DEPARTMENT OF HEALTH AND HUMAN SERVICES
SECRETARY'S ADVISORY COMMITTEE
ON REGULATORY REFORMTeleconference
Moderator: Douglas Wood
September 9, 2002
10:30 am CT
OPERATOR: Good afternoon and welcome to the teleconference of the Secretary’s Advisory Committee on Regulatory Reform. This meeting will conclude at 3:00 pm Eastern Standard Time.
The public comment period is scheduled to begin at approximately 12:30 and will last one half hour. Individuals wishing to provide public comments will need to press star 1 on their telephone keypad when prompted by the operator to enter the queue.
Each speaker will be allocated 3 minutes at the discretion of the Chairman. Each member of the committee will have an open mic during the entire meeting. And we request that you - that each member use the mute button on your speakerphone when you are not speaking to the rest of the committee.
Any of the members who need to leave the call before the end of the meeting should verbally notify the Chairman of his or her departure.
The Chairman of the committee is Dr. Douglas Wood and he will be leading the discussion today. Ms. Peggy Sparr, Executive Director of the committee will be assisting Dr. Wood. Dr. Wood, we are ready for you to begin.
DOUGLAS WOOD: Thank you very much Paul. Welcome everyone. And before we begin I need to do a call of the role of the committee members who are on the call.
I might begin with Mr. Jeff Bloom?
Dr. Kristin Crosby?
KRISTIN CROSBY: I’m here.
DOUGLAS WOOD: Bruce Cummings? Gary Dennis? Ron Dollens?
RON DOLLENS: I’m here.
DOUGLAS WOOD: Tony Fay?
TONY FAY: Here.
DOUGLAS WOOD: John Finan? Lisa Gigliotti?
LISA GIGLIOTTI: I’m on the call.
DOUGLAS WOOD: (Unintelligible)?
MAN: Here?
DOUGLAS WOOD: Mrs. Hellmann? Gary Mendoza? Nancy Nielsen?
NANCY NIELSEN: Here.
DOUGLAS WOOD: Erik Olsen?
ERIK OLSEN: Here.
DOUGLAS WOOD: Patty Shafer?
PATTY SHAFER: Here.
DOUGLAS WOOD: Gary Redding?
GARY REDDING: Here.
DOUGLAS WOOD: Judith Ryan? Judith Ryan?
JUDITH RYAN: I am on.
DOUGLAS WOOD: Leonard Schaeffer? Suzanne Pattee? Schaeffer?
SUZANNE PATTEE: Here.
DOUGLAS WOOD: Judith Sutherland?
JUDITH SUTHERLAND: Here.
DOUGLAS WOOD: Bill Toby?
BILL TOBY: Here.
DOUGLAS WOOD: Karen Utterback?
KAREN UTTERBACK: Here.
DOUGLAS WOOD: Trish Walden?
TRISH WALDEN: Here.
DOUGLAS WOOD: Kern Wildenthal?
KERN WILDENTHAL: Here.
DOUGLAS WOOD: Jack Rovner, I missed you in the roll call. Are you there?
JACK ROVNER: You did and I am here.
DOUGLAS WOOD: Thank you Jack.
We now have 18 members of the committee present which constitutes a quorum. And so we will proceed with the meeting.
This teleconference today includes people who are on the line with us. And at the last count I heard something like 45 or 6. We have here in the multipurpose room at Health & Human Services and the Humphrey Building in Washington about 12 to 15 public members and other staff members who are supporting us.
We have had a few little technical problems to start we’re working through. And our contingency will be that we will handle this predominantly in the audio fashion until those are solved. We do have a couple of members who are participating by audio anyway.
Our goal today is to address some issues that we have had from Minneapolis. And in that context then, we will have to manage the meeting in expeditious fashion.
If there are other problems that we encounter in terms of long discussion we will put those to the last part of the meeting and identify whether or not we want to continue work on those in anticipation of our last meeting in October or whether we will simply consider that they represent pieces of work that will be unfinished by this committee but which nonetheless can be a basis of further discussion and potentially further action by the Department of Health and Human Services.
If we do not adopt an item today, then we will discuss the circumstances in the Executive Committee and make then decisions about whether or not we think it could be prepared for final discussion in October or whether or not we will simply leave it then as an unfinished item.
We have a large number of items for the members. And as we get to the items and the consent agenda, the staff here have suggested that we number them for easy reference so that all of us know exactly what we’re talking about. And as I mentioned, as we get to those then, I will go through that numbering to make it easier for us to follow when we know what we have adopted and what we have not adopted.
We want to remind all of the members that where you’re using a speakerphone, please keep them on mute until you are ready to speak because I cannot see you and rely on the usual clues that let me know how urgent a matter might be for you. I’ll ask you to try to alert me by voice, obviously to let me know what you need to say.
In order for us to maintain a quorum, I asked that each of the members to let me know when you are leaving the conference not to return. If we drop below a quorum, then we will have to discontinue the aspects of the meeting that require a quorum for voting.
At this juncture, let me ask Peggy if she would like to make any particular comments as we head into the first item. So Peggy, anything you want to add? Not a thing.
Peggy Sparr: Not a thing.
DOUGLAS WOOD: With Peggy’s hard work as well as the work of the staff that has gotten us to this point. I really want to recognize the HHS staff as well as the CMS staff. We’ve relied heavily on CMS expertise in doing these national phone calls to make this one work.
And so David Clark and his colleagues in particular have been extremely helpful. I’ll tell you that those of you who are on the call - are not here, he’s right behind me sweating.
Our first item today is to look at the pieces of the agenda which represent a consolidation of work that we have done of all of the recommendations that we had accomplished. We have put them out for your review earlier. You should have seen them. We asked the staff to reconcile all of these recommendations and to make a master list.
In that process, we have identified several pieces which will require careful consideration. You will recall that we asked each of you to tell us if you thought that the changes were simply editorial and not substantive and if there were circumstances where there were clearly substantive changes, then we would need to deal with those and make sure that we were comfortable with them.
Now those actually are in Tab 2 of your binder. Or if you are following on Present Online, they are coming up. Paul are you… actually I’m one tab off. It’s Tab 3 in your binder.
MAN: (Unintelligible) manipulate this on the screen itself.
DOUGLAS WOOD: If you’re following in your binder, again go to Tab 3. And we have a format here where working on to getting you accustomed to how this will work.
If you look across the top, you’ll see how the previously adopted recommendation number then the original recommendation and the language that was used and then the modified recommendation which represents our attempt to try to clean up the language or to consolidate.
Now in this circumstance there were ten items that looked like they might have potential changes beginning with 102. There are three of them as we have discussed in the Executive Committee where one of us has asked that we move them to a discussion period. And those are numbers 254, 275 and 275.
In keeping with our usual approach, let me ask if there are any members of the committee who would like to move any of remaining items to discussion.
ERIK OLSEN: Mr. Chairman, this is Erik Olsen calling.
DOUGLAS WOOD: Go ahead Erik.
ERIK OLSEN: I discussed this with you earlier. And I have just major problem with Item 1 through 5 which are the HIPAA resolutions. And basically because the wording has gone from simple phrases, it leads to illegal language.
So I would like - I don’t necessarily want to lose in this discussion, but I would like the dissent post recorded on my part to those because of that procedural issue. So if no one else wants them - to discuss them, I’d be happy just to leave it at that.
DOUGLAS WOOD: Okay Erik, that’s a good point. Let me also remind the other members of the group, for the purposes of our vote on the consent items, let me remind you that you may dissent when we do the vote on the consent items without asking to move them to a discussion.
So it is not necessary that we delay all of them to discussion.
ERIK OLSEN: That’s fine.
DOUGLAS WOOD: Is that satisfactory for you Erik?
ERIK OLSEN: Yes.
DOUGLAS WOOD: Are there any other items of concern about the method that we will follow for members of the committee?
JUDITH RYAN: Judith Ryan. I would just like to concur with Dr. Olsen’s observation and will raise questions for dissent in the agenda.
