APPEARANCES:
Committee Members
G. KRISTIN CROSBY, M.D.
BRUCE DEVEREUX CUMMINGS
GARY C. DENNIS, M.D.
SUSAN DESMOND-HELLMANN, M.D.
MICHELE M. EVINK
EUGENE ANTHONY FAY
JOHN FINAN, JR.
LISA GIGLIOTTI, J.D.
APPEARANCES:
THOMAS R. HEFTY
HEIDI MARGULIS
MARY M. MARTIN
GARY S. MENDOZA, J.D.
NANCY H. NIELSEN, M.D.
DR. ERIK OLSEN
GARY B. REDDING
JACK ROVNER, J.D.
APPEARANCES:
JUDITH A. RYAN
LEONARD D. SCHAEFFER
PATRICIA OSBORNE SHAFER, R.N., M.N.
JUDITH G. SUTHERLAND
WILLIAM TOBY, JR.
KAREN B. UTTERBACK, R.N.
PATRICIA M. WALDEN
KERN C. WILDENTHAL, M.D.
APPEARANCES:
DOUGLAS L. WOOD, M.D., Committee Chair
Also Present
CHRISTY SCHMIDT
JEFF BLOOM
C O N T E N T S
PAGE
Call to Order and Committee Work Plan
Douglas L. Wood, M.D. 7
Group Reports
Group 4 (Coordination)
Jack Rovner 22
Group 3 (Communications and Oversight)
Erik Olsen 29
Group 2 (Flexibility)
Heidi Margulis 33
Group 1 (Data and Information)
Bruce Devereux Cummings 38
Panel Five: Existing Best Practices and
Alternative Case Studies
FDA Case Study
Janet Woodcock, M.D.
Center for Drug Evaluation and Research, FDA 51
Negotiated Rulemaking
Judith Ballard
Office of the Secretary, HHS 62
CMS Case Study
Barbara Paul, M.D.
Physicians' Regulatory Issues Team, CMS 71
Questions and Answers 82
Closing Comments
Douglas L. Wood, M.D. 93
P R O C E E D I N G S (8:13 a.m.)
DR. WOOD: Good morning, everyone. Welcome back, and our guests and observers, welcome to the second day of the meeting of the regulatory committee. We're making good progress.
Now, we have two major objectives for today. The most important one actually is the first part of the morning, where we will work on making this project manageable and making the decisions that will be important about how we will be successful in identifying those kinds of things that can be immediately approached as well as, from my perspective, the more important work, and that is to leave a framework for how we can help the agency -- that is, CMS, as well as the FDA and others -- with a new structure for approaching regulation for the future.
Now, if you then think about what we want to accomplish in the last part of the sessions today, that is to let you understand some of the good work that is already underway. We need to make sure that we do not waste any precious time or resource, either our precious time or resource or the time or resources that have already been devoted to this activity by people within CMS and FDA, because a tremendous amount of work has already been done in listening and visiting providers and consumers and that we want to make sure that we incorporate, and in fact we might identify that there are some possibilities of best practices that should be replicated or expanded or made part of a future structure in a permanent way. So that's the objective of the second half of the day.
If you go to Tab 5 and go back to Letter C, we'll pick up again with some draft documents. As we go into the breakouts, we need you to consider the principles of issue selection and prioritization criteria that are in Tab C, and then we need to think of how we want to approach the subcommittees, which are in Tab D, and in particular for the subcommittees, let me share with you some of the thinking that we've had about why we've chosen this approach.
One option for us was to take the traditional approach of dividing up by program. So dividing up by either Medicare or Medicaid or FDA, or dividing up by traditional Medicare, Medicare managed care, or dividing up by hospitals and large institutional providers, physicians, home health, or allied health providers.
The concern about that was, first, it would be somewhat silo-oriented in the sense that it would stay oriented to a specific care delivery system or care delivery type, when in fact beneficiaries use resources from lots of different provider types and organizations, and the issue really for the future is how do you craft a system that makes it easier for the beneficiary to use, easier for providers to use, and do more coordination?
So we thought it would be better to take a different approach, one that would be more oriented toward figuring out how you actually deliver services, and services here may be more than pure health care services, as was articulated in the discussion yesterday by several members of the committee, and then you how do make sure that you take advantage of your opportunities to coordinate all of those, particularly being able to apply advances in information technology and information systems, so that if we gather the information about, say, a permanent disability for one program, if you gather it at the time of enrollment, a permanent disability is not going to change. I mean, it's permanent. So you ought to be able just to export that information elsewhere and use it for things like risk stratification, et cetera, et cetera, et cetera. So what you see in front of you, then, is that line of thinking, and as the staff and I thought about the structure, this is why we took that approach.
Now, it will require all of us to think a little differently than we have in the past, but I wanted us to be more innovative and to think about things in a different way. It also means that some of us may actually be doing some things that might be a little bit outside of our typical area of expertise, but the other thing that I wanted to take advantage of was a fresh perspective, because in that circumstance there is a possibility that some of us could take an idea to a different area that in fact would be an extremely good way of doing things and that others perhaps had not thought about.
So that's the philosophic reason for this particular structure, and what I wanted to do for you was to outline a few basic questions that we want to consider, and then we'll get you into your work groups and get you started.
The other thing we need to consider actually is how we will do the site visits. The most important consideration for the site visits is what we want to accomplish in terms of content and structure. We're still working on possibilities of sites. The final selection of the sites depends on a variety of factors, but including the Secretary's desires. So we have to make sure that all of those, then, are considered and then we'll make the final decision about where we go. So we've thought about a number of different options, but as I say, the final decision about where we go depends upon putting all of those things together.
Now, again, if you look at the subcommittee options behind Tab D, you will find the proposed outline of the committees, or the subcommittees, actually. The Data and Information Subcommittee is first, and the immediate objective here is to find ways that we can streamline and reduce or even eliminate data collection.
Now, the opportunities there for crosscutting again would be if you collect data, you should be able to collect it once and you ought to be able then to use it for anything that you want to. It should be more accurate if it is collected as close to the site that it is generated, and to the extent that we can use existing technologies, and there may then some recommendations for the regulatory process in terms of how we then structure information technologies to facilitate this activity.
We have put a preliminary list of themes and issues and specific examples about not only problems that have been already noted, but areas where we think there could be some improvement in structure.
Now, this is not an exhaustive list, but for this subcommittee and each of the others, you need to look at this, and again, in order to get the work done, we need to prioritize. So every one of the subcommittees will have to identify two or three or maybe four top options for immediate activities and work on those, and then you think about, again, the way that you would do this in the future. That is, the structure for the future.
Now, the other thing that we're going to be interested in actually is your thoughts, again, about how to manage the work. I think all of us have an understanding from the discussion yesterday that we have a huge job in front of us. We can't do everything in eight months, and we need to make some decisions about what we're going to do in that time frame and stick to them.
That obviously means value judgements, and if some of us have different feelings about some things than others, we'll have to balance those out and work at it together and develop some consensus. It may be that we decide that we'll put some things down low on the list because we don't think we can accomplish that much in a short time or that there are other groups that are working on it or that it is not critical to what we're doing. If you think about the breadth of regulations, I mean, we haven't really talked about anything that relates to human subjects research involving Medicare beneficiaries, for example, just to name one. So that's where you need to do a lot of work in the groups this morning.
Now, we have tried to structure the groups. Christy and her staff have put together a group of facilitators for each one of the work groups, including people from CMS and from FDA, and what we'll need to do then is to utilize the capabilities of those staff members.
Later on this morning, we want each of the groups to come back and to give us thoughts about the way that we need structure the work of the subcommittee, as well as what we want to do in regional hearings.
Now, from the perspective of the regional hearings, one of the potential structures would be that every subcommittee would work at every regional hearing and that some members of the subcommittee would be at that hearing and some would not.
The other option is to think about setting up the agendas of the regional hearings so that we concentrate, say, on the work of two of the subcommittees at each hearing, and that would potentially make it a little bit more manageable in terms of the travel schedule for all of us on the group, as well as to define the agenda, and it may actually allow us to take more advantage in figuring out what we want to do in the regional hearings.
So we need you to think, too, about what you would like to do in the hearings, who you would like to hear from, what you would like to see. So those are the other pieces of information that we need from you. So when we come back for, then, the group reports later this morning, we'll use that to put together in a framework for how we're going to do our work as well as the regional hearings, and then turn that around to you as quickly as we can.
Now, in terms of the assignments for work this morning, we tried to consider specific preferences where they were expressed. Not all of you had a preference, so we've done some assignments otherwise, and I'm not wedded to those from the perspective of making future changes if there is something that we see, and actually the structure, too. If we can think of a better structure, we should consider those options.
Christy, would you like to comment about how you want to move people around, where rooms are going to go, and leaders for each of the groups?
MS. SCHMIDT: Okay. I think we're going to pass this out now, and you'll see where you are. This is, as we said, the work groups for today. This doesn't mean that these are going to wind up being the permanent subcommittees. It's so we can get our work accomplished today.
Group Number 1 -- Bela, if you would stand up -- Bela's going to be your lead staff person. There will be two other staff people with her, and she will guide you to Room 705A.
Let me also tell the public that every group will be discussing all of the questions that the Chair just referred to. In particular, this group is going to look at the issues of data and information. There is going to be room for the public in all of the breakout sessions.
Group 2. Paul, will you stand up and put your hand up? Paul Hughes, he's going to take Group 2 to Room 425A.
Group 3. Laina Bush, will you stand up and raise your hand? Laina is taking Group 3 to Room 443E, my favorite room, my conference room, HP conference room.
Group 4, you have the easy job. You get to sit still in Room 800. Joan Sokolovsky, will you stand up and raise your hand? She is going to be the lead staff person in your group.
There will be notetakers in each of the groups, so you will have the ability, hopefully, to either make a handout for the group when you report back or some kind of overhead slide or something on the computer if your chairperson is going to do that.
We were going to ask, and I don't have the list any longer, certain of you to be burdened, at least for the day, with chairing these subcommittees. So you're kind of responsible for herding everybody in your subcommittee, at least for today. This is not a test. Bruce Cummings in Group 1, Heidi Margulis in Group 2, Erik Olsen in Group 3, and Jack Rovner, Group 4.
You also have before you, and so do all of the staff people, something that was given out to you this morning, which is "A Guide to January 8th Advisory Committee Breakout Sessions." Let me just tell you -- sorry. There were a number of pieces of paper that came out this morning. There's also a revised mission statement in there, given the discussion yesterday.
