[This Transcript is Unedited]

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Subcommittee on Standards and Security

Conference Call

Monday, October 31, 2005

1:00 p.m. CST

Coordinator

Pardon the interruption. All participants stand by for today’s NCVHS teleconference. At the request of the company, today’s call is being recorded. If anyone has objections, you may disconnect at this time. Miss Squire, you may begin when ready.

M. Squire

Okay, I’ll go ahead and call the roll. Jeff?

Jeff

I’m here.

M. Squire

Harry?

Harry

Here.

M. Squire

Simon?

Simon

Here.

M. Squire

Stan?

Stan

Here.

M. Squire

I take it Judy’s not on. Maria?

Maria

Here.

M. Squire

Vivian Auld? Susie Burke-bebee? Jorge?

Jorge

Here.

M. Squire

Michael Fitzmaurice? Kathleen Fyffe? Margorie Greenberg? Wanda Govan-Jenkins? Rob Kolodner? Randy Levin? Dnna Pickett? James Scanlon? Steve Steindel?

Steve

Here.

M. Squire

Karen Trudell? That’s it.

Harry

Why didn’t you mention Stan and Simon?

M. Squire

Stan Huff?

Stan

Here.

M. Squire

I did.

Stan

She did.

M

Simon, did she get you?

Simon

Yes, she got me.

Harry

Okay, good.

Jeff

Don’t we have another person who’s out in California?

Lorraine

Yes, Lorraine.

Harry

Lorraine. What is your last name, Lorraine?

Lorraine

It’s Doo.

M. Squire

Okay, I have you down. Thank you.

Harry

Okay, ready to go? The purpose for the call today is to discuss whether or not, and Jeff and I have spent a little time on this, whether or not the subcommittee wants to submit any comments to the NPRM process for claims attachments. You all hopefully have the agenda, and we’re going to let Lorraine get going. Lorraine, if you can at all possible hold your comments to the 15 minutes so that would give us enough time at the end to get a sense of what we want to do after we hear that, that would sure be appreciated. Does everyone on the call have a copy of Lorraine’s presentation?

W

Yes.

M

When did that come out?

W

Last week sometime I thought I saw it.

M

The 20th of October.

M

Okay, I’ll find it.

Harry

Does anyone else have any other business before we listen to Lorraine, and then we’ll break into our discussion? Lorraine, please start.

Lorraine

Okay, thanks very much, and hello, everyone. Some of you I know and some I don’t. I will be as efficient as I can, and I’m assuming then that we’ll try to hold the questions until the end if it’s at all possible.

Harry

Yes, that would be great.

Lorraine

I think that most of you have probably heard similar presentations from Bill Braithwade and Steve Barr many years ago, and I think there was a hearing about a year and a half ago. We were fortunate on September 23rd to be able to come out with the NPRM. We were required to by the HIPAA legislation have a rule for electronic submission of the health claims attachment, and just so that we’re all grounded, the healthcare claim attachment that this rule is specific to has to do with those that are used for adjudication of the claim when it first comes in and not for some of the other purposes that attachments are often requested, typically post review or for fraud and abuse, so we’re specific to the first point of entry of a claim when it has to be adjudicated.

The current state, and this is still the current state as it was even when this was first conceived, for claims attachments it’s typically very manual. It’s manual inquiries, phone calls, letters, faxes, even e-mails asking for documentation, and then the provider office has to find that information and send it back manually. Often times, because there’s a human component, there are a lot of inefficiencies; records get lost or it goes to the wrong department, and then it has to be redone.

Jorge

Lorraine, this is Jorge. As you go through your slides, because you’re doing a virtual, just let us know what slide you’re on.

Lorraine

Sorry. I’m on three. There’s a little three on the right side. Obviously, I’m not going to regurgitate exactly what’s on here because that would be pointless, but I will tell you when I’m on the next one. Thank you.

The other issue that we have from a business perspective is that there isn’t any standardization of what a health plan can ask for, so each health plan has its own business rules and its own policies and will ask for different parts of the chart for different reasons, and so the providers can really never predict who’s going to want what not from the health plan, but also from each different health plan.

Because a lot of these are documentation from a chart, they’re also sometimes difficult to interpret and sometimes too much information is sent. Also, we’re still not using very much electronic data interchange because there isn’t the standardization either of the communication protocol or of what the expectations are. We’re really just getting into all of that because of HIPAA for just claims and some of the other transactions. Right now, the costs for conducting claims attachments is pretty high for everybody.

