorities and timeframes and requirements. By any chance do you have the time to be able to stay so that as we go through our work plan you would be able to make your comments or observations?

MS. CRONAN: Yes, absolutely.

MR. BLAIR: Great, thank you.

DR. COHN: Stan?

DR. HUFF: I don't know if we're to the point to ask this question but can somebody tell me what it means exactly in terms of who is eligible? It says all of the folks, eligible individuals within the voluntary prescription drug benefit program, what does that really mean? Is that only outpatient prescriptions? Inpatient prescriptions? Discharge medication from institutions?

MS. CRONAN: I think it's Medicare beneficiaries who have elected to enroll in Part D.

MR. BLAIR: Part D meaning --

MS. CRONAN: The new drug benefit.

DR. HUFF: I'm not smart enough to know what Part D is, I'm getting closer so maybe I should know this.

MS. TRUDEL: To answer your question, Stan, the payment for a drug under Part D is only when it couldn't be paid for under Part A or Part B of Medicare. So if it could have been paid for under an outpatient hospital benefit or an inpatient hospital benefit it isn't a Part D drug at all. I think that's where you were going, so we're not talking about inpatient within a facility, we're talking about primarily patient carries scrip to the pharmacy, or that's the traditional outpatient way to do it.

DR. COHN: But Stan actually you do bring up a very good point, and first of all Part D I tend to think of as D stands for drugs, and that's how I remember it, but it's obviously the new benefit under the Medicare Reform legislation. I think you did bring up a good question where you sort of said geez, does it handle inpatient, and the answer is probably no, definitely no since that's already a Part A covered benefit, but we'd have to actually look at the question which you brought up which was something dispensed on discharge from the hospital, I think we'd have to do some analysis to figure out whether that's a Part D benefit or a Part A benefit. And I don't know that one off hand, so I think you're bringing up a very interesting question about how close to the hospital process are we getting.

DR. HUFF: Well, I guess the other thing is that in the back of my mind I'm starting to think already about what scrip does and where it's used, and scrips, typical domain has been outpatient prescription drugs and usually oral drugs, in other words scrip doesn't have, as I remember, I'd have to review, but it doesn't, for instance if we prescribe this as outpatient IV medication I'm not sure that scrip has, so I'm just trying to figure out whether some of those harder cases actually fall into the scope of --

DR. COHN: Well, I think that will be part of our investigation, and I don't think you have to figure it out right this second but you're asking exactly the right question. I mean because that really is part of our scope discussion and really our investigation is to try to figure out where the gaps are and how they can best get handled. So Stan, we're glad you're on the team. Other thoughts or comments? Questions?

Okay, well Jeff with that maybe we transition to talking about the second version of the draft work plan. I think some of you have it, I'm trying to think whether everybody has copies of it. Harry, do you have a copy of it? Judy, you have access to it. I would just sort of comment that as I reviewed it I thought it was a vast improvement over earlier versions. I also really appreciated the fact that Jeff had taken the actual legislative language and attached it to the back so you could sort of go back and forth to see if there were things missing, which is always very useful, it's always very good to stay grounded. Jeff, do you want to lead us through?

MR. BLAIR: Sure.

Agenda Item: E-prescribing Work Planning - Mr. Blair and Dr. Cohn

MR. BLAIR: I'm just going to pause for a sec, you'll let me know if you've got a copy in front of you.

DR. COHN: Kelly, do you have a copy or not?

MS. CRONAN: I think I'm getting one in a second. I've got it, thank you.

MR. BLAIR: Kelly, I don't know if anybody mentioned to you that I happen to be blind, so there's going to be certain ways that I talk about things that are going to reflect that that might otherwise seem odd but that's the reason why. And I don't, I didn't go back and memorize the work plan but let me just take you through some of the steps. The first section basically is the outline of the plan, where we basically indicated the statement from the law, the scope, the statement of the law, and the law being the Medicare Prescription Drug, Modernization, and Improvement Act, and the third statement in there that really was kind of interesting because it's been more directive then many of the other directives to the NCVHS, which was quite a list of the stakeholders that we should consult with. I interpret that meaning as receiving oral or written testimony from.

And then that kind of gives you a heads up on that. Kelly has actually taken us through most of those items, so that's good, we don't need to revisit that. And then the next section is the work plan with the five sub-items of the work plan, and then the last part the appendix for your reference is the portions of the law that at least as a non-lawyer and a non-legislature I was able to identify as pertinent to this effort. There are items, there are references in the law to other sections and I think the first thing I would ask for help for on behalf of the NCVHS and I don't know whether it's to you, Jim, or Karen to you, or Kelly to you, but some of the other references to the law we did our best to try to identify what they were if they were in other portions of the Medicare Prescription Drug, Modernization, and Improvement Act, we think we found them, but if there could be some independent verification on those references that would help us to know that we're not overlooking something.

MS. CRONAN: Yes, we'll be sure to do that.

MR. BLAIR: Now to the work plan. This is our second version, I in no way imagine this is going to be our last version, this is work in process, this is to sort of get us to think through where we're going with this and Karen and Maria have been very helpful to Simon and myself in terms of certain things that should be reflected in this particular work plan, so I'm going to just mention some basic assumptions that are reflected here.

And the basic assumption here is that we should have the final recommendations to the Secretary no later then June of 2005 and that if possible we'd like to see some interim recommendations earlier then that to the degree that we can do so. And so this particular version was an attempt, a cut at trying to do so. I'm a little bit nervous and that's why I'd really like your critiques whether we are giving enough time to all of the stakeholders, whether we've included all the stakeholders, and the method to maybe test that a little bit, is in the work plan one of the, it's not the first or second item but it's identified a list of what I perceived the requirements to be. And if there's some important requirements, information requirements that are off of that list it would be very helpful if we could identify those, either in this meeting or shortly afterwards, to make sure that we're gathering information to reflect those requirements, the requirements for an e-prescription set of standards.

I'm using the set of standards very broadly because that could be message format standards or it could be what I'd call terminology standards, or code sets, and it also could include areas of standardization which may not exist, Kepa kind of alluded to that, there's a lot of decision support knowledge based standards that may not exist as national standards but may exist as standards that PBMs use or health plans use in terms of how they construct their formularies or private sector drug to knowledge based vendors may use, and so that has yet to be determined.

So maybe the first thing I would ask is as you look down the list of requirements, and this is kind of general, do you see any glaring major errors in that list of requirements that has been left off?

DR. COHN: Jeff, are you referring to the entire subcommittee for discussion on that?

MR. BLAIR: Or anybody here, yeah.

DR. COHN: Okay, good. Kepa?

DR. ZUBELDIA: Jeff, I have a question. On the final recommendations you have a first draft, second draft, final draft, and the first draft says April 2004, second draft May 2004, final draft June 2005, are those years correct or everything is 2005?

MR. BLAIR: There's an error there, here let me back up, before I could to the schedules could I just stick on the requirements first because I'm going to go through the schedules and explain that a little bit more. Does anybody see where I've left off a requirement?

DR. COHN: I guess maybe I'll start out and it's more my reflection earlier about this issue of other medical information, or whatever, and I think what you have here is a list that at least to my view is relatively complete for that first requirement, which is really the support e-prescribing, I think we just need to somehow, actually I'm just pulling out the provision for other information to prescribing health care professionals and dispensing pharmacies and pharmacists. And I think you've done a very good job on that one. I think we need to somehow reflect this application of medical history information, and just as I think really one of the requirements. I would suggest that we leave that undefined at the moment and maybe that's one of our priorities, maybe priority, and I think we have five priorities, maybe it's priority six to further define that.

