P R O C E E D I N G S

(Whereupon, the proceedings commenced at 8:05 a.m.)

CHAIRMAN WOOD: If I could invite the committee members to the table.

Good morning, everyone, and welcome to the second day of the Miami Regional Hearing for the Secretary's Advisory Committee on Regulatory Reform.

This morning we will be spending time reviewing issues related to EMTALA. This should be quite a productive session.

We're looking forward to hearing the overview from CMS, and I'm pleased that Leslie Norwalk has been able to do this on a relatively short notice. She's doing this as part of a change in assignment, and I'm actually quite happy that she's been able to devote so much effort to it.

We've talked about the issue on the telephone several times and yesterday spent some time talking about this, so I'm quite anxious to see what she has to say today.

The Atlanta Consortium has done a considerable amount of work on EMTALA, and we're quite privileged to have with us today several people who will be participating on the panel later who will help give us a perspective from the field. And I think will be extremely helpful to us in making recommendations.

So with that being said, I'm pleased to welcome Leslie.

And it's all yours, ma'am.

MS. NORWALK: Thanks. Tell me if I can -- if there's a way to get rid of the rest of that. That's all right, we'll leave it as is. Is there a way to get rid of the -- so there's just the slide?

That would be great. Lots of professional speakers, I think.

I'm Leslie Norwalk, I'm Tom Scully's counselor, which keeps me very busy. As part of that role, I am working on -- or with the Secretary's Regulatory Reform Task Force, and I've been asked to speak today on EMTALA, which is the Emergency Medical Treatment and Labor Act.

Now, why is EMTALA so important? Let me give you a little bit of history and some anecdotal evidence as to why this came to pass.

On January 31st, 1985, Dan Rather reported on CBS nightly news about the death of Red Barnes. What's so unusual about this death that it captured the attention of the national news media?

Well, three days earlier on January 28th, Red Barnes was stabbed in the side of the head in California. A most unfortunate incident, but I'm afraid not uncommon in this particular area where it was drug ridden.

An ambulance was called and he was taken to Brookside Hospital where no neurosurgeon would treat him. Over the next several hours, a couple of other hospitals also declined to provide him treatment. Finally, more than four hours later, a fourth hospital did admit him for treatment, where he died three days later.

In February, a wrongful death suit was initiated against the hospital and in addition, the county, state and federal governments launched investigations regarding this activity.

Now all of this activity caught the attention of one, Fourtney Pete Stark (phon.), perhaps you've heard of him. Now Congressman Stark introduced a bill in the House of Representatives, and this bill ultimately became EMTALA, the subject of our discussion this morning.

Now, in spite of the fact that EMTALA passed the House and the Senate and became law, there was very little other than this anecdotal evidence in terms of whether or not -- little evidence whether or not hospitals actually were dumping patients, but there were a considerable number of state laws and Court decisions which indicated that perhaps this was a problem.

In any event, EMTALA has three main statutory requirements. The first one is screening, which is to say the hospital is required to provide an appropriate medical screening examination. The second one is stabilization, that no further deterioration of the patient's condition occur. And the third one is transfer. In order for a transfer to occur when a patient has not been stabilized, either the patient requested it or the medical benefits outweigh the risks, and I'll get to these three a little bit more specifically in a minute.

The interesting thing about EMTALA, although it comes up in the Medicare conditions of participation, it applies to all individuals. So just because one is not a Medicare beneficiary does not mean EMTALA applies. In fact, hospitals cannot dump any patient regardless of their insurance status. That was kind of the point of the statute passing to begin with.

Now the interesting thing about EMTALA and what makes it so difficult for this particular Committee to take a look at, is that there are different requirements that come up in different ways. There's the statute, there's regulations, there's interpretive guidelines, there's Court decisions, there's regional enforcement both by CMS as well as the OIG, and all of these things bring in different facets of EMTALA and in some way, shape or form are impacted on each other and how you fix this issue, inasmuch as we think a fix is required, will depend on where the actual requirement lies to begin with. All right.

As I go through the presentation, I will highlight the areas that have been brought to our attention at CMS as being problematic.

I went with Administrator Scully to Phoenix not too long ago where we had a town hall meeting and meeting with the physicians and hospitals and heard quite a bit about some of the concerns there and I expect that they will be echoed here and I really look forward to hearing the panel's discussions as to what they are concerned about.

Now the first requirement is the screening requirement. Now, the statute says that if any individual, as I noted before regardless of their Medicare status, comes to a hospital emergency department, an important term, a screening exam must be provided by the hospital.

Now, the comes to a hospital emergency department is defined by regulations and not in the statute, and that particular term is somewhat controversial, and I'll discuss it when I get to the regulatory section. All right.

The purpose of the screening is to determine whether or not an individual has an emergency medical condition. EMTALA applies until the patient is stabilized or there's a determination made by a physician or another qualified medical personnel that there is no emergency medical condition. So this is a very important term, because if no emergency medical condition exists, then EMTALA no longer applies.

So whether or not there's an emergency medical condition is one of the key points of EMTALA. So which is to say, if you don't have an emergency medical condition, the hospital is no longer obligated to provide additional care regardless of your insurance status.

Now the second requirement is stabilization, and if a hospital determines that the individual does have an emergency medical condition, then that hospital within its capabilities, must provide the medical examination and treatment required to stabilize the individual. Now, what are in the hospital's capabilities include its on-call panel, and that's been the subject of much debate, which I will again turn to in a minute.

If the stabilization of the individual is beyond the capabilities of the hospital, which is to say the hospital's staff and equipment, et cetera, then the hospital must transfer the patient to another hospital that is, in fact, capable of providing the stabilizing treatment to the individual. If the individual refuses to consent to treatment or to transfer, then the hospital is relieved of its EMTALA obligations.

Again, so just to recap, within the capability and capacity of the hospital, the hospital must either treat the individual until there is no longer an emergency medical condition, or the patient is stable for transfer or discharge.

The third statutory requirement is the transfer requirement. EMTALA prohibits the transfer of individuals that have not been stabilized, unless a physician certifies that the benefits of the transfer outweigh the risks of the transfer, or if the individual requests a transfer after being informed of the risks and obligations of the hospital.

So a transfer can only occur if it's an appropriate transfer. What's an appropriate transfer?

Well, in order to meet the EMTALA obligations, the hospital must provide an appropriate transfer, which is a transfer where the transferring hospital has provided treatment within its capacity to minimize the risks of that transfer, and the receiving hospital has the capacity and capabilities to provide that treatment, and has agreed to accept the transfer and provide the treatment. And more on the receiving facilities in a minute.

An appropriate transfer will include the personnel and transportation to get from one facility to the next and the transferring hospital is also required to send with it the individual's medical records. In summary, these are the statutory requirements.

Now, the regulations, which is not to say I've given this an exhaustive review of every requirement in either the statute or the regs, there are additional requirements, but just to give you guys an overview as to I think what will be the most important points this morning.

As I mentioned before, the comes to the emergency department, one of the important phrases in the statute, this phrase applies to the screening requirement that the hospital must provide to determine whether or not an emergency condition exists.

CMS has defined the phrase to include the following hospital property: the hospital main campus; the parking lot; the sidewalk; the driveway; ambulances either owned by the hospital not on hospital property or on hospital property; or non-hospital owned ambulances that are on hospital property; buildings owned by the hospital within 250 yards of the main hospital building if the services provided in those buildings and billed under the hospital's provider number; and as well as hospital outpatient department's that are on or off the hospital campus. Now again, this is a regulatory definition.

Yes, I'm sure we'll hear more about it later. I heard a lot about it in Phoenix. I've actually heard a lot about it in Washington, as well. But I think this is one example of where additional anecdotal evidence drove this process.

My recollection was that there was a woman who -- I think this was in Detroit, there was a man who was shot and left in the hospital parking lot just outside the ambulance bay and was not in fact taken care of, and I think that often, as I noted before, the anecdotal evidence will often drive this process. So now we have this definition of what comes to the emergency department is.

In addition, the regulations define what is stabilized and what a transfer is. The regulations define stabilized to mean that it is medically unlikely that the transfer of the patient will not materially deteriorate the patient's emergency medical condition within a reasonable medical probability.

Now, the regulations define transfer basically to mean any movement by hospital personnel of that individual outside of the hospital. The interpretive guidelines further define what a transfer is and I'll get to that momentarily.

Now the main point, or one of the main points in EMTALA is that obviously it's an anti-dumping statute, so the concern is that hospitals were not treating patients because of their economic inability to pay. So one of the -- this is also actually in the statute, the hospitals are prohibited from delaying an examination or treatment in order to ask about the patient's ability to pay for that care.

But when an individual comes to the emergency department, as we've defined it earlier, CMS permits the hospital to follow a reasonable registration process, provided that these procedures do not delay screening or treatment. Of course what that is I'm sure is also subject to some debate.