Moving on to page four, the benefits are pretty clear I think. One thing that’s not on the slide is the 837 claim itself, part of the reason we’re not electing to use that for attachments is it’s already very over burdened with data, so if we were going to make a recommendation, we needed another set of tools to …

By standardizing the attachments, we’re obviously going to cut back on the manual effort for both the provider and the heath plan. That decreases the overhead and because there will be standards, what we’re communicating and how we’re communicating will be clearer, and the data will be able to be used more effectively for research on whether it’s post fraud and abuse patterns, quality, outcomes, revenues, expenses, costs, and the hope is that it will also reduce the denied claim or pended claims, also known as suspended claims because there will be more efficient, predictable information going both ways.

The beauty of doing this now is that it ties in with electronic health records that the industry is moving head long into the world of electronic health records, which means that the data is going to be computer enabled, and so it’s going to tie in with the ability to send these attachments in a computer generated way. We are obviously going to stay very connected to what the office of the national coordinator is doing and what the standard development organizations are doing related to health records. Even though it has been a long time coming, it’s probably a good thing that it’s happening now.

On page five I talk about what the scope of the rule is. It affects all the covered entities, so it’s health plans, the covered healthcare providers and clearinghouses. As with the other HIPAA regulations, health plans must and providers may, so health plans have to be able to conduct the transactions; either to send them at the request of the provider, or to respond to them, but the provider can elect whether or not to use the transaction. If they do something electronically, they have to use the standard transaction, but if they choose to continue operating on paper, they do have that option the way this is written.

Right now, there are six types of attachments that are ready, if you will, that have been balloted through HL7, and I’ll describe those in a minute or two. We’re proposing use of the X12 transactions, which are already what are used for the HIPAA transactions, and we’re using clinical document architecture created by HL7. That’s actually an improvement over what was in the original NPRM that was drafted probably back in the late 1990s and then also takes advantage of XML, which is a very powerful tool for making things readable both for computer and for an individual.

Someone had sent an e-mail about how the privacy and security provisions apply, and we could talk about that as part of your questions, but I just wanted to mention here that because it’s a HIPAA regulation covering covered entities and the data is electronic, then whether it was paper then the privacy rule affected it and not that it’s electronic, the security rule will govern. We can talk about some of your specific questions here, but I wanted to at least mention that that was a part of it and there is actually a section in the preamble that addresses that. I can give you the page numbers later.

On page six, we list the standards, and as I said, there’s a 2X12, a 277, which is the request for the information and the 275, which is the response. The LOINC codes, the logical observation identifiers names and codes, there are probably between 30,000 and 40,000 LOINC codes now. Claims attachment does not require that every covered entity be able to use every single one of those codes. There is, in fact, a subset specific to claims attachments. The only two attachment types that will be required, if you will, to have the capability to use the entire LOINC code set are those related to clinical reports and laboratory results. That’s because those resources change and the LOINC database gets updated with new tests and new information, and so they have more volatility, if you will, in terms of the codes that can actually be used, but the organizations that would be likely to have submit a claim attachment of that information will probably already be using that code set. Again, we can go into that more in the question session.

The HL7 booklets are also called additional information specification, and they are the instructions, if you will, or the list of codes that are used to make the request and actually submit the response. The clinical document architecture is what literally carries the information from the attachment and whether it’s an imported scanned document, or whether it’s actually coded information, it goes in that CDA document, if you will, that is embedded in the X12 response, in the 275 response.

On page 7, we list the attachments. These are the ones that have been approved – ambulance, emergency department, the nine types of rehabilitation therapies, all laboratory results, medications and clinical reports. Medications is not e-prescribing. They are the very simple answers of what did the person come in taking already? What did you give him or her while she was being treated, and what did you tell him or her or send them away with when they left? It is not any kind of a prescription activity.

The other thing is what we’ve asked the industry and what we’ve done a survey on is to find out these six – again, they started this work in 1997. We want to make sure that these are the six that health plans are still requesting attachment information for, and if not, we need to know what things should replace them and what the balloting timeframe would be. Ones that we also know are of interest and are being developed are for home health DMA, which I think is particularly going to be relevant for Medicaid agencies, periodontal services and the children’s preventative health services. These are very wide reaching attachments, but they are going to be balloted in fairly short order. The other one that we know is going to be necessary, but there’s a signature issue is consent for hysterectomy and sterilization, but there’s a fair amount of work that has to be done on that.