MR. BLAIR: Okay, actually in a sense I was figuring that we could either do it as priority six or to some degree some of that may be reflected in, I think I have it as priority two, which is the decision support activities where we may have to relate to history, drug to various other health care information. It maybe some of in both.

DR. COHN: Okay, all set.

MR. BLAIR: Anything else on requirements?

DR. COHN: Kepa.

DR. ZUBELDIA: On the requirements list you have e-prescribe messaging standards as one entry. Does that, I assume that's going to include refills and is going to include response messaging standards and supplemental information messaging standards and all of the above, right? It's not just, because the rest of the requirements are well detailed, like drug to drug interactions, drug to allergy checking, drug to laboratory resource checking. But on the e-prescribe messaging standard it looks like its everything lumped together and there's a lot more in that.

MR. BLAIR: That is the way I was envisioning it but I certainly can as we go along a little but further get more detailed on that.

DR. COHN: Other comments, Karen? Michael?

DR. FITZMAURICE: I'm not sure where it might be in here, Jeff, the drug labeling information. I think FDA has a, I don't know if it's a standard but they have a way that they would like manufacturers to report that and we probably could just incorporate that in here.

MR. BLAIR: Yeah, and that reflects the fact that I wasn't sure how to reflect it, I was thinking that it was going to be part of the terminology standards because on our PMRI, core set of PMRI terminologies where we have RxNorm and NDF-RT and the ingredients, manufactured dosage forms and product types from FDA, I was assuming that the FDA work was going to be consistent with the labeler identification but I really wasn't sure, so I'm not sure whether it's part of the terminologies or whether that is a separate item, so I think that's, I think that's a valid question.

MS. CRONAN: To the best of my understanding I think that the terminologies will enable the structured product label, which is what the intent of the language was, but there actually is an HL7 process also going on, a standards setting process related to SPL that might want to be considered. And I don't know if it would be additive or actually could be part of what we're considering as terminology standards.

DR. FITZMAURICE: I think the FDA reg refers to the presentation of the labeling information as opposed to the vocabulary within the labeling information.

MS. CRONAN: That's true, within the physician labeling rule there is a section, a highlight section that could enable a certain format or a certain type or amount of information to be communicated, which could perhaps be perceived as part of this knowledge representation here.

MR. BLAIR: Thank you, I think we really need to add that to our requirements list then.

DR. ZUBELDIA: Also, the requirements list doesn't show drug history information and I thought that Kelly said that that's one of the requirements.

MR. BLAIR: Separate from, I thought it was when it said history that it was patient history, you're saying drug history? Or you're talking about the history of medication --

DR. ZUBELDIA: History of medications prescribed to this patient.

MS. CRONAN: It could be interpreted as a subset of medical history.

MR. BLAIR: Unless there's another major omission there from the requirements list would it be okay if I stepped you forward into at least the priorities the way I grouped them, I'm not sure that these are the right ways to do them but we certainly can consider changing these. But as I started to look at those requirements in order to try to see if there was a way to come up with interim recommendations I tried to see if I set the priorities and then try to group them then that might enable us to have a set of hearings, multiple sets of hearings, where we could come up with a logical break for interim recommendations. So you can wind up seeing how I identified that, which is, and I'm not going to read down the list of each of five or six priorities that I had because I think you can read them there, but when I looked at that and then I matched them against how we would get information about each of them it appeared to me as if the first three priorities, it wouldn't make sense to ask people to come back and give us information separately on those, it seemed to be so interdependent.

So I grouped priorities one, two, and three together because I felt like if we have vendors who are offering information systems software to facilitate e-prescribing, or if we look at some of the entities that are already beginning to implement e-prescribing, there's a number of initiatives in Massachusetts, Rhode Island, HIMSS has a demonstration project that's about to start with the Cleveland Clinic, there's several around the country that have been moving forward, Share Scrips and All Scrips, so I figured that, so I called those users, folks that are beginning to implement now I've referred to as users and the health care information software developers I've called vendors. And then I separately indicated more broadly providers that might be planning to implement these things in the future and payers and PBMs, and I grouped them into hearings as you wind up seeing, figuring they would be addressing those first three priorities.

Now there's, Simon observed that since I'm only listing the sessions for testimony I figured there would be an additional session, not for testimony, that would follow those three where the subcommittee would probably need to meet by itself and pull a lot of this stuff together. Now in my mind I was figuring that the first session would probably be March, the second one in May, the third one would have to be a new subcommittee meeting that we would either schedule for June or July, and then the meeting where we would pull all of this together to begin to draft how we would do the interim recommendations on these would probably be September now, and then the full committee would wind up approving that in November. I'm leaving a little bit of time in there because to be honest with you I feel as if there's probably going to be more testimony needed then what I've just identified here, and that we're either going to need another session in there somewhere or a follow-up session or additional testimony. So now that I've kind of described that first, those first three priorities leading to an interim recommendation on those topics in November, let me ask you all do you feel comfortable with those priorities? Should we change those priorities? Do you feel comfortable with the times for the testimony? What are your opinions and feelings?

DR. COHN: I think a number of us have comments, I see Kepa, Kepa first and then Steve.

DR. ZUBELDIA: Jeff, I would go first for the low hanging fruit. There are certain things that are pretty much in agreement by most of the prescribing retail pharmacies groups, for instance the use of the NCPDP scrip for retail pharmacy prescriptions is pretty much common. Perhaps the use of the NCPDP transactions for eligibility, since the eligibility would be done against a pharmacy benefit plan. But there are other things that are a little more controversial for which there's not really well defined standards, and there's some things for which there's clearly not a defined standard, like labeling, or the medication history. And that may take a little bit longer while the industry rallies around the standards organizations to define these standards and by then perhaps you can get testimony when there is a brand new standard that has been defined, so --

MR. BLAIR: [Inaudible.]

DR. COHN: -- get some authorities to come in and at least give us some of their perspective and background of what the lay of the land looks like almost before we hear testimony from people that are using it or otherwise, which of course just makes our work plan longer but I think you obviously observed that you thought this was a pretty bare bones work plan. I don't know if that makes sense to everybody or not but I've seen some people nodding their heads that that is probably a little early education might be useful.

DR. ZUBELDIA: Now that Marjorie's not here let me ask something, can the NCVHS hire somebody to do an inventory of standards in this area?

DR. COHN: We're actually going to be I think engaging a consultant to assist us with this work. Now Steve.

DR. STEINDEL: A couple of comments, some of them are in line with what you just made Simon and with what Kepa made as well. One of the things that I see that's missing from the first three priorities is what's coming out as a gray area in my mind, and that's the area of medical history/drug history, and how we should handle that within the world of e-prescribing, which may not be necessarily the same as being handled within the EHR, because essentially what we're doing is we're introducing a drug benefit, what is it 2006 it's supposed to go live, is that correct?

DR. COHN: Correct.

DR. STEINDEL: Yeah, that's what I recall as the date, and that's two yeas away and if we went for a full medical history as a requirement for e-prescribing we're saying that every physician in this country has to have an EHR by 2006. I don't think we're in a position to even think about that, so I think the medical history part, the drug history part, I think we need clarification on what's required in that area, or maybe we can provide clarification on what can be done in that area, one or the other.

