SECRETARY'S ADVISORY COMMITTEE ON REGULATORY REFORM

MONDAY, FEBRUARY 25, 2002

HYATT REGENCY HOTEL, MIAMI, FLORIDA
9:05 a.m. - 5:15 p.m.

VOLUME II

(Whereupon, the proceedings continued after the lunch break at 1:30 p.m.)

CHAIRMAN WOOD: I would like to invite the Committee members to return to the table so we can begin our afternoon. I apologize for the delay in the serving of lunch. We've lost some time that we'll unfortunately have to try to make up as much as we can.

I'm particularly pleased to be able to welcome today Bobby Jindal, who's talked with us more about the work that we have in front of us and how we can help him and his colleagues and the persons of the Steering Committee. We've made this reference to the Steering Committee from time to time.

At our first meeting in Washington we were anticipating we might have some time at the end to be able to share some specific recommendations with Bobby, but we know that he was called for some more important things, and we -- I know individually, as well as collectively, offer him our great congratulations, and we're very happy that you're with us now, and I would invite you to share a few of your thoughts with us before we start the afternoon.

MR. JINDAL: Thank you, and I will keep my remarks brief to get us back on schedule. I've seen several of you already, and already the most important question I've gotten is was it a boy or a girl.

I'm pleased to report -- I apologize having to leave you so abruptly last time. I'm pleased to report we had a baby girl, our first child, and she did me the honor of waiting at least 36 hours to be born. So I had plenty of time to get back to the delivery room. Her mother wasn't so pleased with her patience, but she's a healthy baby girl. She is going to be -- I guess she just turned seven weeks and is doing very well.

I really wanted to bring you greetings on behalf of the Secretary. I know he personally wanted to be here and will be coming to some of the field hearings. This week and next week he'll be testifying in front of the various budget committees in Washington with the Congress coming back from the recess, and there's also significant welfare reform announcements and events and developments, so he's meeting with the governors in Washington, so he did want to send his regrets.

I've already heard from several of you that the morning has gone well, and one question that I've gotten from so many of you, because you do have so many good and specific ideas, is about the outcomes of this Committee and what is the Secretary's intention, and so I'll remind you of where he started as to start off our afternoon session, which is the Secretary absolutely is looking for concrete tangible solutions and recommendations on ways that we can make the rules and regulations less onerous, less burdensome, to providers and beneficiaries across the country.

His mandate is very clear. His willingness to follow through is very clear. He wants to be able to implement specific changes to reduce the paperwork, reduce the burden, make our healthcare system much more responsive, more efficient and to emphasize high quality.

Now, it may not surprise any of you, now that we're getting into the details of the work, that you're never going to find a rule where everybody simply jumps up and says absolutely that rule needs to go, that form needs to go, that paperwork is absolutely redundant, and the reason being that there will always, behind any rule or paperwork or form, form some rationale or some reasoning, and so I hope nobody was astonished that all of the wonderful examples that you brought to this Committee, you haven't met with some explanation from somebody.

The Secretary certainly doesn't want you to back away from the challenge. That doesn't mean the first time somebody says yes, but or oh, we've thought about that, or oh, we're going to do that one day, he certainly doesn't expect you to back away.

He is aggressive. He is impatient, and he wants to make changes as quickly as he possibly can, and so what he has charged us with doing, what he's charged you with doing is to sift through those, and when they're reasonable, certainly accommodate those explanations, answers and other justifications you'll get, but to persist. You bring a valuable experience to this table, you bring valuable experience, each of you, from your different backgrounds to this process, so what he's looking for you to do is to use your experience collectively as a group to say we understand the obstacles, we understand the rationalizations, we understand the reasons, but we think there's a better way to do it, and here is the way that we think we need to go.

So with that, I'll stop there. I do have, as any proud father would, a baby picture, and so I'm happy to share with you afterwards in a private moment, and I'm happy to bore you to tears with details about my baby girl.

I will leave you with this final thought. Last night -- my daughter has a wonderful ability to know when her father's leaving, and so she chooses not to sleep those nights so we can enjoy late night TV together, and so I had the wonderful experience of watching the Home Shopping Network last night, showed up at the airport to find out from the airline representative, who looked at me and said, AYou don't think that you're traveling today, do you,@ and so I'm happy to say that I'm here despite those challenges and obstacles.

I thank you for letting me join you this afternoon and tomorrow.

CHAIRMAN WOOD: I'm anxious to know what you bought. That's when I know you've got -- when she's got you truly wrapped around her finger.

I'm particularly pleased to begin the afternoon by welcoming Michael McMullan to share with us what CMS is doing for beneficiary communications and education. It's been a privilege of mine actually to work on a project -- I won't say how long ago -- with Michael, which I do think has had a measurable and significant impact on the outcome of care for Medicare beneficiaries.

I'm particularly anxious to hear from her about what she and her colleagues are doing at CMS to communicate and educate our elderly and other beneficiaries in the use of these services.

So Michael.

MS. McMULLAN: Good afternoon. I'm going to -- at the risk of having slides after lunch, we're going to go through these slides, and I will try to do it as quickly as possible.

This overview slide -- I'm going to be talking about all of this, but the significant components of the National Medicare Education Program include the 1/800-Medicare, which is a toll free help line; Medicare and You handbook and other publications, and there's a whole table full of the publications that we develop, and I put at each place the order form so you can see the array of things that we do, the Website, www.medicare.gov, and I commend that Website to you, it is really quite comprehensive, and REACH and SHIPS, and those are the only acronyms.

REACH is the Regional Education and Bad Choices in health, and that's an activity that we do through our 10 regional offices to reach out at the community level, and I'll be talking a little bit more about that later, and SHIPS are the State Health Insurance Assistance Programs, and they go by many different names in different states, but they're run out of either the Office on Aging or the State Health Insurance Commissioner's Office, and their principal purpose is to be -- to provide advice to people with Medicare about Medicare and other insurance products, including supplemental insurance and Medicaid.

I also wanted -- this is not talk about customer service, but I wanted to just share this sort of pretty picture with you to tell you that we hold ourselves responsible for certain performance metrics, and it's very hard to read and I apologize for that, but in developing our materials our outcomes that we're seeking, and I'll only go through those, is that we want to be responsive to diverse groups, and I'll talk a little bit about what we do to meet that outcome.

We want to be convenient and accessible and a trusted source of accurate information, which is an interesting issue for us, and I'll talk a little bit about that as well, and we want to be perceived as courteous and professional.

The National Medicare Education Program began after the Balanced Budget Act of 1997 was very explicit in its expectation of what we are to do for Medicare beneficiaries, and that Act requires that we provide general information about benefits, how people elect different health plan options, rights and protections, including appeal protections and information about supplemental insurance, also known as Medigap.

They -- it also required that we provide comparative information about health plans, including their supplemental benefits, satisfaction information, quality information when it becomes available, cost sharing information, service areas and other pertinent decision factors for our consumers.

The law also instructed us to use direct mail, a toll free telephone service, the Internet and a national publicity campaign. So the Congress was very explicit in its direction on how we were to go about this.

And the purpose of the education campaign was to provide people with Medicare with the information that they need to make the best decision for them about their health plan options, and the target is both the beneficiaries themselves and the people who care for them, and we refer to that group of people as caregivers, although it's interesting that that's not a way that people see themselves as caregivers. That's our shorthand for that. And we also are in the business of making sure people get accurate information and protect them from misleading information.

One of the most important things about this next slide is that we want to be able to speak with one voice so people get reliable, consistent messages about what their opportunities are, and that's difficult when you are talking about reaching 40 million people through many different avenues. We have contractors that process our claims. We have the State Health Insurance Assistance Programs. We have the telephone customer service representatives. So we have literally thousands of people that we have to equip with information so that they can give the same answer each time someone asks the question, and we, I think, are doing a good job of providing that kind of consistency, but it is a challenge.

And, finally, we want to provide consumers with information about the quality of care so that they can make decisions and incent the system to improve the outcomes of care. It's an important consumer-driven quality aspect of all of this.

We have four main objectives, and these have not changed from the beginning. We want people to receive accurate, reliable and relevant information. Accurate, meaning that it's factual; reliable, meaning that each time they ask they get the same answer; and relevant, meaning that it's important to them.

We use a lot of consumer research approaches to determine what people want to know. We also work with them on what they need to know so the relevant factor is very important, particularly with the current population of people with Medicare.

They're a relatively passive group of information seekers, different than some of the younger populations, and so it needs to be relevant to them at the moment that they need it, at the moment that their lives have changed and they need information about healthcare. We want to give them the opportunity to access information when they need it, and we want them to understand the information when they get it. And so we've gone through an extraordinary effort to simplify the way we explain information to people with Medicare.

There are some examples of our publications on the back table for people to look through, and they're on this table in the front here for the panel members, and it's been a very interesting process. I've learned a great deal about how to explain things simply to people, and we have a lot more to learn.

We also want people to trust the materials that we give them. The principal direct mail is Medicare and You. That's the name of our handbook. We want them to trust the 1/800 number, and we want them to understand that these are authentic documents for them, and that they were -- include the correct information.

A little bit about our population is 87 percent of people with Medicare are eligible because of age, 65 and older; 13 percent are eligible because of disability. If you're disabled for 24 months, on the 25^th month you become eligible for Medicare. Included in the disabled category are people with end stage renal disease, which is kidney failure, and people with kidney failure, the majority of them are eligible for Medicare benefits; the majority of people eligible are in the 65 to 74-year old age group.

The fastest growing sector of the Medicare population is 85 and older, which brings with it other challenges in communicating.

Eighty-five percent of the Medicare population are white non-Hispanic, nine percent are African-American non-Hispanic, and seven percent are Hispanic. These are self-identified categories.

Sixty-one percent of Medicare beneficiaries have incomes below $25,000.

The next statement is where the majority of the population is. Those are high population states. Proportionally it looks different than that. If you looked at the proportion of aged people in sun states, they're proportionately higher, and I think the highest proportion of elderly per capita live in North Dakota, as an example, not a high population state.

Thirty-three percent do not have high school diplomas. Thirty-five percent are graduates or have certificates, and 70 percent have no college, and this is significantly different for the minority populations. They are less well educated.

Now, when it gets to what do people know about Medicare; they love it. I should tell you that all people that we survey love Medicare. They don't know much about it, however.

Medicare and Social Security are probably the two most well-liked social programs, but they don't know much about it. Very few people, 37 percent of the population, don't know about Medigap, or supplemental insurance, and Medicare does not pay for everything, so for those people who do not have an employer-sponsored retirement, health benefit or don't have other supplemental insurance, such as Medicaid, then they -- all of the cost would be out of pocket, so Medigap becomes a very important part of what they need to know.

And 56 percent of the people know little or nothing about managed care, and if you remember, the origin of the -- of the educational benefit came out of the Balanced Budget Act where they were trying to encourage people to look at their other health plan options, other than the fee per service part of Medicare.

The way people want to receive information -- 38 percent of beneficiaries prefer to talk to people face to face. Now, again, 40 million people, face to face is not a reasonable option to be able to think about how we would provide that, and though people say this, they are as apt to want to do it person to person. So doing it over the phone, even with the State Health Insurance Assistance Programs, often they contact that -- which is a community-based program, they contact people over the phone.

Twenty-five percent like to read, want to see the material in front of them and read it. Nine percent learn through TV, and three percent use the Internet. Now, that number of the Internet is growing. A larger proportion of our population, each time we do a survey, show that they have access to the Internet, and we certainly do see that among the caregiver population using the Internet to get information.

I think I'll -- just for the sake of getting back on schedule -- the other ways that we can reach this population are through media and our advertising campaign. This last year we did a lot of television advertising to increase people's awareness of 1/800-Medicare, and the other information outlets. We also have used radio.

Print, it's interesting, this -- mostly the aged population are very big newspaper readers, but they don't notice print ads as much as they notice news stories, and so it's understanding how to effectively use print media to reach this population.

Now, just to go through the components of the educational program, and I'll talk about each of these in turn so I won't read through all of the -- this list. I'll just talk about each of them.

As I mentioned, the Balanced Budget Act of 1997 mandated that we provide an annual mailing and told us that it would -- all of the mailings were to go into the -- be mailed by October 15^th, and so each year we mail out the Medicare and You Handbook, and there are copies on the table.

We have the handbook available in English and Spanish, audio tape, video -- there's a video production and Braille so that it is available to all of those audiences. We mail out 34 million handbooks, and the 34 million instead of 40 million is that we mail one handbook in a household of four or fewer people.

We have 26 different versions of the handbook because we include in those handbooks information about the health plan options available in the area so they're specific to the area.

Each month we mail out about 200,000 handbooks to new Medicare enrollees, and we send out copies to health plans and congressional offices, and we have two other versions of the handbook.

We send the handbook to the libraries, the public libraries, and in this library version we have other publications that we have written that complement the handbook, and when the -- we refer people to the libraries to use the Internet, so from the beginning we've done this library edition, and we worked with the libraries to make sure that it could be shelved. So this handbook is available in most public libraries.

And we also have a physician's version of the handbook, and in the physician's edition there's additional information in the front about new benefits and payment information for physicians. So this is made available to physician offices.

We have a long list, and I put one at each table, of other publications that we do that are targeted to particular needs of the Medicare beneficiary. For example, when we did -- when we do new payment systems, we will explain the new payment system and its effect on the -- on people with Medicare, or if there's a new health benefit or particular focus of health benefits, we'll write a little flyer or brochure on that so that it can be used for people who have a specific interest.

We do all of our publications in Spanish. We do some publications in other languages. The issue in other than Spanish is that we don't have the quality assurance mechanism to develop multiple language versions. What we rely through the REACH that I mentioned earlier, we ask our regional offices if they have the ability to do other language versions.

They will often develop them, but we need to have a quality assurance mechanism, and if they have other -- people who speak other languages in the community or can arrange that with community-based organizations, then other language versions are done.

We've done some in Chinese. It's very challenging because culturally some of the Chinese concepts are not easily trans- -- it's not even translated, easily explained. The insurance process is not easily explained in Chinese. It's not -- oh, nor in English, someone said.

We -- for those people who are Internet-savvy, we had in December 3.9 million page views. That means visitors looked at that many pages on the site, and in calendar 2001 it was nearly 40 million page views.

The toll free help line. We started the toll free help line in 1998 with five states, 1/800-Medicare. What we do, and this is really a very interesting approach for us, the customer service representatives use what is called a desktop, and on their desktop they have scripted answers to questions, and they navigate through the desktop to answer the questions of people calling in, and this is the way -- I said earlier our biggest challenge is getting reliable -- accurate reliable answers, and so this is the way that we use this, and we've been very successful doing this.

We started out in a much more structured process. Now it's much more conversational, but it's been a very successful approach in getting people the answers that they need.

We went 24 hours a day, seven days a week this year, in 2001, and we added another level of training to our customer service representatives so that they can answer more questions, meaning that people did not have to leave 1/800-Medicare to get the answers to some of their questions.

We -- in 1999 when we started, we got one million calls. In 2001 we had five million calls, and we estimate the calls this year to go up to six million calls.

The average call time is seven minutes, which is long for a call center, but not long for this kind of a call center. I think Social Security is about -- in their call center runs about five and a half to six and a half minutes.

