September 1, 2004
Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, D.C. 20201
Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
(703) 352-0091
TABLE OF CONTENTS
Call to Order, Welcome and Introductions, Review of Agenda - Dr. Lumpkin
Update from the Department
Privacy Letters, Marketing, Fundraising, and Privacy Advocate - Mr. Rothstein
NHII Letter - Dr. Lumpkin
Standards and Security, Letter on e-Prescribing - Dr. Cohn
Agenda Item: Call to Order, Welcome and Introductions - Review of Agenda - Dr. Lumpkin
DR. LUMPKIN: Well with the start of this meeting summer is officially over, however for the Standards and Security Subcommittee they would never know that there was a summer. What did I do on my summer vacation? And thanks to all of you who worked so hard over the summer to bring forward the recommendation that we have in our packet on e-prescribing.
We have a full day today, we’ve got three letters from Privacy, we have a letter from NHII, and then we have a short letter on e-prescribing, which they just folded last night after talking to no one, but I think it was 65, is that number I remember correctly? People who testified at the various hearings, very impressive, so we have a fair bit of work today. I actually was following up on one of our reports that we issued, when did we do the report on the territories?
MS. GREENBERG: I think it was ’99.
DR. LUMPKIN: Around ’99, and just a few short days back from a trip out to American Samoa, Guam, and Iyap(?), which is one of the states of the, federated states of Micronesia, a compact nation, sort of sparked by our report. It was really a fascinating trip, I think perhaps for us one of the most fascinating parts was to go to a place like American Samoa, population of 50,000, and to go to the hospital, the LBJ Tropical Medicine Hospital, which was really a fascinating institution in of itself, but to realize that they were implementing Vista and had a number of the components in place, it really was very impressive and had gotten a lot of support from the VA hospital in Hawaii in setting up that system. So the activities of this committee are no unknown even all the way across, not quite the International Dateline but certainly on the other side of the equator in the Western Pacific, so it was really quite a fascinating trip and sometime maybe I’ll tell you about my trip to American Samoa and the gecko that decided to climb up my shirt on the inside, it was truly an interesting experience.
So having done that that’s what I did on my summer vacation, it wasn’t really a vacation.
Why don’t we start off with introductions, my name is John Lumpkin, I’m senior vice president with the Robert Wood Johnson Foundation and I am chair of the committee. And we’ll go around, as usual we’re broadcasting on the internet, also as we go around if you have any conflicts if you would state them at this particular time. So why don’t we start off with Jim.
MR. SCANLON: Good morning, I’m Jim Scanlon, I’m the deputy assistant secretary for science and data policy in ASPE at HHS and I’m the executive staff director of the committee.
DR. COHN: I’m Simon Cohn, the national director for health information policy for Kaiser Permanente, a member of the committee.
MR. ROTHSTEIN: I’m Mark Rothstein, director of the Institute for Bioethics, Health Policy, and Law at the University of Louisville School of Medicine, member of the committee.
DR. CARR: I’m Justine Carr from Beth Israel Deaconess Medical Center in Boston and a member of the committee.
DR. STEUERLE: I’m Gene Steuerle, I’m a senior fellow at The Urban Institute and also a member of the committee.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the national committee and staff to the Subcommittee on Standards and Security, and wondering if John Lumpkin bought any insurance from that gecko who crawled under his shirt.
DR. HUFF: This Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City and I would need to recuse myself from any votes relative to HL7, I’m a co-chair, vocabulary co-chair within HL7.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.
MR. ROTHWELL: Charlie Rothwell, National Center for Health Statistics, representing Ed Sondik, I’m the director of the National Vital Statistics System and also the National Survey of Family Growth.
MS. FRIEDMAN: Maria Freidman, Centers for Medicare and Medicaid Services, staff to the Subcommittee on Standards and Security. I’m also glad John has revealed his plan to have NCVHS go for total world domination.
MS. MCANDREW: Sue McAndrew, Office for Civil Rights, and I am liaison to the subcommittee, and I would also like to introduce to Christina Hyde(?), from my office, who will also be helping with the liaison duties to the Subcommittee on Privacy.
MR. LOCALIO: I’m Russell Localio from the University of Pennsylvania School of Medicine and a member of the committee.
DR. VIGILANTE: Kevin Vigilante, principle at Booz-Allen & Hamilton, and member of the committee.
DR. LENGERICH: Gene Lengerich, member of the committee, Penn State University.
MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina, member of the committee.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member of the committee.
DR. HARDING: Richard Harding, University of South Carolina, member.
MS. BEREK: Judy Berek, Centers for Medicare and Medicaid Services, liaison to the committee.
DR. WARREN: Judy Warren, University of Kansas School of Nursing and I would need to recuse myself if we have a vote about HL7, I’m the co-chair of the patient care technical committee.
DR. MAYS: Vickie Mays, University of California, Los Angeles, member of the committee.
MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, member of the committee.
MS. GREENBERG: I’m Marjorie Greenberg, National Center for Health Statistics, CDC, and executive secretary to the committee, and I did want to note that although we weren’t able to obtain laurel wreaths in honor of the e-prescribing Olympics several members of the NCVHS team are wearing crowns.
MS. AMATAYAKUL: Margaret Amatayakul, consultant to the Subcommittee on Standards and Security.
MR. ALFANO(?): Bill Alfano, Blue Cross and Blue Shield Association.
MS. VERTAIN(?): Laura Vertain with Wexler and Walker Public Policy on behalf of IMS Health.
MS. JONES: Katherine Jones, National Center for Health Statistics, CDC, and staff to the committee.
MS. DRISSEL(?): Danielle Drissel, Hogan and Hartson.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC, committee staff.
MS. POKER: Anna Poker from Agency of Healthcare Quality and Research, lead staff to the Quality Subcommittee and staff to the NHII.
MS. PAISANO: Edna Paisano, Indian Health Service, staff to the Subcommittee on Populations.
MS. HYDE: Once again Christina Hyde with the Office for Civil Rights.
DR. KILE: Frank Kile, American Dental Association.
MS. ZIGMAN-LUKE: Marilyn Zigman-Luke, America’s Health Insurance Plans.
MR. MUSKO(?): Tom Musko with the Office of Health Policy at ASPE.
MR. RODY(?): Dan Rody with the American Health Information Management Association.
DR. CATECORD(?): Doug Catecord on behalf of the American Medical Informatics Association.
MS. WHITE: Gracie White, NCHS.
MS. FLORAKOWSKI(?): Irene Florakowski, American College of Surgeons.
MR. LANDRIGEN(?): Dan Landrigen, Atlantic Information Services.
MR. DUBOIS: Jason Dubois, American Clinical Laboratory Association.
MS. GREENBERG: Jackie Adler --
DR. LUMPKIN: And Jackie Adler.
MS. ADLER: Jackie Adler, NCHS and a member of the NCVHS team.
DR. LUMPKIN: Great. Just before we get started, Richard which side of Cape Fear are you on?
DR. HARDING: I hope the correct side, we’re just kind of waiting, we don’t know yet.
DR. LUMPKIN: Well, we’ll all be hoping that, well, I don’t know what you hope when you have a category four storm heading --
DR. HARDING: You’ve all seen the rain but you ought to see the wind.
DR. LUMPKIN: How close are you to the shoreline?
DR. HARDING: 80 miles, so if it’s a glance it just gets a lot of rain but if it’s like comes straight on --
MR. BLAIR: We can’t hear him --
DR. LUMPKIN: What he said was he’s 80 miles from shore but Francine is it, Frances, didn’t we have Gaston and Hermoine already, anyway, not all of them grow up and some of them sort of procrastinate before they do grow up, but certainly we’ll keep our fingers crossed for your home territory.
Why don’t we start off with the update from the department, Jim?
Agenda Item: Update from the Department - Mr. Scanlon
MR. SCANLON: Okay, thanks John. Good morning, everyone. Since we met in June, it doesn’t seem so long ago, when we met in June actually a number of things as you all know occurred over the summer relating to health information technology, data policy, and other activities and let me just spend a couple minutes updating the committee on what those were and where we’re heading.
You’ll remember first back to May, May 6th, the Secretary convened a summit involving over 100 leaders in the health information technology industry and made a number of announcements, three major announcements, and several of the NCVHS members were there. First of all the Secretary announced on behalf of the department, and VA, and DOD that we were adopting an additional Consolidated Health Informatics standards for use in the federal health care enterprise. That announcement brought the total number of CHI standards up to about 20 and they include most of the standards, clinical data standards, that were recommended by the committee here. I won’t go through those 15, they’re available on the website, but I think you’re familiar with all of them including SNOMED, LOINC, Rx-Norm, Daily Med and so on.
He also announced at that meeting the availability of SNOMED CT for downloading for free from the NOM Website and he also announced at that meeting the appointment of our National Health Information Technology Coordinating in HHS, Dr. David Brailer. You’ll remember that the President signed an Executive Order on April 27th, just a month before, creating such a position, and he was actually appointed fairly quickly at the May 6th meeting. Now Dr. Brailer met with the full committee I believe at our June meeting and he met again with the Executive Subcommittee in July and he was unable to come to this meeting, I think he’s actually moving, trying to move, but we’ll have him again at our November meeting.
Later in the summer on July 21st HHS held --
DR. LUMPKIN: Jim, did you mention he was like Modern Health Care number one?
MR. SCANLON: That kind of upset the Secretary --
-- [Laughter.] --
DR. LUMPKIN: Modern Health Care does an annual list of the most influential people in health care and David Brailer was listed at number one.
MR. SCANLON: He’s going to have to try to stay in first place I think.
And at our NHII conference, again many of you participated in that conference in July here in Washington, HHS released the framework for strategic action as called for in that Executive Order, I think you all have copies, this is on our HHS website as well. And it was called the Decade of Health Information Technology Delivering Consumer Centric Information Rich Health Care. It includes a number of goals, I won’t go over them here this morning, and a number of strategies and specific action steps and I think David’s office will be pursuing some of those action steps in the months ahead.
You’ll recall that the conference concluded with a public meeting of the NHII Workgroup of the committee in which the findings and recommendations from the various breakout sessions were presented to the full committee and to the workgroup and I think we’ll be discussing them later today for transmittal to the department. So actually a number of very positive things are occurring, things seem to be moving along very well.
In terms of budgets we are pretty much winding down now on fiscal year 2004, in fact this is the final month, September, and the new fiscal year ’05 begins October 1st. Very few federal agencies have budgets enacted already for fiscal year ’05 and most likely will have a Continuing Resolution so I will describe just briefly what the President’s budget request for ’05 includes in the area of health information technology and data policy and again we hope this will, these will turn into actual budgets later in the fall.
There’s about $115 million dollars in the President’s ’05 budget relating to health information technology and data standards and so on and this includes a couple of things that I’ve described, they’re continuations from the ’04 budget. The ’05 budget would continue the joint AHRQ/ASPE data standards initiative, remember this was $10 million dollars for use, for the promotion and the development and the adoption of standards. And that funding came in very handy in fiscal year ’04, it really allowed us to fund a number of critical developmental projects such as Rx-Norm and Daily Med and it allowed us to begin a number of the terminology mapping projects that the committee had recommended, among the major and the core terminologies as well. So that initiative at least so far is included at the level of $10 million in the President’s ’05 budget.
Also in the President’s ’05 budget there’s $50 million dollars in the AHRQ budget, this is a continuation of an ’04 initiative. This provides planning, demonstration, and evaluation grants for improving patient safety through health information technology in hospitals and ambulatory care practice organizations. I think the first year of grants probably will be awarded, Mike you know better then I, probably this month --
DR. FITZMAURICE: Yes.
MR. SCANLON: It would have to be this month, and again that would be continued at the level of $50 million in the President’s ’05 budget.
A new investment in the Office of the Secretary would be an additional $50 million dollars in the President’s ’05 budget that will be included for demonstrations really dealing with the community and regional data exchange networks and the whole practical interoperability. The focus here would be on data exchange networks and interoperability so that would be a whole new grant program here in HHS.
In the ’05 budget we actually have some good news on the population statistics side as well as the information technology side. The President’s budget includes a $25 million dollar increase for the National Center for Health Statistics, this was the amount determined to be needed to transform, maintain, and stabilize the core statistical systems there, vital statistics, health interview survey, NHANES, and so on in the health care provider surveys and allow a little bit for methodological research as well. This you’ll recall was the Data Council’s highest priority across the department for data investments in the ’05 budget and the Secretary agreed, OMB agreed, and the President forwarded that request to Congress so we await their decision.
For the ’06 budgets, which is really not that far away, we’re always working on the next year’s budget, we’ve already begun to plan, very preliminary, and the Data Council is beginning to review all of the requests for data collection investments and discussing initial thinking on what the priorities and the strategies might be for ’06 but that’s in a very preliminary stage.
Just a couple of other things, the Data Council is looking at a couple of areas in the months ahead and these are largely in the populations statistics area though e-prescribing will be one of those areas, and our leadership in HHS asked us to look at some gaps in these areas. The first will be at our September 8th meeting of the Data Council, next week, we’ll be looking at some data gaps in the prescription drug area. This is not the e-prescribing so much as the data on prescription drug utilization and expenditures and so on, really for program and policy purposes as well as research and statistics so we’ll have that discussion. And the second part of that meeting will probably have Dr. Cohn briefing us on the e-prescribing standards that the committee will probably approve later today and tomorrow so the theme of that meeting is on both the data side and on the standards side for e-prescribing.
Later in the month, September 20th, we are planning to convene our HHS agencies and the Census Bureau to look at national and state health insurance data and some related health care resources and access data and we’ll be inviting the Census Bureau there as well. The focus there will be to look at sort of where we are, where are the gaps, are there opportunities for coordination and methodological work and joint analytical work as well.
And then looking to October we’ll be looking at how do measure income and wealth and related resources in our surveys and major data systems and then what are the opportunities for coordination in analytic work, methodological work, there as well. We’ll also be looking at in just very preliminary way the use of standards, data standards, statistical standards, and other standards in our HHS surveys.
Let me stop.
DR. LUMPKIN: Any questions? Steve.
DR. STEINDEL: Thank you, Jim. The money that you were talking about for AHRQ, the $50 million dollars, if I recall correctly the funding this year was for a new program and that program, the proposals were to extend out to three years. Is this $50 million dollars a continuation of that program or is it $50 million dollars of new money?
MR. SCANLON: No, it’s the $50 million of that program, it’s not an additional, but there is an additional $50 million that is new in the Office of the Secretary for the other.
DR. MAYS: I just want to ask a couple of questions about the work at the Data Council on some of the population issues. Some of the things that you talked about like how to measure income and wealth, pops has discussed for quite some time, what’s the most effective way for us to make sure that during that discussion either our past recommendations or current activities that we have are transmitted, is that through Simon, should we send a note, or should we resurrect things, what would you suggest?
MR. SCANLON: Well, Simon will be, Simon attends and participates in the meetings, the income and wealth measurement issue will be at the October meeting, we could, Simon, any way we want to represent the views of the committee. I think we’re going to start by looking at how do we now measure, it’s largely income at the moment in our major surveys to some extent, some of them get a bit on wealth, I think no one’s entirely happy with the way we measure even income so I think we’re starting with the fairly basic approach. So I’m not sure, certainly we can talk about this about Simon will be there, we can make any other arrangements as well.
DR. COHN: I just had a suggestion and it just occurs to me that probably the best thing to do is for us to share the agendas with you and then see if there’s pertinent documentation or other respectives from the Population Subcommittee as these issues come up. I think that Data Council as obviously received and considered all the letters, as you know there’s nothing like just in time information.
DR. MAYS: My second question, in terms of your planning in terms of the budget, again I guess I want to get in on that because it seems like we tend to recommend things that have budget implications and since I want to look ahead, again, what’s the probably the best way for us to see if things that we’ve recommended in the past that were unable to be funded, is there a need for us to raise them again or what?
MR. SCANLON: Well, I think you’re right, I mean we got through a lot of trouble in the Data Council to try to have an influence on the budget because if the resources are not there in advance then you’re hardly going to be in a position to plan beyond that. But I think for the recommendations for the committee, a number of them from the past are sort of being fed into the process, for example, the NCHS budget enhancement is to some extent comes out of committee discussions. The National Children’s Study is a more complicated budget issue, they did by the way, they are responding to our letter and they tell me that they’re actually addressing most of the issues that we raised in the letter, at least at the planning stages, but there’s a big budget issue there, that’s a very expensive study, there’s certainly no money in the ’04 budget or the ’05 budget for that, but that’s a bigger, I think everyone’s aware of the funding there.
But it’s hard, the only activity on the ’05 budget of course is on the Hill now and so we’re kind of locked into what may happen there. For the ’06 budget it’s very preliminary, I don’t think, I think in a few months it will be a little clearer, it’s just unclear now and we’re pretty much looking at the ’05 budget as the basis for the ’06 budget. But I can assure you that the recommendations from the committee get factored in, any way we can get the committee more directly involved consistent with FACA we can certainly do that.
DR. LUMPKIN: Other questions? Thank you. Maria?
Agenda Item: Update from the Department - Ms. Friedman
MS. FRIEDMAN: Good morning. HIPAA keeps rolling along. In Medicare compliance we’re up about 97 percent and we’re actually conducting some additional analysis to find out what’s up with the other three percent, we’re very pleased to see the numbers there. As far as regs, the claims attachment reg is still scheduled for December of this year, since that had been presented to the committee before I thought I would let you know about that.
MPI we had issued an RFI for an enumerator, we got the advice that we wanted and so now our contracts people are looking to issue an RFP sometime in the near future, I don’t have a date for that yet. Enumeration is still scheduled to begin at the end of next May.
Enforcement, I have some detail for you on that. To date we’ve received a total of 168 complaints, of this 145 are related to transactions and code sets violations, the remaining 23 were related to privacy and of course we dutifully sent those over to Sue and company and some non-HIPAA kinds of issues. For complaint status, currently 58 of the 145 complaints are open, of the 87 that have been closed 43 were deemed invalid and 44 were resolved by the parties involved in the complaint or via the completion of a corrective action plan that was approved by CMS. Apparently there are five open and active corrective action plans.
The kinds of complaints we’re getting have changed a little bit, following the deadline last October most of the complaints we got were related to transactions and code sets and now we’re getting some on a little wide range of issues, we’ve gotten several, actually 42 regarding trading partner disputes alleging that excess fees are being charged. And of the 42 trading partner complaints six have been closed. So we’re working them.
And let’s see, I think I have just a couple notes on CHI, Jim took care of a lot of what I had to say about the standards adoption, so we are working with ONCHIT to coordinate CHI and FHA and we’re looking at activities in phase two and they break into three major categories and that’s implementation of the standards that have already been adopted, maintenance and improvement of standards that have already been adopted, and the need for new standards. Of course a critical piece of all this is mapping and NLM is charged with mapping and maintaining of CHI standards. An example of mapping activities for example would be SNOMED to ICD-9.
So that’s it.
DR. LUMPKIN: Okay, any questions? Mike?
DR. FITZMAURICE: Any word on when the health plan identifier will be out?
MS. FRIEDMAN: No. I wish I knew but I don’t.
DR. LUMPKIN: Just one question on the enumeration for the national provider ID, I don’t know if Jim mentioned to you I had my sights set on 007, is that still possible?
MS. FRIEDMAN: Does that mean Brailer is going to be number one?
DR. LUMPKIN: Let me think about this, no the Secretary is not a provider so he has a shot.
Any other questions?
DR. COHN: John, I guess we could have CMS explore the concept of vanity plates as a profit center which is I think where we’re going with this conversation. I guess I also wanted to comment that given Maria’s presentation it seems like the mapping issues which are NLM are really critical to the success of all of this and we may want to have NLM come specifically in November and update us on exactly what’s going on with all of that. I mean I get some updates but it would be nice to hear it directly from the people doing it.
DR. FITZMAURICE: Are there any statistics on how many claims have been slowed down as part of the compliance process in CMS? I think the plan was to pay electronic claims within 14 days and to slow down the payment of the non-complaint, or non-electronic claims, to 29 or 30 days.
MS. FRIEDMAN: I don’t have any information on that but I can report back to the committee, I don’t know if we have that data actually, I can check.
DR. LUMPKIN: Okay, Susan?
Agenda Item: Update from the Department - Ms. McAndrew
MS. MCANDREW: I love this part because I really get to upstage CMS.
These numbers aren’t official yet because we haven’t closed out the August numbers but as of last night we were, we had received 8,096 complaints, including the 23 that were referred from CMS. We have closed approximately 57 percent of those claims, the complaints. We have still not issued any CMPs, civil monetary penalties. The issues continue to be the regular suspects, uses and disclosures and safeguards are far and away the most frequently complained about issues. Access continues to garner a number of complaints, and then behind them are complaints about minimum necessary standards, violations of notice, and violations of authorization standards.
The complaints continue to come in largely from provider groups, private practices, general hospitals, pharmacies, outpatient clinics, group health plans struggles along in fifth place as an entity against whom most complaints are filed. I would say in terms of our closure rate we continue to close a little more then a third of the cases for non-jurisdictional or failure to allege a violation reasons. There are about 15 percent of the cases are closed following some sort of corrective action or the provision of technical assistance or other forms of voluntary compliance. The large gap in the middle is an issue we continue to work on with our regions in terms of coding because there is a large, we made a mistake of putting an other category, closure category in there and that button gets pushed far too often. So we are trying to work through what is being put into that other category so we get a better sense of the exact reason of the closure of these cases.