MR. BLAIR: Steve, one of the pieces on that is while the recommendations that we have to give might be June of next year and the Secretary has to wind up giving his report by September of next year, then there's 2006 for the demonstration project, then I think it's, is it 2008, the early part of 2008 before final recommendations? So we might be able to start to lay this out in phases or --

DR. STEINDEL: Well, I think this gets to what the main point I was going to make, and this is in line with what Simon was talking about and what Kepa was talking about. I would look at a first session that's more educational, and as Simon was pointing out sort of a lay of the land state of the art of what's going on there from the experts, and also not just the standard and medical experts but a lay of the land from what the department expects as to how this would proceed with things like history and what's required by the law. I mean we've been briefed very, for a few minutes today and a few minutes maybe some other day, but it might be good to have a really formal session laying out what we need.

DR. COHN: I guess I don't want to create expectations for this session, which will probably be in late March assuming that comes into place. I'm not sure that I would have an expectation that the department would have complete understanding of this area either and I think that for all of us it's sort of a learning area where we begin to understand what the essentials are, and so I think it's maybe a little bit early, and Kelly you can help us with this one, but I don't really expect by the end of March that you will have all the answers to all these questions and I think that's the point of getting the experts in, to begin to understand what's essential and what's not.

DR. STEINDEL: And I think part of it would be laying out what questions exist.

MS. CRONAN: Perhaps we could just make sure that we have a continuous dialogue so that any questions that arise during our discussions that are important for you to address during the hearings, we make sure that you know that. But I just wanted to make a quick comment to address your comment about standards for medical history. I think it's important to keep in mind that the more that these standards enable advanced decision support, which those applications already exist and they are already being used, the better of we will be and the faster that everyone will realize those benefits. So I don't think that we should be putting that off thinking that it's something that's going to take a long time to develop and it's not important enough right now, I think it's something that is really important and a certain segment of the market is already out there using those applications.

DR. STEINDEL: And then, that's very helpful, it's helpful in terms of ordering the sessions and coming forward. In terms of ordering the sessions I'm kind of in agreement with what Kepa was talking about, and I might want to see what you have laid out, Jeff, as your session three, as being the first meat session, not the educational session.

MR. BLAIR: What did I say for session three?

DR. STEINDEL: That's where you have the pharmacies, the participating pharmacists, pharmacy benefit management, the SDOs, to lay out the scope of what's out there and what people are using today, and then come in with the next session being what you had as session one, which is a demonstration projects, etc., so we can see how what people laid out as what they think is out there, then we find out from the people who are really out there, what really is being used. Then I would have a more educated sense of interpreting what the demonstration projects are.

MR. SCANLON: I think as well if we start off with kind of an overview and a state of the art then it's a little, at the moment other then a official matters I'm not sure very many folks know whether there are many standards to look at or very few, or whether they're mature standards with a high degree of penetration or virtually nothing, or one of a kind. So I think that overview session kind of sets the framework for you, what are the gaps, what's the nature of the standards, are there competing standards, are there no standards, are they one of a kind kind of standards that are more vendor specific. From that point you can form a much more sophisticated and informed kind of a way of proceeding, and again, if there are obviously low hanging fruit that would help then they would, you could sort of sort that out. I'm afraid at the moment it's hard to even, I mean except for real aficionado's I'm not sure that anyone has a good sense now of what, in terms of national standards, what the situation looks like.

MR. BLAIR: let me ask you this because I think several folks have said they'd like some type of a beginning session which is an educational session, what is the status of what's out there, what are the gaps, and what is needed. Now I didn't label it that way but when I was indicating that we would pull in the current users, the folks that are out there implementing these systems now, that's kind of what I thought they would be telling us, that we would script it in terms of answering those questions, but you didn't see it that way. Are you thinking of folks different then those folks to tell us, so who are the other folks besides those folks that could tell us what's being used today, what are the gaps, what are the standards that are needed, who should we add to that grouping that could give us that education?

MR. SCANLON: I always like to start myself Jeff with kind of an industry analyst approach like we did for HIPAA and for patient medical records standards, I don't know who the authority would be, a vendor free, I think that's the next stage but I sort of like an industry wide perspective on that without any ax to grind.

DR. COHN: I actually agree, without any ax to grind I think is the critical issue, I think if we're listening to vendors and others who are actually using things clearly they have made a decision and its in their vested interest that we support their decision so they don't have to change, I think that we have to realize that they are going to have their own perspective. So yes, now of course the question of finding such as you described as them --

MS. CRONAN: It might be someone within NCPDP who has been working on these issues for quite some time, they might not be quite as well versed on all the decision support applications but I know of at least one person who knows this area very well.

DR. STEINDEL: It might also be helpful to check with the Congressional staffers who helped put together this bill, if they know anyone, people that could meet this requirement.

MR. SCANLON: It's a lot easier to write these things.

DR. STEINDEL: Yeah, I know, I know, we were looking for sources, we were looking for academic --

MR. SCANLON: I'm thinking it's not even one person in terms of the overview, I think it's different perspectives and there are folks from NCPDP that Kelly was speaking, but they're industry analysis who actually follow who's doing what, what's further along, they don't have any, they're not trying to get you to buy their stuff and they could just give you a broader view of how it looks. We did this for HIPAA and for PMRI and it takes a bit of searching, and there's no one view that is correct but I think that generally gives you a good framework for proceeding. I'm sure we could identify vendors.

MR. BLAIR: Let me ask you this. Are there other comments or questions about that first grouping of priorities, because I have a little bit of concern about separating priority number four off from the first three, like I said I was looking for some way to try to get interim recommendations to you soon, now by doing it, by separating off the state and federal regulatory agencies and accrediting agencies and medical oversight entities into probably the January/February timeframe of 2005, do you feel comfortable separating them off this way?

DR. COHN: Do you mean for the general overview or the --

MR. BLAIR: Well, that would be a second interim recommendation that might come in March or April with the final one coming in June.

DR. COHN: Well, I may not be understanding exactly what you're asking, I mean I guess I saw a general overview as being a general overview and not just limited to priority one, two, and three. But then I do think we need to cleave up the testimony and probably the recommendations in some way shape or form, but I may not be addressing the question you are asking specifically. Were you asking more generally about whether once we have that overview can we cleave up our recommendations? Or were you primarily asking about that initial overview?

MR. BLAIR: Well --

DR. FITZMAURICE: Jeff, can I take a stab at it?

MR. BLAIR: Let me try to explain, what I was thinking is that we would gather testimony to address priorities one, two, and three, and try to be ready to give an interim recommendation that related to those three priorities by November of 2004. And hopefully we could meet that date because we were deferring two other priorities areas for later testimony, the priority four, which is hearing from state and federal oversight entities until later, and then the e-signature subject, which we would have hearings on later. Now this was like I say an attempt to get interim recommendations sooner, do you feel comfortable with separating these out this way?

DR. COHN: Comments from the, Harry, your first comment.

MR. REYNOLDS: I know I'm not official but I do have a question. Are you, in priority four are you wanting to hear from them based on how they might be able to use the data as a byproduct of e-prescribing? Or how they would actually be involved in e-prescribing?

MR. BLAIR: The first, but I'm not sure that that's a proper assumption, that was my assumption but maybe somebody here would wind up saying that that's not correct and we really can't leave them out of that initial recommendation, in which case we may have to push the initial recommendations later.

DR. COHN: And I guess I would answer that by, as I looked at this one I was perceiving that there are state regulatory bodies that regulate how you prescribe and limitations and licensures and all that, and I thought that's what that was but maybe I misunderstood. Karen?

