[This Transcript is Unedited]
Hubert Humphrey Building
200 Independence Avenue
Washington, D.C.
TABLE OF CONTENTS
COMMITTEE MEMBERSHIP:
DR. COHN: Good morning. I want to call this meeting to order. This is the first day of two days of meetings of the National Committee on Vital and Health Statistics.
The national committee is the public advisory committee to the U.S. Department of Health and Human Services on health information policy.
I am Simon Cohn. I am associate executive director for health information policy for Kaiser Permanente, and chair of the committee.
I want to welcome committee members, HHS staff and others here in person. I also want to comment, at least for the moment, that we are not on the internet, but we will be I expect shortly, and I will let everybody know when we do get connected. As always, I do want to remind everyone to speak clearly and into the microphone.
Let's go ahead and have introductions around the table and around the room. For those on the national committee, I would ask, if you have any conflicts of interest related to any of the issues coming before us today, would you so please publicly indicate during your introduction.
I want to begin by observing that I have no conflicts of interest. I actually understand that we also have Harry Reynolds calling in for this session. Is that correct, Harry?
MR. REYNOLDS: Yes, sir.
DR. COHN: Okay, would you like to start by introducing yourself?
MR. REYNOLDS: [Via speakerphone.] Harry Reynolds, Blue Cross and Blue Shield, North Carolina, member of the committee and no conflicts.
DR. COHN: Will we see you tomorrow in person?
MR. REYNOLDS: You will see me at dinner tonight. I will call in now and then I will call in to the standards and security breakout and then I will leave from the airport.
DR. REYNOLDS: All right.
MS. GREENBERG: Good morning. I am Marjorie Greenberg from the National Center for Health Statistics, CDC, and executive secretary to the committee.
MR. ROTHSTEIN: Mark Rothstein, University of Louisville School of Medicine, member of the committee, no conflicts.
DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of the committee, no conflicts.
DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the committee. I do chair AMIA, whose report is going to be presented later on this afternoon.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member of the committee, and I have no conflicts.
DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center, member of the committee and no conflicts.
MR. LOCALIO: Russell Localio, University of Pennsylvania School of Medicine, member of the committee, no conflicts.
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services, liaison to the committee.
MS. MC ANDREW: Susan McAndrew, Office for Civil Rights, privacy liaison for the committee.
DR. W. SCANLON: Bill Scanlon, Health Policy R&D, member of the committee, no conflicts.
DR. STEUERLE: Gene Steuerle, member of the committee from the Urban Institute, no conflicts.
MS. MC CALL: Carol McCall, member of the committee. I am with Humana, no known conflicts.
MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, no conflicts.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and Quality, liaison to the full committee and staff to the Subcommittee on Standards and Security.
DR. HUFF: Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City. No conflicts.
DR. STEINWACHS: Don Steinwachs, Johns Hopkins School of Public Health, no conflicts.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the committee.
MR. BLAIR: Jeff Blair, member of the committee, director of health informatics at Lovelace Clinic Foundation. I am not aware of any conflicts.
MR. J. SCANLON: Good morning. I am Jim Scanlon from the DHHS office of planning and evaluation and I am the executive staff director for the committee.
MR. SCHUPING: Jim Schuping(?), chief staff executive with WEDI.
MS. CHAPELL: Jody Chapell, American Optometric Association.
MS. JONES: Kathleen Jones, CDC, National Center for Health Statistics.
MS. PICKETT: Donna Pickett, National Center for Health Statistics, CDC, and staff to the Subcommittee on Standards and Security.
MS. BICKFORD: Carol Bickford, American Nurses Association.
MS. HORLICK: Gail Horlick, CDC, and staff to the Subcommittee on Privacy and Confidentiality.
MS. JACKSON: Debbie Jackson, NCVHS staff.
MR. BRUCKNELL: Mark Brucknell(?), Academy of Managed Care Pharmacy.
MR. KRUGE: Andrew Kruge, Academy of Managed Care Pharmacy.
MR. AFANO: Bill Afano(?), Blue Cross, Blue Shield Association.
MS. BEEBE: Susan Beebe, ASPE and staff to the Subcommittee on Standards and Security.
MR. BROWARD: Roger Broward, Rx Benefits Coalition.
MS. BUENNING: Denise Buenning, CMS, lead staff, Standards and Security Subcommittee.
Ms. GRANT: Good morning. Miriam Grant, Office of Minority Health, staff to the Committee on Populations.
MS. FRANKLIN: Angela Franklin, American College of Emergency Physicians.
MR. TOBIAS: I am Matt Tobias. I am a reporter with Modern Health Care.
MS. Nook. I am Marilyn Sigmond Nook(?) with American Health Insurance Plans.
MR. HUFF: Good morning. I am John Huff from the National Center for Health Statistics.
MS. BEALE: Allison Beale(?), American Health Information Management Association.
DR. COHN: I want to welcome everyone to this last meeting of the year, and obviously happy post-Thanksgiving. Before we move into the agenda with you, I have a couple of opening comments, as I normally do for these sessions.
There are a couple of different topics that I want to sort of bring up and discuss briefly. First, this meeting marks the beginning of a transition.
We have three members of the committee for whom this will be their last meeting as NCVHS members. I want to take a moment and acknowledge them for their participation and dedication to the activity, knowing that we will be having additional comments as the day goes on, and obviously dinner this evening.
Those three members are Russ Localio, Bob Hungate and Stan Huff. I actually just want to really thank you all for your dedication and hard work and participation on the committee.
You will be missed and I guess I am hoping that you will all join us for dinner tonight and be my guest at a dinner I think in honor of your retirement from the committee.
[Applause.]
I also want to announce that Don Steinwachs and John Paul Houston have been re-upped for another four years. Additionally, we have new members whose terms actually begin on December 1, which is on Friday.
We will see at least potentially one tomorrow visiting, but all of them will be participating for the next full meeting and probably some of them will be beginning to show up at subcommittee meetings that may be occurring either later on this month or into January.
Those new members include Garland Land, who is executive director of the National Association for Public Health Statistics and Information Systems, which is a large mouthful.
We also have Leslie Pickering Francis, Dr. Larry Green, and Dr. Mark Overidge(?). Those will be new members, as I said, starting on Friday.
Now, we will, obviously, at the February meeting, deal more extensively with introductions. We will be introducing them as well as asking them to talk a little bit about their background and interests, and we will be doing some orientation for them between now and the February meeting.
Next, I want to take a moment and thank the members of the ad hoc work group on the NHIN. As you know, the NCVHS was asked by ONC, to review and synthesize the results of the first ONC forum and the functional requirements identified by the NHIN prototype consortia contractors and, by the end of October, to find a minimum but inclusive set of functional requirements for the initial definition of the nationwide health information network.
In this work, we established an ad hoc work group. I chaired it. Jeff Blair and Harry Reynolds were vice chairs. Other members included John Paul Houston, Kevin Vigilante, Judy Warren, Stan Huff and Paul Tang.
Mary Jo Deering was the lead staff for this activity and I want to thank the many other staff members from the committee who participated in this work.
We also want to acknowledge Margaret A(?), the consultant on the project, and of course we want to thank John Muntz, who is not here for acknowledgement, but was the one who actually asked for the work to begin with, and we really appreciated his ongoing participation in the activity.
Now, this work has now been delivered to both the Secretary and the Office of the National Coordinator and has been posted to the internet, and I think you all know was approved during an open conference call at the end of the October.
With the passage of the report and its work done, I will be dissolving the ad hoc work group, which as you know has always been the intent, to create ad hoc work groups for specific topics and then dissolve them at the end.
In my tenure, we have not actually dissolved anything. This, I think, will be the first time. So, I thank you all for your service, and depending on what the work looks like going forward, we may need to have another group like that or similar, as I said, going forward.
Finally, given that this is our last meeting for 2006, I want to take a moment to reflect on the good work in progress this year.
First, the activities of the privacy subcommittee continue at a fast pace. I think we need to reflect on their very good work this year.
Certainly, their document that was approved at the June full committee meeting on privacy and the NHIN is a very excellent document.
I think we are seeing it increasingly used in the wider community on a primer on the issues as we move into the NHIN.
Obviously, their work continues. We have had hearings since and I think continue with the hearing at the conclusion of the meeting tomorrow extending into Thursday morning. Obviously, we look forward to more work and we obviously want to thank them for their work this year.
The populations subcommittee has had a number of conference calls over the summer and fall and had a hearing this fall on data linkages, and I believe is planning hearings on surge capacity, as I understand.
The population subcommittee today is coming forward with a letter on MMA Part D and data issues that we will be discussing later today.
The quality work group has been active and is forging a strong relationship with AHRQ. We will be talking later today about hopefully a breakout session or some way of handling the issues that are coming up for them during this meeting. It is not currently on the agenda, but I am sure we will be able to announce that by the end of the day.
The Subcommittee on Standards and Security has been very active this year, holding hearings on NPI implementation, e prescribing, and HIPAA lessons learned.
They are coming forward with three letters for action today, one on NPI, another on the last consolidated health informatics phase II recommendation, and then finally a letter responding to an FDA NPRM on structured product labels.
Of course, this is against a backdrop of significant congressional and department activity this year, which I will defer to Jim Scanlon a little later on to discuss more, since it has been sort of an interesting year, both from the congressional and department perspectives.
Obviously, as I comment on that, though, Secretary Leavitt continues to consider promotion of interoperable HIT to be one of his key priorities, and his involvement in leadership on this issue has bene, at least to my view, phenomenal.
Of course, in all of this, the NCVHS continues to play an important role, advising the Secretary and department directly on many of these issues, including advising and participating in AHIC work groups. So, I want to thank you all for that additional liaison activity.
With that, let's move on to the agenda review, and we have a pretty full agenda for the day. This morning we begin with department updates. Jim Scanlon will lead off, followed by Karen Trudel and Susan McAndrews.
Then we are pleased to have Rob Kolodner, the acting coordinator of the HHS Office of National Health Information Technology here.
Rob, as you know, has been the chief health informatics officer for the VA, and the visionary behind VA's Vista EHR system.
Following the morning break, we move into beginning our discussions about the letters being brought forward. I think we will handle the standards and security letters first.
After lunch we will continue with the discussion of the populations subcommittee letter being brought forward. Then, at that point, we will talk about the HIPAA report.
I will leave it up to the committee, given that many of you have not had a chance to see the HIPAA report previously and have not gone through subcommittee discussion about whether this is something that is being brought forward for action today or more discussion and coming forward in February for action, and that will be part of the discussions on that particular work item.
We also this afternoon going to be taking a few minutes and begin discussions related to current and planned work of the various subcommittees and work groups.
As you will remember, we decided as an outcome of our strategic planning session this past June, to expand discussions of the activities of the subcommittees and work groups, with the hope of providing greater cross fertilization, as well as providing committee guidance earlier as work plans are being developed, as well as early in work product development.
So, this will be a conversation in which we will ask the subcommittee chairs and work group chairs to sort of talk about what their plans are going forward, as well as reflect on any of their work products.
Finally, we are very pleased to have a presentation from the American Medical Informatics Association on the subject of secondary uses of health data.
I think this is an issue of great interest to us, one that we have written previous letters on, and I think that the AMIA work helps move that discussion forward. So, I want to thank them for being here and willing to participate and brief us on their document.
At about 3:30 we will adjourn the full committee and break into work group and subcommittee sessions for the remainder of the afternoon.