Going to page eight on the flexibility of the rule and the reason that most of us think that it is doable in the timeframe is that the providers can still submit information on a paper document, if you will. You can completely ignore electronic, which we don’t wish for, but he or she can do it in a scanned document, which can be transported then through the transaction and can be then looked at by the claims examiner on the other end at the health plan.

If any of the organizations are more computer driven with their systems, then they will be able to send the information as a coded. The health plan, with the use of XML, can still convert the coded information into human readable information and still have a claims examiner look at it, so it’s almost a complete win-win. The functional benefit to both parties is very, very high. What of course it does is really encourage everybody to be participating in some way, some form of electronic communication and beginning the process of getting away from paper as the vendors develop their tool.

Reiterating this on page nine is what we call these variances; human decision, which is essentially, it’s still documentation going over in an electronic transaction, which could be converted to data or text, and then the computer variant, which can be automated and either interpreted by the computer or converted by the computer into something that any one of us could be able to use.

On page ten we talk about what the variance, the human decision and the computer variance can do. Again, the human decision variant doesn’t make you change your business processes very much at all. It doesn’t force a big change on the legacy systems that are in operations, and it’s a way that health plans can begin to encourage providers to move closer and closer to these electronic transactions because it doesn’t mandate that they make tremendous changes either.

From the standpoint of the code set, which I had mentioned earlier, the LOINC is the question, if you will, and so they may only need to know here’s the question I need, which could be send me the record, and then the provider just has to send that code back and no other code back but with the documentation.

The computer decision variant allows us for some of those more advanced organizations to be able to send things codified or in narrative text and ultimately the whole adjudication process is going to be expedited because the computer will be looking at very finite, clear data and will be able to have its business policies coded, and the computer will literally be able to make that decision.

The other thing I think that – the benefit of these standards are organizations can implement them in a methodical way so it isn’t like all six necessarily have to be done immediately; that there can be a trading partner agreement of how they’re going to be implemented so that the testing can happen in a more staged and organized way, and that’s something that we’ve heard a lot about from the industry.

Page 11 is a little graphic, and one of these days when I get to play with this, I’ll actually have it moving so that you can see as these things come in, but essentially it really is just showing that the provider delivers the service, submits the claim, and the health plan decides whether or not they need more information and will send back a request for the documentation; provider gathers it, sends it back in a transaction and presumably it’s sufficient to pay, and the rest of the process is electronic and the provider gets an 835 remittance advice.

Page 12, the industry readiness. As I think most of you know probably, this work began seven or nine years ago, and the people on the HL7 attachments group never failed to let me know that. They did, however, I think, have the benefit of some time to improve the HL7 standard that was going to be the version that was going to be used. This clinical document architecture is much more robust and has much better flexibility. Some organizations are already beginning to use this technology, so they’re beginning to get ready for it, and particularly in the Mayo Clinics and some of the other larger organizations that we’ve heard of.

The empire pilot, which was done through a Medicare contract, we should have that final report actually in about a month, has gone phenomenally well. They’ve not done computer decision variant. They’ve only done the human decision variant, but they have indeed been able to exchange a transaction with the request; have the provider interpret it and be able to send back the information imaged in the response transaction, so it in fact does work.

On page 13, we talk about the LOINC codes, and I kind of made reference to the fears that people had originally had about having to program to have 30,000 or 40,000 codes, and we’ve actually gone through all the different attachment types and it looks like in most of them there’s less than 40 questions, and I can send you sample lists of any of these if you like, so less than 40 in the human variant and about 180 or 190 in the computer decision. If you go into the laboratory and the clinical reports, the volume is going to go up. I think in laboratory we had 20,000 possible answers for the kinds of questions that are there, but again, those will be from organizations that are probably accustomed and already have adopted this code set for other purposes.

Page 14, this leads into the section on the industry impact. What are we going to be doing to the covered entities? The health plans, obviously the advantage is that they can begin with very simplistic questions and answers, send me the record, but they can get an early investment even in being able to do that and having a more orchestrated business process. They will certainly decrease their own administrative expenses for postage and mailing and copying.