DOUGLAS WOOD: All right then, we have these items in front of us. Would a member of the Executive Committee be prepared to make a motion for their adoption with the exclusion of 254, 274 and 275 that are going to discussion later?
JUDITH RYAN: This is Jack Rovner. So moved.
KRISTIN CROSBY: This is Kristin Crosby.
DOUGLAS WOOD: We have a motion for approval and then a second. Will those who are in favor please - for purpose of the adoption, let me make sure about those who would dissent since that’s the most important. Erik, on which items would you like to dissent?
ERIK OLSEN: 102, 103, 106 and 107 and 111.
DOUGLAS WOOD: I understand 102, 103, 106 and 111, correct?
ERIK OLSEN: And 107.
DOUGLAS WOOD: Judith Ryan?
JUDITH RYAN: 102, 106, 107.
DOUGLAS WOOD: 102, 106 and 107 is what we have Judith. Is that correct?
JUDITH RYAN: That is correct.
DOUGLAS WOOD: Thank you. Are there other dissents?
BILL TOBY: Mr. Chairman, this is Bill Toby. I’d like to also cast my dissent with Erik and - as well. And it’s 102…
DOUGLAS WOOD: Okay.
BILL TOBY: 103, 107 and 111.
DOUGLAS WOOD: So Bill we have 102, 103, 107 and 111?
BILL TOBY: Correct.
DOUGLAS WOOD: Okay. Are there others? Hearing no other dissents for each of these then the motions would be adopted with this - we recognize the dissents of the individual members as they have been indicated to us so far.
Items then are adopted with the dissents as recognized from each of the committee members. Remind you please to keep your mics muted when you are not speaking.
We now are at about 12:30 at a time that we have incorporated for public comment. We have members of the public who are here in Washington that I will invite to speak, as well as members who might be queued on the phone.
So we’ll begin with people who might be waiting on the telephone. And Paul, our operator, would you please begin the public comment period?
OPERATOR: Chairman Wood has invited the public to provide public comment. At this time, members of the public may enter the queue to provide verbal testimony by pressing star 1 on their telephone keypad.
We ask that the commentators begin by stating your name and organizational affiliation. Each speaker will be allocated 3 minutes at the discretion of the Chairman. One moment please for your first response.
Your first response is from Gwen Tony.
DOUGLAS WOOD: Please proceed.
OPERATOR: Ms. Tony, your line is now open.
DOUGLAS WOOD: You may proceed Ms. Tony.
GWEN TONY: (Unintelligible) just a general topic that was going to include federal and state coordination for duly eligible beneficiaries. And this has been sort of an issue in our state. I had worked for the intermediary - one of the intermediaries for about six years.
And my take on this is that Medicare should always be primary to any state program or waiver, you know, passport -- whatever the state has.
And we’ve had some discussions with the state departments where in some cases they feel that it’s up to them to - if they want to provide services at the same time that there is their option to do that because they have different criteria.
And I’m trying to get additional clarification on is Medicare always primary and - because I feel in cases that they’re paying - that it’s duplicate payment. So that was the question and the - hoping that you would be able to address that in your meeting. Thank you.
DOUGLAS WOOD: Thank you. Paul, another caller please?
OPERATOR: Your next question is from Mr. Edward Siguel.
Edward Siguel: Hello?
DOUGLAS WOOD: Go ahead Mr. Siguel.
Edward Siguel: I’m Dr. Siguel. I have a medical (unintelligible) degree and a Ph.D. And my expertise is in systems design, economic and cost benefit analysis. I know they’re creating optimal - regulatory policy is very tricky. However, the committee fails to address the major issues in healthcare which are a bloated inefficient system.
The solution is proposed, stick to correct problems caused by the inefficient or ineffective roles. They do very little to revamp the system with optimum regulatory policies.
Just reading the committees’ recommendations along as I try to do on several on the Web site is a gigantic task beyond the skills of most physicians or administrators. The system is already overwhelmed with frequently changing rules that have practically zero impact on sales (unintelligible) cost.
For example, many recommendations you propose sound very good in theory like your process for insuring the use of (unintelligible) or the process for expediting procedures.
However, the committee might as well recommend that people lead longer and healthier lives and pay less in healthcare costs. Nobody disagrees with the purpose of your recommendations. The problem is implementing them.
We could probably save more money and improve life expectancy by supporting a system where people are randomly chosen for health care and the rest are forced to (unintelligible) to more address the point.
To address the fundamental issues, I’ve proposed that the committee develop a strategic system-wide solution rather than a small change in regulation. As an example of the system-wide solutions I propose the following. You need to create uniform guidelines for consent forms for all procedures. The consent forms that people use today are ineffective.
The key part is regulatory matters. You need to have more uniform procedures on how people can comply with HIPAA. You need uniform guidelines for claims processing software, guidelines that are acceptable to all the users in HEK. You need uniform claims processing across payors and you still need different system for Medicare, Medicaid and the difficult insurance.
We should have a system for national medical licenses so doctors are not committing crimes when they - consultation from people across the state.
We can (unintelligible) healthcare - we can collect the cost of healthcare and we can improve the quality. It’s possible to say right now, more than 30% in Medicare and Medicaid (unintelligible), and at the same time, you can improve the quality of medical care. I know that it can be done. I know that you can do it.
I put together a model that was used by Congress and HEW to create the HMO programs in the 1970s. And I also created one of the largest and most efficient healthcare (unintelligible) systems in (unintelligible) that is big. We collected data from more than drug abuse treatment centers and 100,000 people every month. And I also (unintelligible) the cost of the system by more than 100 and got a (unintelligible) report from (unintelligible) to ours.
I work with the medical society, and my request would be a task force to recommend improvements and keep on patient care. And we found that the implementation of HIPAA at the doctor’s level was chaos. It would not really save any money but would cost a tremendous amount - I mean time and effort without any society improving the quality of care or saving time and paperwork for the physician.
I will be happy to answer any questions you fellows have. Thank you very much for your time. We’ll present some of the recommendations in writing before the committees’ meeting in October so you will have a better opportunity to review them. Thank you.
DOUGLAS WOOD: Thank you. Paul, do we have another caller on the line?
OPERATOR: There are no further comments at this time.
DOUGLAS WOOD: Thank you. There are no public comments - or so have signed up here on the possibility that there might be someone in the audience from the public who would like to make a comment. Is there anyone here would like to address the committees?
There are none. Then I thank the members of the public who called today. We’ll conclude the public comment period and move to the next portion of the agenda.
We have a large number of items to consider. In order to try to make those work, we have created a unique identifier grid. And one of our newest staffers in particular, Scott, was most helpful for those.
But in order to try to make sure that we keep them straight, I’m going to go through these for the members of the committee and attached the unique identifier to them so that you can see them.
So if you have your pencils handy, I don’t know if you all came prepared to do homework, pencils and pens but here we go.
Any under HIPAA privacy, Number 102 becomes Number 1. Number 2 attaches to 103. Number 3 attaches to 106. Number 4 attaches to 107. Number 5 to 111 and Number 6 to 254.
Under multiple reviews, Number 7 attaches to 274. Number 8 to 275. Number 9 to 303. Number 10 to 306.
Okay, then Information Subcommittee under Smartcards, Number 11 attaches to A. So 1A is (unintelligible) Twelve attaches to 1B. Number 13 attaches to 1C.
On the Coordination Committee there are a number of carry-over agenda items. Under Number 1, Federal/State Coordination. Roman Number 1, our unique identifier 14 that will go against their recommendation 220. Fifteen goes against - let’s see, 15 against 2D; 17 against 2G; 18 against 18A; 19 against 16F; 20 against 22A; 21 against 22B.
And then there are a couple where there are no numbers that we’re working on, (unintelligible) 22 addresses an item of coordination between federal and private sectors regarding Hospice providers, utilization of a registered dietitian in Hospice. And 23 attaches to providing an exception to 24 hour nursing services standard in Hospice, conditions of participation and the rest of the care is provided.
For new consent agenda items for the coordination of the technical committee on coordination from the Federal and state Medicaid our number 24 will go against 1A which is to collaborate with states to ensure that state plan amendments or state waiver requests are approved in a timely manner, et cetera.