We have in addition made approximately 125 referrals to the Department of Justice and you probably have seen in the papers there was the first prosecution under HIPAA by the Department of Justice, there was a guilty plea that was entered in a case in Seattle where an employee of a health care provider in Seattle was using, had taken patient identifiers and had used that to obtain credit cards in the name of the patient and had charged something in the neighborhood of $10,000 dollars worth of goods on those credit cards and he has entered into a guilty plea with the U.S. attorney out there, currently the plea agreement envisions a term of imprisonment from ten to I believe 16 months, and the plea agreement is subject to the sentencing and acceptance by the judge and that will, there will be a hearing on that I think in the early part of November, November 2nd. So the Department of Justice has made their first charges under HIPAA and I understand that there may be others still to come but there is at least one identity theft has gone down because of HIPAA.
Other then compliance I wanted to make you all aware, we have recently put up on our website new fact sheets, consumer oriented fact sheets about the privacy rule and about individual’s privacy rights, and we are in addition to making them available on the website we are interested in partnering with groups that would be interested in having printed copies of these available for distribution at the local level, entities that have interactions with the public, we are more then welcome, if you’d like to hear from them and if you all have any suggestions for us as to how to get these into a distribution stream we would be very appreciative of your efforts.
Finally I wanted to let you know that we have based on your last set of recommendations, I wanted to let you know that we have also a new frequently asked question that addresses disclosures to the law enforcement community and when you, it provides a general roadmap throughout the rule, not just the law enforcement section but the other types of disclosures that were scattered throughout the rule about who can, when you can make a disclosure to law enforcement, we think that that will help move that dialogue along, there’s additional specific questions that we will be addressing per your recommendation with the DEA.
It turns out that not only the DEA but the IG and even DOL is interested in clarification not so much on the law enforcement disclosures but also potential for law enforcement officials to be involved in health oversight so that they have two hats that they can wear in terms of accessing information and they wanted to make sure that it was also clear that just because they have a badge doesn’t mean they necessarily have to do this through a law enforcement type disclosure. So we are working on some additional FAQs that will clarify those issues.
DR. LUMPKIN: One question on prosecution, the civil monetary penalties, do you have to do a referral to the Department of Justice to assess a CMP?
MS. MCANDREW: Yes, I mean we do, our CMP authority has to be, DOJ does have to approve a CMP before we issue it but it’s a different referral then the criminal referrals that we’ve been making.
DR. LUMPKIN: So when you said that there have been no CMPs assessed then would that, would I be correct in assuming that none of the I think 125 referrals to DOJ were all for criminal prosecution and not for CMPs?
MS. MCANDREW: Right, they were all criminal referrals and actually the way the law is structured we cannot impose a CMP on any activity that’s subject to the criminal sanctions.
DR. LUMPKIN: Thank you. Other questions? Russ?
MR. LOCALIO: This is Russ Localio. Sorry to sound like a broken record but I want to read your frequently asked question answer number 302 dated March 3rd, 2003, this is the answer, we do not believe that the privacy rule will hinder medical research, indeed patients and health plan members should be more willing to authorize disclosures of their information for research, etc. Has OCR or anybody else to the best of your knowledge in HHS in the last year and a half assessed whether your beliefs as of March 2003 are well founded? Or am I the only person who constantly gets complaints about the negative impact of the privacy rules on research? Do you know if NIH has complied any information on this?
MS. MCANDREW: As far as I know there has been no survey or study or statistical sampling undertaken with regard to the impact of the rule, not only in the area of research but with regard to any of the potential disclosures, how much they are used. We do continue to get, to have dialogues with the research community and we are aware of their concerns, not only I think the AAMC as well as others have raised concerns about confusion, negative reaction to the authorization process, the multiplicity of forms, we are working these issues through with NIH and with others in terms of what additional clarifications need to be made and whether or not it’s an implementation issue with regard to the research or whether there is need for changes in the way the privacy rule interacts with the research areas.
MR. HOUSTON: Regarding your statistics side, could you reread the, you had described by type of entity who were the most common complaint, subject of complaints, you had said first was providers --
MS. MCANDREW: It’s private practices, general hospitals, pharmacies, outpatient facilities, and then group health plans.
MR. HOUSTON: In that order?
MS. MCANDREW: In that order.
MR. HOUSTON: I know last time we’d all met there was a desire to sort of get some concrete statistics and I know that some of this is probably in response to that request, is there something that you can provide that’s written that has sort of the detail behind this or is OCR not able to do that?
MS. MCANDREW: We have been working with our data management people and we are trying to develop a report that would, what is the term, I keep seeing it, more robust data --
MR. HOUSTON: I think last time I had given you some --
MS. MCANDREW: You had given us and we are trying to, we’re testing now a report that would provide some of those crosswalks between mapping issues to providers and both to geographical patterns and right now we’ve gotten, we’ve gotten the report but it’s a little hard to manage, it comes out a 500 page report, not what I need, so we’re continuing, trying to boil that down to something that can be eyeballed and made sense of.
MR. HOUSTON: Thank you very much.
DR. LUMPKIN: Vickie.
DR. MAYS: I just want to follow up on the question that was raised by Russell because I guess I’m also one of those people that gets barraged with these questions. I guess I’m wondering if there’s a way to be proactive about trying to determine what to do for the research community not NIH per se, what NIH may need as an entity versus what a person who’s out there in the field may need might be a little bit different and I do think that there might be some misunderstanding, I mean even here I think when we were talking about what predominates in terms of the CFR, etc., those are the kinds of questions that would be I think helpful to kind of proactively try and get information out and I’m just wondering, even as we talk about categories, the research one doesn’t come up too often. Is there a way in which we can make sure that we can address some of these needs? Because I know the AAMC held testimony, etc., so that you all could get some sense of what some of the issues were.
MS. MCANDREW: I just did want to make clear, I mean when I mentioned NIH it really wasn’t their research issues per se but we have, we do work with NIH as a liaison, as our liaison, to the research community as well as with the Office of Human Subjects Protection. And we, I understand that the Secretary’s Advisory Committee on Human Subjects Protection is formulating a set of recommendations which I believe may largely be based on the AAMC’s concerns and so those will be coming to the Secretary and we are interested in working with the research community to make sure that barriers that we did not intend to exist are taken care of.
DR. LUMPKIN: Gene?
DR. STEUERLE: Sort of along the lines of I guess questions of Russell’s and others, and I guess Susan we even talked about it briefly, I don’t know where responsibility in the department lies for gathering data on the cost of these various provisions, and not just cost to the research community, so that there’s some way of assessing sort of what’s being done. And I think we all hear complaints and those are anecdotal and certainly some material is hard to quantify, maybe it’s just me, I don’t get a sense that there’s some group who’s job it is to assess the cost of these various, I was thinking whether it was something narrow like what’s the cost of dealing with the complaints that you have which would be a narrow subset of issues to the possible potential cost to the research community to other cost of compliance and I don’t know, I don’t know how to ask even the question but is there some committee that deals with statistics, is there some data gathering arm that’s looking at the cost side of this so that there’s some way to assess in a slightly more scientific, and I recognize some of the data would be qualitative but even qualitative data is often better then none at all. Or is that something that the committee should think about?
MS. MCANDREW: Actually I may defer to Jim because I thought at one point there was discussion about --
MR. SCANLON: There was some, these things are very hard to do, it’s hard enough to develop benefit cost analyses for any regulation and this area I think it’s particularly difficult. We initially thought that we would in ASPE try to get a sense, and this was for research and public health, this was not overall costs and benefits of a regulation, we would try to look at what was occurring but it was really very, first of all we were at the initial stage of the implementation of the regulation and it was hard to tell how things would settle out.
Secondly, when we asked folks who design evaluations, and we have plenty of them within our office as well, I don’t think anyone really had a research design to be able to do this, other then a normal actuarial and sort of economic analysis which is largely assumptions, I don’t think we had any real benefit costs to rely on.
So we’d certainly, if the committee wants to look into, now the other thing is what’s the objective of such a study, again, I think you’d have to be clear about going in, what’s the objective of such a study anyway.
But if you have ideas or you want to pursue how one might approach this analytically or methodologically I think we’d be receptive. But we sort of ran up against, we could not find any real design, evaluation design to do this, and others thought that it was just premature, that until things had settled a bit it was hard to know what was noise and what was a real barrier. So again, we would, any advice you have we’d be open to it.
DR. LUMPKIN: Okay, I’ve got Mike, Mark, and Richard and then we’re going to have to move on. Mike?
DR. FITZMAURICE: I want to respond to Russell’s question and then to the following conversation. AHRQ is funding a contract with APT(?) Associates to do a purposeful investigation, not a scientific survey, but to find out what the burden of the privacy rule is on researchers. So it’s asking a couple handfuls of people, maybe three handfuls of people, in different research areas what is the burden to you of the privacy rule. It’s not meant to estimate the cost of it but to get categories of burden and to get some idea of the magnitude. The results of the study should be out next summer, it’s just begun this summer.
Secondly we’re also working with Academy Health, we’ve held two workshops to inform the research community but we kept our ears opened and listened to what they’ve said back to us. We had an expert meeting in June, plan to have a wider expert meeting late this fall, but the sense is that the burden of the privacy rule is also tied up with the burden of the common rule and that what the requirement of the research is to go to the IRB for privacy rule, they then get involved in a lot of common rule considerations, particularly if the university gives assurances that they will pass all the research through the IRB process.
So I’m not sure that we can separate the two out but we’re trying to get a handle on what is the total burden of researchers for researchers of the privacy rule and try to separate that form the common rule if I could, and then what are some action items to try to reduce that burden and still maintain the same kind of methods. One subtle point that we’re concerned about is are there some methods that are so burdensome that researchers are not going into that methodology, not developing research in that area, because it’s too burdensome for them.
DR. LUMPKIN: Mark?
MR. ROTHSTEIN: Thank you, John. I just want to remind the members of the committee that in June 2003 we sent a letter to the Secretary in which we urged the Secretary to put into place some formal mechanism for doing research on the HIPAA privacy rule to find out, not just in terms of quantifying the benefits which, quantifying the costs which as difficult as that is is the easier of the two, to try to get some idea of whether the privacy rule was actually succeeding in improving the privacy of health information and that of course might take a range of sort of qualitative measures and we thought that maybe it would be the province of some other agency in the department to put out RFPs and actually researchers from the wider community. So that continues to be an interest of certainly, a personal interest and the full committee is on record on that.
The other point that I want to make relative to research that many people here may not know is that on August 10th OHRP issued new guidance on research repositories that in my judgment further widened the rift between the privacy rule and the common rule which is acknowledged in the OHRP document and that of course runs contrary to our last letter, or some letter that we sent, in which we urged the department to try to harmonize the common rule with the privacy rule and therefore it was somewhat discouraging to see this new guidance and I would hope that the department somehow would reconsider those issues to try to relieve the burden on researchers.
DR. LUMPKIN: Now as that a final rule or an NPRM from OHRP?
MR. ROTHSTEIN: It was a guidance.
DR. LUMPKIN: Guidance, oh --
MR. HOUSTON: Is there a way to get that printed out while we’re still here? Is there somebody who would, I’d love to read it and I don’t think I have seen it.
MR. ROTHSTEIN: Well it’s on their website so it is available, could some staff, Sue, you must have a copy of that somewhere --
MS. MCANDREW: It’s not ringing any bell.
MR. ROTHSTEIN: August 10th is the issue date from OHRP.
DR. LUMPKIN: Richard?
DR. HARDING: For the sake of time I’ll pass and talk to Susan privately.
DR. LUMPKIN: Thank you. Well, thank you for the updates, we’re going to move on to the privacy letters, which I think, I believe are under tab two, three, that’s correct. The first one marketing.
Agenda Item: Privacy Letters - Mr. Rothstein
MR. ROTHSTEIN: Thank you, you should all have a copy in your books on the marketing letter, this is of course is a topic that we’ve discussed on many occasions and John for the benefit of the internet folks should I read the letter or how do you want to proceed?
MR. BLAIR: If in fact since this was in the briefing book, if virtually everyone on the committee has read their stuff before they got here then maybe Mark could focus on the recommendations, is that, do we have the flexibility to do that?
DR. LUMPKIN: Yes, I think so, that was a good suggestion. Mark?
MR. ROTHSTEIN: Thank you, we can speed up the process then. Let me just go to the essence of the letter and explain it, this is a different kind of letter then we usually write because it does not contain recommendations, it contains concerns. And the reason for that is the following, as explained in the letter we didn’t think we had enough information to make specific recommendations and yet we didn’t want the issue to be lost until we had more hearings and we weren’t even sure whether we ought to have more hearings until we got further input from the department.
So we listed those concerns and let just review those for you, they’re on the second page of the letter, we’re concerned that PHI is being used to target individuals for the sale of specifics products and services without any disclosure of the commercial relationships of the covered entity and commercial entity. Second is that we’re concerned that in the course of some commercial activities that target individuals their PHI may be disclosed and we’re concerned about that, such as sending out product specific postcards to individuals saying you should switch from brand X to brand Y of your anti-depressants. And third, we’re concerned that covered entities have no requirements to afford individuals an opportunity to opt out of receiving communications regarding products and services and we note that this is quite complicated when you apply it to the full range of covered entities and we ask the department to further explore that issue.
So these were the three areas of concern for us but we don’t have any specific recommendations, we may hold additional hearings on this but as you’ll see our plate is very full, especially now with e-prescribing on top of NHII on top of our regular HIPAA stuff and we need to focus very clearly on what we’re doing. So that’s the essence of our letter and I’d be happy or other subcommittee committee members would be happy to answer questions.
DR. LUMPKIN: Any questions on the letter? Seeing none I think I’m willing to entertain a motion that we send the letter.
MR. BLAIR: I make a motion that the committee approve this letter on marketing, privacy and marketing.
MR. HOUSTON: I’ll second it.
DR. LUMPKIN: Moved and seconded. Is there any debate on that? All those in favor signify by saying aye.
COMMITTEE: Aye.
DR. LUMPKIN: Any opposed say nay. Any abstentions? Okay. The second letter.
MR. ROTHSTEIN: Our second letter deals with the issue of fundraising another frequent topic of our concerns and our recommendation appears on the second page, we believe the privacy rule had adversely impacted fundraising and we are recommending that HHS allow covered entities to use information related to the patient’s department of service for fundraising activities without an authorization and we further urge that this be applied broadly, that is the designation broadly, and to retain the prohibitions on disclosure of information relating to diagnosis for treating physicians.
So in other words the broadest possible definition of department of service so you can imagine in a hospital setting we would be thinking of six or seven broad designations rather then the subspecialty group. This in itself we believe would be very cost effective for large general hospitals, at the same time would not infringe upon the privacy rights of patients for reasons that we explain in the letter.
DR. LUMPKIN: Any questions on the second letter? Russ?
MR. LOCALIO: This is Russ Localio. It was several years ago when I first read the rules on fundraising and I said this is going to be an issue and there are going to be a lot of complaints because I always follow the money. But having said that and I’m not really opposed to this change what I do want to say is this in some fashion raises a problem of expectations of privacy because we’re now going to have people who have been treated who are no longer going to have an expectation of privacy about what department they were treated in for purposes of fundraising but the research community faces real problems in this same area because they cannot use the same even broad designation to try to recruit patients in many institutions, this becomes a problem in recruitment. So you can recruit people, when this letter goes out in some sense you’ll be able to recruit people for fundraising using this type of information but not for research. And I think that poses some inconsistency, so again, I’m not opposed to this, I would just like to see the same type of consideration given to other essential activities of institution.
DR. LUMPKIN: Other discussion on the letter? Judy?
DR. WARREN: When I read the letter I was just wondering if you heard testimony from patient advocacy groups about this, what their response to recruiting for fundraising this way was.
MR. ROTHSTEIN: We did solicit input from patient advocacy groups, not in terms of witnesses at this hearing, we did get written testimony from the Georgetown Health Privacy Institute. We also in the past have received oral and written testimony at at least two, maybe three prior hearings on this issue and so we are familiar with the issue.
My impression is that there have been few complaints about fundraising and I’ll defer to Sue whether there have been any complaints that she’s aware of in terms of fundraising. It could be that there may be further complaints if this new policy were implemented. I think that clearly the current policy strikes a balance between patient privacy and the interests of non-profit organizations to support their research and clinical activities through patients and I think the current rule strikes a balance that is I think quite favorable in terms of the patient side of it.
I’m not sure, I mean knowing the way I tend to look at things the members of the full committee would realize that I would not support this letter were it not for my belief that a very slight increase in patient privacy may be gained at a very substantial cost to the financial viability of the institutions and therefore I am convinced that this is warranted.
DR. LUMPKIN: John.
MR. HOUSTON: Let me just add one comment, I know it’s stated in the letter but I think it’s relevant and important. One of the issues that we did hear of was the fact that if you were a free standing specialty facility you would be able to do fundraising to that specific patient population anyways and really who is disadvantaged in these cases was very large hospitals and health systems that had a number of specialty areas and then would be at a disadvantage in terms of trying to do fundraising to those specific populations. So depending on who you were you might be able to do targeted fundraising, you might not be able to do targeted fundraising, just simply because of your organizational structure.
So in one sense we sort of saw that there wasn’t any additional infringement on a patient’s privacy just simply because of that and I think also having come off the marketing hearings it’s clear that you have, here you have pharmacies and other people, individuals, who might be sending mailings to a patient which were very descriptive of their condition under the guise of treatment or offering treatment alternatives, whereas I think what we heard from the fundraising people is they take great pains to respect the privacy of individuals and they take great pride in that yet they demonstrated statistically there was a substantial impact on profit giving.
DR. LUMPKIN: And I would be remiss to note that we do have agreement between two lawyers which is also equally unique. Vickie?
DR. MAYS: My first point actually was raised by Russell, Russell we seem to have so much agreement today. But the second one I want to get to is the one that was also just raised, what bothers me in the letter is if you heard from like patient advocacy groups it might be helpful to have a little balance to it or something because when you actually read it, hear what’s talked about, is when you’re reporting what happened with Johns Hopkins and then you talk about their inability to secure approximately one half of their patient agreement it worries me then, and it’s like we can hear from you that the patient advocacy groups and others have said that they’re okay with this but in just reading the letter I would worry just a little bit that that side isn’t represented.
DR. LUMPKIN: Bob?
MR. HUNGATE: A related comment, Bob Hungate, the disclosure form that I recall signing in my dentist’s office, my doctor’s office, and at the hospital made mention of sharing of information for processing of claims and various assorted things. I don’t think it said anything about fundraising and so I’m not sure about the coherence between this recommendation and what the patient has allowed in terms of what they signed off on so that’s an element of uncertainty in terms of the applicability of this on the street and I don’t know how to deal with that.
MR. ROTHSTEIN: Well, I think certainly if a change were made in the privacy rule that it may be one of the things that would have to be added to the NPP, which would indicate that non-profit organizations will be given X, Y, and Z, and you have an opportunity to opt out of that information if you want, I think that’s certainly a position that I would take but it’s not one that the subcommittee specifically addressed. John, do you want to speak to that?
MR. HOUSTON: I agree with you, I mean I just simply agree with Mark, I think we could probably add that to the letter --
MR. ROTHSTEIN: But I am, I think Vickie also raises a good point and maybe we need to revisit this letter in terms of the documentation and add some additional language. The other thing that I would further suggest that we revisit is possibly taking out the specific statistics that we have in there because these are industry reported numbers and frankly I’d have no idea what that means given the fact that the contributions to all sorts of charities have declined over the last several years and I wouldn’t want people to draw any conclusions from our listing those in the letter.
MS. MCANDREW: If I could just respond to a couple of things, in terms of complaints that we have had I don’t know that we’ve actually had a formal complaint about fundraising, I do know early on with regard to some of the complaints that we had about notice one of the most frequent things that people reacted to was the inclusion in the notice of the reference to fundraising, this is just isolated instances and I can’t indicate that it’s any kind of a trend but it does also serve to go to the notice conversation and the current requirements are that there be an expressed reference to use of patient information for fundraising purposes in our current notice requirements. What that reference is would only go to what the rule currently permits used for fundraising purposes and if we made this change in the rule that provision for notice is already there and it wouldn’t need to be changed.
DR. LUMPKIN: Gene?
DR. STEUERLE: I view this letter as partly information providing and I guess I would not take out the data the industry is providing because that apparently is although anecdotal information they’re providing on what they think are issues of concern to them. By the way, giving to the charitable sector is not really down on average, it went down and then it went back up a little so I wouldn’t make too much of how you compare to national statistics.
I do see, this gets back to some earlier issues sort of in conflict here, I think from a legal standpoint the issue is what does the law require as to regulate, what is the intent of the legislator. But from an economics standpoint the general rule is if you don’t know the burden of proof is on the regulator and not the regulated so when you restrict somebody from fundraising and I have actual experience about a lot of fundraisers quite honestly, but when you restrict somebody from fundraising without fully knowing what’s going on the burden of proof is, the general principle of government is on the regulator and this is saying we’re having an impact in an area, we may, we don’t know, we may be having a negative impact, and that calls into question at least if that regulation doesn’t have to be there, that interpretation doesn’t have to be there, whether we want to do it.
