DR. WOOD: If you can all come back to the table, we'll begin. This is the last of a series of regional natural hearings that we have conducted around the country. And as we have made these trips to different parts of the United States, it has always been a piece of work that has been undertaken partly by our staff, but our staff has worked every time with the Medicare regional office in putting together the visits.
And we are this time just as happy to be helped along by the staff of the regional office. In this case the staff is actually not in Minneapolis, but they're in Chicago. Region 5 is a Chicago office, and I wanted to recognize the great work of the regional office in helping us put together this meeting and in particular Dorothy Collins and David Dupree, they were here earlier. You have to stand up and be recognized, David.
(Applause.)
DR. WOOD: And Dorothy probably is outside. But we're going to again thank you for your contribution on our behalf.
At this particular time, you know, when the Secretary was here yesterday he made a comment that he saw all of the FDA's best here, and he wondered who was back home doing the work, and a little bit about CMS, too. But we haven't actually heard directly from one of the other FDA people who is here and has helped us a lot in putting together these discussions about FDA issues, and Tom McGinnis has been extremely helpful in putting that together.
(Aapplause.)
DR. WOOD: No, you have stand up. Yeah. We have a new inside joke in this committee. It's last person standing at 9:00 o'clock. And, by the way, the award for last night goes to Dr.Nielsen.
DR. NIELSEN: More than one drink, too.
DR. WILDENTHAL: I know it wasn't me.
DR. WOOD: So you can all aspire to that award at the last meeting of the group. Let's go ahead with some consent agenda items and in order to try to get things accomplished in a fashion where we can keep most people here. Let's go next to communications so Dr.Olsen.
DR. OLSEN: Thank you, Mr. Chairman. I would start off by just announcing one thing, that Patty Schafer is unable to be with us today, and it's not a business conflict. It's a positive family activity, and so she's putting her priorities where they should be.
In that regard, I draw your attention, you have received this. It doesn't take action, but under the clarity of communication provider education, where there was a mistype in there, and that will be corrected in the subsequent papers, and Patty asked me to convey that.
I've also been asked, Mr. Chairman, by my good associate, Dr.Dennis, that since he has to leave shortly that we-- oh, excuse me. We are to refer now as we discussed the communications committee agenda the materials that you received yesterday. And on Page-- I want to skip, if I can, and Vella will get made at me for doing this, but, Gary, what page is this on? And Gary wants to--
DR. DENNIS: Page 8.
DR. OLSEN: Page 8. It's on EMTALA. Dr.Dennis has to leave. And-- no, it's not Page8. Page 6. Page 6. And it's for the consent agenda, but I want to draw your attention to it.
DR. DENNIS: It was the old Page 8. It's the new Page 6. If you're looking in the notebook, it's on Page 8.
DR. OLSEN: It's not the document in your notebook. It's the one that was passed out yesterday,
MS. SPARR: For those of you if you have the notebook, it's on Page 8. There was no change. And if you have the newer document, it's on Page 6.
DR. OLSEN: And it's on the board, and I move it, and we have Gary here to discuss it if anybody wants to.
DR. WOOD: Is there a second?
VOICE: Second.
DR. WOOD: All those in favor, aye.
(Ayes.)
DR. WOOD: Any opposed, no? Actually before we do that, does anybody want to take it off the consent agenda to be particularly precise?
(None.)
DR. WOOD: If no one wishes it, I will consider the previous vote binding. It is adopted. Please proceed.
DR. OLSEN: Mr. Chairman, we have some hold-over issues and on the-- is this-- I think I'm supposed to go to this from yesterday. It's on Page 2 of the new, and it has to do with beneficiary education. Miss Shafer is not here.
The number, the one which we have some new wording on No. 13, I will read that to you. I think people wanted it more specific. And the wording would read, "To continually evaluate and improve education and communication strategies to ensure that beneficiaries find materials easy to access and understand so they can make informed decisions about their rights, options and obligations."
And, Mr. Chairman, I move that for No.13.
VOICE: Would you repeat that?
DR. OLSEN: Yes. "Continually evaluate and improve education and communication strategies to ensure that beneficiaries find materials easy to access and understand so they can make informed decisions about their rights, options and obligations."
(Applause.)
MS. SASTRY: I have, "To continually evaluate and improve education and communication strategies to ensure that the beneficiaries find materials easy to access and understand so that they can make informed decisions about their rights and obligations."
DR. OLSEN: Rights, options and obligations. And you are terrific.
DR. WOOD: Being consistent with what public comments were suggested this morning. So is there a second?
VOICE: Second.
DR. WOOD: Does anybody wish this for -- actually this is for Carol from yesterday, so we don't need to worry about that. All who are in favor, aye?
(Ayes.)
DR. WOOD: Any opposed?
(None.)
DR. WOOD: It is adopted. Continue.
DR. OLSEN: Now, Mr. Chairman, it's on that same page, No. 4. And that was held over because it actually was going to be part of a--
DR. WOOD: Mr.Bloom has a larger proposal.
MR. OLSEN: Mr.Bloom has a larger proposal, so I would recommend we just slide over that at this point, and we refer to his-- or how do you want to handle that?
DR. WOOD: Actually, this morning we said we could adopt this, and we could reconcile it later. If you want to do that, that would be perfectly reasonable.
DR. DENNIS: Second.
DR. WOOD: Okay. All those in favor, aye?
(Ayes.)
DR. WOOD: Opposed?
(None.)
DR. WOOD: Okay. And then what we'll do is we'll reconcile with the larger proposal.
DR. OLSEN: And essentially No. 7 involves the same type of thing.
MR. BLOOM: Ours was already adopted on that.
DR. WOOD: Yes, so we'll consider this --
MR. OLSEN: Was that on the consent agenda?
MR. BLOOM: Yes.
MR. OLSEN: Okay. Then it will just be incorporated.
DR. WOOD: If you would like to move it for adoption, we would incorporate.
MR. OLSEN: Yes, we would.
DR. WOOD: All those in favor, aye?
(Ayes.)
DR. WOOD: Any opposed?
(None.)
DR. WOOD: Okay. Then we'll reconcile. Okay.
HON. MARTIN: Mr. Chairman?
DR. WOOD: Yes, go ahead, Steve.
HON. MARTIN: Any concerns that might still exist if we take them up the one in a little while and even though it may be different when we address it in a little while, they can be reconciled with each other at that point, correct?
DR. WOOD: Yeah, we should be able to reconcile there.
HON. MARTIN: For example, I think Miss Evink just raised an issue that the language here says that you're providing reimbursement to the community agencies, but it doesn't say anything about the alternate reimbursement to the provider. And so--
VOICE: It will be reconciled.
HON. MARTIN: Okay.
DR. WOOD: The other problem, unfortunately, is for the agency to figure out whether they can afford that, so it becomes another interesting problem. Okay. Continue, Dr.Olsen.
DR. OLSEN: Thank you, Mr. Chairman. The next item is on Page 4 of the new set-up. Now, I'm going to turn it over in a minute to Dr.Nielsen who will cover these. However, by a mistake, No. 19, 20, 21 and 22, which have to do with rural activities, were not included in the original, so I guess those need to go to discussion, so since they were not -- and Peggy is raising her hand.
MS. SPARR: They were in the materials that were provided in the communications report. It was just a mistake. It didn't make it in the extracted list, so you did all have that information prior to.
DR. OLSEN: So what's my instruction? I would like to move the entire slate for consent agenda and let Dr.Nielsen explain it. That's what I would like to do.
VOICE: Second.
DR. WOOD: So we have a motion for the second, and then I'll recognize Dr.Nielsen for explanation.
DR. NIELSEN: Mr.Chair, I don't feel compelled to explain what I think is pretty self-evident. I'll be happy to answer questions.
MS. EVINK: Could you bring 19 up, please, so that we can read those?
DR. NIELSEN: You should have it on what you got yesterday.
MS. EVINK: But I don't have that piece of paper.
DR. WOOD: So let's ask if there are any members who would like to withdraw or to-- I shouldn't say withdraw. Are there members who would like to move any of the items on this consent agenda to discussion status? Jeff?
MR. BLOOM: Just a point of information. I thought from previous testimony that firstly it is already supposed to be doing this, so are we just reinforcing that they're supposed to be providing assistance to rural communities? Is that the system?
DR. WOOD: No, in fact I don't think hers says providing assistance to rural communities. If you go on the basis of testimony, they have all these programs; but there really isn't any direct support of the rural, so our concern was how could we-- do you remember in Pittsburgh we talked about the concept of actually getting even an account service representative, if you will?
MR. BLOOM: I thought someone said that they were supposed to-- maybe they don't exist but they're supposed to help them with grant writing and things like that. So I have no problem with this. I was just trying to be clear.
DR. WOOD: I appreciate the comment, actually, and this will probably help us get them going.
MR. BLOOM: Sounds good.
DR. WOOD: Are there any ones that we want to remove from this consent agenda for discussion? Peggy?
MS. SPARR: Item 12 was moved to the discussion agenda. It wasn't listed in here, but it was.
DR. WOOD: Okay. Item 12 is the discussion. Any others? Okay. Then that would leave us with Items 1 through 18 under Roman Numeral 1 with the exception of 12. And then with the new ones we had, which are 19 through 22, they were in your briefing document, but they were not on the original consent agenda. We'll incorporate those in the motion for approval. So we have a motion with a second. And the only item moving to discussion is No. 12. All those in favor, aye?
(Ayes.)
DR. WOOD: Any opposed?
(None.)
DR. WOOD: Those are adopted. Dr.Olsen, proceed.
