“Management Strategies for the Fragile Neonate”

Dr. Koffler is published widely in peer-review publications in his specialty and is co-author of the book, Primary Care of the Newborn. He has spoken on those topics, as well as managed care, health economics and bioethics throughout the country. His presentation today will focus on strategies of the management of the fragile neonate.

Dr. Koffler has a wide range of clinical experiences in pediatric and neonatal and managed care. In his role as director of nursery services at the University of New Mexico School of Medicine, he has developed a perinatal regionalization program for the state that effectively reduced the neonatal mortality rate. In addition to being an academian, he has been the Chief Medical Officer for two managed care organizations.

Dr. Koffler also serves as Chief Medical Officer at Presbyterian Salud, a New Mexico managed care Medicaid HMO. He is medical director at Prudential Healthcare New Mexico, pediatric instructor at the University of Cincinnati College of Medicine and University of California at Davis. Dr. Koffler’s positions also include clinical professor at the Department of Family and Community Medicine at the University of New Mexico Hospital School of Medicine, professor of pediatrics at the University New Mexico Hospital School of Medicine, and clinical professor of pediatrics at Stanford University.

My name is Herb. I am a recovering academic. What I wanted to do was give you some background information as to where babies are coming from, not that you don’t already know that but…and let you know that, in fact, the world of newborn intensive care hasn’t been around that long.

It’s only been around since the late ‘60s. It has been built on the observations and innovations of not just physicians over the years but clearly of nurses, of midwives and, usually, I say parents, but it’s really moms.

If you think back to the ‘60s, there was really a hands-off policy for critically ill babies. Babies less than 1,500 grams or three pounds, if ill, rarely survived. You may hear stories of the two-pound baby that survived, but, in fact, that infant probably wasn’t ill and probably was under grown for some reason.

Things didn’t start to change until the ‘70s, when technology became available to start addressing the questions that had evolved over the decades prior to the ‘70s. We were able to start addressing basic questions that had come up prior to the time that technology was available.

As the technology became available and people were trained in the specialty of newborn intensive care, more babies survived, more neonatologists were trained, more nurseries started to open and, in fact, as nurseries started to go out into the community -- and I am going to come back and talk about that a little bit -- basically, newborn intensive care grew into a big business.

I guess that is one of the reasons that I am here, to talk with you about how to talk about and look at this big business.

Although this little guy looks cute, let me just tell you that the complexity that we see in the newborn intensive care unit is directly related to the number of IV poles and the number of lines that are entering any given little baby. This guy, in fact, only has one support and that’s the fact that he is on a ventilator. He is able to be swaddled and cared for.

The intensive care unit for infants, and now we are talking about survival down to one-pound, can do all the things that you and I would expect if we were in an adult intensive care unit, or in an adult cardiac care unit. All of those apparatus have been adapted so that, in fact, we can take care of little babies.

There are a lot of biases out there, and this is one that you cannot read in your handout, and I wanted to read it to you. It’s not from the pediatric literature. It’s from the ethics literature, but it was published in one of our pediatric journals.

It says, “Neonatology is the most lucrative practice that pediatrics has ever enjoyed by a specialty that is near the bottom of money-winners. Pediatricians don’t make big dollars. Neonatologists have the potential for making big dollars. Neonatology has had, and in some situations, continues to be the support of pediatric departments, especially in academic settings. It has made some neonatologists wealthy. I think most of the academic neonatologists it has made very wealthy.”

You can see that this is a perspective as to: Are these people who are taking care of critically ill babies, really gouging the world? The billings and dollars are heart-stopping. It’s become increasingly common to generate bills in excess of a million dollars of the care of an extremely low birth weight.

It talks here that: is there any wonder why any caregiver, lawyer, HMO organization, or parent questions a neonatologists motive for resuscitating infants who have little more than a ten percent chance of survival and a greater than a 50 percent chance of having a severe lifelong disability? This attitude frustrates the heck out of me. I don’t agree with it but it’s one of the issues that is out there, and I wanted to present it to you because I am going to come back to talk about it and present another view as we go through some of the slides today.