I will discuss, at the end of the day, additional meetings for tomorrow morning, depending on what we need to have happen.
The NCVHS dinner will be at 7:00 p.m. tonight, and we will be talking about that later on this morning or the beginning of the afternoon, as well as getting interest from the members about who will be attending.
With that, let's begin our department update. I do want to note to everyone that our clock, for whatever reason, no matter how long I talk, it still remains 8:00 o'clock, which is good. Time stands still at the NCVHS meeting.
I think my understanding it is about 9:20 in the morning. We will obviously stay on time. We are also intending to adjourn the full committee by 12:00 noon tomorrow. You can count on it, plus or minus about four minutes. With that, Jim, why don't I turn it over to you.
Agenda Item: Update from the Department.
MR. J. SCANLON: Thank you, Simon, and good morning, everyone. Since we met in September, we have had a number of developments occurring related to data policy and health IT issues.
Karen will update us on HIPAA issues, Sue on privacy issues, and Rob Kolodner will be coming by later today to update us on the work of the national coordinator and the AHIC.
Let me just update everyone on other data policy issues. On the legislative front, the 109th congress, as you all know, is winding down.
There was a fair amount of interest in health IT legislation in the 109th. It doesn't look like, though, that any of it will be enacted in the remaining days of this session.
By every indication, it looks like the 110th Congress, which will begin in January, has a lot of interest, a lot of members interested in health IT. So, we are very likely to see some number of bills introduced then.
Several of the bills, you will remember, would involve the NCVHS in some new responsibilities, particularly relating to a streamlined process for HIPAA updating of standards. So, we will look forward to January and see what that brings as well.
Similarly, on the budget side, here we are in fiscal year 2007, which began in October, and most federal agencies have a continuing resolution, not unusual. HHS does as well, while congressional deliberation occurs on the President's 2007 budget.
You will remember that, in the President's budget request for 2007, it included about $169 million for health IT. That was an increase of about $58 million over the 2006 level.
About $116 million of that would be for the Office of the National Coordinator for Health IT. AHRQ would get $50 million for continuing its grant programs, and my own office, ASPE, for evaluation and economic analysis and so forth, would get about $4 million.
Now, again, we don't know where the budget will end up for 2007, and the chances are we will have a continuing resolution until January or February.
In the 2007 budget, in terms of population health data, at least in the President's budget, it looked like most of the major HHS statistical systems were being funded at straight line levels which, as I said previously, is actually an accomplishment in a fairly tight budget year.
We are just beginning work on the fiscal year 2007 budget, so really not much to report there.
On the Data Council side, in terms of data planning, the council, in developing the fiscal year 2008 budget, as it does every year, looks at all of the data investments being proposed by agencies, and looks at opportunities for coordination and cross cuts and data estimates and so on.
In addition, as part of its activities, the Data Council was focusing on what are we currently doing and what is planned in the budget to address and support the top 10 priorities that I described at the last meeting of the committee, and I believe that you have a handout of what those 10 priorities are as well.
At our November Data Council meeting, we had a round table discussion. We got through about half the agencies in terms of what they are doing, their planning, directed at the priorities. At our December meeting, we will continue on with the other agencies.
There are three projects -- I think I have told you about a couple of them previously -- that, under the auspices of the Data Council we started, pretty much at the end of last fiscal year, we are just getting rolling.
We have initiated a project with the National Center for Health Statistics and other statistical programs, to look at the potential uses of electronic health record data for health survey and statistical purposes.
So, this relates to the secondary uses discussion that the committee has had previously and we will hear later today, but actually the department has bene thinking about this for quite a while.
It actually started even before HIPAA where, for our health care surveys, the department has always looked at the role of administrative data that can be linked to those surveys. So, there is a long history.
We will now be looking, for the family of health care surveys at NCHS for other provider based and plan based surveys that we do, what is the potential role and what is the potential road map, and how do we do this in a smart way for the fruits that electronic health records will some day bring us, to the point where they can be used in surveys and research.
We will clearly involve members of the committee who have been involved in this as well. I think we are thinking of probably a little background paper and probably a workshop, that we would invite the relevant members of the NCVHS as well.
Secondly, I think I have mentioned this before, there was great interest last year in looking, for our data systems and our surveys, at how do we collect income data and asset data, and how does it compare among the various surveys, how does it compare to bench marks. How does it compare to other distributions of data.
Income data, you will remember, is one of the policy variables on most of the surveys, poverty level, general income levels and so on.
A survey that doesn't collect that is really very limited in terms of policy uses. So, we have started an evaluation and we will be looking at that.
We will be looking at probably 10 of the major federal surveys that already collect income, to some extent asset information.
We will be looking at how useful and what quality that information is, and what improvements might be identified moving forward.
A third, one additional one, that ASPE, under the Data Council auspices, just initiated last year during the summer, actually -- again, there has been great interest in this area. We just needed a little while to get it organized.
We will be looking at how can we improve the utility of our HHS data and statistical systems and products for the policy community, the health and human services policy community.
The focus here will be on how are the results of those surveys being used now, how useful are the data products and services, how do policy analysts and policy users use that data, and what could we do to make that more useful. Again, we will be involving the NCVHS members in that area as well. Let me stop there and leave enough time for other reports.
DR. COHN: First of all, let me announce that we apparently are on the internet now. I want to welcome those listening in.
We are just in the process of updates from the departments and Jim Scanlon has just presented. Are there any questions from the committee before we move on?
DR. CARR: Just a question. There are 10 goals? We have nine on our lists. Is there another one?
MR. J. SCANLON: I haven't updated the last one. The 10th one is international health diplomacy and it is actually in a formative stage.
At the moment, it includes some very specific activities that are really in the developmental stage. The 10th is international diplomacy and we don't quite have an update of that.
DR. W. SCANLON: Jim, can you talk about what I guess the sticking points were in terms of the IT legislation, why we don't have a bill?
MR. J. SCANLON: Yes. There were probably more than a dozen bills introduced at various times in the 109th congress.
The two that had legs were the House bill that was a combined bill that included the streamline process for HIPAA, would codify the Office of the National Coordinator.
It would have required the adoption and implementation of ICD-X and it would have included a streamline process for updating already adopted HIPAA standards. The committee would have been involved right in the middle of that process.
A senate bill had -- again, these were moving targets -- a senate bill had a number of grant programs and other financing assistance.
So, the discussion, I think, between the Senate and the House and the various staffs were, well, what exactly -- I think if there wasn't disagreement, there was some uncertainty about the adopting of ICD-X.
I think there was a fair amount of support for the streamline process for HIPAA, HIPAA updates. In terms of should the legislation include grant programs and other financial assistance, again, I think there was a disagreement and I think there were privacy issues as well.
I think that, in the time that was available, it just wasn't possible to work these out. I learned with HIPAA to never say that legislation won't occur, because it actually did when everyone around the table was predicting it wouldn't, there wasn't enough time.
If the health IT bill isn't enacted, and what exactly it will contain, it clearly will pick up the interest in January.
I think there were too many issues. There were cost issues. CBL had to score some things. It got more complicated and I think there just wasn't time to work it all out.
DR. STEINDEL: Jim, I think you should mention that, in addition to ICD-X, it was also focused on the introduction of 5010. So, there were two issues associated with it.
MR. J. SCANLON: The bill would have required the adoption and implementation of the ICD-X and there was some disagreement about the dates that that would occur.
Frankly, the health industry itself was divided. There were some folks who wanted to press forward as soon as possible.
There were others who raised significant cost and implementation issues and wanted more time. So, when there is not unanimity or consensus in the community itself, it just makes it harder to be worked out there.
As Steve said, there were also -- it would have required the bill, the adoption of the new version, the 5010 version, of the administrative data standards as well as, Steve, I think the NCPDP next version.
There was a time line that was included in the bill in which those would roll out, and then the other issues as well. There were too many issues to sort of work out. More time was needed.
MR. ROTHSTEIN: Just a brief comment. I wanted to follow up on Jim's point about the Data Council considering the use of information from health studies and the like in policy development.
Thursday morning the Subcommittee on Privacy and Confidentiality will be holding a hearing on how would you design a system to study the effects of the HIPAA privacy rule, and we are consulting with various experts to give us some insights on how we could do that if it were done, with a goal toward policy development.
DR. COHN: With that, Karen, why don't we move on to your presentation? Thank you for joining us.
Agenda Item: HIPAA: Data Standards.
MS TRUDEL: Thank you. I will start out by providing a short HIPAA update, and then move on to the standards of e prescribing. Then I would like to kind of get off the topic a little bit and speak about some of the activities that CMS is undertaking in terms of personal health records.
So, with respect to HIPAA enforcement -- and every time I say this Sue just kind of breaks up -- since October of 2003, we have a grand total of complaints related to transactions and code sets of 521, of which 96 remain open.
None of the open complaints affect payments to health care providers. Most of them pertain to issues that relate to the complexities around trading partner agreements.
With respect to security complaints, we have a grand total of complaints, since April 2005, of 162. Ninety-four of those remain open.
They are more difficult to investigate and more than 60 percent of the open complaints are also considered to be dual provision complaints, which means that we are investigating them in partnership with OCR.
In other words, there is an implication that there has been both a privacy and a security complaint engendered by one action.
Normally they have to do with the alleged unauthorized access of electronic PHI by a third party. So, we do look at them in concert with OCR.
We have not received any complaints related to the use of the employer identifier, but we are gearing up at this point to handle potential complaints related to the national provider identifier use, because that standard goes into effect on May 23 of next year.
So, we are re-tooling our system so that it can accept complaints related to the NPI. We are training investigators so that they can handle the complaints, they know what to do, developing new FAQs to help the industry comply. So, that is pretty much the status of enforcement.
With respect to regulations, we are working actively on assessing the very complex comments we received on the claims attachment proposed rule.
We are talking for the first time about using both HL7 and X12 and also using LOINC in one standard transaction.
As you can imagine, the technical comments that we received are pretty complicated and we are working with the appropriate groups to get through those, as well as looking through some of the policy issues in terms of, the six attachment types that we proposed, were they the right ones. Are there additional ones. Are there ones that we should take off the list. So, there are policy issues that we are addressing as well. I believe we are scheduled to publish that final rule at some point late next year.
With respect to the national provider identifier, at this point, 1.46 million NPIs have been assigned. As best we can estimate -- and it is a little difficult to estimate what the denominator is because we don't know how some organizations are going to enumerate their subparts, we don't know how many additional NPIs people are going to need.
We think it is about 63 percent of the total of individuals who are going to need NPIs by next May. With the monthly rate that we have been receiving requests and issuing NPIs, we think that everybody who needs one will have one in time.
There have been a lot of discussions -- and Simon, you alluded to that -- in terms of will the industry be completely ready to process NPIs only as of next May.
We have partnered with WEDI and other industry organizations to craft some additional messages for health care providers, explaining why it is important for them to get their NPIs well ahead of time. Don't wait until the week before May 23 of next year.
Why it is important to convey those to their health plans and to begin to use them and test them in HIPAA transactions, again, well before May of next year to make sure that the claim flow and their reimbursement flows will not be interrupted, and to get the health plans time to build the cross walks between their legacy identifiers and the new NPIs.
That is not a trivial task and, if there is one message I can send to people, it is that. We are all very serious about this and we are really sending out the word every way we can to begin to do this now and not to wait.
We are continuing to do a lot of environmental scanning. CMS is looking at our own fee for service experience.