DR. OLSEN: Mr. Chairman, the next subject is of the Roman Numeral 2, I guess, advanced beneficiary notices. I would move to the consent agenda Nos. 1, 2, 3, 4, 5, 6, 7 and 8. And you will note that later on there is another ABM one that is on the discussion agenda, so I move Nos. 1 through 8 to the consent agenda.
DR. WOOD: Would you clarify that? They are on the consent agenda.
DR. OLSEN: Excuse me. I move they be adopted. Sorry.
DR. WOOD: Okay. I just wanted to make sure. Well, we have a second then, but let me ask then are there any of these that we should move to discussion? Was there any of these items? Seeing none, all those who are in favor, aye?
(Ayes.)
DR. WOOD: Any opposed?
(None.)
DR. WOOD: Those are adopted. Proceed.
DR. OLSEN: The next item, EMTALA, we already did. So Item 4 is the CLIA, laboratory improvement amendments, recommendations. And I, again I have my expert here if we have questions; but Nos. 1 through 14 are on the agenda for consent, so I so move.
DR. DENNIS: Second.
DR. WOOD: Are there members who would wish to move any of these items to discussion?
MS. PATTEE: No. 2, Item No. 2. I would like to move Item No. 2 to the discussion agenda.
DR. WOOD: 2? Others? Okay. Then our motion would be that under Roman Numeral 4 with the exception of Item No. 2, which would go to discussion, all those -- move for approval with a second, all those in favor, aye?
(Eyes.
DR. WOOD: Any opposed?
(None.)
DR. WOOD: Those are adopted.
DR. NIELSEN: With the notation that the title "amendments" has only one M.
DR. WOOD: Actually only two, to be precise.
DR. NIELSEN: You know what I mean.
DR. WOOD: Only a compulsive electro- physiologist. Dr.Olsen, proceed.
DR. OLSEN: Thank you. Item No. 5 is collegeality and communications with providers. And we have Items 1 through 6 that we have recommended to be on the consent agenda, so I move their adoption.
DR. NIELSEN: Second.
DR. WOOD: Are there any of these six that members of the committee would like to move to discussion? Okay. There is a motion for approval with a second. All those in favor, aye.
(Ayes.)
DR. WOOD: Any opposed?
(None.)
DR. WOOD: They are adopted. And so that brings us to Part B, beneficiary enrollment. Correct?
DR. OLSEN: Yes, it does, Mr. Chairman. A very brief preliminary comment on that. That was an issue that seems to be getting resolved by the fact that the 800 number now is on the card, and the card goes right next to the enrollment. And, therefore, the person does have a number to call right away when they get 65 years old.
But it's still we have a couple recommendations in here to, you know, evaluate the impact of the new materials and then be sure that it's better that they call the 1-800 Medicare number than the Social Security number which is in the letter. So even though essentially the committee felt that the situation is being addressed, we thought these two recommendations were in order. And we have them on the consent agenda, and I so move those.
DR. NIELSEN: Second.
MR. FAY: Clarification. It's Items 1 and2?
DR. WOOD: Yes. So we have a motion and a second for Items 1 and 2. Do any of you wish to move either one of these items to a discussion? I think there may be a little reconciliation here, too, based on the one we just did personally. But we'll work on that with reconciliation later.
But we did say we were going to continuously work to improve all materials. We're making sure that beneficiaries would be able to exercise all their rights, options and obligations, which I think basically covers this from my perspective.
DR. NIELSEN: Pass it.
DR. WOOD: Am I wrong? Okay. We'll reconcile it later. So there is a motion with a second. All those in favor, aye?
(Ayes.)
DR. WOOD: Any opposed?
(None.)
DR. WOOD: We'll reconcile it. We cannot be-- we have a fundamental problem here. We cannot be about regulatory simplification if we can't make our work as simple as it can be, so--
DR. OLSEN: Mr. Chairman, I don't know if the next item here was moved to discussion. And is that what we're doing on our agenda now?
DR. WOOD: We're doing our consent first. So if we go hold that item, then we'll move to the others and come back to it.
DR. OLSEN: This finishes my report for now then.
DR. WOOD: All right. So in terms of next consent agenda, Mr.Fay.
MR. FAY: Thank you, Mr. Chairman. Our consent agenda is in the binder, Roman Numeral 5, Tab A. In addition, I will be-- point of clarification. We voted on the multiple review consent agenda items earlier, so I won't have to do that on this go-around.
DR. WOOD: We'll reconcile them, actually. I think it would be appropriate to go ahead and just incorporate them, and then we'll reconcile them.
MR. FAY: Roman Numeral 1, the first set of recommendations deal with the HIPAA standard transaction codes with a baseline recommendation to improve the current transaction codes for drugs, which is the J coding system, to make them more representative of the type of drug, the dosage, the method of administration, etcetera, and in the long term adopt a coding system that is very specific to the type of drug used.
MR. ROVNER: Mr. Chairman, as a point of information for the committee on this, on May 31st HHS issued a notice of proposed rule making to amend the transaction rules to rescind the NDC code set, national drug codes, which have been set as the standard codes for coding drugs and standard transactions.
They are also not issuing under this new notice of proposed rule making any drug codes, so they would not issue-- would not adopt the J codes which are part of HICPICS, nor would they adopt the NDC, so there would be no actual standard codes for the standard transactions which will go into effect either this October or October of 2003, depending on if you follow the compliance plan.
And I thought I should point that out in case any of the committee members are not aware of that. I think that merits why these particular proposals are worthy of our committee for adoption, because a lack of any coding at all creates problems, perhaps even worse than having to convert to the national drug codes for institutions. But somewhere along the line somebody has got to bite the bullet and figure out what the codes at to be, and I turn it back to Tony.
MR. FAY: Thank you, Mr.Rovner, for making that clarification. We were, as a subcommittee, aware of the final rule issue pursuant to the standard transaction codes, and we decided, anyway, to proceed with this recommendation. And we took several situations under consideration, including patient safety, potential national initiative for computerized drug order entry and also the potential that Medicare may likely have a prescription drug benefit within the next few years.
DR. WOOD: So we have a motion for Roman Numeral 1, Items 1 through 2. Is there a second?
DR. NIELSEN: Second.
DR. WOOD: Does anyone wish to remove any of these items from the consent agenda before we vote and move them to discussion? All those in favor, aye?
(Ayes.)
DR. WOOD: Any opposed?
(None.)
DR. WOOD: They are adopted. Mr. Fay, proceed.
MR. FAY: Roman Numeral No. 2 falls under the category of multiple reviews. And it basically follows the recommendation made in a GAO report concerning CMS or recommending that CMS not establish its own separate review program distinct from the state efforts to ensure the accuracy of MDS data for payment purposes. I believe the GAO report was published in February.
HON. MARTIN: Mr. Chairman, question?
DR. WOOD: Steve, go ahead.
HON. MARTIN: Does the subcommittee intend an effective distinction between the use of the phrase "in the near term" versus "in the short term"? Because it appears-- it goes back and forth through the document.
MR. FAY: Near term is defined by this subcommittee as being a longer time frame than short term. It could also be known as intermediate term.
MS. EVINK: I think we were considering short term immediate.
MR. FAY: That's correct. Short term would be immediate. Near term would be intermediate.
HON. MARTIN: Okay. Thank you.
MR. FAY: Mr. Chairman, I move to adopt.
DR. NIELSEN: Second.
DR. WOOD: Which ones are you moving adoption?
MR. FAY: 1A and 1B.
DR. WOOD: Okay. So these are the Roman Numeral 2, Items 1A and 1B. So there is a motion for adoption. Is there a second?
MS. RYAN: Second.
DR. WOOD: Are there any of you or is there any one of you who would like to remove any one of these to the discussion agenda? All in favor, aye?
(Ayes.)
DR. WOOD: Any opposed?
(None.)
DR. WOOD: They're adopted. Roman Numeral 3.
MR. FAY: Mr. Chairman, our third recommendation is to recommend that CMS establish a customer satisfaction survey process to be conducted by an organization independent of CMS and its contractors. This process would perform periodic, i.e. quarterly or semi-annual reviews, along with a continuous customer feedback process.
We also recommended this customer survey process include beneficiaries, physicians, providers and suppliers. And we further recommend that the results of the customer survey process be made public and also be included in the contractor performance evaluation criteria.
MS. RYAN: (Inaudible).
MR. FAY: Thank you, Miss Ryan. I would also point your attention to an edit that we made that is on the screen that is not on your book. These results would be used in establishing the bidding schedule and be a major consideration in contract awards.
DR. WOOD: Heidi?
MS. MARGULIS: I have a question for the committee. Is it the intent here to include the customer satisfaction survey results as a performance indicator or a performance standard for contractors? Is that the intent? Similarly, I would offer that the office of personal management through federal employees health benefits program does something similar.
MR. FAY: It is our intent that these customer satisfaction surveys would be a performance measure.
MS. PATTEE: Point of clarification, Mr.Chairman. I just wanted to ask for the meaning of the new sentence and particularly the bidding schedules. I don't understand.
MR. FAY: Mr.Hefty, would you take that question?
MR. HEFTY: This is simply to raise the importance of the customer satisfaction scores in terms of rebidding contracts as well as the contractor evaluation process for new contract awards. So it's when contractors rebid their own work, as well as bid on new work.
MS. PATTEE: And why should that be affecting the bidding schedule? Shouldn't be that on a regular basis or something?
MR. HEFTY: I'll defer to CMS. There is not currently a regular bidding schedule, and in the pending legislation there will be a limit on how long contracts can go without being rebid. And this would say contractors with low performance scores, low customer satisfaction scores are rebid more frequently than contractors who do well.
DR. WOOD: Does that clarify for everyone? Heidi, did you get clarification?
MS. MARGULIS: Perhaps it could be indicated within the provision that it is intended as a performance standard. That's different than publishing it, I believe.