One twenty-five will go against Roman numeral 2A, issue immediately a written statement about Medicare Hospice providers recognizing individuals’ right to self determination.
Our 26 goes against Roman Number 3A under Coordination of Benefits and Third Party Liability. And 27 goes against 3B; 28 is against 3C.
So the Coordination and Subcommittee for FDA issues, Number 29 will go against 1A, number 30 against 2A, Number 31 against 3A; number 32 against 3B; number 33 against 4A.
Number 34 goes against - a toll-free number for adverse event reporting, Roman Numeral 1A; 35 is against Roman Numeral (unintelligible). Six is for 3A FDA CMS coordination issues; 37 is against 3B also under the same FDA CMS coordination of use.
C, 39 is against 4A; 40 is against 5A; 41 is against 6A; 42 is against 7A; 43 is against 8A; 44 is against 8B.
And under flexibility subcommittee carryover items, actually some of these haven’t been deleted. But just in order to get them lined up for you, 45 goes against 1A; 46 against 1B, 47 is against 1B1; 48 is against 1B2; (unintelligible) B is against 1B4; 51 is against 1B5; 52 is against 1B6; 53 is against B.
Fifty-five is against D1; 56 is against D2; 57 is against E; 57 - I’m sorry, 57 against E; 58 is against F; 59 is against G; 60 is against H.
For new consent agenda items under the flexibility segment, the predictability of CMS regulation 61 is against 1A; 62 is against 2A; 63 is against 3A; 64 is against 4A; 65 is against 5A; 66 is against 6A; 67 is against 7A.
And we will try to make sure that we - we’re trying to keep these alive during this discussion so that we can keep track of what we have and in fact, incorporate them.
At this point, let me ask Paul to please - Paul our operator actually, to share with committee members again, the procedure that you should use in voting using your telephone keypad so that we can keep track of our votes and especially recognizing those who will be dissenting. So…
OPERATOR: Ladies and gentlemen, Chairman Wood has invited the public to provide public comments. At this time, members of…
DOUGLAS WOOD: Paul, we’re past the public comment. I need you to remind the members about the voting mechanism.
OPERATOR: I do apologize. Each committee member will need to use the keypad on their telephone to record their official vote. If you agree with the recommendation, press 1 on your telephone keypad. If you disagree with the recommendation and want to dissent, press 2 on your telephone keypad.
If you would like to abstain from voting, press 3 on your telephone keypad.
DOUGLAS WOOD: Are those instructions clear to all the committee members?
MAN: Yes.
DOUGLAS WOOD: Okay. Anybody need any additional clarification? Okay, hearing none, what I’d like to do then is to go through the consent agenda items that we would ask to be removed in our usual fashion and then go on to the new one - or actually the rest of the agenda for us to approve.
So let’s begin with data and information. Tony?
TONY FAY: Thank you Mr. Chairman. Just on agenda Items 11, 12 and 13 have been considered by the Data & Information Subcommittee relating to the deployment of Medicare smartcards basically on a pilot basis to begin with with an eye towards moving towards a national basis.
Subcommittee felt that if we or HHS or a public private and partnership were to have to decide in advance what constituted a Medicare smartcard, that could unduly delay the process of getting these cards deployed and in the hands of beneficiaries and others to use or payment to help your operation purposes.
So what our recommendation basically called for is beginning with the pilot study, HHS would deploy Medicare smartcards to a limited population. The smartcard would contain a chip that would contain the same information that’s on the front of the Medicare card, i.e., the beneficiaries name, the health insurance number and the date that the beneficiary became eligible for Medicare. That would be shift in a protected encrypted form so that it could not be altered.
And in fact the D & I subcommittee actually discussed this at length and decided that was going to be a much more secure process than the basic paper cards which are actually very easy to forge.
On the chip would be a large unprotected area which would enable different providers, either hospitals or physician offices or retail pharmacies to basically use that as a storage area for whatever information they thought could go on the card. And this would replace the hodgepodge of smartcards and magnetic strip cards and credit cards and run cards and sort of proliferating now by going to a - sort of a single meeting.
As a continuation of the process, HHS would invite the open source community at large -- vendors, practitioners, (unintelligible) admissions et cetera, to come up with ideas on what you could put in this unprotected area of the smartcard keeping in mind of course that, you know, we’ve got HIPAA privacy regulations and we will have a security regulation forthcoming.
This is sort of an open source that we’re advocating similar to how some open source types of software have been created such as Linux and OpenOffice. We feel that this would accelerate the development and deployment of a useful smartcards as opposed to a closed source process where you - you know, you try to figure it all out in advance.
DOUGLAS WOOD: Tony, you have three items then that you were moving for approval, correct?
TONY FAY: Yes sir.
DOUGLAS WOOD: Are there - before we ask for a second, are there any members who would like to pull any of the items from the consent agenda and move to a discussion?
ERIK OLSEN: Chairman, Erik Olsen. I actually have an amendment – (unintelligible) for use now or later?
DOUGLAS WOOD: Let me ask you to hold it for just a second Erik and see if there are any other items we want to pull and then we’ll go to the amendment? Is there anyone else who would like to remove any of these items from the consent agenda?
Hearing none, let me ask Erik then if you might discuss your amendment with the group and Tony in particular to see what we’re dealing with. So Erik, please proceed.
ERIK OLSEN: Yes, Tony and the group, obviously a key concern - it could be for everybody (unintelligible). I’m going to - what I’ve done is (unintelligible) in Number 12B that we just add a (unintelligible) special attention should be given to privacy concerns. Just kind of emphasize that (unintelligible).
TONY FAY: Mr. Chairman and Dr. Olsen, that is certainly consistent with the detailed issue statement that’s attached to that where we go into a little more depth with the privacy concern. So the chair - the D & I subcommittee would have no objective to adding that sentence.
DOUGLAS WOOD: Then it will be added. Is there another second for these motions?
JUDITH RYAN: Second, Judith Ryan.
DOUGLAS WOOD: Thank you Ms. Ryan. Other discussion?
MAN: Mr. Chairman, I really could not hear the amendment.
DOUGLAS WOOD: The amendment actually is that we would add a sentence to Number 2 - to B or actually what we have identified as 12. Special attention should be given to privacy concerns.
MAN: Thank you.
DOUGLAS WOOD: And as noted by Mr. Fay, that actually is represented in the issue statement where greater detail is found.
BILL TOBY: Mr. Chairman, this is Bill Toby.
DOUGLAS WOOD: Go ahead Bill.
BILL TOBY: We can add a sentence about fraud and abuse concerns. I just wonder if it would be somewhat appropriate to have the OIG take a - to work - the OIG on this as well.
DOUGLAS WOOD: There are a couple of different ways we can potentially handle that. And this is an important point of the discussion since this is a follow-up from our Minneapolis discussion.
Remember that our approach is to try to make sure that we can give recommendations or discussions to HHS, CMS, FDA staff for technical advice before things - before ultimately HHS or CMS would make final decisions.
This area is one that is a very important one because although we recognize there are problems in our current structure, this one would carry potentially some significant additional expense because of the need to do the integration, the databases, and things of that sort. So there might be a reason for example, why HHS would find a need to consider that this recommendation would not be something that would be truly a simple regulatory fix.
So in that circumstance, as we think about those, Bill, we might want to specifically in setting this up, identify the concerns to HHS. Would that be consistent with your thinking?
BILL TOBY: Yes, absolutely. Just to be coordinated with and give technical consent and advice from the OIG, that would be fine with me.
DOUGLAS WOOD: Tony, is that consistent with how your group has discussed this?
TONY FAY: Yes sir Mr. Chairman it is, is that we discussed several types of input that would have to go in the process. And how to pay for it was the biggest question. And ideas came to the surface like we could potentially solicit industry to help pay for it since they would obviously be a big beneficiary of a smartcard system.
DOUGLAS WOOD: All right. This is clearly one of those recommendations that will be a long term proposition that would require funding and/or potentially legislative activity.