We will be talking with our Medicare advantage plans and our Part D plans. We are doing a lot of outreach with the Medicaid programs, and we are also partnering with others like WEDI and HIMS to do some environmental scanning and surveying, to looking at the preparedness of various efforts. So, we are very much on top of that as well.
Let me move on to e prescribing. We have completed our site visits to all five of the e prescribing pilot sites.
We are very excited about a lot of the work that is going on out there. They are getting a lot of very, very valuable information for us.
The evaluation contractor is now at work. They are doing their own site visits and data collection, and they will be providing us with their input on a flow basis through January, so that we can begin crafting the report to congress, which is due in April, as quickly as possible.
We will also be developing -- we believe that even the initial results of the pilot are telling us that there are some additional standards that are mature enough for us to move forward with.
There are others where we need to go back to the drawing board, collaborate with some of the standards developing organizations, share some of the lessons that we have learned, and work with them to maybe go for a round three.
We do believe that we will be able to propose some standards in an NPRM, a proposed rule, which again, we are targeted to get out the door in April.
In addition to that, though -- that is obviously not anywhere near the end of the process -- we need to develop -- and we are very close to developing -- a road map for CMS in how we move forward with e prescribing, to leverage what we have already done, to look at some additional partners and ways to promote e prescribing among the physician population, how can we work with our quality improvement organizations to do that, as we move into their ninth scope of work that is being contemplated now.
How do we work with AHRQ to develop a research agenda to continue to move additional standards. How do we work with the Office of the National Coordinator to see if we can leverage the standards experiences that we have learned CMS and inside the Part D program and expand them to potentially a national use case. Those are some of the things we are thinking about.
A slight departure to talk about personal health records, but over a year ago we published a request for information about what Medicare's role in personal health records should be.
A lot of the input we got said that Medicare shouldn't be in the business of building PHR products, that what we should be in the business of doing is enabling the sharing of Medicare data when there is appropriate authorization by the beneficiary to other existing PHR projects and products. Of course, we are also supporting the AHIC's consumer empowerment work group.
The first thing we did was develop a proof of concept project, where we took a very small view of what we could do, and have two contractors that are working on the not-so-simple process of taking Medicare claims data and seeing how it can be displayed and used in existing PHR products.
We contracted with two organizations that already had access to Medicare claims data, and they then partnered with organizations that already had existing PHR products.
We have had some demonstrations from them. The project ends in the middle of December, and they have given us a number of use cases that show exactly how Medicare claims data can translate into existing PHR products, the value that that data brings, although it is certainly by no means the universe of data that you could put into a PHR, but how it contributes to a PHR, and how you can translate, for instance, ICD-IX codes into clinical terminologies, clinical terms, that can be reader friendly.
The results of that will feed into some increasingly robust activities as we begin to look at the aspects of authorization and the authentication that would go into building up this kind of translation, and what requirements we might want to put against someone who had a PHR product that we would be willing to actually share our beneficiaries' data with.
We are also working with the Office of the National Coordinator to look at some of our Medicare advantage plans and to study some of the PHR products that they already have in place for Medicare beneficiaries, to look at that in kind of a more rigorous way and get some ides about usability. So, that is pretty much what we are doing in the PHR area. Thank you.
DR. COHN: Thank you. Michael Fitzmaurice and then Paul Tang and Justine.
DR. FITZMAURICE: Karen, three questions. First of all, with regard to the national provide identifier and the priority of sharing their NPIs with the health plans and the health plans being able to verify it, is the mater file available to the health plans so that they can verify the numbers that they receive from the providers? If not, what are the issues involved with getting that out?
MS. TRUDEL: The data dissemination notice -- thank you for bringing that up, it is an important issue -- the data dissemination issue that explains what data we will share from the NPI file has not yet been published. So, on, the master data bases are not publicly available at this time on a wide basis.
The issues -- I think I have mentioned this before -- are the need to balance the need of plans and other covered entities, to have this information so that they can incorporate NPIs appropriately in their processing systems, and the need to protect some of the information that relates to individual providers.
We do have already, ready to go, a number of different data dissemination mechanisms. Some of them are large files. Some of them are small files that, as soon as the notice is published, we can kind of have out the door and ready to roll.
DR. FITZMAURICE: The second question is, you said the five site visits are completed and you found some very valuable information.
Have there been discussions about extending these site visits maybe to further test additional standards or to get additional information about electronic prescribing, or is it when they are done, they are done?
MS. TRUDEL: These particular contracts were limited funding, limited time line. I think what we have been talking with John White at AHRQ about is how to proceed from there with another what we call research agenda.
We need to do another round and we recognize that, but the initial funding that we received won't take us there.
DR. FITZMAURICE: Very good. The last question is, you talked about Medicare shouldn't build a PHR product that allows sharing of the Medicare data with other products.
I can imagine a member of the public saying, well, if these are my data and the Medicare program is willing to share my data with me, can I access them only to a commercially sold product, or can I download them into my Excel spread sheet?
In other words, am I tied into one of the few commercially available products, or can I have just have a dump of the data into my spread sheet and then look at the variable names and definitions for Medicare and say, all right, now I can understand a little bit about it, maybe not as I could have with the commercial product, but it is cheaper.
MS. TRUDEL: When I talk about a PHR, I am meaning one with the full types of functionality that the consumer empowerment work group has been talking about.
The kind of spread sheet type access that you are talking about, I think that we already enable, through what we call the Medicare beneficiary portal, which is mymedicare.gov.
So, there is already access to claims type data and claims status data and reminders about preventive services that are available in mymedicare.gov.
What we don't feel that we will be in the business of any time soon will be building a fully functional personal health record.
DR. FITZMAURICE: Thank you, great answers.
DR. TANG: Thanks, Karen. My question has to do with the PHR, a follow up of Mike. You mentioned that there is a proof of concept evaluation going on.
It sounded like it involved looking at patient friendly terms of these medicare diagnoses and claims. Is there any work going on to examine the accuracy of claims data versus clinical diagnoses that you might find in a medical record?
MS. TRUDEL: That is a good question. This was a very limited proof of concept and it was done with medicare fee for service data, with no clinical data against which to measure it.
I think that that is one of the things that we need to talk about as we move forward into some of the other aspects of where we are going. I think it would be very interesting to talk to AHIC about what they are doing in that regard as well.
DR. CARR: Thanks, Karen. Back to e prescribing, I am wondering if, in the initial studies, there were any evaluations of the impact on physician or clinician time in writing a prescription electronically versus jotting it on paper, and whether there has been any analysis just in terms of time for the individual prescriber.
MR. TRUDEL: The pilot participants have been looking at not just the standards and how they work. They have been looking at impact to work flow.
They have been working on trying to quantify return on investment and cost benefit. So, yes, I think we will get some good data on that.
I haven't been to all the pilot sites myself, but I did go to the one in Ohio and they did say that, while in some cases the physicians themselves are not interacting personally with the e prescribing software, they are doing so in very close communication with their medical assistants, and that the practices are just happy as anything about how well it is going. I think there is a lot of savings there.
DR. COHN: Paul, do you want to join us for standards and security later? We can talk about it. Karen, will you be at the subcommittee meeting this afternoon? Okay, good. We will continue the conversation this afternoon. I am trying to keep things relatively on schedule. Sue McAndrews, our last presentation, and thank you.
Agenda Item: HIPAA: Private Rule Compliance Update.
MS. MC ANDREWS: Since the complaint system went on line in April 2003 through the end of October 2006, we have received some 23,270 complaints. We have closed approximately 76 percent of those claims.
I am taking the opportunity of the subcommittee hearing on Thursday morning to present a more detailed look into what these closure cases are like, as a way of what kind of data may be available from the complaint system in terms of measuring the HIPAA compliance activity.
I will say that by and large, of the closed complaints, somewhere in the area of a third to maybe 40 percent of those closed cases warranted an investigation. The others were closed for administrative, jurisdictional reasons.
Of the cases that we did investigate, close to 70 percent of those were closed after achieving some corrective action on the part of the covered entity.
So, there has been a lot of effort continuing to go into our compliance efforts. We also had late summer, early fall, some media attention in the area of dumpster cases, where pharmacies were taken to task for having protected health information as well as meds thrown out in dumpsters that were unprotected and accessible to the passers by.
That investigative reporter has subsequently gone back and done a follow up report, not only in Indianapolis where this all started, but has gone dumpster diving across the country behind pharmacies and has found substantial protected health information as well as medical waste disposed of in an improper and unsafe manner.
So, we are giving some attention and will continue to give some attention to these dumpster cases, as well as trying to pay some attention, in the coming months, to getting some wider spread corrective action and attention focused on record abandonment and improper disposal of large masses of protected health information.
Curiously, one of our very first complaints that we got back in April of 2003 was a dumpster case, and they just have continue to crop up from time and time, and we think this is something that is relatively easy to solve, and we are hoping to get people to focus a little bit of attention on these kinds of activities. There just is no reason for it.
Other than that, I thought I would just use the time to review some of the collaborations that we have been involved in and continue to be involved in recently.
Certainly we have spend a good deal of time coordinating with ONC and the AHIC on their various HIT initiatives, including working with the consumer empowerment work group on personal health records, as well as the confidentiality, privacy and confidentiality work group.
We have paid a good deal of attention over the summer, and it is likely to continue well into next year, working with disaster planners in preparing for responses to pandemics and other natural disasters.
We have a tool up on our web site to help emergency responders and emergency response planners, understand how to properly access information that is protected by the privacy rule.
We continue to evolve and expand that tool in response to continuing questions from the emergency response community.
So, we expect that collaboration will continue, and response, as well as it being a high departmental initiative.
We are wrapping up our work with the White House task force on identity theft. They I believe now will be making recommendations to the White House in February of next year.
The report had been due in November, but they gave themselves an extension in order to solicit input from some of the private stakeholders that may be impacted by some of the recommendations.
Finally, we have been working on a number of fronts and collaborations with the research community. We have joined a task force that is department wide that is looking at harmonization of the HIPAA privacy rule, the common rule, and the FDA research regulations, to make sure that we are not working at cross purposes, and that we can create a superhighway, or at least one road, many access but one road for researchers traveling down this path.
We also did some collaboration this last quarter with the office on human research protections, who were looking into guidance on the definition of research, and trying to untangle the mess you get into as research creeps into quality improvement activities and other kinds of operational studies as well as FDA surveillance and just public health activities as opposed to public health research, and trying to shore up those lines.
I will say that those were -- when you think of the definition of research, what an esoteric term. There was lively debate.
So, we are continuing to work on several fronts with the research community. We have no particular time line that I know of in terms of those products, but we are hopeful of making the world safer for research. I think I will stop there.
DR. COHN: We will take a couple of questions here. Jeff and John Paul and Mark.
MR. BLAIR: Susan, applause for all the initiatives. So, I want to dig deeper. One of them is with the 23,000 complaints that you have had a chance to process.
Has there been any breakdown of that to determine what portion of those complaints is from protected health information that was in paper or audible versus electronic?
MS. MC ANDREWS: At least since April of this year, if it has involved an electronic system, those would show up largely in the complaints that we are forwarding either to Karen to handle under the security rule, or that we will be handling jointly if it also raises a privacy rule concern as well, beyond just the safeguarding of the electronic information. No, we don't -- we haven't gone back and tried to break out the data, new or old, into those categories.