DR. WOOD: Peggy?
MS. SPARR: Just so you're aware, on the provider communications thing there is something about performance standards for customer service and customer satisfaction. That's Item 15 that addresses that particular--
MS. MARGULIS: But I believe this has to do with contractors, and this person would prefer that it be within this provision.
MR. FAY: I believe if you read the attached issue statement, and this particular recommendation is really directed at carriers and intermediaries and was not meant to be a recommendation for M+C plans.
MS. MARGULIS: I want referring to M+C plans. I was in terms of it -- I should have said carriers and intermediaries, rather than contractors. I also believe it should be true for us, but that's another issue for another day.
DR. WOOD: So the question is asked? Mr.Rovner and Mr. Finan.
MR. ROVNER: Another clarification. By customer, since we're talking about intermediaries here, what universe are you referring to?
MR. FAY: Customers of intermediaries in our subcommittee's opinion would be the beneficiaries serve by the parday intermediary as well as the providers as served by the parday intermediary.
MR. SCULLY: So that would include hospitals?
MR. FAY: Hospitals and skilled nursing facilities, home health agencies, rural health clinics?
DR. WOOD: So actually physicians are already in. It's just this large word "providers," so that would mean hospitals. Okay. Mr.Finan?
MR. FINAN: Mr.Chairman, I'm not an electrophysiologist, but I have many friends who are. And the second one I think come after semi-annual.
DR. WOOD: Correct.
MR. FAY: Correct.
DR. WOOD: Are there any other questions regarding intent? So we have a motion. Is there a second?
VOICE: Second.
DR. WOOD: These would be Items 1 and 2 under Roman Numeral 3. Is there anyone who would wish to move either of the items to a discussion agenda? All those in favor, aye?
(Ayes.)
DR. WOOD: Any opposed, no?
(None.)
DR. WOOD: They are adopted. Roman Numeral 4.
MR. FAY: Mr. Chairman, our final set of recommendations concerns rural communities, specifically rural providers, but also note that it is directed towards health care delivery in the rural area. For rural providers a subcommittee now presents ten recommendations addressing issues unique to rural providers.
Our subcommittee hopes to present more recommendations at the Washington committee meeting. The recommendations presented today are aimed at reducing the burden of rural providers with respect to issues that are readily manageable by larger urban providers but are difficult if not impossible to manage by rural providers.
One example of this is the requirement that rural hospitals bill for CRNA services under Part B instead of Part A. Allowing Part A billing of these hospital-based services would eliminate the need to issue a separate bill for each surgery and obtain provider numbers for temporary CRNA employees.
In addition to this recommendation, we have nine other recommendations that include issues such as a proposed pilot for a single survey for critical access hospitals. Recommendations address, targeted towards addressing the work force shortage issues in the rural area, as well as issues addressing certain categories of wage index reclassifications for rural hospitals. Those are set forth on Pages 6 and 7 under Roman Numeral 4.
We have I believe moved two items to the discussion agenda already. I've been clarified. At present there are no items on the discussion agenda. So moved to adopt.
DR. WOOD: There is a motion and a second. Now, let me ask which of these items would be moved to the discussion agenda at the discretion of any of the committee members? Dr.Olsen?
DR. OLSEN: I just want a clarification, none of the numbers, but it's the one in the single survey that you aren't-- and we've discussed this earlier on the agenda. You're not eliminating surprise inspection of skilled nursing facilities where it's appropriate. I think we've discussed that before, and I want to be sure that that's-- what?
MS. SPARR: That's for the M+C?
DR. OLSEN: Yeah.
DR. WOOD: This one the way it's worded now, if I'm looking at the same one you're concerned about, which is No. 8, would be in the long-term result-- I think this is the one. The results of a single survey process for critical access hospitals would guide CMS in making a decision about a single survey process for other providers of rural services. Isn't that what we're trying to get across here?
So really it follows No. 7 which says we're going to do is pilot project of a single survey methodology, and then see how we do with that. It doesn't really address any of the other existing inspections of the inspectors, which are the ones of the unannounced variety. Judith?
MS. RYAN: Perhaps in putting this together as one report and in consolidating it, we could simply use that same language that we used that it would not affect those periodic or unannounced surveys of these facilities.
DR. WOOD: In our final report we should probably should make that 8 follows 7 more precisely, saying we're going to try to learn from what we do in the first one.
DR. OLSEN: Mr. Chairman, I'm satisfied that our discussion clarified that.
DR. WOOD: Very well. There is a motion with a second. Let me ask then if there are any of these that should be again removed to a discussion agenda?
MR. FAY: Point of clarification, Mr.Chairman. There was a small wording change in Item No. 9. We had understood that the HERSA office of rural health policy or the national advisory committee on rural health actually reported to the HERSA office of rural health policy. It indeed reports directly to the Secretary. And we have made that notational change on the master copy on the screen.
DR. WOOD: Okay. Does everybody see that change? All those in favor of the consent agenda item under this Roman Numeral, aye?
(Ayes.)
DR. WOOD: Any opposed?
(None.)
DR. WOOD: Roman Numeral 4 is adopted.
MR. FAY: Mr. Chairman, that concludes the work of the data and information subcommittee.
DR. WOOD: Regulatory flexibility. Miss Margulis.
MS. MARGULIS: Mr. Chairman, I yield my time. I do not believe there are any issues on the consent agenda form. My subcommittee noting that yesterday this subcommittee chair probably cheated by having the provider solvency issue placed yesterday.
DR. WOOD: Well, you're the flexibility subcommittee, so it's a little hard for us to be rigid. Let us return now to discussion agendas. And let's go back then to coordination. Mr.Rovner.
MR. ROVNER: Thank you, Mr. Chairman. We have for our discussion agenda two items on the HIPAA transaction rules, and I would not propose to bring either of them up, although I'll entertain any questions.
On Item 2, which is automated standards and cost code setup dates, we have actually asked staff of HHS to get us more information on in fact what does HHS interpret this or the rules to actually mean with respect to this. So I would propose to defer this until we get a report back, and Item 3 is really more of a point of information than something that I think that we need to discuss. So with that unless there are any questions by committee members, I would like to yield to my colleague on the coordination subcommittee, MissGigliotti, to take up the federal/state cor -- there is a question. Yes, MissRyan?
MS. RYAN: I would just urge that we not simply drop pursuits of No. 3, that we look for technical advice on where that is as well.
MR. ROVNER: I would then ask Peggy if she will ask our contact at HHS to get back to us on at least a report on what the status is of developing code sets for basically non-institutional-- or I should say non-acute care providers because my understanding is they still don't have any.
MS. SPARR: Okay.
MR. ROVNER: With that, I will ask MissGigliotti. But if I may for a moment, I would like to mention that we are deeply indebted to our two HHS staff members, Karen Palmer and Carolyn Washburn, who have probably burned more paper and midnight oil than anyone to help us get all this stuff out, prepared and to you all. So we thank them. And, Lisa, it's all yours.
MS. GIGLIOTTI: Thank you very much. In order to expedite matters, several, two of the issues that were moved to discussion item we've met over lunch and developed some language and would like to present that. And we take them out of order, but I think it will speed matters quite a bit.
The first one I would like to bring up is 16E, and in the status column was listed as moved to statutory section, moved it to the discussion agenda. The language that existed there is a statutory change. And I'm going to defer to some committee members. They had excellent suggestions on a short-term fix. We have submitted the language to Carolyn and Bela and wonder if it's available on screen. In the meantime while they're finding that, did you want to address a short-term fix or Kirstin, would you?
DR. CROSBY: I don't have it written down.
MS. GIGLIOTTI: Okay. I'll just describe what we're going to do here. The short-term fix would be instead of the statutory change, just having fiscal intermediaries and carriers apply this in a more-- apply the definition of terminal illness in the six-month kind of constraint in a more common sense way.
For instance, if, you know, it's so hard to prognosticate when somebody will pass; but if we could just have a little bit of understanding that this is an expected or an average expectation of life. So that if somebody is still alive at six months and one day, you know, it's not an automatic trigger for a huge local medical review. We're on Page 7.
So the language that we drafted is being typed in as we speak. Fiscal intermediaries and carriers should apply the definition of terminal illness in a common sense manner, recognizing that the six months language is an expected average only. A person certified as expected to die within six months may survive longer, but continue to be terminally ill and in need of hospice. Question?
MR. UTTERBACK: This language was actually changed to include-- and I can't quote it, but the implication of normal life expectancy, so that I guess I would suggest that this has already been addressed. And there may be some state issues in terms of state licensure that haven't followed along to adopt the federal change. But I'm wondering whether it needs to be present since it has recently been addressed from a federal perspective?
DR. WOOD: Yeah, this is what -- and we were just talking about this. The provision is in BIPA, so what we can do with this one-- I mean there is a couple different ways we can handle it. We could defer it for technical advice and get it clarified, in which case if it's clear that it solves a problem, then we're done. Or we could in fact pass it but then reconcile it on the basis of what staff comes back to us with. Karen, go ahead.
MR. UTTERBACK: I think there is a fairly large issue that still surrounds the perception or the matter of education, and whether that be with consumers themselves or be with physician groups. So maybe it could be recouched to address the educational side of it, rather than the regulatory language.
DR. WOOD: Heidi?
MS. MARGULIS: Thank you, Mr. Chairman. Additionally -- and I would turn to the physicians on the panel -- my concern would be is this understood by any oversight agencies who would come to interpret what these terms mean? And so I think something in a revised statement needs to ensure that oversight agencies take into consideration the same intent as we are intending at this point. That doesn't make sense, but just so that people don't get shot for something that--
DR. WOOD: Go ahead.
MS. MARGULIS: Shot for something that they did under the knowledge that it was promulgated to allow them to do that.