Now, as I mentioned earlier, recipient hospitals also have responsibilities. Now both the statute and regulations require when hospitals with specialized capabilities to accept an appropriate transfer request provided that the hospital has, in fact, the capacity to accept the individual. So for example, if it's a burn unit, and the patient comes severely burned, provided that the capacity at that burn unit is available, then that unit would be required to take the individual who would be transferred from another facility.

Not, yet again another anecdotal story. Congress added this requirement in 1989 in response to a situation in Detroit.

A 32 year old woman had been robbed and beaten in the head with a bat and was taken to a hospital that did not have a neurosurgeon on staff. Now this hospital contacted 14 other hospitals with neurosurgeons on staff to arrange for a transfer so that she could receive specialized care. All of these hospitals refused.

Yes, you can see what happens when you have this anecdotal evidence.

In addition to the specialized hospital requirement, I believe this incident also prompted Congress to require hospitals to list physicians who take call as a part of what their capabilities are.

Now, this is not the first time we have addressed EMTALA at HCFA or at CMS now. In response to a -- I'm sure request from many in industry, HCFA developed an EMTALA working group in 1996, which was made of I'm sure a number of people who are -- at least from organizations of a number of people who are in this room, including those listed there. We tried to do both the emergency physicians, the hospitals, the doctors, public advocacy groups, health plans, et cetera.

Now the interpretive guidelines that came out of that are available on our Web site and I believe are also in the material that we provided. Now these interpretive guidelines are more than just the regulations, they go through each of the regulations and state how we at CMS interpret that and give guidance to those in our regional offices as to how to enforce EMTALA.

And what do they say? As I mentioned a second ago, the hospitals are, in fact, required to maintain a list of physicians who are on-call to provide stabilizing treatment after the screening process, as well as to screen if required by the emergency department. Now this requirement is in the statute.

The interpretive guidelines further explain however, that the hospital must abide by its own guidelines to enforce call. So for example, whatever the hospital's by-laws, staff by-laws has in it regarding call lists, et cetera, that's what we at CMS expect the hospital to do, so you have to be careful what you say because we hope that you will enforce it.

While this list of physicians on-call must represent the list of services that the hospital provides to the public, CMS does not dictate the composition of the call list. It is widely believed, erroneously, that CMS enforces the, quote, unquote, rule of three. Which is to say that if a hospital has three or more physicians in one specialty on staff, then that hospital must include the specialty on its call list. This is not a CMS requirement. I'm not exactly sure from whence it came, but perhaps someone on the panel knows how this got started.

In any event, in addition, under the stabilization and transfer requirements, generally a hospital may not refer a patient with an emergency medical condition to a physician's office. And this is true unless the physician's office has specialized capabilities that the hospital, in fact, does not have, and the benefits of transferring the patient to that doctor's office, in fact, outweighs the risks.

Now, a hospital with an emergency department offers services for emergency medical conditions within its capability and capacity to do so.

Now, much of the statutory and regulatory requirements stem from the capability and capacity of the hospital. The interpretive guidelines state that CMS will determine the hospital's capabilities from the physical space, equipment, supplies and services that the hospital provides. The capabilities of the hospital staff include the level of care that the hospital provides within the training and scope of their physician licenses.

CMS considers the hospital's capacity by considering the number of people in a specialized unit, the number of staff on duty, the equipment on hospital premises and whatever the hospital does to accommodate patients when the hospital exceeds its occupancy limits.

So basically the moral of that story is depending on how the hospital organizes its services for the general public, they need to do that regardless of the patient's ability to pay and they need to not delay treatment or screening or an examination, et cetera, to ask these questions. And this is all a part of that requirement.

CMS will consider a hospital's capabilities and capacity to determine whether EMTALA applies. An established emergency department is not specifically required. Consequently, CMS applies EMTALA to hospitals that offer emergency services for emergency psychiatric conditions or emergency treatment for substance abuse. Well, you can comment later. I promise I'll listen.

If screening or stabilization require ancillary services that the hospital provides outside of the emergency department, then the patient should be directed, not transferred, to a hospital owned facility that are a part of the campus, next to the hospital, owned by the hospital, and operating under the hospital's provider number. So this is akin to or this stems from CMS's definition of, comes to the emergency department, and how broadly as currently defined.

In terms of the screening guidelines, as I noted earlier, hospitals must screen patients who come to the emergency department and ask for a screening to determine if an emergency medical condition exists. This is of course true regardless of the presumed financial status, race, national origin, et cetera. Triage does not meet the hospital's requirement to screen.

The medical screening exam is a process that's used to determine whether or not the patient has an emergency medical condition. If the process determines that the individual does not have an emergency medical condition, then the hospital has fulfilled its obligations under EMTALA.

Now I think this is where we get some Court controversy over whether or not this is, in fact, a federal malpractice statute because while the importance is the process that is used to determine with reasonable clinical confidence that emergency medical condition does or does not exist, obviously this is a -- you've got the cross of a legal requirement under EMTALA as well as a medical requirement to determine what is an emergency medical condition. And that has caused I think also some controversy.

Now CMS considers the medical screening examination to be an on-going process that will not end until the emergency medical condition itself has ended, or the patient has been stabilized and appropriately transferred to another facility.

Now the interpretive guidelines distinguish between stable for transfer and stable for discharge.

In order for the hospital to consider the patient stable for transfer, the hospital must reasonably believe that it can transfer the patient with no material deterioration in the patient's medical condition, and the receiving facility has the capability to manage the patient's emergency medical condition.

There are four requirements of an appropriate transfer. The provision of treatment to minimize risks of the transfer, permission from the receiving hospital to transfer such an individual, inclusion of the medical records and the physician at the sending hospital has the responsibility to ensure that the patient is appropriately transferred, has the right equipment, the right staff along for the ride, et cetera.

Now, stable for discharge is that the patient has reached a point where continued care can be performed on an outpatient basis or later or an inpatient basis provided that a plan of care for follow-up is provided with the discharge instructions.

The main difference between these stable for transfer and stable for discharge are how and where the follow-up treatment can be provided.

It's a little bit different with transferring patients with psychiatric conditions. To be stable for transfer the patient must be protected from himself or others, and to be stable for discharge, the patient must no longer be a threat to himself or others.

And one important point to remember, that stable for transfer and stable for discharge do not, in fact, require final resolution of the emergency medical condition.

Now it's interesting that -- one controversial aspect I'll say of EMTALA is, in fact, when the hospital's obligation to stabilize a patient actually ends, and I look forward to hearing the panel's comments on that particular issue, but I think this stems from what, in fact, is stabilization.

Now secondly, EMTALA stabilization requirements apply to all areas of the hospital and not just the emergency department. So much for the interpretive guidelines. There's plenty more there, but those are the highlights.

Well, I'm not going to go into detail today about the CMS OIG Special Advisory Bulletin. The main points addressed in the bulletin are this, dual staffing in hospital emergency departments, prior authorization, the use of advance beneficiary notices, or ABNs, which I expect will be the subject of future task force hearings, patient inquiries regarding financial liability for emergency services, and voluntary withdrawal of the patient, which is to say when the individual leaves the hospital on his own accord.

CMS review procedures -- let me see if I can do this without -- I have a nice chart, let me see if I can get to it.

Here's an outline of the EMTALA complaint process, which is that the entire EMTALA process is in fact complaint driven, either a complaint is received at the State agency or at CMS. The regional office will authorize the investigation. The State agency, in fact, conducts the investigation over a very short time frame, five days.

If a violation is cited, then the State agency has 10 working days to forward the paperwork to the regional office. If there is no violation cited, then the State agency has 15 working days to forward the paperwork to the regional office.

The regional office will review the findings and determine the status of the case, and depending on whether or not something is medically indicated, which is to say there's a screening or stabilization issue, the PRO may also review the case, which takes an additional five days, and then the regional office determines whether or not there's compliance or non-compliance.

Of course, if the hospital is in compliance, then the case is closed. If not, there are a number of other options. Either the PRO does an assessment, the OIG is notified, and/or CMS can put the hospital on termination track.

Now, when the PRO is notified, the PRO does a 60 assessment and will forward it's findings to the OIG and copy CMS. OIG will determine whether or not it wants to impose civil monetary penalties and in terms of termination, typically what happens is the hospital is required to file a corrective action plan and from that point, CMS would determine whether or not there's compliance.

If there is compliance, the case is closed, otherwise the hospital would be terminated. A very Draconian penalty, but that's what we have from the statute.

So the possible outcomes for the CMS review procedures are this. No violation, there's a past violation but no termination, a violation but there is no immediate and serious threat, consequently there are no fast track terminations, which I think is 23 days. So the termination track would be 90 days on that third one.

The fourth one, violation, immediate and serious threat, CMS would take more immediate action to terminate the hospital's status. And questions of appropriate screening and stabilization should be referred to the PRO, which is our Professional Review Organization, for those of you who don't know.

As I mentioned before the CMS penalty is Medicare termination, the OIG can impose civil monetary penalties on both the hospital and/or the physician of up to $50,000 for a violation, depending on the size.

So it's a very expensive proposition one way or the other, and we certainly understand that at CMS, and I'm sure that's why a lot of you are here and concerned about the issue.