Without other discussion, let me ask if there are any members of the committee who would (unntelligible) for Item 11 which is to immediately deploy smartcards to select the beneficiaries in the pilot study?
Hearing none, then we will adopt that without dissent. Are there any who would dissent for Item 12? Hearing none, it shall be adopted without dissent.
Are there any who would have dissent for Item Number 13? Hearing none, it will be adopted without dissent.
Now again for the committee members, these are ones and relatively new, and given that our time frame is very short, we won’t have the time to go through this whole technical assessment we virtually had before.
I will discuss with the members of the Executive Committee later this week and next how we want to structure these and put these in our report so that it will be clear to others who might read the report that it’s an area that we’re very interested in but that there might be some other substantial implementation, challenges that will have to be confronted as we go forward.
Okay, let’s go then to coordinations, subplanning Mr. Rovner.
JACK ROVNER: Thank you Mr. Chairman. The Coordination Subcommittee has several new items that are - and held over items from Minneapolis hearing. The first one are the set of recommendations with respect to federal state coordination involving a variety of issues from dually eligible beneficiaries, coordination of benefits and so forth.
I would like to yield to Lisa Gigliotti of the Coordination Subcommittee who has held - who has headed up this particular area of our work and let her present the recommendations. Lisa?
LISA GIGLIOTTI: Yes, thank you. And I am turning now to Page 4 under the Coordination Subcommittee and that is Tab 6. Actually did you want to - Dr. Wood, did you want to go on line with 14, 15 and 16 et cetera?
DOUGLAS WOOD: Please Lisa. So we’re on Items Number 14, 15, 16, 17 to start with.
LISA GIGLIOTTI: Okay, and 14 was 1. You had it listed as 1. Could you please - I can’t locate that here. Could you please give me the heading for that one?
DOUGLAS WOOD: Under federal state coordination, that was your old Number 220.
LISA GIGLIOTTI: Okay. And I believe at this point I was instructed that we can withdraw the adopted - previously adopted Number 220 because we are consolidated 220 with items Number 15 and 16. And basically we had three separate recommendations that dealt with either state plan amendments or state waivers and this theme of collaborating with state and federal officials, working on timeliness and decreasing documentation that’s required and also collaboration to foster state innovation.
So it is Page 6 under the tab that I talked about, the new language.
DOUGLAS WOOD: And if I understand that one Lisa, that would be our ID Number 24. And this language would be elaborated with states to ensure the state plan amendments and state waiver request. For example, 1115 waivers are approved in a manner that is timely, significantly decreases unnecessary documentation of foster state program innovation, correct?
LISA GIGLIOTTI: That is correct. But technically, do I need to move to withdraw those three former issues?
DOUGLAS WOOD: Yes.
LISA GIGLIOTTI: Okay, I move to withdraw formerly adopted Item Number 220 and carry over consent to items from Minnesota Numbers 2C and 2D.
DOUGLAS WOOD: And 2…
LISA GIGLIOTTI: D as in dog.
DOUGLAS WOOD: Great, 2C, 2D and 220 go together.
LISA GIGLIOTTI: Correct.
DOUGLAS WOOD: Okay.
NANCY NIELSEN: This is Nancy Nielsen. So Lisa you are substituting what appears on Page 6 under 1A for those other three items?
LISA GIGLIOTTI: That’s correct.
DOUGLAS WOOD: Everyone see the substitution?
LISA GIGLIOTTI: So can I do a simultaneous move to adopt that or should we do two separate action items?
DOUGLAS WOOD: We’ll do them together Lisa.
LISA GIGLIOTTI: Okay, then I…
DOUGLAS WOOD: You have made the motion actually.
LISA GIGLIOTTI: Okay.
DOUGLAS WOOD: Is there a second?
GARY REDDING: Gary Redding, second.
DOUGLAS WOOD: Okay. Are there any other discussion?
SUZANNE PATTEE: Suzanne Pattee. I have a proposed amendment.
DOUGLAS WOOD: Suzanne Pattee. Is that you Suzanne Pattee? Ms. Suzanne Pattee.
SUZANNE PATTEE: Thank you Dr. Wood. Last sentence of this recommendation says that this states to promptly provide a continuum of services to all beneficiaries in the least restrictive setting regardless of whether those beneficiaries have disabilities.
I’m wondering if there is a way that we could add hiring services be provided to all beneficiaries (unintelligible) disabilities to make sure that all beneficiaries would be able to benefit from this recommendation.
LISA GIGLIOTTI: I’m sorry Suzanne Pattee, you cut out for part of your recommendation. Could you please restate it?
SUZANNE PATTEE: I’m wondering if we could add to this sentence, a clause that these - recommendation would be required services to be provided to all beneficiaries regardless of whether those beneficiaries have disabilities so that all beneficiaries could get the benefit of this information.
DOUGLAS WOOD: Suzanne Pattee, this is Doug. Can you clarify for me how that is different than the language in the last sentence?
SUZANNE PATTEE: The current last sentence of this would enable states as opposed to require states.
DOUGLAS WOOD: Oh, okay. So you’re actually wanting us to change the word enable to require?
SUZANNE PATTEE: That would be an easy fix, sure.
DOUGLAS WOOD: Lisa?
LISA GIGLIOTTI: I don’t have any problem with that change.
DOUGLAS WOOD: Okay, Gary Redding as a state perspective, did you hear that?
GARY REDDING: Yes I did. And…
MAN: (unintelligible) is not responding to my computer.
LISA GIGLIOTTI: Gary, can I jump in for a moment? It’s Lisa. Suzanne Pattee, this - actually this sentence was added in a way to offer the statement, in other words, here’s our reasoning why. If we’re able to work more collaboratively and in more timely fashion and have innovation we might - it would enable us to promptly provide. But I think - I’m not sure it’s appropriate to put the word require there.
SUZANNE PATTEE: And I’m trying to get at a different issue in which some of these labors may only apply to a subset of the population of beneficiaries and not to all of them.
GARY REDDING: Right. And I - and this is Gary Redding. And I think that that issue is a separate one from what this recommendation is trying to accomplish I believe.
DOUGLAS WOOD: So Lisa, do you wish to make any modification to the language that you have proposed?
LISA GIGLIOTTI: I don’t at this time. I do not.
DOUGLAS WOOD: Okay. We have your motion and did I hear a second? I did from Gary. Okay, any other discussion?
ERIK OLSEN: Doug this is Erik. Are we - was that an amendment of Suzanne or not?
DOUGLAS WOOD: No, there’s no amendment Erik. It was a matter of discussion where Ms. Patee had raised a question about amending the last sentence that we will not amend. So what we would be voting on would be the language as you have it. And then last sentence in particular would read this would enable states to promptly provide a continuum of services to all beneficiaries in the least restrictive setting regardless of whether those beneficiaries have disability.
Are there any members who would dissent from the adoption of this motion?
JEFF BLOOM: If it doesn’t say required, I’d probably dissent.
Woman: I dissent.
DOUGLAS WOOD: Are there others. Mr. Bloom, we have who else?
Patty Osborne Shafer: Patty Shafer.
DOUGLAS WOOD: All right, so we have Mr. Bloom, Ms. Shafer. Anybody else?
SUZANNE PATTEE: This is Suzanne Pattee. I’ll dissent.
DOUGLAS WOOD: Okay, so we have three dissents. Suzanne Pattee. We use the phone keypad approach. Then as you load now it should match up with three dissents. Let’s try it and see what we get.
It’s quite musical.
Woman: Yes.
DOUGLAS WOOD: Okay, and Paul, do we have that?
OPERATOR: We’re still waiting on a few responses.
DOUGLAS WOOD: Everybody should vote.
Woman: Do you want the yes votes or just the dissents.
DOUGLAS WOOD: Anybody should be able to vote now… no or abstain.
Patty Osborne Shafer: Hi, this is Patty Shafer. Just tell me which was the dissent button again. I think I did it right.
OPERATOR: It would be Number 2 ma’am.
Patty Osborne Shafer: Okay.
DOUGLAS WOOD: One is for okay. Two is for no, and 3 is abstain.
OPERATOR: We have a total of 15 yes and three no.
