[This Transcript is Unedited]

National Committee on Vital and Health Statistics

Subcommittee on Standards

June 20, 2013

National Center for Health Statistics
Hyattsville, Maryland

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030

P R O C E E D I N G S (8:35 a.m.)

DR. SUAREZ: I think we are going to go ahead and start. We should receive a printed copy of the agenda in just a couple of minutes. They are printing them and bringing them down. I think the three main agenda items we had were number one, just review the letter that we edited yesterday and finalize it, and then have it ready for the meeting later this morning for approval.

We want to talk about the plan for the committee for the next several months, just to go over again the plan that we laid out in the last couple of months actually. We will be able to review that and update that. Then, we want to talk about specifically some of the next steps on this roadmap that we’ve been talking about so much. We want to move from talking to doing, and I think there is interest in defining some concrete next steps with respect to how we proceed in developing that roadmap. Those are primarily our three agenda items for the meeting.

This is the agenda that was on the board for the subcommittee. Later this morning, we will do the second letter, but the first letter, we talked about it on Tuesday, so I don’t know that we need to go back to that letter.

MS. GOSS: Are you talking about the correction NCPDP letter?

DR. SUAREZ: No. Yesterday, we edited the attachment letter. That is the one we have to go through today. The second letter we developed at the standards meeting on Tuesday. That is the NCPDP letter. We can go over it, if we want to. I think we have a small correction to make on that letter.

MS. WILLIAMSON: Are you going to make additional edits?

DR. SUAREZ: We need to type the edits or the changes that we are going to make here. Just to recap, we presented the letter. It was sent to the full committee beforehand. Then, we presented a redline version with fresh changes yesterday, and we didn’t get any additional changes to those redline edits. Then, we added some more changes during the meeting yesterday. Those are the three.

MR. SOONTHORNSIMA: Let’s go to recommendation one. This is a comment that Bill provided yesterday, in terms of wouldn’t it be nice to be able to have a capability where the naming standards, as well as the version, can easily be to better help facilitate the transition for various stakeholders. That is really more of an architectural issue from the standards standpoint. Bill thought since we have this theme of forward-looking, why not put this in here, recognizing that it is a bigger issue and probably begs a lengthy discussion around architecture and how some of these standards could be harmonized over time, and allow the industry to embrace new standards with further flexibility.

The way we wrote this is, furthermore, the complexity, pace and scope of changes require us to rethink how these standards are evolving and applied, because the industry lacks the adequate agility and flexibility promptly adopt them. Bill, I am not sure this is strong enough or specific enough.

DR. STEAD: Well, I re-read the whole letter, in light of the conversation yesterday and some of the discussions we had around it. I think in many ways, so the first two recommendations due, in fact, the two recommendations, plus the fact you have taken out the specific versions, telegraph the flexibility. I think it is a bridge too far to try to get into the architecture. I think that what you are suggesting is a good step. It works for my approach, if it works for the rest of the group.

DR. SCANLON, W: The first half works, I think, works for me, but I think the second half, I wouldn’t want that to be interpreted as an excuse to try and slow the evolution or stop. The issue is, I mean, in life, there are stretch goals, and sometimes, those are important. I think maybe rather than stating it as a flat-out fact that the industry lacks agility and flexibility is to say that, take into account the industry’s agility and flexibility to promptly adopt them.

MS. GOSS: Do we also want to say something about industry is lumping everybody together and they’re not all alike, size, resources, competencies, motivations, business models all come into factor. Is there some sort of industry’s diversity, agility, or just diversity is an easy way to say it, industry’s diversity, agility and flexibility to promptly.

MR. SOONTHORNSIMA: Industry’s diversity, agility and flexibility, that is good, so we just add diversity.

MS. KLOSS: I think we should keep it simple. That is all right, that is good, that is all right, that is fine.

DR. SUAREZ: Is this Okay? All right, good. What you see there, for example, on recommendation two in blue is what we already discussed yesterday, so we are not going to rehash that, I guess.

MR. SOONTHORNSIMA: Then, what we did, we also changed the number because we move recommendation 14 up, so we just have to renumber everything else. Those are the only other changes.

Go to recommendation four, please. Alex, do you want to talk about this one?

MS. GOSS: During lunch yesterday, there was a discussion among X12 and NCPDP leadership with me about this letter, and they gave me a number of suggestions related to recommendation four, six and twelve. In this case, the old recommendation number four, we had discussed and agreed during the full discussion yesterday that we needed to put a context about the supplemental documentation was in reference to what? We agreed to add supplemental documentation needed about a patient to support, so about a patient was what we agreed to add.

When you look at the types of functions that might be captured in the other type activities, it could be more than just about one patient. To just give us some flexibility, we suggest that we add parens, as parens, so that we would have that flexibility if they were doing that post-payment audits and they were wanting for information on a variety of patients, that would not be precluded.

You don’t have to do anything, Michelle, it is good to go. What happened was yesterday, when I got back from lunch, I ran through these changes with Walter and then Ob, and then we’ve made a few of those recommendations already in here, to help us move along more quickly this morning.

DR. SUAREZ: The addition is basically the parens.

MS. GOSS: That is all it is from yesterday, just to give us some flexibility. Also, it was good to learn that NCPDP, X12 and WEDI had worked on the definition that is in the old recommendation number three, now new recommendation number four.

MS. KLOSS: That definition did come from testimony.

MS. GOSS: However, they had debated the word, the inclusion of outpatients. Don’t be surprised if we get some comments back from them, but it seemed to be palatable yesterday in the discussion. That is it on that one.