MR. BLAIR: The reason that I ask, the reason that I am interested, is that the original intent of the HIPAA privacy law, one of the major intents -- I won't say the original one -- was to help the public have greater confidence in having protected health information in electronic form.
I think it would be very helpful is that data could be analyzed to determine the degree of violations or abuses of privacy information, health care privacy information, to determine whether most of the abuses are when it is in electronic form or whether it is coming from violations when it is in paper or audible. Maybe you could consider having someone do a breakdown of that. That might be helpful.
MS. MC ANDREWS: We can consider that. I think it would require the cases to be manually reviewed, because it is not an element that we capture through the data input screens.
The only other caution I would say is that it may well also simply be reflective of the proportion of usage of electronic systems today as opposed to any true measure of the relative safety of paper versus electronic systems.
MR. BLAIR: I acknowledge that.
DR. COHN: Before we move to the next question, Bob, I just want to do a time check with you because we are running a couple of minutes late. Are you okay for an extra 10 or 15 minutes? Okay, great. John Paul?
MR. HOUSTON: Thanks, I just wanted to make a comment more than anything else. I think it is good that there is some collaboration going on with the research community, because I think that is an issue that we all identified as being something that needed to be addressed.
I am hopeful that what we end up with is, in fact, harmony in that regard. I think there, for the longest time, seemed to be sort of denial that there was really an issue there.
So, I am assuming that the intent at the end of the day really is to have a harmonized understanding of how research is to be conducted under the common rule as well as HIPAA and other OHRP related documents and guidance; correct?
MS. MC ANDREWS : I am not sure of the actual vehicle that the guidance will come out in, but it is to identify areas in either -- in the three rule making areas that the department has control over, to identify where there might be inconsistencies or problem areas, and how best to smooth them out.
MR. HOUSTON: The intent is to resolve that?
MS. MC ANDREWS: Where there are conflicts.
MR. ROTHSTEIN: Very briefly, I wanted to remind some of the newer members of the NCVHS that, since 2002, we have sent at least three, possibly four, letters to the Secretary in which we have recommended specifically what is taking place now between OCR and OHRP. I want to praise you for that initiative, and we wish you much success and speed in your work.
One brief request -- and I think this should be easy to do -- is that, when you compile the data on number of complaints and administrative closures, et cetera, if you could do a run by month instead of just the aggregate totals, that would help, at least in my view, in analyzing the data over time. I think that would be valuable and I think it could be done rather easily.
MS. MC ANDREWS: We have done it by year. I am trying to remember whether it was calendar year or fiscal year. It is probably relatively easy to break that down further into quarterly --
MR. ROTHSTEIN: Quarterly would be find. It doesn't need to be daily.
MS. MC ANDREWS: Monthly, it seems to me, would have a little bit --
MR. ROTHSTEIN: Just to follow it over time. You could develop a variety of hypotheses in terms of administrative closure should do what over time based on people's misunderstanding of the jurisdiction and so forth.
DR. TANG: Thanks, Sue. As you know, there has been increasing media attention about the whole enforcement of the privacy rule.
Their contention is that there has been I think several hundred that get referred on to the Department of Justice, and there haven't been any prosecutions.
What kinds of reasons would you give for that, and how do you typically address those concerns, recognizing that, as we go more and more into the HIN world, we need to have some kind of way of assuring the public that we are prosecuting these violations.
MS. MC ANDREWS: As of the end of October we have made close to 350 referrals to the Department of Justice. There have been three cases to date of criminal prosecutions.
I don't believe any of those three arose out of a referral from OCR, but from an independent source developed by the Department of Justice.
What accounts for that, there can be a variety of reasons. I will say the Department of Justice, it is not that they don't investigate these cases.
Certainly they don't investigate all of the referrals, but the FBI offices across the country have taken up a number of these investigations, and we simply are not privy to how that all works out.
So, I do think many of the referrals, however, are not -- are more technical in nature, given the language in the statute and what comes within the DOJ jurisdiction, and really wouldn't register on many radar screens as a truly egregious criminal act.
Nonetheless, to the extent DOJ does not take up a referral case, we do take that case back and look at it in terms of whether there are aspects of that case that are within our civil jurisdiction, and we do try to investigate those cases, so that it is not something that simply falls through the cracks.
The other thing that we have been trying to emphasize in response to some of the media requests, is that we do think, to the extent that they are largely based on the fact that we have not brought a civil monetary penalty to date, that that is not, from our perspective, a measure of the vigor with which we investigate cases or achieve enforcement activities, that many of the actions that we have achieved through voluntary compliance, we consider to be active enforcement of the rule and we are quite proud of our record in terms of getting things fixed for individuals as well as others, system wide.
MR. HOUSTON: Is this to say, when DOJ does decide not to pursue, they will tell you that they are closing a case? So, you do grossly know whether something is an open case or a closed case that you have referred?
MS. MC ANDREWS: Yes.
DR. FITZMAURICE: Sue, are there any proposed changes to the privacy rule expected to be announced in the next 12 months and, if so, could you briefly describe what they involve?
MS. MC ANDREWS: How to put this. I mean, there are discussions ongoing in terms of how to improve the rule and, based on reports internal or external, in terms of what we figure is not working, or not working as we intended.
However, I am not at liberty at this point to identify any particular areas that may come out as a rule making in the next year.
DR. COHN: Sue, thank you very much. Mike, thank you very much for that last very good question. Not answerable, but a very good questions. Sue, thank you and Karen, thank you.
With this, we want to move to our final presentation and discussion. Rob, I want to welcome you and obviously congratulate you on your new role as acting coordination for health information technology.
We are obviously very pleased to have you here. I introduced you a little bit and everyone pretty well knows you, but I do want to reflect, obviously, on your role previously as chief health informatics officer for the VA, and realize it is the division behind the VISTA EHR system.
I am looking to see whether I am making you blush or not, but we think you have done a greta job with that, and obviously we are very pleased with you in your new role. So, welcome, and thank you for joining us.
Agenda Item: Report from the Office of the National Coordinator.
DR. KOLODNER: Thank you very much, Simon. It really is a pleasure to be here, especially seeing so many friends around the table and colleagues I have worked with for so many years. I look forward to helping to advance the agenda that many of us have been working on for a long time.
It really is an exciting time right now in health IT, and it is an exciting time for me personally, obviously. I have been very fortunate to have this opportunity to take on the challenging role, and look forward to hopefully making some contribution during the time that I am in it.
I also wanted to take the opportunity to thank the NCVHS and the members for the work that you have been doing, starting with the work on the initial functional requirements for the nationwide health information network.
Also -- and we really do appreciate the opportunity to work together with the office of the national coordinator and our FACA committee, the AHIC, and I think that it is the beginning of what I hope is a long and very productive collaboration where we are able to each bring to the health IT agenda the strengths that the different committees bring and the abilities to advance the agenda, and for you to advise HHS in ways that also move us forward.
The goal really is to create these opportunities to work early on and collaborate together, so that, as we identify things that we are moving forward on in the AHIC that we want you to participate on, and as you identify activities and areas of focus that may be of interest to us, that we can keep engaged.
I know Jim Scanlon and I have been working out how to improve that collaboration and move it up to the next level, and it is really building bridges and having more cooperative involvement from the very beginning. I look forward to that.
I mentioned the NHIN functional requirements also. We have worked together on two NHIN fora that you have been active participants in.
Those have really been excellent opportunities to inform the constituents about significant progress in many areas, especially the requirements and security aspects of the NHIN and what those need to be.
We have got the upcoming participation by Simon and Jeff at the AHIC meeting in December to present those initial requirements. Hopefully that will proceed.
That will be occurring while the Secretary is in China, and he plans to participate at a distance, but to participate and not miss that meeting.
I also wanted to use the opportunity just to highlight a number of the requirements that we have been able to make in the national health HIT agenda, and the activities that AHRQ has been responsible for coordinating.
I use that word coordination as very important, because I see this as something where the role of the office is to leverage all the talent and good work that is out there and to hopefully synergize those activities in a very positive way.
So, we have achieved one of the milestones, almost finishing the turn of the crank that the Secretary talks about with the standards, and that is that coordination body for standards did deliver the first set of interoperability standards for the first three use cases, and they did that in October, end of September, October, of this year.
That includes 30 standards and almost 800 pages of interoperability guidelines. You know, that last part I think speaks to what is different now from what we have done before where, oftentimes, as we all know around the table, we identify standards, but the problem is that there has been enough variation, enough wobble in how those have been implemented, that it really hasn't achieved that interoperability.
I think that the interoperability guidelines are something that I am glad there are people who are obsessive enough to get down to that level of detail, and thank you, for all of those who have been a part of it.
It really is taking that so that we can really have, as I say, have a programmer go off in one corner in one institution and program to their standards, and another in another corner, and that when they bring it together, they don't have to go through testing and everything else because they know it really will operate because the standards have been specified specifically. That is no mean feat.
So, on another part of that turn of the crank, that is, the certification of the CCHIT, the certification commission, continues to expand the electronic health record certification.
It now has 35 certified ambulatory EHRs, and we expect one more round of certification to go through testing in this first year cycle, which began mid-year, around May, June.
We are also finalizing the first inpatient certification criteria to use in testing in patient systems.
Finally, we are working with the CCHIT to begin their foray into the specialty EHRs, and we will be beginning to explore that area as well very shortly.
We also had an EHR adoption report that was published by the Robert Wood Johnson Foundation where, after many different numbers floating around, we now have a methodology and a criteria set by which we have determined a baseline, that about 10 percent of doctors in an ambulatory care setting, are using electronic health records with four specific functions that we consider to be important, that are derived from the IOM EHR report.
That is, computerized prescribing, computerized test ordering, the electronic receipt of test results and electronic physician notes. Certainly the last one is the one that I think is the bar that is one that will be a little higher than many other systems.
So, that combination of four functions, when you use that, you get to the figure of 10 percent of doctors using the notes.
That is one that we believe is sufficiently specified that, in fact, CDC will be putting it into their inventory in the first surveys on a regular basis, that we will be able to actually track that number.
It is lower than some of the other numbers that were used, the 24 or 25 percent being doctors who have something electronic, but it is not well defined whether they are using it, much less what function.
Seventeen percent that have something clinical, again, because it doesn't have specificity, it could vary from year to year. That is why we are using 10 percent as the baseline.
There was a final report that HEMA issued with the critical how to workbook for state health information exchange activities. That also is pushed on the web and we plan to provide some ongoing support, so that they can address some barriers and solutions and health information exchange cost models and some Medicaid involvement analysis.
So, there is continued work. To emphasize that focus now of coordinating with the states, we recently issued a contract with the National Governors Association for a state alliance for e health.
That is starting the collaborative process to address the cross state issues. That is one that they will lead and facilitate and our role is to coordinate and foster that advance, because a lot of the activities have been, and will continue to occur, at the state.
The key there is to not have the tower of Babel but, in fact, be able to bring about a coalescence as we move forward in a variety of policies and other approaches.
Some upcoming activities that we have in 2007, I mentioned the AHIC meeting on December 12. There are also some meetings, an AHIC meeting in January, and a forum meeting related to the NHIN.
At the AHIC meeting on January 23, we will actually be doing the NHIN prototype architecture demonstrations and some presentations on the business models. So, we are beginning to move that forward.
We will also have the first state alliance for e health meeting in Washington on January 26, and that will be an open meeting. So, people are encouraged to come and attend and participate.