I don’t know whether this makes sense or not, I guess I would favor putting the letter, I would favor putting in Russell’s comment about other implications for providing this information and you’re going to have this tension between if Congress clearly intended that you couldn’t fundraise then yes, maybe as a legal matter, or you couldn’t provide this information to fundraisers then maybe that’s an interpretation. But if that’s not a clear intent and you don’t know, as I say the burden of proof is not on the hospital community and the fundraisers to prove that they’re doing more harm then good, it’s on the regulator to say we’re restricting you from doing something and we have some evidence that this is worth doing. So I’m somewhat speaking in favor of the letter with the additional information, I would not take out information.
MR. ROTHSTEIN: Well I appreciate your support for the letter but I would say that I disagree with your rationale, I think as a principle of ethics and as a matter of law when you invade someone’s privacy and disclose private information about them without their consent you better have a pretty darn good reason and that means that the burden is on those who would claim access to that information without the authorization or consent of the individual. I think in this case after weighing the best evidence that we could get that it was justified but only with all the various caveats that we want to put there, but we’re certainly willing to concede that it’s a close case. And for the record we have previously in a letter to the Secretary suggested changes along these lines even before the rule went into effect, if you’ll check back through our fundraising recommendations to the department, so this is not that great a departure, it is sort of a revisiting of the issue and sort of a post implementation date assessment of what we perhaps need to do to improve the implementation of the rule.
DR. LUMPKIN: Judy, and what I was motioning to you to is that we can’t let you two sit together again because when I look at you and say Judy then you don’t know who --
DR. WARREN: I just wanted to support that when I read this letter I really got a negative impact because it didn’t mention anything about patients, it only mentioned about the ability of institutions to fundraise. And so I came in prepared to really be kind of negative about the letter but if you could include in the letter the piece about the patients and that you’ve heard from the advocates then I’m very pleased with that, so I just wanted to support your inclusion of some of that content.
MS. BEREK: We sat together on purpose just to confuse you. And I’m not speaking as CMS, I’m speaking right for a second as a patient of multiple institutions and facilities, and I get just as angry when I get fundraising letters that are clearly based on private information as I get drug company letters, and I have never filed a complaint but I think in fact it is a real issue for people, for patients, and it’s something to just think about in terms of, I mean I understand the institutions need money but I think we really, before you vote on this since I don’t have a vote we really ought to think about that.
DR. LUMPKIN: Okay, I think we’ve given some guidance to the subcommittee.
MR. ROTHSTEIN: Indeed. The third letter I’m confident will be less controversial, although I do have two minor changes to make, this draft you see was on July 19th so I propose to change the first sentence to the end be retired instead of will retire --
DR. LUMPKIN: Okay, can you perhaps read the entirety since, given the character of the letter.
MR. ROTHSTEIN: Oh, sure, I’d be honored to read this letter.
On July 30th, 2004, after more then forth years of service to the Department of Health and Human Services, John P. Fanning, the Department’s Privacy Advocate, retired. The National Committee on Vital and Health Statistics (NCVHS) is writing to commend John P. Fanning on his distinguished career. For many years the members of the NCVHS, and particularly its Subcommittee on Privacy and Confidentiality, have relied heavily on John Fanning’s intelligence, experience, dedication, good judgment, and common sense. We are indebted to him for his exemplary service and wish him well in his retirement.
The NCVHS would like to take this opportunity to reaffirm the importance of the position of Privacy Advocate. New developments in health information technology and its legal regulation make clear the increasing importance of thoughtfully anticipating and addressing the numerous issues of health privacy. We respectfully urge the Department to begin the process of selecting a successor to Mr. Fanning.
DR. LUMPKIN: Is there any opposition to this? All those in favor signify by saying aye.
COMMITTEE: Aye.
DR. LUMPKIN: Opposed nay. That was moved by Mark Rothstein and seconded by John Houston.
Well, I think we have, is that it?
MR. ROTHSTEIN: Yes, John, that’s it.
DR. LUMPKIN: What we’re going to do is take a 15 minute break and then we’re going to proceed with the letter on the NHII.
[Brief break.]
Agenda Item: NHII Letter - Dr. Lumpkin
DR. LUMPKIN: Okay, the next item is a letter to the Secretary as a follow-up to the meeting of the NHII Workgroup, this meeting was at the tail end of the Secretary’s Health Information Technology Conference/NHII Conference that was held in July. It seems like it was just yesterday, it seems like it was yesterday but it also seems like it was a long, long time ago.
We have in front of you the letter, I will just read the areas that were identified, this letter will be sent in addition there will be two appendices attached to it, one is the reports that were given by the various breakout sessions to the NHII workgroup, and then the second being we received from communications from individuals subsequent to that conference.
Some areas where additional work appeared to be needed first was understanding from the consumer and health care industry perspective, approaches and best practice and the issues related to the use of master patient indexes and other methods to assure that healthcare information can be reliably associated with the right individual. And in this we note that the NCVHS will schedule hearings on this issue, at the Executive Subcommittee we kind of worked out a lead subcommittee for that activity, right Simon?
DR. COHN: I think in some cases we realized that some of these things were joint subcommittee activities.
DR. LUMPKIN: Yes, yes. The second is issues related to patient control of their personal health information, deficiencies in the privacy rule, and the need to balance data exchange that is essential to health care with enhanced personal control. And we are holding hearings and will continue to hold hearings on this area.
General policy issues elated to personal health records and the workgroup is scheduling a hearing for this fall and we’ll talk about the agenda for that hearing at our meeting this afternoon.
The next is general policy issues related to developing a research agenda for the NHII, this again was discussed at the Executive Subcommittee and we’ll talk a little bit about this more tomorrow but the importance of looking at that as a role of the NCVHS paying attention to the research agenda.
The next is issues related to the movement of data between health care, population health, and personal health dimensions in general and secondary uses of data from any dimension.
The next item was developing a comprehensive statement on rules of the road, including but not limited to interoperability, legal obstacles, and in general the key things that potential participants need to know about how to participate in NHII. And the workgroup will be discussing that this afternoon, Steve Steindel developed a straw document for us to work off to begin that discussion.
There were two issues that were raised but we thought that since there was some indication that this was already ongoing in HHS we did not put on the agenda, the first is metrics for measuring progress and the second is conformance testing.
The proposal is we would send this letter with the attachments, which would be essentially a report from the conference to the Secretary. Are there any questions or discussion on the letter? Mike.
DR. FITZMAURICE: A question on the first page, first bullet, the committee recognizes that the issue of linking personal health information is associated with that of privacy and authorization which will also be examined as indicated next. Does that mean next in time, that is that’s the next thing on the agenda, or is that a word that could be deleted?
DR. LUMPKIN: I think it means the next bullet, below, yes.
DR. COHN: John, I guess as Michael brings up this first bullet, I guess it was causing me to look hard at the sentence that I think he was referring to. And I guess I’m wondering, it says the committee recognizes that the issue of linking personal health information is associated with that of privacy and authorizations which will also be examined as indicated next, and I guess the questions I’d have for you is I’m not sure that I necessarily saw the first sentence as being explicitly linking personal health information though it may lead us to that conclusion, and I guess I’m trying to figure out whether the issues are privacy and authorization are in hearings identified next, or whether they’re part and parcel of the hearings around master patient indexes and all of those issues.
DR. LUMPKIN: Well perhaps the clearest would be just to say which will also be examined, period.
DR. COHN: Okay, I guess is there different wording other then linking personal health information that we might use? I mean we’re talking about linking between the patient and the information, is that the linkage we’re talking about? Or are we necessarily talking about linking all information about a person to that individual, which linkages are we talking about here?
DR. LUMPKIN: I think in the context of this it really is the issue of record linkage, so it’s how do you uniquely identify, let me not use that term, how do we take an individual and assure that the information that is being used to do clinical or other kinds of care related decision making is actually that person’s information.
DR. COHN: Maybe this is a friendly amendment only because I’ve tried to stay away from this particular concepts in the bullet that has anything that I have to do with. But I’m actually wondering if basically saying something like the committee recognizes this is an issue both of standards as well as privacy and confidentiality or something on that level, and both will be examined, and maybe leaving it at that.
DR. LUMPKIN: The committee recognizes that this is an issue of standards --
MS. GREENBERG: This is what, a standards and a privacy issue?
DR. LUMPKIN: Yes, the committee recognizes that this is both a standards and a privacy issue and will examine both aspects. So let me try to see if I can read that again, the committee recognizes that this is both a standards and privacy issue and will be examining both aspects. I hope somebody has that. Good. Any other, Bob?
MR. HUNGATE: Yes, on the second page the third bullet relating to issues related to the moving of data, second sentence says the information flows are essential to strength and quality assessment and research as well as other endeavors. I would like to add the concept of quality improvement to quality assessment in the verbiage there.
DR. LUMPKIN: Quality assessment and improvement --
MR. HUNGATE: Or improvement, assessment and improvement is probably the right order.
DR. LUMPKIN: Okay, so that sentence will read these information flows are essential to strength and quality assessment and improvement and research as well as other endeavors. Okay, seeing no other questions or comments I think we can move this one, it’s been moved by Jeff and seconded by Simon, oh, John seconds --
DR. COHN: I think John seconded it, yes.
MR. HOUSTON: Yes, I second it.
DR. LUMPKIN: Okay. All those in favor signify by saying aye.
COMMITTEE: Aye.
DR. LUMPKIN: Opposed say nay. Any abstentions? Okay, we’ll ship that one off.
Let’s move on to discussion of our major item on e-prescribing. A letter was sent out before the meeting, the draft of the letter, and I hope everyone had a chance to read it.
Before I toss it over to Simon I would just again like to congratulate the Subcommittee on Standards and Security for doing such a wonderful job in such a short timeframe, I know it was extremely a lot of work and I also wanted to thank the staff members who worked with the committee who spent their August not recreating in the Western Pacific but actually working on getting this forward and I thought the letter was certainly has moved us in a big step towards e-prescribing, so let me turn it over.
Agenda Item: Standards and Security, Letter on e-Prescribing - Dr. Cohn
DR. COHN: Well John thank you, obviously I hope that we all feel as positive about it after we’ve gone through our reading of it but we do appreciate the nice comments.
Obviously it’s with great pleasure that I bring forward for consideration by the full committee this first set of recommendations on standards for e-prescribing. As you know this is a work of the Subcommittee on Standards and Security and is really meant to be the first of two sets of recommendations planned as requested by the Medicare Modernization Act of 2003. As I think we’ve said a number of times there will be additional hearings later this fall and winter with an additional set of recommendations coming forward so this is I think an important set of recommendations but there will be more that we will be considering in March.
Now we will soon start reading this letter and given that you’ve only had about a day and a half with it I think we do need to read through it and sort of take it section by section by comments. But before that I want to just thank a lot of people, I think we want to start off by thanking Jeff Blair, our vice chair, who has been instrumental in moving the work plan forward, developing and moving the work plan forward, and obviously Maria Friedman who has been our lead staff, obviously without them we would not be able to come forward today. I also wanted to thank just a moment and just recognize all the others, subcommittee members and then staff, obviously Harry Reynolds, Stan Huff, Judy Warren, all of whom have spent much of their summer in Washington helping make this all happen.
Now John indicated all the days of hearings we’ve had, he neglected probably because he didn’t know about the additional ten days of open conference calls we had in the last week to try to bring this letter to a more polished version for you all to consider. Obviously we also want to thank all of the other subcommittee members that have been assisting us, Steve Steindel, Vivian Auld, I’m missing others, Randy Levin and others, who I think once again without their work and assistance we once again would not have a polished document at this point.
MS. GREENBERG: And of course Margaret.
DR. COHN: I’ll get everything but the obvious here, obviously Margaret A, who is before us, who’s I think done a tremendous job, Marjorie also who has sat in all meetings and all conference calls to provide input and guidance in all of this. Have I missed anybody? Is there anybody in the room, oh, Michael Fitzmaurice, thank you, I knew I was going to, since I didn’t have this list, Jeff I started out with so I think I’ve covered everybody, oh, Karen Trudel, okay Karen is not a member of the staff but it certainly felt like it during last session --
MS. GREENBERG: She is staff.
DR. COHN: Are you staff? Okay, anyway, this will teach me to try to name off everybody without having a list.
Anyway, it was my original plan actually to bring some Power Points to set the stage and actually I was persuaded that that is not something that we should do, on the other hand John Lumpkin did bring up one issue so we will go through one Power Point as we go through the letter just describing the process of e-prescribing, so I can’t say truly we’re not going to do Power Points but what I want to emphasize is that it’s very important the letter be able to stand on its own. This letter is not going to be very effective and not going to do what it needs to do if anytime it’s being discussed one has to start out with a couple of Power Points to describe what’s going on and so I’d like you all as we go through the letter to keep that in mind and so if things are not clear we need to hear from you about that.
Now we have about, I guess at this point we have about three hours to go through the letter and I realize that’s a lot of time, but on the other hand getting, one hour before and then two hours after lunch, but on the other hand this is a 15 page letter so I don’t want to, I think we probably will need the time. It has I believe I think it’s 16 observations and about 40 recommendations so it puts it sort of on the level of an IOM report in terms of the number of recommendations so I think we will need this time.
Before lunch what we’re going to try to do is to go through sort of the introductory material, it basically describes things like current prescribing and e-prescribing environments, our process leading to the observations and recommendations and make sure that everybody is comfortable with that. After lunch we’ll jump into the observations and recommendations. Obviously I think what we’ve asked people to do and as you look through this we obviously want to talk about the issues and the recommendations, if there is wordsmithing, and we obviously know that everyone’s good at this, we would ask unless it’s substantive that you basically hold the wordsmithing and we’ll take it and incorporate it as appropriate into the letter. Indeed I guess we would hope that eventually what would happen is that the letter would be accepted with the ability to do further wordsmithing as necessary as long as it doesn’t change the meaning of the document, so that’s one again what we want to keep in mind. Is everybody okay with this at this point?
Now any questions before we start with the reading? Okay, now I think you also notice that you’ve received, and it’s obviously smaller print so I do apologize, a slightly marked up version. I will note where there’s been a couple of changes, once again wordsmithing changes and the addition of a footnote as it comes up but being over 50 I find the larger versions a little bit easier to read so I will read from that and Margaret you can help us if we come to an area where I’m noting that there’s a change.
Okay, the letter starts out and I’ll just read it section by section and then I’ll ask if there’s any comments.
Dear Secretary Thompson:
The National Committee on Vital and Health Statistics has been called upon by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to develop recommendations for uniform standards to enable electronic prescribing, otherwise known as e-prescribing. E-prescribing should enable significant improvements in patient safety, quality of care, and cost effectiveness. Standards for e-prescribing must not only meet the requirements of MMA but must also be compatible with all other standards that are becoming part of the NHII. This includes standards developed under HIPAA and the Consolidated Health Informatics Initiative.
In order to expedite the development, implementation, and pilot testing of e-prescribing standards by HHS NCVHS is providing this first set of recommendations. Additional recommendations will be sent in March 2005.
Comments? Russ?
MR. LOCALIO: This is Russ Localio, when I read the first section here I just said to myself I think I know where people are going but it doesn’t say exactly where you’re going. The report on April 14th of 2004 talks about recommendations da, da, da, in ambulatory care but the letter, and I kept going back and forth when I was looking at the letter, it does not have that restriction so I would have to ask the fundamental question is it the purpose of the e-prescribing letter and initiative to be confined to ambulatory care prescribing and if so why and if not why.
DR. COHN: Jeff, I see that you want to answer that, please go forward.
MR. BLAIR: It’s a good observation and it really was missing up front intentionally because the MMA focuses on ambulatory care but as we go through the letter we point out that we cannot look at the issue of e-prescribing in isolation only in the context of ambulatory care. Some of the recommendations, or many of the recommendations, have to be specific to MMA but they also have to be compatible with the other standards and that is the reason that we didn’t at the beginning isolate this to ambulatory.
MR. LOCALIO: I gathered that because when I read the statute I said well it’s obvious this is confined to Part D which is ambulatory but again, I’m not sure that, given the letter is meant for more then, the intention of the letter, the audience for the letter is more then Secretary Thompson, do we agree on that?
DR. COHN: Yes.
MR. LOCALIO: Okay. So I don’t know how you want to address this problem because it hit me in two seconds when I started off, that this was a big issue, I just see the problems of prescribing inpatient which is what I’m more familiar with as being different but the same, and I just don’t know how to react to what you just informed me that you’re deliberately leaving out the fact that it’s ambulatory or that that’s the statutory authority.
MS. GREENBERG: Well, I was just wondering if you could just say standard, expand this one sentence here, standards for e-prescribing must not only meet the requirement of MMA and the ambulatory care environment but must also be compatible with all other standards and the rest of that sentence.
DR. COHN: I’m struggling because I think, I actually agree with you, Russ, and I actually think the best place to stick it is actually at the end of the first sentence, to enable electronic prescribing in ambulatory care. But I actually think we need to probably at the subcommittee level talk about how best to insert those terms and where it should be in the first paragraph, or how we frame it, because what we’re really talking about is Part D, which is 99.9 percent and ambulatory, actually is probably 99.999 and ambulatory --
MR. BLAIR: Marjorie’s suggestion I think really was a very good one though because it --
DR. LUMPKIN: Let’s do this, rather then trying, I think we can bookmark that as a potential solution, let the subcommittee work on that.
DR. COHN: But Russ I want to thank you because I think it actually is a good point, that we need to somehow, because I really think that even though we do touch on other environments it’s really focused on enabling ambulatory e-prescribing so we need to come up with a way to say that up front.
DR. LUMPKIN: So we can ambulate on.
DR. COHN: Yes, we will ambulate on. Other comments in this first section? Okay.
Current Prescribing Environment. Today prescribers, and by that we mean physicians and others who write prescriptions, make their drug-prescribing decisions using whatever medical, medication, and eligibility information is known or available to them. Typically they give a handwritten prescription to the patient or fax it to the dispenser, in other words the patient’s pharmacy of choice. At the dispenser tasks are somewhat more automated. Through internal and external electronic claims, eligibility and benefits verification processes the dispensing pharmacist may identify contraindications, lower cost alternatives, or the need for prior authorization. At any of the steps in the process the dispenser may need to contact the prescriber by phone for clarification or approval of changes. Dispensers also must frequently call the prescriber to obtain approval for refills or renewals where they are not specified on the prescription or when they have run out. According to some estimates almost 30 percent of the three billion prescriptions written annually require dispenser calls. This equals 900 million prescription-related telephone calls annually.
Many reports have identified that the current prescribing process is prone to errors. Prescribers may not have access to the latest drug knowledge. They often do not have a complete or accurate medication list or even medical history for their patient, and, as a result, they can miss potential contraindications or duplicate therapies. Dispensers often have difficulty reading handwritten prescriptions and frequently have little or no information about the patient’s condition for which the prescription is written. Contacting the prescriber by phone to clarify what is ordered and to make changes often results in delays for the patient, and it is time consuming for both the prescriber and the dispenser. There are disconnects between the prescriber and the patient in the medication process, with little or no feedback to the prescriber on whether a prescription was filled of what generic substitutions were made. Each year more then eight million Americans experience outpatient adverse drug events. Analysis shows that e-prescribing systems can avoid more then two million adverse drug events annually, of which 130,000 are life threatening.
Questions? Comments? Okay. Do people want to have a quick look at the e-prescribing process at least as I think Margaret and the rest of us envision it currently? Is this a useful quick Power Point? Margaret, do you want to just quickly go through, and I will apologize to everyone but this is a, and once again we just have to realize that the process is highly variable but I think this describes often what is a normal set of processes occurring and communications between the prescriber, dispenser, otherwise known as the pharmacy, and payers or pharmacy benefits managers, which obviously at the end of the day is the one paying for much of the medication prescribed. Margaret, do you want to quickly just go through this?
MS. AMATAYAKUL: Okay, this is a work in progress. The prescriber examines the patient and reviews the patient’s chart, writes a prescription, gives the patient a paper copy or faxes to the dispenser the prescription. The dispenser receives the prescriptions, hopefully, checks the pharmacy information system for allergies, other medications the patient may be on, and some limited formulary information from the payer perhaps if they have the patient already registered. Calls the prescriber if the prescription is illegible or if there are an other issues that need to be discussed with the prescriber. Then transmits a claim to the payer, payer receives the claim, checks formulary and benefits, and advises the dispenser if there are other contraindications that the payer PBM may know about and the pharmacy did not, indicates the co-pays and whether there are any prior authorization requirements.
The dispenser then calls the prescriber if there’s a change needed, so the prescriber receives the call from the dispenser, calls the payer PBM for prior authorization if necessary, calls the dispenser back with prior authorization if necessary. The dispenser then may have to reinstate the claim, at that time the claim is paid and the dispenser receives payment and finally the prescription gets filled.
DR. COHN: Everybody got that? They’ll be a test at the end. Any questions? And once again this is a highly variable process but this sort of speaks of all of the communication that occur between and obviously why it may make sense to computerize a lot of all of this.
Current E-Prescribing Capabilities, which is the next session.