The majority of information that they ask for is information about their Medicare Plus Choice options because we will run them through the options in their area and send them out information that's pertinent just to the area that they're interested in, interested in what Medicare benefits are, enrollment, replacement cards, and the -- one of the most interesting part of this is that in 2001 we increased the volume of Spanish-speaking calls significantly.

Spanish speakers were not calling the number, despite the fact that we had Spanish-speaking customer service representatives. We did the ad campaign that I mentioned, and we had the significant increase in Spanish speakers calling 1/800-Medicare. It still, though, is not representative of the proportion of the population that are Spanish-dependent.

The most frequent -- the two most frequent issues that we deal with are issues of eligibility to Medicare and replacement cards. Both of those are activities that we coordinate with the Social Security Administration so we're looking at ways to facilitate to prevent those calls by making sure people get those answers up front and can easily access that information.

After that for the non -- for English speakers Medicare Plus Choice is the next question. For Spanish speakers Medicaid is the next question.

I think that -- oh. One of the interesting aspects of the call center is that we handle a lot of the calls through the automated voice response unit, and if you look at the handbook, we give people what the voice response unit will sound like when they call and what they need to do to get to a customer service representative.

The reason that many calls are handled here is that people sometimes just want a publication or they can listen to frequently asked questions and answers on the voice response unit, and we handle about 40 percent of the calls through that and the remainder through customer service representatives.

This is what our call center, just schematic, looks like, and it's interesting. I've learned a great deal of things that I never knew before, but the -- what we -- we handle the distribution of the calls through the network level and so we can direct the calls to the next available operator so that it's very efficient.

The most important thing, though, is the square box on the right is the desktop that we use to make sure that people get the answers to the questions that are accurate and relevant to what they want to know, and we spent a lot of time thinking about how to make that knowledge in that desktop appropriate to this population and how to train the customer service representatives.

Another element of what we do on the National Medicare Education Program is building partnerships, both at the local and national level. The regional Education by Choices In Health, one of their main responsibilities at the regional office level is to find partners in the community so that we can leverage one relationship to reach many people in the community.

We look for employers to get information out through their employer -- employee benefit managers. We look for the Triple As. We look for AARP or any natural organization that touches the population that we serve to try to leverage, as I said, one relationship to meet many people.

We have a National Partners Alliance Network. We meet quarterly. This alliance network is made up of advocates, organized medicine, organized law, employee benefits administrators, other federal agencies, and we share with them what's happening in the education program and other aspects of things that are going on within Medicare so that everyone has the opportunity to have that information, and then they will share among themselves things that are important.

In the last meeting we heard about Tri-Care, which is a benefit for military dependents, interesting coordination of benefits issues for many people.

We also have a federal advisory committee called the Advisory Panel on Medicare Education, and Heidi Margulis was a part of that committee until -- and they have provided us with recommendations on what we need to do in the educational program and also are another way for us to make sure that the external community knows what we're doing, and then we also have a very large Train the Trainer Program, which I'm going to talk about later.

I think I talked about this.

The Train the Trainer. Our point of developing a Train the Trainer program is we have a lot of resources in the federal program that we put to making sure that we explain the Medicare benefits and opportunities as clearly as possible, and we want to be able to share this as broadly as possible.

And one approach that we have used is to train others who then have outlets into the community about this, and for the last three years we've done national Train the Trainer programs in each of our 10 regional offices and train people in the community about Medicare basics; benefits, enrollment, eligibility, rights and protections, Medicare choices, coordination of benefits, a whole array of activity so that we can get the information into the community.

One of the things that we are doing that I think is going to be very useful is that we're going to turn this training into web-based training, and the reason that we want to do this is, is again, as I mentioned earlier that the Internet is just an enormously useful tool in reaching many people, is that if we can create a web-based training tool, we can make it available to virtually everyone, and so hospital discharge planners or hospital admission staff can learn information that we would never have the opportunity to reach them with if we didn't use a vehicle such as the web. So we're very anxious for this product. So, again, we can reach the maximum achievable audience.

National publicity campaign. This, again, was part of the instructions we received in the Balanced Budget Act that they wanted us to do an annual national publicity campaign for the purpose of people understanding their open enrollment options and other aspects of Medicare, and one of the things that we use that advertising campaign to do is build people's awareness of the information channels and their trust in those channels because when we sat down and talked to the marketing and advertising professionals, they said you can advertise something, but you have to be willing to deliver on your promise. So don't advertise something that you don't have to give.

So it's very important that the 1/800-Medicare number and the Website and the other aspects of the program work effectively, and they realize the promise of the advertising.

The -- meeting the needs of the individual beneficiaries, the State Health Insurance Assistance programs. These I mentioned are part of the State departments of insurance or State Department on Aging. They often work through community-based organizations like Triple As, and they provide individual counseling, either on the phone or face to face.

The other thing I wanted to mention to you is that our agency -- this is -- doesn't have our new name yet, but this is called the Health Care Financing Review. It has research findings that it publishes quarterly, and in the fall 2001 review is on consumer research, most of it funded by CMS for the purpose of understanding how to communicate effectively with our beneficiary population, and this is available through the CMS dot -- CMS.HHS.GOV Website.

Consumer research I talked about.

Just an aspect of what we do in the consumer research, we want to understand who the target audience is that we're trying to serve. We want to understand what we're trying to get them to do, whether it's awareness or action. We want to present the information in a way that people perceive that there's something in it for them or else they wouldn't pay any attention to it. We want to understand how to convey it to them in a way that they can see themselves in it. That's the image.

We want to plan around an activity supporting actions to make sure that people have the resources that they need, and that in a local level is the REACH and SHIP activities, and we want to be able to understand when people are ready to receive the messages, and this is perhaps the most difficult part of what we have to do, is that most people on insurance and health care want the information when they are at the moment, the event in their life.

And to make sure that it is accessible to people when they need it and helping people know that there's something there for them to access information is very important, and we're still learning how to do that aspect of it.

So with that, that ends my prepared remarks. I can take questions now or wait until the panel, whatever you like.

CHAIRMAN WOOD: We will actually ask for them now, Michael, so, Heidi.

MS. MARGULIS: Thank you very much, and I'd like to say that Michael and her colleagues have worked on about $1.95's worth of funding to do all that they've done, and at least from one industry perspective have really done a yeoman's job of getting the word out, and I commend you for that.

MS. McMULLAN: Thank you.

MS. MARGULIS: As Michael mentioned, I served on the Advisory Panel for Medicare Education. There is an annual report, Michael, that if you can, I'd like to see that every member of the panel gets a copy, and I will turn my copy over to Erik for the Communications Committee because there are a number of very good solid recommendations in the area of how to reach minority populations and most vulnerable of the senior population.

I might also add that some of the recommendations made by the Committee which probably don't appear in here are some that we chatted at our very last meeting about, things as easy as if one looks at the Medicare and You handbook, it has 27 pages, I believe, of telephone numbers of where to call.

We suggested that similar to my ID card, that there be a 1/800 number, no matter what, and that perhaps that number be printed on the Medicare beneficiaries' ID card, just like ours, so that it's very easy, and one doesn't have to search through many, many pages.

But I believe that funding has probably been one of the primary reasons that a lot more hasn't been done, and also working with some community-based organizations to get the word out are among a number of the recommendations.

MS. McMULLAN: We are doing a pilot in the State of Pennsylvania where people can reach any of the Medicare contractors through 1/800-Medicare. There are a lot of technology issues behind that, and we're working through them in Pennsylvania.

What we do plan to do for the plan year 2003 handbook is to use 1/800-Medicare as a place people can get the right telephone number by calling, and we would refer them and give them the right telephone number, doing the network solution so people only need to call one number, and then they're directed to the right place will take more time.

DR. CROSBY: I'd like to ask if you could do this for physicians in an education project, as well, because patients often bring their confusing communications to their family doctor for interpretation, and often the doctors are not any better equipped than the patient to answer the question.

And last week speaking with one of my physician colleagues about my responsibilities on this Committee, he told me that it was his office practice that they would call repeatedly to the regional office or CMS until they got the same answer twice in a row, and then they would go with that.

MS. McMULLAN: The physician education part of it is handled by a different group than mine, but I'll tell you what I know about what they're doing, and as far as the beneficiary materials, things that could be made available to a beneficiary through a physician, we're happy to look at ways that that can be done effectively so that the right information gets to them.

As far as physician education, there is an entire group of people whose mission it is to improve our communication with healthcare professional physicians and other healthcare professionals, and they have -- also have a Website called Med Learn on CMS.HHS.GOV.

They have part of that activity are -- is represented in some of the open door activities that are going on, and they're looking at improving the way that the -- improving the information base that we make available through our Medicare contractors to respond to physician questions on coverage and local medical review policy, which you've heard about earlier, and we're actually looking at putting local medical review policy in a navigable database on the Website, and that's -- that'll be coming this year. I don't know exactly when.

CHAIRMAN WOOD: Patricia Shafer, then Dr. Nielsen.

MS. SHAFER: Thank you. I had a couple questions, but one was -- I think you alluded to in the beginning that it's sometimes difficult. There's lots of different people that will give answers, you know, when a beneficiary calls and has questions. Yet you have outlined a lot of good steps in really trying to get a handle on the educational needs.

From your perspective, what are some best ways to try to get some consistent, clear, understandable answers? I mean it sounds like in some ways the way you describe this that there is a central repository of information, yet outside of here, you know, I don't hear that that's the case. They have people calling different places and they get different answers.

So maybe you could comment on that.

MS. McMULLAN: Uh-huh. The -- we are building a central repository of information for the Website and for the telephone, and one of the things that we are looking for is how do we make that available more broadly. The telephone desktop is built to make it efficient, you know, the least wasted time for the customer service representative, but there's an enormous amount of information there that other people could use to answer the questions if they got them directly.

So we're looking at ways to build a database that allows people to get the same -- have the same opportunity to access that information.

So the -- there are lots of different steps. Simplifying the language that we use. I had a video that I was going to show and decided that it would take too long, but one of the issues that came up has been in a Spanish-dependent individual. They said, AI have this wonderful book. It tells me about physician assignment, but I don't get -- what is assignment, you know, even though you've explained it to me, I don't get it.@ Explaining things simply, we can learn how to do that.

Some concept, some insurance concepts are not intuitive, and physician assignment may be one of them for people who don't have experience in the -- in the native American insurance system where assignment is just part of what we have come to expect under different terms.

Simplifying the rules, but that's something that often Congress needs to do, would be one aspect of it, and I -- we deal with another group within the agency on trying to explain the juxtaposition of Medigap rules, supplemental insurance rules, with Medicare + Choice activities, especially if there's an issue with non-renewing plans. It's very complicated, and explaining that simply to people is -- is quite challenging.

So some of it is the complexity of the system, and insurance products are complex, and that's what we're dealing with. There are a lot of rights that are afforded to people with Medicare to protect them, and that makes layers of complexity and to navigating to help people find the information that they need among all of those things, you know, finding out which election period you're in, of which there are many, trying to get them right where they need to go without having to sort through all of that. So coming up with the navigation tools are important, and storing it -- and having one place.

The knowledge-base concept, which is gaining popularity in a lot of different aspects of what we do is really important here so that we only have one answer to the question.

MS. SHAFER: Along those lines, what readability level do you target most of your materials to, or do you have -- like Your Medicare and You that is comprehensive, and then do you -- do you do fact sheets are more, you know, more simplified versions --

MS. McMULLAN: We work with low literacy and plain language experts, and we target the sixth to eighth grade level. Having said that, some of the concepts that we need to explain are not at that level.

The -- we have commissioned Jean McGee (ph), who wrote a book that's available for writing for people with Medicaid to -- in plain language, in cultural -- culturally appropriate ways to relook at her work and look both at Medicare/Medicaid and Medigap so that we can learn from people who have studied this for a long time how better to do it, but sixth to eighth grade.

Now, another thing that I don't believe I mentioned, in our regional activities we've asked the regions to focus both on partnerships and the vulnerable populations and vulnerable in our context means people who have access barriers, either because of language, location or literacy, and so often the population who have low literacy or language barriers need to have more face-to-face simple explanations.

CHAIRMAN WOOD: Nancy.

DR. NIELSEN: You talked about the average length of time of the phone calls to the 800 number. Does that include being on hold and -- I mean I'm just curious. I don't know. I've never called it.

And, also, what is the abandon rate for people left on hold? And then I have just one other question.

MS. McMULLAN: Okay. We pick the phone up within three seconds. We have a very high almost instant call answering, and I don't believe -- I don't know the abandoned statistic because we don't have many. Usually if there are any abandoned calls, it's because we're having a problem in the network where the call -- there's just some blip. We really are very quick in answering the calls.

DR. NIELSEN: That's wonderful.

MS. McMULLAN: I invite you to call. I really do. It's a wonderful service.

DR. NIELSEN: This was actually a very impressive presentation. I have a question.

How much of this was being done before the Balanced Budget Act of 1997?

MS. McMULLAN: Before the Balanced Budget Act of 1997 we sent the handbook out to all new enrollees, and in, I believe it was 19- -- I should know this. We had occasional mailings to many people -- to everyone, but we only sent it out regularly to new enrollees, and we wrote -- we wrote things like the Guide to Health Insurance.

In the Guide to Health Insurance, there's a copy on the table, we do with the National Association of Insurance Commissioners and explains lots of different health insurance products that complement Medicare, and the -- when we assumed the responsibility for that, I couldn't understand it, and I have a master's degree, and I do this. This is my living.

So I couldn't understand it, and we now -- it's not -- I don't believe it's at sixth or eighth grade level, but it now is an understandable document. So we did -- we were -- I think we put a lot more burden on our contractors to answer questions, and we relied on them in understanding the program fully, and so there wasn't the -- necessarily the consistency. A lot more was forced into the contractor community. We did very little centrally.

CHAIRMAN WOOD: We'll have time for just two last questions so we can try to get back to schedule. I'll have Mr. Bloom and then Mr. Toby has a question.

MR. BLOOM: Thank you. Just have a quick question. I realize this is a very difficult thing since Medicaid is different in every state, obviously, but in looking over and doing some research prior to this meeting, it seems that there's a -- a lack of information for dual eligibles to find out exactly what they're eligible for, if they're eligible for Medicare or Medicaid.

What efforts are being made to provide the materials for people that are dual eligible, and, obviously, it's a great challenge, and perhaps this will be something that'll be taken up at a future date, but I was wondering if you looked into doing some more things in that regard, >cause in this list of materials there's nothing that indicates anything for dual eligibles.

MS. McMULLAN: Right. The issue on Medicaid is that they are state-specific and sometimes sub-state-specific programs, and we did one pilot of a state level book, and it's on the table. It's the guide for people with disabilities in the State of Colorado where we worked with the Social Security Administration, the State Medicaid Administration to develop a book for people with disabilities because there are more programs at the State level.

It's very difficult keeping that current because State programs change much more frequently than federally managed programs. Medicare is a federally managed program, and the rules -- people may feel they change frequently, don't change as frequently as something that's managed on a local level.

We do rely on the states with help from the federal system to develop the Medicaid materials, and you're right, people with -- who are dually enrolled in Medicare and Medicaid have two sets of programs to coordinate.