MR. SOONTHORNSIMA: Okay. Recommendation five, we also a discussion around for which supplemental information is needed? This could be expanded to administrative, clinical, medical. Instead of being so expansive, why not just say information, just cut out the word medical, because it is already implied? That is what we just did.

Move onto recommendation seven. This one is about the versions, as well as expansion of pharmacy pri- auth. Alix, there are two comments here. One is about the pharmacy and the second one is version.

MS. GOSS: I will start with the pharmacy portion, which was what we discussed yesterday in the full committee. We were to receive the language from NCPDP and X12 regarding what was the right transactions standards to reference here. There needed to be a distinction made between pharmacists-initiated prior authorization for drugs and biologics, versus, yes, maybe Michelle we should make that drugs plural and we didn’t. If you could add an S right there and then one below.

There was a pharmacist-initiated prior authorization and a prescriber-initiated authorization, which translates into different standards needing to be used. We have specified for pharmacists that they would use the NCPDP telecommunication standard, whereas prescribers would have the choice of using either NCPDP script or the ASC X12 278, because we should not be calling it ANSI X12, that is technically inaccurate. That would be the recommendations for those transaction standards.

The second comment that was made, if you could scroll back up a little bit, Michelle, thank you. On the message content format, it has been noted that we are very specific in our version, whereas in the other transactions, which I realize are not promulgated at this point, in contrast to the message content standard, we are choosing not to be specific in the actual version. I am bringing forth the question of why did we not stay consistent with that rule in the message content format section?

DR. SUAREZ: One of the main reasons was that this particular standard for HL7 is the one that has been adopted for use. In the spirit of alignment and consistency, we thought it would be helpful, and the recommendation basically from the standard development organization HL7 was to reference the specific version in this case.

I think it is helpful, given where and when this regulation potentially will be published, to give the flexibility to the regulator to put in there the right version at the point of the regulation.

DR. SCANLON, W: This recommendation stands out among all the recommendations in this letter, in terms of that it is not sort of a principle, it is not sort of kind of setting a priority. It is simply a choice, which maybe it is the best choice that possibly be made, but it is a choice without a justification. I mean, we are asking this full committee to vote on this. I mean, even being on this standards committee, I can’t tell you that this is a good choice. I think that there is an issue about how we work that is raised by this kind of a recommendation.

MS. GOSS: These recommendations are made, based upon a lot of testing and validation in the industry.

DR. SCANLON, W: That is fine, and the industry can sort of present that to the secretary. We are an advisory committee making judgments.

MS. GOSS: This is what the industry came forward and recommended.

DR. SUAREZ: Not only that, Bill, we did go systematically through the criteria, setting regulation as to the stage of each of these standards, in terms of maturity, in terms of applicability. We had a matrix and we presented it during the subcommittee’s discussions, a matrix that evaluated each of these standards against the criteria that we had.

MS. KLOSS: What is Bill suggesting? He didn’t finish his sentence.

DR. SCANLON, W: What I am suggesting is I am not trying to change his recommendation. I am saying that in terms of sort of how the committee operates, with going from a subcommittee to the full committee, we are bringing to this full committee what appears to be sort of a set of choices that are just black and white choices.

Yesterday, when we were talking about versions and Bill made a suggestion, it was a principle. It was a principle about what you want to build into, choosing your versions and sort of relating to changes in versions, in order to improve sort of the usability of all of this. This one is, again, just a single choice, fixed in time. Again, I am not arguing that it is not the right choice fixed at this point, but it is so different from the rest of the recommendations.

Read the rest of the recommendations, and they are all about take into account this principle or that principle. In some ways, that is really, in my mind, sort of where the full committee, as an advisory committee, needs to be. It is like, in good conscious, how sort of if you are not on the standards committee, and even if I am on the standards committee, I am stretching my conscious on this, how do you vote for this, saying that this is what the secretary should do?

MS. GOSS: Based upon the industry feedback and the level of processes that have validated functionality of transactions standards and workflow integration, this is indicative of what the industry has pruned out, and what we are recommending be proposed for a larger level of conversation and review through the regulatory process and then MPRM, in lieu of just making it a final rule.

DR. SCANLON, W: If the industry wants to communicate with the Secretary, the industry should communicate with the Secretary directly. The NCVHS is an advisory committee representing multiple types of interest. It should be a filter for industry communication.

Listening to them, assessing them relative to sort of other bits of information or other sorts of information, and making a judgment, not just what the industry said, but what our judgment is. I think the problem I see with this, in terms of a standards committee and NCVHS is this is more work than we can take on. You know that it is sort of one of my things.

To fully assess this as a committee, as a subcommittee and as a full committee, to fully assess these kinds of aspects sort of this, and to make a judgment like this. I mean, maybe these are the only ones, the only choices. But as a committee contribution to the secretary, it would be then these are the only choices. Here are the areas that need strengthening, I mean, those kinds of things. This, again, it is just like black and white, as opposed to all the other recommendations which are principles.

DR. SUAREZ: This committee has been for 20 years recommending specific standards to be adopted. The process that we have followed, and I have been following that since the beginning, has been to evaluate which are the standards that exist in the industry through input through the industry, through input from the standard development organization. We have a DSMO, a designated standards maintenance organization structure that was named in regulation to determine, which is the right set of standards to be recommended, and to maintain those standards, and come back and present to us what it is that is being recommended.