MS. TRUDEL: I think if priority four has to do with again a form of downstream data use it makes sense to separate it out. But if it has to do with state pharmacy requirements, prescribing requirements, I think it almost has to be, that input has to be part of the discussion of one through three to get the sense of what's feasible and what's not feasible given existing laws and how the world is working today.

DR. COHN: And certainly as I look at the list of testifiers planned for the fourth priority it looks as you described it state boards of pharmacy, state boards of medicine, other groups like that though obviously I think your intent there was to be looking at those issues.

MR. BLAIR: Correct. Karen, would it be okay, though we can't answer that question probably today, but we'd probably have a revised work plan where we could try to sort out that question, and then we could make accommodations to the work plan based on the answers to that, is that alright?

MS. TRUDEL: Absolutely, I mean I view this as being a sort of work in progress and Maria will work with you to update it as needed. One possibility for getting that kind of input would be to invite those individuals to the session, the wrap-up session after the first three hearings, where the subcommittee will sit down and try to solidify everything that we've heard to date. It might be good to have that kind of input there at that time, so you could do that at a --

MR. BLAIR: Like in September?

MS. TRUDEL: Yes, so the first meeting would be the industry overview, meetings two, three, and four would be to take testimony on priorities one through three, and meeting five then would be sort of an assimilation and feedback from regulators.

MR. BLAIR: Now, I think we're all aware of the fact that we're probably going to have to add additional hearing dates, hopefully we can add enough where the schedule doesn't slip too much for that first interim report --

DR. COHN: Actually I think what was offering up, I understand HHS is getting us apartments for the duration in Washington. Joke, joke.

MR. SCANLON: We'll get you apartments in the neighborhood.

DR. COHN: Kepa, I think you were next.

DR. ZUBELDIA: If you're going to be looking at state board and pharmacy requirements you probably ought to consider folding priority five into priority four, because a lot of those requirements are related to signature requirements and documentation requirements, things like that.

MR. BLAIR: It sounds like we've just disappeared and we do not have interim recommendations anymore, it sounds like we want all of the priorities --

DR. COHN: No, I think we could --

DR. ZUBELDIA: The rest of my comment is on bundling one, two, and three, so you can have recommendations on one and two before there are any recommendations on three because there's probably not going to be a standard right away for the priority three type of environment.

MS. TRUDEL: But I think Jeff's point was the fact that we're going to wind up having to bring the same people back multiple times.

DR. ZUBELDIA: That's probable.

MR. BLAIR: See, that was one of the things I was, I figured that a lot of the questions on what message format standards are you using, the adequacy of those message format standards, what decision, how are you doing the decision support functions, and are there standards that you use, and other provider issues, I was assuming that if somebody's going to come in and we're going to hear testimony from them that all of that stuff is so bundled that to have them come back three months later and then wind up separately addressing another part of decision support or --

DR. ZUBELDIA: Not really, there's two separate bundles in the messaging and standards section, there's one that is in use today, it's implemented, that's a prescription standards and eligibility. They're different standards, one is the scrip, the other is the NCPDP standards and that's, you can have interim recommendations on that very easily. There's another bundle of standards that are yet to be developed, or either modified current standards or new standards that are yet to be developed for this and it's going to take a lot longer to have recommendations on those just because of the immaturity. So I would not bundle those two things together because then that would be delaying the standards that are clearly acceptable today.

MR. BLAIR: Okay, then let me go back to one other piece. If we go down that path and we fold in electronic signatures, that also is I think a fairly substantial topic area which might require separate education, again hearing from the vendors of those systems, the users of those systems, the folks that are requiring legal compliance for those systems. If we start to fold that in I don't look upon that as just folding it in by adding an additional question.

DR. ZUBELDIA: What I meant when I said to bring that into priority four is that if you're going to have the state boards of pharmacy and state representatives here, what are the state requirements for electronic prescription, they are to also at the same time tell you what are the signature requirements in their state.

MR. BLAIR: Oh, I see what you're saying, okay, the e-signature is folded into four, state and federal requirements for the e-signatures.

DR. COHN: Karen, you had a comment?

MS. TRUDEL: I haven't thought this completely through in terms of groupings of priorities but it might be beneficial to take a similar tack that we did with Consolidated Health Informatics, which is that we identified a number of domains, took one roll through, found the ones where we could adopt standards easily, went ahead and made recommendations on those, and then the ones where we could not adopt standards we circle back and take another shot at it. That means you could do all the hearings at one point, at one time, bring most of the people in just once maybe, or twice, and get a sense of for instance all of the functionality that some of these vendors have all at one time and figure out whether of that range of functionality perhaps the scrip is the easiest thing to make a recommendation on now. The next thing to think about would be addressing formularies and take it that way.

DR. ZUBELDIA: That has been very effective for CHI.

MR. BLAIR: Let me see if I understand you. We have NCPDP scrip now, and folks are using it or a variant of it. And when you're winding up saying that's the low hanging fruit, and you're separating it from the decision support areas, is that what you're saying is the longer term, is the decision support?

DR. COHN: I think that's to be investigated, Jeff.

MS. TRUDEL: Exactly.

MR. BLAIR: But Kelly's winding up indicating that's one of the high priority areas, so if that falls to a second tier do you feel comfortable with that?

DR. COHN: Well, Jeff, I don't think we're talking about tiers, I think we're talking about low hanging fruit versus things that take a ladder, and I think it's sort of scanning the environment, if something's not there we could meet, we could live in this room and it's not going to make it happen --

MR. BLAIR: So you're saying scan it first with the overview and the introductions first and then we'll wind up seeing how to divide near term into long term. Is that what you're saying?

DR. COHN: I think that's what I'm hearing, though I'm not necessarily saying that that's the absolute way but probably it does make some sense. Steve, you were --

DR. STEINDEL: Yeah, I'm just going to echo what's being said, and especially I like Karen bringing in the CHI analogy on how that was approached, because there were, I look at it as four phases with regard to CHI. There was the very first phase where we talked about it in terms of low hanging fruit but you may have called it already picked fruit, it was in the supermarket and already there and we just wrote a letter and said NCVHS already did the work. And that was the first set of recommendations. And the second set of recommendations when the domains were established those domains were broken up into low hanging fruit that we felt things could be brought back fairly quickly, and then stuff as Simon points out that we need a ladder for. And some of the stuff we found that we needed a ladder for comes into the fourth phase because we found even the ladder won't reach it and we have to develop new ways of getting to the fruit. And I think that's a very good analogy to what's going on here. We don't have a group that's already picked the fruit, so what we should be looking at is the first set of hearings, be it either just the educational session, though I don't think that would be true, but the combination of the educational session, hearing from the standard development organizations, and hearing from the users what we're going to find from them is a set of low hanging fruit and probably exactly what Kepa's talking about, like the scrip standard and things like that that are being widely used and implemented now. And we can make a recommendation at that point and saying this is what we found, this is what people are using. Also from those testimonies that we heard during this period of time we have found the following we need to look at further and we will come back with you over the next N period of time with that and formulate our hearings then, our hearing schedule then.

MR. SCANLON: Successive actions.

DR. ZUBELDIA: My very first question to Kelly, is that acceptable? Because the Secretary has to adopt or recommend or create all of these standards by a certain date, then there is not this leeway to get everything that we --

DR. STEINDEL: I'm assuming that we would do what I'm looking at this the first three sessions relatively quickly, in time for doing something by September.

DR. COHN: And one needs to recognize using that analogy that sometimes the solution to this isn't a taller ladder, sometimes it's water and fertilizer. And if there's nothing there there's nothing there.