We are doing some demonstration projects and figuring -- figure out how to better coordinate both the programs, the benefits themselves and the explanation of how to take advantage of those benefits.

MR. BLOOM: Thank you.

MS. McMULLAN: Okay.

MR. TOBY: Thank you, Mr. Chairman.

Michael, my -- my question goes to I guess what Dr. Nielsen said, her last question, and it has to do with the long-term effect of beneficiary confidence. I worked in the Medicare program, I guess, for 30 years. I remember doing this before and nothing as good as this. This is as good as it gets. I have never seen such a massive education program.

And so I'm -- I just have two questions. One is how is the program currently being funded, and, two, what is the outlook of getting this program funded under the Medicare Trust Fund? If it's not funded under the Medicare Trust Fund, it eventually will fall away.

MS. McMULLAN: The -- this gets into inside budget knowledge here, but we are -- we rely on appropriated funds and user fees. That's the way that we are funded, and what Mr. Toby's talking about is some programs are allowed to be apportioned from the trust fund, and so it doesn't rely on an appropriation, and this is -- it is -- the predictability of funding is greater with an apportioned program just because there are lots of different demands on appropriated dollars.

We are funded by user fees. It's the proportion of people in Medicare Plus Choice plans to the total of our total budget. It is constituted with user fees. The original program was funded exclusively with user fees, and now it's funded proportionately with user fees, and the rest of the money -- largely the rest of the money comes out of appropriated funds, and then some of the activities that we do, the -- some of the surveys that we do serve multiple purposes, and one of the purposes is quality improvement and so some of the funds comes out of the account that goes to the quality improvement, which is the pro account, which is an apportioned account.

This is very inside the beltway, and I apologize, but we have multiple funding sources. Some of it -- this year we also had a directed appropriation for the State Health Insurance Assistance Program. So the Congress told us of the money you get, you are to give 122 million to the State Health Insurance Assistance Program.

So there are different aspects of the way we're funded that is -- and the way that we're funded, that is the nature of a federal program.

MR. TOBY: Excuse me, but my question was is there -- in the future do you think it will be funded out of the trust fund, because, if so, it'd be permanent, and we can all be very happy.

MS. McMULLAN: I think -- I don't -- I can't predict that. That's really an OMB philosophical view.

MR. TOBY: Well, what's your judgment?

MS. McMULLAN: It's not a popular way of funding programs, and the reason that it's not a popular way is that Congress reviews appropriations, and they -- they make decisions on what should be funded and what shouldn't. When it's apportioned, it becomes a fully executive office activity, and it's not subject to the same scrutiny.

So it's not a -- it's not popular to do that, and so I don't know whether or not Congress would choose to or not.

CHAIRMAN WOOD: We have the field perspective this afternoon offered by several individuals, and I'm very pleased to be able to introduce them to you.

Beginning to my left and going down the table is Leslie Powell from Legal Services of Greater Miami, and next is Barbara Weese, who is an AARP volunteer. She's from Leesburg.

Mr. Hugo Huapaya from the First Coach Service Options in Fort Lauderdale, and then next is Jane Rauer. She is from SHINE, which is the SHIP in Florida. She's from Hillsborough County.

And then last is Mr. Ramon Perez-Dorrbecker from the Little Havana Activity Center here in Miami. And we're particularly pleased to have all of you with us today, and I'll ask Ms. Powell to lead.

MS. POWELL: Thank you, Dr. Wood.

Good afternoon. As was stated my name is Leslie Powell. I'm an attorney with Legal Services of Greater Miami. I work on a number of issues relating to the Department and community here, including issues related to Medicaid and Medicare. I'm happy to hear the presentation, as many of you are, about the educational efforts in Medicare and hope that similar efforts are being made in Medicaid.

In my experience, although I have no statistics, the Medicaid population is probably lower educated, and with the institution of Medicaid Managed Care we certainly have some concerns that they will have difficulties making choices and understanding covered services. In fact, we have seen many of those problems already, and I hope to talk about those and some other things today.

Specifically I was asked to talk about language access and cultural competency issues, and I will also be discussing the simplification of application and eligibility processing and then the standardization of notices.

As a preface you're going to hear a lot today about burdens to providers and agencies, as well as burdens to the beneficiaries in accessing services, and I just want to be clear that in my experience the needs of beneficiaries and providers are not mutually exclusive. Those regulations which ease the process for providers can still maintain protections for beneficiaries. Beneficiaries obviously benefit if more providers participate in the Medicaid and Medicare programs in a way that allows them to focus on care and not the administrative hoops.

And on the other side providers benefit when their recipients can approach their medical care with knowledge of what their choices are, what services are available to them and including what rights they have to request a review of decisions that are made in relation to their medical care. Such solutions only allow for a more trusting relationship between the provider and the beneficiary, and I think that that really should be the goal of regulatory reform is making sure that that communication between the provider, the beneficiary and the administrating agencies is made easier and helps in that development of the relationship.

To begin with the focus on language access and cultural competency issues, as might be suggested, Miami is definitely a place where this comes up. I could share many, many stories with you of difficulties that beneficiaries have had in accessing services due to the language barriers that are there.

Clients often receive notices in English when they speak Spanish only, and we've actually had a number of cases where individuals with names of Spanish origin received notices in Spanish and don't speak any Spanish. So it's sort of -- it works both ways. There are some difficulties there.

On a more personal level we have clients who tell us they go to doctors' appointments where they can't find a Creole speaker, for example, who can translate for their doctor so their child is asked to translate very personal medical details to the doctor, and that obviously is a difficult position.

So these issues are important to the community here, just basically the ability to communicate clearly, effectively and accurately about healthcare decisions.

In response to Executive Order 13166, the Department of Health and Human Services has recently issued detailed guidance on language access issues. Prior to that, also as a response to that Executive Order, in August of 2000, CMS sent a letter to state Medicaid directors encouraging them to incorporate the Executive Order guidance and reminding states of available funding to pay for interpretation and other language access services.

To date, only five states have agreed to accept that matching funding. States should be encouraged by CMS to accept this additional funding in order to provide interpreters and written translated notices and educational material. This could clearly bridge the gap allowing beneficiaries to better understand the services that are available to them and also to improve their medical care.

Formal regulations enforcing the steps detailed in the Executive Order are also necessary, and failure to enforce would not only be fiscally responsible, but enforcement allows this guidance to let beneficiaries fully receive the benefits available within Medicaid and Medicare.

In addition, data collection, which details each individual's primary language, is essential to ensure that each person gets a notice in their primary language and also to compile statistics to ensure that proper written translation and provision of services is made in prevalent languages.

There was some discussion of the dual eligible issue, and that in particular does affect the population in South Florida. There are a lot of dual eligibles down here, including with the buy-in programs, and it -- to have those explained in the prevalent languages would also be a useful requirement.

Moving on a little bit to managed care issues, many of these issues about language access are prevalent in the new managed care regulations, the Medicaid managed care regulations, which are in the pipeline and I understand may be coming out within the next -- or the final regulations may be coming out within the next few months.

We regularly see clients who are enrolled in an HMO without their knowledge. They don't know how they were enrolled in that HMO and not the one that they had already been participating in. When they attempt to disenroll, they can't find an operator through the enrollment hotline who speaks their language.

I have had reports, although I don't do much Medicare work myself, that similar problems have happened with disenrollment and informational seeking done through the 1/800-Medicare hotline, that they've asked to be transferred to a Spanish operator and have not been -- that has not happened. Either they've been disconnected, or there wasn't one available.

These new Medicaid/Medicare -- Medicaid managed care regulations need to make clear that providers and administering agencies communicate with individuals in their primary language so that continuity of care and services are not affected.

Multi-lingual outreach and education is also important. It's not easy for anyone to deal with HMOs, especially disabled and elderly recipients of the programs; therefore, CMS must mandate and fund well-developed outreach and educational efforts. Detailed plan descriptions should be made readily available for each recipient.

A few years ago in our office we had a training by the -- the agency that runs the hotline, the Medicaid managed care hotline in Florida. They came to our office and discussed the plan descriptions and the process for clients enrolling in managed care, and when we asked for a copy of the plan descriptions, we were told it wasn't public and it wasn't available to us.

The following year we requested an updated training, and we were told that funding for such outreach was no longer available, either, and my thoughts are that if the advocates for the clients can't get this information, then how are the recipients supposed to get it, and there really needs to be a focus on making sure those plans are made available in -- at a level, at a literacy level that the individuals can understand. For beneficiaries to have actual choice they must have an opportunity to review the plan in their own language.

Sort of as an aside to the language issue, I do have some concerns about the direction taken and the proposed regulations for Medicaid managed care. The most recent proposed regulations seem to have removed some of the protections that were available under general Medicaid regulations and under the Medicare Plus Choice regulations for managed care.

For example, the proposed regulations fail to define that a failure to act on a request for services in a timely manner is an appealable action. This means that someone requests a service, they don't hear anything from the HMO. They are actually given appeal rights to determine why they weren't responded to, whether that was an actual denial of service, and that is something that should be addressed in those regulations.

I am hopeful that this process of regulatory reform will not attempt to further limit the individual rights under Medicaid and Medicare as it appears that those proposed regulations have done.

CHAIRMAN WOOD: Could you please wrap up for us.

MS. POWELL: Sure. The other two issues, just to sum, is that there -- I would like to congratulate the Department and CMS on its implementation of the children's health insurance program and the eligibility processing for Medicaid of pregnant women.

They have minimalized and simplified and streamlined the process from what were very lengthy applications to a one to two-page application by removing the asset test and the asset verification. It's reduced the administrative burden. It's reduced the administrative cost, and it's also reduced the burden on the recipients of the benefit.

And I would also like to congratulate the use of standardized notices and the beneficiary notices initiative through the Medicare program which is -- really, they're excellent steps toward simplifying the understanding that's necessary for the beneficiaries in their ability to access the services.

And to hit a little bit on what Dr. Crosby has -- had stated in her questions to Ms. McMullan, provider education and beneficiary education are really the keys. When those two things work together, when all sort of interested parties can communicate, I think that that's really the -- should be the focus of the regulatory reform effort.

CHAIRMAN WOOD: Thank you.

Ms. Weese.

MS. WEESE: Thank you. First of all, I'd like to say how glad I am to be here today, and I'm a little bit shaky after seeing that 65-year old woman this morning. I wasn't quite sure I was going to get unconfused enough to come back this afternoon.

I have a number of many of the same statistics that were just given by Ms. McMullan, so I'm going to skip down to a few other things. Let me just sum that up by saying number one, education; number two, education; number three, education is what we need in all of these things, and, yes, there are an awful lot of people out there who are not well educated enough to take advantage of what's going on.

There is another large group of people out there who were very well educated, were very, very coherent, but especially in Florida have passed the age of 80, and many of those people find themselves now needing help from someone to interpret their rights and their -- and their use of Medicare.

As a former middle school teacher I want to tell you half the eighth graders can't read on the eighth grade level, and I -- I don't want to disparage high school teachers, but I don't think they learn it before they leave there. I think that level is very high to expect as a literacy level for the average American. I could say I'm a snob from New York and our standards are a lot higher than Florida, but that's okay.

One of the top challenges these beneficiaries who've all been told their statistics is to get the information that they need, and I'm going to give you some of my experiences with this. It was mentioned that many of them are in a crisis situation when they want the information because their health plan pulled out, and, boy, do we see that in Florida, or they need a nursing home right away for themselves or for a relative. If you ask them to locate their Medicare handbook, they tend to get a bit testy. Yes, they remember having one; no, they can't locate it, and what are you going to do for them.

We in AARP in Florida get a lot of calls from seniors of -- I think they think we're kind of an oracle, that we know all these things and at our fingertips, have all this information, so usually we suggest, you know, get their handbook out and we'll help them with that.

This is a special concern here in Florida where nursing home problems have been so pervasive, disgustingly pervasive. I went on the Website before I came here to check out the homes, nursing homes in my county and found the information helpful, and I found it easy to read, but then I have a master's degree, too, but in many cases the last inspection of that nursing home was a year old or close to that, and I understand they're done annually.

In my county, Lake, I found out that there are 17 nursing home beds per 1,000 persons over the age of 60, and those figures, of course, do not include the younger disabled people.

I can also tell you in Lake County that a great many of those people over 60 are a lot over 60. We have many more seniors than we have children in Lake. It's a big retirement area. All those northerners came down, and they don't want to go home, including me.

AARP in Florida has made nursing home a top priority. We certainly did last year, put almost all of our efforts into a nursing home reform bill. We need to know about all problems, both those found in the annual surveys and those found when surveys -- surveyors investigate specific complaints.

Complaint investigations can reveal problems just as serious as those found in the annual surveys, and I'm going to tell you right here last year, although it was denied all over the place, we had person after person tell us they had overheard in a nursing home someone being called, saying that an inspector would be arriving within a week. I don't know what that means to you, but I know what it means to me.

Now, here's another thing. I have two people I'll tell you about, and I hope your stomachs are strong. Both of them felt that their loved ones, one a husband, one a father, were in great nursing homes. They touted them. They told wonderful service they were getting. They were both going to the nursing home every day.

One of the women became ill herself and now can only go visit her father two, maybe three times a week. I happened to encounter her at a meeting after she had just returned from the nursing home, and to say that she was near hysteria would be putting it mildly.

She went in and found her father at noontime sitting in a urine, feces-soaked wheelchair and obviously had been there for quite awhile. She immediately got a CNA and demanded attention. She got the attention and her father was cleaned up.

She was complaining bitterly about this, wanted to know how this could possibly have happened, and she was told by the staffer that if she wanted to make sure her father -- he did have sores when it finally came out -- didn't have sores, then she should check him when she came in, to which she replied, AI have never seen my father in his underwear, and if I walked in this building and started checking my father personally, he would be devastated.@ So she went home and called the Ombudsman. Now we hope something will come out of that.

The other woman who thought her husband was getting great care was so impressed because every day when she went there at the same time he was dressed, and she thought now, boy, talk about a level of care. He's dressed. He's sitting in a chair. This is wonderful. That was until the day that she was called by the nursing home that he'd been hospitalized, and she arrived there to find out that he had very, very severe sores from neglect and concluded that one of the reasons he was probably dressed every day and sat up -- now, obviously, these men were not communicating, but not an awful lot of people in nursing homes communicate well, even if they can communicate. They depend totally on others.

So I don't know, but something's got to be done about that. We felt staffing -- staffing education, more staffing. Then there's the problem if you are -- do not speak English and the staff only speaks English, and then there's the other problem, if you don't hear well and you only speak English and the staff members have a strong accent, you can't understand them, either, and that could be any kind of an accent, including the New York accent.

These are things that we know are extremely difficult and extremely difficult to fix, but that doesn't mean that we don't have to keep looking at them and fix them.

We have to keep going on with all of this and trying harder to make our nursing home and community-based services, which we heard about this morning and I was gratified to hear, about these programs this morning because all of us know that that is another avenue that has to be fully researched and fully implemented.

Many of our people don't need a nursing home, but they go simply because there is not available service for them, and we have a lot of -- believe it or not, it's hard to realize in Miami, but Florida has a great deal of rural country, and the services, as in every other state with rural country, whether it's doctors or hospitals or nursing or staffing or anything else, are very limited, compared to more metropolitan areas.