We have a set of criteria set in regulations that we have followed, to evaluate each and every one of the standards that we recommend, by virtue of saying how mature they are, how scalable they are, how tested they are, all those evaluation criteria. I think we are responsible for advising the secretary on when there is a new transaction advising the secretary on the definition of that transaction, the applicability of that transaction and the standard to be used by the industry of that transaction.

We have followed that. I think it is, indeed, a recommendation that presents to the secretary the discussions and the deliberations on the evaluation that we followed to make this. We are not a pass-through committee that takes the information from the industry and simply put it in a letter. We follow process and we follow criteria, and we have plenty of discussion to have the industry and someone else, if it’s the case, come back and say, wait, there is this other standard that you haven’t considered.

I think we have done as much of a complete work with respect to any of the transaction that we have recommended in the past, but this particular one. I think we are presenting this recommendation. The question on the table right now is not about that. The question on the table is about diversion.

MR. SOONTHORNSIMA: Bill, I think I understand your perspective. I think what you are saying is we are being very specific perhaps, and we are saying, these are the choices and these are the only choices. Given that perspective, what might you change then?

DR. SCANLON, W.: I actually don’t have a proposal to change. I think in the interest of this letter going forward, and I sort of respect sort of what Walter is saying in terms of sort of the deliberation that has gone on, in some respects, behind the scenes sort of for this. What I am saying, in part, this is anticipating sort of the later discussion about where the standards subcommittee is going, that this kind of a recommendation, to me, is not sort of consistent sort of with what NCVHS’ charge is, which is to give the secretary sort of the rationale and evidence and principles about what should be done. This is a choice.

I was going to say I wouldn’t cite the last 20 years, because I am interesting in sort of changing sort of what has happened over the last 20 years. Because I think that we are at the point where we have aspired to administrative simplification for 20 years and we haven’t gotten there. We are revisiting it now because we haven’t sort of succeeded.

It is the second largest unnecessary health care cost, as identified by the IOM, and we really need to make progress. Something has got to change about this process. That is why I feel that, you, as this subcommittee and full committee move forward, that we need to think –

DR. SUAREZ: Linda and then Alix.

MS. KLOSS: I really see both sides to this, I believe, and have had some of the same discomfort because I don’t have personal understanding of DSTU release version 1.1 US, what it is and what it will do. I know others do and can look at this, and it says something that it probably doesn’t say to a lot of the members of the committee. They are taking the advice of the Standards Subcommittee that has put a lot more work into it.

I am wondering, and I did think about this when I read the letter originally and then didn’t do anything with that thought, but the following standards should be adopted for attachment-related transactions. I think that header could describe, this is a composite of the standards that were recommended through broad industry input and represents the most appropriate standards for this task at this time.

MS. GOSS: To make it that it is really, all the recommendations need to be taken together. To your point, Linda, it is really that this is what we are proposing would go out in an NPRM to get further validation from the industry as a whole, because we are making these recommendations on the limited set of testimony that we received at that hearing. Having been involved with claims attachment since 2000 timeframe, I have worked on some of these transaction standards and I have been in the collaborative work between the HL7 and X12 community on this.

I know how much this has been road-tested, but it is has been a limited segment. I think that is what has promoted our, let’s go out for MPRM, because we don’t want it to be de facto. Something has to be put forth to force the conversation to advance.

MS. KLOSS: It hasn’t necessarily been road-tested in combination for this application, correct?

MR. SOONTHORNSIMA: In the interest of time, I think I am trying to frame up from everybody’s perspective. We do have one recommendation, the first recommendation that is much more strategic. At the same time, we also have the tail end of this NPRM process for the review.

This is a task at hand for us. We are charged to make a recommendation and this is the best recommendation that we do at this point. You kind of frame it up. You have got the strategic aspect of this, you have got the task at hand, this the best composite, I love that word, of a set of standards that we have. Lastly, the vetting process that we are recommending to take place, and that is a recommendation something down the line.

MS. KLOSS: Michelle, I think I would not put that as the first sentence. I think I would leave it as, the following standards, unless you put it there, should be named in the NPRM.

DR. SCANLON, W: That changes it quite a bit, because that is saying you want additional input on this. It is not saying we are saying absoslutely –

MS. KLOSS: Ready for adoption.

MS. GOSS: I really get your point there, Bill, and I struggle that you have all of these recommendations that really need to be acted on and together. One of the things that some of us discussed yesterday was the further clarity about the flow of the recommendations, and that we probably would be benefitted if we moved what used to be recommendation 12, I guess it is now 13, up to more closer proximity to this, because you really need to put the context about the regulation should not define specific standards or methods, and they should be adopted. Then, have overarching principles, and then, if you are going to get down to standards, then this these are the ones we think you should use.

DR. SUAREZ: We have got to move on. The idea is to insert this sentence?

MR. SOONTHORNSIMA: I think the sentence softens it.

DR. SUAREZ: The introduction of letter, and I can cite here, places where we already say this. That is okay, we can insert that sentence. Is there any other comment on this sentence?

DR. SCANLON, W: Well, was the idea to bring in the NPRM? The following standards are suitable for inclusion in an NPRM. They are a composite of the standards that were recommended by the industry.

DR. SUAREZ: Instead of saying should be adopted? I would be very concerned about that.

MS. GOSS: How about compromise? How about for inclusion in an NPRM proposing adoptions of these?

MS. GREENBERG: I think it is fine to say for adoption. I realize I came in a little late to the discussion, but I think I am following it. I do think that there are very few people on the committee who know anything about any of these specific standards.