I am on the program to talk about the fact that high-risk infants are often on your watch list, they are very expensive, and you say, “What the heck can I do about them?” What I would like to do is give you some suggestions to predict and manage the potential problem and then slowly go through how we do this at Paradigm Health to review the approach we take to work with the facilities and physicians who are taking care of the babies. The information on the statistics that I am going to present was in the journal called “Pediatrics.” It was in December 1999, and it was a review of vital statistics. The vital statistics for 1998 are complete. They are not complete for 1999. What I wanted to show you here is that the number of babies continues, over the last couple of years, to go up.

We are heading for four million births a year and, in fact, the increase from 1997 has been two percent from ’97 to ’98. In this world, in the United States where we have an improved vital economy at the present time, you would think that that would put us in a situation that we would have less critically ill babies. I’m going to tell you why we don’t.

This is the U.S. birth rate per 1000 population. These are numbers that you can use in a given health plan to determine what you will project as the birthrate for the population that you are taking care of. As you can see here, there was a dip between ‘96 and ’97 and then it went back up in ’98.

If you looked at the birthrate 50 years ago, it was quite a bit higher than this. It was about 24 per thousand. If you looked at it just ten years ago, it was almost 17 per thousand. The number in ’98 was a situation in which it appears that this decline has finally been halted and that in ’98 the number of births, the birthrate and the fertility rate was finally starting to go back up. Babies are back. I think the boomers are going to go ahead and produce populations that, in fact, are going to produce not only healthy babies but also critically ill babies.

This is looking at age specific birthrates. The top number has maternal age live births for the age range of 15 to 44, but then you can look at specific numbers in three-year age groups from 15 to 17, down to 40 to 44. The reason I present this is to let you know a couple of things. One -- I think, historically, the bias is that those aggressive teenagers are out there having all the babies who have problems. Let me tell you that the birthrate for teenagers has gone down consistently over the past seven years. The use of prenatal care has continued to go up over the last decade. So wouldn’t you expect less problem babies? The answer is no.

The interesting thing here is that the birthrate for moms over 30 continues to rise. In 1997, the number was the highest that it has been in the last 30 years. The number in the age group from 40 to 44 has doubled since 1981. You’re also starting to see in the news, women over 50 who are back and starting to have babies. The elderly parents are making up for postponing putting off their pregnancies.

The percent of low birthrate infants and a low birthrate infant is defined as infant less than 2,500 grams. That equates to five and a half pounds. I think historically it might have been considered that an infant less than five pounds was premature. That is not correct. In fact, that is not even the correct terminology. The correct terminology is pre-term. The nomenclature is really built on week’s gestation and not on weight. The critical points here are the low birth weight, which again is 2,500 grams or five-pounds, eight-ounces, or 1,500 grams, which is the very low birthrate infant, which is three pounds four ounces.

We now have additional nomenclature that identifies the ELBW, the extremely low birth weight infant, which is less than a 1,000 grams and one that I hope to put in the literature which is the ULBW, unbelievably low birth weight infant, which we are now seeing infants between 500 and 750 grams being born and surviving.

But, in fact, the reason I present this today is to identify for you that, again, despite the fact that we are in a healthy economy, despite the fact that we have adequate and improving prenatal care, these numbers aren’t going down. They are staying stable and maybe, in fact, going up. These are the birth weight infants that populate newborn intensive care units. These are the infants that account for 65 percent of all infant deaths. These are the infants that are coming from the population that we were just talking about.

This graph identifies for you the consistency of this PT, which stands for pre-term, and you can see it is a percent of pre-term or low birth weight births over the years, from 1980 to 1998. The pre-term numbers are going up. They are not going down. The low birth weight numbers, in looking at healthy babies 2000, we had hoped to decrease this number to less than six. In fact, that’s not going down and the very low birth weight infants continue to remain constant and make up probably around three percent of all our deliveries.

Triplet and other higher order multiple births -- and they have grouped them in three-year age groups: 80 to 82, 89 to 91, 95 to 97 for different age groups. You can see, under 20, the numbers have remained fairly similar over those two decades, but look what’s happened here. As the older moms started having their babies, they are having higher order multiples of twins, triplets and greater. The occurrence of twins has risen 52 percent since 1980. It rose three percent just between 1996 and 1997. The occurrence of triplets has risen 16 percent between 1996 and 1997 and over 400 percent since 1980. So people are starting to have litters now, rather than just one baby at a time.