Has everybody found this guide? All right.
There are some times on the side. Those are suggested times that the subcommittees might spend on specific areas, starting with the draft operating principles. If you recall, yesterday you moved one statement from the mission statement into the operating principles. We've taken care of that electronically, but you need to look at the rest of the principles and debate those.
The second part will be the issue selection criteria to see how you feel about whether the criteria that are there in the draft are consistent with the charge. There are four questions to consider under that just to get your discussion going on how that happens.
May I say the key question in that one is D4, which says, "Given a set of criteria for selecting and prioritizing issues, what are the top three to five topic areas the committee members want to address?" It would be ideal if, in your committee, you stayed within your certain topic areas, but that's not always going to be the case. Issue areas and members are going to probably wind up floating across subcommittees, but this getting focused and that particular question is going to be key to our success.
The third area is C, committee organization. On there, I'd point out the part in bold, which the Chair has talked about in terms of both committee organization, how we'll accomplish our work, what you want to achieve in the regional hearings, and that includes to provide specific assignments to staff, so that you can get to the next step. Specific assignments are really important.
Finally, D is regional hearings. I think the Chair described that. It's not where we are precisely, but what it is you want to achieve by that regional hearing and how do you want to conduct them.
The final two pieces that you will see are the analytic framework. They've been in your books. There's a separate guide paper for CMS issues and FDA issues. They're really parallel. There are certain tweaks that you have to make when you're dealing with two very different organizations. That probably will need less time in your discussion and we can do some more backs and forths via email on that, but that is to say this is for every issue you select, that this is how the staff will approach those issues and what information that you will get about each of those issues, so that every issue will be reviewed in the same way and you have the same information elements, so that you can make your judgements about those particular issues. So we'll want your feedback on that, and that's the final part of it all.
DR. WOOD: So we have a great deal of work to do. We have the great opportunity that we can organize it the way that would be most productive for us.
So you have two hours. You'll have to manage your time well, but go at it. After you're finished with the two hours, we'll have a little break, and then we'll get together and look at the outcomes of those.
Len, I didn't see you back there, but go ahead.
MR. SCHAEFFER: Have you thought about how you're going to use the staff to get on top of all the information that exists out there? Because what I was struck with yesterday is there's been a tremendous amount of work done already, and if we could access that in an organized way, we'd have a running start, and to duplicate that is a waste.
DR. WOOD: Yes. Actually, that's part of why I structured the -- the staff and I were thinking about how we wanted to do the meeting. So yesterday's meeting in the latter part of the day was to try to give you a flavor of that and figure out what we don't need to reproduce.
There are some things from yesterday that I found that, again, if we identified, for example, from legislative pieces what truly was regulatory, we just could identify them, and there may be others to come, and so we're going to have to figure out how we consolidate that, and I haven't actually figured that out with staff just yet about how we would do that. We'll have to do some categorization.
MR. SCHAEFFER: Well, yes. I think if you organize it, however the committees end up, that's the first bit of information, and it sounded to me like there's a tremendous amount there and that it's basically sifting through that that will tell us where we want to go. We don't have to do a lot of original work at all.
DR. WOOD: I mean, part of the motivation, too, is when you see some of the work that's being done and to identify where there might be some potentially very good practices that, if we could spread across programs, we would do very well with, because there is a lot of good work being done.
Okay. Lots to do. Have at it.
(Recess.)
DR. WOOD: While we're getting back to the table, the paperwork, along with your suggestions about how to make it better, are due to Christy. So if several of you have turned it in, then it's here.
There is a matter of a property log that we have to generate for any of us on the committee, as well as anybody in the audience, who brought a laptop computer, and I'm told that the importance of that is if you want to keep your computer when you leave the building and avoid its confiscation, for whatever reason, that's why we need that log. So that's our second assignment. We can figure out how to manage that little regulation, too.
The grid that we gave you yesterday to prioritize short-term, intermediate, and long-term suggestions, some of you have probably started working on that. Others will do that a little bit later, but we need you to do that with as much detail as you can, particularly on the immediate-fix things, and get those back to us, so that we can collate them and we will get them out to you by electronic means so you can see what's there, and that will give us a framework of reference for the future.
MS. SCHMIDT: We'll also put out that log electronically this afternoon, so you can fill it out on your own computers at home.
DR. WOOD: Now, we have now about 40 minutes to hear the reports of the subcommittees, and the objective here is to begin to see where there may be consensus, where there may be some overlap, where there may be some concerns. Each of you have a lot to do, and in order to manage the time so that there might be some time for discussion, your presentation or summary will have to be very fast. So I hope that you have chosen representatives of your group who can speak quickly and with great persuasive skills, although we don't necessarily need to debate a lot of issues. This, again, is more or less a fact finding to figure out were we right on some of the operating principles and structure and where we need to make additions. So that's where we need your suggestions, and especially your thoughts about, again, how we want to structure the regional hearings in terms of topics, subcommittee performance, and the like.
So let's start with Group 1, Data and Information.
PARTICIPANT: Bruce Cummings isn't here yet.
DR. WOOD: Yes. We'll go to Group 2. So we'll go to Group 2, Flexibility, and I know from listening to part of that discussion that there was a possibility that we would slightly change the name of that.
PARTICIPANT: She's not here either.
DR. WOOD: We're making very good progress. I'm so impressed.
(Laughter.)
DR. WOOD: Well, we'll just start and go from backward up. So Number 4, then. Coordination.
MR. ROVNER: I guess I will be reporting. I'm Jack Rovner and I was designated by the Chair to be the chair of the subcommittee.
I will try to be brief, so I'll cut through a lot of the things that we discussed to talk about two things. One is some suggested changes for the proposed operating principles, and then a procedure that we came up with that we would like to recommend as a way to organize ourselves and proceed.
On the operating principles, which is 5D, first we want to see that sentence that used to be the last sentence of the original mission statement included as the first point.
Secondly, in Item 5, we recommend that the following be inserted in the first sentence after where it says "make every effort to maximize public." Insert "and all stakeholder, including patient, input," so that it's clear that we want a broad public input, including those from advocates and patients, et cetera.
In 6, this isn't necessarily a changing of the wording, but we would like to recommend that the committee explore the use of videoconferencing and other means of communication, not only for committee members to attend things like regional hearings, where they may not be able to show up, but at regional hearings to look to ways to have outsourced ways for the public to get input without having to come to the meeting site, whether you can have remote sites for people to come and participate by videoconference and so forth.
Then on 7, we felt more comfortable if we would change the wording to be more mandatory, because that's how we understand the rules to be, actually, for -- I guess we're special government employees for this time. So that in the first sentence, it would read in the second line after "organizations and professionals, members," it would be "members are required to carefully delineate their personal positions from those of the advisory committee," and then in the next sentence it would say, "When making public statements, members are required to include a disclaimer," et cetera.
Then finally, we just want to make sure, in terms of a clarification of our roles, that it is appropriate that we as individuals in the committee being, as stated here, the experts can consult privately or however we need to gather information on our own, and then using that as far as working with the committee as a whole. We want to make sure, if there are any supposed restrictions or restraints upon what we can and cannot do, we want to know about them now, beyond what's been presented to us.
After that, what I'd like to turn to is the framework that we came up with for the committee to proceed both as a process and on the subcommittee and committee level through the public hearings, because we thought that the framework for committee operations was, as one of my subcommittee members put it, very elegant, but may take too long a period of time to get things done.
What we suggested and as the Coordination Committee, we have identified for our committee three major headings that we want to focus on, all in the coordination aspect: federal-state coordination, coordination across or within HHS and across the federal agencies, and then coordination in the public-private sector, really looking at service delivery coordination, and within those areas we've identified a whole bunch of content topics that we want to focus in on.
What we suggest as a process is the following, that each of the subcommittees, and we're pretty comfortable with the four subcommittees identified, today identify, say, anywhere from four to six focus topics that they believe is what they want to have working on and focusing towards the first public hearing in February, the end of February, and this same process would proceed before each public hearing.
The committees we recommend suggest a set weekly phone call, phone conference, for the subcommittee members -- my committee suggested Fridays at 10 o'clock Eastern time -- with the thought that we will select our content issues that we are most interested in focusing on for the upcoming public hearing. We would ask the staff to give us a briefing memo on somewhere between the four to six topics that we are most interested in at this time, content topics. Through the process of the conference calls, we would focus down onto one or two key, focused issues, which we would then recommend be the focus of the public hearings, so that at the public hearing, there would be somewhere between six and eight focused issues that we want to really hone in on.
The process would then have the subcommittee chairs, probably two weeks or 10 days before the first public hearing, have a conference call with the Chair of the committee to agree that this is the agenda for the public hearing and these are the focused issues. We would then ask the staff to fully publicize that the hearing will take place and these are the issues that we want to receive input on.
We recommend that at least two members of each subcommittee attend each regional hearing. Other members of the committee as a whole are welcome to attend, but we think at least a minimum of two per subcommittee should attend the hearings, as well the champions or the experts on their particular subcommittee's issues.
Our goal would then be at the hearing to take the public comment, consider the issues, and then at the conclusion of the hearing, digest what we've heard and be prepared to make a report to the Secretary within seven to 10 days, based on what we can get from staff support, in which we would break it out into three areas on the issues that we proposed for the hearing. One would be quick fixes, areas that we believe the Secretary, HHS, CMS, and FDA can take action relatively promptly to fix some problems; intermediate fixes, things that we think are fixable and should be done, but may require a rulemaking or something similar to that or other coordination effort; and then more long-term issues that the Secretary, CMS, FDA, et cetera needs to look at it.
That's the process we would recommend, so that, as we see it, each public hearing would result in firm recommendations of action to the Secretary within a week to 10 days after the hearing and the process would keep us moving, focused on precise subjects that are of major concern to the subcommittees and keep us in the process of actually achieving action, leading up ultimately to the conclusion where we would file our final report in October.
In terms of running the subcommittee process and the regional hearings, I kind of outlined what we think the subcommittee process and the committee process would be, and we think that subcommittee communication on a weekly basis, for example, is important, but leaves each subcommittee to proceed as they believe best.
For the public hearings, again, we think that they should come into them with one to two focused topics per subcommittee.
We would like to have through the process the subcommittee identify the kinds of operational people that we want to hear from to see how the particular issues that we're proposing affect their day-to-day operations and to reach out through our staff support or other resources to try to get those people to come and tell us what it's like to live under the regulations and what maybe can be done to improve the delivery, quality, effectiveness, and efficiency of health care delivery in the government programs.