We've heard all sorts of things as I mentioned before. I've been to town hall meetings, and I've also had all sorts of provider groups come talk to me about their concerns about EMTALA.

I'm very much looking forward to hearing what the panelists have to say and hope that they can provide us with suggestions for solutions, which is really what we need.

I think I know a lot about the problems, but I'd like to know more about the solutions, and I hope they'll balance both the provider and the patient in those solutions so that the Task Force can consider both of those very important components of this problem.

And I look forward very much to hearing what the Task Force has to say in terms of further recommendations. Thanks very much.

CHAIRMAN WOOD: Thank you, Leslie. Let me stop for a minute and see if there are some specific questions that committee members have of the statutory requirements, the interpretive guidelines and the regulations for Leslie.

Gary?

DR. DENNIS: Thank you again, for that overview. One of the issues that constantly comes up with transfers related to EMTALA has to do with the hospital's capabilities, and I'm going to give you an anecdote and then you can go from there.

A situation where I was called, there was a patient that I had operated on at birth. I'm a neurosurgeon, and the patient had hydrocephalus and I put in a shunt at birth. The child is now 15, the child is living in West Virginia -- I live in Washington, D.C, -- living in a small town.

The patient comes to an emergency room and has no insurance, and has a shunt obstruction. The child is in a coma, very sick.

I get a call. The doctor in the emergency room says, I have one of your patients. And I didn't remember who it was, and they said, you know, the mother used your name.

And I said, "Well, great, maybe we have some records on her somewhere on microfilm, we'll try to find some."

He says no, this is her situation, she was in a coma and she needs to be seen immediately. I said call the neurosurgeon on-call.

Well, no neurosurgeon will come and see her. I said, "Well, closest hospital, send her there. How far away is it?"

He says, 20 minutes. I said take her to that hospital, get her out of there, she needs to be seen right away.

The doctors there, the neurosurgeons there refused to come to the emergency room. I said, "Well, how many neurosurgeons practice over there?" He said, three or four doctors. I said, "Well, send her to the next closest hospital."

"We're going to send her to you, doctor, and if you don't take her, then we're going to accuse you of an EMTALA violation." This is what he told me.

I said, "What are you saying? That little girl is going to die, take her to the closest hospital."

He actually sent her to me, it took four and a half hours for her to get to me. He passed 13 hospitals with that little girl to get her to me and I saved her life. But the issue there was, that the closest hospital was not really applying, so my question is, why has that been avoided in the statutes and regulations and the working groups? Because I didn't hear any reference of that. All I hear is references to the capabilities of hospitals.

And I'll tell you the issue now is a lot of these hospitals do not have the extensive coverage that they need to provide care for all these emergencies. Can you comment on that?

CHAIRMAN WOOD: That may be a tall order for Leslie to do, but she'll give it a try. Feel free to call on anybody else that you might want for support.

MS. NORWALK: I appreciate that. I'll make one brief remark, and then I'm happy to let Dr. Bitterman comment.

My general thought on that -- first of all, even though I'm counselor and I'm a lawyer, I'm not going to be providing legal advise, so this is my role at CMS, I just want to make that clear.

And I actually have my lawyer in the room, but he won't help me with this either, so. In any event -- I have to watch so I keep myself out of trouble.

I think that the point of EMTALA is obviously not to pass 13 hospitals. If you call a hospital, if a hospital calls another hospital because the initial hospital does not have the ability to take care of that patient and what that patient needs.

Now, as I mentioned before, the statute does, in fact, require the second hospital that does have both the capability and the capacity, to accept that patient. It is in fact an EMTALA violation on the receiving hospital's end to deny the transfer of the patient.

So I'm not sure in your scenario how that all worked, but it seemed to me that at least one additional hospital that, in fact, had a neurosurgeon on-call in fact declined to take the patient. That's problematic, that's what I would say to that.

Now of course, you did the right thing, when it came -- even though you thought this is ridiculous, this patient should not come to me, I'm farther away, it's taking more time for all appropriate medical reasons, but once the patient showed up, you, in fact, then had the EMTALA obligation, or the hospital had the EMTALA obligation to provide stabilizing treatment to the individual, so, I don't know if that answers your question.

Anyone from CMS want to comment otherwise? Okay. Dr. Bitterman.

DR. BITTERMAN: From experience, I could tell you that all three of you violated the law. The hospital, the failure to provide its on-call physicians, the other hospital for failure to accept and treat it when they came, and you, for failing to accept appropriately when asked by putting contingencies in the way. There are no territorial limits to this law.

So by you saying you must call other people before you call me, that in and of itself is a violation.

So how we define capacity, how we define appropriate transfer and how we work this out to best take care of the patients, are things we're going to ask the Committee to address when it relooks at these definitions.

CHAIRMAN WOOD: Nancy.

DR. NIELSEN: Well, that just -- that just really frosts it.

MS. NORWALK: I'm only the messenger.

DR. NIELSEN: You were doing fine until he talked. You know, when there is something that is impossible to comply with, then there's something really wrong common sense wise, and I think we just have to -- we just have to have some common sense. That was not what I originally wanted to say, but I couldn't resist after that last comment.

What is -- I have two questions, actually. One is, right now the penalties are monetary and termination.

MS. NORWALK: Correct.

DR. NIELSEN: If there were to be alternative levels of penalty, how would those changes be made? Could they be made within CMS, would they require statutory change?

MS. NORWALK: Yes. It would require statutory change, that's correct.

DR. NIELSEN: All right. The second one is -- it goes back to kind of a common sense part 2, but as a physician I need to say that having dealt with emergencies, having run ICUs for many years, bad things happen. Emergencies don't always have good outcomes, and this particular -- everything, from the statute to the interpretive guidance to the Court interpretations, it all hinges on outcome.

If something bad happens, everybody is frosted, everybody, no matter how hard they tried, no matter how they thought they had stabilized the patient -- I have been in a situation in an ICU where I thought I had stabilized a patient and the patient died anyway. God forbid that that should happen in the ambulance, that's the problem.

So there is a situation -- I guess I'm trying to understand the malpractice aspect --

MS. NORWALK: Right.

DR. NIELSEN: -- because there clearly is a malpractice -- I mean everybody has an obligation to try to do the best that they can, and if they do not do the best that they can, then they're liable for those actions.

MS. NORWALK: But not under EMTALA.

DR. NIELSEN: Understood, but --

MS. NORWALK: Provided they follow the appropriate process, et cetera.

DR. NIELSEN: Well, that's really my question to you, because the concern that physician's have is that even when they do their level best, if there's no neurosurgeon at this hospital and the patient is going down and is only going to be saved by a neurosurgeon and they transfer the patient and the patient crashes, then it's the transferring hospital that gets nailed, so how does EMTALA --

MS. NORWALK: Address that issue?

DR. NIELSEN: Sort out bad outcome with everybody having tried to do the right thing, that's my question.

MS. NORWALK: I think there are a couple of points to that. The first is the requirement under EMTALA in terms of the transfer, is that if the benefits of transferring the patient in fact outweigh the risks, then EMTALA would say transfer the patient. And that's certainly in the instance of if the patient stays in your hospital and the patient is going to die, that's problematic, so a transfer certainly is appropriate.

Then the second issue which is one of really more Court interpretation, what happens when -- I have no idea what the Court's would do on a particular topic, but hopefully from a CMS perspective, the regional office would get our PRO involved, and with a PRO involved, you'll have a physician at least looking at these determinations.

So the point is not I think to have -- and hindsight is 20/20, the point is what happened at the time, so that you could say the doctor did all that she could within her abilities to stabilize this patient to make sure the patient could transfer without further material deterioration. Sometimes the best -- no matter how hard we try, we're not successful.

I'm sure that all these cases are very, very fact intensive and how one outcome, how it's determined, the outcome of the actual case -- I'd like to tell you that I'm an expert in all of CMS's enforcement activities and all the Court decisions, but that would not be accurate.

So I don't know if that answers your question, but gives you some sense of --

DR. NIELSEN: It did in general, but just a little follow-up to help me understand one thing.

Going back to the comment that was made just before, why would Dr. Dennis be held to an EMTALA sanction if he is five hours away and is not on-call, but happened to put the shunt in?

Does a telephone call when the guy is at home watching TV with his wife, I mean, I don't know what the circumstances were, but I'm just asking you, a telephone call from anywhere in the country?

If I get that phone call about a patient of mine who happens to be in Phoenix, I am suddenly responsible? I don't understand.

DR. BITTERMAN: It depends on what capacity you're on-call. If you're on-call for your private practice, the law doesn't apply.

If you're on-call in the capacity -- if you're on-call for that hospital's emergency room that night and they're calling that hospital to accept the patient, then you indeed become attached to a duty and have a legal duty to accept that patient in transfer, regardless of how far away it is, unless it's really inappropriate to come that far.

I mean, if they're truly going to die before they get there, you can say so. But if they will make it or possibly will make it, you have a legal duty to accept it, because the government has said and enforced, that there are no territorial limits on this, across state lines, out of county, out of referral area.