DR. WOOD: MissNielsen?
DR. NIELSEN: Well, I'm not sure how you would phrase it. I would like to pass it or at least recraft it and pass it because we need to emphasize this. We heard testimony here. We heard testimony at one of the hearings about this. So even if something has already been done, people don't know it. So whether one should add language at the end saying this common sense approach should be widely publicized to all interested stakeholders, or something along those lines.
MR. UTTERBACK: I think there is still the risk that Heidi brought up, oversight. That because of the conflict that is likely to continue or still exist between federal and state-level licensure issues that there may need to be encouragement that states evaluate their minimum standards to bring them in line with the language that was adopted federally so that as the surveyors who are conducting both the licensure survey and the certification survey don't have their own conflict to deal with.
DR. WOOD: It sounds like to me like what we're going to need to do here is to incorporate some stronger language that is more prescriptive about the training of state surveyors and care or medical directors in terms of the enforcement of the provisions of BIPA. So if I might suggest that we actually defer this to refine it.
MS. GIGLIOTTI: Mr.Chair, when you're saying defer, does that mean we're going to adopt it and work on it later? And what happens when it gets deferred? Is there a possible of losing it before August?
DR. WOOD: No. We'll incorporate it on our last meeting, but we should get it tidied up. Okay. Proceed.
MS. MARGULIS: Thank you. Moving on to Issue No. 2, Page 8, Miss Utterback was kind enough to provide us with a much more concise and clear language, and I don't -- is that up on the screen?
DR. WOOD: Karen, you want to make any comments?
MR. UTTERBACK: I was just going back to I had a document that includes how many states require licensure at the state level for hospice programs. And if I counted right quickly, there are 39, so there is a high probability that you've got conflict between the local minimum standards, the state minimum standards and the federal language.
MR. FINAN: Karen, can I ask a question? In 22B what would the hospice professionals recommend as the frequency of the local medical reviews?
MR. UTTERBACK: Bela is actually putting some language up there. From the testimony that we've heard and my experience, what was trying to be communicated was that it ought to be the focus of the medical review process to be identifying and evaluating those patients who have been on service more than six months or more than their life expectancy had been projected to be. So we reworded this to imply that those would be the cases, if you will, that would be likely selected for review.
And then we also heard quite a bit of discussion about local medical review policies and how those were being used through the medical review process in a very critical manner. And so we attempted to create some language that advised that those local medical review policies would be used to provide guidance, that they would not be approached in a way that if there are 16 criteria that if all 16 aren't met that it is automatically denied. So I'm waiting to see how she gets that up there, but that was the context in which we tried to make the changes.
MS. GIGLIOTTI: On 22A, local medical review process, if you could change the word "process" to "policies," please, to reflect what MissUtterback just stated. And with those changes, I move to adopt 22A and B.
DR. WOOD: For 22A, the word "hits" should be stricken and replaced with probably the--
VOICE: The.
DR. WOOD: Right. "The," exactly. I guess for clarification, in 22B we talked about non-cancer diagnosis only. But it seemed to me that what we were trying to accomplish was to say that in the circumstance where we weren't smart enough to figure out that death would occur within the six-month time frame, we wanted to make it so that we were not penalizing hospice providers, physicians or the families of beneficiaries by our failure to exactly predict the time of a patient's death. So I'm not sure that we would be specifically limiting this to non-cancer-related diagnoses.
MR. UTTERBACK: The local medical review policies speak only to non-cancer diagnoses of hospice patients.
DR. WOOD: Is that true everywhere?
MR. UTTERBACK: Yes.
DR. WOOD: Some of the testimony we had suggested that it wasn't. That's why I was asking.
MS. UTTERBACK: The only local medical review policies that I am familiar with with hospice pertain to non-cancer diagnoses.
DR. WOOD: Did we check the web site, the LRMP web site for all states' policies?
MR. UTTERBACK: Anecdotally, we certainly -- you know, I've heard in New York that they have reviewed cases that had a cancer diagnosis where they did, where the life span exceeded that, so--
DR. WOOD: That was the testimony we had in Colorado, actually, where they said that it in fact occurred, so--
MR. UTTERBACK: We have two issues occurring here. The first is one of how frequently medical review should occur. And medical review is general, and it applies to the entire hospice population. So I was going to suggest that "A" goes away and that both issues are addressed as a medical review process. Identifying those patients that are on service greater than six months, which is believed in theory to be the average life expectancy of a hospice patient.
And then additionally those cases that are selected for review that are of a non-cancer diagnosis status would be reviewed using the local medical review policies as guidance only and not as a 1, 2, 3, 4 checklist kind of criteria for coverage.
DR. WOOD: Now, I'm thinking about this from the perspective of the carrier. The local medical review policy is the agreed-upon method by which I will make a payment. So if I'm only supposed to use them for guidance, why would I use them at all?
MS. GIGLIOTTI: It's not just a payment but also for certification that they can continue to be in the program?
DR. WOOD: Well, they can continue to be in the program if they want to pay for it out of their pocket, but if I'm going to pay for it as a carrier and you're telling me I'm only going to use this LRMP as guidance, that would put me in a rather difficult position. If our concern actually is that the LRMP is being applied inappropriately, we should just eliminate it.
MS. GIGLIOTTI: Just eliminate what?
DR. WOOD: Just eliminate all the language related to local medical review policies and say that determinations of medical necessity would then be based on a case-by-case evaluation, something of that sort. We're having some trouble with this. Should we defer to tidy this one?
DR. NIELSEN: Yes.
DR. WOOD: Okay. We'll defer this one, too. Leslie just offered some technical advice, so call her.
MS. NORWALK: I mean I think the six months is also an issue because, A, I think statutorily it's the six-month issue. Secondarily you have to worry about I think part of the issue is fraud, that the doctor perhaps should have used the crystal ball to determine how long the patient would live. And I think at least in some areas of the country the concern is whether or not providers are taking advantage of the fact that you don't have a crystal ball. I'm sure most providers are well intentioned, so--
MR. UTTERBACK: And I would agree with that, and I think the local medical review policies have largely been established with regard to the non-cancer related diagnoses because they are more difficult to predict, and physicians and the hospice community was looking for some structure by which a comfort level could be established in admitting and caring for those patients. So to strike them completely is probably not a direction the hospice community would want to go, either.
DR. WOOD: So I think we need to go back and work on it. The circumstances are the testimony indicates that the medium hospice stay is eight days. Well, I mean.
VOICE: (Inaudible).
DR. WOOD: Right. I mean it's only eight days. What's it worth? But we clearly need to work on that a little bit. Dr.Crosby?
DR. CROSBY: It strikes me that there is a little confusion. We actually are addressing two issues. There is local medical review policy used to determine whether Medicare will pay for the hospice care. And then Miss Utterback is alluding to the fact that there is also state certification review of how quickly or how slowly your hospice patients die that relates to whether or not you meet state criteria for licensure. I'm confused.
MR. UTTERBACK: No, the state survey process both for certification and licensure is not going to be doing any medical review processes. That came up as Heidi was reflecting on there could be conflict. For example, if the physician certification was for patients that -- you know, the language in the state minimum standards reflected a more absolute adherence to a six-month expected life span, they may cite the agency in a survey process, even though the federal standard would be more lenient and contain language that talked about in a normal span of that patient's illness.
So there is two different topics. One is survey and certification processes, and another is medical review. This language was dealing with the medical review process.
DR. WOOD: Yes?
MS. RYAN: It seems like so much of our discussion is focused on the payment process and on the regulatory fear, and I know that there is concern about fraud and abuse from the regulatory side. But I would observe clinically that the fear on the part of the physician and staff is so great that the problem is on the other end. And we aren't getting people into hospice care when they need it.
DR. WOOD: Let me just put it this way. Earlier this morning we had this discussion about how we're going to make some fundamental changes in the program. And a comment was made actually that persons who are in hospice use fewer end-of-life resources, so why is it that we want to put artificial barriers in place for people who want to use hospice resources, even if they think it's going to take them longer than six months to complete their full utilization of the hospice benefit?
DR. NIELSEN: But that's the statute, isn't it?
MS. GIGLIOTTI: Yes, statutory language.
DR. WOOD: Okay.
MS. GIGLIOTTI: We're trying to find something workable and a more immediate fix.
DR. WOOD: I would suggest that quite frankly, I would suggest that we make it very clear and that there should be no application of local medical review policy for hospice stays of six months' duration or less, period. Any review of a hospice stay after six months should be accomplished on a case-by-case basis for the short term. Then for the long term we should make a recommendation that CMS change the eligibility and coverage criteria for a hospice benefit.
MS. RYAN: Are those words taken down verbatim?
DR. WOOD: Well, I'm not good enough to remember.
MR. UTTERBACK: I think that's what the language say. Medical review selection processes should be designed to assess patients with greater than six months' length of stay. Medical review practices for non-cancer-related diagnoses should rely on local medical review policies as they'll-- you'll get an extra word in there. As guidance only.
So we are attempting to move the medical review process from one that is totally random and subjecting cases of eight days' length of stay to when we're looking at cases greater than six months in making a judgment as to whether or not they may or may not be appropriate.
DR. WOOD: Well, in that last sentence I mean all we're really saying is medical review practices for stays longer than six months should be on a local review policy and guidance only. And that non-cancer-related diagnosis I think is irrelevant because you're really talking about any stay that's longer than six months. Am I-- I mean what's everything think?
MS. RYAN: That is the real problem as you've described it in a clinical setting.
DR. WOOD: Karen?