In my experience, the committee relies on the standard subcommittee to do due diligence, as Walter said, and every evidence is that they do. Particularly, since you are recommending this in an NPRM anyway, that there be an NPRM, I think this language leaves some wiggle room for imperfect knowledge.

MR. SOONTHORNSIMA: We are deliberate enough. I think the point from Walter and I is that we have to be specific. That is our task at hand.

MS. GREENBERG: That is expected of you. CMS will suffer if you are not specific.

MS. KLOSS: I like the way you phrased this better, though, than what is here. The following standards are suitable for adoption. Didn’t you say that?

MS. GREENBERG: I said I recommended or I proposed for adoption. I think proposed because suitable already assumes that people know more about them than they do.

DR. SUAREZ: Let me suggest the following three sentences, very short here. The first said, the following standards are proposed for adoption. The following standards for attachment-related transactions are proposed for adoption, period.

These standards are suitable for inclusion in an NPRM, period. This is a composite of the standard that were recommended by the industry, period. Does that work? Okay, so let’s move on and see if we can finish this letter. Did you capture that?

MS. GREENBERG: Why don’t you just say, these standards should be included in an NPRM.

DR. SUAREZ: These standards are included in an NPRM per recommendation.

MS. KLOSS: Maybe two sentences, as they represent a composite.

MS. GREENBERG: These standards represent a composite of the standards that were recommended by industry, and should be included in an NPRM. I put that at the end. These standards are a composite that were recommended by industry, and should be included in an NPRM.

MS. GOSS: While they are making that wordsmithing, would there be any objections to moving up recommendation, what used to be, 12, which is now 13, to be a little bit closer? Does everybody have a letter in front of them? Because recommendation 12 says the regulation should not define specific standards or methods of transport as the only ways for exchanging the attachments. It is getting more into the standards world.

The general proximity is my goal, the specific locations.

DR. SUAREZ: The place that I see it fit is after this, the recommendation whatever it is, number eight now.

MR. SOONTHORNSIMA: The next one is, this is to address, I think it was Jim who raised the issue, of minimum necessary. To clarify reference to OCR, we simply are stating, in other words, requesters of information should not ask for and senders should not send more than what is minimally needed. Just to clarify what this really says.

MS. KLOSS: That is wording that comes out of the FAQ, right?

MR. SOONTHORNSIMA: No, I don’t think we took it literally. We just tried to simplify it, say what we mean, that is what it is.

DR. SUAREZ: Jim Walker suggested some different language. I talked with Jim, and so he withdrew that. We agreed that this was the statement that we would suggest this morning.

MR. SOONTHORNSIMA: We told him, something like this we would put in there and we could clarify it.

DR. SUAREZ: Now, just some background, number one, like I said yesterday, we are not proposing any new regulations or minimum necessary. Number two, the only thing we are doing with this is asking the secretary to emphasize in the regulation the applicability of minimum necessary to this transaction.

Number three, we are recommending that the Office for Civil Rights include this in the guidance for minimum necessary. Number four, by inserting this statement, we are just simply restating what the principle is, which under minimum necessary today, which is organizations should not ask more than what they need for purposes of achieving the goal for why they requested information, and entities should not disclose more than what they need for, in order to achieve the purpose of the disclosure. That is all we are doing here.

MR. SOONTHORNSIMA: Next, recommendation 13.

DR. SUAREZ: We are moving this to become new recommendation eight. We will first move it, move it up to be the new recommendation eight. That is the first change. The second one, I think, is addressing a concern that the envelope standards are, and this is the hard part that I have been struggling with, because if you go up a little bit on this, the standards we are recommending in this list includes a routing envelop standard for X12.

Now, that is a standard that is used when people use the routing mechanism of X12. There is another way to conduct this transaction, which is a direct submission of an H07 message to a payer, without the X12 275 envelope.

MR. SOONTHORNSIMA: If the parties agree to use that method.

DR. SUAREZ: In some ways, in this recommendation seven, it gives the impression that everybody has to use the routing mechanism of X12 275. That is not the intent. We need to insert in this recommendation, the transport, a statement that says something about the routing standard recommended in recommendation seven should not be required when trading partners, or is not required when trading partners agree to use other routing style envelope standards, not standard, but mechanism.

MR. SOONTHORNSIMA: Didn’t we say that earlier, the first sentence?

MS. KLOSS: She added an additional sentence to the end of the paragraph.

MS. GOSS: Why don’t you highlight first to make it yellow, so that we know that we just added it, since it is different than what we moved.

MR. SOONTHORNSIMA: You don’t think the second sentence takes care of that?

MS. GOSS: I think that the second sentence says it. We also said and/or envelope or routing mechanism. I think that the last sentence clarifies the intent. This starts to get a little slippery to me, because I feel like we could be interpreted as giving conflicting recommendations here, and I don’t think we are trying to do that.

What we are trying to say is, if you are going to use standards, use the vetted and approved sort of standards. Your mechanism for getting that payload from point A to point B, there needs to be some flexibility so that we don’t inhibit innovation. We are trying to help with conformance and ability to do effective change here. We are trying to also leave the door open.

MR. SOONTHORNSIMA: May I suggest then, shouldn’t that be a footnote under the previous recommendation, recommendation seven, instead of here? That point you just made, a footnote somewhere here.