The only ones that you do not have to accept are outside the boundaries of the United States.

CHAIRMAN WOOD: Karen Utterback.

 

MS. NORWALK: Pat.

MS. UTTERBACK: I'm just looking for clarification to the comment that you made to Dr. Dennis about placing contingencies, because, you know, as an outsider looking in, I would say Dr. Dennis was seeking clarification that this was the right decision for that particular patient at this time, but your comment seemed to very quickly move that beyond the point of common sense and questioning and trying to be sure there was not more appropriate care closer to where the child was to the level of he had an offense.

DR. BITTERMAN: See, the way I would answer that I would say, look I'm happy to accept it, but, have you considered that there's closer places and it might be more appropriate to take that child someplace else than here.

There have been plenty of cases where -- and this has happened in actual HCFA investigations where they said you couldn't put that contingency there at all. You just had to simply say yes if you were called.

So it removed it out of your comment about common sense. Mark Twain said that's sense uncommonly used.

MS. BENDER: Can I interject now here? My name is Pat Bender and I am the sub for the EMTALA lead in the CMS office in Atlanta. And I wanted to say here that we have both right and wrong.

If you were the doctor on-call for neurosurgery in your hospital, then, yes, what you heard about being an EMTALA is true. If you were simply being called because you were the original doctor who put the shunt into that person, and the family named you as the doctor and you were not on-call, then no, you would not have an EMTALA.

But either I missed something or I heard you and it didn't get picked up.

I believe you said that the first hospital that the patient came into did have neurosurgeons on staff and on-call and they refused to come in. That's a big EMTALA for that hospital, very big. But once they did call you and you were on-call in your hospital?

DR. DENNIS: I was on-call.

MS. BENDER: Then he's right. You were in an EMTALA.

DR. DENNIS: I was on-call, I simply agreed that I would take the patient but I thought it was a greater risk for the patient to be transferred to me. I never said I didn't want the patient. I wasn't putting barriers there for the transfer.

I don't really think I was guilty of an EMTALA violation. I simply told them that what they were doing was an EMTALA violation. That the other hospital 20 minutes away was guilty of an EMTALA violation and so were they.

But they said well, we don't have these -- these doctors won't come in, that you may have a call schedule here but they won't come in. So if you don't take the patient, then you'll be guilty of an EMTALA violation.

But I think what I was raising is, I was trying to give you a dramatic example of how screwed up it's being applied -- I mean how screwed up it is and it's being applied in a very strange way.

But what I would say is that one of the big problems is there's no statement, there's no reference to the closest hospital that can provide the services anywhere, and I think that that is one of the big missing links in this whole picture.

If somehow that was included, you wouldn't have to include all the hospital grounds and X,Y, and Z, naming all the different places where -- you know, if you don't take care of this patient you're going to be guilty, no. If it's the closest hospital where the service can be provided, and that's the way the EMS system operates in cities.

They don't operate based on EMTALA, they operate on the closest hospital. And I think that somehow a different dialog needs to come out to in the end look at the quality of care of the patient as well as the systems ability to provide that quality and develop a balance. And somehow that's missing in the regulations.

The regulations were kind of a knee jerk response to certain anecdotal experiences, but Dr. Crosby just leaned to me and said, you know, CMS's responsibility is to do this on an evidence basis. What's the evidence for doing this or that, what's the rational thing to do. Congress may come up with lots of knee jerk responses, but the interpretation of those has to do with what makes sense.

MS. BENDER: But before I go back to the back where I belong, the other thing that I would say to you, at least in the Atlanta regional office, is when we have an EMTALA and we have those questions about why they would send them four and a half hours away rather than 10 minutes away where there's another hospital, we would send that case, number one, for a 5 day PRO review.

If the PRO agreed that it was an EMTALA, we would send it automatically for the 60 day PRO review. And in both of those reviews, the regulation allows for the PRO reviewing physician to call you and ask you what went on, why did this happen. And that mitigates -- in an attempt to find all the information and to mitigate the potential for a penalty to you.

DR. DENNIS: Can I ask one more question?

CHAIRMAN WOOD: Go to follow-up and then I'll come back to Tony Fay.

DR. DENNIS: You bring up peer review, and I'm the Chairman of the Board of a QIO and peer review organization, I'm on the Board of another one, and I know that peer review organizations to not get referred cases for EMTALA violations hardly ever.

Now it may be in Georgia, you know, you are really -- I like your state, you're doing it right, but you know, there's no requirement that that be done. And it seems to me it's too discretionary on the part of CMS or whoever is doing the review.

Somehow that part needs to be included in these regulations so that there's mandatory peer review before you start, you know, heaping out fines and attacking people.

You have to understand the situation better, what the quality of care should have been, what the situation was from a medical perspective, whether it was medically necessary, and right now, as far as I can see, that is way down the line in the review process and it's not really required.

MS. BENDER: Okay. I really am going to sit down after this.

By regulation, before a case can go to the OIG, it's supposed to have the 60 day PRO review. In the Atlanta regional office where we cover the eight states, we send out a 5 day PRO review on every case that has a 2567 or a statement of deficiency, automatically. We go for the 5 day Pro, and then if the five day PRO says yes, they agree there was an EMTALA, it automatically goes to the 60 day.

But by regulation, the 5 day is discretionary, but the 60 day is mandatory before it goes to the OIG.

CHAIRMAN WOOD: Can we get a copy of that regulation for review?

CHAIRMAN WOOD: Can we get the copy of that regulation to review?

MS. NORWALK: I'll tell you where it is, I think you actually have it in your materials. It's 42 CFR 489.24(g), Consultation with Peer Review Organizations.

DR. NIELSEN: Could you repeat that?

MS. NORWALK: Sorry. 489.24 in 42 CFR -- it should be in your book, actually. The end of the EMTALA regulations. It's under Tab 4, I think -- 4A.

And then if you go to page 3 of 489.24, in the second column, half way down, you'll see consultation with peer review organizations on page 3. Did you find it?

CHAIRMAN WOOD: It's actually under -- it's a little more than half way down, but in going through this last night and then your process diagram, Leslie, what struck me was that it seems that there is -- as Gary has suggested and I review for PROs as well, and as a cardiology reviewer, I would sure expect to see a lot of potential cardiology cases. We don't get them.

So clearly there's something about the way this is written that is not working in practice. We don't have any information about how often that's done, I take it, from CMS. That is, you don't know how often the procedure is actually followed from region to region or state to state?

MS. NORWALK: I don't off the top of my head. I'm delighted to get that for the Committee. If you'd like to -- I'll see what I can do before --

CHAIRMAN WOOD: It may not be possible to get. I think that's part of the problem.

MS. NORWALK: I suspect that they do have that sort of information, so I'll just need to work with them.

CHAIRMAN WOOD: Tony Fay.

MR. FAY: Thank you, Mr. Chairman. It would help my thought process a little bit if I could understand what happens once the case is referred to the OIG, is there an opportunity for a fair hearing before an independent administrative law judge prior to determining the final resolution, or is this just a negotiation with the OIG with sort of that penalty exclusion from the program being the alternative outcome?

MS. NORWALK: No, the ALJ process is included in the OIG penalty sanction phase.

CHAIRMAN WOOD: We have with us several members of the public, as it were, but people who are actually involved in the care of patients with emergent conditions ranging from physicians, emergency physician specialists, emergency care providers from ambulance services to give us a field perspective, and this will I'm sure highlight for us several specific issues that we have with EMTALA that we might need to address.

And I'm pleased that all of them have come today. I know some of them obviously are in the middle of a busy work day, like Dr. Lavernia next to me, but we'll try to get through this as quickly as possible so that we can have time for discussion and get these busy folks back to their activities.

Some of them have also come from some distance, Dr. Bitterman in particular, from North Carolina, Mr. Hinson, from Georgia, we appreciate your taking the time to come and share your perspectives with us today.

I'm going to ask each of them as they begin to quickly tell the members of the committee as well as members of the audience their particular job so that we can get a little better idea of the perspective that they bring to this.

And I'd like to invite Dr. Diskin actually to begin. Dr. Diskin is from the Mt. Sinai Medical Center here in Miami Beach.

DR. DISKIN: When I found out that I would be the first one to speak, I thought what I might do is set up the milieu or environment in which the EMTALA regulations exist.

I'd like to thank you for the opportunity to speak before you today. I come before you as a physician member of the Florida Medical Association, often beleaguered under a morass of regulations and paperwork that threaten my ability to render quality patient care.

I also come to you as Chairman of the Department of Emergency Medicine at Mt. Sinai Medical Center here in Miami Beach, home to one of only three residency programs in emergency medicine in the State of Florida. As an academician who is finding that he spends more time explaining to his residents how to avoid regulatory violations, avoid malpractice litigation, and comply with a myriad of governmental regulations than he does teaching them clinical medicine and how to save lives, and who finds himself explaining how every patient encounter could be a potential adversarial relationship in one form or another.