The state alliance is also going to be fostering a number of meetings and sponsoring a number of meetings. There will be some state learning forums that will be scheduled throughout 2007.
They have three task forces and the meetings will begin in February. One task force is on privacy and security, and that is really following on the work of the ISPIC, and another having to do with the practice of medicine task force and some of the licensing issues there.
Finally, the state role regarding the health information exchange and really beginning to take on some of the issues raised by the HEMA report.
So, those are some of the things that are coming just in this next quarter. Really, there is obviously a lot more to come.
We have got a very large and challenging health IT agenda ahead of us that certainly you have bene working on for years and now has become something that is really moving forward, and Secretary Leavitt is very committed to that.
There are some significant opportunities, I think, for collaboration, not only among the committees but with a variety of entities, parts of HHS and other departments, as well as the private sector, and it is really that public private collaboration moving forward.
So, hopefully we can use these opportunities to work together toward transforming health care, because that is what it is all about. It is not about the technology.
It is about transforming health care and making it higher quality at lower cost, and I look forward to seeing that. At this point, I can stop and take any questions you might have.
DR. COHN: Bob, thank you very much. I actually just had a qualification myself, and I think I see a number of hands going around the table.
It actually had to do with the new state alliance, and I think you maybe have answered the question. Is this the vehicle for moving forward the recommendations from the security and privacy collaborative work?
DR. KOLODNER: Actually, it does provide part of that. Jody Daniel will be here tomorrow and can provide more details, since she is the lead director of that. You can talk with her some more tomorrow when she is here.
MS. TRUDEL: What plans do you have over the next year to identify and prioritize new use cases?
DR. KOLODNER: Well, we already started that process. There was discussion at the last AHIC. In fact, one of the concerns was that, with the various work groups, that we could very easily go down a stove pipe, so that you have the EHR in one place and the consumer empowerment in another.
What we did is, we brought together their top priorities as well as some visioning that the early work groups had done.
We created a matrix where what we wanted to do was to identify priorities that cut across the work groups. What we will be doing on December 12 is presenting what we call some proto use cases for EBAC from the AHIC members.
The intention is to have another set of activities which then can be used to generate these cases and, from those, additional standards. We have got a lot of work to move forward, not to create standards, but to create the standards that we can get that next round of instrumentation guidelines on.
So, we expect to turn that crank another time this next year is the intention, so as to do one more time, and hopefully gain a momentum by doing that.
So, the specific details I can't give you at this point, but we certainly plan to move forward and move the use cases to the implementation and certification.
DR. FITZMAURICE: Two questions. First of all, it is extremely good for the country that you are in the position that you are in right now, but it has a time limit on it.
I am wondering, has there been any discussion about extending your interim stay as director of ONC, or is it expected to be over finally in February?
DR. KOLODNER: There have not been discussions at this point, but they will be occurring shortly and that would be up to the Secretaries as to whether or not my detail will or won't be extended.
DR. FITZMAURICE: So, you do not plan to run for President, but you are not ruling it out.
DR. KOLODNER: I have learned never to say never.
DR. FITZMAURICE: The second question is that interoperability requirements include use cases, high level architectures, message standards and data element specifications, and harmonization across SDOs.
Interoperability requires all of these, but the most important of them, in my opinion, putting privacy aside, which I don't mean to put it aside, is data element harmonization, reduce the wobble in standards that prevents interoperability.
Will there be a stronger focus in ONC in the coming year on resolving differences across SDOs and their data element names, definitions and how those variables are represented?
DR. KOLODNER: As you know, Mike, ONC doesn't do that, but what we have is a contract. The whole approach has been to set up a mechanism and a methodology that we can begin to mature, and one that is trusted and works.
The HITSBE really is that mechanism. So, what we need to do is to work with HITSBE to see, is that something worth their time. Is that something that is the band width, or do we allow a mapping to occur between some of the different names.
I think the key is whether the boundary on those data elements is the same. It is when you don't align those elements, and that you may even use the same name, but they really mean different things, that you really get into the most problem.
We will be working with HITSBE and certainly, as an active member of that, you get to have your two cents with that process.
It is one that I think we have developed a relationship where we certainly can say, these are the things we want you to work on, but there is a certain amount of independence because we want that process not to be controlled by the government,b ut fostered and stimulated so that it becomes a process that everybody trusts.
I think that one of the things that is continuing and will continue to clarify is when the recommendation comes from HITSBE to the AHIC, does the AHIC get to override that.
I think they would, if the HITSBE was simply a subset and a part of the government, but in fact, it is an independent entity. So, we get to say whether we accept or not, the AHIC, and then the Secretary gets to decide whether to accept the recommendations or not, but it is really an independent process.
MR. ROTHSTEIN: I have got a brief statement disguised as a question. The question is, how, if at all, is the NCVHS' June report and letter to the Secretary on privacy and confidentiality and NHIN being implemented, in terms of its effect on the architecture development or the NHIN or other elements of the system being developed.
DR. KOLODNER: I can't give you a definitive answer about that. Obviously that was a statement as to paying attention to that.
What I would suggest that you might do is talk with Jody about it tomorrow, since she is our lead for privacy and security.
I think at this point in time I don't know of a direct link between the recommendations and what we have done so far, but the question is what we will do in the future.
MR. HOUSTON: A quick comment in that regard, being on the AHIC CPS work group, I guess. I know I have made the recommendation on a number of occasions that that letter be considered in some of the outstanding issues, as well as some of the recommendations be considered as part of that work group, to make sure that, as they are setting their agenda, that they are also considering all the work that we did.
I think a lot of those outstanding questions really do need to be resolved, everything from opt in opt out to some of the other recommendations that we made. So, I know it is on the table and I think it would be helpful to continue to push that, because I think it is a valuable letter to use.
DR. KOLODNER: Mark, the answer is, you have a mole.
DR. WARREN: The question I have is, I guess it is one of coordination. We have talked today about NCVHS has a privacy subcommittee, AHIC is certainly looking at that.
We have the contract out for the HISPIC to look at privacy and security. Now we are having a state governors alliance for privacy and security.
What efforts are out there to kind of have these various groups collaborate or coordinate their work? I am hearing pieces in a lot of different meetings I go to that are all the same thing, but everybody is working at it from a different perspective.
DR. KOLODNER: I think it is a good question. Certainly in terms of the linkage across the NCVHS and the AHIC activities, we are working at the staff level to define how we complement one another rather than how we compete with one another.
With the contract this year with the state, the intention with the state alliance is to leverage and build on the activities that we had accomplished with the HISPIC, and to have that extend into some of the states because they have obviously some of the issues across the states that need to be addressed.
Again, because Jody is the lead on that, and I am still coming up to speed within the office, I would suggest that that might be a question that you repeat again for Jody, and I think you will be pleased with the answers.
DR. WARREN: I will be sure. Jody will have a lot of questions tomorrow.
DR. KOLODNER: She is expecting them. I will give her warning.
DR. STEINDEL: Rob, thank you, and I am encouraged to hear that there may be hope for a future in your response to Mike's question.
What I would like to comment on and question on is, as I think many people are aware, I wear many hats and some of them are directly involved in what your office is doing.
I am involved with HITSBE. I am also one of the people that is directly involved with CCHIT. I am on their interoperability work group this year and on the ambulatory functionality last year. With my position at NCVHS, I am also involved with e prescribing, et cetera.
What we have come up with, and what I encourage you to try to expand is somewhat related to Judy's question and what has been mentioned.
One of the most exciting things that I have seen recently being presented in front of AHIC has been your matrix that you brought forward at the last meeting in initial format, with the intent of trying to create this cross coordination effort between all of the issues that are facing us.
I really encourage you to try to flesh that out and really create a true mechanism for discussion. As a big example that we are facing right now in trying to adjudicate, in CCHIT, and with HITSPE, involves the certification of interoperability in two areas, laboratory and e prescribing.
One issue that we have run across with e prescribing doesn't involve the HITSBE specifications or anything like that. It involves what is going on with the Medicare Part D pilots, and how far along they are.
I am just pointing that out, not as an obstacle or anything, but just as an area to bring into your matrix and have discussion in front of AHIC, and make people aware that there are many aspects of this problem that confront the interoperability issue.
It is not really, in my mind, the HITSBE standards that are the ultimate judge that we hand to the IT developers or whoever, and say, okay, build against these standards.
It is really against whatever criteria is being tested against for interoperability by whoever. It is probably going to be CCHIT at least for the initial stages, but there will be other interoperability testing being done, especially as we get down to specialty levels. Those issues are different.
We need to consider all of this in the mix. What we are try to do is actually test where the rubber meets the road. Can we exchange this information between two people and post it into an electronic health record so that a clinician can use it. Think about that when you are putting your matrix together.
DR. KOLODNER: Thanks for your comments, Steve, and it is clear that you are the glue that is tying together all of this.
DR. STEINDEL: No, I am not.
DR. COHN: Any other questions? Well, Rob, I want to thank you very much for joining us. Obviously, we look forward to increased collaboration and synergies between all the various groups as we move forward.
Obviously, we look forward to having you, and we will be obviously having ongoing conversations but also hopefully seeing you on a regular basis at the full meetings. So, thank you. I also want to thank Sue and Karen and Jim for help on this session.
We are running a couple of minutes late, so we will adjourn until 11:00 o'clock, and then reconvene on the letters.
[Brief recess.]
DR. COHN: Now, our next set of items are letters. We will be starting on those in just a second. However, I just want to take this occasion, we have a new member who arrived during the break, and I just want to introduce him briefly.
I think I mentioned him during our beginning introductions, but Garland Land has joined. He, as I said, will become a member starting on Friday. December 1 his term begins, but he is sitting in with us for today and will you be here tomorrow also? He can't vote until Friday.
Just very briefly, Garland is the executive director of the National Association for Public Health Statistics and Information Systems.
He previously held a number of senior positions at the Missouri Department of Health. Garland was telling me that he actually still lives in Missouri and I guess commutes here twice a month.
Hopefully he will now be coming three or four times a month to join our committee. Anyway, thank you for joining us.
With that, we are going to be jumping into three letters.
Agenda Item: Subcommittee on Standards and Security Letters.
DR. COHN: We are asking Denise to assist us with the initial reading of them. I think part of the question will be what letters need to go for committee discussion this afternoon, get past with word smithing, et cetera, as we sort of go through them. Now, Denise, what order were you planning on taking these?
DR. BUENNING: I believe that the agenda calls for the NPI letter first. Then the CHI disability letter, and then finally the national drug code letter.
DR. COHN: Okay, so we will have an initial reading. I do want to tell people that the NPI letter will go to committee this afternoon for further discussion, even though I think the letter is well written at this point.
MR. HOUSTON: Simon, I have a question. I had a real problem with the NPI letter. I wasn't sure what the purpose of the letter even was, and I question whether this committee needs to consider sending it.
It sounds like the letter sort of said that they needed to do more work. I think this is the one that was the case. Maybe I have my letters mixed up. I am just wondering why we are sending this letter.
DR. COHN: Yes, Jeff?
MR. BLAIR: Sure. John, your observation, I think, is correct, that this is not in the character of most of our recommendation letters, where we are recommending a specific standard or a specific action.
This is a situation -- you are talking about the letter with respect to the national provider identifier; correct?
MR. HOUSTON: That is correct.
MR. BLAIR: This is kind of, I might say, a little bit of a positional letter. The testimony that was occurring during our subcommittee meetings, we debated whether or not to actually write a letter.