DOUGLAS WOOD: Good it matches up
OPERATOR: Zero abstain.
DOUGLAS WOOD: All right. You know, obviously the importance for us is to make sure that we understand who has abstained. And so I have Mr. Bloom, Ms. Shafer and Ms. Patee. So this is adopted with those dissents.
LISA GIGLIOTTI: Okay, would you like to move on to Item Number 17?
DOUGLAS WOOD: Okay. Go ahead Lisa.
LISA GIGLIOTTI: The former consent agenda Item 2G, the language worked with HHS staff and now reads CMS should work with OMB, Office Management and Budget to develop a policy that would recognize savings in Medicare and other HHS programs when determining Medicaid waiver request budget neutrality.
DOUGLAS WOOD: And you are withdrawing that?
LISA GIGLIOTTI: And substituting the new language. You know what? Oh, you know - hold on a second. There might be - is there HHS staff on the line that can help me locate a budget neutrality? Did we have a new version written up?
Woman: CMS Staff? Do we have somebody who can help?
LISA GIGLIOTTI: Sorry to hold everybody up here. I think we might have rolled it into…
Woman: Can somebody in Baltimore help us with that?
LISA GIGLIOTTI: Dr. Wood, do you have something that indicates that I would be withdrawing that?
DOUGLAS WOOD: I have stricken in our language…
Woman: There’s no one here in Baltimore that can help on that apparently.
LISA GIGLIOTTI: What page are you on, Dr. Wood?
DOUGLAS WOOD: Page 4.
LISA GIGLIOTTI: Okay. I believe then we must have rolled it into one of our previously adopted…
GARY REDDING: This is Gary Redding. I’ve read through these and I don’t see where that’s rolled into anything that’s in here. So unless we can show that it’s rolled into something else, I would have to object to this being stricken.
LISA GIGLIOTTI: How about Item Number 221 on our master list?
Peggy Sparr: Lisa? This is Peggy Sparr. If you’ll recall, I think we have an item already, not one that’s up for vote today but that was part of the editing process we did, that already dealt with budget neutrality. And that’s why it was withdrawn because it was a loose item that was just hanging out on the carryover item agenda. I’m going to look now to find it in the document.
LISA GIGLIOTTI: Okay.
Paul Hughes: It’s 221. Page 45.
LISA GIGLIOTTI: Gary, are you satisfied with Item Number 221? It doesn’t mention the OMB language but other than that it talks about budget neutrality.
GARY REDDING: I am satisfied with that, yes.
LISA GIGLIOTTI: Okay. Would you like an amendment that says should also work with department of the Office of Management and Budget? Or are you satisfied?
DOUGLAS WOOD: This is Doug. We’ve actually in essence already adopted 221.
LISA GIGLIOTTI: Okay, okay.
DOUGLAS WOOD: We don’t really need to…
LISA GIGLIOTTI: That’s right, that’s right. All right, then I move to withdraw Item 2G, please.
MAN: Hear a second?
GARY REDDING: Gary Redding, second.
DOUGLAS WOOD: Is there anyone who dissents? Since there is no dissent, it will be adopted.
LISA GIGLIOTTI: Okay, moving on to Item Number 18A - 18, which is our previous 18A. If you recall, in Minnesota we started to redraft language and didn’t want to get into a turf war.
We talked with HHS staff and among ourselves and stepped back. And basically what we were saying is that we just want to make sure that surveyors are clear that the intent of 42 CFR 418.88B was not to preclude others than a dietician. So we have the language that you can find at the bottom of Page 4. And I move to adopt this language.
DOUGLAS WOOD: Are there any questions for Lisa about what this one will be? So what we will be doing is replacing 18A with Number 22 which says we’ll issue a written guidance to surveyors stating that the intent of the federal regulation was not to preclude nurses or other qualified health professionals from providing dietary counseling for these (unintelligible). Is there a second?
Woman: I second.
DOUGLAS WOOD: Any other discussion? Are there any who dissent? Hearing none, we will consider that adopted without dissent. Lisa, continue.
LISA GIGLIOTTI: Okay, moving on to Item 19 which is the previous 16F, we have new language. And the new language - this issue, excuse me, dealt with the issue of the 24-hour nursing requirements for condition of participation. And this recommendation would deal with if there is a situation where respite levels care is needed, we’d like the conditions of participation when released to state that there can be an exception to this 24-hour nursing services during respite level of care.
The exact language is - reads as provide an exception to the 24-hour nursing services standard in the Hospice, conditions of participation when respite care is provided. And I move to adopt that language.
DOUGLAS WOOD: Is there a second?
KAREN UTTERBACK: I second. This is Karen Utterback.
DOUGLAS WOOD: Is there other discussion? Are there any who would dissent from the adoption of this motion, that is to replace Item 16F with new language that says we will provide an exception to the 24-hour nursing services standard in the Hospice, conditions of participation when respite care is provided. Any dissent? Then it is adopted without dissent. Lisa?
LISA GIGLIOTTI: Yes, I’d like to move on to Items 20 and 21. They are previous from Minnesota and they dealt with the local medical review process.
And after consultation with HHS staff and some Hospice people in different states we were informed that although there are sometimes many reviews asked of Hospices before the six months are done, it’s actually less than 1% of their total amount of cases. So we decided that at this point we would - we felt best to withdraw those two recommendations. So I move to withdraw our Item 20 and 21.
DOUGLAS WOOD: Is there a second, actually?
KAREN UTTERBACK: I’ll second that. This is Karen Utterback.
DOUGLAS WOOD: Are there questions for Lisa? Is there any dissent? Hearing none, it will be adopted without dissent. Lisa?
LISA GIGLIOTTI: I believe that Item Number 22 is the dietary one so actually we adopted that language.
MAN: We did.
LISA GIGLIOTTI: Yeah, so that’s done. And on the last Hospice Item Number 23 - oh yeah, no that wasn’t Hospice - that was the - I think that was the 24-hour care. Correct?
DOUGLAS WOOD: We just did that.
LISA GIGLIOTTI: Yes. And then Item Number 24 with the new language on collaboration, correct?
DOUGLAS WOOD: Right.
LISA GIGLIOTTI: Okay. So moving on to Item Number 25 should be the CPR requirement, end of life requirement. And as you know, a lot of medical evidence supports not resuscitating somebody who is terminally ill. But there are people who wish to have advance directives or wish to be resuscitated. And we just want to make sure that Hospices have a plan for those that choose that option.
So the language now reads CMS to issue in written statement, Medicare Hospice providers must recognize the individual’s right to self-determination and life closure and provide a plan for Hospice patients that request to be resuscitated or do not have a DNR or advance directive. And I move to adopt that new language.
DOUGLAS WOOD: Is there a second?
TONY FAY: Tony Fay, second.
DOUGLAS WOOD: Is there a discussion and question for Lisa about this one? Are there any members who would dissent? Hearing none, it was adopted without dissent.
LISA GIGLIOTTI: For Items Number 26, 27, and 28, we heard this issue repeatedly and it’s a situation where Medicare and Medicaid - there might be a dispute over who is going - who’s eligible and who is going to be reimbursing for services provided. Timeliness seems to always be an issue there. We voted on a recommendation dealing with skilled nursing facilities.
But here we tried to tackle it from a broader perspective. And so for 3A which is our Item 26, we are recommending that an advisory committee - an advisory group be formulated and the group would submit recommendations on, for example, how to - like the timeliness of decision making and accountability of fiscal intermediaries, etc. Would you like me to take these each separately?
DOUGLAS WOOD: Let me ask if there - I think all the members of the committee have seen them, actually. So let me ask if there are specific questions about any of these items or if there is any member who would like to move any of them to discussion based on this - on their side? Anybody would like to move them to discussion, we would do that now.
Woman: Dr. Wood, I think there is an error in the language of B on our Page 7. In the middle of B, it’s to ensure the timely - it says in here recumbent and I believe in our previous versions it was recoupment. And that makes more sense, the timely recoupment of payments. So if you could just take note of that. Excuse me?
MAN: Maybe it was that the payment’s live.