I come to you as a practicing emergency physician who spends more time on his shift doing paperwork, trying to find specialists to care for patients, and convincing HMOs that their patients really do require admission, than I do at the patient's bedside.

As a physician, who after 20 years of practice finds his chosen specialty under siege from all directions, a physician who may be unable to obtain malpractice insurance this year, or may see the premium increase as much as 200%, and a physician who finds the members of his specialty are no longer being sued for bad medicine, but are being sued for bad outcomes, regardless of the quality of the medicine practiced or the unusual life threatening nature of the patient's disease or presentation.

I come to you as a physician who due to the shift in managed care rarely finds himself speaking to a physician who knows anything about the patient on the other end of the phone and who must often beg specialists who know they will not get paid, will likely get sued for any bad outcome, to get out of bed in the middle of the night to come and see a patient in the emergency department.

And I come to you as a physician who has seen emergency department's so overcrowded that cardiac patients are sitting in chairs with monitors attached and fire rescue ambulances lined up out the door with their patients on stretchers.

Lastly I come to you as a private citizen who is afraid for the safety net of our nation's emergency departments that it is failing, and my family or your family will not be able to receive the care they need, when they need, and where they need it. The next time I have a medical emergency, will I be able to find an open emergency department offering the services that I need, will there be a specialist on-call who will be willing to come take care of me.

Will I be able to get past the 30% of patients who are indigent and use the emergency departments as their source of care because they've learned that they can't be turned away?

Will my managed care plan pay for my services or will I be so afraid that I'll get stuck with the bill that I avoid needed emergency care?

Will the best doctors in my area quit medicine or move away because they can no longer afford malpractice insurance or no longer wish to practice under the constant threat of losing everything they and their families have worked for their entire lives?

In the midst of all this, my professional life has become a regulatory alphabet soup, OSHA, DEA, DPR, HCFA, now CMS, KCHO, the Joint Commission, OIG, FDA, PRO, CDC, and of course, EMTALA.

We are here this morning to speak about EMTALA, but the regulatory morass sometimes the ambiguity and the administrative requirements of the EMTALA laws and regulations are only a symptom of the pervasiveness and burden of the convoluted regulatory environment on the practice of medicine.

Having been doing this for 20 years I ask myself this simple question, do we render better care now than when I started in practice, despite all the technological and pharmaceutical advances and despite the highly regulated environment? I'm not sure.

EMTALA started out with a very simple premise. A patient should not suffer loss of life or limb due to the refusal of a hospital to determine if an emergency condition existed, and if one existed, stabilize and treat the patient's emergency. A prohibition against so-called patient dumping.

Instead, it's become an unfunded mandate to deliver medical to our uninsured population and one of the least cost effective delivery systems for chronic and non-urgent care possible. We often hear the phrase, "I know you're required to see me, so I want to see a doctor now."

It has become one more source of malpractice litigation against physicians, by-passing the State Courts by claiming a violation of federal law.

It has become a source of confusion as to its impact on the transfer of patients to hospitals contracted with the patient's HMO and a cause of action for patients and their families who have questioned release from the hospital, sometimes weeks after admission through the emergency department.

What do I think that could be done to clarify the EMTALA laws and to have regulations help us deliver quality care? Let me offer a few suggestions.

Review in detail and remove all ambiguities from the law, rather than perpetuating a document that has spawned a cottage industry of consultants and lawyers to tell us what they think it really means, and investigators who can define reasonable as they see fit.

What is a reasonable response time for an on-call specialist? What are the obligations of the on-call doctors, if any, to follow-up a patient discharged from the emergency department and referred to their offices? Clearly state who is qualified to perform medical screening exam prospectively, not retrospectively. Clearly define the responsibilities of the hospitals to send out their own personnel to physician's offices located on or nearby hospital premises.

Second, have the regulations be a vehicle to encourage specialists to take call for emergency departments, not be the reason they drop off the staff or drastically limit their availability.

Physician's limit their on-call responsibilities or fail to respond for three reasons. They have been sued or a concern with being sued for taking call on the highest risk patients at a time when the benchmark is not the will of God, but the latest major league baseball contract.

They're not paid, especially when the patient is insured, and they are not paid, slowly paid or underpaid by the patient's managed care plan for services rendered at the most difficult times and under the most difficult circumstances.

Or third, lifestyle issues requiring them to be away from their families, limit social obligations, and exhaust them for their regular practice responsibilities the next day.

We need to address the first two concerns to encourage more physicians to take call and thereby spread the lifestyle interruptions amongst the greater number of physicians. Limited tort reform protection for emergency physicians and on-call specialists responding to emergency departments.

At a minimum, the physician should be afforded protection against excessive pain and suffering awards. Malpractice insurance for these physician's services should be accessible, available and affordable.

Fund the unfunded mandate. As an example, by requiring payment at at least Medicaid rates by states for medical screening exams and emergency treatment not otherwise compensated within 180 days after treatment, and clearly require all payors including ERISA Plan (phon.) to compensate physicians and hospital usual and customary rates for federally mandated services.

Next, clearly state in the regulations that they are not intended as a course of action for federal malpractice tort litigation. While we've been successful in defending this, the costs of such a defense are enormous, and may not be covered by malpractice insurance.

The investigatory and appeals process must be streamlined and reasonable. An EMTALA action could easily bankrupt a physician if he chooses to appeal it, especially with Medicare fees being cut off from their practice. Hospitals and physicians are often quick to make any settlement so as to avoid cutting off Medicare funds while an appeal taking years is in process.

Due process, peer review and varying levels of corrective action, including education, should be emphasized for physician enforcement. The law should be clarified that every patient sent to the emergency department does not require a medical screening exam. For example, the patient send for an X-ray injection directly by their personal physician. The prudent lay person definition of someone presenting with an illness or injury of sudden onset should apply.

Let me conclude by saying that I fully support the intent of EMTALA. Hospitals and physicians should be obligated to provide screening and stabilization services to patients presenting with emergency medical conditions. This emergency care should not be delayed based in any way upon the patient's financial status.

What I am opposed to is the ambiguities in the law, the unfunded mandate, the continued widening of the scope of EMTALA to non-emergent patients and beyond the emergency department to sites often remote from the original legislative intent, the emergency department. Thank you.

CHAIRMAN WOOD: Thank you very much, Dr. Diskin. Next is Dr. Lavernia.

DR. LAVERNIA: Good morning, and I would like to apologize for wearing my jammies, but I had to work today and I have to go back to work.

I would like to state that the reason I'm here is because I think the work you all are doing is so important and the opportunity with the administration is so large that my academy wanted me to come hear and speak on behalf of the 18,000 Board certified orthopedic surgeons that we have.

I'm currently Chief of Orthopedics at a community hospital, Cedars Medical Center, and I'm also a professor of Orthopedic Surgery at the University of Miami. I've spent the last ten years trying to teach residents how to do surgery, how to evaluate patients, and I couldn't echo more Dr. Diskin's issues about how important it is to streamline some of these regulations, because I spend about 20% of my time right now teaching my guys how to avoid getting in trouble.

We're here to today to discuss EMTALA. I would like to encourage the panel to look into other things in terms of regulation.

We are decimating graduate medical education in America. We have the best graduate medical education in the whole world. People come here from the best European, South American and Islandic universities that train here, and we're just being decimated by over regulation and careless administration and careless litigation in terms of the issues that we face on a day to day basis trying to train the next generation of specialists that are going to be caring for my kids and your kids. We really have to take the opportunity.

When it comes to EMTALA in specific, we need some clarification on the issues that orthopedic surgeons face on a regular basis. I have, Chief of Orthopedics at Cedars, have had three guys quit the emergency room over the last year because they cannot afford time off their practices.

Miami is a city of 3 million people. There's not one orthopedic surgeon that gets paid for taking call here today, and we all have to come in at night, take care of patients that are unfunded, and the next day have a full office to care for.

Our malpractice rate just went up about 30%. The average guy in Miami pays about $85,000 a year in malpractice, and it's just unsustainable. With the onset of a lot of new surgery centers and the scope of practice that some guys are doing, the most talented guys are just choosing not to go to hospitals and just do outpatient surgery. And pretty soon, the emergency rooms around Miami will not have orthopedic surgeons to cover and access to care will be extremely limited.

One of my colleagues when he found out I was coming here to talk to you told me that in the Orlando area there are two hospital systems. In both of those systems, at least half the hospitals don't have orthopedic surgeons every day. And what that means is, limitations to the access of care.

What can be done in terms of EMTALA? We would really like to clarify the emergency services with regard to the site of service, point of stabilization and the responsibility for follow-up care. We have tremendous problems with patients on-call getting splinted for a fracture, sent to an orthopedic surgeon's office the next day, and the patient's have to be seen that next day, in a lot of cases at no compensation, when running an average orthopedic surgeon's office in Miami costs about 300 to $400 an hour. With the malpractice rate, that would probably go even higher.

We need to clarify the rules regarding the treatment in the orthopedic surgeon's office. What exactly do you mean by stabilize and treat? That is extremely, extremely nebulous right now in the regulations and is being utilized by a lot of litigious patients to really put a big hurt on most guy's practice.