CHAIRMAN WOOD: Could I ask you to wrap up.

MS. WEESE: Yes. So we tell everybody to call SHINE, actually, if they have problems that sound like they're easily solvable.

I did hear about the Medicare 1/800 number and some other people alluded to that. I had several people, when I asked them to call that, tell me, AI called, but they're always busy.@

I think we have to understand, too, that a lot of our older people are really older people, are short-tempered because they're frustrated. They know that they're not receiving and comprehending information the way they did 10 years ago, sometimes five years ago. They know they depend on other people, and so anything that we can do to bring this more down to a more personal one-to-one level, whether it's going out and talking to people, having resources available at our agency, a person to answer the phone maybe who specializes in this type of a client, is something that is extremely needed, and we're very aware of that here in Florida.

Thank you.

CHAIRMAN WOOD: Thank you.

Mr. Huapaya.

MR. HUAPAYA: Good afternoon, Mr. Chairman, and thank you for the opportunity to address the Secretary's Advisory Committee on Regulatory Reform with my observations from the beneficiary communication and education perspective to improve Medicare.

I will address these observations on four points. First I will describe how regulatory and legislative complexities can create and cause obstacles or may further some beneficiary interaction with Medicare. Secondly, I will give you some examples of regulations and procedures that are complex, lengthy or burdensome for beneficiaries. Thirdly, some of the challenges we have in educating and informing beneficiaries about Medicare and its complexities. And fourth, practical and specific solutions.

Number one, regulatory legislative complexities are received from beneficiary feedback. This is in personal comments that I get when I address the media, the public, beneficiaries in person through the media and the press. My personal observations are as follows. The examples for regulations are detailed under the coverage, specifically, eligibility issues, payment issues and beneficiary and provider interactions.

For example, on the eligibility there's a seven-month enrollment period that can be daunting for some people to understand that they can't wait a year and five months before they can enroll in Medicare Part B if they choose not to take it initially.

Secondly, for disabled people they may have to wait 30 months to be in Medicare because Social Security has a five-month waiting period that's mandatory before they receive the first check. In addition, they will have to wait the 24 months of receiving disability benefits before they're in Medicare, and it becomes effective the following month. So we're looking at 30 months before someone with disabilities can be on Medicare. I understand from our Social Security partners that some of the people actually expire before they become entitled to Medicare.

Lock-in periods that became available or in effect this year can add to some of the confusion because there's a particular procedure to follow if someone wants to change an HMO. They most enroll in the second one so that that will automatically disenroll them from the first. If they don't follow that procedure, they can be left in a position where they cannot enroll in another HMO, and they will have to be in original Medicare. They need to be well informed of this particular detail.

Payment issues. I was just talking previously about getting into Medicare, the pre-Medicare section. This is during Medicare. To getting services, for example, a beneficiary may be asked to sign an advance beneficiary notice, or ABN. This notice might be technically and legally correct, but it doesn't get the message across. Some people are confused about you may -- this may or may not be covered, and there is no set amount of what you may or may not have to pay.

After the Medicare services they may receive a Medicare Summary Notice, and the language might be, again, technically correct and legally correct, but the message doesn't get across. Many people don't understand when they hear you have met the $100 deductible, they really don't know what that means.

So compound that with fragmentation of services, that is, receiving services and calling different agencies, organizations for these services, on questions they may have about bills, for example, supplemental insurance policies or who they go to for what.

We talk about the third item, and that's a challenge of educating and informing beneficiaries about their Medicare benefits and rights. The way I separate the audience is that first let you know that beneficiaries are not one audience. They're a diverse group of people that are English or non-English speaking with limited English proficiency.

Also, there might be active or passive learners. This, in addition to other sub-populations that are just physically hard to reach, they might be disabled and also in rural areas. And another part of the audience, caregivers or healthcare professionals. For the English and non-English we try to reach the French Creole speaking, the Chinese, Russian and Spanish in South Florida.

For the active learners and passive learners that are culturally diverse it is imperative to know how to address the information so that they would understand it. Basically want to give them the information in the format that they need, in the language that they understand and prefer. Some of the disabled are patients with mental deficiencies that rely on caregivers, and some of them have literacy issues. That's why it's important to address the caregiver in education, the information outreach.

Now, some of the proposed solutions I believe are practical and specific. First, make regulations easier for -- and simplify things for Medicare. Make it easier for beneficiaries to enroll. Make MSN, the Medicare Summary Notice, and the Advanced Beneficiary Notice easier to understand and use more plain language.

As an example, to say a service is 24/7 doesn't really translate well, whereas, if we say any time every day, this is better understood.

Increase outreach to caregivers. We partner with the Social Security Administration, Florida Medical Quality Assurance and the with Department of Elder Affairs SHINE program. We address several groups of people that we can -- by partner with the shared resources, and they can receive official Medicare information before they need it.

These are the pre-retirees, these are people that are not in Medicare yet. They need to know about the enrollment periods. This is also the next wave or large well-informed demanding beneficiaries, the need to have the information, again, before they need it.

I'd like to address the under served population need face-to-face communications. We propose to have expanded partners and advocacy groups to reach people, and some of these groups are the Centers for Independent Living, Goodwill, National Federation of the Blind to address specific targeted disabled groups.

And two more items, innovative communication vehicles, such as partner with national public radio, Public Broadcasting Service. This will use radio, TV, close-captioned and Webcast to a large number of people. This will be, of course, the English-speaking active learner beneficiaries.

Look at what MPR and PBS have done for helping kids understand just basic information. We can do this for the adults. New partnerships that can help Medicare beneficiaries and caregivers is the target with MPR.

For disabled, specifically nationwide radio reading service. This will reach not only the blind or low vision, but the print-impaired, dyslexic, homebound and people with mobility impairments.

First Coach partners with 10 radio reading stations in Florida. We reach thousands of peoples with CMS-produced public service announcements that they broadcast on test stations in Florida. They reach a specific targeted group.

For example, WLRN in Miami has almost 10,000 radios, and this is broadcast on a subchannel so that information is reached to a very targeted group.

Lastly, one thing that would help beneficiaries that are non-English-speaking is to have concurrent translations of beneficiary publications. This would help with timely delivery of the information, and instead of having sequential preparation from English to Chinese or Spanish, we will have current -- concurrent translations that will offer timely information.

Want to thank the Advisory Committee for the opportunity to address these issues. Thank you.

Ms. Rauer.

MS. RAUER: Good afternoon. I'm the State of Florida's volunteer coordinator for SHINE, serving the health information needs of elders, one of the 53 SHIP programs throughout the United States.

I'd like to first express my thanks to CMS for the wonderful relationship that we have with our regional office in Atlanta and with Baltimore. They have provided the SHIP program with wonderful technical support and on a timely basis.

As SHINE team members we face some very challenging problems on a daily basis as we work with the elders in Florida, and particularly here in the Miami-Dade County area. We were able to serve approximately 100,000 reported clients last year. Most likely that number was even greater. We expect that we'll be able to capture that this year as we have been introducing the new national client intake form that helps us capture the information.

One of our greatest challenges in the area of our counseling is in the prescription drug problems. Well over 50 percent of our clients' inquiries deal with elders asking us for help with this most pressing issue. They cannot afford the high cost of drugs. Counselors deal with client frustrations as they try to help the elder clients resolve this most compelling problem.

Florida has faced HMO terminations for the past four years that have affected 250,00 elders in this State, leaving many elders with no available HMO coverage in many of the state's 67 counties. Elders here in Miami-Dade have been somewhat more fortunate than their rural counterparts, but they, too, have experienced change in their benefits that their plans cover and in what they must provide for themselves out-of-pocket.

Marketplace changes have made healthcare difficult for our elders as they cope with providers leaving plans for business reasons which forces our elders to secure new physicians and medical facilities that not only present a transportation challenge for them, but one of a personal nature as these elders now have to establish new relationships with new providers.

In the rural areas there's no available public transportation, and in the urban areas elders sometimes face the problem of public transportation being inaccessible or unreliable, causing frustrations and stress for the frail and sick. Even though that is not a problem that SHINE can assist with, we are able to usually forward that elder on to another agency that might be able to help them with transportation.

SHINE works diligently with limited resources to continuously educate our SHINE counselors. These individuals work on a one-to-one basis with elder clients in solving or reaching an agreeable compromise on a health insurance problem.

In addition, SHINE counselors make presentations to elder groups apprising them of their Medicare benefits, as well as the rural community health clinics and the service that they provide to seniors and the communities they serve. In the urban areas we educate them on the availability of community health clinics and their types of services.

We educate the elder veteran on services available in their veterans affairs clinics and hospitals. Educating elders on QMB/SLMB, or the Medicare buy-in programs, make them aware of the benefits available that can help them if they meet the eligibility criteria. This program, folks, is one of the best kept secrets.

We have to dispel the myth of being on the dole if you apply for QMB/SLMB. Accepting assistance of this nature is of the hard sell. Pride is everything with these elders. They are the product of the Depression era, and they maintain strong views on being independent. Perhaps a new method of enrollment would capture more of the eligible individuals. Publicity of the program's value done on a national level may also increase awareness of its value and take away the handout taboo.

Within each area of this great State we have cultural diversity issues, and Miami is representative of the melting of many nationalities and cultures. SHINE has had to find ways to make sure that the elders are made aware of the services that we have available to them.

SHINE has tackled the problem of culture diversity by educating and certifying SHINE volunteer counselors who are bilingual, as well as being a member of a specific cultural group. Peers working with peers. We have recruited volunteer counselors from the Hispanic communities, the African-American communities, the Asian-Pacific Rim communities and the Creole communities here in Miami-Dade.

SHINE has 19 counseling sites available in Miami-Dade to help the elders with their health insurance issues. We continue to pursue the Native American communities to avail themselves of our service.

We continue also in our effort to educate the blind, deaf and physically challenged individuals, both those over 65 and those under 65 eligible for Medicare about their Medicare benefits, as well as what other programs and services are available to them.

Other areas of the State have the same kind of challenges as they have here in Miami-Dade, as well as different ones.

SHINE must address the issue of low literacy, lack of communication and the lack of computer Internet skills. We have made great strides, but we have a long way to go to make sure that every elder 65 and over has the necessary information to make informed healthcare insurance choices.

We respectfully request Health and Human Services to continue to support our effort as SHINE works to expand and improve our program. We have needs for additional awareness by communities of our free counseling program. Perhaps knowledge of our work is best spread by the personal exchange of individuals, each to another.

Additional CMS involvement in the production of public service advertisements that address availability of the SHIP program and what services we offer are free. Coordination and correlation of materials and providers of information would certainly make the Medicare maze easier for elders to traverse.

Currently when we get a client on the phone, they may have already spoken with nine different offices, leaving them frustrated, upset and very confused. Usually after a few minutes a counselor is able to address their problem and start working on a resolution. They're delighted to find out that they can now call one number to get the answers to their question. This one-on-one relationship leads to a high level of trust and comfort for the client.

SHIP programs are a good investment for CMS. We get the word out to the elders on cost -- on a cost-effective and timely basis, along with solving many problems that the elders have with their health insurance.

In summary, SHINE has made excellent strides in providing elders with service. This has been demonstrated in the areas of the HMO terminations. We were there ready to go from the minute we heard. SHINE providing beneficiaries with education in their native language by bilingual counselors here in the Miami-Dade area, and our SHINE team here in Miami-Dade has done an outstanding job of that.

This is not to say the job is complete. That would be a misnomer. The work has only just begun. Additional help and services continues to be needed in the area of prescription drug coverage, advertising of the QMB/SLMB program, along with streamlining of a delivery system of services that is user-friendly.

Thank you for your attention.

CHAIRMAN WOOD: Mr. Perez-Dorrbecker.

MR. PEREZ-DORRBECKER: Good afternoon. It's a pleasure to having me in front of such distinguished panelists and personalities, and, Madam Assistant Secretary, it's a pleasure to see you back home again.

Little Havana, as we are better known, is a leading Hispanic health and human service organization in the State of Florida, nationally recognized for its diversity and quality of service, serving more than 45,000 seniors 60 years of age and older in Miami-Dade County through 18 multi-service community centers where nutrition, health and social services to elderly, children and their families are provided.

The average age of our participants is 79 years. The expertise in serving this segment of elderly South Florida population -- elderly, they're elderly, very low socio-economic status, less than proficient in the English language, first generation immigrants from Latin America.

I have identified at least six barriers to access Medicare-Medicaid health insurance services. The first one. I believe there's a lack of culturally proficient and language-appropriate public information on eligibility requirements to qualify Medicare-Medicaid services, lack of information and ill-informed rumors circulating in immigrant communities combined to discourage low socio-economic status elderly immigrants from seeking the services they need.

Immigrants are reluctant to apply for federally funded services, given the restrictive changes to eligibility from publicly funded services enacted in 1996 as a consequence of new immigration and welfare laws, front line eligibility workers trying to serve immigrants may flounder in the new maze of eligibility requirements.

Two, to ensure their effectiveness, front line eligibility workers should be culturally sensitive and competent to their population that they serve and be bilingual with their primary language.

Three, there is virtually absence of public information on eligibility for the Medicare savings programs. Qualified Beneficiary Programs to Specified Low Income Medicare Beneficiary Program, the Qualifying Individual Program, the Qualifying Individual 2 Program, these are programs that could pay for all or part of Medicare B premiums for very low income eligible Medicare beneficiaries.

There is no -- four, there is no ongoing sustained outreach effort to inform and guide eligible low socio-economic status elderly persons who are language and culturally different.

Five, public information on eligibility should be simple and easy to understand. With elderly radio continues to be an excellent vehicle to get their basic information.

Six, those responsible for helping others access services should be well informed on the steps to follow to access services and be able to guide those seeking services to how and where to go to fill out applications and other requirements. All too often misinformation leads to delays in accessing needed services or prevent a person from accessing all services he or she should.

Recommendation. Instead of relying on hiring outreach workers as federal employees, it would be more economical and efficient for CMS to contract directly with grassroots -- grassroots community-based organizations to do the elderly beneficiary education outreach. Community-based organizations personnel often share the culture and language of their clients and are experts at securing and/or advocating for services needed by their clients.

Another area is to promote better access to basic healthcare to persons of low socio-economic status and culturally different, particularly elderlies.

One, community-based basic primary health services, both preventive and treatment, should be available.

Two, community-based agencies should have greater capability to provide healthcare services. The elderly are very receptive to health services provided within their familiar environment, like vaccinations, education, screenings, et cetera, but many are reluctant to travel out of their communities to seek these same health services. Hospitals and outpatient clinics may be viewed unfamiliar and sterile and maybe even threatening to an elderly person and too costly.

We feel needed health services not sufficiently covered by Medicaid are though emergent care is covered, some debilitating chronic health conditions that impact functional ability on long-term health status are not currently covered by Medicaid/Medicare.

Examples. A second set of dentures that would ensure maintenance of nutritional status for frail elderly persons is currently not paid by Medicare/Medicaid.