Woman: I’m back. That’s like thinking we believe the promise, sitting back, taking it easy.
ERIK OLSEN: Doug, this is Erik, I have a question for Lisa.
LISA GIGLIOTTI: Sure.
ERIK OLSEN: On this 45 days - were these two recommendations (unintelligible) by program integrity? Did they have a problem with this? That’s my question.
LISA GIGLIOTTI: We actually discussed this with CMS Staff, or at least Michele Evink did. And they did not. As a matter of fact, they were quite helpful with formulating B and C. Actually, A, B, and C.
DOUGLAS WOOD: Is there anyone who - come back to ask a question, is there anyone who would like to remove any of these from the consent agenda? Are there any other specific questions for…
MAN: I have a question. This is - Jack might know the answer. For B, where it’s requiring the Medicare fiscal intermediary to pay claims in review for longer than 45 days. I know in terms of collecting from the beneficiary that court case that I cited before doesn’t allow that. I don’t know if the court case blocks any payment and the fiscal intermediary makes the decision on the validity of a claim.
DOUGLAS WOOD: Jack, would you like to respond?
JACK ROVNER: My recollection of the case is that it has to do with trying to collect from a beneficiary which is barred. I don’t think it has anything to do with which agency, state or federal, ought to be paying first and so forth.
MAN: Okay, so this will be fine.
LISA GIGLIOTTI: Right, basically we’re trying to get for whoever provided the services some kind of relief in a more timely manner.
MAN: No, I think it’s a great idea.
LISA GIGLIOTTI: Okay, well, I move then to adopt them -- 26, 27, and 28 -- in a block.
DOUGLAS WOOD: Any second?
JUDITH RYAN: Second, Ryan.
DOUGLAS WOOD: Any dissent? Hearing no dissent, these will be adopted without dissent.
LISA GIGLIOTTI: Mr. Chairman, that concludes all of the items under federal and state coordination at this time.
DOUGLAS WOOD: Very well. Thank you very much, Lisa.
LISA GIGLIOTTI: You’re welcome.
DOUGLAS WOOD: Jack, your next large group is the FDA issues.
JACK ROVNER: Yes, thank you Mr. Chairman, and thank you, Lisa. On the FDA issues, we as a subcommittee were aided greatly by Suzanne Pattee, a member of our committee who is also the Chair of the ad hoc FDA subcommittee which had a number of members of our coordination subcommittee and other subcommittees on it.
These recommendations are really the product of that ad hoc subcommittee brought then to the coordination subcommittee which examined them and moved to place them before the full committee. I would therefore like to yield to Ms. Pattee and let her lead the discussion on these items.
SUZANNE PATTEE: Thank you Jack. The first item before us, we will go to Page - looks like it’s Page 9. And it is the carryover agenda from Minneapolis.
The first item refers to our discussion on the use of a patient toll free number for reporting of adverse events. And this is noted that it was part of a public law passed earlier this year. I don’t know that you can read it, so I’ll just move it forward for consideration by the committee.
DOUGLAS WOOD: Is there anyone who would like to remove this from the consent agenda? Do we have a motion that there is second?
JEFF BLOOM: Second.
DOUGLAS WOOD: The second by Mr. Bloom. Any other questions? Discussions? Are there any members who dissent? Hearing no members who dissent, this is adopted without dissent. Suzanne Pattee, proceed.
SUZANNE PATTEE: On Page 10 we have recommendation Number 30 which is regarding adopting safe labeling practices for all FDA regulated products. This recommendation addresses some of the discussion we heard in Minneapolis about concerns on labeling standards and presentation and definitions for labels. I move that this be considered by the committee.
DOUGLAS WOOD: Anyone who would like to remove this from the consent agenda? Is there a second?
LISA GIGLIOTTI: Second, Lisa G.
DOUGLAS WOOD: Thank you, Lisa. Any other questions or discussion? Are there any members who would dissent from the adoption of this motion? Hearing no dissent, it is adopted.
SUZANNE PATTEE: Number 31 - Number 31 and 32 both address the ability for FDA and CMS to coordinate when reviewing new technologies. These were addressing specifically new medical device technologies.
The first one is allows a memorandum of understanding to be developed between the two agencies that would safeguard confidentiality of trade secrets and data and would consult with stakeholders on that development of that (unintelligible).
The second one allows for the notification of CMS when an investigational device exemption has been granted to ensure that CMS can act timely. I move that these be considered by the committee.
DOUGLAS WOOD: Is there anyone who would like to withdraw this from consideration? Is there a second?
Patty Osborne Shafer: Second, Shafer.
MAN: I actually have a question. From the perspective of just doing business, if the FDA and CMS tried to work together to get a process that was more effective than what we have now, would that really require a memorandum of understanding or couldn’t they just do it in the course of the way they want to do their business?
SUZANNE PATTEE: This is Suzanne Pattee. Mr. Dollens and Patty Shafer, my understanding is that they can and are coordinating but there is concern about maintaining the confidentiality of the data. And that’s what the memorandum of understanding would address specifically.
MAN: Okay, so really the issue is more of the confidentiality of the trade secrets and the propriety data that manufacturers would submit as part of the FDA approval process, and making sure that we would be protected in the process of making (unintelligible) decisions?
SUZANNE PATTEE: Or they would continue to be protected as CMS reviews the same data.
MAN: Right.
RON DOLLENS: This is Ron Dollens. That’s exactly right. And I do think as we saw in the hearings that the FDA and CMS has started down a process of trying to make this process more efficient.
MAN: So things have already started, but this would strengthen the process that’s sort of underway.
RON DOLLENS: That’s exactly correct.
MAN: Okay. I always like to give credit to people who are already doing their work.
SUZANNE PATTEE: I move then that this be considered.
DOUGLAS WOOD: Is there any dissent? Who had the request for an amendment? Did somebody have a request for an amendment?
Patty Osborne Shafer: This is Patty Shafer. I seconded already, I thought.
DOUGLAS WOOD: We do have a second. Is there then any other discussion? Are there any members who dissent? Hearing none, it was adopted without dissent.
SUZANNE PATTEE: Number 33 goes to the safety in joint product naming and then…
DOUGLAS WOOD: Aren’t we on 32?
SUZANNE PATTEE: Oh, I’m sorry. I was hoping we did 32 as part of 31.
DOUGLAS WOOD: Okay, I missed it.
SUZANNE PATTEE: It was another block. Sorry about that.
DOUGLAS WOOD: Why don’t we move 32 then and make sure that we’ve got it official.
SUZANNE PATTEE: I move that 32 be adopted.
DOUGLAS WOOD: Okay. Does anybody want to remove it from the consent agenda? Is there a second?
Patty Osborne Shafer: Shafer, second.
DOUGLAS WOOD: Any other discussion? Anybody who dissents? Hearing none, it is adopted without dissent. Now we can go to 33.
SUZANNE PATTEE: My apologies. Number 33 encourages the FDA to work with the sponsors of new drug applications to follow protocols that would evaluate the potential for look-alike and sound-alike errors for generic and proprietary names and to do this prior to the approval of the name and the drug. And it would help to minimize post-marketing errors for name similarity and practitioner confusion. I move that this be considered by the committee.
DOUGLAS WOOD: Is there anyone who would like to remove this from the consent agenda? Is there a second?
JEFF BLOOM: Second.
DOUGLAS WOOD: Mr. Bloom. Is there any question or discussion? Are there any members who would dissent from the adoption of this motion? Hearing none, it is adopted without dissent. So, Suzanne Pattee, 34.
SUZANNE PATTEE: On the next page we have Number 34 and this complements the previous recommendation we adopted Number 29. This encourages the Secretary to encourage all relevant parties both industry, consumers, and pharmacy groups to issue educational materials to assist with the new toll-free number on adverse events. I move that this be considered by the committee.
DOUGLAS WOOD: Is there anyone who would like to remove it from the consent agenda? Is there a second?
KRISTIN CROSBY: Second, Crosby.
DOUGLAS WOOD: Thank you, Dr. Crosby. Any other discussion or question? Are there any members who dissent? Hearing no dissent, this is adopted. Number 35.