E-prescribing has the capability of addressing many of these issues. The eHealth Initiative provided a helpful framework to conceptualize e-prescribing systems. It describes graduated levels of functionality, producing differing sets of benefits. Today, various levels of e-prescribing systems are being implemented. However, the lack of prescribing standards has forced the industry to use workarounds to accomplish many aspects of e-prescribing. The following describes levels of e-prescribing systems derived from the eHealth initiative framework and the extent of their use today.
The first bullet is Basic Reference Information. E-prescribing reference tools provide basic drug information, dosing calculation, and formulary information. Recent estimates suggest that about 15 percent to 17 percent of prescribers use such systems. These systems may prevent errors by making appropriate reference information readily available. While there are several formulary reference products on the market, their content and format are not standardized. Some community projects have attempted to map the various formulary products to one another.
The second bullet is Standalone Prescription Writers. These e-prescribing applications produce a legible prescription and include dosage information. They do not provide access to any patient specific information or connectivity with dispensers.
The next bullet is Integrated E-Prescribing Systems. These systems are more sophisticated in several ways. Some products combine patient demographics, allergy, formulary, and plan information. Others can assist in medication management. Still others may connect the prescriber with the dispenser to transmit a prescription. To obtain patient demographics and allergy information the products depend on either linking to a practice management system or the re-entry of data. To receive formulary and plan information prescribers may connect with third party information exchange networks that integrate medication history and other eligibility information from pharmacy benefits managers. To route e-prescriptions to dispensers prescribers often use electronic fax, which require re-entry of the prescription information by the dispenser. Some prescribers with electronic data interchange capability are routing prescriptions through a switching network. The National Council for Prescription Drug Programs, hereafter referred to as NCPDP, has developed a standard called SCRIPT for communications between prescriptions and dispensers. NCPDP estimates that 75 percent of pharmacies have the capability to receive messages using the SCRIPT standard. However, fewer then three percent of all prescriptions are written by prescribers using an integrated e-prescribing system.
The final bullet, Electronic Health Record Systems with E-Prescribing. Still further enhancements to quality and patient safety can be achieved by integrating the medication order into the overall process of medical care delivery. This level of e-prescribing requires an electronic health record that integrates data from multiple sources, is used at the point of care, and provides evidence based clinical decision support. EHR systems are deployed at an estimated 14 to 28 percent of practices. It is unknown how many of these are comprehensive EHR systems and how many utilize standard industry protocols.
Comments, questions? Shall we move forward? Okay, Standards Evaluation Process.
Charged with the task of recommending standards for e-prescribing to promote patient safety and quality health care NCVHS scheduled testimony in 2004 to learn what standards are needed to support e-prescribing, how MMA requirements are supported or not supported by current standards, i.e., standards gaps and limitations. Finally what related issues exist that may affect the implementation or acceptance of e-prescribing.
After this information was gathered NCVHS then reviewed the standards gaps and limitations with the standards developers. This dialogue helped NCVHS determine what standards have adequate industry acceptance and what actions are necessary to address gaps and limitations in standards for them to be available for the MMA demonstration projects beginning January 2006, and then we have an appendix that will be included that describes the work plan, which I think you’ve all received previously.
The MMA provides that pilot testing of standards is not required where there already is adequate industry experience with the standards. At the July 21, 2004, Health Information Technology Summit HHS announced its intent to accelerate the implementation of e-prescribing by proposing an initial set of well established standards for implementation by January 2006, when the Medicare Part D benefit begins. Standards appropriate for inclusion in this initial set are identified in the NCVHS recommendations below as “foundation standards.”
I think I’ll stop there for a second and ask if anybody has any questions at this point. Obviously we’re referencing part of the MMA regulation, we’re also mentioning this concept of foundation standards as being something the Secretary might come as an initial set. Okay.
Stakeholder Testimony. NCVHS received testimony from all stakeholder groups identified in the MMA, i.e., standards setting organizations, practicing physicians, hospitals, pharmacies, practicing pharmacists, pharmacy benefit managers, state boards of pharmacy, state boards of medicine, experts on e-prescribing, other appropriate federal agencies. In addition, testimony was heard from e-prescribing networks, demonstration projects, software developers, and consumer advocacy organizations, and then we have an appendix with a list of all the testifiers. In over 11 days of deliberations from March to September 2004 NCVHS heard from 65 testifiers and other industry experts.
In making its recommendations NCVHS utilized the guiding principles and requirements identified in the MMA for selecting e-prescribing standards. And these bullets are improve patient safety, improve quality of care, improve efficiency, including cost savings, not present an undue administrative burden on prescribers and dispensers, be compatible with other standards, permit electronic exchange of drug labeling and drug listing information maintained by the FDA and the National Library of Medicine, include quality assurance measures and systems, permit patient designation of dispensing pharmacy, comply with HIPAA privacy regulations, and support interactive and real time transactions.
Types of Standards and Important Related Issues, and then we’ll sort of discuss all of these three areas, and this is really I think an important one that everybody just needs to be aware of because it really speaks of the scope of the recommendations.
There are three types of e-prescribing standards that NCVHS identified and evaluated as being necessary to support e-prescribing. They are message format standards that provide communication protocols and data content requirements, including those to support medication decision making, terminologies to ensure --
MR. BLAIR: Simon?
DR. COHN: Yes?
MR. BLAIR: I think there was a sentence or two that was skipped at the bottom of the guiding principles.
DR. COHN: Oh, I’m sorry, you know you’re right, okay let me read this and I will go back and reread that. Thank you, this will teach me for trying to zip through this.
Terminologies to ensure data comparability and interoperability, and identifiers for all relevant entities within the e-prescribing process.
NCVHS further observed that deployment of e-prescribing may involve policy or workflow issues that are outside the scope of standards but are important related issues.
Now as Jeff has commented and I apologize, there actually is a sentence that I skipped over and let me just reference this in related to guiding principles for selecting standards and then we’ll discuss this whole page.
It says in addition NCVHS believes the standards should be vendor neutral and technology independent, preferably be developed by ANSI accredited standards development organizations, and have suitable indications of market acceptance.
So I just want to stop there and Jeff I do apologize for missing what you’re right is a key sentence. Well, we’re moving through.
Our next section and this is the remaining part of the document that’s observations and recommended actions, Jeff before I jump into this one I actually had meant at the every beginning to offer you an opportunity to make any comments. Do you want to make any comments as we move into observations and recommended actions, other then I need to read slower --
MR. BLAIR: There’s only one brief comment and the one comment that I kind of would share with the full committee as we start to go through this is that the Subcommittee on Standards has come up with recommendations and brought it to the full committee many, many times and what we’ve listened to the industry in the past. And as much as we’ve tried to be close and sensitive to the industry the e-prescribing recommendations I think are remarkable in the degree of, I think maybe the word is almost collaboration, we worked so closely because we were limited on time with the testifiers and we reviewed so closely back with the developers of the standards and terminology developers in crafting these recommendations that I think it would be very fair to say that these recommendations very closely reflect the advice and guidance of the e-prescribing industry.
DR. COHN: And I think I want to second Jeff’s comments, I mean this was I think an extraordinarily open process by all accounts even down to our ten hours of conference calls over the last week which were all once again posted conference calls. So I think that once again I think the industry certainly, at least from my perspective, felt that they were heard and hopefully we’ve moved this process forward.
Anyway, with your permission shall we move into our observations and recommended actions at this point? Okay.
NCVHS observes the that the U.S. healthcare system has made considerable progress in developing pragmatic solutions for e-prescribing. These solutions provide an excellent foundation to build upon. The status of each e-prescribing standard evaluated is described in detail in the working document in Appendix C, which is how many pages is it? 65 pages, we didn’t send that out, and once again this is more of a reference document that will be included with the letter, it’s an appendix.
DR. LUMPKIN: There are many trees that are very glad that you didn’t send that out.
DR. COHN: Yes, exactly, this is sort of the fact base upon which we used to help validate a number of the recommendations.
Following is a list of observations and associated recommended actions. The observations describe the purpose and extent of industry experience regarding a standard or issue. The recommended actions under each observation recognize first any foundation standards, then the actions to address additions, development, and pilot testing necessary to meet the MMA requirements. While foundation standards do not in themselves need to be pilot tested they do need to be tested with the expanded functionality required by MMA. The observations and recommended actions are grouped as follows: general overarching items, message format standards, terminologies, identifiers, and important related issues.
Comments? Okay.
Observation 1, actually Observation 1 and 2 are these, are things that we describe as general overarching items. Observation 1 is general standards compatibility. Many testifiers emphasized to NCVHS how important it is that e-prescribing standards be compatible with all HIPAA standards, CHI standards, and clinical data terminologies recommended by NCVHS in November 2003. This is to avoid dual standards for Medicare Part D and all others. The testifiers’ observations are consistent with the MMA requirements that e-prescribing standards should be compatible with HIPAA standards and “general health information technology standards.”
Recommended Action 1.1: HHS should ensure that e-prescribing standards are not only appropriate for Medicare Part D but also for all types of prescribers, dispensers, and public and private sector payers.
Recommended Action 1.2: HHS should ensure that e-prescribing standards are compatible with those adopted as HIPAA and CHI standards and with those recommended in November 2003 by NCVHS for clinical data terminologies.
Only 15 more to go.
MS. BEREK: I’m going to make one general comment, I’m not from the part of CMS that actually does this piece so that I read this letter last night cold without any general knowledge, this letter does an incredibly good job of explaining the issues, the problems, and then coming up with recommendations and I think that’s why we’re so quiet, that you really have done an incredible job of making it possible for those people who do not do this every day to understand where you’re going. So the silence I think is a real compliment to the people who wrote the letter.
DR. COHN: Well, let’s wait until we’re done with the rest of the 15 recommendations --
And Jeff and Margaret you obviously need to be lauded for incredible work.
Okay, so we’re into Observation 2, which is general standards versioning. There are lessons learned from HIPAA regarding both the value of standards and the need for flexibility to respond to industry requirements and technology changes. There are a number of approaches that could be considered to provide the industry greater flexibility and ability to advance while maintaining standardization of messages and data. For example the CHI has set a precedence for this through adopting a version of its clinical information standards as a baseline from which new versions may be adopted by the industry when ready although this process is different from the process required for standards adopted under HIPAA.
Recommended Action 2.1: HHS should work with the industry in its rulemaking process to determine how best to afford flexibility in keeping standards in pace with the industry, including standards for HIPAA and e-prescribing. For example HHS might consider recognizing new versions of standards, without a separate regulation, if they are backward compatible.
Okay, the next set are leading to message format standards.
Observation 3 is Prescription Messages, actually let me, I think we have one minor wordsmithing change in Observation 3 as I remember so let me, okay, these are just very minor grammatical fixes. Prescription Messages: The NCPDP SCRIPT standard provides for the exchange of new prescriptions, changes, renewals, cancellations, and fill status notifications. Each function has varying degrees of industry experience. The NCPDP SCRIPT new prescription function is most widely used. The renewal function has good industry acceptance, represents an easy transition, and provides the most immediately apparent return on investment. The NCPDP SCRIPT standards cancellation and change functions are currently underutilized. The business case for fill status notification from the dispenser to the provider has not yet been made.
The NCPDP SCRIPT standard allows for both free text in certain fields and choices of codes. It is critical to standardize on common, interoperable terminologies to provide automated decision support required by portions of the MMA that relate to patient safety and cost benefits. These items are specifically addressed in later recommendations.
Recommendation Action 3.1: HHS should recognize as a foundation standard the most current version of NCPDP SCRIPT for new prescriptions, prescription renewals, cancellations, and changes between prescribers and dispensers, and the world all has been removed. The NCPDP SCRIPT standard would include its present code sets and various mailbox and acknowledgement functions as applicable.
Recommended Action 3.2: HHS should include the fill status notification function of the NCPDP SCRIPT standard in the 2006 pilot tests.
DR. MAYS: Observation three you say the business case for fill status notification for the dispenser da, da, da, can I just ask are you advocating they do it or I’m just trying to understand why, that sentence just seemed to be there, do you advocate that, do you need it?
DR. COHN: Would somebody like, Stan --
DR. HUFF: The reason I think the sentence is there is that potentially fill status has an important medical benefit, that is the prescriber could know whether this thing would fill and so it could give the provider significant information about compliance. On the other hand we heard testimony from patients who said we actually don’t want our physician to know whether we received that or not and so this is an issue that we actually listed as one that we said we need more experience, then we actually need to talk to more people and we need to do experiments about that and that’s why we left this one in question.
DR. MAYS: Now I understand it but it just seemed kind of --
DR. COHN: I think Harry has a comment too on this.
MR. REYNOLDS: It also comes into play when we talk about downloading medication history because whether you do or don’t have the fill status when the person goes to the doctor the next time if the medication history is pulled down you also have the fill status again. So the whole thing around that process is why we left it that it needs to be piloted to truly understand exactly how this all works together.
DR. MAYS: Can you say that? Because otherwise it just hangs.
DR. COHN: Well, what should we say? Because the second piece which is Harry’s comment is actually the reference to the business case which is this issue of well, do people even really need it which seemed to be the question from the industry given that people would have an opportunity potentially if they were getting the medication history to pull down the next time they were seen. I don’t think we actually specifically addressed, we heard what Stan was referencing but I think we didn’t want to address it necessarily in the body of this particular recommendation. Marjorie?
MS. GREENBERG: I’m thinking it’s more, the problem I think is more one of parallelism which talks about one of the part standard is widely used, another part has good industry acceptance, a third is under utilized, and then you’re trying to say why the fill status I guess isn’t used at all, or maybe isn’t, so maybe just a kind of, I think this is kind of shorthand so people in the standards area understand well you’ve got make a business case before a standard is actually adopted and what have you, so maybe just a little expansion of that last sentence.
DR. COHN: Well maybe we need to say something, I’m just sort of thinking, Margaret may have a suggestion here but we’re almost sort of saying that the fill status notification function is not used and its business case is in question or is uncertain. Would that help, be a little more parallel?
DR. MAYS: Well, it’s kind of a little different, it’s interesting once you explained it it was a little different and it’s not just about the business case but it’s more that, you’re almost saying the business case needs to be made as if it’s a definite as opposed to we just need to have the business case made because it seems like it’s fine but we just need to have a case made for it. But it seemed like what was said today was that you’re not sure whether to do this or not, that’s a little different.
DR. LUMPKIN: It’s not just the business case, it’s the use case.
MR. BLAIR: Maybe this in combination with clarifying the sentence that Vickie has properly pointed out could be confusing to people, forgive my lack of a photographic memory but on the recommendations do we then recommend an action that the fill status be included in the pilot tests so that we could evaluate this? I thought we did but I’m not sure --
DR. LUMPKIN: Yes, 3.2.
MR. BLAIR: So if those are the two parts of the ways to address Vickie’s thought, but I’m not sure, Vickie, does that still leave an open question?
DR. LUMPKIN: I would suggest maybe we could have language something along the line the fill status notification function is not used today and its use case is not clear.
DR. ROBINS: Because the comment that was made over here is that the patient may not want the physician to know so what do you do if you are able, you do the pilot and you’re able to make the business case, which is that it makes sense from a cost perspective or an efficiency perspective to the dispensers and the prescribers but then the patients don’t really want it, so then what do you do? I mean is there a privacy issue here too?
MS. GREENBERG: Well, yeah, and I guess Stan’s point was not one that I would have incorporated into business case, it was more the issue of whether it’s redundant or whether people would use it or whatever. Being part of treatment and payment, I mean I would think that the provision of the information is already allowed under HIPAA but you could say here when you’re talking about the need for pilot tests, you could say to evaluate the use case or something like that, and patient acceptance if you thought that needed to be included in the pilot, I don’t know if you --
DR. COHN: That’s actually not a bad suggestion.
MS. BEREK: If I understood what Stan said is that we’re really trying to balance patient privacy and patient quality of care and so I think maybe that’s what needs to go in this sentence is that we need to look at the privacy and quality tension and the balance and I don’t know, I’m not a good wordsmither, but I think those are the two tensions really because if the quality of care works then the business case is there because it will give you better quality of care which will thus save money, but you need to, I mean I tell my doctors whether I take my drugs or not, I find it hard to believe people don’t want them to know but I think it’s worth looking at.
DR. COHN: Well, actually I won’t comment --
DR. CARR: I was going to say just something to the effect of clinical utility and value added, something, to be explored, but I think, I don’t know if it’s for us to decide the issue about whether the physician is allowed to know if the patient took the medication but I would vote that they are, speaking as one. I mean there are other ways physicians can measure and find out if a patient has taken their medicine so it’s not outside the realm of information that a physician already knows.
DR. LUMPKIN: And filling a prescription and taking the medicines aren’t the same thing.
DR. MAYS: I think Judith’s point is important because it gets back to what Harry just said and I think that, the notion of thinking about privacy and the patient and quality of care are the two issues here because I agree with what was said at first about you can make a business case but we’ve just left out this very important comment about the patient.
DR. COHN: I think for the record let me make a couple of comments, I don’t think I ever heard, this was nothing something we held specific testimony on in relationship to this particular issue, in fact if it is going to be brought up it will be brought up at the Privacy and Confidentiality hearings in relationship to all of this stuff. I think we heard allusions to this particular issue. I find myself, I think there’s a term here, I’m not sure the term is privacy, but I don’t know what the right term is just because this is so intimately involved with treatment and care of the patient, I guess I’m having trouble, it just doesn’t seem like it’s the right term here just because we usually speak of privacy as inappropriate access to information. But as I say that I’m just trying to think of where we go with this thing, we may be handling it appropriately by the way Margaret has wordsmithed it up here but we should look at it. Judy?
DR. WARREN: Well I’m wondering the issue, and I’m speaking purely from a standards perspective, we have several different parts of the SCRIPT standard and so as we took a look at each one of these messages that were part of the SCRIPT standard we were trying to figure out which ones were foundational and that we could recommend and which ones needed further testing. And so when we looked at fill status what the industry told is very few people use this currently, however the standard’s out there and so we felt that it should be evaluated within the pilots. We really didn’t talk I think about the ethical problems of privacy and I’m wondering if that should be in some place else but not with this recommendation. And then as soon as I say that then I struggle with the whole notion of privacy but somewhere we’re mixing apples and oranges in this and I’d like for us to try to clean it up a little.
DR. STEINDEL: What we heard during testimony as I recall it was there was discussion of the use of the fill status notification and the implications of it. The fill status notification can serve one of two purposes and is designed in that way, one is when the actual dispenser fills the prescription, i.e., the drug is sitting on the shelf waiting for someone to come in and get it. And there was a general feeling from the providers that that message really did not do any good. What they really wanted to know was when the patient came in to pick up the drug and the fill status notification is not really being used for that. And then several people brought up the implication that sometimes patients do not pick up drugs for a lot of privacy related reasons, some of which may have to do with affordability of the drug, some of it may have to do with their willingness to take the drug, they just accepted the prescription from the physician because they wanted to leave the office but really had no plans to take it, and we never explored that in any depth. And I think this is all related to the issue that the fill status notification is not clear and it needs to be explored in pilot if we want to use it and what are the implications of it.
MR. BLAIR: I want to plagiarize in open public session and steal some of John’s words and Steve’s words. John you wound up pointing out, Steve you said the implications of the use of fill status and then I’d steal John’s words is unclear. If we say that in the observation piece then in the recommendation piece we indicate how this needs to be pilot tested to resolve the unclear issues related to the standard.
MR. ROTHSTEIN: I just wanted to make a general observation and I’ll leave to Simon and his folks where to put this, and that is the issue that we’re talking about now, and that is patient control of this information, is one that we’re going to be seeing in a much greater light when we get to NHII. And it’s an overall theme of how much control the patient should have over the patient’s own health information as we go to a more electronic system, and we may want to flag it somewhere in the letter, I mean I’ll leave up to you the specifics of that, but I think that it’s an issue we’re going to see repeatedly.
And Simon I would say that this is precisely defined as privacy, this really is the right of an individual to control certain information, whereas what we often call privacy is really confidentiality, the provisions that restrict the redisclosure of information without authorization or consent. But we’ve been dealing mostly in HIPAA and elsewhere with confidentiality issues and security issues, etc., but now we’re going to have to focus on the real privacy issues, the core issues of control, and that may be even more complicated then the stuff that we’ve been dealing with.
DR. COHN: Well, maybe I should ask Mark just sort of odd question, does it make sense for us to say in the observations here that testimony regarding the fill status notification revealed that there may be confidentiality issues that, privacy, I’m sorry privacy, privacy issues, real concern about possible privacy issues that will be explored with the Subcommittee on Privacy and Confidentiality in later hearings?
MR. ROTHSTEIN: That would be fine, we have plans to do that.
MR. HOUSTON: I notice on page 13 though you do speak of the fact under next steps that there are issues related to privacy and security with respect to e-prescribing, so you do have that place there already because I would argue that it’s not just the fill status, the whole concept of using e-prescribing does raise privacy implications and so I think this is a global issue that you may want to leave more global.
MS. GREENBERG: After this discussion I’m thinking that maybe the best thing to say here is that the fill status note, you had it before, the fill status notification function is not used today and further testimony and testing are needed before recommendations can be made. Because that just, you’re not making, that’s what is obviously needed, that’s what I’m hearing, rather then getting into the issues of use case, value, privacy, I mean you’re not ready to make a recommendation on this other then you know, it sounds like you even need more testimony on it.