These higher order babies also account for three percent of the birth population. If you walk through any newborn intensive care unit, about 50 percent of the babies in that given ICU will be the product of a twin pregnancy or greater. Almost all triplets are less than 2,500 grams. About half of the twins are less than 2,500 grams. So, just by definition, they get admitted to newborn intensive care units and that’s part of the population that you’re covering.

To look at it from a different perspective, where do special care units come from? About ten percent of pregnancies are considered to be high risk. It may be for medical reasons. It may be for psychosocial reasons. It may be for economic reasons but about ten percent of pregnancies are high risk. If I gave this talk 15 to 20 years ago, I would tell you that two to four percent of all live births is going to require some special care unit. Giving this talk to you in the year 2000, I can tell you that the numbers are now eight to ten percent of all live births are admitted to special care units. What’s the difference?

Well, my bias is that newborn intensive care units 20 years ago really just took care of, specifically, critically ill babies. It was mostly done in academic medical centers, and it was only done by neonatologists. In the late ‘90s and beginning of this century, the number of babies that get admitted to newborn intensive care units has clearly expanded.

One of the reasons is that pediatricians have advocated their roles as going into the hospital and taking care of babies and the other reason is that all of the neonatologists out there who are in academic units, community units, and even smaller units now have to justify their existence.

As you know, it’s a critical piece of marketing for a hospital to have a positive maternity unit, a positive reflection on what they do for women’s health because it’s the mom who dictates where the rest of the family is going to go for their medical care. That theme is going to keep coming up as we go through this presentation.

The disconnect between the ten percent of high risk pregnancies and the ten percent of babies who are admitted to special care units is that the diagnosis of a normal pregnancy can only be made retrospectively, after it’s all over. This ten percent of babies doesn’t always come from the ten percent of high-risk moms. A high-risk pregnancy can produce a normal infant who does not need a special care unit. On the other hand, a pregnancy that seems entirely normal may produce an infant who is critically ill.

Prior to the time of having the window into the womb, the ultrasound, if you went through a newborn intensive care unit, up to 40 percent of the admissions in a newborn intensive care unit were not anticipated until the time of delivery. So you have to anticipate and be prepared for the fact that something might go wrong.

What’s changed over the last two decades? Well, a whole series of things have changed that you think would allow us to have less critically ill babies. Let’s start with the fact that we now have in-utero diagnosis. I talked about ultrasound, the window to the womb, which is just a remarkable tool. One of the situations, in my opinion, is that it is overused, you will have some of your obstetrical practices getting multiple ultrasounds on normal women, and that’s not inexpensive.

There are other screening tools that you all know of. We can get a serum AFP. We can do an amniocentesis to look for chromosomal abnormalities. We can combine all of these with the ultrasounds and get a lot of the information about what that fetus now looks like, something that we didn’t have historically.

The use of antenatal steroids in the pre-term, early labor situation has allowed for the infant to have lung maturity that they never would have had prior to these studies that were done. We now have a mom who is 28, 30, 32 weeks, and a normal gestation by the way is 40 weeks gestation. You talk about it nine months, but it’s ten lunar months, it’s 40 weeks.

If that mom can appropriately be treated with steroids that will get across the placenta and mature that infant’s lungs, they will have one less problem for the given weight that they are born at, when they get to the newborn intensive care unit.

Pulmonary disease was the major limiting factor initially for the survival of these little babies and then, in the mid-80’s, artificial surfactant became available. Surfactant is a material that allows your lungs to stabilize. You and I take a deep breath and we exhale and those little air sacks, the alveoli don’t collapse all the way down. They don’t collapse all the way down because of a product we make called surfactant.

The infant doesn’t have the physiologic makeup to successfully produce surfactant until they are 36 weeks gestation. Once artificial surfactant became available and could be instilled into the infants’ lungs by an endotrachial tube, we were able to get beyond some of the initial critical problems of breathing that these babies might have. What happened when artificial surfactant became available is it became a marketing tool.

Let me just go back with you and talk about the evolution of newborn intensive care and regionalization. In the ‘70s, regionalization was such that there were specific hospitals identified that had enough critical mass in the way of trained physicians, trained nurses, appropriate equipment, and support systems to take care of these critically ill babies. They were called Level Three Units.

Level Two Units were units that might be staffed by trained nurses and had an obstetrician and pediatrician who were interested in neonatal, perinatal care, but didn’t have all of the support equipment.