Increasing the number of physical, speech and occupational therapy sessions would ensure better rehabilitative outcomes for elderly persons who have suffered broken bones or functional deficits due to strokes. Current number of sessions paid by Medicare/Medicaid are not enough to effect functional rehabilitation. The unintended consequence of this short-sighted economic measure may be the much more expensive nursing home institutionalization.

A more comprehensive outpatient care that includes medical nutrition therapy as an integral component of treatment, particularly for chronic illnesses and conditions like diabetes, hypertension and obesity, among others.

Much more targeted health education campaigns should be done to educate low socio-economic status culturally and language diverse immigrant elderly persons about the health-sustaining value of preventive measures and lifestyle changes.

Mainstream flu and pneumonia vaccine campaigns and efforts to promote periodic colonoscopies have not increased the use of this valuable preventive diagnostic measures by culturally and language diverse low socio-economic status elderly persons.

CHAIRMAN WOOD: Can I ask you to wrap up, please.

MR. PEREZ-DORRBECKER: Mainstream women's health promotion and disease prevention campaigns have not increased the use of diagnostic mammograms and pap smears by culturally and language diverse low socio-economic status elderly women.

Recommendation. Instead of hiring health educators, outreach workers as federal employees, it would be more economical and efficient for CMS to contract directly with grassroots community-based organizations to do the culturally and language-diverse elderly beneficiary health, education outreach effort. Community-based organizations personnel share the culture and language of the clients and can develop outreach health education campaigns expertly designed to engage the attention of the client population.

Thank you.

CHAIRMAN WOOD: Thank you.

I'd like to give the committee some time for questions. Let me start with Gary.

MR. DENNIS: First of all, I'd like to thank the panelists for such a very detailed discussion of this topic, but I have a couple of questions related to limited English proficiency and how that should be managed, and it's been very difficult over the last year, as you know, in trying to come up with a solution to that, and I have a couple of questions about it.

The last statement I heard was a very interesting one. Mr. Ramon Perez-Dorrbecker, what you said made a heck of a lot of sense to me. I don't know how CMS would do that, but you suggested that community organizations provide services for cultural competence, outreach and translation. That was the impression I got. And that's really one of the big problems that we're having.

As a physician we have problems providing all of the educational services, as well as the translation services, for patients of diverse backgrounds, but especially for Spanish-speaking persons, and I was wondering whether there's any reason why such contracts couldn't be developed.

Currently, you know, physicians' offices might be required to provide those -- those services, and there's really no payment for them. If -- if the states apply for the additional services and additional money to provide services, why can't that money go towards paying individuals like community organizations to provide that service for doctors' offices or clinics or wherever they happen to be? Anybody on the panel.

MS. POWELL: I can address that to a degree. I know that there have been -- just in my discussions with colleagues across the country on this issue that there have been some similar projects like that, either in getting language schools involved to provide it as part of their training sessions or to get community-based organizations involved, and I think that that's an excellent idea. I don't see any reason why that funding can't be used to that degree.

I know that New York, California and Maine have set up some excellent programs in that regard, and I have a little bit of information that I could probably gather together and share with you if you'd like that in terms of those programs and what they've been set up to do.

DR. NIELSEN: On just that -- just that topic, I called the New York State Medical Society over the weekend to find out if there was any reimbursement in New York for physicians who have to hire an interpreter, and, of course, you know the answer to that.

The American Medical Association has -- had polled all of the states and heard back from 28 of the states to find out what the cost for an in-office interpreter would be because right now the burden is on the provider, the physician, to do so, and I have that here. This was provided to the OMB, but I'm not aware, Bobby, that this has been provided to HHS, and, clearly, we need to get this information out because there is some misunderstanding.

Let me give you a couple of examples. In California interpreter rates, depending on the language, are $75 with a two-hour minimum up to $90 with a two-hour minimum, and the MediCal rate for a new patient, medium complexity, is $57. If the person has been a patient for awhile, it's $24.

There's clearly a problem as you go through to see if Medicaid in any of those states pays for an interpreter. I could only -- of the 28 states that responded I could only find two where there was any reimbursement from the State. One was Oregon and one was Utah.

We have a lot of work to do here because -- let me give you an example. It's one thing to be located in an area where there is a heavily Spanish-speaking population. It's another thing to be practicing in Queens where there are 127 languages. That is simply -- it's just not possible for a doctor to do this every time -- every time they see any of those patients. Not only do they not make anything, they lose, and they lose big time.

So we have a very serious issue, and like Gary, I was impressed with the idea of perhaps having a community organization get involved, but I have yet to hear where the funding is coming from. What is this -- at the moment, as far as I know, there is no funding stream.

CHAIRMAN WOOD: I was actually surprised to hear that there are these funds that are available. Do you know the source of those?

MS. POWELL: And in New York. We sure want to know where the one in New York is.

MS. POWELL: I could give you a copy of the state Medicaid director's letter. It was issued in August of 2000.

CHAIRMAN WOOD: Christy's telling me it's Medicaid, it's up to the states. Heidi, do you have the answer to it?

MS. MARGULIS: I believe -- thank you, Mr. Chairman.

I believe that there is an issue, and I would look to -- I was wondering if Michael's still in the room, because this is a recommendation that the advisory panel did make with regard to -- I think at an earlier meeting, Michael, that we discussed grants to community-based organizations because I know that had been a big issue among committee members, and it was my understanding there was some problem or some issue or some barrier that this committee might look at in terms of the ability to grant -- to make grants to these organizations. So at least from the Medicare side outside of SHIPs I was unaware, and maybe a demo, that there was money out there, that there was some problem.

MS. McMULLAN: I'm not aware of the Medicaid State -- Medicaid Director's letter so there are people who can answer that question directly.

The grants -- the grant process is one where we do lots of competition, and that's why in the grants to the states that was the whole genesis of that, to have some infrastructure that you could give automatic grants to essentially that would then go into the community levels. Managing a grant process that would address all community organization in all states and territories would be quite complicated.

MS. MARGULIS: Is there a process, other than a grant process? In other words, they -- I believe some of the speakers spoke about instead of hiring counselors, in essence, who become federal employees, that in lieu of that community-based organizations be used.

MS. McMULLAN: The -- I'm not --

MS. MARGULIS: Is there --

MS. McMULLAN: I will certainly look into this and provide the full answer to the Committee. I'm not aware of anything other than a contract, a grant or a cooperative agreement, and the grant is the least complicated of the three.

CHAIRMAN WOOD: Other questions. Erik.

DR. OLSEN: This is for Michael. Mr. Toby and I were comparing our cards. It has the -- has the address in case it's lost, you can drop -- but it doesn't have the 800 number. Is there a reason for that?

MS. McMULLAN: This came up. I think Heidi mentioned it. It came up at our other advisory panel, and we really hadn't looked at it, so we now have a newly mocked-up card with the 1/800 number, both on the front and also the reference number on the back because now there's a reference number, but it's to the Social Security Administration.

We -- because this would be a new card, we'll have to clear the use of this through the Department, but what we would like to be able to do is get it cleared so that we could put it in the handbook for 2003 and give it out to all new enrollees and use it for all replacement cards because my mother is a Medicare beneficiary, and I said, AHave you ever looked at your Medicare card for the number?@

She said, AThe only way I would look at it is if it's on the front. I'd never look at the back.@ And the back, the print is small, also. So we're going to put it on the front and hope to do it for this next year's version.

MR. TOBY: Mr. Chairman, if I may -- I'm sorry.

CHAIRMAN WOOD: Well, let me come to Judith, and I'll come back.

MS. RYAN: Just an observation that when we look at management to the care of the older adult in the community, about 87 percent of that care now comes from the informal caregiver, not from the professional side of the equation, and when you look at the cost of substituting professional care, specifically for these kind of things like interpretive services, it could just escalate.

So I've had some experience with the block nurse programs and with the parish nurse programs that have been supported by the local community organizations. It's true that where does the funding source come from is a big question, but it seems that some of the recommendations that we've had from these panelists about ways in which to use the language journals, the radio stations that we already know are piping their message to that target population makes a good deal of sense.

CHAIRMAN WOOD: Mr. Toby.

MR. TOBY: Thank you, Mr. Chairman.

I'd like to speak to the Medicaid issue because I've had a lot of experience in New York in managing that program at the federal level.

I can tell you that I haven't seen the letter. You mentioned in 2000 in New York State, but the Medicaid program is one in which the State actually administers the program, and they have broad flexibility.

They don't have to come to the federal government to say they want to fund, you know, for language instruction or for translations. They don't have to do that. They just send a state -- send in to the federal government a State plan, put it in their plan and say we need this, and New York does a lot of that.

New York is also a State which has always, I must say, has been very innovative throughout the Medicaid program for 35 years. If New York State, because of its language difficulties in program administration, they see a need to do something, even if HCFA or CMS does not reimburse, New York will go ahead and do it and not even bill the federal government for it, but they will do it, and some of the states will be just as innovative, but the Medicaid program is very flexible.

It doesn't have to be medically related as it does in the Medicare to get reimbursed.

CHAIRMAN WOOD: Tony. Tony Fay. Go ahead. Why don't you answer that question.

MR. HUAPAYA: I'd like to add that the Medicare contractors, such as quality improvement organizations and the contractors that process Medicare claims understand the complexity of Medicare and can best address the needs of education and training to beneficiaries, caregivers and also the Medicare providers.

One of the things that happens as being part of our contractor, the process making claims is you can see the entire loop of the Medicare claim from the beginning one -- say a provider begins with services through the whole claim process until he gets adjudicated, gets paid.

So questions regarding claims, for example, which is the majority of the issues where people call Medicare about, their medical claims, are handled best by contractors.

CHAIRMAN WOOD: Tony, I'll give you the last question.

MR. FAY: Thank you, Mr. Chairman. A quick comment and a quick question.

My mother's on Medicare, but she's also very lucky. She's got Tri-Care for life, and this is a supplement plan for military retirees and their spouses, and, you know, I always help her with her Medicare bills and try to interpret the EOBs or MSNs, and for the first time last time I was home I actually saw the Tri-Care EOBs that were incredible because they're in plain English, and they have codes on them in big print that say things like good news, your bill is paid in full, you don't owe anybody anything for this occasion of service. And I just thought that was so plain.

I mean there was no question that that bill had been satisfied, and, of course, I realize that's a program funded or administered by the Pentagon and so forth so maybe they're just a lot more direct, thanks to our Secretary of Defense.

But I guess the question I would have is where do we stand with respect to redesigning the Medicare MSNs to try to get them to the same place where they are going to be understandable by the end user?

CHAIRMAN WOOD: Michael.

MS. McMULLAN: We are looking at the Medicare Summary Notice. That's what he's referring to. The current version is easier to read than the explanation of Medicare benefits, which was the first version, and we're looking at ways to simplify it. It is -- and we will actually look at the Tri-Care to see if there are things that we can learn from it.

The difficulty in simplifying a claims-based form is being able to provide sufficient information in the space allowed without making it too burdensome, and there are a lot of -- of rules that we have to follow, as well as to what -- how we can explain things, but we are looking at ways to simplify it and would be actually anxious for any advice people can give us that is far better -- and I mean I know that this is not what you want to hear, but it's far better than the explanation of Medicare benefits, which was the original version. So we've gotten one step forward and we need -- we recognize that we need to make it better, and we are looking at it.

CHAIRMAN WOOD: I saw some nods here that indicated an agreement. I appreciate that.

I want to personally thank -- and on behalf of the Committee thank our panelists today for sharing your perspectives with us. We will try to take advantage of your good ideas and incorporate them in some of the recommendations that we make.

We do have some time scheduled for public comment. I'm a little bit behind schedule, but I would like to take about a 10-minute break, and then we'll come back and hear from members of the public.

(Whereupon, a short break was taken in the proceedings.)

CHAIRMAN WOOD: I'd like to begin hearing public comment, and if the committee members would come back to the table.

We have several people who have asked to make public comments, and we will try to accommodate as many of you as we can. I would like to offer four minutes each for each of you who want to make pubic comments.

We would be grateful if in your comments you could address specifically some solutions that we might consider. As I mentioned this morning, when we were beginning the process of comments, the charge of this Advisory Committee is quite clear, and the charge is that we need to make recommendations to the Secretary for regulatory reform or regulatory simplification.

We do not address issues of expansion of benefits or legislation that might influence coverage of services that are no now covered. Those are things that we can note, but there really isn't anything that we will do specifically about them except to note them. So we are, again, much more interested in what you might be able to suggest to us about specific regulatory -- regulatory reforms or solutions.

The order that I'd like to follow here, just to give you an ability to be prepared, Ms. Kathy Reep first, followed by Ms. Sue Homant, followed by Ms. Peggy Schafer, and then I'll pick up from there. So Ms. Reep.

MS. REEP: I know a number of other people came up here with prepared statements, and mine is not prepared. I just brought the hospital manual with me, luckily just a few pages.

Two issues that I wanted to address that from a regulatory burden perspective have caused significant problems for the hospitals in Florida and across the country, because I have dealt with these issues, not only from the Florida perspective, but also dealing with my counterparts across the country.

The first issue is -- relates to Medicare secondary payer questionnaire. The MSPQ, as it is affectionately called, is a questionnaire of about a little over 20 questions that is a requirement on hospitals, and according to the hospital manual in Section 301 it indicates that we are to complete or ask these questions of the patient for every admission, outpatient encounter or start of home care. So we're dealing with admissions, outpatient encounters and home care services.

Hospitals do not object to that. We support it because it does help us meet our obligation under the conditions of participation and under our contract with Medicare to verify that Medicare is the appropriate payer and the primary payer.

However, under the issue of outpatient encounter we go to the hospital manual again, Section 230.1 where it defines an outpatient, and an outpatient is defined as a person who has not been admitted to the hospital as an inpatient, but is registered on the hospital records as an outpatient and receives services from the hospital.

It goes on to say that when a tissue sample, blood sample or specimen is taken by personnel that are neither employed nor arranged for by the hospital and is sent to the hospital for performance of tests, the tests are not hospital outpatient services.

These are typically the services that are provided by a reference lab. A specimen is drawn by the physician or someone in the physician's office. It is sent to the hospital reference lab for completion of a test.

What hospitals are being forced to do, and this was clarified as of January of this year, when the hospital manual was changed to say that patients -- non-patients, it actually says, any provider that bills Medicare for services rendered to Medicare beneficiaries, including non-patients, must determine whether or not Medicare is the primary payer for these services and must complete the Medicare secondary payer questionnaire.

There is some leniency on the questionnaire for reference labs and that we can rely on one that was obtained elsewhere in the hospital within the last 60 days, but that's difficult to do when you're dealing with perhaps an off-campus reference lab.

This is not a burden that is on freestanding reference labs. It is a burden on hospital reference labs only. We do not have a patient in front of us. We merely have a specimen, and it seems that the most recent guidance conflicts with other sections of the Medicare instructions.

It's also very awkward for a hospital-based reference lab to contact the patient who had no idea that their blood specimen or their tissue sample was being sent by their physician over to XYZ Lab, but the hospital calls them up and says, AI want to get your Medicare number, and I want to get additional information and ask you these 20-odd questions to complete the Medicare secondary payer questionnaire.@

The patient has no clue that the hospital is involved or why the hospital would be involved, so it is very awkward, very confusing, and we think it would be a key service that you could eliminate that requirement for the Medicare secondary payer questionnaire for hospital-based reference labs.