We decided it was important to write this letter even though we haven't completely finished hearing all of the status from the industry on the NPI.
There are a number of things that are problematical on this and we felt we couldn't wait until virtually February, since this is the last time the full committee meets until February.
By then, it is going to be very close to May 23. So, a number of our concerns are in this letter and it is kind of a positional letter, I would phrase it as, to say, these are important issues. We are going to continue to gather information, but we do encourage Health and Human Services to closely monitor the status of people getting enumerations for the national provider identifier.
So, if action can be taken beforehand, that is fine. If not, then we will be coming back to HHS. Does that answer your question?
DR. COHN: John Paul, without going deeply into this conversation, this letter may actually get a little more content by the end of the day. So, I would have you hold your view about whether or not the letter is worthy of going forward.
MR. HOUSTON: That is fine.
DR. COHN: Is that reasonable? What I am hearing from you is not so much objection to the letter. You are just sort of wondering whether or not it says anything.
MR. HOUSTON: When I read the letter, one of the last paragraphs says, and we are going to do more things in January.
I am thinking, okay, if you are going to do more things in January, why are we even -- I just didn't think the content was there to say, we will send this letter out.
MR. BLAIR: The answer to that specific question was that getting a letter out in February is very close to May. So, it is a timing issue.
DR. COHN: Denise, would you like to read it over, just a first reading?
MS. BUENNING: Addressed to the Honorable Michael O. Leavitt. Dear Secretary Leavitt:
The National Committee on Vital and Health Statistics, NCVHS, is responsible for monitoring the implementation of standard transactions, code sets and identifiers adopted pursuant to the Health Insurance Portability and Accountability Act of 1996, HIPAA.
The committee has been tracking the implementation of the national provider identifier, NPI, and wishes to convey to you our preliminary observations on the industry's progress toward meeting the compliance date, which is May 23, 2007, for most covered entities.
The committee has heard testimony on several occasions regarding the readiness of providers, plans, clearinghouses and the software vendors that support them to use the NPI in HIPAA transactions.
We have concluded that, while significant progress is being made toward compliance, some key activities may not be completed by the compliance date.
Providers must obtain an NPI and use it for HIPAA transactions by the compliance date. To date, over 1.2 million NPIs have been issued, which the Centers for Medicare and Medicaid Services, CMS, estimates represents the NPI by approximately 50 percent of the total provider universe.
However, few of the providers who have obtained NPIs have communicated their NPIs to their health plans. Few providers have communicated their NPIs to the facilities where they practice, and few are sending NPIs in HIPAA transactions.
Many health plans and clearinghouses report that they are now able to accept transactions with either legacy identifiers or NPIs.
However, most are still developing cross walk logic to enable them to associate a provider's NPI with the legacy identifier already assigned to them in the plan's processing systems.
This is critical to assure accurate adjudication and payment, as well as to connect the provider with his or her historical data.
The plan's abilities to complete their cross walks depend on having the NPIs of their provider populations. Plans need time to populate cross walks with NPIs and to test the cross walks prior to May 23, 2007, to prepare to accurately process claims and other HIPAA transactions on or after that date.
Therefore, providers who wait until close to the compliance date to obtain and use NPIs, or if software vendors wait until close to the compliance date to make changes to support using NPIs, they run the risk of having their transactions rejected and payments delayed because their plans and clearinghouses will not recognize their NPIs.
Industry implementation efforts over the next few months will significantly impact compliance on Mary 23, 2007.
The NCVHS will hear additional testimony on this issue in January. We plan to obtain input from a variety of provider organizations and health plans, clearinghouses and software vendors. We will provide more information to you then.
In the meantime, we recommend that HHS closely monitor compliance activities and take action as needed to encourage compliance and early testing by all covered entities. Sincerely, Simon Cohn, chairman, NCVHS, with cc to HHS Data Council co-chairs.
MR. BLAIR: Simon, did you want to take questions after each letter?
DR. COHN: I think that probably makes the most sense, rather than reading all three letters. Other than I think probably the very reasonable comment about, well, geez, why should we even send this letter -- I think as I listened to is, I don't think there is anything wrong with the letter. It obviously doesn't state a firm, strong position on anything. It is more of an FYI sort of letter. The question is whether the subcommittee wants to add something additional to it during its breakout this afternoon.
MR. BLAIR: Could we give Harry Reynolds a chance to --
DR. COHN: He is not on the phone right now. He will be coming back this afternoon. Do others have comments about this letter or the issue? Carol?
MS. MC CALL: More a comment based on the earlier comments about the reason for the letter. What I would say is, absent being able to provide specific recommendations and findings, I hear that there is a strong desire, because of a sense of urgency, to let people know what is going on.
So, when I read the close, in particular the last paragraph, I would recommend, and I am punching up the sense of urgency with the need to give them an early signal that things aren't necessarily on track for a May 23 all clear. So, more clearly state why this is coming out now absent specific recommendations.
MR. BLAIR: Do you have any particular wording in mind that would help us?
MS. MC CALL: WE can word smith it off line, but I think in the last sentence it says, in the meantime we recommend that they closely monitor.
Something in that last paragraph and perhaps tying it to an opening that says, this is absolutely vital and that is why we are telling you. So, it has to be more than a recommendation. Maybe, we strongly urge.
DR. COHN: So, I think our suggestion is, we urge HHS to closely monitor.
DR. WARREN: Would it be helpful, Carol, if what we did was put this in the format of a formal recommendation instead of just having it in the paragraph the way it is? There is only one recommendation out of the letter. That is why it was put into the paragraph.
DR. COHN: I think it might look a little awkward, with the nature of the recommendation. I mean, if there is something more substantive, then you could, I think, cull it out.
MS. MC CALL: As I was reading the context of the letter, what it reminded me of is the HIPAA implementation, kind of oh, so long ago.
There is a delightful history of that, actually, in the packet. It says, we had a date, we had to push back from that date because it took time for people to get ready.
Then it also went further to say that there were issues in the implementation, that while we required some covered entities to do it, we didn't require other covered entities to submit it.
So, I found myself wondering if this was, in some ways, kind of a repeat of that. If it is, at least at a high level, it might be worthwhile -- we strongly urge, because of things that we have experienced in the past -- to understand these signals early, the vote early, vote often type of thing.
Is it kind of a repeat? I guess that is a question, then, to the group. Are there similarities to things that we have learned from HIPAA implementation around privacy and transactions and the whole EDI?
MR. BLAIR: There are some similarities, but I think this one is more -- at least my perceptions is that this is more a timing piece, that we are so close that we felt we couldn't wait until February, to be silent until the full committee meets in February.
DR. STEINDEL: I look across the table and I see our CMS colleagues are remaining stoic on this. You know, again, in my multiple hats, one of my hats I wear is as a public health representative to NUCC, where this has been very much discussed. So, I have heard this from a lot of sides, as well as from the NCVHS side.
This is in response to what you were asking, Carol. I think there is a sense out in the community that every time we have come close to a HIPAA deadline, it has been extended. So, there is this sense, okay, it is just going to happen again. We don't have an urgency.
I think what we can say, and I think what I heard Carol repeat this morning, even though she may not admit the way I will interpret is, we have had absolutely no evidence from CMS that they have any intention of extending this deadline, and that it will happen on May 23.
I am stating this just from my interpretations, and from what I am interpreting about what Carol said this morning. I will not put CMS on the spot and ask them to affirm or deny that statement, but I think that is the sense of this letter.
I think some place we do have to state in there that every indication NCVHS has is that this will happen and we are pointing out things that should occur before this happens.
That date is coming very, very quickly, which is why there is a sense that we want to get this letter out at this meeting and not wait until after the January meeting because that just even shortens the time frame -- or the February meeting.
DR. COHN: Michael?
DR. FITZMAURICE: There is one issue that I missed before and now I see, that it doesn't talk about the desire of the health plans to get access to a national NPI data base for validating what the providers give them.
I would suggest that, in the third paragraph, that in the middle of it there is a sentence that reads: Plans' abilities to complete their cross walks depend upon having the NPIs of their provider populations. I would add, and access to the national provider identifier data base or NPI validation.
Now, I don't know what the name of that data base is. It has a name like NPES, NPPES. You can just call it the CMS' national provider data base for validation.
What that will do, I think, is to start lighting some fires. The fires would be, do the providers know they have to do this, do the vendors know they have to do this, do the health plans know they have to do this. Do we know that we have to get that data base available, because everything is critically dependent upon this date.
DR. COHN: So, Michael, I am sorry: would you give your suggestion again? Are you suggesting something be added here?
DR. FITZMAURICE: I would add to the end of the sentence, the sentence that starts off: The plans' abilities to complete their cross walks depend upon having the NPIs of their provider populations and access to CMS' national provider identifier base, or NPI validation, or we could spell out the NPPES, what it means. That was a central part of a lot of the testimony.
DR. COHN: Yes, agreed.
DR. FITZMAURICE: I just missed it before. I should have seen it when we were reading the letter report.
DR. COHN: Oh, can you write that down where you think it needs to be so that we can look at it in the subcommittee?
DR. W. SCANLON: I guess I am thinking that the recommendation in some respects is naive with respect to the timing involved.
I mean, if there are only six months left and you are asking them to first of all monitor and then figure out if there is a need for intervention and then presumably figure out what the intervention is going to be and then implement the intervention, how much time of the six months is left before people in the community are going to be able to get the notice and be able to respond.
I am wondering, if there are only six months to go before May 23, if we really shouldn't be in a position of saying, do something now.
Make the awareness of this date much more in people's minds, so that they take the action. In some respects, start an information campaign that you could argue maybe is not going to be necessary, but it is not going to be effective if it is postponed several months for there to be the information gathering and then the development of an information campaign.
DR. CARR: The way I read this, there is an inherent progression that, until every provider has their NPI, the next step can't happen.
The way it is set up with the single deadline, is it even feasible? Given the way it is structured, is it feasible to expect that step two could be done if step one is due on the same day as step two?
DR. COHN: And step two is use of the NPI?
DR. CARR: Yes, the cross walks, by the payer.
DR. COHN: Karen, do you want to comment on that?
MS. TRUDEL: I think I will stop being stoic. The process is really an iterative one, in that most plans at this point can accept either a legacy identifier or an NPI.
Some providers may already have their NPI, they may be using it, and the plans can accept that. It is a question of when you reach a critical mass of providers that have NPIs.
At some point in time you need to cut off accepting those legacy identifiers. If you haven't reached the critical mass, the providers that aren't cross walked yet will have their claims rejected.
This really is a situation that is similar to the original transactions and code sets. It is not that the plans aren't ready to accept them. It is that, until this whole process occurs, a certain number of providers could be at risk. So, yes, step two and step one can and are being carried out simultaneously.
DR. CARR: Does step one have to be completed before step two can be completed?
MS. TRUDEL: For any given provider, yes, but in toto, no. In other words, if you have one provider that has an NPI, the plan can begin processing that NPI.
DR. COHN: Carol, do you have some additional comments on this?
MS. MC CALL: Yes, just to kind of continue on this same idea, did you learn enough information through testimony to be able to make a specific recommendation that might sound like the following:
Do you know enough to say, look, the cross walk, once you know Dr. Jim has his NPI, it takes about a month for everybody to go through that cycle.
If the go live date is May 23, Dear Secretary and Dear Campaign, tell physicians to get it by April 23 or they are at risk come May 23 of not being able to get something paid.