A Level One Facility was a regular birth facility. If an infant was born at a Level One or Level Two facility and they were unable to care for that infant with the degree of technology that was available, they would get sent to a Level Three Unit, typically at a university.

During the ‘70s, as these units became busier, the academic world started to train more and more neonatologists. As those neonatologists got ready to go out into the world, they no longer could all get a position at an academic medical center, so they had to go out into the community. The community hospitals were very excited to have them. All of a sudden they could say, “You, Mom, can come deliver here because we have a specialist in newborn intensive care.”

The obstetricians were happy because they didn’t have to send the mother off anymore to the tertiary care unit, they could take care of the mom. In fact, the obstetricians have always said, “I can always take care of the mom, she will deliver here, and you, pediatrician, me, you just take care of the kid.”

And I would say, “Wait, I don’t have the whole support system.”

If I was a community neonatologist, I started out in the community and said in my relationship with the contract that I had with the hospital, “I’ll take care of kids down to 34 weeks.”

Then the obstetrician would come to the administrator and say, “Wait a minute. This guy has been trained in newborn intensive care. You now have surfactant. You can buy a ventilator. Why can’t you do it less and less?”

So, to justify my existence out in the community, I now take care of kids 32-weeks, 30-weeks, 28-weeks, and we just keep pushing that limit back and back. As some of these technologies have become available, all of those things are able to be done in special care units that are not just in academic medical centers, but in very good community hospitals and in some community hospitals that have less than 500 births, that don’t have a critical mass, that in my opinion shouldn’t be taking care of these babies. You’re getting a little bias here.

There is no question that we have improved ventilatory techniques and improved ventilators. In fact, the ventilators are so good that respiratory therapists and nurses, now do things the physicians used to do, and the physicians don’t even necessarily get critically involved in those babies.

You see some abbreviations here. The first is ECMO, extra caporal membrane oxygenation. This, essentially, is bypass for an infant with severe lung disease. We see this used not in pre-term infants, but in term infants who have complications, such as pneumonia or meconium aspiration. That can really only be done in Level Three or now they are called Level Four Units, quaternary units that have ECMO.

NO stands for nitric oxide. It’s a pharmacological tool that can be inhaled and decrease pulmonary vascular resistance. So, some of the infants who used to go onto ECMO can now be treated with nitric oxide. The pediatric neonatal community is in a big harangue now of trying to figure out who should be allowed to use nitric oxide, and should it only be done in a facility that has the potential for ECMO because, if the infant fails nitric oxide, they will have to go onto ECMO and that has not been resolved yet and you will see that fight over the next couple of years.

Finally, somewhere in the near future, the abyss is coming to the newborn intensive care unit. Liquid ventilation will be available. It’s been available since my training, but it hasn’t been adapted to humans very well yet. It’s coming. Improved vascular access is another one of the technological advances. We now have nurses that can put a 27-gauge needle into a vein. I can’t even see those vessels anymore. We have ways to go ahead and support infants with IV support that we couldn’t do in the past.

We have micro lab techniques. In the ’60s, in order to do a blood sugar on an infant, they needed the same volume of blood that you and I now give when we go to the laboratory. So just imagine taking ten cc’s out of a three-pound infant, or now a two-pound infant, to just get a blood sugar that you have to monitor every two to four hours or to do a blood gas.

We know have micro techniques that take a portion of a hematocrit tube. We have micro surgical techniques that are not only available once you are out of the womb but there are surgical techniques that are being done in utero. An infant can be diagnosed with a congenital diaphragmatic hernia now and there are two centers in the United States that, on an investigational approach, will operate on those infants in utero to try to improve their outcome.

Prenatal nutrition has been adapted to the newborn so that we can give amino acids and lipids and parallel the growth curve that we would expect a newborn infant to have as if they were still getting all of their support from mom and the placenta.

Thermal environments are critical. You and I are known as homeotherms, which means we keep our temperature at 98.6, despite what the surrounding temperature is -- if it’s hot or cold. A neonate doesn’t become an actual homoeothermic until they are around four pounds. That’s around 1,800 grams.