With respect to site visits, we were somewhat neutral on that. If a site visit, however, makes sense for a set of particular issues, we would recommend that the site visit be done, say, the afternoon before the public hearing, so that it doesn't take time out of the two days that are set aside for the public hearing.
Among the kinds of people that we did identify, just to mention, that we'd like to hear from, at least from our subcommittee's point of view and some of the content issues that we're concerned about, would be operational people who have to deal with auditors -- federal, state, et cetera -- and how we could perhaps learn how those could be coordinated better, compliance officers at health care organizations, and those kinds of people in the billing offices, et cetera.
We also believe in terms of the public-private coordination, we were particularly taken by the comments yesterday of Ms. Holzer from Maryland, and we'd like to reach out and try to get better input from the beneficiaries, the patients and the patient advocates, on exactly how much good they are receiving from the kinds of information overload that is out there, to see if we can tackle that. So our view was those are the kinds of people we'd like to reach out and hear from.
I think that in a nutshell, hopefully, briefly, summarizes where we are from our committee in our recommendations.
DR. WOOD: Very good. We'll have to really move on this.
You have something to add?
MR. BLOOM: Yes. There was something else that we had recommended that I don't know if he was clear on and I think we had found this. We recommended that at every field hearing, that every subcommittee have a part of that field hearing, so that there's not a field hearing focused on just one subcommittee, but each two-day hearing have one or two panels for each subcommittee at each field hearing.
DR. WOOD: Good.
MS. SCHMIDT: I think that is implicit in what we're saying.
MR. BLOOM: Okay. Thank you.
DR. WOOD: We'll move to Group 3.
DR. OLSEN: In the interest of brevity, I'll say we agreed with a lot of what Mr. Rovner had to say, so I'll maybe get into the differences, but as far as agreements, for sure we thought that each area of subcommittee ought to be within each hearing.
I'll try to go through the list and try to skip some of these.
We had a concern relative to using the various teleconferencing and email in the subcommittee work.
We were requesting the public notice and what have you and we want to be sure that there is good public access and we get all the comments during this process.
We, too, agreed that we should, in our areas of issue, develop an issue paper. I think you called it a briefing paper. We thought we should assign a subcommittee member to coordinate with the staff person for each of those issues, but with input then from the entire subcommittee as the issue paper developed. That issue paper should then also have a series of research items needed and questions that would be appropriate.
We were concerned that by listing issues to be focused on at the hearings that we might stifle other issues from coming forward, and we therefore made it very clear that these were preliminary issues, and as other issues emerged through the hearing process, that they, of course, would be added if they were in our area or whatever subcommittee's expertise.
We thought that the hearings, perhaps to focus on the issues better, may have breakout groups within the hearings, within the four areas or whatever. Somehow, that the hearings would have breakout groups, so that you could break out into your areas of expertise as the hearings progressed.
I'm looking to my committee to see what I've left out that was different than what the other group had.
Are we supposed to list our issues or do we just hand those in to you? What's your pleasure?
DR. WOOD: Well, it would be good for you to list the issues so the others can hear what you're thinking about.
DR. OLSEN: Then I will go through that.
PARTICIPANT: The site visits. The issue of site visits.
DR. OLSEN: Oh, yes. We were not fans of site visits, basically, and I think pretty much would agree that where they're necessary, of course, but only if they were really necessary, because of the time element, and so basically we did agree with the other group.
Thank you.
Anything else from my group? Yes, please.
MS. SHAFER: The only thing that sounded different here, too, is that we didn't really talk about a formal report to the Secretary after each meeting.
DR. OLSEN: Yes. Excuse me.
MS. SHAFER: Because I think that this is a work in progress as we're collecting the information, but we did call for more kind of summary of comments, so that we keep working on these issues.
DR. OLSEN: Yes. We would have a summary of comments after each hearing relative to our group and so they would be kept up to speed, but we would delay the process further until towards the end when it could all be brought together.
As far as our issues, what surfaced at the top was a periodic release of information, and we argued what "periodic" meant, but that's to be determined later, but clearly daily we thought was too often, but so that it manages its frequency and to encourage, with that staggered frequency, its technology compatibility so software could be prepared, disseminated in a useful and concise manner, et cetera.
We thought that we ought to supplement the enforcement process of the regulations by creating a collaborative and collegial, versus an adversarial, relationship. Perhaps an annual publication of lessons learned in a positive way, GAO and OIG to identify such best practices.
On stakeholder issues, we very much -- of course, the word "plain English" kept coming up, both in the appeals process and the responsiveness. Again, in the clarity of communications, the plain English, the tone of the communications, to explore acceptable modes of communications, and to maximize the use of technology and Websites.
On specific policies and changes, we listed the E&M guidelines, the EMTALA, and the CLIA as areas to focus on.
I would ask the committee if they want to expand on that brief summary.
(No response.)
DR. OLSEN: Thank you, Mr. Chairman.
DR. WOOD: Heidi? I'm sorry.
MS. GIGLIOTTI: I just wanted to clarify that when we talked about a shortened process, really what we're looking for is the quick fix. We heard and heed the Secretary's call that if there are things we can do next week, 10 days, or one month from now, what could we do, what would the process be for getting in front of the full committee and being able to take a vote on those quick fixes, and that's what we identified, not that we were going to try to not include that with the larger concern.
DR. WOOD: I think this is a good question, and one I wanted to leave for the end, because it's in my mind after the presentation of the first group. So we'll keep that in mind at the end because we need to synthesize how we're going to do exactly the communication between the groups and the identification of issues.
So now I'm ready for Heidi. I was ahead of myself.
MS. MARGULIS: Thank you.
Without having the benefit of hearing the first group, but hearing the second, I would say that -- oops. Let there be light. Our group concurred -- that's what we think of regulation.
(Laughter.)
MS. MARGULIS: We basically summarized, in handwriting I hope everyone can read, what we discussed, the themes of what we discussed.
So under operating principles, our concerns centered around avoid duplication in subcommittee and full committee, such that we present draft recommendations from our subcommittees to the full committee for consideration, and that we also present the options that we did consider, having reached those conclusions.
We were concerned, and I believe, Mr. Chairman, you just stated, that we do need a process for sharing concepts across subcommittees. That was a point of discussion among us.
In the issues section, we agreed with Len in terms of being sure that prior to our beginning that we have the information from all branches of government and stakeholders, including consumers, in terms of recommendations that have currently been placed on the record, and that those be categorized so that we can use those as a jumping off point.
As well, to encourage those who testify to make recommendations, and we had two requests for clarification. One is that, clearly, we are not here to debate statutory changes. However, we are here to reduce burdens on the regulatory side. However, there is some spillover to the statutory side. So what is actually the process for making statutory changes following our review of the regulatory process?
And then, Item Number 6 in that particular section was a lot of language that brought us to the point of what's the point?
And I don't want to take too much time, but under committee organization, we thought that it would be helpful to have all subcommittees' information prior to the full committee meeting, so we would have an opportunity as homework to review it prior to coming to the full committee, to expedite that process.
That where the term "regulatory process" was used, that the draft document that we looked at tended to infer that interpretive guidance may be better than the regulatory process. In many cases, that is not the case. So we want to make sure that the consideration of the regulatory process also considers any interpretive guidance that is issued to ensure that the guidance doesn't exceed the intent of the regulation, which doesn't exceed the intent of the statutory intent, so to speak.
We used the theme areas to categorize our specifics. These were three topic areas we asked the group to consider. How to better operationalize and implement rules, including pilot testing, evaluation, and feedback processes for raising issues and obtaining input. There was considerable discussion about cost impact statements and how OMB and others score rules, et cetera. So that was also included in that one.
The second one was how to adapt to market changes and changing relationships, including the relationship with local and national decisionmaking, with states, and also, in the interpretation area, this would include some issues that could be coordinated with the Coordination Committee, not to be too redundant.
Thirdly, how to identify and remove obsolete regulations and requirements.
So those were the three general areas under which our specifics fell.
Lastly, we talked about the regional hearings. We agreed with the previous group, with Erik's group's concept. Broad publicity and outreach to all groups, not just through the regulatory processes of Federal Register, et cetera, but sort of the news route to ensure that we're reaching all constituencies, to really give folks guidance that it would be very helpful if, in their testimony, they not only presented the problem, but if they had recommended solutions, those be given as well, and that at the end of those hearings, that there be a summary categorized into our subcommittee groups, but no specific recommendations, that it be a part of the work papers, et cetera.
We also believe in the hearing process that it should be broad-based, with all subcommittees' areas represented.
Finally, we ran out of time, and had some text edits for the analytical framework.
I would turn to my colleagues, and Paul and Sharon.
And one issue that I believe that others have brought up in terms of how we will work, it will by telecon and email, and as regular as needed as we get more structure in terms of this process.
I also believe that we said that it appeared on the hearing dates that the last or the next meeting of this group is going to coincide with the last hearing, I believe, and the group's thought was it would be good to have all the hearings finished before the full committee met, so that we could synthesize all the recommendations.
MR. HUGHES: We were wondering about timing in terms of the subcommittee meeting being part of the next full committee.
DR. WOOD: Bill, you want to make a comment?
MR. TOBY: I only have one embellishment to make. Bill Toby here.
That was the second point that Heidi made, and I just think it needs to be emphasized a little more, and that is that we said it was essential that we have the information that already defines the problem and recommends some solutions, as Len Schaeffer mentioned this morning, and I think we talked in some detail about how impressed we were with the presentations yesterday by Pat Morrisey of Commerce, Leslie Aronovitz of GAO, Jonathan Blum of the Senate Finance Committee, and John McManus. It was very clear yesterday that these people have thought long and hard about the problem and they have come up with some resolutions. So we just felt it was essential that we have that information and it be put before us as we deliberate.
Thank you.
MS. MARGULIS: Anyone else?
(No response.)
MS. MARGULIS: Thank you, Mr. Chairman.
DR. WOOD: Group 1.
MR. CUMMINGS: Good morning, Mr. Chairman. It's my pleasure to report to you on behalf of the Data and Information Subcommittee, a group that was really an embarrassment of riches, just such an outstanding group, with a treasure trove of suggestions. I've got a couple of things I'll just quickly walk through to really focus, then, on the substantive or the content issues.
In terms of the draft operating principles, like others, we thought it would be important to emphasize the value and utility of electronic media for communication purposes, and we were reminded by one of our members to be active listeners, rather than voluble public speakers, on behalf of the work of the committee.