The issues that we have heard of before, and I think are probably still going to come in from a comment perspective is the privacy concerns; if the providers continue to send in everything when it hasn’t been asked for as they begin to hone in on the questions. Health plans, this is the must issue, have to be ready, but they may not have any providers who are wanting to play and yet they’ve had to program to it in order to be compliant by the deadline. Health plans probably are not using LOINC codes, and the issue of the storage, and this has been coming out actually in a lot of other listserve trails, how much space is going to be needed to store these electronic documents? We don’t know that yet because we don’t have enough experience with it.

On page 15, from the provider perspective, again they can use something as inexpensive as an off the shelf scanner. I don’t know, they’re $60 or $100 now, and just scan their documents in, but still send them in a compliant transaction. Their administrative costs would go down, and they’ll have standardization. They know that there is a finite set of questions that every health plan can ask about those particular services, and that’s it, so they can actually plan and make sure that those charts and records have that information in them. It really encourages the provider community to begin moving towards electronic health records. Hopefully the software vendors are seeing the writing on the wall and beginning to program their systems to do this.

I think what’s important is we are really now expecting administrative and clinical systems to begin communicating. The original set of HIPAA transactions did not require that, nor particularly encourage it. What’s happening now in the rest of the industry with the electronic health records and now with this NPRM is that we really are saying these systems need to be communicating, and the software vendors are beginning to hear that.

Challenges on the side for providers, it’s the experience with LOINC, and we’re hoping to get some feedback and comments from that to really validate how much it’s widely used. Because vendors are waiting for a regulation before they really do anything, we don’t know what the costs are going to be. Will there be transactions fees?

Jorge

Lorraine, your voice got really low.

Lorraine

It got low? I’ll pick up the phone. Is that better?

W

Yes.

Lorraine

Jorge?

Jorge

Yes, thank you.

Lorraine

At any rate, the costs from the vendors in terms of transaction fees or the implementation of the software is an unknown because it really hasn’t been built in any way. Different providers will be affected differently because right now, these six are pretty clear that they’ll be affecting certain provider communities, but there will be a whole other set of providers that won’t be affected. Again, we don’t know what the stressors will be, and we are hoping to hear from the specialty organizations.

On page 16, we talk about the impact for clearinghouses and vendors. Again, this is to their advantage because they’ll also have more consistency between their clients, so they’ll know the data set that health plans can ask for these particular attachment types of their providers, and the vendors, as I said earlier, can really begin to put the two systems together in terms of administrative and clinical.

One of the challenges I think that’s not written here is without a mandate, we hear from the industry that there’s just not enough justification for building it. If we build it, will they come? If they regulate it, yes we will. We don’t know really what the timeframe will be for building as robust an infrastructure is going to ultimately be needed. Certainly the clearinghouse community has probably less experience with the LOINC code set, but we did learn recently that I think it was WebMD has already done a mapping of the LOINC codes to a code set that they already had in place.

These kinds of things are going on experimental basis, and then we just hopefully need to hear from them in terms of what the cost and the business issues were related to doing that.

On 17, we go into an issue that’s near and dear to everybody’s heart, which is how much is it going to cost to implement this? We don’t have data yet on the HIPAA implementation because it’s frankly a little bit premature to have real ROI implementation since it’s only been a couple of years. It’s also very difficult to get specific information because no organization wants to give their data, and there hasn’t been an effort yet to get aggregate data and then prepare a report.

WEDI does have a workgroup that is just beginning work on that, and so I would expect that in – probably not until early 2006 will we actually see the results of that, but at least there is some work that has begun. The data that we had to use in preparing our impact analysis was a report that WEDI did in 1993 and the industry has changed significantly although the claim that maybe 25% of claims require claims attachments in the survey that was done by WEDI is actually still about on target. It seemed to have ranged from 10% to 25%, which is kind of remarkable when you look what the numbers can be. We are hoping to hear from some commentors on what the input would be. The comments we have received thus far obviously are not specific to that extent. I’ll talk a little bit about what we’ve heard so far.

On page 18, we solicited industry feedback on a couple of very key items. One was on the concept of solicited versus unsolicited attachments, which is the idea that if a provider knows every time I submit a claim for this service they ask me for my information, I’m sending it in advance. I’m just going to send it to them. What we said is you can still do that as long as the health plan has directed you to do that and not willy nilly, so there has to be some agreement that the health plan is expecting it, and that had to do partly with the privacy and security issues of too much data being in the wrong place and not necessary and also with storage issues. We’re waiting to hear back from the industry on that.