Until that time, they’re poikilotherms. They can’t get it together to maintain their temperature. That is a generalization. There are some infants that can do it before that, but the fact of the matter is, don’t expect an infant that you’re following to be sent home before they get to be four-pounds. Otherwise, they are going to have some kind of thermal environment that they are going to go home in, which probably means an isolette or an incubator. We aren’t doing that very often.

By the same token, the other issue in the newborn intensive care unit is that you have to maintain a stable thermal environment. They have to be able to tolerate their feeds and they have to be without life threatening insults such apnea and bradycardia. But thermoregulation has been a major support that we have found over the decades and we can now handle very well.

Finally, NRP training, neonatal resuscitation program, this is not the same as the adult and pediatric certifications, but it is an approach for consistency of care to go ahead and support any infant in a standard approach to making sure that they will get adequate ventilation and cardiac support. These programs are now being done, not only nationwide, but internationally. Any facility that has a delivery service should have people who are certified in neonatal resuscitation. As I mentioned, there is no way you can anticipate every problem that is going to come down the pike.

This slide is in contradiction to the first slide that I presented talking about those no-good, money-grubbing neonatologists and kids that don’t survive. This was also in the pediatric literature. It really is a compilation of information, not entirely accurate, but what it says here under weeks gestation…it goes from 24 to 29, the next column is percent survival, and it goes in ten percent increments from 40 percent survival at 24 weeks gestation, to 90 percent survival at 29 weeks gestation. So, those kids around 1,000 grams, around two pounds have a nine-out-of-ten chance of surviving.

The next column has percent survivors without major handicaps. Again, it parallels the same numbers that it had in survival from 40 percent down to 90 percent. So, in fact, those tiny babies aren’t necessarily going to be damaged. There are a lot of issues that need to be paid attention to so, in fact, they are not going to be damaged. It is not as bleak as even some pediatricians and obstetricians think it is.

What does it cost to take care of these babies? As you go back to try to find the numbers in the literature, it is really hard to come by. You will see numbers quoted between five to ten billion dollars a year to take care of high-risk newborns. I don’t know how you arrive at that number but, in fact, it is not sufficient, because you have to talk about the maternal-infant dyad and how much does it cost to take care of the mother and the baby. How are we going to approach that and what are we going to do about it? So the true cost is really what the mother-infant dyad is and it’s a lot.

How do you calculate what it would cost for any given patient that you’re taking care of? Well, typically you would multiple the length of stay times whatever the per diem is. But all of you who have health plans know that there is a different rate. There is a different contract. It may be percent of billed charges. It may be billed charges. It may be…there are variations on that theme. If you just want a rough number to plug into around what does standard newborn intensive care cost a day, it’s about $2,000.

What’s the average length of stay for a baby in a newborn intensive care unit? I would have said historically it is about 15 to 20 days. But I just presented to you the fact that there are smaller and smaller babies being born and smaller and smaller babies surviving. Ergo, the length of stay is getting longer and longer and longer. Babies are surviving to be discharged.

In a study that was published about a decade ago, it was predicted that the number of neonatal intensive care beds in a well-managed system -- sound like M&R to you -- as going to be cut by 50 percent by this year, by the year 2000. About two years ago there was a survey published by the American Hospital Association that compared 1986 ICU beds to 1998 ICU beds. Now remember the prediction was that there was going to be a 50 percent decrease. For Level Two Units in 1986, there were 286 units. In 1998, there were 611. For Level Three Units in 1986, there were 584. In 1998, there were 796. They are not going down. They are going up. Again, it depends on the network that you are in and how you have evaluated them and whether or not they are in a center of excellence.

So why is it a big deal? It’s a big deal because, if you are the medical director of a health plan and you try to do a denial, I can tell you they are problematic. I can also tell you that you don’t want to be on the six o’clock news. You don’t want to be messing with a set of quadruplets that was just in the newspaper three days ago that were born to this 54-year old lady.

You have to know the culture. You have to know the language. You have to know that in fact the clinical status of these infants can change very, very quickly, and you have to know that each nursery has its own tribal culture, if you will. There is a lot of variation in provider practices. We talk about evidence-based medicine, but everybody has their own religion as they go through how they are going to take care of a given baby, and any of you that have worked in a newborn ICU know that. You will go from one unit to the next unit and the care is a little bit different. It’s a little bit different because we don’t have defined best practices for some of the issues at the present time.

Neonatology is a very highly technical field and it’s continually, perpetually evolving, getting better and better and better. So it’s not simple to be looking at it from the outside in.