In terms of the issue selection, we had sort of a four-part set of recommendations. The first is, as we go about this inquiry, maintaining a patient focus and, moreover, looking at a patient in the context of the continuum of care. I think we're all very aware that right now we tend to have with respect to data kind of a hardening of categories, where information or data is organized by setting and by conditions of participation, and this hardening of the categories is very apparent to patients and to providers alike, and obviously what we want to work toward is data that is organized in a way that's transparent and seamless for providers and patients alike.
Our second recommendation was that we should define data requirements for patients to the greatest extent possible, so that they would be identical in Medicare and Medicaid programs. Our sense is that right now there's a fair measure of fragmentation among and between the states and in their respective Medicaid programs and, in turn, in the Medicare program, and as part of this, we propose to seek out through the regional meetings and hear more about at the full committee meetings best practices where the data has been more fully integrated between Medicare and Medicaid.
Third, we want to propose a value-added format in the way that data is organized, accessed, and used. We characterized this in our group as the "Tony Test" in honor of our esteemed colleague, Tony -- not to be confused with Eugene -- Fay.
(Laughter.)
MR. CUMMINGS: And those questions, those tests, that make up the Tony Test are what data is required, who uses it, who has access to it, how is it used, why is it used, and can it be streamlined or eliminated? And again, overarching all of this is the focus on the patient.
Fourthly, we wanted to encourage demonstration projects, at least one that would be explicitly patient-oriented and a second that would be perhaps provider-oriented, and I'll do the second one first.
In the case of the provider pilot, we were particularly interested in claims denial, on how better data organized and processed would diminish the potential for claims denials.
From a patient perspective, I think this is the one where we spent the greatest amount of time talking. One of our colleagues, Tom, pointed out that metaphor of the UPS person, who has available to him or her a handheld device where all manner of information can be readily accessed in a moment about where packages are, where trucks are, et cetera. We have nothing analogous to that in the health care system. Instead, we have these separate data silos that are almost impervious to patients.
So that became kind of our stalking horse, to look at a demonstration project where data would be organized around how patients actually move through the system of care, and using kind of a scenario basis, someone presenting to the ER, and then in turn is admitted to an acute unit, and then they may need home health or long-term care, et cetera, and to use each of those steps around these patients as opportunities to evaluate, coming back to the Tony Test, the data that's required, who uses it, and so forth.
Our hope is that out of this demonstration project, there would be the opportunity for vendors who would see, instead of having to develop software that's unique and specific to specific data niches, the MDS form or the OASIS form or whatever, the opportunity to really develop products that track this entire continuum and that would be certified by CMS as having met all of the standards, so that if a provider were using one of these certified software packages, one would know at the outset that you were fully in compliance from billing and other perspectives.
We had an excellent list of topics suggested to us, and much of our time was taken up with the MDS, the OASIS form, critical access. We were heartened to know that a number of these things were already actively being examined by the Secretary and his staff, and we just wanted to commend them for that effort, and we'll continue to look forward to the specific changes that will be emanating about those things.
In terms of the committee organization, our group was interested in staying with just one subcommittee, but was interested in the opportunity to examine other issues or issues that cross along the subcommittee lines.
In terms of the products expected of the subcommittees, we're happy to have this be a largely staff-driven effort in terms of preparing executive summaries of recommendations for the full committee to consider, and we further commended the notion of having these summaries prepared with an eye toward containing next steps that would encompass the work of the subcommittee, recommendations for projects, and recommendations for cross-fertilization with other subcommittees, and last, but not least, themes that may be interagency in nature.
The example that came up there was where FDA will have one process for approval of a new technology, but this is happening quite independent of CMS and whether there will be a reimbursement payment for that new technology. It occurred to us it would make lots of sense to have those occur on a concurrent and joined basis.
In terms of regional hearings, our group actually liked the idea of at least a modest amount of attention accorded to some type of site visit, augmented by presentations about best practices, particularly around this interplay between Medicare and Medicaid, but certainly not limited to that sphere, and one of our colleagues was particularly interested, where there were really good examples of coordination between Medicare and Medicaid in various regions, knowing were the rules bent or were the rules simply ignored that made this best practice possible?
PARTICIPANT: With full immunity.
(Laughter.)
MR. CUMMINGS: With full immunity, of course.
And last, but not least, of course, that they should have substantial public input.
We suggested that, to the greatest extent possible, the regional meetings would involve only a one-night stayover, if at all possible.
Finally, in terms of the analytic framework, we liked the outline that we examined. Our group did not look at the FDA framework. None of us present felt particularly comfortable or expert in that area. But with respect to the CMS framework, we were largely in accord with it.
Again, we want to focus all of the different categories around this notion of value focus, and although it was not on our list, we were reminded of the wonderful remark or question that was raised yesterday. Is there room for common sense? We hope that somewhere that would be embedded in the analytic framework.
Then lastly, and we're not sure exactly how to express this, but I think many of us felt that we would rather see stronger, more vigorous enforcement with substantially greater penalties for outliers than a regulatory framework that presupposed that good people may be about to do bad things, and that was a tradeoff that we were prepared to consider. More serious enforcement penalties, but a kinder, gentler regulatory framework that assumes that most people were trying to do the right thing, and not work so much on an exceptions basis.
Thank you.
DR. WOOD: Any other comments from that group?
MS. RYAN: Dr. Wood?
DR. WOOD: Judy?
MS. RYAN: We did give some consideration to thinking of representative voices on this committee and suggested further consideration of your suggestion that there might be some kind of a catch-ball process between a committee not substantially enlarged or reconstituted with consumer groups, but we did feel that maybe there was room for the added voice of a trained patient advocate and of someone familiar with the academic research process that related to development of new products and services under FDA.
DR. WOOD: Good.
Now, in listening to these, there are a couple of issues that come immediately to my mind. First, actually, is how do we make sure, since each of these subcommittees is going to be doing a lot of work, that we at least have a minimum of an executive summary available from each subcommittee for every other subcommittee on a regular basis so we can keep track of what's going on? So that's something for us, I think, staff-wise, but I hear everybody say we need something like that.
Then the next consideration actually is that in terms of then taking recommendations, we'll have to have a way that the immediate recommendations can be actually seen by the whole committee and then get back again to the working group. Remember that we are advisory, so that there's a working group that we're going to send recommendations to.
The ones that are immediate or short-term, there shouldn't really have to be I think lots of debate about. I mean, what we really want to do is to take those short-term things and feed back immediately to the appropriate groups and say here's what we've identified, and then we know that there will have to be some work done within the agency to figure out exactly who's going to have the responsibility for something or if something can be done. We might think something is really easy, but it may turn out that it's a little bit more complicated.
For example, the EMTALA things, there's a regulation that apparently has been recently added that you can think about rescinding, but the problem is that I personally am not comfortable enough about knowing whether there is some case law precedent that goes behind that that we would have to deal with, and so we would need to depend on the capabilities of the agency and its staff to make those decisions. So we wouldn't necessarily have to vote among the group. We should simply be able to identify the issues that we're going to send forward.
Now, again remembering the important part of developing in the long-term a structure for future performance, and we heard a lot of discussion about this, about the entire process of going from regulation generation to interpretation, and that's something that I would like us to be able to continue to look at as we go along and develop, rather than have to put that late in the process and then not have an adequate amount of time to each of us contribute to that.
Now, from that perspective, what I am thinking about here is the concept of an Executive Committee to help then keep that process going and then set the agendas for our subsequent meetings. So if we took, then, the chairs of each of the subcommittees and the Chair of the committee and staff, we would then have periodic telephone conferences to make sure that we are managing the collective work in a productive fashion.
So those are my two major comments. If there are strong objections, write them down or tell them to me now, but we actually need to go on to the other part of the meeting, so that we can finish in a timely fashion.
Gary?
DR. DENNIS: Yes, a couple of things that came up. One is the listserv for each of the groups, each subcommittee, and that whatever is being deliberated would be available to other members on the larger committee, although the communication wouldn't necessarily have to be directed toward. But there would be a general communication that maybe the Executive Committee would send out, since you've created it, that would say click here if you want to know what this subcommittee is doing, X, Y, Z, if it's not your subcommittee, so everyone will be fully informed.
The second thing had to do with conference calls. There was an issue raised about whether that's something that requires public notice, and I don't think it is, but could you clarify that?
DR. WOOD: Well, I think, from the perspective of conference calls, it does not require public notice, but my anticipation is that as we handle this, the work in the subcommittees, particularly in terms of the items for immediate recognition, those go up on our Website right away, and so the public would be able to see what had been suggested, and as we then consider the framework for the committee meetings, especially in terms of this longer-term framework, we would then use the subcommittee output to define the agenda for the next meetings, and where there needs to be, then, formal endorsement by this group, we would try to get that to you ahead of time and then the agenda would be structured so we identify what we want you to consider and decide, and that actually does require I think a little bit more formal notice, especially if we're going to be making any significant recommendations for which we would want other public input at the larger committee meeting.
DR. DENNIS: But for clarification, I think there was a discrepancy --
MS. SCHMIDT: We'll meet with OGC and make sure that we've got everything straight, and we'll let you all know about the subcommittee communications. All right?
DR. DENNIS: All right.
DR. WOOD: All right. There are a number of you who I know have some fairly tight flight connections on the committee. We'd like to finish the morning by again working to bring all of us to a fairly common level of understanding and to be able to see some examples of good work being done which might be the identification of best practices for the future.
Now, the committee members actually do have a bag lunch that is available for them. I apologize to members of the audience. They are coming in now. What I would do is, as invite those who will be presenting to come to the table, if the committee members would like to take a lunch and either enjoy it now or if you want to save it for your airline food --
(Laughter.)
DR. WOOD: -- and feel like you've really gotten something out of this meeting, then you can do that, too.
Then Christy has one quick announcement about paperwork.
MS. SCHMIDT: One quick announcement on this. There are some ethics principles and some other forms being handed out to you. If you need another copy of this finance form, we've got spares of those. Let us know. If you're going to have any questions about it, see me later, and we will get somebody back to you to answer your specific question. If they are completed, give them to me.
DR. WOOD: So we'll take a couple of minutes. So if you would like to go get something to eat, do that now, please.
(Recess.)
DR. WOOD: We recognize that there is a considerable amount of work that is underway and so for the last part of the day, we'd like to share with the members of the committee some work that's being done that could be potentially identified as best practices.