MR. UTTERBACK: Many of the cases that do run over six months are non-cancer-related diagnoses. And it is an area that was highly scrutinized and which experienced a fairly high denial rate two to three years ago. So the local medical review policies related to non-cancer diagnoses, which are the only ones that exist to my knowledge in hospice, attempted to clarify for not only the reviewers, but also for providers, physicians and consumers that those diagnoses were appropriate for hospice care to meet the end-of-life issues.
So I believe it is appropriate to leave them there in order to provide a context for their use through the medical review process.
DR. WOOD: Okay.
MS. GIGLIOTTI: Would you suggest inserting a sentence before that then, Dr.Wood, that was more general for all cases, and then--
DR. WOOD: I think what we have to do as we are looking at we need to review the LRMP web site and make sure that we're comfortable with the concept that it is only non-cancer diagnoses. There is something that to me suggests that it's not exactly that way based on testimony we've heard. So I think we ought to try to make sure we're certain about that. We have the time to do it, so we can do it between now and Washington.
Okay. Let's go on to the next item.
MS. GIGLIOTTI: Let's return to Page 3, and I believe that Item 1B was moved to discussion agenda.
DR. WOOD: Correct.
MS. GIGLIOTTI: Mr.Fay, was that your--
DR. WOOD: Under Roman Numeral 2, Item 1B. CMS should create a Medicare waiver authority.
MR. FAY: While I don't disagree in theory with the recommendation, we may need to expand it or clarify because Medicare does have a waiver system currently. For instance, Maryland is a waiver state, and they have their own reimbursement system for reimbursing Medicare. It has to be the same benefits and everything. But as best as I understand, they don't follow the federal DRG system or the outpatient PPS system. So I would suggest that maybe we--
DR. WOOD: Well, the technical advice probably resides in my counselor to the left, MissNorwalk. She explained that to us this morning, so let me ask Leslie to--
MS. NORWALK: I think that CMS currently uses all the waiver authority it has now. Trust me, if we had additional waiver authority, Tom, as creative as he is, would use it to do other things and accomplish as many policy goals as possible. At least demonstrate whether or not they actually work.
Other than -- the Social Security Act only permits us to waive two things; payment and then to provide services that are incidental to other Medicare coverage services. That is the only-- those are the only two places where we can have waivers, and we do already. You may want to talk a little bit about the waiver process or something else, but in terms of actual authority, that's the only authority that we have.
DR. WOOD: So to be more helpful here, if we look at the structure of this, are we saying that CMS should create a Medicare waiver authority that permits the same degree of discretion as in Title 19?
DR. NIELSEN: But CMS can't do it.
MS. MARGULIS: It sounds like we can't.
DR. WOOD: I mean it would obviously have to be legislated. But I mean the circumstances, what we're trying to say here is that if we want to have Medicare waiver authority, the way we would to rewrite it, it would be that CMS should have a Medicare waiver authority that is exactly the same as the waiver authority in Medicaid.
MS. GIGLIOTTI: We would say good luck.
DR. WOOD: I mean if you want to write the-- I mean you can't do this the way it is now, anyway, I don't think.
MS. GIGLIOTTI: Correct. And in the statutory section for statutory changes where we ask the Secretary please to work with members of Congress, there is explicit language which addresses that. In 1A which we adopted and talked about streamlining the federal Medicaid waiver review process, perhaps we could just work on streamlining the Medicare waiver review process.
DR. WOOD: Well, coming back to 1B, if we have language elsewhere which really addresses the circumstance, should we defer this or withdraw Item 1B?
MS. GIGLIOTTI: We can withdraw it.
DR. WOOD: Mr.Rovner, are you comfortable with the recommendation?
MR. ROVNER: Yes, I would endorse that we withdraw it and put it back on the statutory agenda where it is already.
MS. GIGLIOTTI: Move to withdraw Item 1B.
DR. WOOD: All those in favor?
(Ayes.)
DR. WOOD: Any opposed?
(None.)
MS. GIGLIOTTI: The next item I have moved to discussion agenda is 2C and 2D, which we may be able to take together. They are also Mr.Fay's concerns.
MR. FAY: I agree in concept that we should have a defined tolling period for the state planned amendments. I'm not sure the 45 and 60 days are adequate. I guess just having worked with some other states, it seemed like longer periods of time were required.
Plus it's interesting to note I did read a week or two or so ago -- and maybe it was a CMS press release -- about they're going to be centralizing the waiver authority or the approval of waivers and that they will make those more public I guess just to put more sunshine into the process. So that would be helpful to understand, too. But short of that I would just-- I don't know if I would strike the tolling periods or suggest longer tolling periods, but I just-- maybe we should hear from CMS and what their thoughts are.
DR. WOOD: Leslie?
MR. BLOOM: I have a vague memory, and perhaps my memory is incorrect, but I recall from the first meeting in January that Secretary Thompson committed to acting on a waiver request within 90 days that it was received. And that seems like that would be the appropriate time period to put-- my memory could be defective, but I'm pretty sure he said that at the opening remarks.
MS. NORWALK: I was not fortunate enough to be involved with this committee in January, so I'm afraid I do not know. But I would-- a couple of points. I suspect it would be awfully difficult for us to actually get through the entire regulatory process that we're going to automatically deem something that we don't approve. I suspect that there would be ways of gaming that system. I mean I just know how it works.
And it is probably unrealistic, which is not to say-- we are very committed to moving things through the process quickly. I mean I know that when Tom started, we went through a significant backlog of waiver requests. I mean the poor staff, we were killing them. So I think we're very committed to doing this quickly.
I think you're probably right the time frames are a bit short. And it's such-- I think there are other ways to get at the issue that are maybe less stick and more carrot approach, like whether it's the national review teams that we discussed this morning or having individuals, two individuals from CMS assigned to each state so that we can be involved in the process early on.
I would also point out that CMS is not the only body that's involved in approving these ways but in fact OMB is, et cetera. And sometimes when you have a deadline and it can be used against you inasmuch as, "Well, we can't approve it. We're simply going to deny it. So try again."
And then get-- I mean I think that's-- we don't want to create that sort of environment. We would rather work with you than have some clock make it work against you.
MS. GIGLIOTTI: Right. And also part of the reasoning behind this non-negotiable language was that let's say there was already a 90-day time line there, at any time you could just go to a state and say we need more information. That would stop the clock and extend it longer, and I think it was frustration states on that part as well. I'm a little reluctant to just strike the days, the length, because then it doesn't-- it kind of loses its teeth that way. I have problem with extending the length of time.
MS. NORWALK: I just want to give you my comments. Of course, I'm delighted to look at whatever recommendation you eventually give us, but in terms of what we'll actually do, I was just giving you a little hint of what you might expect.
MR. REDDING: Mr. Chairman?
DR. WOOD: Go ahead.
MR. REDDING: Just a comment. I think that-- well, I appreciate MissNorwalk's comments especially with regard to what might happen. Once you get to that 45-day time frame and there is no answer from CMS and then the answer comes back "No," that wouldn't be acceptable to states, either.
But, you know, one of the things that I would certainly like to see is an effort on the part of CMS to at least address their concerns earlier in the process in terms of requesting additional information. Right now it's a 90-day clock that starts when an amendment request is submitted. It's generally around the 88th or 89th day that we get a request for additional information. And then we have another 90 days or so to get a response back.
So I mean I like the fact that there are time frames in here. I don't know if the 45 or 60 are the right time frames, but if there was a way to then have the little discussion about, you know, CMS has issues. Let the states know about those earlier on. That certainly would help. And I think that's part of what this committee is trying to get at, quite honestly.
MR. FAY: There appears to be evolving into one of those chunky issues, but what I might suggest, and I think the idea of tolling periods is good, is that maybe we take this back and work with CMS a little bit and come up with a series of tolling periods. For instance, there would be a drop dead date for a first request for additional information. There would be a timetable on the state to return that information. There would be some wiggle room obviously built into the process to accommodate things like holidays and weekends. And try to maybe refine and make this more sophisticated, but still, you know, sort of lay out the notion here is the process, here is the timetable. Let's both work together and follow it.
MS. GIGLIOTTI: That mechanism exists today, but it's not working. I think Mr.Redding gave a good example of that. Perhaps another way to work it would be altogether not longer than, you know, six months or something like that. I'm not sure.
DR. WOOD: Erik or Jack?
MR. ROVNER: I hate to be the pessimist, and I endorse my subcommittee's good intentions on this. But, as you know, MissNorwalk is a lawyer, and I am a lawyer. And--
MS. GIGLIOTTI: And I am a lawyer.
MR. ROVNER: And Lisa is a lawyer, and so actually so is Suzanne, so I am not alone. But the fact of the matter is that I think that no matter what you do when you set time frames like this, you run into the problem, it's impractical and people end up having, being forced to game the system. So I'm not sure that this approach accomplishes the good intentions of the Heidi.
As I listen to what Leslie says and what others think about the process that you go through in many things. In other areas that I practice in where you have time limits, what will end up is someone when they run into that deadline will either deny it, make a second request or whatever because they need to buy time. It isn't necessarily bad intentions or otherwise. It's just the reality of it. So I'm going to suggest that we need to reconsider a better way to get at the intent of this. Because I think setting time lines is just -- we're just setting ourselves up for the same problems you now face.
MS. GIGLIOTTI: I will agree to defer and have further conversations with CMS staff and MissNorwalk on the condition that it is not dropped and it is in final, in whatever form, is in the final recommendations to the Secretary. And goes for 2D-- excuse me -- C and D both.
DR. WOOD: Okay. That will take us to 2G.
MS. GIGLIOTTI: What happened to 2F? I have that listed as -- and I'm not sure who moved that to the discussion agenda.
MR. ROVNER: This was moved prior to today, so it could have been anyone.
DR. WOOD: I'll tell you why I slipped over that.