Another issue, very quickly, that you'll hear more about tomorrow under EMTALA is local medical review policies in the emergency department. Hospitals are required under EMTALA to provide the appropriate medical screening. This is determined by the physician, the tests that are ordered by the physician or performed by the hospital. We do not have the opportunity to get a medical -- advance beneficiary notice from the patient; however, we are denied payment for these services, and it, again, is a regulatory burden.

We would recommend that the medical review policies not be applied to emergency situations.

Thank you.

CHAIRMAN WOOD: Thank you.

Sue Homant, followed by Peggy Schafer.

MS. HOMANT: Thank you for the opportunity to give you comments today and welcome to Florida on behalf of all of the Florida hospices and the 67,000 patients that we served here in Florida last year.

I don't know if you know this, but one out of 10 hospice patients is treated in Florida, and even though it wasn't hospice care, end of life care was not in the agenda today, we just couldn't let you leave Florida without talking a little bit about that and some of the regulatory barriers that we see for those 10 percent of the hospice patients that we treat.

Most of the issues I'm going to bring up, and I'm just going to list them because I know we're short on time here today, really deal with access to hospice care, which, by the way, happened if they're solved, we see some very good long-range ways to save money on behalf of both the federal and state government, so a kind of a double good thing there.

Since we only have time for our list, I'm going to just go through the list and then be happy to elaborate and get on our soapbox at any time you so request.

In spite of the great growth of hospice in this country in the last 20 years since the start of the Medicare hospice benefit, right now only about 25 percent of the deaths in this country receive hospice care, and some of that has to do with the changing of medical care and a lot of it has to do with some of the way the old hospice benefit was created that are no longer quite as efficient as they could be, and one of the quickest solutions that we think to improving access and to make more people available to good end-of-life care, reduce suffering and also improve the quality of life while at the same time having a tremendous ability to reduce cost is to implement what we call a Medicare-supported palliative care consultation.

Many people, many, many people, do not get good end-of-life care because they don't know enough about such care. The current system does not encourage conversations about end-of-life care because people with life-limiting illnesses are busy pursuing a cure, and understandably so.

Our recommended solution is to implement palliative care consultations to allow the hospice story and end-of-life issues to be officially discussed while people think a cure is still possible. That sets them up to do advance care planning and make choices that are relevant to their definition of quality of life which often eliminates much desperation and grasping at futile treatments as the disease progresses. Allowing a physician to call in a hospice team to discuss the myriad of end-of-life issues early in the disease progress is only good for a patient, and I distributed a white paper that the National Hospice Organization has prepared that really does go into the palliative care consultation a little bit more in depth.

Our second on our list is the medical review policies that are currently required under the policies of the fiscal intermediaries around the country. Current regulations for admissions to hospice only require the -- the certification by two physicians that a disease is terminal. However, around the country a number of policies have been implemented to make it much more difficult for a physician to refer a patient to hospice care. We'd like you to take a look at that. That's number two.

Number three are the regulatory barriers that prevent a hospice patient in a nursing home under skilled care to receive hospice, so we have a lot of our families of dying patients who are choosing for financial reasons to receive skilled care in a nursing home, and when they do that, they have to forego hospice care and end-of-life treatment from the end-of-life experts.

Number four and five are two that are kind of together. They have to do with the high tech patients that we are now treating, patients that we weren't treating 20 years ago when the Medicare hospice benefit was first implemented. Those are people who still need treatments like high cost chemotherapy and palliative -- excuse me, radiation therapies that will also help relieve symptom and pain but are very costly to a hospice.

The other high cost days are the days of admission and the days of discharge. There actually are some regulatory pieces that could be changed a little bit to handle those high cost days. I'm told when I talk with my hospice CEOs around the State that the day of admission for a hospice patient can run anywhere from 500 to $700 in cost, and the average hospice around this State for a routine home care day picks up $100. So we have a great disparity between what the cost is and what the actual Medicare payment is. So that's reasons four and five.

And the last on my list, number six, is we'd like you to take a look at allowing a reimbursement for nurse practitioners and advance practice nurses. There are a number of times when they can provide everything that is needed. Certainly, in most cases the reimbursement by Medicare would be a little bit cheaper than having to call in a physician when maybe the busy physician wasn't needed at that point in the treatment.

So I will close right now and thank you for listening to our list, and we hope that you will elaborate on those things as you do your hearings around the country.

CHAIRMAN WOOD: Thank you very much.

Slight change of schedule here. Next, Mr. Rosenzweig, followed by Monica Felder. So, Mr. Rosenzweig.

MR. ROSENZWEIG: Good afternoon everyone. My name is Lester Rosenzweig. I'm a registered dietician, and I'm associate director of the National Policy and Resource Center on Nutrition in Aging here at Florida International University in Miami.

I have over 20 years' experience in home and community-based older adult nutrition programs in both Florida and New York State. I appreciate the opportunity to talk with you today about OASIS and modifications needed to improve the nutritional status of Medicare beneficiaries receiving home care.

Today's system of providing home healthcare does not follow the Institute of Medicine's nutrition recommendations because of a lack of national standards and the omission of registered dieticians. Today's OASIS data set does not include some indicators to detect nutritional risk; however, actually it contains some indicators, but critical factors are missing.

These include assessments of recent unplanned weight change, appetite evaluation, availability of food, assessment of quantity and quality of dietary intake, need for a special diet, numbers of medications taken and possible food and drug interactions.

In addition, there is no designated space on the OASIS form to pull together nutritional risk indicators from the various domains and develop a nutrition assessment and care plan. Regrettably, poor nutritional status may go undetected and nutrition therapy undelivered, resulting in slower recovery, poor care and higher treatment cost.

I learned firsthand the shortcomings of OASIS and how agencies supplement it. I conducted an evaluation that compared assessment instruments, including OASIS, with those used by three home healthcare agencies in upstate New York. I was looking for nutritional risk, and when found, if interventions were provided.

I found OASIS had few of the 21 nutrition risk indicators of the nutrition screening initiative level one screen. Although all three home health agencies supplemented OASIS with other nutrition risk indicators, it was a lack of uniformity.

At least one of three patients had nutrition risk who needed nutrition therapy and instruction on medication use fell through the cracks. Patients were not referred to an RD because standardized scoring criteria were not used for nutrition risk to initiate the referrals. Both the scoring problems and/or the lack of nutrition risk indicators in the assessment tool itself diminish the effectiveness of the screening process.

I propose the following recommendations. When modifying OASIS to detect nutrition risk and improve the management of nutrition-related chronic conditions in home health settings, seek the discipline -- discipline-specific advice of registered dieticians to ensure incorporation of critical nutrition risk items and sufficient information to determine the need for a nutrition care plan.

Likewise, seek the input of a registered detrition to promote uniformity for risk items, their scoring and nutrition services while encouraging home health agencies to accommodate cultural diversity.

When providing home healthcare services, involve registered dieticians in developing systems that generate appropriate referrals and patient care plans.

Begin to document best practices in outcomes research to determine cost-effective methods for screening and providing nutrition care while reducing the paperwork burden.

Home healthcare agencies should evaluate how effectively they address nutrition risk and provision of nutrition therapy.

Thank you very much for the opportunity to talk.

CHAIRMAN WOOD: Thank you very much.

Monica Felder, followed by Miriam Harmatz (ph). Monica's not here?

MS. HARMATZ: Hi. My name's Miriam Harmatz. Thank you very much for the opportunity to comment here.

I'm a staff attorney at Florida Legal Services. We work with legal services, lawyers and paralegals who represent low income Floridians on a variety of issues, including Medicaid and Medicare.

On behalf of beneficiaries our position is that any regulatory reform effort must maintain and even strengthen all of the regulations that concern beneficiary notices and appeal rights. These rights are guaranteed by federal law and the Constitution, as you all know, and they are particularly critical for recipients in Medicaid HMOs who are in Florida locked into the HMO for a year.

Under the federal -- the current federal regulation recipients are entitled to notices whenever any adverse action is taken, and adverse action is defined to include any termination or reduction or suspension or denial of services. As far as I know, HMO enrollees never receive such notices.

Our proposed remedy or our suggested remedy would be that under the proposed federal Medicaid managed care regulations, the definition of action for HMOs be amended to include similar language as is currently in federal Medicaid regulations for all recipients, so that any HMO failure or refusal to furnish or arrange for a service in a timely manner would trigger a notice, including the recipient's right -- reason for the denial and the recipient's right to file a grievance or an appeal of the denial.

We know that those regulations are forthcoming but would urge you to take another look at that really critical issue of notice and appeal rights in Medicare -- I'm sorry, Medicaid, for Medicaid managed care.

In the Medicare context, I know that was talked about a lot today and I appreciated the panel's comments. I know from Legal Services lawyers who represent the elderly and disabled that notices are, again, critical, particularly the Advanced Beneficiary Notices or ABNs. Because, of, again, all of the concerns discussed today, lack of education, language barriers, et cetera, the procedural safeguards that are now in place are critically important and need to be maintained.

We appreciate the efforts that HCFA, CMS, has taken in their beneficiary notice initiatives to make notices more readable and understandable, and we're encouraged that that process continue, and that the goal to be -- that notices be for the benefit of the beneficiaries continue to be the primary goal.

Another Medicaid regulatory issue related to U.S.-born children of certain immigrants is -- which should be reformed is the Medicaid program currently uses the old AFDC residency rule, and this has resulted, at least in Florida, and I know this doesn't happen throughout the country, but in Florida we have a situation where children born here in the United States of parents who hold valid visas are being denied Medicaid because they don't meet the residency requirement, and for that our proposed remedy is that Medicaid adopt the residency requirement in the food stamp program which children are getting and which, you know, clarifies that, you know, the parent need not have an intent to permanently reside in the United States.

And another final issue that we'd like to briefly mention is in the area of beneficiary applications. For that we urge regulatory reform that would allow for streamlining those applications, simplifying the application. Many low income people don't receive the benefits that they're eligible for, and, as we know, that's due to a number of reasons, including the owner's application process and, again, language and cultural barriers.

It's undisputed that a simplified mail-in application which eliminates the need for face to face interviews and redeterminations and asset tests goes a long way in solving that problem. We've seen in Florida and other states for children, for example, when a short mail-in application was adopted, thousands of children who are now -- who are eligible for Medicaid are now enrolled.

It is important to ensure that breakthroughs in drug research are available to all, especially since generic drugs are not equivalent for many Hispanics, African-American or Asian populations. Because of differences in metabolism means differences in the drug rates of absorption and effectiveness.

In looking for cost savings, the savings of preventing illness through access to appropriate pharmaceuticals should be taken into account when developing prescription access policies. We urge you to consider the urgency of policies that will ensure full access to the broadest range of FDA-approved pharmaceuticals for the American health consumer.

Thank you.

CHAIRMAN WOOD: Thank you.

We appreciate the comments that the members of the public have made, and the written comment period is still open so if there are others, we're anxious to hear those.

I'd like now to take some time to review what we've heard today from the Committee members and to begin to synthesize some specific recommendations, and I'd also like to take a little bit of time to see if there are other specific questions that any of you have about EMTALA for tomorrow so we might be able to perhaps focus the discussion a little bit.

First for today's discussion we had a great deal of interest and specific comments, particularly in regard to OASIS, and there are several levels of recommendation that may be possible there. So let's take a few minutes and consider what we might accomplish in terms of OASIS.

Is there anybody who'd like to begin? Nancy?

DR. NIELSEN: Well, it sounded like the one thing that nobody disagreed with was extending the five-day to 10 days and the seven days to 14 days for the lock-in, and I'm just wondering if there's some reason that couldn't be an immediate recommendation.

CHAIRMAN WOOD: What we'll do -- I heard that, too, actually from a number of providers, actually, and I think what we can do is we -- that one appears like it can be a short-term recommendation. We can get that on right away, and then we can hear from the agency if that might be problematic for whatever reason, although it should be one of our lead recommendations.

Others from OASIS? Jack.

MR. ROVNER: I agree with what Nancy just pointed out. Also, I would be interested to get feedback now from CMS on the specifics. In the panelists and apparently the material we were given there were a number of specific entries on the OASIS form that they have picked out as should be deleted, not modified, but deleted because they don't apparently serve a purpose or they're redundant.

I would like to hear back from the agency for us on why that cannot be done. As I understand the testimony -- this is an area where the form can be modified without regulatory process. It's just a question of getting it right, if you will. It's clearly a -- I think the consensus is that the form is a great idea. It accomplishes something, but it may not be quite where it ought to be. It may be too burdensome, so I'd like to get that feedback on the things that were recommended that could be deleted and find out what purpose they actually serve.

The other area perhaps in a more long-term, I'd like to get a better feel for the Committee on what can be done to more automate this process. Clearly, and perhaps our subcommittee on communications or information technology can, but clearly there's got to be a technological solution here that eliminates a lot of redundancy and improves this process, and I don't really have a feel for what that opportunity is, and I think we would be -- it would be beneficial to get some more information on that.

CHAIRMAN WOOD: Let me come to Erik, and I'll come over to Karen and Judith.

DR. OLSEN: I want to second what Jack said about the technology. Just seems like a number of people said that you didn't have to ask each question each time or whatever, and obviously technology would solve that problem because it knows that's one that has been asked and it doesn't need to be continued each visit or whatever. So I really want to say that -- I think that is the long-term solution here.

But going to the intermediate or shorter, in other words, in reviewing some of -- I don't want to leave out the idea of the outcome quality study as relates to the questions. I think they did indicate they were starting to work on that, and I think that has to be a very important part of any reduction in number of questions, is how they do relate to the quality outcome of the process. So I don't want to leave that out.

CHAIRMAN WOOD: Karen Utterback.

MS. UTTERBACK; Just two comments back toward that. One is that as the consideration is given to changing the form, it is very important to keep in mind that it is not just changing the question, but then there is programming behind the scenes and from an industry that has had lots of change in the last three years I'd offer that we are essentially over that learning curve, and it may be better to leave well enough alone, if possible, for a period until we do see the value of those other questions, and even changing one question will cause every agency then to incur programming costs, and it -- it's not as simple as changing something on a form.

The second comment is that --

CHAIRMAN WOOD: Can I hold you there for a minute --

MS. UTTERBACK: Yeah.

CHAIRMAN WOOD: -- and ask a specific question.

MS. UTTERBACK: Yeah.

CHAIRMAN WOOD: Now, from the perspective, though, of the completion of the reports, and there are a couple of options here. For example, one would be you go through and you eliminate questions. The other option is that as you do the review of the quality of the data, that is, which questions were answered and which were not, if you decided that it was not critical you had a piece of information, I mean like estimate of life expectancy, for example, wouldn't it be possible to achieve the same outcome ultimately by simply saying we wouldn't treat that as a scorable concern or treat it as a -- as an adverse event or reportable problem?

I mean it doesn't solve the problem that you have to collect the data, although it might not be that easy because you don't expect the nurses to be really precise about it.

MS. UTTERBACK: Well, an aspect that I don't believe really came out in the testimony today is that both the OBQM and the OBQI reports at this point have no basis in regulation, if you will, as they relate to the survey process.