MS. CRONAN: I also think to the extent the early hearings will identify the gaps, that that will obviously be all heard at the same time, and hopefully will inspire some new standards or development of new standards as necessary.

DR. COHN: Exactly, extending the analogy on to the absurd. Other comments or questions? And Jeff, I think what you're hearing is a slightly different slice on this, which is looking at all of this stuff and just cleaning off, I mean as we find things that are obvious and there's industry consensus we can advise the Secretary sort of in waves as well as beginning to get agreement that there are gaps and working with the industry to figure out how the gaps get filled.

MR. BLAIR: Let me paraphrase it so that you can correct me if I don't have it right to prepare this next version, is what I'm hearing is we need a good solid set of orientation education sessions up front, then to hear from those folks who are implementing the standards and those folks that are developing the standards, and the vendors, so those are four entities. And at that point we should be able to know what the low hanging fruit is in terms of what is being used, and what is not being used, and we should be able to make an interim recommendation at that point. Did I hear this correctly? Yes?

DR. COHN: I think you are and I think the presenters are the same presenters, probably in the same panels, it's just that we're having different expectations of what we're going to find.

MR. BLAIR: Okay, thank you.

DR. ZUBELDIA: And the approach of the CHI model of approach I think was excellent to break it up into domains, if you can get some of the presenters to actually work in those four groups that are identified in the domains and break it up it may be very, very effective without having to --

MR. BLAIR: When you say domains in this case what are you saying? Domains?

DR. ZUBELDIA: You have for instance the drug labeling, that's a specific domain separate from the history of medications, which would be another very different domain, or formulary alternatives, where the PBM has to respond, these are the alternative choices, those are things that don't exist today as a standard that has been adopted and if you have experts from the PBMs and the vendors and the pharmacy chains working with you on those domains to identify the possibilities I think it would be a very effective approach.

DR. COHN: Okay, and I think we probably need a little more education to figure out where exactly the domain cuts are at this point, which is something to determine. We actually have Carol Bickford who's standing up and would like to make a comment, so Carol, would you like to make a comment or ask a question?

DR. BICKFORD: Yes, sir. You have identified state boards of medicine as being interested parties in the stakeholder discussion, you need to be looking at other regulatory bodies for other health care providers who have prescriptive authority, for example advanced practice nurses, chiropractors, DOs, whatever. Physical therapy might fit into that as we're looking at new ways of doing health care practice, whoever has current prescriptive authority in relation to medications or whatever you're considering to be whatever.

Another entity that's missing is infusion therapy, you're looking more at pills, but what about the infusion therapy, the home therapies that's being utilized for our acutely ill patients in the home setting. There was one other thing but of course I can't remember it at the moment, so I'll stop with that. Oh, alternative therapies. Thanks.

DR. COHN: Thank you for your comments and certainly the issue about making sure that our, we cast a wide enough net on the state boards to handle everyone who's writing prescriptions is very significant. I think the other areas I would sort of to me is a scope issue relating to the Part D benefit, and I think we use that as the way to figure out what's in and out of scope and I actually don't know whether infusion is a Part D benefit or whether it's a Part A benefit, I actually maybe should know that but I think that's something we need to research. And similarly the other issue is the context of medications being provided under the Part D benefit and we sort of need to see where the edges are on that.

MS. TRUDEL: We can provide clarification on that before we get started, that could be part of the first session.

DR. COHN: Sure, great. Steve?

DR. STEINDEL: I have a nitty gritty question for the department, what do they mean by standards? And I think we need a clarification on that because generally speaking when we talk about standards we talk about nationally accredited standard bodies and what they've accepted, and I think when we look down this list we're well aware that for that many of these do not exist.

MR. SCANLON: Actually we were talking a little bit about this today. I view the lack of specificity as an opportunity, others view it I guess as --

DR. STEINDEL: You notice the word, I said we would like a clarification.

MR. SCANLON: Standards are standards, but I was going to suggest that part of the committee's deliberations include, when we get a little better handle, sort of the criteria for what should be a standard or what might be adopted as standard, much as we do for HIPAA and then patient medical records --

DR. COHN: And maybe to merge some of these concepts, it may be that some of the things that we see are not standards yet and maybe part of our role is to recommend that they get into the standards process. Because in a sense when we're talking about standards we're talking about an ANSI accredited standard and anything can get into that process, it's just that some things have not gotten into that yet, they may be more research vehicles or academic research vehicles or whatever, and maybe that's part of our suggestion, that that be expedited in that process.

MS. CRONAN: I completely agree and I think that the statute actually provides some parameters to follow, too, you need to be balancing the objectives of trying to improve patient safety and efficiency of health care with not imposing too much administrative burden.

MR. SCANLON: These would be part of the criteria and the balancing.

DR. COHN: Is there anything else, is this a new topic that you wanted to bring up Jeff?

MR. BLAIR: Well, it's feedback, it's a feedback question. I think, really this is a question addressed to Jim, Kelly, and Karen and Maria, the subcommittee has kind of crafted a different perspective now on how we might go forward on the work plan and I just wanted to know if all of you felt comfortable with the way we are planning to revise the work plan.

MS. FREIDMAN: Jeff, it's Maria. I'm fine with this, personally I really like the idea of starting off with an educational overview simply because this is not a homogeneous group, everybody's in different places in terms of their knowledge about each aspect of this, so if we all get on the same page in the same way at the same time that would be great.

MR. SCANLON: I'm certainly comfortable Jeff, the only thing I would keep in mind is that I think in this area particularly that the work plan will be more or less a living document, and at any point it's a draft and it can be refined and added to almost at any meeting.

MS. TRUDEL: This is Karen, fine with me.

DR. COHN: I see everybody sort of nodding their heads, I mean feeling that we're doing the right thing here.

DR. STEINDEL: Can we comment on the location --

DR. COHN: I think Steve wanted an apartment, too. I think the other observation about all of this is that I think there's an intent as we move forward to elicit testimony from the industry and other parties that not all of it is going to be Washington centered, and I think we need to make sure that we're somewhat broadly inclusive of regional differences, as well as best practices, and we just need to be aware of that because that does add some burden I think to the support staff in terms of making that happen. There's a reason we typically do things in Washington because it's so much easier for our staff recognizing that we already have a pretty extensive burden, or actually I guess we are burdensome because we have so much work that we're trying to get done, but I just think we need to include that as we sort of move forward.

Jeff, do you have other questions or other thoughts about all this? I mean I think we're all sort of thinking of digital signature and some of the pieces around that as being a somewhat separate, I don't want to use the term digital, it's probably electronic signature, as a somewhat separate though essential step in all of this. Stan?

DR. HUFF: Well, one thing I was thinking about in regards to that is I think it's separate if you think you're going to assign a whole message or a whole thing, if you want to assign individually pieces inside then it becomes tangled somewhat with the message standards themselves. So I don't know if we have that requirement, I was just puzzling over that in my head --

DR. COHN: Which requirement is which you mean?

DR. HUFF: Well, if we have the requirement to assign individual pieces of something, of the message rather then just assigning the whole message, because if you're assigning pieces of the message then you have to have places to keep the keys and the encrypted part separate from the data part, and it actually gets involved in the format of the message.

MR. BLAIR: When we prepare our questions for the users initially and the vendors initially that's something we really need to get clarified up front, whether the signature is imbedded, I guess is what you're saying.

DR. HUFF: Right.

DR. COHN: As well as the standards developers somehow, they had perceived this all working when you get into a place where this becomes an important aspect of the whole thing, or has to be somehow accommodated.