We need to require physicians to render care based on their scope of usual practice. Currently we have some subspecialists that have not seen, for example, pediatric orthopedics.

I have not seen a child case in ten years. Yet I'm required, when I'm on-call, if there's a child in the emergency room to care for that. We really need to clarify the expectations for responding to the on-call services. Most guys sometimes operate eight, 12, 15 hours a day. They have to be on-call the whole night, they're expected to come in and take care of problems, and then the next day they're expected to go back and perform with an office full of patients.

We need to support payment for EMTALA mandated service in extension to the hospital. Currently most hospitals have some type of tax break or in some case make adjustments for their reimbursement when it comes to indigent care. Doctors don't have that.

We encourage the panel that as a way to support the indigent care process in the whole country, that physicians get extended some tax breaks when they care for these patients, in some type of way, form or fashion. I think that would improve the issues about unreimbursed care.

We would like to also suggest that we scrutinize the regulations and guidelines to make sure that they are consistent with the law. The regulations are being utilized for all sorts of evil purposes right now.

We would like to involve the provider community in evaluation of the EMTALA process and we would like to see some guys that actually have mud on their feet, talk to you all and be taking time from their busy practices to find out what goes on in the actual trenches.

And finally, I would like to let you know that the American Academy of Orthopedic Surgeons stands ready to assist the Advisory Committee in any way that we can, and we very much appreciate the opportunity to be here today and speak to you.

CHAIRMAN WOOD: Thank you very much.

Next, Ms. Jodi Lehman from the Miami Baptist Hospital.

MS. LEHMAN: Good morning, my name is Jodi Lehman, I'm the corporate vice-president and general counsel for Baptist Health South Florida, which operates four hospitals in south Florida. Thank you for allowing me to come.

I am here today on behalf of the American Hospital Association's nearly 5,000 hospitals, health system, network and other health care provider members. We are pleased to testify today on an issue of great concern to the health care community, the effect of the Emergency Medical Treatment and Labor Act regulations on our nation's hospitals.

As an attorney, I've worked exclusively with hospitals and health care organizations. At Baptist Health South Florida, I oversee risk management and all legal services, and also assist our hospitals and staff in balancing their efforts of complying with EMTALA and delivering patient-focused, quality emergency services.

Baptist Health South Florida is the largest not-for-profit health care organization in south Florida. Our hospitals include Baptist Hospital of Miami, with 551 beds, our flagship; South Miami Hospital, with 445 beds; Homestead Hospital with 120 beds; and Mariners Hospital with 42 beds. We also have three satellite facilities for after hours urgent care, and other outpatient services.

In 2001, we provided approximately $100,000,000 of charity and uncompensated care in our system. There were about 87,000 emergency department or ED visits at Baptist Hospital alone; 29,000 at South Miami Hospital; about 35,000 at Homestead Hospital, a hospital located in a low income community ravaged by hurricane Andrew in 1992.

Emergency departments are a critical part of our health care system, and they are experiencing increasing demands for care, which often strains capacity. The linchpin of EMTALA is non-discrimination. EMTALA was intended to ensure that each patient has access to emergency services, regardless of ability to pay.

EMTALA is also a critical element in the experience that our patients have when they seek emergency care at our hospitals. Under EMTALA, hospitals must screen patients seeking emergency services to determine whether an emergency medical condition exists, and if so, stabilize the patient.

If they are unable to stabilize the patient, they can appropriately transfer the patient to another hospital for stabilization. You've heard about that.

This basic protection that EMTALA provides is essential to the mission of Baptist Health. Unfortunately, the government's current interpretation and enforcement of the law effectively limits the options we have for delivering patient care. Consequently, there's a lot of anxiety in ED's about how clinical decisions might be judged under EMTALA retrospectively.

Our nurses, physicians, and medical technicians want to empower patients to make informed care choices, by setting realistic expectations about waits and delays caused by extraordinary demands and overcrowding in the ED. We want to appropriately use all available resources for each patient who comes through our doors, but the specter of EMTALA is creating reluctance to even suggest other clinical settings where appropriate care could be provided sooner.

Some of our concerns lend themselves to easy solutions, while for others, there are simply no quick fixes. Today, we'd like to offer several suggestions to overcome existing cumbersome regulatory requirements and work with the Committee in developing solutions so that we can create an appropriate climate in our EDs.

In such a climate our health care professionals would be able to communicate our capabilities to our patients, permitting them to make decisions about their care and giving hospitals the flexibility to do the best thing for the patient.

I can tell you of an example from our own Baptist Hospital. Baptist Hospital is the second busiest ED in Miami-Dade County, and our visits are steadily on the rise. While we continue to expand our ED capability, we do not have the inpatient bed capacity to handle an unlimited number of patients. All patients are initially evaluated to determine whether they are critically ill. However, extended waits at Baptist for patients who are not critically ill are well known. Patients do not like to wait.

In fact, one patient was so frustrated that while in our ED she contacted a local television station to publicly say what so many patients feel. She was asking for information that we felt we could not provide while still complying with the law. The current EMTALA environment drives a wedge, such as this one, between patients and care givers.

In this instance, our nurses felt they could not tell her what her wait would be nor what other care options might be available until a comprehensive screening was completed, for which she'd have to wait hours.

We ask that the requirements for screening prior to transfer be adopted for patients who are initially evaluated as not critically ill. Making this change should not have an adverse effect on the quality of care provided to patients.

One of the issues we've been asked to address also is the implication of EMTALA on a hospital's ability to respond to a disaster, mass casualty event or bioterrorism threat.

Under current regulations, compliance with EMTALA could limit a hospital from responding in the most efficient and effective way to a disaster situation, or from following protocols established by public health authorities. Instead, we suggest that when a hospital is operating as part of a disaster response team, what patient care is given, and where it is given, be dictated by the disaster or mass casualty event protocol.

EMTALA is designed to deal with individuals on a case by case basis. Disaster and bioterrorism threats require a system response. Using government controlled protocols, whether local, state or federal, will assure that hospitals respond as part of the community emergency response system.

A fuller explanation of our recommendations on this critical issue is attached to our written statement, which will be provided.

A few minutes ago I spoke of the EMTALA climate in the ED. I'd like to suggest other ways this climate could be improved.

The first step to establishing a more EMTALA anxiety-free climate in our EDs is convening a Committee of those with a stake in EMTALA implementation to problem solve as implementation issues arise. An EMTALA Advisory Committee consisting of those from both the private and public sectors, would help create a process to see that EMTALA works in an appropriate and effective manner.

Another important change would be to provide hospitals with appeal rights in the complaint process. Currently hospitals have no recourse if they are found in violation, initially in violation of EMTALA by the regional office. There's no due process or administrator level review before the RO issues public notice of termination and subsequently sends a termination letter.

This letter alone is the sanction most feared by hospitals. Because of severe time constraints to respond, no hospital can risk publication of the notice or ultimate termination by trying to convince its regional CMS office that a violation did not occur.

An appeal process would enable care givers to exercise and defend their professional judgments without the threat of prematurely published newspaper notices announcing the government's intent to terminate the facility from the Medicare program.

Mr. Chairman, many hospitals also find the payment for services provided in the ED are often retroactively denied on the basis of local medical review policies. Although we have a law in Florida that applies for managed care, if we don't provide the services, we are in violation of EMTALA, yet by providing the needed services for examination and stabilization of Medicare or Medicaid patients, we may be at odds with the LMRP.

In order to avoid this situation, we believe that services provided in the ED under EMTALA rules should be excluded from LMRPs, as they are in the State of Florida.

Mr. Chairman, hospitals and the thousands of health care professionals who work there on a daily basis providing care, take their responsibilities seriously. When a patient comes through our doors, our first actions are to assess the nature of the injury, determine the appropriate care and then provide it, without determining whether or what type of insurance the individual has. These individuals should not be calling lawyers.

We look forward to working with this Committee to establish more common sense guidelines and commend Secretary Thompson for his leadership on this issue.

CHAIRMAN WOOD: Thank you.

Next, Mr. Davis.

MR. DAVIS: Good morning. My name is Scott Davis, and I'm the Director of Special Projects for Memorial Healthcare System in Hollywood, Florida. And I assure you this is a very special project.

We are the public safety-net hospital for southern Broward County in the county immediately north of Miami-Dade here. We operate three hospitals, a free standing nursing home, and several off-campus outpatient service providers.

I first want to thank the administration and Secretary Thompson for establishing this Committee, and the members of this Committee for dedicating your time and efforts to improving our nation's health care programs.

We all are here because we have a commitment to providing the highest quality patient care services when and where they are needed. And where we providers and practitioners furnish that infrastructure and direct hands on patient care, CMS also contributes by providing the implementation and administration of the benefits and coverage of those services.

The benefits and coverage of those services have changed over time and coupled with those changes, the fiscally responsible management of the program have led over time to incrementally more and more complex and interwoven rules and regulations. Where those rules and regulations place an undue burden on the provision of that high quality patient care, we all have an interest in reducing that burden, and shifting the resources back from paperwork to patient care.