So I'm particularly pleased to welcome three people for the discussion, Dr. Janet Woodcock, Ms. Judy Ballard, and Dr. Barbara Paul. Dr. Woodcock will start with an example from FDA, Ms. Ballard has an example of negotiated rulemaking, and Dr. Paul leads the Physicians' Regulatory Issues Team and is a good example of how you can change issues of communication and oversight.
So I'm particularly pleased to welcome them, and I think from that perspective then -- where did Janet go? Oh, there she is. Out of the sight of the projector. So I'd like you to go at it any way you want to.
DR. WOODCOCK: Thanks. It's a pleasure to be here.
I was asked to talk about a process that is known within the agency and the industry as the Prescription Drug User Fee Act, affectionately called PDUFA. I'm going to present this as an example of the kind of reform, a process for reform, that has happened. There may be some practices here that may be illuminating as go forward in your work.
The background of this particular regulatory initiative was since the 1962 efficacy amendments requiring that drugs be shown to be safe and effective before they were approved, there had been an emergence of what people termed a "drug lag" or concern on the part of the clinical community, in particular, that new drugs were being made available in other countries to patients and physicians much sooner than in United States.
This continued through the 1980s and there was quite an emphasis on access to new medications and new treatments. The industry complained that the entry into the U.S. market was delayed and very formidable, and really from the '70s until the '90s this was the Number 1 issue that FDA confronted. There were many blue-ribbon commissions, presidential commissions and other bodies, examining the problems -- perceived problems, at least -- with the U.S. drug review process.
In 1990, with the first Bush administration, a number of recommendations were made. More cooperation with industry, wider use of advisory committees and outside bodies in decisionmaking, shorter time frames, and trying to get sufficient number of staffing for the agency that time frames could be moved up.
But there was still concern that these measures were not enough, and in 1992 Congress passed the Prescription Drug User Fee Act, which was a sort of joint effort between the agency, Congress, and the administration, and the drug industry in trying to make a regulatory reform that would work.
The simple scheme that was put forward was this. The industry would pay fees for marketing application review. So every marketing application that was submitted would be tied to a fee. This is in the new drug side. The fees would pay for additional physician and scientist reviewers and for upgrading the FDA infrastructure, and they could only be used for those activities.
In return, and this was probably the most important part of the program, FDA and HHS agreed to trying to meet goals and timelines for the review process. So the regulatory reform included accountability, very transparent accountability. There was a letter written from the Secretary to the Congress agreeing to the goals and laying them out over the five-year program, the five years that the program was in existence.
This was extremely crucial. It was very public. A report had to be given to Congress every year on how the FDA was doing in meeting these goals and there was a commitment on the part of all that these goals would be met.
Nevertheless, in the outside world, it's hard to remember at this time, but there was really widespread skepticism that any of these goals would be met. It was felt that this would be another futile intervention into what was widely viewed as a regulatory problem.
The first user fee program, PDUFA 1, was to run from 1992 to 1997, with a sunset provision in '97, and that was another part of this. It was viewed really as an experiment. If it didn't work, it would sunset in '97.
FDA met our exceeded all the review goals, the approval times fell dramatically, and the program was actually awarded an award called the Innovations in Government, which was given by the Ford Foundation and the Council for Excellence in Government, as an innovative program that actually made quite a difference.
Now, the example that was passed out, the case history example that was passed out to you today, reflects this program, reflects the 1992 to 1997 program, which was the essential regulatory innovation.
Upon reflection, when we won this award, we really thought about the characteristics of this reform that made it work. One, as I said, was accountability. A second was it was a win/win for all the parties. In other words, the FDA didn't want to be a barrier to innovation or access in this country. The patient and consumer groups at the time wanted to access to therapies. That was in the middle of the HIV epidemic. The biomedical community had said for the last 20 years that they wanted more rapid access to therapies, and the pharmaceutical industry was willing to kick in and finance this. So if the program worked as designed, everyone would win.
Now, because of this, at the sunset time in 1997, PDUFA 2, as it's called, was passed as part of the FDA Modernization Act. The concept in PDUFA was that the successes of the first user fee program would continue and, as I said, that was mainly focused on review times. When an application was submitted to the FDA, how fast it would be reviewed.
The second concept, though, that was introduced in the second user fee program was the concept of clinical drug development time, which was running about eight years, and that's how long a drug would be studied in people until it was ready for application to the FDA, and there was desire to shorten this time, because all these prolonged times lead to increased cost, and it was felt -- the industry had by this time I think changed their attitude toward the FDA from not really wanting to deal with the FDA to feeling that clinical development time could be decreased if FDA-industry interactions were intensified and there was much more discussion and guidance during the drug development time. So those milestones were put into the second user fee program. Again, I think recognizing the success in changing attitudes in the first user fee program.
Now, this slide is too busy, but most of you are familiar on the left with the Phase I preclinical, then Phase I, II, and III trials, and then marketing application, and all the dots and little triangles at the bottom show the times when, under the new user fee program, the FDA and the industry would have interactions. So there would be much more guidance provided by the agency the drug development to shape how the clinical trials were done, point out what endpoints should be studied, the size of the safety database, and the other types of things we ordinarily deal with.
Now, what were the results of this program? We are now in the last year of the second user fee program.
There was a further decrease in the time it took for drugs to get on the market. So that part of the program continued to be successful.
We have observed in the last two years the first drop in clinical drug development times in over two decades. So it's possible, and it's really hard to make a hard link between these things, but it's certainly possible the second user fee program and increased interaction with the FDA has succeeded in streamlining clinical development and actually reducing that time, and that time for drugs has fallen fairly dramatically off its previous escalation over the past two decades.
Last year, the European Union announced a new program to streamline their review process to more closely resemble the new U.S. review process, and what the EU officials said was that too much R&D investment had flowed into the United States at the expense of Europe. Over the past 10 years, R&D investment from the pharmaceutical industry doubled in the EU, but increased five-fold in the U.S., and it was attributed by the EU officials to the more favorable regulatory environment in the United States.
Now, Europeans just tend to be very upfront about acknowledging all this, and they are designing a new program that contains many of the elements that are in the prescription drug user fee program.
Here are the review times in the chart. The top line is how review times have fallen, and that's months on the Y axis, over the course of the program for all applications. On the left and more dramatic is how review times have fallen for priority applications.
Now, the pharmaceutical industry is interested in all its applications. Most of the biomedical community is interested in the priority applications, because they are the ones defined as making a new difference, making a difference in public health, making a difference in patient care, and you can see those are down to a median review time of about six months at the FDA.
Now, industry benefits from the faster review times under the user fee program. Under this program, the flagship products, which are the new molecular entities, the totally new products, are reduced for about a year of reduction of time to market under this program. Outside figures say that reducing the review by each month saves about $2.5 million or about $30 million over the 12 months, and that increasing the time the drug is marketed under the patent before the patent expires can yield an average of $40 million per month. So overall, you can see that these reductions for the NMEs have provided a positive financial outcome for the firms, even though they have to pay user fees.
What about the public benefits? Well, there is some debate about this or some concern about the impact of the user fee program on the public, which obviously is a sector that also has to win.
It is very clear that there's faster access to drugs that have new health benefits. That is very clear. Those are the priority drugs that I showed you. Overall, they're available much faster to the public than in the past.
In addition, and this is an intangible, I think, benefit, but we have created a much more open and transparent drug review process over the past decade of the user fee program. We've put our reviews up on the Website. We have extensive communication with the community and we're trying to do that more, and that benefits the public.
In addition, the funding of the additional scientific staff, and this is something that isn't really understood or acknowledged very well outside the agency, allowed for a high quality of review that's really brought up the review quality.
What about my time? Am I doing okay?
MS. SCHMIDT: It's getting close.
DR. WOODCOCK: Close? Okay.
An additional benefit is that we've extensively participated as a result of PDUFA in standards development, public standards. We've issued over 100 technical guidances on drug development. This helps ensure uniform, consistent quality in drug development, and for the public interest, we've issued guidances on how to study the compounds for drug-drug interactions, for example, which is something that is extremely important, that before these drugs are introduced, we understand what their drug interactions are. We've also issued guidances on how to study drugs in children, so that companies can do those studies, but we've over 100 of these.
In addition, we've internationalized the standards and much of the resources made available under PDUFA helped us to do that. That means that clinical trials need not be repeated all around the world and that there are uniform standards around the world for how clinical trials should be done and the technical standards for drug development, and that's been very important.
I'm almost done.
In addition, the FDA with our resources has been able to have a new focus on patient safety in risk management of pharmaceutical products. With the faster approval and then quick launch of drugs into the market now, it's obvious we need greater vigilance after drugs are approved. We totally improved and revamped our adverse reporting, we have a new computer system that speeds detection of problems, and we are rapidly determining if new problems develop, new adverse reactions develop, after marketing.
We also have developed a risk management approach to pharmaceuticals where we try to anticipate and put in management steps for drug safety problems that may be anticipated after the drugs on the market, and this always is true. The user fee program does not mean we're approving perfect drugs that have no side effects. Haven't found any of those yet.
Additional benefits, and this may be a lesson learned that is quite important for your effort, the e-government part of the user fee program was very important. We were required to develop electronic capacity for filing. We used to be getting these new drug applications on tractor trailers coming into the agency. It was very obsolete method of trying to deal with things.
Currently, 38 percent of the new drug applications are completely electronic. We archive them paperless. The majority of the big pieces of submission are submitted for the rest of the applications in electronic-only format.
Adverse event reporting. We have an internationally standardized electronic process. So all over the world, when an adverse event is found, it can be reported the same way, two different regulatory agencies using the same terminology. This is really helping us pick up these problems.
There are many other things we're doing. We're trying to go paperless totally, and the user fee program really was the impetus.
Management and cultural changes. These cannot be neglected and were excruciatingly difficult in the early part of the user fee program. We had to institute project management for review process and initiatives. It's crucial to meeting the goals. Project management, improvement and consistency requirements across the units, so that the regulated entities are getting a consistent message no matter where they went in the agency, and we're still working on that, but we've made a lot of strides.
Development of a proactive stance toward our regulatory responsibilities and to public health, where, if we identify problems in our regulatory approach, we should fix them.
Diminishing the adversarial relationship with the regulated industry. That was an early part of the program, probably in the first five years. It was very important in the success of the program.
In summary, the user fee program accomplished its intended goals and more, and that's not to say there weren't unintended consequences, and that's something you always have to consider as you're making reform efforts.