MS. GIGLIOTTI: Leslie is ready for--
DR. WOOD: You know, our chart specifically says to work on regulatory things. As far as I know, this is not in anybody's regulatory authority.
DR. NIELSEN: That's right.
DR. WOOD: It's okay if we adopt it to consider for a long-term recommendation, but I don't know we need to spend much time on it here otherwise.
MS. GIGLIOTTI: I would go for G, I believe, as well.
DR. WOOD: What I would suggest actually is that Items F, G, -- F and G under 2 be put into long-term recommendations with one technical question being asked of CMS, and that is whether it is on a regulatory basis possible to recognize Medicare savings within Medicaid programs? There's that a second issue I think that's in G, yeah.
MS. GIGLIOTTI: Yes, and we heard a lot about this morning, too, budget neutrality.
DR. WOOD: Right.
MS. GIGLIOTTI: So I would like to have further discussion as well.
DR. WOOD: So what I need, is some technical advice back from CMS before we make any sort of a final recommendation.
MS. GIGLIOTTI: And I agree it doesn't need to be done today, but for further discussions.
DR. WOOD: We can ask for technical advice on the matter.
MS. GIGLIOTTI: On 2G only.
DR. WOOD: 2G would be to ask for technical advice to come back. Since this is really the Medicare savings, we would not change the coverage of long-term care or prescriptions under the Medicaid program. We wouldn't change that. It's how do you recognize the savings, correct? Can we make that a technical advice question? Jeff?
MR. BLOOM: Actually, unfortunately I have a lot of experience with this. The revenue neutral thing is not a grill thing. It is just something that they've been operating under. It's not a statute. It's not a regulation. We've come up across this constantly with trying to expand drugs for HIV for people with AIDS.
And it's simply a concept that has been out there, but there is nothing mandating that things have to be revenue neutral. It's simply the way they've been operating. But as far as I know, there is no regulation that dictates that. It's simply the way they've been operating things because this is technically run into constantly when we're trying to cover with people with AIDS -- with HIV to get them AIDS drugs. And we do run into the revenue neutral counseling thing, and there is no written mandate that has to regard neutral. It is simply OMB's desire that it be that way.
DR. WOOD: Well, I guess my sense of this from the discussion we heard this morning is that there are difficulties in terms of how states who are providing certain benefits under the Medicaid program for dual eligibles, particularly this one that may not be written precisely for dual eligibles. But for the dual eligibles it's a significant issue.
And I guess the question still here is one of technical advice to know what statutory and regulatory options are available to us. You haven't seen it yet for technical advice yet, have you? Based on our process then I think it would be appropriate that we send it for technical advice and then get it back for final review.
MS. GIGLIOTTI: So moved.
DR. WOOD: Mr.Rovner, since it's our committee, any objections?
MR. ROVNER: No objection. I think that will work fine.
DR. WOOD: Okay. Then we go to 3.
MS. GIGLIOTTI: 3A is also on the discussion agenda.
VOICE: (Inaudible).
MS. GIGLIOTTI: Yes, I would, but I'm not sure who asked the question or what the concern is.
MS. NORWALK: Again I think that's probably would need to be a statutory change. I'm fairly certain, although I would have to reread the statute. It is always a good idea. That the way that-- I don't think we can deviate from the way the statute requires us to provide the benefit as opposed to-- we can't provide an alternative benefit, so to speak. So I don't think without a statutory change we could do this, although I understand your concept.
MS. GIGLIOTTI: I read the statute to look for something like that, and in some private practice I did we've been able to take insurance benefits and flex them and still be within whatever agreements there are, et cetera. So can we also do some technical assistance with each? I move that we defer this for technical assistance.
DR. WOOD: Okay.
MS. GIGLIOTTI: That brings us all the way to 6C. And on this issue I believe Senator Martin had a concern, and I yield to Mr.Bloom to respond.
MR. BLOOM: Well, I don't know what concern is.
HON. MARTIN: I actually, real quick, was just reading that. And I didn't get a chance to finish reading it, so I just pulled it out. I probably should have pulled out 6 as a whole. But I'm not going to deal with it. It's fine. It was minor, anyway. So I won't deal with it. I'll just move that it be agreed to.
MR. BLOOM: Thank you.
DR. WOOD: Do you want to move that then for adoption?
MR. BLOOM: Yes.
DR. NIELSEN: Second.
DR. WOOD: Okay. Leslie, by all means.
MS. NORWALK: Terrific idea. I'm thrilled that DC has actually done this. I think a significant amount of this is actually outside of CMS's authority to do a single enrollment form. Obviously, we don't have any control over Medicaid enrollment. We don't do eligibility. That's within the state.
So in terms of the second part of that sentence-- the second part of that, the second sentence, immediately have CMS look at which state programs are best meeting their goal of global benies in all eligible federal and state programs means first faults beyond CMS because so many of the programs that are federal may be HHS programs, may be outside of HHS. And in terms of the dual -- or the Medicaid programs are really in the states' hands. So I think it is really broader that a CMS issue you, although I think it is a laudable goal to have one enrollment form. It makes a lot of sense, but --
DR. WOOD: Miss Ryan?
MS. RYAN: However, CMS would have the authority to do what this recommendation suggests, would be to look at what's out there, wouldn't it? And develop a model or a template? It doesn't say CMS would do it.
MR. BLOOM: If we just switch CMS to HHS, will that capture what you need?
DR. WOOD: I'm sure that it would be. I mean ultimately we're going to have to think about some larger recommendations here, so let's change it to HHS.
HON. MARTIN: Mr. Chairman?
DR. WOOD: Steve, go ahead.
HON. MARTIN: Mr.Chairman, the point that's just was raised, it's still going to involve the state authority for limitation. And this was the broader point I was going to raise. It might be good to have a standardized form, but it's not simply-- it's not as simple as CMS looking at it and recommending.
MR. BLOOM: I think the point is to look at the examples of states that have done it. And for other states that may want to consider doing it, they can look at it and see the best practices and perhaps adopt it. It's not a prescriptive thing, but it's merely a thing showing here is what some states have done. Here is the best practices. Look what DC has done. Hey, Virginia, this might be good for you. Take a look at it. It's not mandating that they do it, but it's a way of showing them a path to making things better.
DR. WOOD: We're looking at this in a couple different ways, but all it really says I think is we should look for opportunities from people who seem to have done this the best way. It doesn't say that any state you have to do it this way.
MR. BLOOM: Correct.
DR. WOOD: Now, I think we have a motion to move this on for adoption. Is there a second?
DR. NIELSEN: Second.
DR. WOOD: Any other discussion? All those in favor, aye?
(Ayes.)
DR. WOOD: Any opposed?
(None.)
DR. WOOD: It is now adopted.
MS. GIGLIOTTI: Moving along to the next item, 7C, to that I yield time to Mr.Bloom to address the concerns.
MR. BLOOM: I'm not sure if people had the concern about it.
MS. GIGLIOTTI: Mr.Fay. Thank you.
MR. BLOOM: Okay. Go ahead, Mr. Fay. Obviously I know one of the concerns is that each state has a different program, but --
MR. FAY: That was my concern. I didn't know if we were going to have a single 1-800 Medicaid number with fifty items. You know, punch 50 if it's Wyoming, which I thought might be a challenge.
MS. GIGLIOTTI: W-Y-L?
MR. FAY: Yeah. So I just thought we might want to clarify that.
VOICE: Chunky.
MR. FAY: Or maybe let the transcript clarify it.
MS. GIGLIOTTI: In our briefing, we elaborated. This was a concern of another subcommittee member to say there are at least a core set of benefits, as MissNorwalk pointed out this morning, that each Medicaid beneficiary is entitled to. And that's an agreement that the states make with the federal government. So at least those people could be informed of the core set of benefits for which they would be eligible. And also there is a core set of eligibility requirements, too, that could be listed.
DR. WOOD: Isn't that the 211 information system?
MR. BLOOM: Mr. Chairman, actually the 211 information system, and somehow could actually substitute for this, the 211 is actually much broader than just Medicaid. The 211 system actually gives the person the information about all of the programs that they would be eligible for, besides Medicaid, food stamps, TANIF, WIC, all state programs that are eligible for and one step beyond that which is a really phenomenal thing which some states have done where they have subcontracted it out to someone like United Way, they've actually hooked them up with an AT&T operator for a buck fifty so they can get someone in any language that they need to provide that information and translation.
So it also addresses the language barrier so that not everyone who speaks English and Spanish in the United States. And it's a program. It is currently scheduled to be rolled out nationally. I actually have the information upstairs in a folder. So it's an ongoing program.
DR. WOOD: So this is slated for full roll-out? I think what we better do with this one actually is send it back for some technical advice. It seems to me that if we're aiming for improving service to beneficiaries, then I can't possibly see how you would ever run a 1-800 phone number since I think for telephone switching systems it would be impossible without an automated management system.
But we're really interested in making sure that people understand what benefits are available to them, so if that's in Item D, then perhaps what we should do is encourage an examination of the function of 211 information systems and how it might be expanded to all Medicare/Medicaid beneficiaries.
MR. BLOOM: That would be very acceptable and I have a folder upstairs on the 211 stuff. So it even has a schedule of where it's supposed to be rolled out. In fact, I think Minnesota is pretty soon.
DR. WOOD: I would say encourage to use the 211 information system for all Medicare and Medicaid beneficiaries. Personally I think we just, knowing how difficult it would be to do C, is withdraw that and go to D because it would be more expansive and inclusive. Is that okay?
MR. BLOOM: Yeah, that's fine. I mean that is basically not to let Medicaid people feel like they're discarded. So the 1-800 Medicare, let's have something for Medicaid as well. And I think Trish knows about this because in Connecticut they have the 211 system, so she may be able to talk a little bit about it.