MR. BLAIR: Would that then remove the recommendation to include it in the pilot test?
DR. LUMPKIN: I hear Marjorie’s comments but I’m not sure that I completely agree with them, I think that we’ve heard testimony, and part of this thing is that let’s test it and find out how real people feel about this sort of thing and I think so taking it out of the recommendation that this should be part of the testing --
MS. GREENBERG: I didn’t actually recommend that it be taken out of the recommendation.
DR. CARR: I have a question, on the Power Point that we saw we saw mapped out very nicely the process, that this is a process, but underneath this is there a data repository, so that if I go to CVS and CVS can talk to my doctor but can my doctor see, have access to all the pharmacies I’ve gone to? I mean I guess it’s a more global issue, we’re fixing a process but where does this data reside and who has access to it?
DR. LUMPKIN: Well, that’s probably more in relationship to the architecture of the NHII as a whole and some discussions about how that sits, I don’t think that anyone, at least what I’ve seen here, nor would we propose a central drug repository, that would have such a negative response I think to many sectors of the American public if we were to create such a repository, rather we’re talking about how we have interactions.
The other piece, and I want to sort of toss this one to Mark, not to respond today, but it really gets to the issue of granularity of the patient’s control of their own health information. My guess is is that if you were to ask most patients they probably believe their pharmacist and their doctors talk, and so that there are very few people who would be surprised if their doctor knew, or if their doctor didn’t know that they didn’t fill their prescriptions. That may be a confusing statement but I think that most people believe that occurs.
So we really have to at some point begin to tease out can you really get to the point, what’s the burden on the system of trying to have every single potential information transaction be under the patient’s control as opposed to classes of transactions, in other words I want my doctor who prescribes my medications only to know about that, as opposed to I want my doctor to know about the fact that they wrote a prescription but not whether or not I’ve filled it. That’s a much higher level of granularity control and I think at some point we’re going to need to make some recommendations in relationship to that although not in this particular document.
MR. BLAIR: The privacy aspects of this are unclear but they’re not the only aspects of its usage that are unclear, so it would be my suggestion that as we go through the modification of the sentence that’s in the observation piece, the observation piece were worded to communicate the status and any issues or problems related to the particular standard, and I think we have to separate out the status and the problems, which are in the observation section, from what our recommendations are below so what I’ve been hearing so far is attempts to clarify the sentence that’s in the observation section and I don’t think I’ve heard so far that anybody has opposed the recommendation to address those. And if that’s the case then if we go back to the observation section if we acknowledge that there are a number of issues, including privacy, which are unclear then it gives us the opening to address them then in the recommendation which says that they need to be tested and we might add in the recommendation that we also need to get additional testimony but that’s kind of a recommendation back to ourselves.
MS. GREENBERG: Steve added a very interesting feature here and what it made me think was that at least I’m still thinking in a paper environment and we’re talking an electronic environment and it sounds like this fill status notification has nothing to do with whether the patient filled the prescription. The prescription is sent electronically to the pharmacy, the patient, unless they say to the prescriber don’t send it, it’s a fait complete, it’s sent, the dispenser then goes through whatever he or she has to go through to get authorizations, whatever, but assuming that everything is okay he fills it, and that’s what the fill status notification is. The patient has not been involved at all at that point, I mean other then getting, but they haven’t taken any action. Am I correct? So this is --
DR. HUFF: That’s one way it could be done, but I mean it’s a matter of how the system is programmed, in other words the pharmacy obviously, it’s sitting there, and they in fact will re-shelve that prescription if it’s not picked up in a certain point of time. And so they could trigger the fill status to be sent at the time that it actually leaves when the patient picks it up if they wanted to program their system that way.
And just to throw one other thing in there, one of the other issues that was referred to in the testimony was in fact providers may not want to get the information because it then increases their liability for non-compliant patients.
MR. BLAIR: That’s not in the letter.
DR. CARR: Well just that right now it seems like a uni-directional system, the prescription is written, it goes to the pharmacy, the drug is dispensed, it goes to the patient, we don’t have a system that’s bi-directional, that sends that information back to the physician and in the absence of a repository I’m trying to figure out how that communication would be happening anyway unless a physician inquired.
DR. LUMPKIN: Well, it would be an end/end(?), so if it sends back a notification to the physician’s electronic health record then it would complete a field and when you called out the prescription right next to it would be a marker that would say filled or not filled, I mean there are any number of ways that you can do that without a repository.
DR. CARR: But is that what we’re envisioning, a bi-directional system that --
DR. LUMPKIN: If in fact, and I think that’s what this whole description is is that most of this thing is uni-directional, this one particular field is bi-directional and is not used.
MR. REYNOLDS: I think if you step back from the process so the full committee can follow, we are recommending when you go through this whole set of recommendations an entire process, and to play off of Justine’s comment a minute ago, it is very bi-directional, this is step one, this is only the first thing we’ve hit that’s starting to get, when you talk about medication history which is another one of our recommendations and the reason I brought the point up earlier was not the business case, it was based on the privacy, it’s based on the quality of care, if a physician is treating a person under ultimate e-prescribing which is this letter, they will be able to download from a PBM or from the Medicare PBM, all of the prescriptions that the person has taken, so there’s no single pharmacy involved anymore, it’s coming down with everything that they get. So we’re talking about one situation where somebody might not want a doctor to know, we’re going to be talking to you about a recommendation in a little bit that says oh by the way it doesn’t matter what pharmacy you went to, it doesn’t matter what doctor you went to, your physician that you are standing in front of right now on their desktop or wherever they are will get a picture of your medication history. When they order a drug it will put against there for contraindications, you will make sure that they are not prescribing, if we use this example, you can be myopic and say no, but on the other hand then the doctor gives a prescription to someone, didn’t know they were taking something else, and we have all these issues that we hear.
So as you listen to the letter and as we take each point we are painting for you a picture of an entire new process. We showed you the chart on the current, you haven’t seen the chart, you’re seeing it an indication at a time on what e-prescribing is. So all of this data, and we talk at times, because it does improve patient safety, it does improve quality, but it does also make more information available then is currently available which brings all these other things into play. So I ask you as you listen to these each one of these is a piece but it is a piece of a full painting that we’ve done for you and that’s what’s going to be, as we discuss this that’s what’s going to be key in relation to our answers to you. Because a single answer looks like it’s out of balance but it’s not when you look at the overall thing but it does raise these issues.
DR. VIGILANTE: I was just going to suggest a process issue, I think and seconding what Jeff said and what Harry is saying, perhaps either we have a more austere sentence that says less, or a more robust sentence that includes sort of all the spectrum of possible objections, I think perhaps we delegate that or come back to it, and focus on the recommendation which I think is sort of the bottom line for this particular segment and just move on perhaps.
MR. HUNGATE: I think I’m probably saying kind of the same thing that Kevin is saying, it seems to me that in the observations we’re making a distinction between those things that are ready for foundation and those that are not and that it ought to be pretty small there in what’s said. But we haven’t done very much to say what the pilot test should cover and so the recommendation it seems to me needs to be a little more complex while the observation can be quite straightforward, which we got it mixed up a little bit the way it is I think, but I’m comfortable with leaving the rest of that to the subcommittee.
DR. LUMPKIN: I’m trying to understand your comment, I’m still going to try to understand it, your recommendation is that there be some fiddling with the last sentence under the observation and that the recommendation 3.2 needs to be enhanced a bit.
MR. HUNGATE: Enhanced, to cover the complexity of our discussion.
DR. LUMPKIN: So something to the effect that HHS should include the fill status notification function in NCPDP SCRIPT standard in the 2006 pilot test, these tests should review issues related to privacy, utility and so forth, and business case --
DR. COHN: That actually probably is a good way, is that --
DR. LUMPKIN: Can we move on?
DR. CARR: I’d like to see Simon’s other Power Points actually now, but I think to Harry’s point we probably need to know the big picture where we’re going because we’re starting with this and we’re heading to the electronic health record and each of these issues as we go through them, we need to where we’re going with them and whether we’re at tier one just making things legible, tier two, checking against other medicines, tier three, checking against best practice or whatever it is, because we’re getting there incrementally and we’re touching on one issue that actually is the topic of an entire other committee.
DR. LUMPKIN: Okay, I think that if you look back on page three and you look at the discussions of the various e-prescribing capabilities I think those kind of give the big picture of what the potential is for the system.
DR. COHN: And we’re talking about levels three and above, and I guess I would also comment that I think Justine you’ve described a uni-directional system but at least in my experience the current environment is not uni-directional, I get calls from pharmacies all the time, XYZ, there’s a contraindication, geez, did you know that XYZ isn’t taking this medicine so before you up the dose you need to be aware they didn’t get it filled last time so you ought to stay at the same dose, I mean all of this happens, it just happens verbally now. So I don’t think we should of say that geez, I mean if there’s lack of information it’s not intentional and that lack of information actually harms people currently, probably all the adverse drug events and all of this, so I think the intent here is to provide a safer better way of doing this and so I think that was the logic underneath all of this.
DR. CARR: But what Harry said is we are going to have a kind of local repository at whatever it is, I mean it’s not the whole electronic health record but according to this you will be able to download all the medications by all the doctors from all the pharmacies, right?
MR. BLAIR: In some cases.
DR. COHN: Why don’t we hold that until we get to it because that’s really an issue of if you’re an insurer and the person is insured and there’s, there are obviously ways now to get that information down to the provider, just in the same way if you work in a health care system you might have an understanding of what other people in your groups have prescribed.
MR. BLAIR: Could I suggest one thing that I think may help a little bit?
DR. LUMPKIN: Jeff, what I’m going to suggest is I think, unless we have something specific on this particular recommendation, which I think we’re done with, we’re scheduled to break for lunch, and we’re actually ten minutes late. Let’s do that and then maybe we can start off the next portion of the discussion with a little bit more framing. Vickie, did you have something --
DR. MAYS: Yes, it was a suggestion, I was going to suggest that maybe it would be helpful to put graphics in that describe the process and that just for the sake of transparency, because I think some people are thinking as some of us were in this uni-directional mode that you say up front somewhere that it’s characterized as being more bi-directional so that, I think people need to get it, this is for more then just the Secretary so maybe the graphic and a second, I mean you have so much appendix so I don’t think putting in a couple of graphics would kill this and just maybe kind of characterizing this as bi-directional.
DR. LUMPKIN: Well actually if you go back to the graphic that you had, that’s a bi-directional graphic there, I mean there’s back and forth, it’s an interactive environment, the question is is that there’s actually, and Simon raised the point that you get calls, but then the assumption is is that if you write a prescription and you give it to the patient and you don’t get a call it was fine and the patient took it, that’s not a reasonable assumption and that’s really the difference of the new environment versus the old environment is that you have the potential to not make the assumption but to actually have the loop completed that when you wrote a prescription the patient filled it and that there wasn’t a drug/drug interaction because there was no fill back, so I think it’s an issue not of it being bi-directional or not bi-directional, but the question of what is the potentiality to enhance quality of care in a new system.
DR. MAYS: I’m just saying make that a little clearer I think.
DR. VIGILANTE: I mean I call now sometimes to find out if a prescription has been filled because there’s sometimes for a variety of reasons I think it’s important to know whether, because I have reason to believe that perhaps its not and it helps me in the treatment, I’ll pick up the phone and say did this patient fill this prescription. So it is bi-directional now but it’s a lot more work, it’s very inefficient, but the information is accessible to me if I want it and this just automates the process.
DR. LUMPKIN: John, last point.
MR. HOUSTON: Can I just suggest a framework for getting through this letter? Because I think it might be helpful based upon some comments I know that Harry made, that maybe we should try to read through the letter because it sounds like there are some common themes as I recollect that may become clear or maybe we want, it sounds like it almost becomes a global issue in some ways, read through the letter and then say okay, if people have comments mark up so we can go back by section and discuss it, or discuss global issues, because again --
DR. COHN: Do you think this is going to come up again?
MR. HOUSTON: Oh, I think it’s going to come up again, just simply based on what Harry said, I don’t remember specifically when I read through it, but then again, I notice in the next steps there is a lot of coverage of the fact that there are some global issues that simply will need to be evaluated, I’m just thinking this might be a little quicker if we went through the letter in its entirely and then went back by section and said does anybody have a comment on 3.1 or whatever.
DR. LUMPKIN: I think it may be perhaps more useful of our time and productivity if people took some time during lunch to read ahead. Some of us, because we sent it out ahead of time hopefully most people have had an opportunity at least to skim through it and I would encourage that people do that and that we still try to work through it methodologically because if we read through there’s so much detail that it won’t be productive to read through and then come back.
MS. GREENBERG: Just in case Margaret is going to work on this flow chart or graphic during lunch or whatever I just wanted to mention the first thing that really struck me when you put it up and it was partly because it then came down, but when you had the prescriber, the dispenser, and the payer but where was the patient. So obviously the patient then gets imbedded in many of the subgroups but I would suggest, and I saw probably that’s the only way to do it, it probably doesn’t make sense to have the patient as a fourth bar up there although you could think about. But at least I would do something with wherever the patient comes up to highlight it so it’s clear that this isn’t just something going on between a prescriber, a dispenser, and a payer, but there is a patient involved.
DR. STEINDEL: I would just like to point out there are multiple diagrams for the e-prescribing process and it is extremely complex and very varied and I think we should leave the diagrams out of this because to put them in would delay the letter greatly or would give the letter less impact because of industry comment on the areas that we missed.
DR. LUMPKIN: And with that we’re going to take a lunch break. We’ll be back at 1:00.
[Whereupon at 12:15 p.m. the meeting was adjourned, to reconvene at 1:10 p.m., the same afternoon, September 1, 2004.]
A F T E R N O O N S E S S I O N [1:10 p.m.]
DR. LUMPKIN: Okay, we’re going to get back in the saddle, starting off with Observation 4 --
DR. COHN: [Off microphone.]
DR. LUMPKIN: We’re going to let the subcommittee look at the wording for Observation 3 before it gets brought back.
DR. COHN: I guess I would ask for committee members to at least take a look at the wording that’s being proposed for Observation 3 and Action 3.2, we don’t need to discuss it right now but if it’s not adequate to, if it doesn’t meet your needs the subcommittee does need to hear about it. And that’s it up there as has been wordsmithed.
DR. LUMPKIN: Well, let me read the two sentences then. It would say as the last line in Observation 3 the fill status notification function is not used today, testimony revealed that there may be business case, clinical utility and individual privacy right implications. And then Recommendation 3.2 is changed to read HHS should include the fill status notification function of the NCPDP SCRIPT standard in the 2006 pilot test. These tests should assess business case, clinical utility, and individual privacy issues.
DR. COHN: Okay? Good. Okay, let’s move on to Observation 4, for Observation 4 I would point out the new 8 pt version of the document that you received that now has a footnote on it and we’ll recognize that as we read through all of this.
Observation 4 is Coordination of Prescription Message Standards: HL7 is commonly used to communicate medication orders within a hospital and with clinical pharmacies within an enterprise. Coordination of HL7 with NCPDP SCRIPT would result in functions being more seamless across healthcare environments. This would remove a barrier to adoption of electronic medication ordering and prescribing. HL7 and NCPDP have already begun to map their standards that support common functions.
Recommended Action 4.1: HHS should financially support the acceleration of coordination activities between HL7 and NCPDP for electronic medication ordering and prescribing. HHS should also support ongoing maintenance of the HL7 and NCPDP SCRIPT coordination.
Recommendation Action 4.2: HHS should recognize the exchange of new prescriptions, renewals, cancellations, changes, and fill status notification within the same enterprise as outside the scope of MMA e-prescribing standard specifications. Now there’s a footnote within the same enterprise where it says NCVHS recognizes that properly defining “enterprise” may be complex. NCVHS encourages the Secretary to clarify the definition in rulemaking.
Recommendation Action 4.3: HHS should require that any prescriber that uses an HL7 message within an enterprise convert it to NCPDP SCRIPT if the message is being transmitted to a dispenser outside of the enterprise. HHS also should require that any retail pharmacy within an enterprise be able to receive prescription transmittals via NCPDP SCRIPT from outside the enterprise.
Comments, questions? Compared to the last one that sounds easy.
DR. LUMPKIN: Well, the committee was very enterprising in coming up with that.
DR. COHN: Okay, Observation 5, Formulary Messages: Formulary and benefit coverage information, including information on the availability of lower cost, therapeutically appropriate alternative drugs (if any), from payer/PBMs to prescribers currently is communicated with proprietary messages. RxHub, which is a national electronic formulary and pharmacy benefits information exchange, has communicated its intent to submit its proprietary formulary and benefits information file transfer protocol to NCPDP to establish industry consensus and ensure the protections for the industry afforded by becoming an ANSI accredited standard. Development of an ANSI accredited standard appears to be possible in an accelerated timeframe. This process will accommodate any specific requirements affecting the implementation of Medicare’s new Part D prescription drug program.
Recommended Action 5.1: HHS should actively participate in and support the rapid development of an NCPDP standard for formulary and benefit information file transfer using the RxHub protocol as a basis.
Recommended Action 5.2, and I would point out that that’s been wordsmithed slightly, now it says NCVHS will closely monitor the progress of NCPDPs developing a standard for a formulary and benefit information file transfer protocol and provide advice to the Secretary in time for adoption as a foundation standard and/or readiness for the 2006 pilot tests. And the rationale here was depending on how that all goes and the industry perspectives on this, if it happens quickly enough and the industry is confident enough about it it actually could be recommended as one of the foundation standards, otherwise it might be recommended as something to be pilot tested.
MR. SCANLON: Simon, this as I recall would support any plans’ formulary?
DR. COHN: Well, by the time, yes, I believe the intent, I can’t speak for the current standard whether it supports everyone but maybe this is supposed to go through a standards process to have it validated and become part of that process so theoretically any PBM which would choose to use it should be able to use it, I think I sort of answered that, I think the answer should be hopefully yes.
Other questions?
Six, eligibility and benefits messages. Eligibility inquiry and responses are HIPAA transactions, and standards have been adopted for their use in retail pharmacy and other sectors. The HIPAA standard for eligibility communications between retail pharmacy dispensers and payers/PBMs is the NCPDP Telecommunication Standard Implementation Guide, Version 5, Release 1. While the HIPAA standard for eligibility and benefits communications between dentists, professionals, institutions, and health plans is the ASC X12N 270/271 Health Care Eligibility Benefit Inquiry and Response Version 004010X092A1 (ASC X12N 270/271), which we will otherwise refer to ASC X12N 270/271 transaction for short. There is good industry experience in using the ASC X12N 270/271 standard for general drug benefit functions. ASC X12 has identified workarounds for some of the gaps in ASC X12N 270/271 standard with respect to drug listings and step therapy. ASC X12 reports that version 4050 addresses some of these workarounds more directly and that version 5010 is under development and can more tightly address industry needs for e-prescribing. Because Medicare’s Part D prescription drug program is new specific requirements are not known at this time and new requirements may emerge.
Recommended Action 6.1: HHS should recommend the ASC X12N 270/271 Health Care Eligibility Inquiry and Response Standard Version 004010X092A1 as a foundation standard for conducting eligibility inquiries from prescribers to payers/PBMs.
MR. BLAIR: Simon, you said HHS should recommend --
DR. COHN: Should recognize, I’m sorry, as a foundation standard, so we’re saying the 270/271 should be a foundation standard for these eligibility inquiries.
DR. LUMPKIN: Is that version A1 or A2?
DR. COHN: Thank you, John.
Okay, Recommended Action 6.2: HHS should support NCPDP’s efforts to create a guidance document to map the pharmacy information on the Medicare Part D Pharmacy ID Card to the appropriate fields on the ASC X12N 270/271 in further support of its use in e-prescribing.
Recommended Action 6.3: HHS should work with ASC X12 to determine if there are any requirements under MMA with respect to how situational data elements are used in the ASC X12N 270/271, especially concerning the quality of information needed for real-time drug benefits. Use of these situational data elements could be addressed in trading partner agreements, and there’s a slight wordsmithing here. Specifications of use of situational data elements, as well as proper usage of the functional acknowledgements, should be included in the 2006 pilot tests. The word these has been removed in directly relating now to what we’re talking about.
Recommended Action 6.4: HHS should ensure that the functionality of the ASC X12N 270/171, as adopted under HIPAA, keeps pace with requirements for e-prescribing and that new versions of the standard be pilot tested.
Comments, questions?
Okay, Observation 7, prior authorization messages. Under HIPAA claims, eligibility, and benefits information between dispensers and payers/PBMs are communicated using the NCPDP Telecommunication Standard Implementation Guide, Version 5 Release 1. The need for prior authorization for a drug is identified between the payer/PBM and the dispenser through this process. The formulary and benefit file transfer protocol developed by NCPDP provides information from the payer/PBM to the prescriber about the need to obtain prior authorization of a drug. The NCPDP SCRIPT standard may be used between the dispenser and prescriber to communicate the prior authorization approval for a drug. However, the request for a prior authorization for a drug from the prescriber to the payer/PBM is now conducted in a manual mode. This is due, in part, to the complexity of the decision making involved in ensuring that the use of a drug considers cost, patient safety, special handling or administration procedures, and other pre-authorization requirements.