The reform efforts and the impetus spread beyond the goal areas and have pervaded successful regulation in the pharmaceutical sector. The FDA drug review is now prepared to deal with a new science, partly as a result of this program, and reauthorization will be required in 2003, and we have this sunset provision that causes us to periodically be introspective about the results of the program.
Thank you.
DR. WOOD: Thank you, Janet.
Judy is going to talk about negotiated rulemaking.
MS. BALLARD: Let me just introduce myself a little bit. My actual title is that I'm a member of the Departmental Appeals Board, which is in the Office of the Secretary, and we conduct hearings and provide review on behalf of the Secretary on a whole range of kinds of cases that arise in the Department's programs, but we've for a long time played a role in promoting alternative forms of dispute resolution in the Department. The chair of the board is a dispute resolution specialist for the Department under what's called the Administrative Dispute Resolution Act, and under that came some responsibilities for, in this department, implementing the Negotiated Rulemaking Act of 1990, informing people about the process, and training people on its use, and coordinating within this department, and as a result of that, I got involved and I have actually convened and facilitated four negotiated rulemakings. There are a number of people, including one of your committee members, who have been involved in those.
But rather than focusing on the actual examples of the negotiated rulemaking, although they all have been successful and reached consensus, what I'd like to do is really to talk about the process. So I'm going to do an overview that will first give you a definition of the process, then kind of a brief overview of the different stages of the process, and then go into a little bit more detail on certain aspects of it, with the hope that you'll come out of it with a better understanding of the process, because there are a lot of misconceptions about what it is.
The Negotiated Rulemaking Act provides a framework for a process, and arguably agencies have some flexibility to go out of that, but most agencies use that framework, and that establishes a process in which a committee of representatives of the interests that are likely to be significantly affected by a rule attempt to come to consensus on the text or content generally of a proposed rule with the assistance of an impartial facilitator/mediator.
The representatives on the committee include a representative of the major agency. Within HHS, it's usually a representative of that component of the Department -- for example, CMS -- that is responsible primarily for that rule.
Interests are also called stakeholders, and obviously you all have some sense of what it means to be a stakeholder. It doesn't necessarily mean that every individual group that might have an interest in the rule has to be represented. There could be multiple parties that are considered one interest, as long as they have a similar point of view or will be affected by the rule in the same way.
The Negotiated Rulemaking Act defines consensus to mean unanimous concurrence, unless the committee agrees to another definition. Generally, the committees do not agree to another definition, but they will come up in their ground rules with some sense of what they really mean by consensus, and that usually is the concept of you can live with the result. It's not going to be the perfect result, but it's something that you and your constituents can live with.
The unanimous concurrence is important from several aspects, I think. One is that from the agency point of view, the agency retains veto power. People often raise the question of, well, is this special interests getting together and negotiating and what about the general public interest? Well, the agency can represent the general public interest in negotiated rulemaking the same way they can in any other rulemaking. Plus, if it's a proposed rule, it still goes through those later stages of the notice and comment rulemaking process that David described yesterday.
In fact, the idea of unanimous concurrence is really a powerful tool, because it means that anyone who's at the table or representing an interest, if they don't want to be responsible for the negotiations breaking down, has some responsibility to try to help to get the committee to consensus.
Again, this is just an overview of the stages. Generally, it should be a voluntary process on the part of the agency, so the agency should make some decision about whether to use the process or not. In fact, a number of the ones done by this department have been mandated by Congress. I hope that there will be more that the Department chooses to do voluntarily in the future.
The start of that process is for the agency to check do we really need a rule, is this process appropriate for that rule, and to make some decisions about what are we willing to negotiate? What would be on the table and what's off the table?
The agency can then use the services of an impartial convener to talk to the agency and various people within the Department who might have some input into the rule, and also to go and talk to the outside parties about what are the issues, what are the interests, who can effectively represent those interests, is the process likely to succeed, and what are the different process elements that might make it actually succeed?
The agency then has a role after this convening if they decide to go forward and have to publish in the Federal Register a notice of intent to negotiate, get comments on that, respond to the comments, which might mean that they adjust the committee membership from what they originally thought, and obtain the commitment from the outside parties to negotiate. The agency nominates a facilitator. Hopefully, it's the same person who did the convening, but that person has to be someone that's acceptable to the committee. Then -- I'll talk a little bit later -- the committee does have to be chartered under the Federal Advisory Committee Act. There are some of the FACA requirements that apply and some that don't.
At that table -- this is again just an overview -- the committee establishes ground rules, and it sounds as though you're doing kind of the same thing here with your operating principles, shares information so there's a common information base and may have presentations from outside parties to do that, and clarifies what the issues are and what the parties' underlying needs and concerns are. The committee may or may not establish work groups, depending, and generates options for solutions and negotiates about either the text or the content of the rule.
If consensus is reached, hopefully, you'll have a proposed rule and you'll also have a written agreement in which the parties agree to things such as not giving negative comments on the rule and to support what it is that the committee has come up with.
If consensus is not reached, it should at least be a beneficial process in the sense that it would clarify and narrow the issues and help the agency to understand what are the concerns of the outside parties.
Why would you use a process like negotiated rulemaking? From the agency point of view, it's generally to get buy-in from the outside parties. As I indicated, it would be in the form of no negative comments. Agencies like EPA who have used this process a lot, they do it to avoid litigation. If they've got buy-in on the outside parties, the agency can generally get quicker clearance of the rule as well.
But in this department, when I talk to people who have been involved in the process, I think they think the really most valuable involved in the process is that there's a dialogue between the outside parties and the agency, better information is brought to bear, the agency is drawing not only on internal expertise, but also on external expertise, and it allows the agency also to really get its point of view across to the outside parties, too. Often the outside parties don't really understand what constraints there are on the agency in terms of statutory provision, the procedural requirements, et cetera, and this is an opportunity for the agency to help the outside parties to understand that.
The dialogue also as well is -- usually interim space negotiation principles are used, so that you're trying to get the parties off of their positions and to focus on what are their underlying needs and concerns.
Unlike the normal notice and comment rulemaking, where the outside parties are simply reacting to what it is that the agency has proposed and to a result in a proposed regulation that the agency may have some vested interest in that point because they've already gone through a lot of a process to get there, in this process the agency may be more open to solutions and the outside parties have a responsibility to not just say, hey, that doesn't cut it with us, but to also come up with what will. What is something that not only they can live with, but also the other interests at the table can live with? And hopefully, that will mean that you've got more creative options generated and a more practical solution to the problem that's going to be able to be implemented in the real world and without unintended consequences.
These are some of the other reasons for using the process as well, and I think it's important that it is something that improves relationships overall.
It's not appropriate for every rule. There are certain criteria in the Negotiated Rulemaking Act, which I've set out here. The Negotiated Rulemaking Act, in terms of the number of interests, says that if there are more than 25 people at the table, that the agency head has to approve it. As you're aware, a committee of that size can be quite challenging, but committees have worked. The largest one that I facilitated was 22 members and the smallest was 12.
There are principles recognized in the Negotiated Rulemaking Act, such as the parties must be willing to negotiate in good faith and the agency as well.
There are other criteria that are common to consensus-building processes that can be looked at. Some of them relate to the nature of the issues, enough room for give and take, and others relate to the nature of the parties and their relationship.
I always recommend that an agency use an impartial convener because they can get better information that way.
Christy tells me I've got two minutes, so what I'd like to focus on, then, and you can read the written materials I've gotten, is there's a diagram that's on page 23 of your materials. That's a wedge diagram and I think it helps you understand the way in which a negotiated rulemaking is somewhat different from a committee like this, and that is that the person at the table in a negotiated rulemaking is not picked for their expertise, but because they are representing an interest.
They have people behind them at the table. They may, during the actual meetings, have an alternate with them. They may have legal and technical experts who are backing them up at the table who they may ask to address a particular question that comes up. There's a general public there, and also the representative at the table has a constituency away from the table that they have to consult with.
So for that reason, the meetings usually are two- to three-day meetings that are set up two weeks to a month apart. Part of the convening is to make sure that the person will be representative and that if they're a member of an association or whatever, that that association has some mechanism to make sure that the person actually has input.
There also are allied interests at the table and they might want to caucus, and so a member can call a caucus at any time if they want to consult with someone else at the table, and a lot of the work of the committee may actually take place away from the table.
Anyway, I'm sure you'll have questions.
DR. WOOD: Thank you. We'll come to questions later.
Next, I'd like to welcome Dr. Paul.
DR. PAUL: Thank you very much. I'd like to thank the committee for this invitation to present today. It's certainly is my privilege to be here.
I'd also like to congratulate Dr. Doug Wood on this appointment. I've enjoyed working with Dr. Wood through the Practicing Physician Advisory Council, another chartered committee under FACA which I'll mention a little later, and I'm pleased to see you here chairing this.
I'd also like to thank my leadership. This project that I'm going to tell you about today was begun in 1998, but really has taken a full head of steam under the new leadership of Tom Scully, Ruben King-Shaw, Linda Fishman, and certainly Tommy Thompson. I want to thank them.
I also want to warn you I'm at the sniffley tail-end of a cold, so hopefully, with my fluids and lozenges, I'll make it through this.
I'd like to tell you about the Physicians' Regulatory Issues Team, a little bit of its history, a few examples of the results we've been able to achieve thus far, and then reflect out loud with you on some of the lessons that I've learned and I think the agency has learned as well.
The mission of the PRIT, the Physicians' Regulatory Issues Team, is to achieve a Medicare program that is truly supportive of physicians caring for patients.
That's not the mission we started with. The mission we started with back in 1998, which was before I became involved with the team, was to respond to allegations of extraordinary page counts of regulations that physicians needed to know and understand in order to care for Medicare beneficiaries, and the team initially was counting pages, looking at how many pages there were of Medicare requirements.
What the team found very quickly were a number of things. They first of all found out that the number is exaggerated and wrong, but they also found out that that number carried an important message to the agency, which was that physicians today do feel enormously burdened by what's going on in the health care environment and that the Medicare program has a role to play in reducing that sense of burden.
As we moved from sort of that dead-end conversation about doing page counts into a much more inclusive sense of burden, which I'll get into on the next slide, we also realized that it was really not good enough for this team to just look for ways for Medicare to be less burdensome. That, of course, is what we should be doing, but we should take it to the next level, which is to find ways for Medicare to actually truly support that clinical relationship, and this is what we as team members and certainly I as I work in the agency carry with me as I work on issues throughout the agency.