DR. STEINDEL: Just as an offhand comment, the clinical document architecture group of course has spent a lot of time discussing this in the new release of CDA, not the one that's going to be used for claims attachment, assigning various sections, encrypting sections, various levels of signature, because this is of course a very important thing in medicine.

DR. HUFF: I think your statement was right, somewhere up front I think, it's almost like so this is, instead of making four make it one --

DR. COHN: So we understand the other requirements?

DR. HUFF: So we understood the requirements for the message standards before we adopted them.

DR. COHN: Well, I guess the question is is maybe this is something that we try to get in our general education, and one of the questions, that might be one of those high level as an important sort of understanding. Steve?

DR. STEINDEL: Simon, I think there are two parts to this question and what could probably be handled very well in the informational session is the requirement for signatures with regard to prescribing, and then maybe a tersery comment about moving this into the electronic world, and then of course what we're going to be looking at more in terms of e-prescribing is how does this move into the electronic world. But I think we need to understand the signature requirements for prescribing.

DR. COHN: This is going to be quite a day session isn't it, two days, well whatever --

DR. ZUBELDIA: -- move to four day meetings. On the topic that Stan mentioned there is a lot of time that could be spent in that and that's something that you guys need to be aware of because there is so many different views on how to do things. The scrip standard itself is in edifact(?) syntax, there is one prescription per message, and the entire message can be signed using edifact structures. So it would not effect the integrity of the message and protect the integrity of the message and so on if the choice is to go with the digital signature. So that's already part of what's known as 9735, which is an edifact standard that covers the message enveloping. But it's not compatible or even similar to what the CDA does with signatures, complete different technology.

DR. HUFF: And that's my, it may be totally irrelevant because I think all of the messages that I know about if you're going to sign them in total we have good solutions for, you can see easy solutions. But if you had to sign, for some reason if you had to sign individual segments inside of the edifact message there's no provision for that.

DR. ZUBELDIA: So the scrip doesn't have loops(?), it's a simple linear transaction, and it can only contain one prescription. The entire transaction set is called edifact message and can only contain one prescription, so there would never be a need to sign specific segments or specific parts of the message.

DR. COHN: Until the next version.

DR. ZUBELDIA: No, no, that's the current version.

DR. COHN: I'm being facetious, Kepa. Well, I think this is obviously something we need to sort of be looking into and thinking about as we go forward. Certainly I think one of the questions I think we'll all have is, and this has been an ongoing conversation about electronic signatures, is that when as a nation we get serious about electronic signature it's going to be useful if standards organizations come to sort of a common understanding about how best this should be accomplished so a prescribing physician doesn't have to it one way for a prescription, another way for a CDA document, another way for a something that's in a claims attachment, and on and on. But it maybe this provides some direction or impetus because clearly we've been looking at electronic signature since HIPAA, it's just that there hasn't been a business case really around it up until now. So this may be a nice byproduct of that.

Other thoughts or comments? Come on Jeff, there must be something else here that we're missing.

MR. BLAIR: Don't look a gift horse in the mouth.

DR. COHN: Well, I guess getting, without even trying to count up the number of hearings we're going to have on this one, I'll let Jeff do that work as you put things together, the committee does have two days of hearings at the end of March, assuming that my calendar is right and I was already reminded that the early part of March I had the wrong dates, but my understanding is that they're the 30th and the 31st, and there's obviously business, there's other things that this committee does believe it or not, like the HIPAA standards for example and the DSMO reports and all that I think we're also potentially planning at the same session, but I think we can certainly plan on devoting one full day to the education and discussion around that.

And I think as we, as Jeff and I look at the other requirements and timelines, I mean now that we have new members we can begin to query for some additional dates going forward. I do hear that people would prefer to meet just two days in a row as opposed to as Kepa commented three or four, but clearly what we're going to need to do some planning to make sure that we have enough hearings to meet this and other to do items that we have. And we just hope that the new members understand, the old members have sort of gotten used to this, this is a pretty active subcommittee. Harry, it looks like you have a question. No, okay, you know what you signed up for.

Are there any other issues, Kelly do you have any comments on this? Any other needs?

MS. CRONAN: No, I think it was a great discussion today and I'm sure we'll continue to talk about this as we move forward.

DR. COHN: I'm sure about that. And I guess our hope would be is that the educational session can be collaboratively developed so that it meets all of our needs, which I think would be, it's a useful opportunity hopefully to get a lot of our questions met as well as bringing in others who need a basic world view of all of this. So let's make sure that we use it appropriately and take advantage of it.

Now, with that it's actually time for a break, so why don't we take ten minutes and we'll come back for our final session before we adjourn, I think we're pretty much on time, I think we'll spend probably 15 or 20 minutes when we get back, talk about all the other things we're supposed to be doing, and then we'll adjourn.

[Brief break.]

Agenda Item: Planning for Next Meeting - Dr. Cohn

DR. COHN: Okay, as I said this will be a relatively abbreviated session, I know we're meeting to stop in the next ten to 15 minutes. I just wanted to thank everyone, I mean I know it's been a tough day and a half with combination of snow storms, snow emergencies in Washington, slush and from my view cold, and I really appreciate the fact that everybody was able to make it and participate, and I think we've made a lot of good progress, I mean the acceptance of the CHI recommendations yesterday was I think a very significant piece in completion of work. Obviously I think we were able to get into the security rule and discussion yesterday, and then obviously the dental standards this morning, which I think was a very useful conversation, and I think gives us all pause for sort of recognition that the specialties have different ways of doing things. Obviously this afternoon we made some significant work moving forward in terms of our DIMA work and the e-prescribing.

Now lest we sort of rest on our laurels I do want to remind everybody that we do have a relatively significant work plan for the rest of the year. I think you're all aware and especially the new members I from time to time pass out a list that I keep, which is called Issues for the Subcommittee on Standards and Security, and I keep sort of a running list of things that we need to deal with, haven't dealt with, need to remember to deal with, just to remind you that we actually have a lot on our plate. And I will apologies, I didn't make copies for everybody but I will reference them as we sort of move forward.

I think we're already seeing that we need to do more work in claims attachments, and that sort of aligns with our tracking implementation for the HIPAA regs, and I think we've identified at the very least March 3rd as a day for us to do that, hopefully there will be an occasion to develop a letter out of those hearings that we can take to the full committee on March 4th or 5th.
Now we also obviously have hearings on March 30th and 31st, and this will be sort of a combination of level setting in relationship to e-prescribing, which I'm sure will take most of one day. But then I think we also have other responsibilities related to HIPAA, and this obviously have to do with hearing from the DSMOs regarding changes and updates to current HIPAA standards and new standards, I think that we are at this point expecting to be hearing from the DSMOs on that day, either the first or the second day depending whether we do the education. The other day we'll be hearing from them, and this is a yearly activity, I know those of you who are interested in the HIPAA standards will be interested to see what the DSMOs have in the way of recommendations as we move forward. And obviously there's a lot of things sort of still open related to that conversation, both what they may be recommending, how we move forward with new versions of standards, any changes that need to be occurring to the current standards. So we'll be listening and talking about that with them.

I guess I'm also hoping at that point we'll be having some time to talk about the general topic, which is another one of our key areas, which is sort of improving the HIPAA process. I know WEDI has been holding hearings, actually these last couple days, on their views and getting testimony from the public about that and I guess we'll be hoping that they will be able to join us for some conversations around that, which will be especially fruitful since we'll already have the DSMOs here to sort of talk to us. And so hopefully the idea will be to sort of have a colloquia discussion around sort of ideas. I know we've had those conversations previously, typically they tend to sort of generate after our commonly held view that clearly we need to make the HIPAA process more efficiently and timely, streamlined, responsive to the market, etc., and then of course it gets to be that issue well what do we mean by that.