The ASC X12N 278 Health Care Services Review Standard, and I will not mention the version here, is a HIPAA standard that provides for prior authorization inquiry and response in general. It provides very limited support for prior authorization of drugs and is not widely used.
Recommended Action 7.1: HHS should support ASC X12 in their efforts to incorporate functionality for real-time prior authorization messages for drugs in the 278 Health Care Services Review Standard for use between the prescriber and payer/PBM.
Recommended Action 7.2: HHS should support standards development organizations and other industry participants in developing scenarios to ensure the proper flow of prior authorization information throughout the entire communications process, and this includes obviously the Telecommunications and SCRIPT standards as well as the 278 standard.
Recommended Action 7.3: HHS should evaluate the economic and quality of care impacts of automating prior authorization communications between dispensers and prescribers and between payers and prescribers in its 2006 pilot tests.
Recommended Action 7.4: HHS should ensure that the functionality of the 278, as adopted under HIPAA, keeps pace with requirements for e-prescribing and that new versions to the standard be pilot tested.
Vickie?
DR. MAYS: Recommended action 7.2, I had questioned, I brought this up, what this issue of scenarios are, I don’t understand that particular recommendation where it’s, you develop scenarios to ensure the proper flow of prior authorization information, what do you mean there and how can a scenario actually accomplish that?
DR. HUFF: With prior authorization the problem is I think we didn’t even understand the information flow, and what I mean by that is that you can imagine that the provider was aware of the need for prior authorization and then they might query the benefit person and ask them what are the actual needs, I mean does a patient have to be over a certain age, do they have to have had this lab test done before you can do this, can you do that, and they respond back and say these are the requirements for prior authorization, the clinician would then fill those out and send them back, but it wasn’t clear how that would work. And so part of what we wanted to get to here is that in fact we need to discuss and examine those issues of understanding whether it’s a single exchange, or maybe the other way it would work is that drugs that need prior authorization they would download the information about what information was needed for a particular drug as part of the benefits, as part of the formulary loading process, and so the knowledge and logic of what needed to be accomplished to get the drug would be known at the time of prescribing.
Anyway, the fact that we didn’t understand all of the issues of how that might work is what we’re trying to allude to here and that developing the scenario is to say it might be one or two different ways that it could work but we really need to say how the information would flow before you could design the transaction that would support that flow, and the content of the messages.
DR. COHN: Vickie, I agree with sort of what Stan was saying here, I’m just sort of wondering if we, if this is a wordsmithing issue here because I think we’re talking about developing scenarios but it’s more then just developing scenarios, it’s sort of like, I’m not sure whether it’s developing and testing scenarios in the pilot, which I think is what we sort of meant here, but maybe we need to add that sort of a concept, would that be helpful?
DR. MAYS: It would be a lot clearer because I was like well how can a scenario, now I understand what you’re trying to do, I think if you added a little more clarity, there’s nothing above that kind of tells you that you don’t have that kind of information so then when it gets down to here, how is the scenario that powerful.
DR. COHN: I think we have some wordsmithing up there, I’m not sure that I’m completely satisfied with it --
DR. MAYS: See, even in a parallel process that part just kind of comes, to me again kind of out of the blue, I mean I understand what you need to do in terms of the last two sentences, the last two parts of that, last two sentences, last two lines, I’m sorry, I’m getting tired here, the last two lines, the first two, it just needs a little more information but I think you all can do, we don’t need to wordsmith here.
DR. COHN: Okay, but I think you’re pointing out something the subcommittee needs to work on and we’ll bring back but I think it’s a good point that it somehow doesn’t quite, I think we have all the ideas but it somehow isn’t well expressed.
Okay, anything else related to 7.2? We’ll see Margaret beginning to work on this, I’m sorry, Russ, excuse me.
MR. LOCALIO: This is Russ Localio. You may want to defer my question to the end but when I see a pilot test of the economic and quality of care impacts of anything I view that as very different from a pilot test of what I would call the implementation of standards in some type of an electronic system. Now at some point I think we have to discuss what are going to be the recommendations, or what should be the recommendations of the committee, on pilot testing, what is going to be pilot tested, and are the pilot tests that need to be done going to be possible, feasible, in calendar year 2006. This is one of them that I really question whether it’s going to be feasible but we can defer that until the end if you want.
DR. COHN: Well, why don’t we talk a little bit about it at least now and then we can potentially talk about it more when we talk about the pilot objectives, which I think is what you’re also reflecting on --
MR. LOCALIO: This is one of them/
DR. COHN: I guess from our view and I’m just sort of reflecting I think some of the testimony we heard, and once again this is not well said here, obviously we thought it was perfect when we walked in but of course as we look at this up on the screen we’re seeing things, but it’s basically, I think for this particularly piece unlike many others I think we’re talking about the pilot test both evaluating the ability of the standard to support the business process, and I’m using the wrong words, in other words it being able to work, but I think we were also very specifically wanting to sort of make sure that knowing how complex and how delicate the balance is around prior authorization within the industry that we wanted to make sure that we understand if changing how prior authorization occurred whether it was going to have unanticipated economic consequences or unanticipated patient care outcomes, so we thought that was part of the criteria for this very specifically.
MR. LOCALIO: I think I agree with you except I submit that a pilot test for what you just said, that concept, I’m not sure that that can be done by the end of 2006 if we start it in the next five minutes, if we started right now I’m not sure that it could be completed by the end of 2006 unless I’m greatly mistaken as to what you’re talking about here. Or do I have a different concept of what we anticipate out of pilot testing of the economic and quality of care impacts of something such as automated prior authorization?
DR. COHN: Well, I don’t know because I don’t know what your concepts are.
MR. LOCALIO: I work on a lot of studies that take three to five years to do, that’s once you get the funding, that are easier to do then this. And yet I know from reading the statute says here, during the one year period that begins on January 1, 2006, the Secretary shall conduct a pilot project to test for the efficient implementation of the requirements described in paragraph two, and that’s basically everything in the Act. So maybe we should defer this until the end but I get the feeling that we can’t possibly, what we’re recommending can’t possibly be done.
DR. COHN: Steve?
DR. STEINDEL: This is a very complex issue both from an industry point of view and as you point out from a study point of view. We are somewhat aided in this in that there’s a natural experiment going on that we really haven’t gathered data that we don’t mention in this, and there’s a significant difference in the rate of prior authorization that goes on in the Medicaid system versus both the Medicare and the private sector systems. So we do have something that we could look at to derive some inferences on the economics and quality of care issues from a natural experiment point of view that can help jump start the pilot. So I think there are ways to derive useful information in a year, I don’t think we’ll get a definitive answer, but I think we will get some useful information.
MR. LOCALIO: Let me suggest then that we defer this until the end and when we talk about what is going to be pilot tested we may want to ask do we really want to recommend that A, B, C, D, E, and F be pilot tested or how do we want to distinguish the things that we think can be done and those we ought to know that they can’t be done.
DR. COHN: Okay, well we can rediscuss it towards the end when certainly when we hit the pilot test objectives and beyond as seems appropriate, I think that’s fine.
Any other comments about all of this? Okay.
Observation 8 is medication history messages from payer/PBM to prescriber. The exchange of medication history may occur at multiple points, among prescribers, between patients and prescribers, between payers and prescribers, and between prescribers and dispensers. MMA indicates that medication history should be provided to prescribers and dispensers but does not explicitly identify the source or actual intended use of the medication history.
Medication history from payers/PBMs to prescribers is currently communicated primarily with proprietary messages. RxHub has communicated its intent to submit its proprietary medication history message to NCPDP to establish industry consensus and ensure the protection of the industry afforded by becoming an ANSI accredited standard. Development an ANSI accredited standard for medication history messages between payers/PBMs and prescribers appears to be possible in an accelerated timeframe.
The following recommended actions address only exchange of medication history from payers/PBMs to prescribers. NCVHS plans to address other medication history communications in its March 2005 recommendations.
Recommended Action 8.1: HHS should actively participate in and support rapid development of an NCPDP standard for a medication history message for communication from a payer/PBM to a prescriber using the RxHub protocol as a basis.
And recommended Action 8.2, which has once again I think been wordsmithed a bit, and I will pull out my little version here, it says NCVHS will closely monitor the progress of NCPDP’s developing a standard medication history message for communication from a payer/PBM to a prescriber and provide advice to the Secretary in time for adoption and/or readiness for the 2006 pilot tests. I mean basically this very much mirrors the recommendations I think in Action 4, and so we’re talking about in time for adoption as a foundation standard and/or readiness for the 2006 pilot test. My apologies for referencing back but our intent was to make this parallel to the recommendations actually in Action 5.2.
Comments or questions?
The next item is Observation 9 which is clinical drug terminology, this may in many ways be the most complex topic that we discuss and I will apologize, I think we made every attempt to make it as understandable as possible but when were talking in the world of terminologies there’s always some complexity.
This is clinical drug terminology. Today’s e-prescribing systems support free text entry of a clinical drug and/or selection of a clinical drug code from one of several proprietary terminology systems. A standard terminology for clinical drugs facilitates automated drug utilization review and decision support for patient safety. It is also necessary for interoperability among different e-prescribing systems. However, it is recognized that not every item ordered by a prescription will always be included in a terminology, e.g., compounded drugs, devices, and supplies. This means that the ability to enter text in an e-prescribing system must be preserved.
The National Drug Code, otherwise known as NDC, is used by dispensers to identify packaged drugs. However, NDC is not appropriate for use by prescribers in describing the clinical drug. To address this need the NLM has produced a clinical drug terminology, Rx-Norm. Rx-Norm provides links from clinical drugs to their active ingredients, drug components, and most related brand names. Fully comprehensive Rx-Norm terminology for all marketed drug products, including generics, repackaged drugs, and over the counter medications will not be available until structured product labels, otherwise described as SPL, for all those items become available to the NLM from the FDA. When the SPLs become available it is the intent of the NLM to update the repository of drug information on a daily basis, and that’s called as the DailyMed. Additionally until the full set of brand names is included in Rx-Norm some “dispense as written” prescriptions cannot be accommodated through e-prescribing.
NCVHS further observes that the FDA is looking to the VA’s National Drug File-Reference Terminology, otherwise described as NDF-RT, to prescribe drug classifications for use in the SPL. In addition the MMA directed HHS to request the United States Pharmacopoeia to develop model guidelines for drug categories and classes that the prescription drug program sponsors participating in Medicare Part D can use in structuring their formularies.
NCVHS documented deficiencies in the NDC that must be overcome to support many clinical applications, including e-prescribing, in its Report to the Secretary on Uniform Standards for Patient Medical Record Information, dated July 6, 2000. NCVHS recommended adoption of the Rx-Norm in the core set of clinical data terminologies in its Letter to the Secretary on Recommendations for Patient Medical Record Information Terminology Standards, dated November 5, 2003.
Recommended Action 9.1: HHS should include in the 2006 pilot tests the Rx-Norm terminology in the NCPDP SCRIPT standard for new prescriptions, renewals, and changes. Rx-Norm is being included in the 2006 pilot tests to determine how well the Rx-Norm clinical drug, strength, and dosage information can be translated from the prescriber’s system into an NDC at the dispenser’s system that represents the prescriber’s intent. This translation will require the participation of intermediary drug knowledge base vendors until the Rx-Norm is fully mapped.
Recommended Action 9.2: HHS should accelerate the promulgation of FDA’s Drug Listing rule and hence the ability to support the correlation of NDC with Rx-Norm, e.g., for passing daily updates of the SPL to NLM for inclusion in the DailyMed.
Recommended Action 9.3: HHS should ensure that, if the Medicare Part D Model Guidelines and NDF-RT differ, an accurate mapping exists so they both can be used successfully.
Enough acronyms for everybody? Russ.
MR. LOCALIO: This is Russ Localio, I’m sorry but again I have a problem with this section, let me just kind of recite a few concerns. There’s the sentence, the FDA is looking to the Department of Veterans Affairs, what happens if the VA cannot deliver a complete version of NDF-RT in time? Then I ask well, what happens if the participation of the intermediary drug knowledge based vendors is not as forthcoming as one would hope under Recommended Action 9.1? And these are my concerns, it seems to me that for this to work it has to rely on the VA, the FDA, private enterprise, and this is at the beginning of the pilot test on January of 2006. Can the recommendations, let me ask this, are the recommendations forceful enough or are they sober enough to get the point across that we don’t have too much time to go here, or am I just desperately worried about this?
DR. COHN: Why don’t we address, I’m going to let Jeff comment, I think Stan, I know we have Randy Levin from the FDA here, I think really what you’re asking is is how much of all of this stuff is good to go --
MR. LOCALIO: Correct.
DR. COHN: Just to bring it down to the basics here.
MR. LOCALIO: If you look on the NLM website as I did yesterday and you look at some of these pointers here, they don’t point to anything real, they point to descriptions of what there is or what might be but this is September of 2004 and we don’t have that much time to go.
DR. COHN: Okay, Jeff, Stan, and then we’ll let Randy --
MR. BLAIR: Russell, you are not alone. The subcommittee shares your concerns very much so and the recommendations that are there we developed in part by trying to see how we could be constructive in these recommendations to address those concerns. Now that I’ve said that, so you know you’re not alone and that we share these concerns and that we try to develop recommendations that would address them, if you or anyone else has a way to either be more emphatic but still constructive I think that many of us would be very receptive to any constructive suggestions to make this stronger.
MR. LOCALIO: I’m not very good at being politically correct because of my background, but suppose there was, I mean I don’t get down to Washington except to come to these meetings, but suppose there was a statement that said something like this, for this to work we’re going to have to have the daily cooperation among disparate agencies, such as A, B, C, and D, and that is a prerequisite for pilot testing to begin on January of 2006 --
MR. BLAIR: Maybe if you focus in on that 9.2 because that’s where we tried to get at this concern and if that, if 9.2 is not sufficient what could we do to strengthen it, but strengthen it in a constructive way?
DR. COHN: And why don’t we let some of these other, we have other people talking and I think some people want to reflect on I think what the status of things are, so Stan, I think you’re next.
DR. HUFF: I agree with strengthening the statements in any what that would be appropriate. One thing that I would point out is that the paragraph in the observation about NDF-RT is in fact observational, that is there is no recommendation here about NDF-RT and that was partly because of the fact that there’s NDF-RT and then there’s this drug classification that was asked, that USP was asked to provide and that all needs to evolve and so we didn’t take any action relative to NDF-RT because that’s obviously much less understood and defined then some of the others.
In terms of Rx-Norm there was testimony that for instance Rx-Norm took the thousand most prescribed drugs in the VA and found that of those top thousand 26 were missing out of Rx-Norm and that most of the things that were missing were names of devices or supplies. So we had a reasonable comfort that Rx-Norm is fairly complete in terms of content so the real part that’s missing and most in question is the mapping between Rx-Norm and the fillable drugs at the NDC level.
The other thing that was testified to, I mean they were all in the same room at least where we had the drug knowledge based vendors, MediSpan and FirstDataBank and those other guys, who have really been supplying most of the content for that, and they said we plan to or we’re already working on doing that. But again, I’ll second what Jeff said, that anything we can say here to strengthen and underscore that that needs to be done would really be I think helpful.
DR. COHN: Which one to go first, Vivian or Randy? Vivian, do you want to maybe talk about Rx-Norm for just a second and then let Randy Levin from the VA talk about his perspective, and I think once again we can sort of reach a conclusion after we heard all of this.
MS. AULD: I am Vivian Auld from the National Library of Medicine. Picking up on what Stan just said the drug knowledge bases, many of those already exist in the Unified Medical Language System, which is where Rx-Norm resides, so a lot of that mapping has already been done up front, it’s just a question of how useful that is to the industry and so that’s what we really need to test. But we’ve been doing this not just on our own but in conjunction with the developers so we feel that it’s pretty good up front. I’m not sure what else, I’m going to hand it off to Randy.
MR. LEVIN: I think some of the testing for the Rx-Norm was test how that model concept would work in the SCRIPT so that can be done at this point. As far as the NDF-RT classification, we have looked at the classification from the VA and we’ve looked, and we’re comparing it to what the USP has been proposing and we’re going to be meeting with the USP to try to see how those two things would match. But we’ve already had a classification system being developed at the VA that we’ve looked at.
MS. BEREK: The Secretary and the CMS administrator have both been very public and very aggressive about saying they’re going to make this happen on time and so I think if it is humanly possible it will happen on time and I will say in the last few years I have watched things that we all said we can’t possibly get done on time get done on time. And so I think if you want to talk about a way of making it stronger maybe in the opening paragraphs you want to talk about the Secretary’s public commitment to making this move at almost inhuman speed and how that is necessary in order to get this done, I mean that’s, but I think we really, maybe you want to end with it, but I think there is no question that he has the commitment to make this happen when it is supposed to happen because nobody wants to go back to Congress and say we’re terribly sorry we can’t do the drug benefit when you want it to be done. There isn’t anybody who’s going to say that and so whatever has to happen for that benefit to go into effect is going to happen. And I think that we sort of have to reflect, think about that as we’re doing this, you may, Russ, look at this and say it can’t possibly happen, well it will. It may not be in great shape when it happens but it will happen.
MR. LOCALIO: That’s what I’m afraid of.
DR. COHN: Okay, let Steve and then I have a comment and then I’ll let Jeff talk.
DR. STEINDEL: I’d like to somewhat react to what Judith just said but it’s in part to what Russ’s concerns, etc. I think we’re really addressing two concerns in this area, the first involves the pilot study. And the pilot study, what we’ve heard is that the pieces do exist for the pilot to work, as Stan pointed out for prescribed drugs Rx-Norm covers a large portion of them, we did hear not in public testimony but informally that the private drug database vendors have been mapping to NDC from Rx-Norm to see if that works, which is not that big of a problem for them because they already map their own clinical drugs to NDCs. So we are aware that that system can work, now much how much of that system will be available publicly for pilots, it’s all in pieces and can be brought together as Judith said for the pilot studies, those will happen.
I think the other important part of this that is only somewhat emphasized but addresses some of Russ’s concerns is we also have to think about a system that evolves this on a daily basis once we start putting Part D into regular use. And there’s parts of that that we are very uncertain about and I don’t think we can just make them happen, in part because they involve a lot of regulatory changes. And somehow, which is what we’re getting at in 9.2, is we have to create an atmosphere within FDA to look at and promote those regulatory changes in an expeditious fashion so that e-prescribing can be maintained beyond the pilot studies. And I don’t know if this adequately expresses that or not.
DR. COHN: Well, I think I was going to comment and maybe I should let others also comment but I’m, I mean Russ, obviously I do hear your concern and I know the context of it which is feeling that there are may some vapor(?) wear(?) out there, if I can say this nicely. I think the good news is that this is being proposed for a pilot as opposed to being something that will be mandated on X date. I think most of us, and I think I agree with Steve, that many of the pieces actually have been sufficiently developed at this point, that they actually are ripe for a pilot, this is not something where we’re saying we’ll get started on it and develop it, you can start now and maybe by 2006 you’ll have something to pilot, there’s actually things that are being published by the NLM on a twice yearly basis, three times a year, four times a year, whatever, basis in relationship of updating this and so there actually is something there.
Now I agree also with Steve that obviously one of our big concerns is this issue about the FDA’s connection to the VA, which right now is being handled through the proprietary knowledge base vendors and their relationship with the NLM but obviously we’d like to see the FDA move faster on this. But I don’t know that we can say much more then what we have in 9.2 already in relationship to that, I mean I think we’re pretty forward about it. I think this actually reflects what we ought to be saying, I guess I wouldn’t argue if we wanted to use more emphatic verbs but I don’t know that for a letter like this that emphatic verbs in the middle of otherwise, I mean all of these recommendations are important so I don’t know what else to say about it.
Jeff, you had a comment, and then we’ll decide what to do about this.
MR. BLAIR: The only area, I guess I’m resonating back to Russ’s concerns and this statement is not in disagreement with what anyone else has said, I agree with everybody’s position on this, this is a specific exposure that I think might be the greatest exposure for the pilot tests, is will the information from the structured product labeling be far enough along to feed to Rx-Norm to support the pilot tests. And I again, I say this as a concern, if there’s something in this letter that we could do to create a higher priority to get that done and that’s constructive, on the other hand if we say it inappropriately where we’re not constructive then I would leave it out. But I want to raise that as what I perceive to be the greatest exposure to impeding the ability for Rx-Norm to be appropriately or fully tested in the pilot test is the information from the structured product labeling.
DR. COHN: Steve, last comment and then let’s wrap up on this one and see if we think that 9.2 represents our feelings.
DR. STEINDEL: I’d like to comment on being a little bit more emphatic because we have a sentence in the observations, NCVHS documented deficiencies in the NDC that must be overcome to support many clinical applications, including e-prescribing, in its report to the Secretary on Uniform Standards for PMRI dated July 6, 2000. Randy, when’s the NPRM coming out? Don’t answer. I think that that’s the point, we’ve got to say something very emphatic, the world has changed and there needs to be, things that need to go through regulation if we want to meet the deadlines that are being put on us by the Secretary there needs to be a realization that the world is changing and there needs to be some more rapid responses especially in the area where we need regulation.