DR. SUAREZ: There are different shades of gray, as they say someplace. The concern here is that, if we leave the addition that we made, and I reread it and rethought about it, if we maintain this and/or addition, where we say that the standards should be agnostic to the routing environment, it negates the recommendation seven above that said the standard should be X12. Actually, I would put that on the title, routing envelope.

In fact, now that I see that, that should be a one-star and should be the first footnote. All the other ones should be double stars and second footnote, because that is the first. All right, this works.

MR. SOONTHORNSIMA: I think that is it.

DR. SCANLON, W: Yesterday, when we were going over this, there was an insertion of a do something by January 1st, 2016.

DR. SUAREZ: Pardon me? Could you say that again, Bill?

DR. SCANLON, W: I said yesterday, when we were going over the letter, one of the changes that was mentioned was that there was —

DR. SUAREZ: That has been included in the first recommendation, if you go back to the first recommendation, Michelle.

DR. SCANLON, W: It was January 1st, 2016, was given as a date to do something by. My question was going to be, what made that date important.

MS. GOSS: Your last three edits are wrong.

DR. SUAREZ: The question that Bill has is under recommendation two. There is a new sentence that was inserted, and actually, this was presented. This includes naming an initial attachment transaction type to comply with by January 1st, 2016. For example, appropriately sequencing the naming of the other attachment transactions.

DR. SCANLON, W: My question is, what is it about January 1st, 2016, that makes us recommend that day as opposed to do this as expeditiously as possible?

DR. SUAREZ: The Affordable Care Act requires the compliance with the attachment standards by January 1st, 2016.

DR. SCANLON, W: I think then I would reference the Affordable Care Act as opposed to us setting a deadline.

DR. SUAREZ: How do you tie it to comply by January 16th, 2016, per the Affordable Care Act? We are adding right after 2016, the words.

MR. SOONTHORNSIMA: As specified by ACA.

DR. SUAREZ: All right, that is good.

MS. GREENBERG: Do you still want, for example, claims?

DR. SUAREZ: Yes, that is one example. It is naming one.

MS. GREENBERG: For example, you mean an attachment standard for claims?

MR. SOONTHORNSIMA: Attachment type. In other words, you are going to define something, don’t do everything exhaustive list of attachments.

MS. GREENBERG: I think it is a little too abbreviated.

DR. SUAREZ: This includes naming an initial attachment transaction type to comply with by January 1st. For example for claims, all right.

MS. GOSS: We made a lot of changes this morning, and we want to bring this back for the full committee’s final run-through and blessing after yesterday’s discussion and deliberation. Would it make sense for several people to maybe take this offline for a minute and read it in the quietness of some space, and then come back, making sure that we have got numbering right?

MR. SOONTHORNSIMA: I can do that with Michelle.

DR. SUAREZ: For this morning, we already processed. The only changes that we are going to present this morning are the additional four changes from yesterday. We are not going to present all this redline. The red line that we already discussed and introduced and talked about yesterday during the committee meeting, we don’t have to.

MR. SOONTHORNSIMA: They will see this whole letter. They will see this, these changes.

DR. SUAREZ: They should see a redline version with only redlines of what we modified today. Not all of these redlines that we also had from yesterday. The blue redline should be accepted.

Before we continue, I think we should probably go around and introduce ourselves, and take a poll for who it is, so that we have it on record. Then, we can take action of this letter.

MR. SOONTHORNSIMA: Ob Soonthornsima, I think I am on this committee, co-chair to the subcommittee, no conflict.

DR. SCANLON, W: Bill Scanlon, National Policy Forum, member of the subcommittee, no conflicts.

DR. STEAD: Bill Stead, Vanderbilt, member of the full committee, no conflict.

MS. GOSS: Alexandra Goss, member of the subcommittee, member of the full committee, no conflicts.

MS. KLOSS: Linda Kloss, member of the full committee, member of the subcommittee and no conflicts.

DR. SUAREZ: Walter Suarez, member of the full committee and co-chair of the subcommittee on standards, and no conflict.

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

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

MS. WILLIAMSOM: Michelle Williamson, CDC NCHS and staff to the subcommittee.

MR. LAZARUS: Steve Lazarus, boundary information groups, CAQH core representing them.

MS. FORRESTER: Rachel Forrester, boundary information group, representing CAQH core.

MR. SCANLON, J: Jim Scanlon, HHS ASPE.

MR. GREEN: Larry Green, member of the committee, no conflicts.

MR. ALFONO: Bill Alfono, Blue Cross Blue Shield Association.

MS. JONES: Catherine Jones, NCHS, staff to the committee.

MS. JACKSON: Debbie Jackson, NCHS, NCHS committee staff.

MS. TURRICK: Kelly Turrick, America’s Health Insurance Plans.

DR. SUAREZ: All right, thank you very much. All right, we will present this to the full committee later this morning. Very briefly, the second letter, we discussed it on Tuesday. This is the letter that NCPDP brought to our attention that was needed in order for CMS to take action on the modification or enhancement of the existing standard for NCPDP pharmacy transactions.

The only small modification that are going to make is on the heading on the reference line of the letter. When we say reference changes, we are going to change the word change to say enhancements to the existing standard, so that is the only change on that letter. We will have a chance to explain this letter to the full committee this morning.

Let’s talk about the next steps for the full committee, the agenda. In the last three months, as we prepared this letter and we had several meetings of the sub-committee over the phone, we kept referencing and using our sort of schedule of activities. I don’t think we have a slide presentation of that on the book. Basically, this was a summary of the schedule of all the activities that were to be completed.