And we've not been terribly successful in our conversations of bringing it down to reasonable actionable recommendations that don't take legislation, that are consistent with federal rules making processes and other things, but it may be that they actually have some ideas that could help us in all of that. And clearly one of my objectives this year is for us to come to a better understanding of what improving the HIPAA process might be and making some recommendations to the Secretary. So we'll be starting on that in March, we may need, and I expect that we will have additional conversations, as the year goes on as we get a better understanding. Now I may be surprised and there may be some low hanging fruit that we can take and immediately move into a letter but we'll have to see.

Now do you have questions about that in terms of that issue or objective? These are just sort of issues that I'm sort of going down that we sort of follow and are trying to deal with.

Obviously we've talked today about the e-prescribing, which is going to be an ongoing issue for this year. We'll be talking about it in March. The next set of hearings after that for our new members, and just to remind our old members, is in May on the 25th and 26th, have I missed, no, actually that is the next session, after the April, I'm sorry, after the end of March session, and I'm sure we'll be diving head over heels into e-prescribing at that point. We may have some discussions if they are not brought up at the March meeting around the issue of code set issues, especially as they apply to the administrative transactions. I do know and have noted the couple of issues I know that Kepa has brought up over the time that we don't want to forget, which is for example use of the ICD procedural codes in the hospital outpatient and how that all fits in with what is typically mandated as use of CPT, things like anesthesia minutes, how those being used and are those being appropriately used on the administrative transactions, and are there thoughts and views on that as we move forward. We'll obviously be trying to balance that along with the e-prescribing as we move forward.

Now beyond that there are just a number of other issues that I'm hoping that we're going to be handling this year, and I guess I should inform everyone that that is actually all we have scheduled for subcommittee hearings, typically we do these six months at a time. Given what Jeff was already saying about the project plan once we get the membership stabilized we'll be querying all of you for dates, and Jeff I think you were already thinking about something, July, was that right?

MR. BLAIR: Either June or July.

DR. COHN: Yeah, well, we already have something at the end of May so hopefully we won't do another one before June given that we have a full committee on the 16th and 17th, but we may have something in July and then we may have something in late August, just because we know you love the weather in Washington. Actually maybe by that time we'll be able to go to sites to talk to people out in the regional areas, and that may be a good occasion given the weather in Washington during the summer.

Other issues that I have on this list here, and I will apologize, some of this is hand written as I've made notes, just for your information is we're hoping at some point this year to have at least an update from CMS on the use of the internet for clinical data, and I think that that's been something that we need to somehow, as we talk bout all of these other pieces, talk about claims attachments, as we talk about everything else, I think an update to understand their current policy, their work to figure out if there is really applicability for them in terms of the internet would I think make sense, I think it's a useful conversation just to check in to find out where CMS is only because it may effect some of our recommendations going on into the future. Clearly we'll want to come up with standards and approaches that work for CMS as well as everyone else in the industry.

Now that's sort of what I have on my to do list. Oh, and I actually forgot CDA as another aspect of PMRI, we were going at some point need to be talking with the groups working on clinical data architecture, as well as the continuing care record to get a slightly better idea, not so much from a claims attachment view though it may be timely at some point to hear from them in relationship to that just because claims attachment does propose using CDA and we probably ought to talk about CDA as CDA as opposed to just claims attachment, but also understand how that relates to the continuing care record and all of that.

As I said these are just items that we need to weave through the year. Steve and then Maria.

DR. STEINDEL: Three things, Simon, first is very simple. Are we going to have a session during the March full committee meeting, a two hour session as well?

DR. COHN: Yes, I understand we do have a breakout session in March.

DR. STEINDEL: Any idea what's going to be covered there? Okay, we'll play it by ear. The second is when you were mentioning internet and CMS you used the words clinical data, do you also mean claims data?

DR. COHN: Yes, actually I do.

DR. STEINDEL: I wanted a clarification on that.

DR. COHN: I probably actually do mean claims data on this, but I guess I'm talking about patient PHI over the internet is really what I'm referring to, which is obviously, as in clinical data but it's really within the claims message.

DR. STEINDEL: And the third is one thing that I feel, and I don't know if it should be at this subcommittee or the NHII Workgroup, but of course we're all aware of the tremendous amount of work that's being done right now on the electronic health record and establishing standards for that, and I fully believe that NCVHS needs to be addressed on the work that's being done there, if nothing else for informational purposes.

DR. COHN: I'm trying to think of when that goes up for ballot, I think it's actually out right now.

DR. STEINDEL: No, it will be coming out for ballot in March.

DR. COHN: Okay, so do you think that that's something that we should try to do either on our pre-day or during our breakout, asking for an update?

DR. STEINDEL: If it's appropriate for this subcommittee, yes. I think it needs to be done this early spring, yes, but whether it should be here or with the NHII Workgroup, or even at the full committee, but we may want to talk to John about that. But I do believe that's something we should put on our plate, we being the NCVHS.

DR. COHN: Mike?

DR. FITZMAURICE: There's also a lot of standards work being done by e-health initiative and others, we may want to schedule a session just to get reports from those groups to see if they're doing anything that would help us. I know that e-health initiative is doing work on e-prescribing and so we need to touch base with them and at least learn what they're doing and reach out to them.

PARTICIPANT: They're on my list for actually one of the expert groups to come in and give us kind of a lay of the land thing.

DR. FITZMAURICE: But there's also like NAHIT, the HIMSS group, there's a lot of groups that are doing work that touches what we're doing and overlaps some of what we're doing, so we need to know what they're doing at some point. I don't think that is more important then our e-prescribing hearings that we've set up already.

DR. COHN: Okay. Maria, what have we forgotten?

MS. FRIEDMAN: CHI, how could you forget? I thought Steve was going to address that.

DR. COHN: CHI, that's right.

MS. FRIEDMAN: Maybe he was trying to fly low on the radar --

DR. STEINDEL: I was trying to fly underneath the radar.

MS. FRIEDMAN: I think we have one more group that needs to come forward, they were scheduled for --

DR. STEINDEL: No, the way I understand it, Maria, they have decided not to report on history and physical and multimedia on phase one. Karen, you're here so why don't you --

MS. FRIEDMAN: We're talking about planning for the next meeting, the question is what about CHI.

MS. TRUDEL: You're absolutely correct, Steve, we're not going to wait and come back, we've decided that we'll just not make a recommendation this time around. We're probably going to be spending the next four months or so internally trying to figure out what our next steps will be, what our next phase will look like, what gaps we have to fill, and that that's going to be a lot of internal discussion both within HHS and within the CHI Committee, so I think you're probably safe to let that one go for a few meetings, and when we get finished we can come back and present what we have tentatively come up with for phase two and get your input at that point.

PARTICIPANT: -- looking at late summer --

DR. COHN: Like may probably.

MS. TRUDEL: Mid summer, early to mid summer.

DR. COHN: Okay, that's great. Obviously I've neglected to mention security, and obviously we'll be following them along them this year and John Paul my apologies for not. We appreciate John Paul's involvement here, it's very clear from all of our conversations that we need to figure out some way to deal with security in a way that is focused on security, and I know that, we really appreciate your involvement but I also realize that that's why you're here as opposed to everything else and so we're really going to have to figure out over the next months, I've said this privately but I want to say it publicly, the best way to handle tracking and identifying issues around the security rule, and I think that will be a discussion we have with the new committee members about their interests and focuses and all of that and whether we continue to have it focused here, have some sort of a bridging with Privacy and Confidentiality, or how really how best to cover that in the most efficient way. Comments?