The attachment types I mentioned, are the six that we have the right ones? Implementation costs – does anybody have any information on which transactions helped under HIPAA and how this set will actually help, or what the predictions might be from some of the software vendors? The question about using X12 and HL7 together – once upon a time there actually had been concern about that, but as the empire pilot has shown us, that in fact, it can be done, and so this new version, the HL7CDA does in fact work, or has been proven to work. Granted, it’s on pilot, but I think it was a pretty powerful one, and we’ll see what – as I said, I think in about a month we get the final results.

On the last page, the industry was asked to submit their comments. It actually will be November 22nd of 2005, and we are being strong in all of our presentations that in addition to the policy in the NPRM because it’s frankly a pretty short regulation text when you think about it, these technical documents really must be looked at by the industry and subject matter experts.

What we feel happened with the original HIPAA transaction sets is that people were not paying attention to the transactions themselves, and to the data content and to the format and to whether or not the information was in fact even collected or available or how it should be sent, and so there were implementation issues, and there even had to be an addendum. Now they’re looking at version 4050 and 5010 to make continuous improvements to these standards.

What I’ve told the industry is that they have to get the right people looking at these technical specifications and of the content of these booklets because if the questions are not the right questions, and they don’t get those change requests submitted so that the booklets can be re-balloted, they’re going to be stuck with a tool that is of absolutely no use. We have the time to get this right, so that’s been my soapbox.

We’re very much encouraging other pilots. There is one, but it’s not a public one, but we’ll still get their information. They’re just not ready for primetime in terms of sharing it out loud. The other big issue that HL7 is actually addressing in a meeting this week is we proposed release one of the clinical document architecture. Release two was balloted and approved and in fact is in use or is going to be in use at a number of organizations and there is a question as to whether the booklets, the attachment booklets need to be converted as well as the implementation guide to release two. That will require some effort on the part of the voluntary SDO workgroup, and so they are discussing what the implications are and what the benefits would be of moving to release two and if they’d be able to make those changes and get them balloted in time for the final rule.

We have received 27 comments thus far and 99% of them are asking for an extension to the comment period to give more time to the industry to review the technical documents. We don’t have a final answer on that yet, but the request has come in from the right organizations, and in order to get it right, I think it’s something that we will obviously take into consideration very seriously. We would advise you if we were to do that.

That is the end of my words. I hope I’ve covered it as you expected.

Harry

Yes, Lorraine. You really did a great job. Since we only have the hour, if anybody has any clarifying questions, if you could go ahead and ask those, and then Lorraine, are you going to be able to stay with us for the hour?

Lorraine

Sure, absolutely.

Harry

Then as issues come up, we can have Lorraine comment on them. Are there any clarifying questions?

M

I don’t have a clarifying question, but I should point out, Harry, that we didn’t at the start – I have a potential conflict of interest because I’m on the LOINC committee, so people should consider that.

Harry

Okay, thank you.

Simon

Lorraine, this is Simon. I actually do have a clarifying question, and it actually relates to the pilot. I haven’t been following it closely, and I don’t know if there’s been any public comments, discussions, presentations, by them. I actually just wanted to get reassurance. I have been hearing other things about the pilot, not being necessarily quite as successful as you described, and I just wanted to hear from you again about its success. I’m also wondering if there needs to be additional pilots or whatever as we move forward? Thoughts?

Lorraine

In order; there is quite an abundance of public documentation about the pilot on the empire Website and on the WEDI Website, and they did monthly reports for us; the whole project plan, the requirements, the design, all of the documents are public, and I can either send them to you or send you the link, so you can visit their site. It’s been very, very well documented and shared, which I think is a positive for us.

Other than the fact that they can’t do the computer decision variant, but they are doing the human decision variant, I’ve not heard the negative comments, and we have a monthly meeting with the project manager. I think if there’s negative comment, it’s conceivable it’s because they haven’t tested all six attachment types, so it may be something related to that. It does go to your next point, which is there absolutely in the ideal should be other pilots. I don’t know that they should be a precursor to being able to publish a final rule because I think we need to see this final report from empire. Also, really understand are there any showstoppers, which we have not heard any thus far.

When the other organization is ready to go public with theirs that may also give us some more insight, but I think pilots, to the extent we can encourage them, is absolutely the way to go.