Just to summarize things, at this point, we have completed this letter. The next round of activities, with respect to this HPAAa-related and Affordable Care Act-related provisions is the operating rules on the remaining transactions. That is the only remaining concrete activity, with respect to Affordable Care Act provisions or HPAA modification provisions.

We are to make recommendations to the secretary on operating rules for claims, for enrollment, for premium payment, for prior authorization and for claim attachments. As we know, there is going to be a long process probably over the next nine months or more for the development of any such rules. They will be brought to NCHS sometime in 2014 for evaluation and consideration. We don’t have really anything else in terms of line-up for any other requirements.

There are some additional things that are still on our sort of set of activities. Number one is the health plan certification. We, as we heard yesterday, expect to have a proposed rule, an NPRM, coming out sometime in the next few months. The clearance process started as Denise explained yesterday. We might see a proposed rule by sometime September or October, sometime then. We might, as a subcommittee, consider looking at that NPRM. Normally, we don’t necessarily make comments on NPRMs, but we could consider doing something, helping assess or address or get feedback from the industry. That is one.

Then, the other set of activities are really related to sort of the ongoing monitoring function of the subcommittee in terms of the standards that are being implemented. We have, of course, ICD10 moving, we have the health plan ID. We have sort of the ongoing standards that are being implemented or adopted. Beginning of next year, we will see some new operating rules being put in place, the operating rules for EFT NRA, the industry adopting them and implementing them for the first time.

Between now and December, and probably now and March, we don’t have anything really concrete in terms of those responsibilities. By next June, as we always do in June, we could convene another set of hearings related to the state of the standards. By the way, as has been mentioned a couple of times, the Affordable Care Act requires the secretary to name a review committee to review the standards and do the sort of evaluation of the state of the standards, and whether there is a need to improve the standards, modify them, change them. That is something that we have been doing through these hearings in June and other mechanisms.

NCVHS is a possible candidate, they say, is an entity actually identifying the Affordable Care Act as a possible review committee. We are waiting to see the formal decision by the secretary on naming that review committee. The first action really on that is beginning to hold the series of hearings around the state of the standards, again, which is what we do every June.

That is basically the long way of saying we don’t really have any concrete set of prior activities between now and next year when we would be looking at the operating rules. We would be looking at some of the other things that I mentioned.

I think there is some priority opportunities that we want to discuss. The first one, of course, is the roadmap that has been already mentioned several times. We have talked about it, and we have had round tables and other discussions about it. I think we have an opportunity to really now invest time and effort of the subcommittee, and really take a step back and consider this roadmap, and actually doing something concrete about it.

I think there is a lot of interest, as we heard yesterday from Rob and from Denise from CMS in doing this, in having this roadmap be developed. CMS has an e-health strategy and they offered actually that that could be used as an element to build on this roadmap. I think that is one of the main topics that I think we have, that we can focus on over the next several months.

A second topic that I wanted to suggest considering is we heard yesterday one of the convergence themes is in the area of public health, e-health standards. I think we have an opportunity now to bring that to be sort of the focus of our work, is the opportunity to look at where we are with public health standards, in terms of different standards being applied to different public health functions. That is another topic I wanted to bring.

Those are the two main topics that I had in mind. There are a few other things that we have heard and that we would want to keep monitoring, things like the dental code issue that we heard last December, the NDC code issue that heard also earlier this year. There are a few other monitoring function type things that we need to continue to keep an eye. The core topic I think is what we wanted to talk about. Again, the two that I offered are the roadmap and the public health data standard.

Let’s start with some comments, Marjorie and then we will go to Ob and Linda, and go down the table.

MS. GREENBERG: I have a question about this review committee. When is the secretary supposed to name that committee?

DR. SUAREZ: I think by the fall, later this year.

MS. GREENBERG: Jim is here, I see. Has the committee ever informed the secretary of its willingness to serve in this role?

DR. SUAREZ: We actually have in a previous letter. I am not exactly sure which letter we used, but we used one of our previous letters to include a statement about our commitment to be in that entity. We might want to consider more formally letting the secretary know. That is something that will be done by the end of this year.

MS. GREENBERG: What do you think, Jim? It is a logical thing obviously because this is a committee that has been serving in this role. I am not exactly sure what it entails.

MR. SCANLON, J: I think even before any formal, let me find out a little bit more about it. Let’s sort of deal directly within HHS, because if there is receptivity, then we can just get the designation.

DR. SUAREZ: Just to let you know, too, I know that CMS, OESS, Rob and Denise and their team are looking at this. I think they are part of the discussion and the decision certainly. It was an ACA provision.

MS. GREENBERG: I think that would be good, if Jim would look into it.

MR. SCANLON, J: Let me talk to the post and see, because we could designate the committee (off mic) if there is a willingness to do it there. We just have to see what else they are thinking of.

MS. GREENBERG: Thank you, Jim. The other thing was, I believe Linda recommended some type of evaluation. I don’t think that could be done just by the committee. I think if the committee felt it was important and scoped it out, then the department could consider whether resources could be put towards working with a contractor.

MS. KLOSS: This is just some context for those who weren’t at the meeting on whatever day that was, Tuesday. We heard so many important change leadership, change management lessons learned through the course of 5010 now through the lift with ICD10. It seemed that there is a body of knowledge for these large scale industry adoptions that could be accumulated in some kind of report that would help us going forward and help the industry going forward.

Perhaps this would be something that could be done as an evaluation contract and a report prepared that could come back to the subcommittee for review and approval. Sort of on the vein following some of the journey themes from the 10-year HPAA report, which touched on these lessons learned. It said what didn’t work, but didn’t say what has been found to work.