DR. LUMPKIN: But this is a letter to the Secretary --
DR. STEINDEL: Right, that’s why I think we need to put a little bit more emphatic language in 9.2.
DR. LUMPKIN: And the language that’s up there would be for 9.2, HHS should accelerate the promulgation of FDA’s drug listing rule and hence stability to support the correlation of NDC with Rx-Norm, e.g., for passing daily updates to the SPL to NLM for the inclusion in DailyMed. This rulemaking is critical to sustain the daily use of Rx-Norm beyond the 2006 pilot tests.
DR. STEINDEL: And John I thank you for pointing me to the screen because I hadn’t looked at it, that would be perfect.
DR. COHN: So Russ, I don’t know that this has fully satisfied your --
MR. BLAIR: It does have the word critical in there.
MR. LOCALIO: Yeah, it’s critical.
DR. COHN: I don’t know that we’ve completely satisfied your desires but at least we’ve aired them --
DR. LUMPKIN: We got a thumbs up.
DR. COHN: That’s good. Okay, shall we move on to the next item --
DR. FITZMAURICE: Could I make a one word suggestion, could we say the timely, right there, that’s it.
DR. LUMPKIN: The timely rulemaking --
DR. FITZMAURICE: Yes, because with 2006 people will say oh we’ve got two years to do it --
DR. COHN: So timely rulemaking is critical, okay. People comfortable with that? Okay, good.
DR. LUMPKIN: Please, come to the microphone and identify yourself.
DR. COHN: I should comment this is one of our experts --
MR. ROTHERMICH: Phil Rothermich with Express Scripts. I just wanted to comment because none of the vendors are here, and a couple places here we talk about including things in the pilots and we ought to keep in mind that the software vendors that are doing electronic prescribing will need some lead time to change their systems to accommodate some of these things and so that ought to be anticipated. It’s really not reflected here.
DR. LUMPKIN: Is that a general statement about the pilots that ought to be someplace in the document?
DR. COHN: I guess what I’m hearing is is that HHS should provide guidance as soon as possible about the nature of the pilots, or the functionality expected to be piloted --
MR. ROTHERMICH: Yeah, my concern is you talk about the structured and codified SIG and you talk about clinical drug terminology, to the extent these systems today are using what’s out there now they’re going to have to change the way their systems work and presumably when you’re piloting electronic prescribing the pilots will involve some of these existing software vendors because that’s what’s out there today.
DR. COHN: Okay, well let’s hold that thought for 13 because I think that may be the place to put it where it says pilot test objectives, and we’ll see if it fits in there which is more along the lines of, and I think this is more as a general statement, that HHS needs to quickly determine the functionality that needs to be tested and let the industry know.
DR. STEUERLE: It seems to me this last question raises the issue of whether there is being developed now appropriate timelines to make sure that things are implemented on time and those timelines including the types of steps and developments that have to take place both within the private industry as well as the public sector, continual statements, things need to be done quickly and timely, doesn’t really give us a sense unless somebody I presume is developing timelines on how these things are going to take place. So does Express Scripts need a month, do they need two weeks, somebody should be sitting back and developing a timeline so I hope somewhere in here that this development of time, instead of constant sentences about being timely and accelerating I hope it’s related to somebody developing a timeline. You don’t really need to respond --
DR. LUMPKIN: Well, I’m not sure it’s necessarily our responsibility to put the timeline, I think what our charge is --
DR. STEUERLE: But there needs to be a timeline.
DR. LUMPKIN: What our charge is is to say what is it that needs to be done and in fact the Secretary is accelerating the timeframe that was put into MMA and because of that acceleration then obviously things need to be done quicker, and the same person who’s accelerating is the one who wants to see it done. But let’s hold that thought for 13.
DR. COHN: I think some of these things can be added as additional actions because I in some ways agree with you, in many ways agree with you and let’s see if we can come up with something there.
DR. LUMPKIN: I mean just to follow up, because the issue is is that it’s probably not going to be good utility for there to be a timeline if only a certain number of people know about the timeline, so if we’re going to make a recommendation it ought to be a public timeline.
DR. COHN: I made a little note here and we’ll try it out when we get to 13. Okay? Can we go to 10? Are we good to go? Okay.
Observation 10, structured and codified SID, I want to thank Mike Fitzmaurice for his help with the derivation of SIG. Patient instructions for taking medications are placed at the end of a prescription. These are called the signatura, commonly abbreviated SIG. Structured and codified SIGs will enhance patient safety, although it is also recognized that free text capability must be preserved for special circumstances. NCPDP, HL7, and others are working on addressing structured SIG components and plan to seek broad industry participation.
Recommended Action 10.1: HHS should support NCPDP and others, especially including the prescriber community, in addressing SIG components in their standards. This should include preserving the ability to incorporate free text when necessary, e.g., for complex dosing instructions.
Recommended Action 10.2: HHS should include in the 2006 pilot tests the structured and codified SIGs as developed through standards development organization efforts.
DR. HARDING: So off label SIGs could be handled in the text, so if you were writing a SIG and it was an off label indication that would be incorporated in the text? It would be free text?
DR. COHN: Well, I think that’s to be determined by the standards development organization --
DR. HUFF: The only time the indication, because the SIG is just a part of this and so if you, yeah, the indication would normally only be there as part of a PRN thing and what we actually said is that, I think we say down below that that’s a thing, the part we’re really trying to standardize in the SIG is the frequency that the codes that are used to indicate whether you’re taking it the route that you’re taking it by and have those be consistent with the JACHO, with JACHO’s prohibited list of things that are ambiguous and all that sort of stuff. So normally you’re not, the indications wouldn’t come in here and whether it’s on label or off label doesn’t really apply to this particular --
DR. LUMPKIN: Well, it seems to me that there are a couple of parts and this may be where it comes in. I’ve got a patient, I’m dealing with a particular ethnic or other group where communication is important, I may need to communicate in Spanish. How do I electronically fill out a prescription that gives the information that the patient needs to know how to take it that then shows up when they go to the pharmacist? I’ve already communicated with the patient, I shouldn’t be relying upon the pharmacist to try to reinterpret something in a language that the pharmacist may not be able to speak. And it seems to me that that plain text section under SIG would be the area where that would occur. Is that correct?
DR. HUFF: Yeah, that’s true.
DR. LUMPKIN: And that would also apply to whether it’s even off label, it may be under experimental protocol that you’ve got a special way you want the patient to take it, you don’t want to encode that, you want to --
DR. COHN: Yeah, but of course there’s a lot that you can encode, QID, BID, TID, QOD, QHS, I mean on and on and this is probably and 80/20, 90/10, and I think this is really an area for, rather then us trying to micromanage this one this is something where it looks like the standards organizations are beginning to work on it and that they need to decide it themselves how best to work in this area.
DR. LUMPKIN: Well my question and concern, and this is one that’s probably significant for us as a committee, I’m not necessarily over confident given the usual composition of the standard development organization community of their sensitivity to issues that particularly affect cultural minorities, ethnic minorities, within this country, and I think we may need to have some sort of statement that as we think about this automated process we’re kind of taking people out of it and there are many instances where if you take people out the chances of misinterpretation when you have a standardized structured language increases particularly for those for who English isn’t their first language, or for who the culture of this country is not their first culture.
DR. COHN: John, maybe I’m thinking about this a little differently but I’m thinking of sort of making it so there would be sort of drop down lists with choices of things that then get sent, maybe codified but they’re basically QID, TID, whatever, whatever, and then that information gets sent over to the pharmacy, and I guess I would presume that there might be some choice of what language gets printed out on based on who’s receiving the medication. How are you thinking of this? You may be thinking of it a different way.
DR. LUMPKIN: Well, I’m thinking let’s look at choice of language, okay, Spanish, but is it going to be Puerto Rican Spanish, is it going to be Mexican Spanish, is it going to be Costa Rican Spanish, so there are really a number of issues where right now the big struggle is how do we communicate. I think for special complex dosing instructions and where cross cultural communication --
DR. VIGILANTE: But isn’t this communication with the pharmacist? This is with the pharmacist right --
DR. LUMPKIN: Well, let’s go back to our process which is right now I write a prescription and I give instructions to the patient verbally. But what becomes written, which is that, now I’ve developed an ability to communicate with this patient either because I’ve used an interpreter or whatever, so I want to explicitly have something that goes with that prescription and then shows up with that medication. So when the patient gets it they will understand in a way that they can understand, which is not just language but also is cultural context, Vickie help me out here, I hope that’s why you’re raising your hand.
DR. MAYS: Yeah, I think what John’s trying to say is let’s not miss an opportunity but I think we’re backing into it as opposed to maybe being clear. Say for instance that in your office you have communicated to a patient a particular way you want them to take this drug, maybe because of diet issues, it may be because of any number of things. And you in your office have the capacity because you have an interpreter or because you yourself have gone to medical school in a place in which you’re taught language. So you then do a set of instructions. What it seems that John is saying is that okay, once this is sent how does that same set of instructions, or is it a standardized set of instructions --
DR. VIGILANTE: I mean something like that you happen to know whether it’s cultural or just patient specific, this patient happens to like yogurt and you want them to take these non-steroidals with the yogurt, something like that --
DR. LUMPKIN: Right, you’ve got a patient who has a developmental disability and you know he takes yogurt at the same time every day and the instruction is, not the standard one, take it with your yogurt. Jeff.
MR. BLAIR: Can we accommodate this by simply adding an additional sentence to the recommendation indicating that HHS should encourage the standard development organizations when they develop the SIG standards to consider language and cultural requirements?
DR. LUMPKIN: That works, that works as a placeholder. Vickie?
DR. MAYS: I guess I’m concerned because I don’t think people are, again, it’s one of these things when we have the discussion it’s like wow, but when you read what you say, once you walk out the room I don’t know they’re going to understand that. Maybe you should say something about this a little bit earlier so that by the time it gets to the recommendation they understand because I don’t think anybody is going to go out of their way to make it, to understand what you mean in terms of the broadness because as soon as you say cultural they’re really thinking racial ethnic minorities, when it really is language, I mean there’s a variety of things this includes. So it may require some little discussion before because this is an opportunity, it’s an opportunity to not have populations come back two years from now complaining --
DR. VIGILANTE: Isn’t it more just about providing directions in a patient specific manner? In however that’s appropriate, whether it’s language or other behavioral --
DR. LUMPKIN: I think that in the Observation 10 there should be some point that the SIG component may be the only place in this electronic media to convey specific patient instructions in a way that cannot be encoded.
DR. WARREN: John as a member of the subcommittee I need to ask a question because I’m getting very confused. We’ve said in here that we need to maintain the free text ability in this message to convey whatever unique directions you want to give, so how is what you’re asking for different then the ability to write out in free text what you want the patient to see?
DR. LUMPKIN: I actually was not suggesting that we change that statement as much as to enhance it so that there’s an understanding that it’s not just because you have --
DR. WARREN: So more then just complex dosing things but comments that would consider culture, etc.
DR. LUMPKIN: And language.
DR. WARREN: If we add it that way then I’m okay with it, so up there on the e.g. for special or complex dosing or cultural sensitivity or instructions, those kinds of issues. The standard itself I think is pretty good, it allows for all that, it’s just letting people know what goes into what box.
DR. COHN: So are we getting there? So we read 10.1 as it’s been --
DR. WARREN: I think it’s more language understanding or something like that, not requirements.
DR. MAYS: Unless it’s literacy requirements, language and literacy requirements.
DR. WARREN: And then change it to requirements.
DR. LUMPKIN: It’s really for special complex dosing, special or complex communication challenges which may result due to language or cultural issues.
DR. MAYS: I think you want literacy --
MR. REYNOLDS: Isn’t it even more basic then that? Isn’t it any necessary communication between the prescriber and the patient? Why make a list? It’s really anything that the prescriber wants to be able to say to the patient.
DR. WARREN: But I think it needs to be a list for exactly what Vickie was pointing out, sometimes we forget to include the cultural pieces and right now, I mean there’s lots of research literature out there that says that we miss it because we don’t consider that and so it’s just one more way to give an example.
DR. LUMPKIN: Right, I think it’s kind of a blend of saying any other communication that’s essential to be there and then especially address those areas, but I think we’re close enough that we can move on.
DR. COHN: Okay, and certainly for this one if Vickie and John would sort of look at this during the next break and make sure we have it right that would be helpful.
Okay, now I’m going to read over Observation 11 and 12 together because they’re basically both different types of identifiers, one’s dispenser identifier and one’s prescriber identifiers --
DR. LUMPKIN: And one knows we love identifiers.
DR. COHN: We love identifiers, and I mean I think you’ll find there’s a certain similarity of the action items and discussion, so I’ll read through 11 and 12 and then we’ll move from there onto the pilot discussions and all of that.
Okay, dispenser identifier. The NCPDP Provider Identifier Number has been in use for a number of years and is widely accepted as the dispenser identifier, otherwise known as the pharmacy identifier. Its database contains information to support various claims processing functions and it needs to continue to be available for this purpose. The NCPDP database can accommodate the National Provider Identifier, the NPI, as a reference field. HIPAA requires the NPI, when it becomes available, to be used in the NCPDP Telecommunication Standard for claims processing. The National Provider System, the NPS, enumerates pharmacy organizations, subparts of organizations at a particular address, and pharmacists.
Recommended Action 11.1: HHS should ensure that the NPI when it becomes available is incorporated as the primary identifier for dispensers in the NCPDP SCRIPT standard.
Recommended Action 11.2: HHS should accelerate the enumeration of all dispensers to support transition to the NPI for e-prescribing.
Recommended Action 11.3: HHS should permit the industry to use the NCPDP Provider Identifier Number in the event that the NPS cannot enumerate dispensers in time for Medicare Part D implementation.
Recommended Action 11.4: HHS should evaluate how mass enumeration of dispensers for the NPI can occur using the NCPDP Provider Identifier Number database.
Recommended Action 11.5: HHS, when requiring the NPI as the primary identifier for dispensers, should protect the ability to maintain linkages to the NCPDP Provider Identifier Number database for current claims processing purposes.
Now Observation 12 is the prescriber identifier. There is no single identifier for prescribers. The DEA Number is widely used as a proxy. Although testimony is expected to be heard from the DEA between now and March 2005 others indicated that the DEA prefers the number to be reserved for use only on prescriptions for controlled substances. NCPDP created HCIdea for the purpose of enumerating prescribers in order to eliminate usage of the DEA on prescription claims when transmitted between dispensers and payers/PBMs. It is not currently made available directly to prescribers. The HCIdea database supports all of a prescriber’s DEA numbers, practice locations, and the NPI when it becomes available. The NPI is the HIPAA standard for identifying all providers, including prescribers, on all HIPAA transactions. The NPI database could accommodate a bulk load from HCIdea to include missing elements, if efficient and valid to do so.
It is further noted that the DEA is anticipated to produce an electronic signature standard to ensure the protection of messages containing prescriptions for controlled substances. Electronic signatures will also be addressed by NCVHS in subsequent recommendations.
Recommended Action 12.1: HHS should ensure that the NPI, when it becomes available, is incorporated as the primary identifier for prescribes in the NCPDP SCRIPT standard. It should be noted that the NPI must be at the individual prescriber level because a prescription cannot be written at a group level.
Recommended Action 12.2: HHS should accelerate the enumeration of all prescribers to support transition to the NPI for e-prescribing.
Recommended Action 12.3: HHS should permit the industry to use the NCPDP HCIdea in the event that the NPS cannot enumerate prescribers in time for Medicare Part D implementation.
Recommended Action 12.4: HHS should work with the industry to identify issues and possible solutions that deal with all elements of the prescriber location and include those solutions in the 2006 pilot tests.
Recommended Action 12.5: HHS should evaluate how mass enumeration of prescribers for the NPI can occur using the NCPDP HCIdea database.
Recommendation Action 12.6: HHS, when requiring the NPI as the primary identifier for prescribers, should protect the ability to maintain linkages to the NCPDP HCIdea database for e-prescribing routing functions.
Comments?
DR. LUMPKIN: Has anybody identified any comments on this section?
DR. COHN: Anybody located any problems?
DR. HUFF: The only thing that occurred to me on rereading this is whether, certainly what we said was true, that we want this used in NCPDP SCRIPT and I wondered if our intent was to focus it only on that or if really we meant that we wanted to use the NPI in any of the messages where users or dispensers were identified. So that we would just add in there in NCPDP SCRIPT and other e-prescribing messages or something like that, that’s a question.
DR. COHN: I think maybe we’ll defer that back to the subcommittee, I think we actually discussed that once, or at least maybe we sent emails off about it and I think it was the opinion of the subcommittee that we not go there but we can certainly review it. Do others have a strong feeling depending on what we come back with on this one?
MR. BLAIR: I think we’d need to really discuss it and think about it, I’m not saying no, I’m just saying we need to discuss and think about it and I don’t know if --
DR. HUFF: [Off microphone.]
DR. LUMPKIN: Okay, we’ll have the subcommittee think about it tomorrow morning.
DR. COHN: Okay, so bring back either the same thing or some changes to it. Steve.
DR. STEINDEL: John in light of the conversation we had this morning do you want us to add a recommendation 12.7 that you get 007?
DR. LUMPKIN: Yeah, that works.
MS. BEREK: I was looking for the vanity plates.
MR. BLAIR: I want to know if we have to have a recommendation to protect ourselves against weapons of mass enumeration.
DR. COHN: I think we’ve been going at this too long.
Okay, shall we move into Observation 13, pilot test objectives.
NCVHS has observed that there were many impediments to full adoption and implementation of the HIPAA transactions and code sets standards. With the requirements for pilot testing in e-prescribing HHS has the opportunity to address these issues. As previously noted, while the foundation standards being recommended here are suitable for early industry adoption there are several areas in the foundation standards that do not support all the MMA requirements.
Recommended Action 13.1: HHS should support the efforts of standards development organizations to incorporate in the foundation standards as many as possible of the additional functions required for MMA as identified in these recommendations.
Recommended Action 13.2: HHS should include foundation standards with as many as possible of the additional functions required for MMA in the 2006 pilot tests.
Recommended Action 13.3: HHS should identify specific goals, objectives, and metrics to guide the design and assessment of the 2006 pilot tests so that the resulting information from the pilots facilitates industry adoption and prescriber usability. The metrics should include economic and quality of care factors.
Recommended Action 13.4: HHS should develop and widely promulgate information concerning the economic and quality of care benefits of e-prescribing, provide comprehensive education on implementation strategies, and address other elements that contribute to successful and widespread adoption.
And probably there’s a 13.5 based on our previous conversation that HHS should develop and publicize a timeline for the pilot projects and expectations of the industry for the 2006 pilots, which needs to be wordsmithed but I think that’s sort of what we’re trying to say. Should develop and publicize a timeline for the pilots as well as expectations for the industry or of the industry, I mean this isn’t quite right but we’re sort of trying to I think reflect on a view that there needed to be a timeline that was publicized and that both related to what it was going to go on as well as expectations of the private sector.
DR. LUMPKIN: I was wondering if there should be an additional sentence also added, a sentence or two, to the observation along the lines of commencement of, beginning a pilot requires some prior actions by the vendor community and that a 2006 start up requires some earlier development of the standards, something like that.
DR. COHN: Let’s see what we’ve got up here.
MS. AMATAYAKUL: Just a note.
DR. COHN: Success for the 2006 pilots will require much pre-work by the industry, something on that level. Okay, other comments?
DR. LUMPKIN: Well, go this way so we’ll start off with Bob.
MR. HUNGATE: In Recommendation 13.4 promulgating information, I’m wondering about privacy, confidentiality protection aspects and the communication that goes out relating to that, I think they’ll be sensitivities, I wonder if they shouldn’t be addressed as part of this, it’s partly a question is this the right place to raise that question. It’s really 13.4, if I said 3 I meant 4, comprehensive education I think should respect the need to communicate to individuals how their information is protected as well.
DR. MAYS: Can I piggyback on his because I have almost the same, so if you’re going to consider this I was going to ask the same thing there, we’ve been worried in these pilot objectives about the prescriber, and we’ve been worried about the industry, but what about the actual patient in terms of their concerns about this process in terms of privacy and confidentiality or any barriers that may come from their perception or attitudes? Is this the place to also consider as a part of the objective to learn if there are barriers that they have?
DR. STEINDEL: Simon I think we do state at the end of the letter that we’re going to be addressing privacy concerning e-prescribing after this letter, it’s obviously a very complex issue and I think just adding a couple of words here and a couple of words there does not do it justice and it needs a separate letter. The question is do we need to point out before the very last paragraph, like someplace in the introduction or something like that, just a one sentence statement more or less to the effect of we understand privacy in the e-prescribing arena is complex and we’ll be addressing it at a later date, something like that.
DR. LUMPKIN: But I think the issue is not being raised, I mean privacy is a whole separate discussion but patients might want to know that there’s a change coming on and how that impacts them.
MS. BEREK: This is slightly unrelated because you’re talking about timeline, I just want to remind us all that in fact the timeline begins when we send this letter, and the longer we take to send this letter the longer it takes to kick off the timeline. Just an obnoxious remark from CMS that can’t issue any regulations on this until this letter goes, so I just think we need to just remember that and finish our wordsmithing tomorrow.