The method. We created a cross-agency team. This is all CMS staff, physicians, technical experts, leadership from across the agency who came together on a number of occasions to identify the new mission that I just articulated for you. Then primarily the team has gone back to their respective components, to Program Integrity, to the Carrier Operations staff, to the Beneficiary Services staff, and carried this mission with them as they go back about their daily work, whether it's creating a new policy or educational item or just making some of the day-to-day decisions that the agency has to make. In addition, I have been able to work across the agency in creating and overseeing several new projects, and I'll tell you a little bit about a couple of those.
The team broke down "burden" into some component parts, and this has been very useful to us in moving, again, into a more constructive dialogue with physicians, and let me just run through these briefly with you.
Obscurity. What do I mean by that? Physicians tell us that sometimes the rule that we're talking about is a perfectly fine rule. It's just that burden is created when they can't find the information they need when they need it, and so reducing burden sometimes boils down to being better communicators and educators and reducing obscurity.
Complexity. What I mean there is that, again, physicians will tell us that they understand we need a rule here, but gosh, we've made it so complex it doesn't really work in the day-to-day sort of flow of an office practice, and probably the poster child for excess complexity from the physician's standpoint I would think are the E&M documentation guidelines, and I'll touch on those in a moment.
Volume is certainly on the list, but I will tell you, as I talk with physicians around the country, that that's not really the top issue. These others really get at issues of burden much more. We're used to big tomes of textbooks. Volume is not really scary to us. It's more all these other things that contribute to burden for physicians, at least from my perspective and my experience.
Variability. Physicians complain about calling the same carrier twice and getting two different answers or calling our regional office and our carrier and getting two different answers, or some of the variability that's built into the Medicare system, having a different policy under Medicare Part A and another one under Medicare Part B. So variability in and of itself can be burdensome.
Then what I call "dribble." What this is is that physicians tell us that every time they turn around, there's a new requirement that they're faced with. It doesn't seem to have much rhyme or reason. It doesn't seem to fit with any sort of calendar as far as they are concerned. It just comes along and it constantly keeps them off guard, feeling burdened by that question, am I doing the right thing? Have they changed the rules on me?
Risk. Physicians tell us that burden is created when the risk for violating a rule is not proportional to the precision or the importance of the rule, at least through their eyes. The example that they give us are E&M documentation guidelines again, a surprise, and what I mean by that is that as the agency has tightened our oversight of payment for E&M, it has brought into relief for physicians that we are overseeing against guidelines that they find to be excessively complex, nonintuitive, and, in their minds at least, imprecise, and to be precisely auditing against imprecise guidelines is what creates burden for the physicians.
Then finally, disconnect. This is an important one and I'll spend some time on this with a project. As I started out in this project a year or two ago and was talking to physicians around the country about the things that we were developmentally doing to improve the program and educate and outreach and going forward, they kept stopping me and telling me, "Yes, but there are certain Medicare requirements that just don't work. I know you think they're good, but they don't work in my office." That's what I mean by disconnect, and there's a project that I'll tell you about that deals with that.
The team very specifically tried to take bite-size issues and create workable solutions that are very specifically tangible to the practicing physician community, and throughout our effort we have been working to amplify the voice of practicing physicians. It's our premise that if we can add that practicing physician voice into our decisionmaking throughout the processes in the agency, that we will end up with better decisions, and some of what I do just is a matter of amplifying that voice at the right time.
I'm actually not going to spend any time on the bottom three items here, frequently asked questions, the Clinical Environment Appraisal Program, and Medicare OneSource. These are fairly developmental. They're described in the packet that you have. I'd like to spend my time on the Physician Issues Project.
This project has gotten some very nice positive press and really grows out of what I told you before, which was I kept getting this push back from physicians saying, "You know, there are just some things that don't work for us."
It was also grown out of my struggle to get around this word "paperwork" and this word "hassle." As I heard it from physicians, I kept saying, well, how do I get my arms around paperwork?
And finally what we did was I had an intern working with me about a year ago, and we decided to go back through correspondence, testimony, to the Practicing Physician Advisory Council, testimony from the physician community to Congress, minutes from meetings, and ask this question. What has the physician community been telling us over the last year or two that are specific Medicare requirements that get in the way day in and day out of the doctor-patient relationship?
When we asked that question and culled and mined all of that input, what was very interesting is we came up with 25 items. It wasn't a million. They were very specific Medicare requirements that were problematic for physicians on a day in, day out basis as they were just trying to get through the day and worry about clinical issues, as opposed to worrying about Medicare's rules.
So we created this list, and then the other thing we did is we went back to the physician community and we took this list, and actually, of the 25, 10 of them we really felt that there were good activities going on in the agency right now that the team didn't need to focus on.
For the other 15, we went back to the physician community and we worked with the Practicing Physician Advisory Council. I don't know how much your committee is aware of this, but this is another advisory council chartered under FACA that allows us to post the agenda through Federal Register notices, to have a very full and public airing of the issues, and then have the council give us advice.
I went to the council with these issues and asked them to take a look at these 15 and validate them, add anything that was missing, and then also just to expand on any of these issues, give us some more information on any of the 15 that we wanted, and then finally to help us pick the top five or seven, and we ended up with the top seven, that we should get working on the front burner, as opposed to the back burner, for this project. So this council was able to do that for us.
Three minutes.
MS. SCHMIDT: And then we have time for questions.
DR. PAUL: Let me just give you a couple of examples. Advance Beneficiary Notices is on that list, and this is an example of a piece of paper, of paperwork, that physicians find problematic in their office. It's an important piece of information for patients, and what we chose to do is break it down into a variety of pieces, so that we could address that burden using a variety of approaches, such as education and frequently asked questions, et cetera.
On E&M, this is an example of good listening. I realize that we're at a frustrating place, probably, with it, but I actually think this is a success story so far. We have been listening very hard to the physician community over the last several years and we have made a number of efforts that continue to be refined and changed based on extensive input from the physician community, and I think that the team that's working on this now is really looking forward to working with the CPT Editorial Board on the next steps for this.
The women's health exam one is just an example of solving a physician problem by educating patients and by creating a brochure -- I brought a few of them that I think are in the back of the room -- in which we use a brochure to educate patients to solve a physician problem.
Let me just reflect out loud, then, for a minute on some of the lessons that I've learned and I think the agency has learned. Certainly, listening hard and listening repeatedly to one's critics. I've talked about vetting the issues. I have found the PPAC on the physician issues to be very useful for us as a place for us to get input and advice.
I think that some of my effectiveness in the agency has been because I get out and keep my ear to the ground with the physician community and that I walk a fairly tight, narrow line in the agency between being an honest and fair representative of the physician point of view, but also being very respectful of the policy staff and the leadership in this agency, the managers, who have a wealth of knowledge, and the fact that something is not quite working is not a matter of ill will. It's a matter of getting the right people to the table and the right information in their hands. I have had no problem getting to the table on any of these issues with the people in the agency, and that's been really a privilege of the kind of position I have here.
Words matter. I think that goes without saying. I think the fact that we gave this initiative a name, the PRIT -- I probably would have picked a different name if I was naming it, but the PRIT, and also the Physician Issues Project, has helped both externally and internally in creating a change in the culture in the agency.
Walking a mile in their shoes. We are accepting invitations to participate in preceptor programs around the country, putting our very experienced and thoughtful policy staff into physician offices and letting them chase around the anesthesiologist and surgeons and really experience clinical care. It's dramatic what happens when they come back.
Also, finally, the lesson learned is to keep focused. Keep focused on the mission, but also my not so secret focus is actually much more fundamental than the mission I just told you. It's all about patients. There are a lot of ways that this agency can support better care for our Medicare beneficiaries. We can fund quality improvement projects, we can oversee their nursing homes, and write regulations. The strategy that I use is finding ways to make the program more supportive of their doctors. It's just one strategy for a very fundamental, very narrow focus that I have, which is on the patients.
I welcome you to look at our home page, and I look forward to the conversation. Thank you.
DR. WOOD: Thank you, Barbara.
Actually, I wanted to thank each of the presenters for doing very well when we're pressing them very hard about their time.
Personally, as I've listened to the presentations, I've come away with some specific lessons learned, and I think they will be extremely helpful to us as we go forward. There is some time for discussion, which I would like to give to the committee, but I think we heard from the FDA example that there needs to be some cultural change to be successful and it is possible. From the discussion of negotiated rulemaking, the same. It takes a bit of a cultural change, but indeed the outcome can be quite good, and I think we've heard a similar lesson from Dr. Paul and her colleagues working on finding issues for physicians, and that's one we could perhaps take some further time to refine.
But I would like to take the time to see if there are specific questions or comments that any of the committee members might have for any of the three presenters.
I can't see everybody behind the projectors, and so Dr. Nielsen, I apologize for not seeing you.
DR. NIELSEN: That's okay. I can't see you through that box there either.
Is Janet still here? My question is, in terms of unintended consequences, there have been some high-visibility drug recalls. Has there been any increase in taking products off the market with the accelerated bringing them to the market proportionally? I think I know the answer, but I want to hear you.
DR. WOODCOCK: Can you hear me?
DR. NIELSEN: Yes.
DR. WOODCOCK: No, there has been no change in the rate of drug withdrawals, although, with the modern science, more drugs are coming before the agency, and therefore the proportion, although it's the same, it's a slightly larger number.
Also, as part of our risk management program and our really improved, I think, public health orientation, we've pulled more older drugs off the market. People get confused and feel that since they were pulled off the market, they were approved recently, but many of the drugs that have come off the market actually have been here maybe 20 years, 15 years, and so forth. There are a number of other older drugs I think that may be wearing out their use in current medicine.
But overall, the answer to the question is the rate of drug withdrawal has been about 2.6, 2.7 percent of approved are ultimately withdrawn and that's been stable.
DR. WOOD: Other questions? Judith Ryan.
MS. RYAN: Would it be possible in the summary of today's meeting to just have the lessons learned sections from each of the projects that have been shared with us to be captured in the notes?
DR. WOOD: We certainly can do that.
I would make the other comment that each of the presenters here today have expressed their willingness to come back to us on other occasions if there is some specific advice that we would like to get from them about the lessons that they have learned. I mean, we've talked about this concept of bouncing the ideas off of people, so if we come up with something about a long-term structural framework, this might be an effective group of people to incorporate in an interagency example of expertise in terms of avoiding unintended consequences and what the impact would be in terms of, for example, changing culture.
MS. RYAN: It also strikes me how much the lessons learned from the physicians group might contribute to the other listening sessions in which Mr. Scully is engaged.