In other words, the information is coming out. It is couched in such a way that it is for the agency to use and to benefit from, and, granted, surveyors have that information, and they may ask particular questions because of patterns that they've seen there, but the process has been a little different in terms of what we're used to with regulation.

What I mean by that is in 1997 when the Balanced Budget Act was passed, it launched the use of that data set into the payment side of things. Also in 1997 there were conditions of participation published as proposed rules that would have then taken that information and applied it to mandatory processes for quality improvement and for survey.

That regulation has never been published in its final rule largely because the work is continuing on the risk adjustment process and the determination of the value of the indicators. So those reports have been presented to agencies in such a fashion that we have been encouraged highly and challenged to use that information, but they have no sting, if you will, at this point. So there's still a window of opportunity here to really be about determining what the value of those forms and those questions are at this point.

If you eliminate questions from the data set, then you do back into CMS changing their computer systems, each agency changing their computer systems, either internally or through a third party vendor, and it does quickly become large.

We -- my second comment had to do with the fact that we are an agency that automated, and we actually paid for our technology through our savings in support staff so the comments that were made about this being, you know, a future direction to look at in terms of handling and managing the data, I would state is accurate.

We as an agency have also been able to see very easily more appropriate ways to apply our resources and have more quickly achieved positive results as a result of having the information.

CHAIRMAN WOOD: Judith Ryan and then Gary Dennis.

MS. RYAN: I was very struck by the contribution that the demonstration made this morning and with the sharing of the Interim Healthcare forms as they related to the way in which they are weighed and use this data, and it seemed to me that there were a number of things on this form as I looked at it that were useful.

For example, when they have put a cloud on the form, they have self-identified those questions where more explication was obviously necessary. They have added a column in which they've suggested something quite substantive, and that is that the valuation might better be able to be recalled if it was prior to the acute episode by maybe some three months.

My question is this. What is the process that is in place to continually work with these user groups to bring forward a continuous process improvement approach to this work, as opposed to deciding that our recommendations would be not to change any question because it might fracture the integrity of the database?

Don't we have enough data now to be able to make some judgments about which of those fairly consistent recommendations that were put before us by the clinical portion of the field now this morning to say which of these might be able to be done, based on data that CMS already has?

CHAIRMAN WOOD: That's an important question. I want to come back to that a little bit later, too.

Gary.

DR. DENNIS: I think along those same lines there were some issues related to whether the data should be collected on all patients, whether it's Medicare patients or what -- some sub-groups of patients. And I would hope that as an intermediate step you can get feedback -- CMS can get feedback on studies that are being reported as to the value of the data that have been collected, as well as the breakdown of that data, so that we know whether the power of that data will be significant if we dilute it or reduce the volume of it that's collected by any group.

And -- and if so, we would -- a threshold would be established as to when it would be meaningless to collect so that we -- no changes would be made that would actually make it not very useful in the future, and then if some -- something is discovered, then a long-term solution would be to change the statutory language regarding it which would simplify the process for those that are using it, but I would -- I wouldn't think that we would make any recommendations about changing it unless we have really studied the data.

CHAIRMAN WOOD: Kristen.

DR. CROSBY: I have a related question. It wasn't clear to me whether the law requires collection of the data on all patients or just on Medicare patients. When we asked that question, what -- the answer I heard was this is how CMS interprets it, and yet we heard at least one commentator state that they would collect it on all patients, whether it was required or not, and then we heard reports of other agencies who find it extremely economically beneficial to not collect the data and enables them to have an edge in hiring.

So I'd like to know what does the statute say? Maybe we're wasting time on this issue if it's indeed statutorily required. If it's not required, why are we doing it?

CHAIRMAN WOOD: Karen's been shaking her head up and down. I think that means she has the answer, although I'm -- I'm going to let her comment, and then I want to come back again to the long-term structure here.

MS. UTTERBACK: I believe the statute's pretty clear, and that is that there be a standardized assessment process, and that is what this data set then becomes a part of. So I would say the statute is clear for all patients.

Now, the -- what you heard this morning is a distinction between types of agencies, and you either had agencies that don't participate in the Medicare/Medicaid program at all, and so, therefore, they're not certified, or, for example, with Barbara's agency they have two divisions within Interim in which one side is the certified side, if you will, and the other side is private. So you get down into State differences in terms of how states license agencies and recognize agencies.

CHAIRMAN WOOD: We didn't -- Patricia Shafer.

MS. SHAFER: Just an addendum to the -- if one were to modify the OASIS set, knowing that it would probably create havoc technologically on updating programs, I think in looking at it there's a lot of this stuff that actually -- I mean I wouldn't be able to fill out this correct, like the whole neurology, emotional behavioral stuff, you know, you can't answer it the way it's coded right now.

So I see it's an evolving document, and I would hope that we could make a recommendation that further changes, really simplify it, make it easier for those completing it.

CHAIRMAN WOOD: Patricia Walden.

MS. WALDEN: I'm a great proponent for not remaking the wheel, and there are a lot of suggestions that are written in Kathy Thompson's document that I think are common sense approaches that we ought to pay attention to that don't involve the sticky wicket of changing -- changing the form, and just kind of looking through it quickly and all, I'll just read the numbers.

Item four, allowing agencies to use a single universal form; item six, eliminating the requirement to perform OASIS assessment in cases where it's known that the patient will require only a single visit; item eight, amend the -- we've already talked about the dates; item nine, revise the guidelines for the OASIS resumption of care assessment also seems to make sense, and I think if we can just go through this -- and then on the last page, 12, 13, 14 and 15, all seem like they're either duplication or some sort of unnecessary requirement that I think could probably be eliminated without too much opposition from anyone.

CHAIRMAN WOOD: Yeah, I thought that was the case, too, actually in looking through them. From the perspective of how you approach this long term I was listening carefully to all of the presenters and thinking about this from the perspective of process, and one of the things that we had emphasized in our earlier meeting, it seems to me that the rationale here is to -- what we want to do is to find a way that we can make the job of caring for patients easier and more likely to achieve the best outcome.

Now, what I heard from this presentation this morning was that for all of its immediate faults, at least the process has a few significant positives. One is it begins to more or less standardize the approach that we take to the assessment of this kind of problem which is a plus.

It also seems to have the additional benefit that it begins to improve the kind of training of the people who do the assessments, and the combination of a more standardized approach and better training would seem to yield for us better outcomes. We will get better data. The data in the long term will be more reliable. We can then use it to do things.

Now, that's basically nothing more than good continuous improvement activity. You get the data, you look at it, you check it, does it make sense. If it does, then you keep going. If it doesn't, you change what you're going to do.

I do think we're at a process or at a point in the process where there is enough information that we have that we can certainly look at it and ask the question, do we need to continue to get this piece of data, does it need to be in this structure, or should it in fact be changed.

The other particular factor that struck me is the development of this is so incredibly long that medical practice has changed faster than this process. So an important lesson for us in the future here is that however we do this in -- whether it's going to be in Medicare, Medicaid or whatever, we've got to find a way that we can make this faster and more reflective of contemporary medical practice, and you have to find a way that you can take advantage of what the users were telling us.

Now, I'm not able to know for sure since I'm not sure that everybody who has the answers is still here, but it seems to me that if we're thinking about this from the long term, and as we approach this kind of a process, whether it's going to be for home healthcare or nursing home care or however even we might use HIPAA and its requirements for care of other patients, including those that might be seen in the offices or outpatient settings in the hospital or in inpatient settings, that perhaps what we should think about is the creation of a scientific counsel that can tell us the science behind making a recommendation for an element in a data set, that is, do the work-up of an element, and then follow that up with a user's group who can actually tell us or tell the industry -- and that would be more than CMS, it would be actually all users -- that would tell you what you've learned in the field application.

Now, this is a process that is actually not entirely innovative because the credit for the idea actually goes to David Eddy (ph), among others, in terms of thinking about how you do performance measurement.

If you're going to do performance measurement and use data to do this sort of thing, you have to make sure that you have done it in a way that makes sense, and he has proposed a method for doing that, based on what some of us might call a work-up of each of the data elements, that is, making sure they're going to achieve what we want.

He wrote an article about that about three years ago now in Health Affairs, which we might actually incorporate for reference because I think it's important from the perspective of how you do these large data sets. But it does seem to me that one of the recommendations that we can make is that we begin to create then this kind of a structure within CMS when we do these things in the future.

I'm a little struck, too, by the inconsistency in the sense that CMS has told its contractors that it can't use black boxes when making decisions about local medical review policies or appropriateness of medical care, yet we're not willing to go beyond the black box when we're talking about sharing the information with providers in the field.

So if we want to make our home health providers more knowledgeable, it doesn't seem to me that there should be any reason why we can't share the risk assessment tool, and this would be another immediate recommendation, is that the risk assessment tool should be then shared with providers in the field that we can use to improve our process.

But as I was thinking about this from a structural perspective, it strikes me that there are some recommendations that we can make for the structure we would want to use in the future, and that these could be almost generic. They don't have to be confined really to home health activities. They can extend across all aspects of care.

And the last point, which I think was perhaps the most important, it was listed last in Ms. Thompson's suggestions that were -- and that is it is important to recognize that the plan of care, if it's derived from a systematic assessment, will more likely yield a good clinical outcome, or at least preserve a good functional status which is critical for the elderly with a chronic condition.

That, again, I think is an important concept for us to get across, because as we're doing regulation and data collection, if we will remember that what we're trying to do is to improve the likelihood of a good outcome, then we have to find a way that we tie those up together.

The reason I think that's important from an outcome perspective is that I see a lot in OASIS that I saw in the Uniform Clinical Data Set, which I talked about earlier this morning. What I see here is that somebody went back and tried to create a data set to describe what they thought might explain the differences in outcome of care without first going back and saying what is important about the process of care, and then how do you want to measure it. So if we would also learn the lesson for the future, don't create the measurement first, create the expectation about what you want to do, and then the measurement plan with it, we would eliminate probably a lot of trouble and expense.

I mean I'm a little hesitant to ask what the cost of development of OASIS has been so far, not that it is entirely wasted, but we probably could have done it faster and for less if we'd done it the opposite direction. And, again, this is a -- this is a method that is actually taught by Berwick (ph) and others when you look at how do you do the best healthcare.

So I'm thinking about this because somewhere along the line we've got to write at the end of the report a structure that we want to be the basis, the new way of doing business, and there are lots of little ideas that have come forth, but I want us to keep thinking about the future and the vision.

Now, having said that, let me get from members of the Committee any comments or feedback about that overall approach. Gary.

DR. DENNIS: Let's just put a name on it and call it evidence-based medicine approach to looking at regulations, and I think that what you've come up with, it could be a template that we could use for almost all the issues. I know that one of the -- one of the recommendations I made on EMTALA has to do with the Technical Advisory Committee, but you could take -- you could elevate that concept a little -- a notch higher and have a technical advisory committee that would look at the -- the basis -- the evidence basis for the elements in the regulations or -- and the outcome, something like that. I mean just, you know, embellish on it. I think it's an excellent approach.

CHAIRMAN WOOD: Patricia Shafer, do you have a comment?

MS. SHAFER: I like the approach, too, and particularly thinking about how care has changed and what's most important. I mean what struck me was nowhere in OASIS do you really have anything about at risk for falls, and we certainly know the problems with fractures and osteoporosis is skyrocketing costs, and issues such as episodic versus constant deficits with skyrocketing in sense of seizures and, you know, TIAs.

So, you know, I would fully support that, that we're keeping up current with what's going on in healthcare and trying to incorporate in our measurements.

CHAIRMAN WOOD: Heidi.

MS. MARGULIS: I would think that for the overall structure of regulatory reform I would concur with what you said because I was jotting down what I called certain principles, over-arching principles for rule-making, and in fact I believe in a framework paper that my subcommittee has begun to devise we call it evidence-based rule-making, and I think the home health example is a good one because it provided a pilot, I believe, at first, and so there was some market testing of the concept.

There, I think -- as I understood this morning, there was a cost benefit analysis done in the beginning, and I'm not sure how good that was, but the regulation turned into something that it originally was not intended to do, which is payment.

So I guess as part of this whole process of setting up a scientific counsel and a -- and a user, user group, et cetera, that I would encourage us to take a look at what I would call market-based cost benefit analyses, such that is the -- is the ultimate consequence, really doesn't match the intent of the regulation, and do real market testing on it before it goes and wrap that all up into some pretty fast time frames.

CHAIRMAN WOOD: Tony Fay.

MR. FAY: Mr. Chairman, I fully agree with the approach to have a more systematic process towards developing data collection instruments and the conceptual design of different programs, and the Ways and Means Committee had conducted a series of hearings last spring and had written a letter to the Secretary on ideas that could possibly be improved through the administrative process, and they wrote about OASIS, and this was before CMS changed its name.

"HCFA should convene a technical experts panel of agency representatives, clinicians and patient advocates to simplify the use of the Outcome and Assessment Information Set, OASIS form, and limit the time and number of individuals that are evaluated. The TEP should consider the effect of the length of the interview on the patient and avoid repetition without cause."

I think that's a good recommendation, but I think we've come much further than that today in terms of not just saying how can we fix it, but how can we alter the process to have a more usable product process and outcome at the end of the day, and I think that will be very helpful in our final report.

Thank you.

CHAIRMAN WOOD: Ron, did you have a comment? No. Others over here?

Now, we didn't talk about this, but there were several who had some comments about the reimbursement, and this is not an easy or short-term solution, but perhaps one of the principles that we should consider for the future, and that is the -- in the original costing we didn't incorporate this in the base year estimate, so that, to me, is a technical matter of how we do the costing which could be a recommendation for the future.

Anybody think we shouldn't put that in as a future recommendation? I mean a long-term recommendation? This is a long-term structural thing. Tony.

MR. FAY: Mr. Chairman, I have a reimbursement background so those questions always pique my interest.

CHAIRMAN WOOD: No wonder it tweaked it.

MR. FAY: And I realize this is a Regulatory Reform Committee, and we're not charged with addressing reimbursement issues, but obviously they're intertwined, and OASIS is a textbook case, if you will, of -- I won't say necessarily an unfunded mandate, but you do have an additional cost that is not in the rate base of how the rates were calculated, and it's -- it is something the industry has had to deal with and either cut costs in other places or lose money on it.

CHAIRMAN WOOD: Heidi.

MS. MARGULIS: I would take it right back to, Mr. Chairman, the issue of cost benefit analyses and -- and taking a look at how best those be conducted, such that it does meet whatever the marketplace issue is that's being discussed and so that it is not an unfunded mandate.

CHAIRMAN WOOD: Judith.

MS. RYAN: There's another piece of cost just beyond the implementation, and that is literally the dynamics of medical practice and of healthcare that you described, Mr. Chairman, and in many ways the way in which these data sets are being used to set price on an annual basis through the congressional process aren't really working, either, and in many ways what we're trying to do is go back to a cost basis that was never fully established based on any scientific principles, either. It was sort of established at the level at which costs were now being charged by an institution which almost structurally disadvantaged the efficient.

And then we are trying to add an element of assessing cost or price to these data sets. Maybe it should be a recommendation now that the scientific panel include from the get-go the introduction into these data systems the elements of cost, because neither were the DRGs, nor was the OASIS, originally developed for that purpose.