But I believe in Connecticut it's a public/private partnership where they contracted it out to United Way, and it has worked out quite good.
MS. WALDEN: Yeah, Jeff brought this to a my attention a number of weeks ago, and I actually dialed the number myself to see what I would get. And it was just incredible how much information was available. And it certainly was state specific. And I don't know how many other states have it, but I certainly think it's a good recommendation to try to implement or replicate that kind of system around the country.
DR. WOOD: Okay. So we have this one then, and I think the way this would look is that we would withdraw C. Is that okay, Lisa? Mr.Rovner?
MR. ROVNER: And you're referring D back for technical advice; and we'll back on that one, right?
DR. WOOD: Well, actually, I think you could consider whether you want to move D for adoption.
MS. GIGLIOTTI: I move D for adoption.
MR. BLOOM: Second.
DR. WOOD: Anybody want to keep D on the discussion agenda? How many in of its adoption, aye?
(Ayes.)
DR. WOOD: Are there any opposed?
(None.)
DR. WOOD: It is adopted.
MS. GIGLIOTTI: Item 16F was moved to the statutory section, which we'll get to in a minute, so we can skip along all the way to Item 18A, which was moved to a discussion agenda. And I'm ready to address any concern raised.
DR. WOOD: It was actually moved to the discussion agenda before we got here, so the question is exactly I think as you see it, and that is who is the qualified individual.
MS. GIGLIOTTI: Right. As we heard from one of the hospice representatives yesterday, it's now more often being interpreted by locals as no, you must have a dietitian, whereas some of the registered nurses who, you know, have specialized for years and years and years in giving dietary advice to those who were terminally ill would appreciate the opportunity to do that, is the concern addressed.
DR. WOOD: Okay. Do you want to move it?
MS. GIGLIOTTI: I move it for adoption.
DR. WOOD: Second? Michelle?
MS. EVINK: I'm wondering if here do we intend to say that it most often means or it may mean or may include?
MS. GIGLIOTTI: I'm comfortable with wordsmithing those words there, as long as it's made clear there is that education piece in there, too, that it doesn't have to be by a dietitian.
DR. WOOD: Maybe we should say "may."
MS. GIGLIOTTI: "May" is fine.
DR. WOOD: Nancy?
DR. NIELSEN: I guess I would want to broaden it a little bit. There are a variety of people of a variety of backgrounds, including physicians, who give fairly specific dietary advice. Now, many physicians don't know how to do that; but when they're involved in hospice care, they will know how. So I guess what I would think that qualified individuals when referencing dietary counseling in hospice could include a variety of health care providers. I think the point is it's not necessarily a dietitian.
MS. GIGLIOTTI: Correct.
DR. NIELSEN: And you've now said it could be an RN. I'm saying I think it could be a little broader than that. It shouldn't be Aunt Tillie, on the other hand, unless Aunt Tillie is a dietitian or physician. All right.
MS. GIGLIOTTI: I suggest that we amend the language, and I'm not sure if we want to be specific enough to say, you know, not necessarily a dietitian but including health professionals?
MR. UTTERBACK: Could we go more general and say that dietary counseling is included in the plan of care and addressed by the team? The concept within hospice is all handled by the team, and then you've got that input. So the issue is really the dietary needs are being addressed in that plan of care, rather than who specifically is addressing them.
MS. GIGLIOTTI: As long as perhaps we qualified it with saying not necessarily a dietitian, just to address their concern here that locals are, you know, interpreting this to mean dietitians. So the team, they might say, well, your team has to have a dietitian then.
MR. UTTERBACK: Again I raise the question of whether or not you've got some local, state licensure issues that are playing a part in this.
DR. WOOD: That might be a difficult circumstance. I think if you do it from the care plan, it actually then is saying what the patient needs happens to be and addresses them. And it also gives you the capability of meeting the local licensure issues. Because if we try to be prescriptive about a particular person and we run into difficulty with state licensing laws, it would be very difficult. Karen, you want repeat the language?
MS. JOHNSON: A question first?
DR. WOOD: Kirstin?
MS. JOHNSON: Is it not generally true that states are allowed to be more stringent in their requirements if they choose to, and the federal regulations set a floor? So I don't believe we're obliged to accommodate the most stringent state requirements.
MR. UTTERBACK: I didn't perceive that that was what we were trying to do. I was recognizing the issue that we may be hearing this through public testimony as a result of some confusion about where the state surveyor is gaining this information. In other words, that same individual is conducting both a licensing survey and a certification survey in the same process.
So if the hospice is being cited by that individual and told that they didn't have a dietitian to perform these services, it may actually be that that language lives in their state minimum standards, and the hospice is not making that discernment. So I want to assure that our language here was clear with, you know, from the perspective of CMS what we want to accomplish; and that is that the dietary needs of the patient are met through the care plan and acknowledged through the team approach to establishing that care.
DR. WOOD: We could also say -- we could put in a sentence that says that dietitians are not the only personnel capable of providing nutrition--
MR. UTTERBACK: I wouldn't go there. I wouldn't go there, either.
DR. NIELSEN: I wouldn't go there.
DR. WOOD: All right. So we'll leave it as the general language.
MS. GIGLIOTTI: Okay. Would you like me to repeat it?
MS. UTTERBACK: Can it be read? I can't read it.
MR. ROVNER: Can can't read it from over here. Would somebody read it?
DR. WOOD: "CMS should issue a written clarification stating that qualified individual when referencing dietary counseling in hospice could include a variety of health care professionals. CMS should employ educational outreach to state survey teams to ensure each team is aware of clarification and applies it uniformly."
MR. ROVNER: Mr. Chairman?
DR. WOOD: Yes, Jack.
MR. ROVNER: I have to-- I have to be blunt. I have a concern that it starts to sound like that we're getting involved in what I have heard in public testimony in various places as a turf war. And I would like to avoid turf wars as a member of this committee.
I thought when Karen was proposing language about the plan of care, that really struck me as the way for us to go because what that seems to say to me is that the surveyors should look at what the professionals, who are supposed to be under state or CMS or whatever, have crafted as the best care plan for the beneficiary, which is who we are most concerned with.
And that approach struck me as avoiding looking like we got involved in a turf war among various professionals who seem to think that they are to be involved for one reason or another. I don't, as personally a member of this committee I don't think I want to be looking like I'm doing anything like that.
DR. WOOD: If that's the case, then if we want to write it, we would have to say something like CMS should issue a written clarification stating that the development of a specific care plan that is accomplished as part of an inter-disciplinary team process should determine the needs of care of the patient, period.
MS. GIGLIOTTI: How does that address the dietary counseling concern?
DR. WOOD: Because the plan then would decide who is going to give that counseling, whether it's a nurse, a dietitian, a doctor, whoever. It's not prescriptive.
DR. NIELSEN: Then put specific care plan related to dietary needs.
DR. WOOD: I think I want to keep the care plan a little bit higher.
MR. UTTERBACK: Well, the components of the care plan are defined already.
VOICE: Then put the dietary needs.
MS. UTTERBACK: So I think in order to be responsive to the testimony we've heard, it's important to include the dietary component of the care plan.
MS. GIGLIOTTI: Especially if we want it to be, you know--
DR. WOOD: You can put in perhaps then the development of a specific-- well, a specific care plan, comma, including nutritional care, comma.
MR. UTTERBACK: I'm partial to development of the dietary component of care plan.
DR. WOOD: I just don't want you to be too specific here. Judy?
MS. RYAN: I'm just concerned that the testimony that we've heard through almost all five hearings has been to call for specific requirements for licensed dietary counselors to be engaged in these processes in long-term care, so that in many ways the testimony has been preponderantly the other way. So I'm supportive of Dr.Woods using more general language here about care plan being used as the vehicle to address these needs.
MS. WALDEN: Dr.Woods, can we say something where we say the inter-disciplinary team which may or may not include a dietitian? And that way at least we're honoring--
DR. WOOD: It says that what we need to do with this is send it back and get some resolution, so I would suggest we defer it to the next meeting and try to figure this out. Nancy?
DR. NIELSEN: Could I just ask a question? Because I remember -- and I was not in Phoenix, but I've been at all the other meetings, and I remember hearing that a dietitian ought to do it all the time in Miami. And I have heard alternatively that please don't make us get a dietitian, so I don't know that-- I mean can you help me numbers-wise? Because I only heard one for and one against, so somebody help me with this.
MS. GIGLIOTTI: Let's defer--
DR. WOOD: I would it go to back to the subcommittee so we can figure that out before we come to the subcommittee. So we're going to send that back. Trish?
MS. WALDEN: Yes, I just wanted to clarify what Dr.Nielsen is asking about. I think that had to do with the OASIS form, not in home care, not just hospice. And there was a lot of testimony by the American Dietetic Association on that.
DR. WOOD: Okay.
MS. GIGLIOTTI: I appreciate the committee's patience thus far. Would you please direct your attention to Page 8? As alluded before, the subcommittee recommended three statutory reforms, recognizing that our charter asked us to look more towards departmental reforms. But we wanted to bring some recognition to the fact that these statutory forms would help with the significant barriers there are to providing quality and efficient care in these areas.
And we would ask further that these be included perhaps in a separate section at the end of our report to the Secretary and in that section urge the Secretary to implore the members of Congress to take up and make these changes, statutory changes.
DR. WOOD: Okay. We still have some other items that are under the consent agenda for the coordination subcommittee, correct, Jack?
DR. OLSEN: Yes, and I see Mr.Bloom has left the room, so--
MR. ROVNER: Erik had a comment.