DR. WOOD: Other questions? Dr. Nielsen again.
DR. NIELSEN: Just kind of maybe an observation or a question for us to consider. I guess all of us have been in a variety of organizations and seated at boards and committees and done a variety of things, and tried to put into place frameworks, some framework that would work, that would accomplish what the end is that's desired. I guess my observation is sometimes it really depends on the people and the attitude of the people. You can't always write a process that ensures -- well, I think you know what I'm trying to say.
As we go forward, it's important that we recognize that there have to be people of good will at all levels, and sometimes all of us have our own styles, our own agendas, and I'm very impressed with the three individuals who have presented to us today and the outcomes that they've presented, but I caution us that sometimes it is a function of not just management, but of leadership in those positions, and I commend them.
DR. WOOD: Let me start with Mr. Bloom, and then I'll go to Dr. Dennis.
MR. BLOOM: I know we're short on time, so I'll make this really brief. I would just ask Dr. Woodcock if at a future date, if we could either have her come back or either submit in writing what have been some of the consequences of the accelerated approval and the less information that we're getting upfront on drugs, and possible solutions that you see in terms of how we can get some more additional information that we are sacrificing in terms of the faster approvals. I don't think anyone wants to stop the faster approvals, but I think everyone recognizes that we are missing a lot of information that we used to get, and your thoughts on that would be I think very helpful to us.
DR. WOOD: Do you want to do any sort of preliminary answer here? Or you don't have to.
DR. WOODCOCK: I really don't totally understand what Jeff is talking about. The number of patients in the average NDA today is probably five to 10 times the average number of patients, say, in the '80s. In other words, the data set, the number of people who the drug has been tested on, probably is around 5,000 people now versus in the '80s it might have been in the hundreds. All right?
The only thing that's really missing is nowadays, when drugs are approved, they are approved before other populations and other countries are exposed, and that was kind of a safety net for the U.S. because Europeans or people in Japan or Australia, large populations, would be exposed to these drugs because of the time lag required for FDA review in the U.S. If in fact catastrophic, very rare side effects were going to occur, they would be seen in those populations often prior to the completion of the review in the United States and the drug would never make it onto the U.S. market.
But I would be glad to give a more detailed explanation about it if people are interested.
MR. BLOOM: That isn't really what I'm talking about. It's the fact that we have 24-week data or 48-week data, instead of longer data sets, and what consequences there have been, if any. If there's not a problem at all, that's fine.
DR. WOOD: Gary?
DR. DENNIS: First of all, those are three excellent presentations, and I'd say that there must be some commonality between them. I think they clearly all had frequent communications, they had quality communications to all the stakeholders, and there were some specific timelines for each of those.
I would hope that in addition to the best practices from each one, the features of them that make them successful can be pulled out, so that maybe we can use them as examples for what to do in the future.
DR. WOOD: I must say, I had the same thoughts and I've been writing notes here, because they helped me considerably in terms of conceptualizing a framework for how we could go at the future, and I will try to synthesize those for the committee to see.
Are there other specific questions? I don't want to exclude any.
(No response.)
DR. WOOD: Judy, from the perspective of the process of negotiated rulemaking, I mean, it really is much more demanding, it seems, for the agency than the old style of going through the notice of proposed rulemaking and waiting for comments to come back and things of that sort. How much more effort is it to do it this way and, then, if you think about it, once implementation occurs, if you spend more effort upfront, do you actually gain and have less difficulty with implementation on the backside in needing to issue technical corrections and all of those kind of things?
MS. BALLARD: Yes. I think the experience is generally in negotiated rulemaking that not only is there better implementation, and sometimes, in several of them that I've done, there's in effect implementation in a slightly different way at an earlier point.
For example, one of them was negotiation about coverage policies for clinical diagnostic laboratory tests because there was a lot of variation among the country, and even though the final policies from the committee took a while to get into effect, a lot of the local carriers modified their policies to be more consistent with what the committee had done.
There is more of a commitment of agency resources early on, but there is also a saving of the agency resources. One, I think there should be in terms of clearance within the Department, because you've gotten the other elements of the Department that are going to be affected by the rule and involved in the clearance involved at an earlier stage. So they've had a chance to have input and they've in effect bought into the result as well.
Also, it should significantly reduce the number of comments. The most comments on any of the four reg-negs I've been involved in were 61 comments, and that was in the clinical labs one, where they developed not only administrative policies for laboratory tests, but also 23 national coverage policies for laboratory tests, and the Federal Register document is about this thick.
So there should be some savings for the agency in going from the proposed rule to the final rule because the number of comments is significantly reduced and there's a way of answering the comments, because most of the things that come up in the comments also came up in the negotiations.
DR. WOOD: Is it your sense, too, that on the backside that once you get to the point of, say, interpretive guidance activities -- this is a discussion that occurred in some of the subcommittees this morning -- it's less in the negotiated rulemaking process because people are actually much more clear about what the intent of the original design element in the program was and how you're going to get there in terms of regulation, and is there any evidence that there's less need for OIG intervention or other enforcement intervention in any of the examples of negotiated rulemaking?
MS. BALLARD: In the ones in this department, it's a little hard to measure that, given the nature of the rules themselves. I would say some of them I can clearly say that there was a better understanding in the community of what was intended, and particularly in one that involved the Inspector General's Office. I think the experience in other agencies, where they've been doing it for a longer time and have a little bit more history of the follow-on, they definitely feel that there's a better implementation, better understanding.
Also, the committees sometimes do actually negotiate about things that go into the preambles. So if they're concerned, to make sure that the interpretation of particular language that they choose is interpreted in a particular way, they can put something in the preamble that will ensure that it will get interpreted consistent with the committee's intent.
MR. TOBY: I have a question.
DR. WOOD: Go ahead, Mr. Toby.
MR. TOBY: Ms. Ballard, I have two questions about rulemaking that's negotiated. My sense of it is that when you get a lot of competing interests together, you're going to have a very acrimonious process. My question is in contrast to a normal rulemaking process and using negotiated rulemaking, what is the timeline in terms of difference? I would think it would be much longer to get a regulation done through negotiated rulemaking, considering the competing interests and what's at stake. We're generally talking about a lot of money and potential burdens.
MS. BALLARD: I think it really depends on the rule and it's kind of hard to measure because you don't know how that exact rule, how long it would have taken in the Department. I think overall negotiated rulemaking still considers favorably, even though there have been some time lags that were just due to normal agency resource restraints or whatever.
But, for example, one of the negotiations was over the solvency standards for provider-sponsored organizations in the Medicare Plus Choice program. That negotiation ended up in a rule much, much more quickly than it could have been done in a normal process, and I think anybody who was involved in that one felt the same way about it. And that -- talk about acrimony. That was one where there was a huge legislative battle that led Congress to mandate that negotiated rulemaking be used, and that acrimony did show up in the negotiations, but I think the parties went out of it still feeling that they got a better result than they would have gotten through another process.
MR. TOBY: Thank you.
DR. WOOD: I've asked the staff, actually, to give us a better flavor of how this works and give us the law that are some examples of negotiated rulemaking because I'm not sure all of us see all of them versus the traditional approach. So we'll get that for you.
Now, we are close to the time that we need to adjourn to honor our promise to you to adjourn promptly on time, so that we do not delay any travel plans, and in the few minutes that remain, I'd like to first thank all the members of the committee for a day and a half of extremely hard work. We pushed you hard, especially yesterday, and I appreciate your forbearance and understanding and the intensity of your effort carrying through this morning when we needed your help in terms of defining how we would move forward.
Now, in terms of follow-up from this morning, after you have heard from your colleagues in the different work groups about what our expectation would be in each of the subcommittees, please consider which of the subcommittees you would prefer to work on, or if you have no preference, let us know that, but let us know that quickly, so that we can reconstitute the subcommittees in a more reasoned fashion other than the, I confess, quite arbitrary fashion that I did it before working with the staff. Even though it was arbitrary, you did a fabulous job in terms of getting your work accomplished this morning.
We will also expect to hear from you again about immediate recommendations. We'll get those back out to you. Mr. Jindal would have otherwise been here today, and he and I would have talked about the circumstances. We will have a conference call, he and I, on Monday, depending on the status of circumstances in Louisiana.
We will then start to put together the structure that we came up with this morning in terms of the subcommittees, get that out to you, and begin to get those pieces in place fairly quickly, because we have to prepare for the first regional hearing, and we will then communicate to you about where that will be and the logistics of getting there. So there will be a lot that we'll work on in the next several days and that you'll hear from us about.
Before we stop, let me ask -- oh, let me actually ask, too, that if there are any other specific items that we should do for the next meeting or if there are other people that you would like have back -- it was suggested yesterday we might want to have Mr. Thornton come back for some additional discussions -- please let us know so we can also arrange for those.
Now, that being said, let me ask Christy if there are any final announcements from today? And she says none.
I'll give the committee members in the last -- Dr. Dennis?
DR. DENNIS: Bring Dr. Paul back, too, so she can go through some more of those issues.
DR. WOOD: Okay. I mean, didn't want to get into a lot of details, but I'll just leave you with two things to consider, and the reason I'm going to leave you with these is just from the perspective of the framework. Now, Dr. Paul has wrestled with two of them. One is the ABN and the other is the documentation guidelines.
Now, the documentation guidelines are interesting in that there's no other, as far as I know, commercial carrier that uses them, and the consideration is actually they don't really worry too much about them in terms of the issue evaluation and management services. They're going to pay for those anyway, and I don't think there's been a lot of change in utilization of those services, either with or without the documentation guidelines.
So as we think about this process, and I'm only putting this out here from the perspective of process, what is the intent? What do you need them for? If it won't make a difference, then don't use them.
And the other is the mother-in-law test that I talked to you about the other day and the ABN, and she keeps asking me, "Why do I have to fill this out? Why can't I just call and find out if it's paid for like I used to do with my other insurers?" So if Medicare actually provided the service of a predetermination, would you actually need ABNs? I think the answer to that is probably no.
But again, the only reason I mention them to you are as potential examples of how we might structure the work or structure the thinking about how we might do things, because if there is a recommendation for how we might improve the functioning of the program, you could substantially improve service to patients and physicians and eliminate, then, a whole set of regulations and all the problems that go with them. So that's the only reason I've put them out there and I don't expect any of us to have the answers today, tomorrow, or next week, but we'll get them.
That being said, let me again thank you for all of your hard work, and wish you care on the way home.
We are adjourned.
(Whereupon, at 12:48 p.m., the meeting was adjourned.)