MS. GREENBERG: Jim being from the Office of the Assistant Secretary for Planning and Evaluation, if you felt that there would be interest in that.

MR. SCANLON, J: I think there would. Any evaluations that produce ideas and findings for HHS to use, and for the industry to use, I think they would be very interested in. I think where the problem is where we are sort of in the fourth quarter now, in terms of budgeting. You are thinking of the fall? Yes, that is fine, that would be a good idea.

MS. KLOSS: I always remind people that there is ICD11 behind this, and we should be chronicling what we are learning, so we get better at this, because it is an industry competency.

MR. SOONTHORNSIMA: You talked about two things, convergence and road map, as new activities focus. I want to touch on the roadmap a little bit. I think we need to, as we discussed yesterday, understand trying to frame up the concept of roadmap in a much higher level.

The three possible areas, and this is just for us to think about, not necessarily adopt, is you have, in my mind, as we transition, there is really the regulatory sort of roadmap that talks about all the mandates that are taking place today, ICD10, ACA, so on and so forth, payment reform. If we can map those things out, and what goals, objectives and timeframe, I think that kind of frames up a roadmap.

Then, underneath that, another sort of roadmap that talks about the changes that had to take place among the stakeholders in the industry. For examples, what health plans have to do with the how (?) is going to change, what the providers are going to do and other entities, as well. That sort of roadmap that would map back to, in terms of their capabilities that they have to change. I am talking at high level now, the capabilities that are impacted as a result of all of these mandates.

The third sort of roadmap that sort dovetails with all this, might be the standards and operating rules that have to be harmonized. We have heard some of that a couple of days ago, as SDOs colleagues, really started thinking about. We can’t just look at these transactions independently. We have to look at this thing as part of a bigger process, bigger function.

Again, regular perspective, what are these changes that are mandated? Secondarily, what are those business capabilities that have to change for the key stakeholders, providers, plans, and what not. Lastly, what standards that have to come together as part of this roadmap to make this happen.

If you marry these three, it is just high level, we might begin to appreciate that the challenges, opportunities and possible tales, we talked about the trail of when we have a mandate, when we have a date, there are always stragglers. Every time you have part of the industry not able to embrace a new or meet the mandate on the targeted date, then they are impacting the next set of roles and capabilities. I think we need to understand the tail of it, as well.

The second, just the new idea that I think as part of the work that we have to do, the marketplace or the health insurance exchange. What are the implications for standards, considering A20, the new capabilities that have to be enabled in order to support ACA insurance exchange.

A34, we talked briefly about A34. That dramatically changes how the business processes actually work today. I think it behooves us to come back in about six months, long after the implementation, I think probably sometime in June next year, not March. Probably June next year, maybe come back and see what are the ramifications. Those are my comments.

MR. SCANLON, J: The A34 will be what the marketplace is (off mic).

MR. SOONTHORNSIMA: That is right. That is what we are using to get enrollment information, enrollment data individual, as we all as group.

DR. SUAREZ: A34, the X12, already has developed and put in place the A34 for exchanges.

MR. SOONTHORNSIMA: This is a point about how the standards have to apply, and the business process and the stakeholders are changing. We just have to understand.

DR. SUAREZ: Sure, so this will be something that we can do next year as an evaluation of how things are evolving. There’s Bill and then Alix.

DR. STEAD: Let me build on what you just said. I like those three layers or lanes of the roadmap. It seems to me it would be very useful to set up above that health care value milestones. Because as much as you described, as you looked at the set of things that are the composite, that can enable attachments, that is a composite of standards.

As you get the three layers you are laying out of regulation stakeholder standards, if we could be looking at what it takes to actually deliver a major step function change in value, and get that down, and then try to have a way to coordinate drive, align, converge, whatever, the lower lanes to drive to that value, so we are actually focusing on the value, not just coordinating the lanes. I think that would be helpful.

I think the other thing that I would like us to still get at is what I was talking about yesterday, which could be part of roadmap, or could be a separate topic, which is around what are the opportunities to rethink how we are doing this to dramatically change the speed, in a way that does work for the industry. I think we need a substantive discussion of that. It can be together or separate.

DR. SCANLON, W: My sort of comment is, in some respects, very consistent with Bill and Ob’s. The workshop we had was very valuable and very rich, but it was too broad. We need, I think in order to make this a productive exercise, to have a sort of ability to frame sort of segments with this and deal with them sort of in-depth, and then sort of relate them.

To me, sort of in addition to what Ob was laying out as dimensions, maybe it is an overarching sort of dimension, which is what Bill brought up. What are we trying to accomplish here? We are trying to change sort of health care, at least, and hopefully we are changing health in the process, too. We can keep our fingers crossed on that.

That goes beyond administrative simplification. That goes to truly changing our health care system. The fundamental question is, what information do we need to do that? And how are we going to make that information flow? The committee, sort of beyond the standards committee, has dealt with this over the years in bringing some of that thinking into this as kind of a step in terms of kind of, in some respects, creating a metric against which to judge things like dimensions that you are talking about, and to identify sort of where priorities should be.

As I said earlier about our letter, principles and priorities are two of the most valuable things that we can give to the secretary. These are the things that the secretary sort of needs to understand and know about, are sort of important. I think we are on the same page. It is not an easy thing, though, to set out. There is a committee roadmap, so to speak, which is hard to specify. That is going to take some work.