MR. HOUSTON: I don't want to mess your quorum up by having to not come to a thrilling CHI or whatever other topics might be only on the agenda, I'd hate to mess up your quorum if I didn't happen to come.

DR. COHN: John Paul we appreciate that.

MR. HOUSTON: I'm a team guy.

DR. COHN: It's okay, but I think we just need to do what makes the most sense for the full committee and to make sure that the area is being well covered as we move into the last year of implementation. Michael?

DR. FITZMAURICE: Simon, I was thinking. I made the suggestion about hearing from these other groups about where they overlap with us but that might also be a topic for the NHII Workgroup and maybe something we want to do jointly with them, and if they want to volunteer some of the time it might not take away from our time. It's a potential for outreach and may have some efficiencies for both of us.

DR. COHN: So basically we're talking about a joint NHII/Subcommittee on Standards and Security discussions with other groups --

DR. FITZMAURICE: Have them report to us what they're doing.

DR. COHN: Well, that might actually be even a full committee item for discussion, which might be sort of interesting.

Now I'd ask new members to obviously not be shy if there's anything we're missing, particular interests or passions that you feel that we need to be addressing this year, and as I said I do apologize because I'm not giving you a copy of this, this is typically sort of my notes and I'll clean it out and send you both out copies via email. But we just as I said try to keep track of all of the issues and try to slot them in to the appropriate hearings so that we can make the appropriate monitoring or progress of all of this. Anything else?

Well, I think everyone should expect, once I said, once we get the membership stabilized, which I think we're on the cusp of, that you are going to be seeing a lot of potential dates coming out for hearings in the last half of the year because I think we really do need to make major progress on e-prescribing and being well along our way by the probably the November timeframe, which is what Jeff I think you were sort of alluding to also, because even once we have all the hearings those of you who are new will appreciate that it's one thing to get information in from everybody but we really need to have time to sit and talk about it and put it together into some sort of a conceptual whole, and that in this area will not be an easy task I don't think.

Obviously some of the stuff is going to be low hanging fruit and we'll be able to create easy recommendations on all of this, but a lot of the other pieces are going to be trying to even figure out how to properly describe and conceptualize them will be I think some work. We'll obviously be looking to have, we will have a consultant in on this project but even still the consultant can only really help reflect on what we're coming to on the basis of our own expertise.

Now I should ask for the new members, do you have any questions? You wonder what you got yourself into?

MR. REYNOLDS: Simon, what I did think was important was what Michael just mentioned, is the whole idea if you sit and listen to the different things that are going on how, like if you take NHII, which is supposed to be the information infrastructure, and then you talk about e-prescribing, that sounds like an information infrastructure of some type also.

DR. COHN: You mean how we all work together?

MR. REYNOLDS: Yes, so those are going to be the things that as you watch each of these things go forward, when you're talking about connecting doctors in hospitals and others together, you hope it's one reasonable path, you hope it's one continuous, a discussion so it doesn't matter whether the doctor is checking on a prescription or checking on somebody that he's got admitted in the hospital or checking with a pharmacy on this or doing that, but that same kind of infrastructure, and then when you talk about what CMS is doing with the internet, it kind of is the simplest of all infrastructures for all of us to hook into philosophically. The main thing is that somehow they have to tie together because you don't want to do it three or four times. So that will be a thing as a new member, that's something I am very anxious to hear to make sure that I understand how many of these we are or aren't creating.

MR. BLAIR: You probably would want to try to see if you could attend February 18th, the NHII meeting here, because Bill Yasnoff and his staff will be providing to us a first cut at a series of models, architecture standards, legal models, as to what the NHII should look like seven to ten years from now and the roadmap to get from where we are now to there. And NCVHS will then wind up making our comments and contributions on those with the idea that they would then be introduced to the public in June of this next, well, this year, to get wider critiques on that.

And in our discussions of having that pull together part of those discussions was virtually a rough laundry list of a lot of projects, some of them federal government initiatives like the Medicare Prescription Drug, Modernization, and Improvement Act with the e-prescribing activities, but some of them were standard development activities, some of them were HIPAA, some of them were the e-health initiative, on and on and on, and how do all of these entities fit in. So I think that that meeting will be --

DR. COHN: I think that's a good point, I think you need to be aware that obviously we're all sort of interlocked and all working together and I think the intent is is that there really be an NHII, not a bunch of disparate projects or activities. I think we move forward with sort of the comfort of having the overall concept and framework in our minds and clearly in all of this and in any of the documents that you would look at would see sort of standards as enablers.

And so it's one thing to have the broad umbrella concept but to obviously move forward you need to put building blocks that are really specific in place, and the HIPAA standards are key enablers, e-prescribing is going to be an absolutely critical infrastructure, the PMRI recommendations, once again just another piece of the wall or the arch that we're creating. And once again not from multiple different NHIIs, but really sort of how we put all of this together in a way that it all works.

And certainly I think that that's the vision that we all hold. So I mean even though we may not talk a lot about the NHII here that's only because we're sort of aware that we have all this super structure and we know that we're putting all the blocks in place to make it all happen. I mean CHI work is yet another set of the key pieces and if at the end of the day the stuff doesn't all fit together we have done something way wrong, and I don't think any of us are thinking that we're doing anything wrong at this point.

So I mean it's a question of whether you start from the top or whether you work up from the bottom, the truth is you've got to work in both places. And I think we've all been aware that you can spend a lot of time talking at a very high level and not get, I mean there's comfort to you but unless you get all the pieces in place you don't have it. But yes, I think you will find some comfort as we talk more about the NHII.

I think it isn't our big concern but certainly in all this as you know the federal government and legislative process has a way of helping set priorities on sometimes what the next piece of rock is in this structure. And e-prescribing is not something that we stated was the next time, though I do have to say there was certainly a lot of wisdom in taking that on as the next big piece because it's really the cornerstone for a lot of patient safety and is really sort of, it's not the next low hanging fruit because I think we've grabbed a lot of low hanging fruit, but it's the first step up on the ladder. I mean I really can't think of a better choice for them to have us be working on and moving forward on.

But you'll have to judge on that one, I mean you may notice that there's a lot of holes as we move forward and we'd appreciate your insight on that. But yes, I think obviously this is going to be a year where we're all going to need to be working together, there's going to be a lot of work to be done both at the high level and the low level, I think everyone will be involved in a lot of it.

I want to thank you very much for a very productive day and a half.

DR. STEINDEL: Just to make a quick comment, if you notice Marietta handed out to the subcommittee the draft CHI letter that will be handed out and discussed at the full committee meeting tomorrow.

DR. COHN: And if you haven't read all of it and memorized it by heart --

DR. STEINDEL: Yes, they'll be a quiz on it at dinner tonight.

DR. COHN: Okay. We'll go over it tomorrow but these are more along the lines of our recommendations in relationship to the CHI recommendations, and overall we're concurring or in some cases trying to improve their recommendations. So well, we'll talk about that more tomorrow. Any final thoughts?

DR. STEINDEL: Do you know the plans for dinner for those who will not be at the 4:00 session? Does anyone?

DR. COHN: Well, why don't we adjourn the meeting and then we can talk about that. Okay, well with that I think the meeting is adjourned and thank you very much for your participation.

[Whereupon at 3:40 p.m. the meeting was adjourned.]