Maria

Lorraine, this is Maria. I think what Simon may be alluding to is we’ve heard from some people that they found some surprises along the way. It wasn’t a smooth road, but on the other hand, everybody is grateful to have the pilot to bring to light some of these things that were unanticipated.

Lorraine

And they resolved them. I think that’s what’s important. One couldn’t hope to have a pilot where the thing worked 100% the first time you ran it. The point was everything was solvable and will be corrected in the guides.

M

I have a clarifying question then a comment. The clarifying question should be very quick. If a provider faxes the information that’s requested in the claims attachment, is that considered electronic?

Lorraine

Faxes have not been considered electronic on the HIPAA transactions.

M

I didn’t think so. I just wanted to make sure.

Lorraine

Right. There’s no way to fax a transaction. You can’t fax an X12 transaction.

M

No, but you could fax the clinical information requested in response to a claims attachment.

Lorraine

Yes. The provider has that option.

M

And it’s not considered electronic.

Lorraine

Right.

M

Okay. My comment; I feel that pilots that test the computer variant are important and essential. That’s really going to be where the problem is in implementing LOINC.

Lorraine

Yes.

Harry

Okay, any other clarifying questions?

Jeff

This is Jeff. Lorraine, it sounds like there are two areas, if I’m hearing correctly, where additional pilots probably would be appropriate before a final rule is set forth where we’re expecting compliance. One is with the computer variant for those pilots that have already gone on. The other is that both for the human variant and the computer variant, for the other six or seven types of claims attachments; there’s ambulance, there’s …

Lorraine

Right. We have six so far, and within rehabilitation there are actually nine types. We have everything from cardiac to substance abuse, physical therapy, etc., etc.

Jeff

I want to ask a little bit about this because with our experience so far with claim attachments and other HIPAA transactions, even when we thought they were pretty much good to go, a lot of things surfaced later. On the one hand, it’s already taken a long time for the claim attachments to get as far as they are, and we don’t want to have additional delays, so do you have a suggestion for us in terms of how we could have some type of pilot testing for these areas that haven’t been tested yet in an expeditious way where we don’t have extensive additional delays for the claim attachments?

Lorraine

The dilemma, as always, would be in funding. There’s actually two; one is funding, and one is why am I going to put out this effort and work if I’m not sure there is going to be a regulation, and we do hear that from time to time, and you all probably do too. Until you make me, I’m not going to invest the money.

I think that we have a lot of support from AFFECT and from the vendor community. We have done a number of forums with the, and probably if we put out – I use this word and I know it’s not a strong enough word, but sincere request for pilots that would test the computer variant, then it’s possible we would get other organizations to come out and actually be willing to do it because I think given the experience with empire and then with this other one that some people know of and WEDI’s support, I think there is some underlying interest, or that’s what I hear when I’m at these meetings, that we probably could dig that out. My sense is that there may be some need to be creative with funding or with some incentive.

Maria

Harry, this is Maria. I would like to ask one quick question.

Harry

Okay, we have to do it quick because the whole purpose was to decide if we’re going to do a letter, and we’re running out of time.

Maria

This is, I think, an important question. What about updates, Lorraine? Is there going to have to be additional rule making because you’re going to have those additional attachments that are in the works. What happens with them?

Lorraine

This is one of the comments that’s going to be forthcoming from HL7, which is that they want us to adopt the, not the version for the attachment, but the framework, the computer framework so that when a new one comes out, we don’t have to go through the rule making, but it will always be voluntarily useable. When a new attachment type comes out, between trading partners, they can be used. We don’t have to put out a rule. We only have to put out a rule if we want to force them to use it. Again, that’s the industry problem.

Harry

As Jeff and I talked a little bit to get ready for this discussion, and Lorraine, you did an excellent job, so please stick with us –

Lorraine

I will. Thank you.

Harry

Ed, we had a group of things we could consider. Obviously, we had sent on March 5th of 2004, a letter to Tommy Thompson discussing this, and in that, we talked about the need for demonstration projects and pilot studies to document all the right things; the costs, the workflow, implementation challenges and so on, and that there be several of these demonstration projects that would include a broad representation of the affected stakeholders.