I'm pleased to be here today to speak with you about some of our concerns and offer some ideas regarding the Emergency Medical Treatment and Labor Act, or EMTALA. The principal purpose of EMTALA was to prohibit economic discrimination in the provision of emergency medical care, thus EMTALA's nickname is the anti-dumping law.

So it might surprise you that a public safety-net provider, one who's core mission is to provide care to all regardless of ability to pay, might have any issues or concerns with this law and the associated rules and regulations, but we do.

EMTALA establishes certain requirements for hospitals which include among others, a required screening of any person who presents to the emergency room for patient care services, and prohibition of inquiry about insurance or payment method prior to screening or treatment. Our issues and recommendations touch on both of these areas.

With regard to the required screening, and in particular with regard to our off-campus departments, the law requires provision of an appropriate medical screening examination for any individual who comes to the emergency department and requests services.

As we heard earlier, the regulations are much more expansive. They define that phrase, comes to the emergency department, to include not only the entire campus of the hospital, but also any hospital based off-campus department of the hospital, regardless of that department's medical treatment capabilities. Although one of the subsection's in this regulation does much to address appropriate protocols for off-campus departments, it fails to consider the practical realities of what these departments are and it establishes inappropriate public policy.

The nature of these departments is almost invariably a small subset of services furnished by the hospital, often a single subspecialty, such as wound care, cardiac rehab or physical therapy. The physicians and other medical personnel in these departments are not emergency personnel.

Given as we've heard the malpractice risks inherent in furnishing services outside of one's training, the safe result of every screening of these departments is that an emergency condition is present requiring further treatment following transfer to the main hospital for that treatment.

Where an off-campus department seeks to establish a protocol for appropriate medical screening, it's difficult to obtain the services of physicians or other personnel willing to be designated as required by the regulations. Part of that difficulty lies in the fact that the term, appropriate medical screening, is not defined in the regulations.

The D.C. Circuit Court gave us one definition, the same level of treatment regularly provided to patients in similar medical circumstances. However, this could be read as a reference to the standard procedures followed in the emergency room. And as we've said, the physicians in these off-campus departments are not emergency personnel.

The extension of EMTALA requirements to off-campus departments is also counter to the best public policy. We do recognize that an entity that claims to be part of the hospital should act as part of the hospital. And we also recognize that these regulations attempt to narrow the EMTALA requirements in these departments. However, the existence of any EMTALA requirements in these departments establishes a public policy that it is appropriate to seek emergency medical care in such off-campus departments.

Given the nature of these departments and the type and level of staff there, even following the protocols set forth in the regulations jeopardizes the timely delivery of the appropriate level of emergency medical treatment. Public policy should instead encourage people to seek emergency care at the hospital, not at the off-site department.

Our recommendation in this area is simply that the requirements for off-campus departments be narrowed to specify that appropriate medical screening means a common sense medically appropriate screening within the capabilities of that off-campus department.

The regulations should also specify that calling 911 for paramedic support, for example, is a sufficient arrangement for transport. Because these support agencies generally have strict policies regarding transport to the closest hospital, the regulations should also explicitly recognize that those policies are not within the control of the hospital, and therefore not a violation of EMTALA when they're followed.

In the area of screening of any individual, one other concern with regard to the screening requirement, is that it does cover any individual who comes to the emergency department, but payment is only provided for services rendered to those with governmental coverage, insurance, or other means to pay. This unfunded mandate is especially burdensome on the public safety-net providers who already bear the brunt of indigent care services.

To some extent granted Medicare and Medicaid disproportionate share hospital, or DSH rules, provide some additional funds to hospitals that serve a disproportionate share of low income patients. However, these programs are essentially inpatient services programs only. The measure of DSH status is based on inpatient utilization rates.

In fact, for Medicare DSH, the measure is based only on Medicaid and SSI utilization, and does not even reflect the services provided to indigents not eligible for those programs. And no measure is made of the extent of outpatient services furnished to low-income patients. Much of the emergency room services and the associated ancillary services, and basically all of the off-campus services, are outpatient services.

Therefore, much of what EMTALA addresses are outpatient services. For EMTALA to place a service requirement on hospitals without providing the necessary financial support is financially burdensome on these hospitals and it risks limiting the availability of services to all patients when those services are needed.

And also, once a patient is screened in the ER, the physician will provide even the non-emergency care that is needed. Not only is good customer service an issue, but there is again the malpractice risk if the patient is referred elsewhere and fails to timely obtain the necessary services. So while EMTALA does not specifically impose the cost of these non-emergency care on the hospitals, for all practical purposes that cost is there.

Now the Courts have recognized that malpractice in the performance of a medical screening is not a violation of EMTALA, those are two separate areas of the law.

We would recommend however, that the law be amended to protect the physician who refers a patient to a non-emergency care site after the screening establishes a non-emergency condition.

In our organization, for example, such sites would include our Urgent Care Center or Primary Care Center, both of which offer lower cost alternatives for medical care. This would help reduce our ER overcrowding and improve the availability of resources for true emergency care.

We would also like to recommend at least some recognition of outpatient service volumes in the determination of DSH payments as a way of somewhat easing that financial burden.

With regard to patient financial obligations, again, in the off-campus departments to start. One of the requirements for a hospital based status of an off-campus entity, is that it must provide to the patient a statement of their financial liability prior to rendering services. This requirement in the regulations, 413.65(g)(7), is exactly contrary to the limitation imposed by EMTALA.

The other requirement that is counter to that notice is that in the local medical review policies where local medical review policies require that we provide the patient with an Advanced Beneficiary Notice if the diagnosis of the patient does not support the medical necessity of that service. And again, the ABN has to be provided prior to rendering the service. You can't do that under EMTALA.

Last year -- or actually, the first nine months of this year, we've written off over $600,000 of payments due to that specific issue in our emergency department alone, primarily just CTs, MRIs and plain chest x-rays.

Finally, the other recommendation we would make is that given the great number of court cases in virtually every jurisdiction, including the U.S. Supreme Court, that have established additional law in the area of EMTALA, we would like to see that law researched and incorporated into the statute and regulations to insure that the laws interpreted by the courts truly reflects the intent of Congress in this area.

Thank you.

CHAIRMAN WOOD: Thank you. Mr. Hinson?

MR. HINSON: Thank you, sir. Hi y'all. My name is Ben Hinson. I'm an ambulance driver from Macon, Georgia, and it's indeed an honor to be here.

I also happen to serve currently as the president of the American Ambulance Association, which is the primary organization nationwide that deals with ambulance and pre-hospital issues.

Additionally, over the past several years I've been directly involved with the new ambulance fee schedule creation which, as it happens, will be published tomorrow, the most radical change in ambulance reimbursement issues that we've had since Medicare began paying us.

Through this process I've had the chance to meet with Mr. Scully a couple of times and with the Secretary. Quite candidly, I've learned more about HCFA and CMS through this process than I ever really wanted to know.

But I do greatly appreciate the opportunity to be here today and I moreover appreciate the Secretary's efforts to remake HCFA into CMS, to make it an agency that works for the benefit of everyone involved.

Kind of the way I've always viewed CMS, I'm reminded of two guys dogs bird hunting down in south Georgia. They're going through the woods and one of them says that's a mighty fine dog you've got there; what do you feed him? Says I feed him Jim Dandy Field Rations. He says that's nice. He says you've got a fine dog, too; what do you feed him? He said I feed him turnips. The guy says I don't believe my dog would eat turnips. The other guy says mine wouldn't either the first 30 days.

So, sometimes I think we just get handed the things from CMS and get used to it and continue to grind through it. I'm delighted that now we're seeing efforts to really change that.

I have to admit I looked forward to this opportunity to speak. I actually was notified before I saw the fee schedule and what it looked like, I was really loading my guns to come down here and blast away at CMS and let you know how I really felt. And I have to admit that last Friday when I read the fee schedule, Mr. Scully and his staff have by and large robbed me of my platform for argument. It kind of threw me off a little bit.

As I read the final rule which has been over five years in development, I was very pleased to see many of the issues that have caused confusion through the years resolved in a very reasonable manner. So here I am with my big chance to lay it all out there and I have to admit we're seeing a change.

We believe CMS is finally headed in the right direction. Don't misunderstand me. There's still much work to do in some very critical areas, but the attitude displayed in this rule shows a willingness to work together to resolve common challenges we've not seen in the past.

I think one of the biggest things we've seen in CMS through this is kind of displayed in one of the favorite stories I try to remember. On December 6, 1941, the biggest enemy of the U.S. Navy was the U.S. Army. On December 7th that changed. They realized they all had to work together towards a common enemy.

And I certainly hope that CMS now will begin to understand that the provider community is not the enemy. We're all on the same side, the providers, the payers, the system designers. We have to work together.