SUZANNE PATTEE: Number 35 is supplemental to Number 30 regarding safe labeling practices. Here we wanted to encourage the HHS to use new and appropriate administration and patient identification technologies to prevent medical errors. One example was in the background information with bar coding but we did not want to restrict this just to bar coding. I move that this be considered by the committee.
DOUGLAS WOOD: Is there anyone who would like to remove the item from the discussion - or from the consent agenda? Is there a second?
JEFF BLOOM: Second.
DOUGLAS WOOD: Mr. Bloom, thank you. Any other discussion or question? Is there any dissent? Hearing none, it is adopted without dissent. Suzanne Pattee, 36.
SUZANNE PATTEE: Number 36, 37, and 38 complement 31 and 32 because they are all on the coordination of FDA and CMS on medical device technology. Number 36 allows the Secretary, with input from affected stakeholders, to establish a process for FDA and CMS to work together, specifically during the design of clinical trials for medical devices as well as permitting parallel reviews for FDA and CMS of new technologies.
And this will prevent - will promote more patient access in a timely fashion for these therapies. And we also did not want to slow down the FDA approval process by having CMS provide early input to clinical trials. I move that this be considered by the committee.
DOUGLAS WOOD: You want to move 36, 37, and 38 all at once?
SUZANNE PATTEE: We could do that, but this was just 36.
DOUGLAS WOOD: They’re kind of linked actually. And they are - why don’t you take all three of them?
SUZANNE PATTEE: Okay, 37 encourages the Secretary to publicly announce and promote through outreach to stakeholders this new process for collaboration and to put forth relevant structures and time frames for the implementation of this regulation.
And Number 38 encourages - it has three parts. The first part would encourage CMS to issue guidance in consultation with stakeholders on the coverage standards that it would use for medical device technology. And we noted here that guidance is not legally binding.
The second part would recognize the importance of and support the maintenance of the local medical review process, support the timely issues of the health care payment codes as expeditiously as legally allowed, and pursue it to the committee recommendation Number 216 which addresses that. And it will limit - also eliminate the requirements that there be six months marketing data submitted to CMS after FDA approval and prior to the acceptance of this application for a payment code.
We felt that this possibly was slowing down the process. It also ensures the effectiveness and the efficiency of the national coverage decision process and permits CMS consideration of reliable data from outside sources for coverage and payment.
The third part directs CMS to establish and maintain and six-month time frame to issue national coverage decisions for new medical device technologies. And this would be if there’s no referral for a technology assessment or to Medicare coverage advisory committee. And this time frame will be 12 months if such a referral is required.
We also thought it was important that the Secretary address staffing and resources to enable CMS to achieve these time frames. I move that these three recommendations be adopted.
DOUGLAS WOOD: Is there anyone who would like to remove either 36, 37, or 38 from the consent agenda?
TONY FAY: Mr. Chairman, this is Tony Fay. I’d like to discuss further Item 38.
DOUGLAS WOOD: It will be removed from the consent agenda for discussion. This leaves us with Items Number 36 and 37. Is there anyone who would like to move these to discussion? Is there a second then for 36 and 37?
Patty Osborne Shafer: Shafer, second.
DOUGLAS WOOD: Okay, who was that - it was Kristen, right?
Patty Osborne Shafer: Patty Shafer.
DOUGLAS WOOD: Patty, okay thank you. Any other discussion? Is there anyone who would dissent from the adoption of Items Number 36 or 37? Hearing none, those are adopted. Suzanne Pattee, go ahead.
SUZANNE PATTEE: Now we move to Item Number 39 on Page 12. This item was mentioned, I think, in the Minnesota hearing. We wanted to encourage FDA to set up a timely process for review of combination products and to develop appropriate policies for this review. And either to do so by dedicated staff or establishing a new office.
I guess an example of a combination product would be something that would be a medical device that delivers a drug. And there is not a consistent way that the FDA is now handling this evidently. I move that this be considered by the committee.
DOUGLAS WOOD: Is there anyone who would like to move this to discussion? Is there a second?
DR. CROSBY: Second, Crosby.
MAN: Just a question. From the perspective of how these are being handled now, if we’re talking about a combination product, wouldn’t the drug to an extent be considered a combination product?
SUZANNE PATTEE: I believe that Mr. Dollens, or the staff, do you have a comment on that?
RON DOLLENS: It would. This is Ron Dollens.
MAN: Go ahead, Ron. So you think it would be considered a combination product?
RON DOLLENS: I do believe it would, yes.
MAN: Then are we having trouble with the current process from the perspective of how those are moving through approval?
RON DOLLENS: I think the agency is really trying to understand themselves how best to do that and biologicals would be in some of the same way. And it’s just not clear and it’s not clear, you know, which brands you’re going to deal with. And I think the agency’s made one direction in terms of drug (unintelligible) stints but I think as those concepts come forward there just needs to be some clarity.
DOUGLAS WOOD: Okay. Any other question or discussion? Are there any members who would dissent? Hearing none, this is adopted.
SUZANNE PATTEE: Number 40 encourages the FDA for - to request electronic submission of application - for the new drug applications but also all relevant further background information. I move that this be considered by the committee.
DOUGLAS WOOD: Is there anyone who would like to remove this from the consent agenda?
JEFF BLOOM: I have a question.
DOUGLAS WOOD: Proceed please.
JEFF BLOOM: I believe this is current law under FDAMA where the FDA encourages electronic submission of all applications including all relevant data. So, I mean, it’s not a problem restating it, but I believe it is current law.
DOUGLAS WOOD: But I mean it’s already happening.
JEFF BLOOM: Right.
DOUGLAS WOOD: And we’re starting the process.
JEFF BLOOM: Right, yeah. They get about 30% in electronics. Unfortunately, 70% still paper. But they’re hoping that will move, you know, forward.
DOUGLAS WOOD: Is there a time frame by which the expectation is that it will be completely electronic?
JEFF BLOOM: There really isn’t. The problem isn’t so much as the FDA as the companies, you know, to some extent. Depending on the company, they’d rather deliver truckloads of information because it makes it harder to evaluate things under the time frames of FDAMA. And (unintelligible). So unfortunately no, there’s not a good time frame for it.
DOUGLAS WOOD: So Jeff are you comfortable enough that this already underway that it should be removed?
JEFF BLOOM: It’s already - I’m comfortable enough that it’s underway. It certainly doesn’t - I think it wouldn’t hurt to reinforce that there should be a more aggressive effort to move in that direction. And, you know, perhaps one of the ways is rewarding companies for doing electronic submissions versus paper submissions.
DOUGLAS WOOD: Well, would the - okay. Very good. Is there any other concern about this one staying on the consent agenda? And is there anyone who would like to second?
RON DOLLENS: Ron Dollens, second.
DOUGLAS WOOD: Okay. Is there any dissent? Hearing none, it is adopted without dissent. Suzanne Pattee, Number 41?
SUZANNE PATTEE: Number 41 addresses the provision I believe in FDAMA for establishing a clinical trials database for drugs and biologics that would be accessible by the public while also protecting confidential information.
This provision requests that, using stakeholder input, the FDA add information about clinical trials for medical device technology to be included in this database. And also to make the implementation of this database for all products in priority. I move that this be considered by the committee.
DOUGLAS WOOD: Is there anyone who would like to remove it from the consent agenda? Is there a second?
Patty Osborne Shafer: Shafer, second.
MAN: Any other discussion? Is there any dissent? Hearing none, it is adopted.
SUZANNE PATTEE: Number 42 addresses the discussion we heard in Minnesota regarding Medwatch forms. And we are requesting here that the FDA develop separate forms for pharmaceutical products and a separate form for medical device products to allow for the submission of appropriate information on adverse events. I move that the committee consider this provision.
DOUGLAS WOOD: Is there anyone who would like to remove this from the consent agenda? Is there a second?
LISA GIGLIOTTI: Second, Lisa G.
DOUGLAS WOOD: Is there any other discussion? Is there anyone who would dissent? Hearing no dissent, this is adopted without dissent.