That was one thing we could consider. Second, we made and observation in our e-prescribing letter a little bit along the lines of exactly what Lorraine just said, and I sent that out to you. It was observation two, but in the recommended action under that, HHS should work with the industry in its rule making processes to determine how best to afford flexibility in keeping standards in pace with the industry, and we said including standards for HIPAA and e-prescribing.

For example, HHS might consider recognizing new versions of standards without a separate regulation. That’s a little bit about what Lorraine was just talking about. We’re already on record for pilots. We’re already on record for these versions rather than the others. The other possibility, and from what I heard from her, we originally listed whether or not, since we are standards in security, we need to say anything about security, and I think since this is still within covered entities, I didn’t necessarily hear anything that took it outside of what the HIPAA law is.

One I listed is whether or not we want to have any comments on whether or not there should be any mandates that it get done or not get done. I’d like to throw those out for discussion based on what we had talked about to see if the committee wants us to proceed with a draft that could be routed around on any of these subjects because we’re not talking about a lot of new findings, and we’re not talking about a lot of new wording. We would be talking about using most of it as collateral that we’ve already had. Now it’s open to the committee for comments.

Jeff

I would support that.

Harry

Stan?

Stan

Repeat the question.

Harry

Whether or not you feel that based on the areas that I listed whether or not we should put together a draft letter that could be reviewed by the subcommittee, and then the full committee has to agree to it unless we hear of an extension based on Lorraine’s comments, prior to the full committee meeting to get this thing out.

Stan

Yes, I’m in favor of that.

Harry

Simon?

Simon

Yes, I’m certainly in favor of that. I think we also should start off by congratulating CMS on getting the NPRM out.

Jeff

I’m in favor of it, too.

Simon

Harry, unless they give you a 90-day extension, that extension is not going to help you very much.

Harry

That’s my point. That’s why I just thought – again, I think we have pretty much – the only one we haven’t talked about is whether or not, and Lorraine brought it up, whether or not there should or shouldn’t be any mandates for adoption based on the other things we’ve heard on HIPAA.

M

I would tell you that I’m really reluctant to use the word mandate again.

Maria

Just to echo what Lorraine had said; we keep hearing the same thing or the same words over and over that the vendor community is loathe to do much of anything until they have a regulation or statute that they can hang their hats on in order to do product R&D and rollout. I don’t know how we break that paradigm. A lot of valuable time gets lost, and we in the government think that we telegraph things pretty clearly, but industry wants it signed and sealed and delivered. I don’t know if that’s something we want to address in this letter. I just like to make that comment because we’re hearing that a lot in e-prescribing and other things as well.

M

That’s true of the government period. I don’t think we’ll solve this on the basis of these couple of regs that we’re talking about. Let me just ask because maybe I’m confused here. This piece really is a mandate at least for health plans to be able to implement all of this even though the decisions about the actual transfer is going to be made based on the request from a trading partner.

Lorraine

Right, from the provider.

M

Isn’t that right? So basically this is at least a mandate as is typically for HIPAA for a health plan to do something.

Harry

Yes, that’s correct.

Lorraine

Exactly.

M

So this doesn’t really change that.

Harry

No, it doesn’t.

M

If you’re not requiring anybody to do anything at all, then there’s not probably a point even to do a proposed rule.

Harry

My question was whether or not the mandate should go further and include the rest of the industry other than just a segment.

M

Maybe the mandate is appropriate if the context is that if you’re going to send a health claim electronically, you must comply with these standards.

W

But doesn’t that implicate everything else you do with HIPAA? That’s kind of how things are with HIPAA. Wouldn’t that require a change in the legislation?

Lorraine

Right now if you submit a claim electronically, you have to use the HIPAA standard. This is saying if you submit one of these attachment requests electronically, you must use this standard.

M

Right.

Lorraine

A health plan can still use paper to request it, but if a provider says I want you to ask me electronically, then the health plan has to be able to ask them electronically using this standard.

M

From that standpoint, I retract the statement I made before that I was reluctant to say a mandate.

Harry

The other thing I was dealing with is when the HIPAA laws first came out, it came out as it was, and now CMS mandates it if you’re going to do business with them, it is using the electronic transactions. So here’s another reg that if CMS decides to do the same thing, then it kind of is a mandate. It’s not a mandate in this regulation, but it kind of is in a mandate to do business.

M

Harry, thank you for the clarification on what you meant by mandate.

W

CMS, because we are the nation’s largest insurance company, what we need so drives other people in the industry.