We have done a lot of kind of initial examinations, sort of both through the roundtable we did, and again, sort of other committee discussions. Building on that sort of made probably through phone calls to say, this is going to be the agenda for what we sort of come together to deliberate that we are going to deal with first, second, third, et cetera.

MS. GOSS: I agree with that. My clarifying question of where do we see the conversation data governance really falling into this? Is this a roadmap, is this a public health standards? I was kind of lost in where you might be seeing that from the Walter and Ob initial proposed topics. Could you comment on where you see it?

Data governance. We know that there needs to be a defined set of the data that we get, that flows from the electronic health records, that can be from that patient provider interaction, that then can be reused, parsed out, all the different ways it needs to, so that we get the value proposition about that data capturing initially at the point of care.

Then, we become very effective in how we use that. How does that sort of go back to priorities, et cetera. I want to sort of tease out where does that fit in this discussion as far as the bucketing that we have put forth. Maybe it is more about a principle to Bill’s point.

MR. SOONTHORNSIMA: Is that a better fit here, though, or is it with the joint committee?

DR. SUAREZ: I am thinking that there is something about it, of course, that we have to focus on. This is a larger question for the full committee actually.

MS. KLOSS: I actually think as this discussion is progressing that development of a roadmap, or thinking through of a roadmap, probably should start at the full committee level, from the framing the value. Then, looking at what the dimensions of this coordinating the lanes are, because it is not just about standards. It is about how the policies converge with the standards.

DR. SUAREZ: You are saying the framework is really something that the full committee [laughter] – that is a nice way to say it is not our (off mic).

MS. KLOSS: No, I think it is, as it relates to standards roadmap. If we are going to frame it in the broader context of advancing true administrative simplification, and taking a look at this in a way that is transformative, then I think it would benefit from at least starting the conversation at the full committee level, and then moving to the subcommittee, rather than the other way around.

DR. SUAREZ: It really is a scope issue and a context issue, I think. The scope of, when we say framework, we had been at least starting to think about it in terms of the standards. The focus being trying to lay out something very practical and very value-based. Elevating it now takes it into a different context, which is perfectly, well, of course, important, but then it’s something that we would have to discuss with the full committee.

I was about to mention a few next steps, since we only have four minutes. The next step that I was going to suggest was that a small group of subcommittee members, so maybe the subcommittee itself, gets together and begins to outline this framework. If we are going to kick it up to the full committee, then it is an executive committee type of function or something like that.

I still believe that there is a need to define a roadmap for standards.

MS. KLOSS: I agree.

MS. GREENBERG: How about, I don’t know if it is a compromise or another way of spinning it, but if this subcommittee, and you are already not huge anyway, so I would think that sometimes you can’t all participate in every call, started to do what you have suggested, and presented it to the full committee in September. You are really just at the conception and the outline, and all that level, rather than completely having flushed it out.

Possibly even before the September meeting, present it in a teleconference to the executive subcommittee, get their input, or just wait. I just kind of defer to Larry on this. Then, you are getting both ways. I think what Linda is saying, which I would support, is you don’t want to get too far down.

There are pieces of this that like the privacy subcommittee might want to partner with, population health, certainly if you are talking about e-health standards for public health or population health. They are going to want to weigh in. It is obvious for the subcommittee to take the lead, just like the population health was sort of the obvious one to take the lead on the community health data.

That could be a plan for the September meeting, which is as far as I know, I don’t know what is going to come forward then. Certainly, time could be provided for a good conversation about it.

DR. SUAREZ: I think that is a great idea. I think we do need to have a small group of people put together something concrete, in terms of an outline, and some description of what this roadmap is and sort of scoping it out, and presenting it to the full committee. I think it is a good idea.

I think that would be the next step that we can take as a subcommittee, start that conversation and develop that.

MS. GREENBERG: You are obviously going to want to work with CMS, but others, as well, because they are thinking about this a lot, too.

DR. SUAREZ: We have been discussing that with them already. Are there any other points or comments?

MR. SCANLON, J: There is somewhat of a conceptual roadmap available on the EHR side and HHS. I don’t think ONC talked about this yesterday. It is a conceptual, which we can share.

DR. SUAREZ: Is it a strategic plan?

MR. SCANLON, J: Well, is the concept of how the interactions, where is data exchange, where is data developed, where is data used? It is EHR-oriented. On the other hand, administrative simplification has to fit in there, as well, and so does the population data. I will see if we can arrange it. It is a joint effort. It is meant to find out where, when you look at where the data flows and where the data reside, and where the data is used and who is doing it, it is really to identify where policy is needed, so where standards are needed. Then, sort of who does that policy.

It is ONC and several agencies, as well. I think conceptually it would help you. The roadmap actually is unfolding. There are actually several maps. It is hard to portray them all on one. I will get that to the group and we can have someone talk about that.

The problem is, you look at the concept and you say, yes, okay. Then, it is not obvious what you do next or what the timeline is. You can start to see where standards are available, where standards are needed, and where privacy and security policies are available already. Then, is there governance needed? It sort of raises the question of what do you have to do next to make it work?

The administrative part of it focuses largely on the HRs, but I think the admin would fit in or would be similar.

DR. SUAREZ: Thank you so much. We are out of time. We do have one minute, so if there is any public comment. No public comment, any public comment? It looks like we don’t have any public comment, so I think with that, meeting is adjourned. It is 10:00 a.m.. Thank you.

(Whereupon, at 10:00 a.m., the meeting was adjourned.)