SUZANNE PATTEE: Number 43 and 44 are related. Number 43 encourages the Secretary to support government-wide efforts to simplify and harmonize requirements related to human subject research protection for patients participating in clinical trials while also maintaining strong protections for these patients in balancing the rights the patients have in the privacy of their medical information with the health benefit of the effective medical research.
The reason this is government-wide is that 17 different agencies have signed on to some form of what they call the Common Rule to address oversight for human subject research protections. So it’s not just an HHS initiative. So we wanted this to be done in a government-wide fashion. This also includes the NIH and the FDA who have separate regulations that they follow, similar to the Common Rule but not identical for the FDA.
The second one, Number 44, encourages the Secretary to support the work of the department’s working group for the department’s response for the final National Biologics Advisory Commission Report on the study of human research.
The National Biologics Advisory Commission issued a report last August to provide some recommendations on how to address and protect patients in human research studies. And it addressed problems for example with institutional review boards and concerns about these boards being overburdened.
The working - the FDA ad hoc subcommittee discussed these issues but did not feel comfortable going into any specific detail on further recommendations but wanted the Secretary to take these issues into - under consideration as priorities.
I also wanted to bring to the attention that the issue statement that dovetails into this recommendation is on Page 22 and later. And this issue statement was not reviewed or discussed by the ad hoc subcommittee and does not reflect any consensus or decisions by the subcommittee. So therefore, these were the extent of detail that we felt comfortable providing on these topics. We move that the committee consider these two recommendations.
DOUGLAS WOOD: So they also haven’t had discussion in your full subcommittee?
SUZANNE PATTEE: They were discussed and we did move them forward, but we did not feel comfortable going into specific details on how to actually reform the research and oversight protection process.
DOUGLAS WOOD: Okay. Is there anyone who would like to remove either 43 or 44 from the consent agenda? Is there a second?
MAN: Second.
DOUGLAS WOOD: Any other discussion? Is there anyone who dissents either from the adoption of Number 43 or 44? Hearing none, they will be adopted without dissent. Peggy has a comment.
PEGGY SPARR: There is one item that is on the - that is research related on the Chairman’s agenda that somehow has - did not get a unique identifier, but it is in the binder of all the committee members. And we’re going to assign that Item Number 68 to the item that is found at Tab 7, the Committee Chairman Report, Page 3.
DOUGLAS WOOD: We have very little time here before a scheduled break. Dr.Wildenthal, are you on the line?
KERN WILDENTHAL: I am, yes.
DOUGLAS WOOD: Can you briefly discuss this for the members of the committee?
KERN WILDENTHAL: Yes, I was asked at the Minneapolis meeting to ask around to the research community to see if there were any special recommendations we might make with regard to the functioning of HHS regulations specifically with regard to research.
I was not surprised but gratified that the overwhelming consensus of everybody I talked with was that the NIH regulations -- which is what most of us think about when we talk about research -- while not perfect were deemed to be quite good in comparison to some of the major problems we’ve been addressing for Medicare and so forth.
Two areas were mentioned on frequent basis needing attention. One of those we’ve already dealt with and that is the coordination between FDA and NIH. And I think those we’ve already dealt with.
But a new item did arise with surprising consistency having to do with how HHS regulates its enforcement of indirect cost negotiations with the various institutions. And the issue here is not Circular A21 which was issued by the Office of Management Budget some time ago and which may or may not be perfect, but it’s clear at least and straightforward and is a reasonable basis on which to arrive at the appropriate indirect cost rate.
The problem is that as administered through the Division Of Cost Allocation which is not an OMB agency, it’s an HHS agency, there is a distressing amount of rigmarole and non-compliance actually with the intent of the regulations with failure to apply really sound accounting principles.
And it becomes a gamesmanship between the agencies and the Division of Cost Allocation which wastes a lot of time and effort and really is not a maneuver or a process that any of us are satisfied with on either side of the negotiation.
And so the short document that I provided several weeks ago was just a summary of the problems and a proposal that we adopt a new method of dealing with Circular A21, not to change it but to have a true accounting mechanism with an appeals process that could put the indirect costs through recovery negotiation basis on a businesslike arrangement.
DOUGLAS WOOD: Dr. Wildenthal, I understand you have to leave at 2:00 Eastern Time?
KERN WILDENTHAL: Yes, if I can, yeah.
DOUGLAS WOOD: Now this actually is an item that we have not moved through the usual subcommittee structure but has come up late in Minneapolis. Let me ask the expression of the members. Having heard this, whether there’s additional information that you would like us to provide or if there’s an area that should be assigned to for further discussion or whether in fact people feel that there’s nothing we need to do about it now, or is there something different we ought to do? Any thoughts along - Erik?
ERIK OLSEN: Yeah, I’m not - I presumed that you were bringing up this new Item 68, so I wasn’t clear that was what was being discussed. I do have some comments on the new Item 68 but I don’t know what is being discussed.
DOUGLAS WOOD: We need to clarify there, Erik. This is actually not the new Item 68. This is a separate issue.
ERIK OLSEN: Thank you.
DOUGLAS WOOD: Are there any other thoughts? Our original thinking was that we would like to have the discussion then be prepared to talk about it perhaps in more detail in October. But that’s why I’m asking, is there any specific thoughts that people might have about what we need to get for you?
JEFF BLOOM: My question would be does HHS/CMS have the authority to do this now or would they have to go to Congress and get some waiver authority? There’s some of that very limited Medicare authority now.
DOUGLAS WOOD: That’s also - Jeff, we were also talking about the other item number. I’m sorry that I’ve got you confused there.
SUZANNE PATTEE: This is Suzanne Pattee. I’m wondering if - guess a change of Jeff’s question. Is it something that HHS can do? Also has HHS staff been consulted on the solution to this problem? In talking about…
DOUGLAS WOOD: No, there hasn’t been much discussion. I mean, the other consideration here, and we can think about especially in terms of our long term recommendations (unintelligible) the report, there are a number of items, as we come through the last couple of weeks here, where we will find out that there may be some areas of concern. But we have not had time to address them fully.
We have not had time to get the usual technical advice from CMS or from FDA. And we may have even in fact adopted a recommendation especially of the group that we’ve just done after Minneapolis where, in order to try to get finished, we haven’t had the time to get through full technical advice.
We might want to simply note in the report that there is a body of unfinished work and that this needs to go through a process of careful technical agency before it’s undertaken, which would be the case where it would be either CMS or FDA or Medicare, actually.
JACK ROVNER: Mr. Chairman?
DOUGLAS WOOD: Go ahead.
JACK ROVNER: This is Jack Rovner. I’d like to suggest in some (unintelligible) in my - in the coordination subcommittee and research areas have tended to come up through the coordination subcommittee, that having presented this as an issue you give the coordination subcommittee a chance, if it can be arranged, between now and October 1 to have a meeting and a briefing from appropriate staff.
And then we can present this as a recommendation if we have one for the meeting on October 1 and 2 or as a matter that needs further examination.
DOUGLAS WOOD: We’ll take that and pursue that because the staff actually is helping me considerably. George is here and Peggy and a couple of others. There is actually probably a process already in place with this. So we’ll take advantage of that.
We have come to the time where we need to take a break because of the national schedule we have to try to keep to a schedule fairly carefully. Let us take now about a 10-minute break with a reconvening at five minutes past the hour of 2:00 and we will finish then with the Regulatory Flexibility Subcommittee Report. And then we’ll come back to the discussion items that we have left.
KAREN UTTERBACK: Doug, this is Karen Utterback. Thank you very much for the opportunity to bring this up. And I think Jack’s suggestion is an excellent one. And I will have to absent myself and won’t be able to count toward the quorum at this point.
DOUGLAS WOOD: Thank you Karen Utterback.
KAREN UTTERBACK: Thank you very much. I look forward to seeing you soon.
DOUGLAS WOOD: So, ladies and gentlemen, we’ll have a 10-1/2 minute recess by my watch. Five minutes past the hour, I have four clocks I can pick from. It’s a wild card choice, but I’ll try to be reasonably accurate.
(break)