My specific purpose to be here this morning is to give thoughts on EMTALA and how they affect ambulance services. It's been interesting to listen to the discussion, Mr. Chairman, and to see that this whole room sits here with a straight face listening to the conversations of all the convoluted things we have to deal with. Much of EMTALA was admittedly created by anecdote that hit the media, not by good system design.

But probably the most striking thing is in this room there are questions about applications of EMTALA, and even in this room we cannot get an absolute answer. We have different regional people discussing it, we have providers discussing it, we have attorneys discussing it, and yet when we go out of the room if we make anything based on the rules that we heard in here today, we may end up in court, and that's problematic in a very big way.

The first thing I want to talk about is how EMTALA applies to ambulance services. I know one of the things this Committee would like is quick, easy fixes for big problems. Well, we can fix that one for you. Make it not apply to ambulances that are owned by hospitals.

Ambulance destination protocol should be driven by local system design, not by who happens to own some of the ambulances in the system. Whoever provides online medical control when the ambulance is on the call or whoever has designed the EMS system more directly controls the destination questions. The system is dynamic. It changes every hour.

EMTALA was created to insure quality health care to those who couldn't pay. But by overcomplication and by applying these requirements to hospital-owned ambulances only, the health care of many patients is negatively affected. Hospitals can actually use the fact that EMTALA applies to them and they own ambulances is a reason to go out and snatch patients, get them in their ambulance and say we had no choice but to bring them back to our place. It's amazing how convoluted this can be.

In fact, in the new rule that will be published tomorrow, CMS reports that less than 10% of all ambulance transports are provided by hospital-owned ambulances. Clearly this is a mis-application of a well-meaning policy.

Ambulance systems are designed all over the nation in very deliberate processes and if a few of the ambulances in the system are owned by a hospital that happens to be in the community, those ambulances have to operate differently than everyone else, and that is bad policy for everyone involved.

It seems like you can redefine coming to the hospital as not meaning getting in an ambulance owned by the hospital, and we've resolved that issue.

On the off-campus issue as people have discussed, I've read the rules on how hospitals have to create another system to overlay response for emergency medical conditions in addition to the local 911 system.

Quite candidly, we saw this happen a little bit in Atlanta during the 1996 Olympics when the Olympics Committee came in and wanted to recreate an entire EMS system as if one did not already exist. And it ended up that people inside the Olympic venue would get a lower level of care than someone outside on the sidewalk. We have a good system. They need to let it work.

I agree with the previous testimony that calling 911 should always be an appropriate response to a medical emergency regardless of where the patient is. If the hospital cannot call 911 and must create another system, you're actually giving a lower level of care to the patient in their facility than the patient would get if he was outside on the sidewalk, and that's certainly not what we're trying to do.

Another issue that EMTALA plays a big part in is diversion. We have ambulances circling every major city in America trying to find a place to land. It's amazing that because of EMTALA not allowing hospitals to close the front door when people walk in with a sniffle, they then close the back door where people who are dying cannot get in.

The only people that can be turned away from a hospital emergency room today are the most critical patients that are in an ambulance simply by the hospital calling and saying don't come.

"Diversion" is an interesting word. Diversion began when we created trauma systems. Diversion said don't come here, go there, and we've set it up, they're ready for you.

Now diversion simply means don't come here, you're on your own. It's very difficult that EMTALA allows the emergency rooms to get completely overcrowded because the hospital must treat the patients and then we cannot get in with the people with life threatening emergencies.

The last issue to touch on is the homeland security issues. I hear them talking about bioterrorism; it's all terrorism. The ambulance services in your community are the front line. It's been interesting for us to watch people try to climb the wall and get over on the team. We've been on the team since the game began.

It's crucial that HCFA -- or CMS, excuse me, when I met with Secretary Thompson, if you ever said "HCFA" you had to put a dollar in the pot. So I'm trying to remember not to do that. And Tom Scully put a lot in the pot that first day.

But anyway, it is crucial that CMS not make quick decisions that cripple the infrastructure we have to respond in disaster situations. Bioterrorism is a big one, but that's the word that's used mostly now. It's the weapons of mass destruction. It's the explosions and the bombs that are the biggest issue from an emergency standpoint.

Chemical terrorism is the same type of thing. When chemicals are dumped and it hits people, everybody knows who's sick and they're sick right then. Bioterrorism is something that manifests over days, weeks and months. We have to look at those and deal with them differently. But I would simply urge the Committee is all these things are created and we understand we're in a new world now, that we not do things with EMTALA dealing with situations that would be on a very calm, civil day and cripple our ability to respond in a mass terrorism situation.

There are many other issues I'd love to touch on and our organization will be getting other testimony in in the coming weeks in the proper format. My consultants will be very frustrated with the way I've delivered this today, but they're back home and I'm the guy here.

So again, we thank you for the opportunity to be here and we'd be delighted to deal with any questions that may come up after the testimony.

Thank you very much.

CHAIRMAN WOOD: Thank you very much. Dr. Bitterman?

DR. BITTERMAN: I'm in the corner here so I'll stand so I can see you and you can see me, if that's all right.

My name is Robert Bitterman. I'm here -- I thank you for the opportunity to meet with you, but I represent the 100,000,000 patients a year we see in our emergency departments in this country. I practice emergency medicine full time.

I'm actually representing the American College of Emergency Physicians. I am the principal author of its book that examines the ramifications and implications of this law, which we're happy to provide the committee for its consideration.

And maybe more poignantly, I am the emergency physician who stood in the Detroit Emergency Department and called those 14 hospitals to try to get that patient care which is why I got interested in EMTALA in the first place. So I speak from that experience.

We in emergency medicine think EMTALA is a good thing. It has helped us. It has allowed us to cajole recalcitrant administrators and our on-call colleagues to allow our patients to gain access to our emergency departments and our on-call expertise. It has allowed us to transfer patients to neurosurgical hospitals or places where they have expertise that we don't have in our smaller facilities.

It has allowed us to deal with managed care, which has tried to deny access to care for our patients, and even deal with Medicaid which we've had a lot of problems with terms of access to care and putting systems in place to deny services to our patients.

So we think it's a good thing. And as we talk about how we should improve it or look at it again, I would ask you to look at why it was passed in the first place. It was because doctors and hospitals lost their way, we forgot that our job was to take care of patients, not to deny them services.

And it was Congress' solution of lack of access to care for the uninsured that it passed EMTALA. It was meant to be an anti-discrimination statute, meaning you take care of everybody the same, regardless of what insurance they have, race, sex, national origin -- routine anti-discrimination statute. And what that did legally is it attached a duty where none existed at common law or at state law. And that was the duty to treat all patients who showed up at hospital emergency departments.

So those two things, anti-discrimination mandate and duty to treat, should be the underpinnings of everything as we consider how we should look at and examine the application of this law. In essence, it is the federal right to emergency care. That's the only federal right to care in the United States is EMTALA. Regardless of whether you're a citizen or a non-citizen, you have a federal right to care in this country.

However, and you've heard other members of the panel bring up the issues, it has had adverse consequences. There is no question that today it governs everything from the time the patient shows up anywhere on our property, they scratch and get across on that sidewalk, EMTALA now governs the care of that patient from initial evaluation, triage, emergency examination, testing, involvement of specialists, on-call, ICU care, inpatient care until the discharge of that patient three or four weeks later is now all controlled by EMTALA. It controls everything we do.

And it has morphed truly into a standard of care law. It does not just examine whether we provide the services in a discriminatory fashion. It examines the actual outcomes, the process and whether we complied with the standards as defined by the government and defined by the courts. It clearly has morphed into also a compliance quagmire. None of us knows what it means anymore, whether it applies, what the issues are, when you have to have a PRO.

We don't get a chance to even look at the PRO if they did one before they come in and terminate the hospital. They hide it from us. We can't look at it.

And whenever there's confusion, there's clearly risk for anybody -- for the hospitals, for the emergency physicians, on-call physicians and for our patients, and that's what we don't want.

It clearly has contributed to the on-call crisis. The government tells us we can't transfer patients with emergencies to the office. Instead, we have to disrupt their practice and bring them to the emergency department. It certainly disrupts their private practices.

It contributes to the overcrowding, the ambulance diversion issues, and indeed it has morphed into a federal malpractice act. All the stuff you talked about, standard of care issues, were originally pleading errors. Now they've learned that once you do have an emergency, from that point forward the stabilization of that patient, including the inpatients, is governed by EMTALA.

And plaintiffs' attorneys have learned how to frame the standard screening exam -- yeah, it's not outcome anymore, but we look at all the ways you do that with your process and your procedures, and if you violated that, then you violated EMTALA.

I suggest to you you've only seen the beginning of the malpractice crisis that relates to that. It's coming and it's coming in spades.

It preempts the state's peer review. It voids all peer review, it voids all the state's tort reform that we painstakingly passed in increasing liability. So it does have those issues.

As you look at these, and I commend CMS for taking the time and energy to do this, just like it did when it looked at the interpretive guidelines, and you, the Committee, to look at this, I ask that you do things and look at three overriding, overarching themes or principles as you do this.

The first is they must be clear-cut when EM