Is there enough specific knowledge to be able to make recommendations at least like that, to at least let physicians know, get it by enough in advance.
MS. TRUDEL: If I could make a couple of observations, because I worked with Harry in drafting this letter, one of the concerns that I think the subcommittee had after the last discussion was that the testimony that we had heard had only come from one organization, WEDI, which I will grant you represents plants, providers, vendors, but there was a sense that there was a need to hear more robust testimony before actually proposing a specific plan of action.
WEDI did propose one, and there was a deliberate decision on the part of the subcommittee not to move forward with that at this time.
That being said, yes, you definitely need -- you could say two months, three months, and I think the outreach material that we are using now is saying, two to three months is what is needed for the plans to carry out that process.
DR. COHN: Other comments on this letter? Obviously, I think these are thoughtful comments for the subcommittee to further work on the letter. I am hearing suggestions from Michael.
Obviously, the whole committee would like the subcommittee to come forward with the answers in this time frame. I fear that this is a letter that is meant to be a step in the process.
I certainly think that, regardless, we should be expecting a much stronger, more focused letter, which I think is what everybody is wanting for the February full committee meeting, but that this is not that letter.
DR. TANG: I strongly agree with what Bill said in the sense that recommending monitoring is just a self fulfilling prophesy to languish and to delay.
I think we want to, at this point in time, if we are going to stop this repetitive delay cycle, we need to recommend that the outreach, with specific concrete actions by specific dates, be put forward to the remaining practices that haven't been assigned their NPI. That would have to be probably done in the subcommittee this afternoon and approved tomorrow.
DR. COHN: Yes, this letter is not put for vote right now.
MR. HOUSTON: That was going to be my comment. You spoke of the February full committee, and I don't think it can wait, based on Jeff's comments.
DR. COHN: Okay, Jeff, work for this afternoon.
MR. BLAIR: Yes, got a little bit of work this afternoon.
DR. COHN: Okay, so that is letter one. Denise, help us with which letter are we working on now?
MS. BUENNING: We are up to the CHI letter, which is under tab 4 in your booklet, again, addressed to Michael O. Leavitt, Secretary.
Dear Secretary Leavitt: The National Committee on Vital and Health Statistics, NCVHS, appreciates your continued support of the consolidated health informatics -- CHI -- initiative, an impressive effort to bring together experts from throughout the federal government to identify standards for the electronic exchange of health information.
Over the past three fiscal years, the department's special funding has greatly enhanced the CHI process by providing rapid enhancement of CHI recommended standards and for ongoing updating, dissemination and mapping of clinical vocabulary standards.
To cite two examples, this funding has been critical to the department's excellent work on the development and dissemination of the RX norm clinical drug vocabulary and the daily med standard product label dissemination service.
This recommendation level on the final phase II CHI report, completes the role that NCVHS has played in the CHI Council acceptance process, i.e., to provide an open forum for review and an independent assessment of the CHI standards recommendations.
The committee plans to request periodic updates on the status of standards recommended and adopted under this process.
Enclosed are the CHI recommendations on the functioning and disability domain. As recommended by the NCVHS during phase I of CHI, these recommendations also address standards for patient?client assessment instruments that contain functioning and disability content.
The NCVHS concurs with these recommendations and recommends approval of the CHI standards by the Secretary, formal government adoption, and federal support for U.S-wide use and dissemination of the international classification of functioning, disability and health, ICF, and the National Library of Medicine's unified medical language system, UMLS.
Other standards included in these recommendations are Snomed CT, LOINC, and Health Level 7 messaging and clinical document architecture, which previously were recommended for other CHI domains.
We believe that there are many opportunities in the federal health enterprise that would benefit from the implementation of these standards.
Therefore, we support the recommendations under -- -- quote -- future considerations on the importance of advancing a use case for the American health information community, AHIC, and the health care information technology standards panel, HITSBE, that includes the functioning and disability domains and associated assessment instruments.
Implementation of the standards in this report are critical to interoperable data collection and exchange for chronic care, long term care, patient assessment and health functioning and disability outcomes.
However, at this time, these priority areas are not well represented in the national standards portfolio. This could be accomplished through a separate use case or incorporation into use cases for chronic care, problem lists, or electronic health records.
We encourage the department's continued use of the collective CHI reports as the foundation for moving standards forward through the AHIC and HITSBE.
We also strongly encourage the department to continue to maintain a central fund for high priority standards support and enhancement tasks.
As the work of AHIC and HITSBE drives broader implementation in real world settings, new requirements for expansion and improvement of these standards will inevitably emerge.
The ability to quickly allocate resources to address such needs will sustain the forward momentum toward interoperable electronic health records. Sincerely, Simon Cohn, chairman, NCVHS, cc, DHHS data council co-chairs and Robert Kolodner, M.D., and there is a 41-page enclosure which I will now read into the record. [Laughter.]
MR. HOUSTON: Thematically, I like the letter and I think we have to send it forward, but we continue to use the word, encourage.
Specifically with regard to the last paragraph, I notice that we encourage them to do other things. This seems to be in the next item we are going to talk about, too, we talk about encouraging.
We need to be stronger in some of these recommendations. I guess I am underwhelmed a little bit by the letters and the fact that they just sort of don't stand out there and say, you have got to do this. That is my only comment.
DR. COHN: So, I am hearing that you would like to see the word recommend rather than encourage.
MR. BLAIR: There is one other thing that we really should mention. The process of our relating to the work of the consolidated health informatics initiative, CHI, CHI has made the recommendation. Our role is whether we concur with their recommendations.
MR. HOUSTON: I am not talking about that part, Jeff. I am talking about the last paragraph, where we speak specifically to funding and continued use of those CHI reports.
I think we can make recommendations in those regards, and I think we should. I think it is valuable for us to use a stronger word than simply encourage in these cases.
MR. BLAIR: could you repeat again exactly your sentence?
DR. COHN: I think Denise has got -- this is the last paragraph where it is our recommendation, except that we have used, have somehow lapsed, into encouraged. I think this is word smithing, rather than probably a friendly amendment.
MS. GREENBERG: Could you read that sentence for Jeff's benefit?
DR. COHN: Now, we recommend the department's continued use of the collective CHI standards as a foundation for moving standards forward, and I think I would put a period right there.
We also strongly recommend that the department continue to maintain a central fund for high priority standards support and enhancement tasks. Is that okay? Okay, Denise, did you get that?
MS. BUENNING: Yes, I have it.
DR. COHN: Then I guess my question is -- other thoughts on this letter? It will need a little more word smithing. I would observe that somehow we have turned the very first sentence of the document into something that looks suspiciously like a run on sentence, which my father might note. When I start seeing four line sentences, I worry.
This is, I think, a result of our own internal edits, but this is something that we can handle by editing. I guess the question I would have is, is this something that needs to go to the work group for further modification, or with the modifications we have just made, and with further word smithing to be handled off line, is this document basically good to go? Comments?
DR. STEUERLE: This goes back to something I have comment on before. My guess is that all of these letters get shipped out and they go into somebody's office like Jim Scanlon's, who basically takes them and highlights two or three things.
The Secretary probably does not read this, does not even know probably what a lot of the abbreviations and terminology means, and wants to know sort of the bottom line, and whether the staff concurs. Probably unless the staff has some concerns, he probably doesn't.
I am still not sure that we draft these letters with full cognizance of how that process works. Having worked in what used to be called the Office of the Secretary of the Treasury, not HHS, I just know how these systems work.
Sometimes just the highlighting of the bullets and getting to the bottom line, if you have something you would really want the Secretary to read, make sure that is just in bold and bullets and highlighted, and the rest of this stuff is the support stuff that he may or may not read, or the staff may or may not read.
That is maybe more for the future than now. I think you have got this letter decent, go ahead and send it. i think it needs a lot more word smithing, because I don't sense that it is the Secretary that you are convincing by this word smithing. You are trying to convince the staff to go along with the recommendation.
DR. J. SCANLON: There are no surprises here. I refuse to discuss the intricacies of the organization, other than to say there is a very deliberative process.
MS. GREENBERG: In the spirit of self criticism, since I have worked on this also -- full disclosure, I worked on this effort for many years and also, at the request of the standards subcommittee, worked on the letter, in which we used the format that has been used for all of the CHI letters, however, I would agree that it takes three paragraphs to say that what we are doing is concurring with the recommendations of the standards on functioning and disability.
I think the letter would be clearer if we put that in the first sentence and then went on with the rest of it. That might not solve all the problems you are suggesting, but I agree with you on that. This time we really went on for quite a while before we got to what we were about, not that the other things aren't important.
DR. COHN: That is true. I do think that the recommendations toward the end, in terms of additional funding and all of that, continue to fund it, are very important also, probably deserve to be bolded or somehow segregated out. I think I would defer to staff about how we might handle that.
DR. TANG: It is just almost to repeat what you just said which is that, in addition to ordering, bold is a very useful technique that may help those who may prepare these statements for the secretary.
DR. WARREN: I guess I have almost a knee jerk response to Gene's comment. Yes, our initial consumer is the Secretary, but these letters are on the internet, and you have no idea the dispersion that this message gets to.
One, all of my students read them. They are required. People who are looking to see and make decisions about what are we focusing on, if they just do a google query, they are going to come up against some of these letters.
I think that the work that we do here, we need to make sure that, even though the initial recipient is the Secretary, it goes far beyond that and provide some guidance, I think, to the private sector that is trying to answer and deal with some of the complexities, the issues that we grapple with here. So, to put some of the history in the letters, this may be the only one that they pick up.
DR. STEUERLE: My comment wasn't meant to disagree with that at all. I would still put it in there. I would just find some way of highlighting it.
DR. CARR: Along those lines, it would see,m then, after these many letters and these many years, we would have a standard kind of format that the letters would go in, beginning with what are your intentions, what are your recommendations and so on, that looks the same, so that anybody looking at them any time would know where to look.
Secondly, that we have some data definitions around what constitutes important enough for a recommendation versus an encouragement versus whatever other words we use.
I think we ought to have some precision in the words so that we all know what we meant. Perhaps it is a function of how many people weighed in on it or whatever, but I find it variable and a little bit hard to follow, how the letters are formatted.
DR. COHN: Justine, I don't think we will vote on it in terms of this letter, but you are suggesting a style guide, as my English professor father would say.
The truth is that different people write different letter and we will see that in the next couple as we go forward, and probably there will be some value to that, as well as obviously -- I mean, when I read these on the airplane flight out, I was reminded that we do have an editor on retainer, and probably a lot of these letters ought to go through the writer, prior to us getting them in final form.
DR. CARR: I agree with that, on the run on sentences. What I was saying is more format, that we have an enumeration of bolding, bullets and data definitions for what constitutes a recommendation.
DR. COHN: Sure, a style guide. We would certainly take that into consideration. I think Steve has a comment and then we need to figure out what we are going to do with this letter, or Mike has a comment.
DR. STEINDEL: Simon, I would like to comment. As a drafter of many CHI letters for this committee, I would like to point out that actually the first three paragraphs of this letter follow the style of the CHI letters.
There is an introductory paragraph that explains our role, then the usual second paragraph about what we are commenting on, and then the third paragraph which says that we concur with the recommendations and then, if necessary, some qualifiers on that concurrence. So, that does follow the style of a CHI letter, and that is contained in the first three paragraphs.