CHAIRMAN WOOD: Other suggestions or comments?

(No response)

CHAIRMAN WOOD: If we could turn a little bit now to issues of communication and education, I'd like to see if there are some specific recommendations that we should consider from that.

Nancy.

DR. NIELSEN: Well, speaking of unfunded mandates, the limited English proficiency issue that we -- we touched on, we really didn't go very far with that. This is time to recommend that somebody -- and I don't care how we couch it. Maybe we can couch it in the way that we heard at the end of our panel discussion of a cost analysis of the feasibility of involving community organizations in providing those kind of translation services, but what was real clear and needs to be said up front is there is no funding stream right now to pay for this translation, and so it has been put clearly on the backs of the providers, not just doctors, but institutions of all sorts.

There was no mandate for this. It's absolutely crazy, so -- and it is going to reduce -- not only going to, has reduced access. People will choose not to participate in Medicaid because that is the hinge on which all other provision of these translation services -- once you accept -- as I understand it, if you accept Medicaid patients, if you see Medicaid patients at all, then what ends up happening is you have to provide -- you, as a provider, whether you're an institution or a physician, have got to provide those -- those services at your cost to anybody.

Whether they're a commercial patient, has nothing to do with the business about being on a federally supported system, and it is really, in my opinion, terribly crazy to say that because a physician provides a service to a patient, that I as the physician am federally assisted?

I don't -- I don't -- I thought that was -- I thought I was a contractor, and they were paying for my service, but I'm not federally assisted because -- I would like to be federally assisted in some parts, but I ain't been yet.

CHAIRMAN WOOD: Other comments? Erik.

DR. OLSEN: I guess I have to argue with the words here. Certainly that some -- clearly there needs to be a reimbursement, you know, and I'm not arguing that at all, but to categorize some effort to communicate to people their problems and bring them into the system somehow isn't absolutely crazy. Maybe it hasn't been thought through and it isn't being implemented, and I recognize all your problems, but this is an important issue.

CHAIRMAN WOOD: Gary.

DR. DENNIS: I'm not sure whether we're going to have much of an opportunity to discuss this in the future, so somehow we need to come up with a recommendation that's going to make this better, and we need to do it today.

Clearly, there is an opportunity for states to pull down Medicaid funds by including it in their State plan, health plan, Medicaid State plan. It hasn't been done by very many states, but that opportunity is here. So there is a funding stream for Medicaid patients potentially, but the issue is who are those payments going to go to.

Are they going to the doctor, or are they going to the interpreters, a service, the community organizations, whatever. I think this is an opportunity for CMS and for the Secretary, Tommy Thompson, to come up with a strong statement, a position on this, that would qualify groups that contract with Medicaid -- with the Medicaid State agency to provide those services, and it would be up to the states to determine what the qualifications are.

That way we wouldn't have to worry about nitpicking this thing to death, and it would give enough leeway to states where there are community organizations that can support those services to actually do that through contracts, because right now the medical interpreter services are extremely expensive, and they're not necessarily any better than -- than somebody's grandmother who's sitting at home doing nothing who knows a heck of a lot about culture and language and disease processes, who can interpret for you, as well, so that we need to have some -- some way to do that.

So I would suggest that we ask Secretary Tommy Thompson to think about a position -- a new position on this which would allow State Medicaid plans to contract with even community organizations.

CHAIRMAN WOOD: Bobby, is that clear enough for you to go on?

MR. JINDAL: One, to Mr. Toby's comment before, I do think you'll find that states have even more flexibility than you might imagine in running their Medicaid programs. It's in terms of matchable expenses.

There's a tremendous amount of latitude on what states can and can't do today, and certainly as part of the Committee's recommendations, you could go back to CMS and suggest to them that they clarify to states that they have this latitude. I think most states you'll find are very well aware of the fact they've got this latitude.

I mean one of the things that you didn't hear about today a little bit, yes, there are federal matching dollars, but states have to also put up matching dollars to draw down these dollars, and I think if you had the State's representative here, what they would tell you is with tight State budgets they're forced to make tough choices.

I would like to back up and make an overall comment about regulatory reform. You've heard the comment before. I think this is absolutely correct that regulatory reform is tied to payment issues in that certainly what may be onerous today may be considered less onerous if there was more money in the system and vice versa, and actually the former chairman of the Mayo Clinic actually made this point to the Medicare Commission a few years ago, and it was a quote the Secretary used to kick off this commission, and Dr. Weller said that, look, we may be willing to accept slightly lower rates if you had fewer than a 130,000 pages of rules and regulations. He said, AOur number one complaint isn't the reduction in rates, as much as we hate it, it's the red tape.@

And so one word of caution I would share with you is that for almost any complicated problem you see, an easy answer for almost any one of those would be well, if we just paid for it, you know, the regulation wouldn't seem that bad, and you can say that about OASIS. You can say that about the English -- the limited English proficiency. You can say that about almost any problem this Committee faces.

Now, I don't tell you that to say never say that, but one word of warning is that, specifically what the Committee was tasked to do was not only suggest to the Secretary, >cause everybody suggests to the Secretary, well, if you'd just pay for it, we wouldn't mind these regulations.

But to also suggest to the Secretary another way to also -- and I'm not saying that you have to say if you lighten the load on regulations, you never have to pay us. Obviously, the two go hand in hand, but what he's looking for in addition to the usual, just pay for it, is also we understand that there are costs to these regulations, we want to help you try to rationalize and reduce the burden on some of those costs.

So the first -- and, again, I don't say that in particular to this issue in particular. I say that more broadly speaking, >cause I know that you have many more meetings ahead of you, and I do caution you that you're going to get -- you're going to see that same temptation for each issue.

And the second broader point is, again, I think the process points are very, very helpful in terms of an evidence-based approach and the other broader views of reforming the system going forward.

I also encourage you -- I know there was some discussion -- Jack and others have mentioned there may be specific things that you see right away, as well, and I'd also encourage you to identify those, as well. You know, if there are questions you think today that don't need to be asked, I'd encourage you to identify those and put those on the table, in addition to saying look at the broader process of how you come up with the next OASIS.

MR. TOBY: Mr. Chairman, if I may, I think that the -- the Balanced Budget Act has already recognized what was said in the last panel we had, and that is that the country has changed dramatically with respect to the need for programs like Medicare to provide services that are linguistically and culturally aware, and it's very clear to me that when -- when the Congress legislates this as a fact to be followed up by HHS, it means that the fact is the country must have changed 10 years before Congress got around to recognizing it.

So my sense is that this panel has a responsibility, which was profoundly, I think, announced by the last panelist when he said that we needed -- we can't possibly reach to people we're trying to reach, at least in certain areas of the country, unless we have people who are trained linguistically, people who are aware of cultural changes, and that we need to think down the pike about the possibility of subcontracting with local community-based groups to reach the population that we are trying to reach. We can't possibly reach them unless we recognize their rights and need to be protected as service to -- as the service delivery system changes.

So I hope we would take this up as something to be -- as a recommendation down the pike.

CHAIRMAN WOOD: Well, I think that actually is an important observation because I must confess, as I read through this rule -- actually, I guess it's not a rule, it's a guidance, that was behind Tab B -- I don't know how many of you went through it last night -- actually I was thinking this morning that a cruel homework assignment for you tonight would be to come back tomorrow with a one-page distillation of what this says.

I'm seeing mixed reactions to this homework assignment, but -- 

MS. MARGULIS: Yeah, let's outsource -- we'll outsource --

CHAIRMAN WOOD: -- I'm getting the idea that I shouldn't --

MS. MARGULIS: We're outsourcing it.

CHAIRMAN WOOD: But here's the example. Now, in Olmsted County, which is the home of the Mayo Clinic, we're confronted with a large number of immigrants. Now nothing as bad as Queens where you have 157 languages, but we got something like 57 different languages in this small little county of about 100,000 people, and tuberculosis became a big problem for us because of the number of people coming in.

Now, the Mayo Clinic, I will tell you, has on its staff paid interpreters so that if a patient comes in, we can interpret any language in -- almost any language in the world. However, the problem is that the local patients who have tuberculosis would often not come in, and there are a lot of reasons for that, but they had to do mostly with the cultural issues that were surrounding the visit to either this provider, that is, the provider, the Mayo Clinic, or the circumstances which were related to their illness, which in this case happened to be tuberculosis, and there are some very significant differences in cultural approaches to tuberculosis around the country.

I didn't realize that until I asked a few of my physician colleagues who have spent time in Thailand or in sub-Sahara Africa or in India, and what I found out was quite striking because it actually gave us the clue of how we should do things differently.

Circumstances are that you actually need to turn around and go into the community with the cultural leaders of each of those sub-segments and let those people help you in the delivery of care. They would do the translation for you. They would help you make sure that there was compliance in taking the medication. They would help you make sure that the patients got into the Public Heath Department, and then we invested $5 million to provide up-to-date radiology equipment and other support in the community health clinic, not at the Mayo Clinic. However, the -- what really made the difference was that we were able to take advantage of the community groups who would help us get the message out in a way that we could never get out, even if we were providing with interpreters.

So I think an important recommendation here is that not all of the solutions should come down to a mandated uncovered or unfunded service on the part of either hospitals or physicians. We should look for different solutions, including the ones that we heard here today.

And so I do think it's possible for us to make a specific recommendation that we look for those community-based resources, and that the suggestion might be, Bobby, that we actually encourage or somehow indicate that one of the -- one of the conditions of participation, if you want to be in Medicaid, one of the expectations is that as a State you will make the necessary investments to make sure that those things happen, you know, just as much as we can say it to providers to do that.

Now, everybody's chomping at the bit here so I must have said something that's really good or bad, I don't know which, so I'm going to start with Judith.

MS. RYAN: Just a question. What is the source of funding for the SHIP program and for the SHINE volunteers that we just heard about today, because in many ways they're talking about cross-cultural training of consultants, and would it be possible for them almost to become the vehicle through which the subcontracting happened with the community-based organizations?

CHAIRMAN WOOD: Michael had answered that question once before, and I must confess, I don't remember all the details. You want to answer it again, Michael, or Josefina?

MS. CARBONELL: Both of us. The --

CHAIRMAN WOOD: Jump right in.

MS. CARBONELL: -- SHINE program is under the Older Americans Act, which is the program administered by the Administration on Aging, and so is the Ombudsman Program, and I didn't stand up earlier, but obviously one of the things that we're doing now in the Department differently is that we're actually talking to each other and actually planning things together.

You can't -- you can't do the stuff that we've talked about today without the community presence, and that's where our biggest -- I think our biggest source of support is and of, really, integration.

So if I think there's a wish list on my part of the -- of the pie is to be able to better integrate the social support systems that we're doing in the community, such as the home and community-based care, the information and referral lines, the elder care locator and assistance programs, the Alzheimer's support service systems and all those things to be able to assist CMS in -- we have over 29,000 community providers and 660 area Agencies on Aging, which are the local planning and service areas, so we don't have to reinvent the wheel, create the community programs. The community programs are there and are delivering millions of services day in and day out in local communities.

So the presence is there. We just have to find the vehicle to better share in -- in both, not only resources, but being able to better target a unified message to get these kinds of programs --

CHAIRMAN WOOD: That sounds like we have a --

MS. CARBONELL: -- and that includes the language and translation, which is, by the way, one of the core services of the Older Americans Act.

CHAIRMAN WOOD: So it sounds like we have a way we can actually do this.

MS. CARBONELL: Absolutely, and we're ready and willing and able, and Secretary Thompson, I think, has given us the direction. Bobby and Ruben --

CHAIRMAN WOOD: Patricia --

MS. CARBONELL: -- is out of the room right now.

CHAIRMAN WOOD: Patricia Shafer, and then Nancy Nielsen, Karen Utterback. Everybody wants a word.

Let me go Patricia first, and then we'll go down the -- go ahead, Patricia.

MS. SHAFER: Well, thank you for those comments. I think that's -- that's nice to hear that there's a -- there's something in the works that could really make something happen.

At the same time, though, I heard from a lot of people saying in addition, once they -- they have a hard time learning about what their choices are, and then once they do, just figuring out how to do applications, very difficult if you know English, and then if you don't know English well.

And a very specific request I would have is if CMS hasn't done it yet is to look at the applications themselves and try to put that in plain English, and then you put it into all the different other languages that we need and -- might be already done, but if not, I put it on the table.

CHAIRMAN WOOD: Yeah, I heard that, too. We need to simplify the application, and Christy and I have been talking about this back and forth this afternoon.

Since the OASIS demonstration was so powerful this morning, we were thinking about -- we're going to try to figure out how we can go through the application process for Medicare and see what it's like >cause it must obviously be a lot harder than most of us think it is, actually.

MS. RYAN: I think it was Medicaid.

CHAIRMAN WOOD: Is it Medicaid? Medicare is easier; they send you the card. So then it's Medicaid that we're trying to figure out.

Nancy and then Karen.

DR. NIELSEN: I really like the direction this is going in because I think it -- it gets back to the responsibility of communities to support one another, and it -- it takes away in a sense the expectation that one part of the community is going to do this.

There isn't a physician alive who doesn't want desperately to communicate with his or her patients. There isn't one out there, but when you read this in the Federal Register and you realize that no matter who walks into my office, what I have to do, it's astonishing, and should I refuse to see that patient, it looks to me like I could be -- I could be accused of discrimination under Title 6. This is crazy.

This is just -- the outcome is desirable. It's the means to get there that is crazy, and I very much like what we're hearing here about utilizing community services.

I would remind you that community agencies have a way, not unrealistically, of wanting to be paid for what they do, just like everybody else has a reasonable expectation that if you give everything away, you're not in business anymore, so we cannot -- I don't mean to harp on the reimbursement thing, Bobby, >cause I think you're absolutely right. If we go down that path, we haven't really accomplished regulatory reform. We've upped the ante. That's all.

But I'd like -- I'd like to hear more development about how this can become an expectation within a community utilizing community groups, faith-based groups, schools. There's all kinds of ways this could be done that would be healthier for everybody involved than what I'm reading in the 15 pages in the Federal Register.

CHAIRMAN WOOD: Karen.

MS. UTTERBACK: My comment was along those same lines, and that is if I read what's contained here within the Federal Register, the onus is purely and solely on me as the provider.

So as a question back to the group to clarify what we've been discussing, it seems as if we're talking about through a cooperative effort between the area councils on aging and others, that it would be almost a beneficiary service that we as a provider then would look toward them to provide, and from an experience perspective, it's not always there when you need it.

So that's just the challenge to the system to make it -- make it happen, you know, whether we're talking about Meals on Wheels or we're talking about homemaker services or whatever the service may be, you know, we talk about the number of slots that are available and whether or not there is one there at the time you need it is not always the case, yet if we fall back to the language here, it's very much, you know, as that client or that patient is presenting to you as the provider, and that you are obligated then to provide those services at that moment in time, so the connectivity and the reality of making it happen when we're looking at multiple resources will present a challenge back to us.

CHAIRMAN WOOD: Gary.

DR. DENNIS: To chime in on that, what we need to do is identify a few safe harbors. Situations where if those services aren't available, that these regulations wouldn't apply.