DR. LUMPKIN: Is tomorrow soon enough?
MS. BEREK: Yes, tomorrow would be just fine. Karen told me I could give you until tomorrow, I was going to say today but she’s doing the work, she said tomorrow is okay.
DR. LUMPKIN: Well it’s good to see that Karen is in a good mood because usually she’s not that lenient. Jeff.
MR. BLAIR: I rise in support of the honorable lady from California, Vickie Mays, who has I think raised a point that I think is not covered in the letter, I do fully agree with Steve’s observation that we will be hitting privacy as a subject and there’s so many aspects to that and covers so many things that that’s why we deferred to afterwards, so I’m not talking about the privacy piece. But Vickie questioned in my mind, at least what I’ve heard, was we’ve not said anything about measuring the reaction of consumers in the pilot test, so when we get down to the pilot test issues, those questions, I think that that would be an appropriate place for us to include that point that Vickie has made.
MS. GREENBERG: I don’t know if this is so much the pilot test, I was going to say on the widely promulgated information concerning the benefits, I mean I think, I don’t know whom that was directed to, whether it was primarily directed to the industry, but I think that we should specifically say information for the health industry and consumers, that we should mention consumers there.
MR. BLAIR: And maybe we’re blurring it when we say consumers versus patients, so maybe when we get down to the pilot test piece we could see what words we put in.
DR. FITZMAURICE: Could I suggest just a word change, instead of promulgate might we say disseminate, to make it distinguished from passing a regulation? Under there where it says, on 13.4, HHS should widely, should develop and widely promulgate information, kind of promulgate regulations and disseminate information.
DR. COHN: Well, I guess I’m trying to keep up with all the comments coming north, south, east, and west, and I’m sort of looking at what Margaret’s doing and I’m somehow feeling that we’re now, we’re going to sort of look at each other tomorrow and have not gotten this right at all, so I guess I want us all to sort of look and sort of think about where the various comments ought to be and I mean once again which recommendations are we talking about here and all of that, and maybe Judy has a comment to help us with this one.
DR. WARREN: I was noticing where Margaret put patient response and this whole action is about disseminating information, and in listening to everybody talk, I mean we’ve not made any recommendations that patient response be part of the pilot and maybe that’s a really strong one and it should be its own recommended action, that when the pilot is designed and developed that it should include paying attention to how patients respond to it.
DR. COHN: Is that one of the metrics that’s just the next sentence there?
DR. WARREN: Oh, I wish you hadn’t asked me that.
DR. COHN: Well, it says metrics should include economic and quality of care factors, as well as patient satisfaction.
DR. LUMPKIN: The metrics should include economic and quality of care factors --
DR. COHN: As well as patient satisfaction --
DR. WARREN: That would be a good place, I’d go with that.
DR. LUMPKIN: Satisfaction is not the right word.
DR. COHN: Well, okay, then help us with that one.
DR. WARREN: Patient acceptance.
MR. BLAIR: Patient reactions.
DR. LUMPKIN: How about just patient factors?
MS. GREENBERG: No, that could mean --
DR. WARREN: Factors is too vague I think.
MR. BLAIR: Patient reactions --
MR. HUNGATE: I think reactions is pretty close.
MR. LOCALIO: Don’t you want patient participation? I mean you have to have everybody participating in the pilot study or nothing is going to be pilot studied, and that’s one of the key elements, they have to go along with it. If everybody wants a piece of paper when they go out of the physician’s office this won’t work, if everybody demands a prescription piece of paper. So pilot testing as in any study, any study, you’ve got to have the patient’s participation and you can’t study them. Think of it as a clinical trial, this is just a very big kind of messy clinical trial and the patients have to consent and participate.
DR. COHN: So is that part of the metrics, is that what you’re describing? That patient participation is one of the metrics?
DR. LUMPKIN: Yeah, but they could participate and not be happy about it, which would not be a good outcome.
MR. LOCALIO: Actually satisfaction is in addition to participation, once they participate if they’re satisfied then you still have a problem.
DR. LUMPKIN: Harry and then Vickie.
MR. REYNOLDS: I’d like to see us consider adding to 13.5 and I won’t wordsmith right now but somewhere in there a clear definition of the functionality to be tested in the pilot, a lot of the discussions that have gone on previously, if the codified SIG is not ready you could still pilot, if Rx-Norm, because there’s still functionality, significant interoperability and other things you can test, so it just, so if vendors have to get ready for the pilot, others have to get ready for the pilot, the quicker, that when that timeline is set it also clearly has to identify the functionality and the functionality may come in stages. If the Secretary could look at it and say I’m starting these pilots now, six months from now that we will also include the codified SIG, da, da, da, da, da, da, it gives you a possible way to, because people can’t develop anything without knowing what that functionality is that they’re having to do if all the long term stuff isn’t necessarily ready.
DR. STEINDEL: Harry, why doesn’t 13.2 address that? We’re leaving it open but we’re saying just put as many pieces as you can when they’re ready, we can’t list the pieces now.
MR. REYNOLDS: I’m not trying to list them but when we talk about a timeframe --
DR. STEINDEL: Yeah, but we already say in 13.2 that we can do this in pieces.
MR. REYNOLDS: I don’t think it’s too clear but I’ll defer.
DR. MAYS: I guess I’m a little concerned with trying to kind of just throw the “patient” whatever factor, whatever, in 13.4, partially because if you go back to your kind of lead in in Observation 13 it really does seem like it’s only the patient in relationship to the industry standards, something like that, so I think it just requires another sentence, either another sentence up above that says something about the patients and then I guess it can be in 13.4, or both, which is a sentence and then maybe a separate recommended action.
DR. STEUERLE: I mean I don’t think we can wordsmith it now but if we’re going to put in some of this information about patients I am concerned that we be clear, that we really want an informed patient reaction, if for instance all we do is ask patients how they feel about some additional information being floated around without them having any idea that perhaps they’re getting better health care, or if this is a pilot that as a result of the pilot it’s done on a broader scale it may improve national health or something, you’re not getting a full consumer reaction, the only patient reaction I’m getting is to the paperwork and all we’re inviting are the negative comments, and it seems to me if we’re suggesting this has to be part of the pilot there has to be an accompanying information process, I mean I don’t know whether it’s a survey or whatever it else, but it has to give them more information just in that they were participating in this process and this additional paperwork is passing around because then we only invite the negative reactions and we don’t get there action to the consumer advantages on the other side.
DR. CARR: I think Vickie’s point and the points that have been made are very good because in fact the patient participation in this is going to change, they’re going to have to arrive at their doctor’s office with their pharmacy number, knowing what pharmacy they’re going to, what the phone number is, when they’re available, and so on. And so in fact there may be some element of patient education and just sort of as I read through this I couldn’t, the whole wonderful document that you guys have done, it made me think of the dimensions of care that we are offering the patient and the system is care that is safe, effective, efficient, patient centered, timely, equitable, and what am I missing, anyway, each of those dimensions and so I think it really is important to bring the patient centered element into it as well and they will have a change in their behavior but their benefits will be that we have more closely approximated the IOM ideal patient encounter.
DR. LUMPKIN: Okay, I think what we need to do with 13 is really to look at the issue of, because I think that the issue of the patient needs to be injected into the observation, into 13.3 under metrics, and then 13.4 in informing, in those three areas.
MR. HOUSTON: I was just talking to Richard about this, I guess there is a classic patient safety issue here that still needs to be considered and the question is is I sort of heard that there’s all these reasons why it’s to the benefit of the patient but I think it’s part of what’s trying to be established here is that there are those benefits to the patient as well as others and so should we say something about pilot test objectives to ensure that it is safe and effective and does it merit IRB, I would think an IRB of some sort needs to be involved in this type of activity.
DR. LUMPKIN: See I told you guys you shouldn’t be talking --
MR. HOUSTON: If they would have put Judith between me and Richard this would never have happened, and then you would’ve never had that problem earlier.
DR. LUMPKIN: I don’t know if you need an IRB if it’s mandated by Congress, that wasn’t a serious comment. Okay.
DR. COHN: I think we’re about done with this one, I guess I would ask those of you who have all commented, I mean what happened was that there were a bunch of rapid fire comments and I would I guess have you all look at these, especially the ones as Margaret, I mean Margaret’s been fiddling with it, once again at the next break you might want to go up and make sure that your meanings at least are up there so we can consider them tomorrow morning, because I heard a lot of things, some of which Margaret got, some of which Margaret didn’t, so I would just ask you to take a look and sort of see how closely it aligns with your views, I don’t think I have much objection with almost, with what everyone was saying, but it’s really a question of how we get it up there in a way that won’t take us an hour tomorrow.
DR. LUMPKIN: I agree, and I know we need to move on because as Jeff pointed out we have 20 minutes and a few more things to go. But I actually want to just sort of ask a question back on the identifiers, and it’s sort of prompted by something that Justine said that sort of made me pause, if I go to my doctor and they ask me who my prescriber is, who my dispenser is, I’m going to say Walgreen’s at 95th and Western. But as I was trying to look back at our description of the NPI it’s going to be Pharmacist Smith or Jones or whatever, how do we handle that?
MR. BLAIR: That’s why there’s the pilot test with the mapping.
DR. COHN: Margaret, I believe actually it gets it at that level also.
DR. LUMPKIN: So the pharmacy?
MR. BLAIR: And it has to map to that NCPDP provider number.
MS. AMATAYAKUL: The NPI maps to the NCPDP database that contains much more information about location.
DR. LUMPKIN: And I have a sister-in-law who’s a pharmacist who works at two or three different locations, which if I’m going, and it may be that there’s no need for that, well, how does my doc know where to send my prescription?
MR. ROTHERMICH: The NPI is used on the NCPDP transactions but the prescribing systems, the actual software systems, can still show Walgreen’s at 95th and Western, so the patient won’t need to know any numbers or anything about that, they’ll still be able to use sort of their common parlance, but the systems behind that support this will be more accurate.
DR. LUMPKIN: And the doc will be able to pick that off of a scroll down list or something like that --
MR. ROTHERMICH: Right, and then the system behind the scenes will have an NPI associated to that pharmacy.
DR. LUMPKIN: Great. Next?
DR. COHN: I think we’re okay. I think Karen wanted a further comment --
MS. TRUDEL: I just wanted to clarify one other issue and that’s that while the NPI can enumerate the pharmacist when we say the dispenser ID we really mean that Walgreen’s address.
DR. LUMPKIN: So the Walgreen’s at 95th and Western would also have an NPI.
MS. TRUDEL: An NPI, right.
DR. COHN: I think the answer is yes.
DR. LUMPKIN: Okay, 14.
DR. COHN: Okay, Observation 14 is support for standards collaboration. A significant level of collaboration is occurring among SDOs and with vendors who have proprietary solutions as there is growing momentum for e-prescribing and other components of the NHII. It is important to support the open, consensus based, actually there’s a change here, what is it, it is important to support the open consensus based and voluntary nature of standards development organizations while accelerating the process of standards development and coordination.
Recommended Action 14.1: HHS should financially support standards coordination activities to ensure a seamless e-prescribing process across provider domains, e.g., physician office, hospital, long term care, dispensers, and payers/PBMs.
Recommended Action 14.2: HHS should encourage standards development organizations to adopt a change management process that permits versions to maintain interoperability.
Comments?
Observation 15, policies to remove barriers. Testimony identified widespread industry concerns relating to safe harbor, preservation of provider/patient choice, and freedom from commercial bias in messages received through e-prescribing applications.
Recommended Action 15.1: HHS should ensure that regulations define the parameters of safe harbor, ensure preservation of provider/patient choice, and require that e-prescribing messages received through e-prescribing applications be free from commercial bias.
Okay? Any comments on that one?
Observation 16, and I think this is another where I’ll have you look at the small print, and this is conformance testing and certification. Testimony identified the need for testing conformance to standards and certification of e-prescribing systems, i.e., standards conformance, functionality, and interoperability. While conformance testing and certification are two distinct but interrelated concepts it should be recognized that some parts of the industry use the term “certification” in the limited sense of passing a conformance test.
Recommended Action 16.1: HHS should support SDOs in their development of conformance tests for the e-prescribing standards and their implementation guides.
Recommended Action 16.2: HHS should require that e-prescribing system vendors validate the conformance of their e-prescribing messages.
Recommended Action 16.3: The HHS Office of the National Coordinator for Health Information Technology should investigate how e-prescribing applications might best be certified.
DR. MAYS: Can you just tell me what you want in terms of support, HHS should support standards development organizations, what does that mean? What do you want them to do?
DR. COHN: You mean in terms of their development of conformance tests?
DR. MAYS: 16.1, yeah.
DR. COHN: Well, I think it might include up to and including funding work that they have to do. Jeff, did you have a comment?
MR. BLAIR: Yeah, Vickie your perceptive, you picked up, we used different words here, we said financially support and we didn’t use that in other standards activities, and the reason that we did that is that for the most part the standard development organizations are self sustaining, but the coordination between standards organizations, am I on the wrong question? What is the phrase, never mind.
DR. STEINDEL: Vickie, this was actually, came up when we used the word support versus financial support in a lot of these, if you notice this is one where you picked it up. This is more of a direction to HHS that when HHS is working with the SDOs, like for instance when I go to HL7 and I’m wearing my HHS/CDC hat and we’re talking about standards, that I should look at those meetings and bring up the question of conformance testing and certification and to try to include that as part of the standards and if necessary go back to HHS and maybe ask for more support in this area, perhaps financial. But we deliberately worded it broadly so it covers both of those but this is somewhat of a requirement that’s more on the HHS people that are working with the SDO processes.
MR. REYNOLDS: I think one other opportunity that’s available with the SDOs is most of them are volunteers and if you want to accelerate something HHS could offer them some financial aid where consultants or others could be assigned to them to produce these things faster then they would be done through a normal voluntary organization, especially since these are key in making sure that people do it right rather then somewhat the interpretation free for all that was going on with some of the HIPAA stuff, so that’s what this meant. Because with the volunteers you can only do it at a certain speed, you put money in you can actually bring bodies of people to the table to go ahead and do it and do it much quicker and in a much more structured way.
DR. LUMPKIN: Okay, next steps.
DR. COHN: Should we read the next steps here? Other comments?
DR. LUMPKIN: Wait, Richard has been talking to John again.
DR. HARDING: Just a minor thing but back on 15.1 the last phrase of the recommendation 15.1, be free from commercial bias. Now I’d like to think that’s possible but it just seems like it’s a negative statement, free from commercial, could it be something else like be evidence based or something that is different because I think it’s impossible to say that we could have something free from commercial bias.
DR. COHN: This is actually referencing both the conference report on the MMA legislation as well as I believe a letter we received from Senator Grassley in the process of our deliberations, and I think there was some, this is a reminder to us that there was a requirement at least from the conference report that it be free from commercial bias. Now how you do it I agree with you --
DR. HARDING: Could you put quotes around it?
MR. HOUSTON: Could we put a footnote that references the conference report or something so that at least if somebody says what are they talking about commercial bias is indicated that it’s simply they can go and understand why we used that particular phase.
DR. COHN: Sure. Is that okay?
DR. LUMPKIN: Next steps?
DR. COHN: Okay, next steps. There are several other message format, terminology, and identifier standards and important related issues that were identified by NCVHS but that are not addressed in this initial set of recommendations. NCVHS plans to receive testimony on as many of these topics as possible between now and March 2005 and make further recommendations in March 2005. The topics include: electronic signature for use in e-prescribing, issues related to privacy and security with respect to e-prescribing, and I want to thank Mark Rothstein for taking the lead on that. A directory that would identify prescribers, nursing facilities, and pharmacies that are able to accept e-prescribing transactions, codification of allergens, drug interactions, and other adverse reactions to drugs, incorporation of indications for drug therapy into e-prescribing messages, a standard for units of measure, methods for patient identification for e-prescribing, use of the National Health Plan ID for e-prescribing, formulary identifier, exchange of medication history among all participants in the e-prescribing process, exchange of medical history within the e-prescribing process, how best to ensure the interoperability among e-prescribing standards, standard codes for orderable items, such as insulin supplies, exchange of drug labeling and drug listing.
And then finally NCVHS wishes to thank you for the opportunity to make these recommendations, Sincerely John Lumpkin.
And the floor is open.
DR. KIMMEL: This is Dr. Zebediah Kimmel from Dr. Brailer’s Office. We’d like to request that NCVHS consider adding the topic of clinical decision support explicitly to this list of next steps and we’re particularly interested in your input on the topic of advanced clinical decision support functionalities which have to heretofore been extensively addressed perhaps in discussions such as these.
DR. COHN: I think that’s a friendly amendment, Jeff has time on his hands.
MR. BLAIR: In concurrence.
DR. COHN: Thank you.
DR. MAYS: Would this be the place to also put something back in about the patients in terms of, since you’re going to get testimony would you want to do it here or do you want to just leave that to the pilot?
DR. COHN: I’m sorry, help me with this one.
DR. MAYS: Well, what I’m asking is here is whether or not, for example you’re talking about getting testimony, is there, we talked about for example learning more about patient’s acceptability and what kind of patient education you may need to do in the pilot, as part of pilot objectives, this is testimony, would it at all facilitate there being any kind of testimony to understand what kind of patient education to do, what kind of patient factors to look at?
MR. BLAIR: I feel as if we’re not going to be able to learn as much about asking patients about their reactions when e-prescribing systems are not in use that much today, especially the ones that we’re talking about, but I do think we could learn a lot if we make sure that patients are included, or the reactions of patients are included in the pilot test so if you feel strongly about requesting testimony I think we could do so but I feel like we’re going to get more information on including the patients in the pilot tests.
DR. WARREN: Just as kind of an aside, we’ve been getting a lot of information in our testimony about patient responses, either from advocacy groups or examples from physicians, and we already have on example that I thought was incredibly good about e-prescribing, that one pediatrician was using e-prescribing and the mothers absolutely adored it because they had to spend less time in the pharmacy waiting for the drugs to be filled. So here they are with sick children, they go in, the drugs are ready when they get there. Unfortunately the pharmacy lost income because now the mother was no longer buying toys for the children while they were waiting for the drugs to be filled. So I think we’re getting some of these things as we’re getting other testimony.
DR. COHN: I think there’s also decreased child satisfaction --
DR. STEINDEL: John, what came to mind with all these comments, in the closing remarks, we’re making recommendations for the pilot and we’re saying that we’re going to hold further hearings on the pilots. Do you think we might want to add a comment that NCVHS would like to review the pilot? The instructions, what they’re going to do?
DR. LUMPKIN: I think that we would be happy to assist the Secretary by reviewing --
DR. COHN: And that’s in the final sentence or two?
MR. BLAIR: Could we describe that as an offer rather then a request, that we are available to do that?
DR. LUMPKIN: Yes. And I’m just concerned that I’m going to get a Dear John letter back from the Secretary.
DR. COHN: Well, I guess we should talk about sort of next steps on this letter, certainly as you can imagine I don’t intend to reread this tomorrow, I think I had my day of reading pages for everyone, so let’s talk a little bit about getting from here to the next version to consideration tomorrow in a serious fashion.
DR. LUMPKIN: Before we do that I have a note on here, something about section 7.3 that we wanted to, did we adequately cover that? And I don’t remember what it was but someone had raised a point and we wanted to --
MR. LOCALIO: Especially if we’re going to offer to review the pilot test, that would be certainly the opportunity to raise some of these issues about the potential success of some of these proposed pilots, or their feasibility.
DR. COHN: So you’re basically okay with 7.3 at this point assuming that we’re able to review what they’re planning on doing, okay, great.
DR. LUMPKIN: I think methodology, the approach tomorrow, there have been a number of recommendations, I think what we should is just walk through those changes tomorrow.
DR. COHN: Okay, and so what we’ll do is get a redlined version with just changes that occurred out of our conversation today, or actually let me think about it, things that I guess we agreed to today we probably don’t need to show, it’s only the things that we’re putting in after the end here --
DR. LUMPKIN: Right, the things that the committee has --
DR. COHN: Deferred, okay, is everybody okay with that?
DR. LUMPKIN: We’re going to get a copy tomorrow, sometime before lunch I assume --
MS. GREENBERG: Will it highlight everything that we’ve added to this version?
DR. COHN: Obviously what we have are a couple of different versions in front of us, we have a version that was sent out, a version that we walked in today that had had some changes made, then there were also some changes that we sort of said oh yes, so I guess what we ought to do is look through all the changes that we sort of suggested during our conversation as well as additional things that the subcommittee, so basically anything from sort of this version on will be reviewed as we go forward, and I guess we will be reviewing it initially at the 8:00 a.m. Standards and Security Subcommittee meeting and yet any changes beyond that will be available to people shortly after the full meeting occurs at 10:00 for them to review and I guess we’ll consider it in the afternoon.
MR. BLAIR: One last observation, I want to especially recognize the patience and the leadership that Simon has provided, that have gotten us through especially these last few months and especially these last few weeks because I think a lot of us really questioned whether this was possible and I think Simon has really provided the leadership, thank you.
[Applause.]
DR. LUMPKIN: And Marjorie said there wasn’t patients on this.
Before we break we need to take a count for dinner tonight.
[Whereupon at 3:05 p.m. the meeting was adjourned.]