What was chosen in this case, because of the nature of the disability report and it is slightly different than the other CHI letters, were the last two paragraphs, that encourage the Secretary to go on and use the new process that he has put into place, to consider adding the new process into this, to fund what is needed from the process, and to continue using the CHI information to inform the process. So, that is where the change has occurred.
Yes, we can use recommend or encourage from a style point of view, but also from somebody who is also involved with those processes as well, the Secretary and AHIC have already embraced this within those processes.
So, just making our statement reinforces the course that is already being taken. If you look at the HITSBE contract itself, it says very specifically that they should look at the collective CHI reports when they are considering standards for HITSBE. So, it is already embodied in the work that is going forward.
We have already had a note that we are involved with the use case processes, and this is just adding another comment on the use case tick marks.
DR. FITZMAURICE: I want to second what you started off maybe 15 minutes or so ago, Simon, that the letter is pretty much ready to go as it is.
I would split the first sentence up into two sentences, put a period after initiative, and then start off with, this is an impressive effort to bring experts together and so forth.
Then I would replace encourage with recommend and perhaps bold those two sentences, and I would say it is good to go.
DR. COHN: I think we need to get a member, if you agree, to bring forward a motion.
DR. TANK: I will make that motion.
MR. HOUSTON: Second.
DR. COHN: Okay, is there a further discussion on this, recognizing that I think Mike has basically described I think the word smithing we all thought we needed. There might be additional other minor word smithing that may occur, adding some bolding, as I think Mike has described and I think others have commented on. Any other discussion about this one? Okay, all in favor, aye?
[Voices heard in favor of the motion.]
Opposed?
[No voices heard in opposition.]
Okay, this letter has passed, then. Congratulations to CHI staff. They have done excellent work. Okay, now our last letter of the morning is a letter on an NPRM that is coming forward. I think we need to have you read it.
I have already made a number of clarifications, which I will probably interrupt you when we get down to the end of the third paragraph and begin to add some things as we talk through them.
I think you probably need to read it. Just be aware that this NPRM comment period ends -- Randy, maybe you want to come to the table. We are obviously inviting Randy Leavit from the FDA to sort of join us to help clarify any questions or otherwise.
So, theoretically we could word smith this one. We could even refer it to the executive subcommittee for their December meeting to finally ratify if there are additional changes.
So, we have a little time, is I think what we are indicating here, but he has intended not that this just be a letter to the Secretary, but a letter also responding and encouraging a final rule.
MS. BUENNING: Again, it is addressed to Secretary Michael Leavitt. Dear Secretary Leavitt: The National Committee on Vital and Health Statistics, NCVHS, is directed by the Medicare Prescription Drug Improvement and Modernization Act of 2003, MMA, to develop recommendations for uniform standards to enable electronic prescribing, e prescribing, in ambulatory care.
During the past several years, the NCVHS has focused considerable attention on the feasibility and desirability of standards that are necessary to support e prescribing, and the need for standard terminology for clinical drugs to facilitate automated drug utilization review and decision support for patient safety.
The FDA developed and maintains the National Drug Code, NDC, a 10-digit code that identifies drug products marketed in the United States.
The NDC relies primarily on paper-based reports on ingredients, dosage forms, strengths, labeling and other information from manufacturers, re-labelers, re-packers and distributors to provide details on marketed drug products.
FDA uses this information for drug safety and other regulatory purposes. The NDC is used by dispensers to identify packaged drugs, but is not appropriate for prescriber use because it does not describe the clinical drug.
In previous reports , the Committee documented NDC deficiencies, most notably the concern about perceived weaknesses of the current NDC data base and linkage of the NDC to RxNorm concepts.
The committee expressed the acute need for harmonization of terminologies in the drug area to eliminate incompatibilities that impair drug utilization studies and patient safety.
DR. COHN: Again, basically, where it says drug utilization studies in patient safety, I think minor word smithing where it says, drug utilization studies, and may negatively impact patient safety.
MS. BUENNING: It impairs patient safety. I was wondering, does this impede or impair.
DR. COHN: I said, negative impact. That is just to clarify that, but continue
MS. BUENNING: Let me just review that, then. The committee expressed the acute need for harmonization of terminologies in the drug area to eliminate incompatibilities that impair drug utilization studies and may negatively impact patient safety.
The committee advised that HHS include the National Library of Medicine, NLM, clinical drug terminology, RxNorm, in the 2006 e prescribing pilot tests to determine how well the prescriber's intent is represented or preserved when the RxNorm information is translated from the prescriber's system into the NDC at the dispenser's system.
The FDA responded by providing the NLM with structured product labeling, SPL, which includes the content of labeling and drug listing data elements.
DR. COHN: We really need to modify that sentence. Randy and I were talking about this one. i think somehow we need to annotate that basically it provided the NLM with structured product labeling information, which included the contents of labeling and drug listing data elements, basically including elements necessary for mapping between NDC and RxNorm, which was the point of that sentence.
That will need a little word smithing. I am becoming a victim of run on sentences myself here, but we need to somehow include that concept in there.
The FDA also established collaborations with, among others, the Veterans Health Administration, National Library of Medicine, Agency for Healthcare Research and Quality and the National Cancer Institute, NCI, for purposes of clarifying federal medication terminology.
This included working with NLM to link clinical drug to NDC and distribution of structured product labeling through DailyMed, and working with NCI enterprise vocabulary services to establish the NCI thesaurus as a source for FDA terminology.
The committee also encouraged the promulgation of FDA's drug listing rule to improve the integrity of the NDC and support the correlation of NDC with RxNorm.
In recent testimony before the NCVHS Subcommittee on Standards and Security, the FDA confirmed that the current NDC data base is not authoritative.
Additional testimony from NLM confirmed that RxNorm linkage to NDC is currently complicated by this lack of an authoritative source.
On August 20, 2006, the FDA published a Notice of Proposed Rule Making, NPRM, in the Federal Register, volume 71, Number 167, Docket 2005N-0403, recommending changes that would allow FDA control over the NDC and would result in a complete and authoritative source of NDC numbers.
The proposed rule would make a complete list of drug products marketed in the United States readily accessible electronically, providing for accurate, unique and unambiguous DC numbers for each drug.
This would allow electronic systems to reliably and consistently link the NDC number to the appropriate drug labeling through structured product labeling, SPL.
The drug labeling would supply the drug ingredient and other information necessary to support the development of medication terminology standards for electronic prescribing.
As such, the proposal would provide important support for the full implementation of the electronic prescription provisions of the Medicare Modernization Act.
The NCVHS commends the cooperation of the FDA and NLM as they address these issues. The NCVHS recommends that the proposed rule be adopted as soon as possible, so that it can foster the resolution of those NDC issues previously identified as problematic. Sincerely, Simon Cohn, Chairman, NCVHS.
DR. CARR: What does it mean when it says, current NDC data base is not authoritative.
MR. LEAVIT: The current list of NDCs is not complete because it relies on the companies who assign their own NDCs to report their NDCs in a listing process. So, our list is not necessarily complete, up to date, because of that, that companies assign their own NDCs.
MS. CARR: Could we just say it is not complete?
DR. TANG: There is a question that it may also conflict. I thought one of the complaints about NDC is that there is a re-use of code.
MR. LEAVIT: That is another issue. There are a number of issues with the NDC.
DR. TANG: So, if the FDA were to be the authoritative source, then it would be the only source.
MR. LEAVIT: It would be the source, right.
DR. COHN: Would that solve the problem of re-use? I am actually looking to Randy to respond. So, does this solve the problem of re-use?
MR. LEAVIT: Yes, this proposed rule proposes a solution for re-use.
DR. COHN: For re-use, okay. Russ, did you have a comment on this one. Do you want to help us with authoritative --
MR. LOCALIO: Well, I have some practical experience in this area. I was trying to, several years ago, when I was a member of this committee, merge the prescription drugs in the Pennsylvania Pace Program, with the FDA's data base, and it just was not helpful at all.
So, the only way you can actually get an idea of what is being used is to go to the private sector and use one of their data bases. It is quite expensive.
Steve and I had some discussions about this. My understanding of what the FDA is trying to do is, for the first time, to have a data base that has all the drugs that can be prescribed on it. Is that correct?
MR. LEAVIT: All marketed drugs.
MR. LOCALIO: All legally marketed drugs.
MR. LEAVIT: All marketed drugs.
MR. LOCALIO: I think, if you put it in that perspective, I think there are data bases that are probably about as authoritative as they can get, that they are not under the control of the FDA and, if you try to use the FDA data base today, it just doesn't work. Does that help?
DR. COHN: It does and I think it puts the exclamation mark there. I am wondering if we need to -- I am actually looking very hard trying to find the word authoritative and where it appears first.
MS. BUENNING: It is in the second to last paragraph.
DR. COHN: Is that the first time it appears?
MS. BUENNING: I believe so.
MR. BLAIR: Does it appear to be a consensus that we do want to change the word, authoritative, to complete? My thought is that, if we do that, there are other aspects. It isn't just like, well, is the list of drugs complete.
I think the word, complete, in this case is multi-faceted. I am afraid that will be lost. Authoritative, as long as we know what authoritative means, might be a more appropriate word.
DR. COHN: I guess the question is, do we put a parenthesis with a couple of e.g.s of what we mean by authoritative, to help clarify what we mean.
DR. CARR: I apologize if I am not sophisticated in the use of the word, authoritative, but it is hard to intuit what is the comprehensive coverage, what does it mean. So, yes, a couple of e.g.s would be helpful.
MS. BUENNING: I think that if you look at the use of the word in that paragraph, it is used three times. In two of those instances it seems with reference to source, as it being the authoritative source. I think in that regard, it probably is appropriate.
Where it is maybe not appropriate or subject to interpretation is where we talk about the current NDC is not authoritative.
MS. GREENBERG: Would it be correct to say that it has not been validated, not complete, whatever you want to say.
MS. BUENNING: So, in that instance, then, what I think I am hearing is that reference to complete.
MS. GREENBERG: it sounds to me that it is not just that it isn't complete, but that it maybe over -- it hasn't really been validated, it sounds like. I don't know. Complete just sounds like there are things missing.
DR. COHN: I am not sure not validated -- I don't know if that helps us either.
MS. GREENBERG: That may not be correct either, but I am not saying it isn't complete.
MS. BUENNING: If there is a dependence on the manufacturers or whoever is reporting this information, in that regard you could say it is not complete, because they are depending on an outside source for it.
DR. COHN: You know, for the purposes of a letter like this, the word, complete, might actually be fine for the first authoritative, and then you can use authoritative later on. Michael, did you have a comment?
DR. FITZMAURICE: The authoritative is in there and it is important because it says that, if it is authoritative, it is under timely, central control. Somebody is in charge.
It is spread around to manufacturers who get around to reporting that they have assigned a number to a drug. This says it is under timely central control.
Now, you might not like central control on a lot of things, but I like to know there is somebody in central control of the labeling of drugs that my family and I take.
DR. STEUERLE: Perhaps the FDA confirm that the current NDC data base is not adequate for use as an authoritative source, period. Additional testimony, and so on and so forth, complicated by the lack of any authoritative source, or an authoritative source, it is clear that what is going on is two things are going on.
You are trying to make the data base more adequate to be an authoritative source, and you are trying to make an authoritative source.
DR. COHN: Okay, everybody is nodding their heads that that is a very good solution to this particular issue. Other comments about this letter?
I was going to also suggest a new paragraph. This starts later on in that paragraph. It says, on