Harry

Yes.

M

You can mandate with out doing a reg or without doing a law.

W

Yes, and that is true.

M

That’s what Harry just clarified, and I think that’s a very good point, Harry.

W

That has been one of the things we hope to do with e-prescribing as Medicare goes, so we hope many others.

M

I think the comment of industry won’t do it until there’s a mandate, if CMS says if you want to do business with CMS, you have a mandate to do it. If you point out they have half the healthcare business, that’s enough of an incentive for industry to do it.

Harry

From committee and staff, do you want Jeff and I and Maria to try to put together just a quick template of what we might say in these three categories; one is based on our observation before where we would recommend that if there’s any way to do versions that are backward compatible and so on that that would be good; that we are in strong support of the pilots and hope that the pilots are varied and that they cover other than just the human variant.

M

Yes.

Harry

And that we don’t really see anything in this attachment that would give us any problem with what we already know in place for HIPAA security?

M

Correct.

Harry

Comments?

M

Harry, as soon as you extended the pilots to use the language that you used, that extension made me very happy. That was my only concern was that if we just said pilot, then it was limited to the human variant.

Harry

Yes. That’s all the attachment types and the computer variant.

M

Harry, you were going to add something from this observation, too, right?

Harry

Yes, right. That’s the one I said earlier, where we could go to new versions as long as they’re backward compatible, you wouldn’t need a whole new regulation, and I think you heard Lorraine mention that two or three times.

M

I didn’t hear that in the draft letter you were just describing.

Harry

Yes, sir. I said that.

M

My apologies.

Harry

Does that meet everybody’s –

M

Yes.

Harry

What I’d like to do is –

M

Harry, just one other thing. It’s different than this letter, but the other thing is I know from our own working here within IHC and within our local union, we really could use more time, too. The people really do want to look at the technical thing, and they’re having a really hard time getting it done this quick. I don’t know if we – even just on this call, just say that we’re supportive of an extension or not, or whether that carries any weight. I just wanted to at least express that I think it would be certainly valid to, in this case, extend this for another 30 days or something like that so people have time to really go through the details of the transactions.

M

I don’t know if that would be in our letter. That’s something that we communicate to CMS, and they’re on the call.

M

That’s why I said it.

W

For it technically to count, it needs to come in writing.

M

So would we say something like –

M

I don’t know that us putting in a letter on the 16th or 17th is going to – I guess we could. We certainly –

Lorraine

Can someone put one in the e-comment system? It just takes a few minutes?

W

No, because it has to get vetted by the full committee, Lorraine.

Lorraine

Oh, I see.

M

Simon, I could see putting the full letter together the way Harry has talked about it, it’s going to be a short letter, and just add at the end that we do feel that an extension should be granted to others who are looking more detailed at the technical implementation areas.

W

I think it will at least be on record that way.

M

… by the 22nd.

Harry

We could phrase it just we would recommend that –

M

We can work on the wording.

Harry

Yes, we’ll work on the wording.

M

I think you can add it just as a comment in this letter.

Harry

What I’d like to do is try to get a draft of this out by the end of next week to everyone.

M

Excellent.

Harry

Just to take a look at it, and then we’ll figure out what kind of schedule we have. Simon, we’ll work with you since we’re dealing with a full committee and everything, okay?

Simon

Yes. Basically, you intend to get a draft out by the 11th, is that what you’re thinking?

Harry

Yes, that’s what I would like to do.

W

Will that give us enough time to make revisions if need be?

M

It would be wonderful if you could get it out a couple of days earlier. This doesn’t sound like a very controversial letter.

Harry

I’ll try to do it this week then.

W

Okay.

Harry

I’ll touch base with you, Maria.

Maria

Okay.

M

Then the idea being that you can then ask the subcommittee for any comment or whatever.

Harry

Right. Is there any other business anybody wants to do today?

Margerie

I just wanted to say – I didn’t want to interrupt before, but I’m on the call, and it all sounds good.

W

I want to thank Lorraine for taking time out. Lorraine is in California under some exceptional circumstances, so we appreciate her taking time out to do this.

M

Lorraine, great work.

Lorraine

My pleasure.

M

Lorraine, we hope you enjoy the weather.

Lorraine

Absolutely.

Harry

Lorraine, we’ll put in there that CMS is flexible enough to even be in California and … We really appreciate it, everyone. Thank you very much.