DR. OLSEN: Relative to what Lisa just said, you know, when we-- there was-- and I don't know what came of it -- the recommendation that Medicare include a prescription drug program. Clearly I spent maybe half my time working on that, and I didn't say anything. Is that going to be among -- you know, I hate to drop that if we're going to include these other statutory recommendations.
DR. WOOD: Let me suggest something in terms of the statutory recommendations. Before we get too far into statutory recommendations, I would prefer that we think about the conceptual framework of a delivery system of the future and then how you get there and then see which pieces we would need to put in place by statutory change and which we might be able to accomplish with regulatory change. And since these are long-term things, then just sort of save them until after we're done. And then let's go on to the other consent item, so we can get this accomplished.
MR. ROVNER: In fact, Mr. Chairman, I was going to suggest that that is exactly what we do, we defer the statutory items. They're here for the committee to look at. They're discussed in our subcommittee's report and recommendations, and I think that's something that will be revisited when we do get to our final report stage.
I see Mr.Bloom has returned. I would like to ask him, to yield to him and ask us to turn to the two items that were left over for the discussion agenda on adverse drug reactions, which are Items 2 And 5. I also as a point of clarification, I don't know if Ron is prepared to do this. Okay. I would ask that before we broke for lunch the committee members to look at the four recommendations made on FDA/CMS coordination. And after Mr.Bloom is done, I'll ask Ron if he would like to step up, and maybe he can address those, also. Jeff?
MR. BLOOM: Thank you, Jack. On No. 2, someone asked me to put on the discussion agenda. I'm not sure who, so I would like to hear what the issue is there.
DR. WOOD: Michelle?
MS. EVINK: My primary concern was the discussion that we had yesterday and the impending impasse of the Best Pharmaceuticals for Children Act is that in putting together recommendations for distribution of the reporting phone number, my huge concern is that through all of this the most important thing is that patient safety be considered.
And I can't think of a situation when an adverse event would be severe enough to be reported to the FDA, but then also really didn't need initial reporting to the patient's practitioner. And in the best interests of patient care and patient safety, their health care provider, whether it's a primary care practitioner or a pharmacist or somebody would really need to be aware that as early as possible because the primary thing that needs to it happen is there needs to be an intervention to alleviate the adverse effect that they're experiencing.
That may include-- it can include a variety of things. It may include him going to the emergency room. It may include taking medication. It may include changing the prescription. But I'm concerned that this focuses on reporting to the toll-free number and doesn't focus on the patient's concern. And providing a toll-free number in the absence of promoting direct reporting, too, the practitioner that they have a relationship would potentially endanger them.
Further, I'm concerned, too, that the statute dictates that the distribution of the toll-free number be given with each Rx. And I guess there are different perspectives on how the list is put together for recommending how the number be given out at the pharmacy.
But I really think that any restriction of how that's accomplished would limit the ability of the pharmacist to distribute that information because in the event saying that it needs to go, needs to be a sticker on the vial, if there is an antibiotic that you receive and you've got room for two stickers, and you need to tell the person that they need to take plenty of water and they need to finish the whole thing, these are two different stickers.
Okay. Now you have to put on a sticker that says that they have to report an adverse reaction to the FDA, then which stickers goes? You know, two of them prevent an adverse reaction. And so they would be my preference, but the other one is mandated by law. So-- on the not mandated, but would be a recommendation. So I would be in favor of leaving that very open and keeping that list as flexible as possible because this is already going to create a significant burden at the pharmacy level.
MR. BLOOM: I want to clarify that for a moment. This is actually the law already, so this is going to happen. The FDA is going to promulgate the rule. What we're trying to do is give them some support and guidance on some suggestions, but not limited to the list of suggestions of potential ways of promulgating the rule. But the rule has already been passed, and this is law, so it is going to happen.
As far as the impact on pharmacies, the bill does mention that they do have to take into account the impact it will have on pharmacists. But the exact implementation of how the law will be put into place will be as the FDA promulgates the rule, and it's simply to try to get them some support since there are certainly going to be some other people that will probably try to block the implementation of this rule.
MS. EVINK: Well, I understand that the law is there, but the law says that the information has to be distributed with a prescription. I was concerned about, initially concerned about limiting the list that limited the way these things were distributed just by the way that it read to me.
And I wouldn't want to limit that because there may be other ways that the pharmacist is able to creatively distribute that because they are going to be required by law to distribute that information.
MR. BLOOM: Right. Well, this should include but not limited to. If you feel better, we could do this may include but not limited to, and that would take the list in and still leaves it open for other suggestions.
DR. WOOD: Part of the difficulty here I would say is if you think of all of the ways that pharmaceuticals are dispensed, they don't come in prescription bottles. And so it misses a whole big piece of options here. So again I would suggest we not be too prescriptive, but to work on ways that you can distribute the information about how and where to report the adverse-- the potential adverse effect.
MR. BLOOM: It isn't going to say prescription bottles. Package insert, pharmacy drug information sheets, on the prescription bottle itself, all directed consumer advertising, printed advertising or any other promotional materials that the pharmacists are going to give with the drug and prominently includes and promote the 1-800 toll-free number through a public information awareness campaign. So it's really not talking about just the sticker on the bottle.
I think the FDA is going towards at the moment, leaning towards putting it on the bottle cap. And if Tom is still here, you might want to speak to it as well, but it's not meant to tie their hands in any way. It's meant to just report. We think this is an important thing, that patient safety is an important thing and to bolster them in promulgating a rule.
DR. WOOD: I understand. I'm just saying are we being too restrictive by talking about prescription bottles and not thinking about how you really want to get it across, but Miss Martin?
MS. MARTIN: My big concern is I don't think the Food and Drug Administration has the resources to handle receiving a whole lot of 1-800 numbers. You're right. The rule is already in effect. FDA obviously is going to advertise the number. I personally am not in favor of really promoting the number because I think the reports really do need to go to the attending physician and to the pharmacist, much rather than calling a 1-800 number of Food and Drug.
And maybe you'll get somebody who says, "Oh, yeah, okay. Sorry you had that rash."
MR. BLOOM: I'm not sure I'm thinking of that type of a reporting system. Actually, in terms of getting out of the noise, that's just one of the concerns about you've got a whole bunch of little things. One of the things that's been discussed is the telephone menu system where you would actually have choices saying did this reaction result in a hospitalization, press 3.
And they would follow up on very serious adverse events, and you would somehow when you're out in the field and the FDA could issue guidance as to the different degrees of adverse events and how to report them. But I don't think there is actually going to a person at the end of 1-800 line initially.
DR. WOOD: Suzanne Pattee.
MS. PATTEE: Thank you, Mr. Chairman. I'm trying to think about how this would be different from the Mr.Yuck stickers, the little poison stickers. And when you have a poison reaction, you call that number for immediate intervention. And I guess we need to make clear that this 1-800 number is not going to give you that intervention. It's just reporting. And it can it be done two months later, not that day.
HON. MARTIN: Exactly.
DR. WOOD: Dr.Nielsen?
DR. NIELSEN: Well, I guess that was essentially the substance of what I wanted to say. This is not a 911 call. This is a report. And it is important in that we need to as best we can ascertain the safety of the pharmaceuticals which are out there.
But there is no way that-- and that's the FDA's problem in how they promulgate it. They're clearly not going to say, you know, call for emergency advice. This is a reporting mechanism only. I guess I am concerned frankly, Jeff, though, about creating a laundry list of ways to go about this. I think I would prefer to leave that sentence out, actually.
DR. WOOD: We also were asked in the charge not to create new regulations.
MR. BLOOM: Actually, we can create new ones if it's for patient safety or if it's for the betterment of the patient. We did change operating principles in that regard, so--
DR. WOOD: Michelle?
MS. EVINK: And I think ultimately the thing that I liked about the initial comment is that having efforts that advanced the goal of increased reporting of adverse events is fine, needed desperately. We have very low adverse event reporting, from my perspective because the current system takes a long time. But 55 percent of the reports come from pharmacists, according to their numbers. So I don't think that-- I mean our goal here in patient safety is that the FDA get good information, get more of the information, that the patient have access to knowing that if they're in trouble, they need help. And I'm not quite there yet on it.
DR. WOOD: Mr.McGinnis, would you like to give a little technical advice here?
MR. McGINNIS: Sure. The bill that the President signed into law in January does direct FDA to do implementing regulations by January of next year. It gives us one year. It says that the pharmacy community has to pass out this number with all prescriptions. And there needs to be a caveat language that that number is not for medical information, so the agency is going to have to devise the prescriptive language to go on these stickers or to go on information sheets, to go on the amber vials itself. So these types of recommendations are appreciated and would be taken back to the agency and put into that rule-making process.
DR. WOOD: Any other questions or comments? Is there a motion for approval?
MR. BLOOM: So moved.
DR. WOOD: Is there a second?
DR. NIELSEN: Move to amend by deleting the second section-- second sentence.
DR. WOOD: Okay. So if we move to amend by deleting the second sentence, it would simply say that we recommend that the FDA promote the broadest dissemination of a 1-800 toll-free number for reporting adverse drug events, and that it should be prominently included and promoted through a public information awareness campaign. Mr.Bloom, are you happy to accept the amendment?
MR. BLOOM: That's fine with me, Mr.Chairman. I just think it's a bit naive to assume that there are not other people that will want to litigate this. And I think if you listen to Mr.McGinnis carefully, I think the FDA would very much appreciate the support of this list of suggestions. And that's all that they are. And it really does help bolster them in promulgating a final rule. So I will defer to the will of the committee, but given the realities of dealing with FDA issues in Washington for the last eight years, it would be very helpful to the FDA to actually have this list of suggestions endorsed by the committee.
DR. WOOD: So you would like to retain the sentence in the motion?
MR. BLOOM: Pardon me?
DR. WOOD: You would like to retain the sentence in the motion?
M