As a medical director for a health plan, it was easy for me to talk to the neonatologists but I certainly couldn’t talk to the neurosurgeons. I had no idea what they were talking about. In fact, being a neonatologist, it was really simple for me in medical school because the neonatal period is only the first month of life. So I only had to one chapter in medical school. Everybody else had to do entire books. I’m just kidding.

Where can you have an impact? Well, look at the benefit package that you have. If you have assisted reproductive therapy, I can guarantee you that you are going to have twins, triplets, quads and greater, as families come to the physician to say, “We need to have more eggs to be fertilized. We need to do in vitro.”

It’s a very expensive thing.

Be sure that you have birth control available as part of your benefit package. I was amazed when I was first affiliated with the health plan that, in fact, didn’t have condoms as part of their package. Well, if you don’t have them, you’re going to have a lot of babies. If you’re going to have a lot of babies, some of them are going to be ill.

You really need to have a high-risk maternity program. You would like to be able to identify that ten percent of pregnancies that I talked to you about that are high risk. You can prevent some of the problems with a mom who is a diabetic, a mom who has lupus, a mom who has other medical problems. You can also make a significant impact as you identify the potential high risk problems to get them to a center of excellence in your network so that you know the mom and the infant, once born, will get immediate help. It’s just hard to define the center of excellence because you don’t have everybody’s outcomes in your network.

In order to define that, you need to go back and work with the neonatologists in your system and find out, in fact, what their outcomes are. I can tell you that many of them don’t have very good numbers. I can also tell you that most health plans don’t have very good numbers. The issue that I talk about of de-regionalization has been very critical.

One of the beautiful approaches of population health and having a managed network is some of the areas said, “Academic medical centers are too expensive, so I’m not going to have those in my network except in emergencies and I am going to have all these defined community hospitals in my system.”

You need to think that through. It’s very helpful to have somebody who talks the language of the newborn intensive care unit. That is why I have it here, collaborative expert interactions, which is a piece of what Paradigm does and I am going to come back to that.

Up to this point, we’ve talked about whether or not we’re going to have a lot of births. Whether or not there is going to be birth control, whether or not we have looked at the front end of making sure we can improve the outcome of pregnancy if we can provide better situations for the mom or at least get the infant to a place that they can be taken care of immediately.

It’s been said that the most critical journey a newborn will ever take, a human will ever take, is the ride down the birth canal. If, in fact, you need a second ride, you would prefer to be in a facility that can take you immediately to a place you can be resuscitated and not have to go in an ambulance or an airplane.

Looking at it at the back end, we have identified that, in fact, once an infant gets discharged from the newborn intensive care unit, if the mom really doesn’t have a good idea of who her doctor is, if in fact there is a relationship, so that she has been skilled in some of the basic things that she can talk to her pediatrician or her nurse or support person, she is going to end up back in the emergency room.

One of the reasons we got into this whole world of approaching managed care is to try to decrease the number of ER visits. As an ER physician, seeing a five-pound baby come in with some respiratory difficulties, it’s one of those, “Oh, my God. I don’t want to look at this kid.”

The knee jerk is to admit them instantaneously. Where do they get admitted? The newborn intensive care unit? Nope. You can’t put them back in the newborn intensive care unit, so they go to the pediatric intensive care unit. By some quirk of fate, the guys in the pediatric intensive care unit don’t talk to the people in the newborn intensive care unit. You don’t even have a history available to you. So, in fact, that gets to be a very inappropriate at times, but clearly a very expensive proposition that if handled correctly you can prevent.

My talk was actually published in [the Nov-Dec 1999 issue of a trade journal]. These are some of the things that were in there…these are some of the things that you cannot read in your handout.

The first thing that we did was try to address a common language that we can have a discussion with the neonatologists in the nursing system that is taking care of that baby. We have tried to define it as acuity levels and the subsets really reflect around the amount of nursing care and the resources that are going to be consumed for the care of that given infant.

So as you can see here, there are six different levels of care. If you can get into that discussion, you can then get into a discussion, in fact, that as the degree of care is stepped down, the costs for that care should also be stepped down. There shouldn’t be one simple cost across a given unit, because infants in intensive care units who get beyond this extreme care which would let’s say be ECMO, and their high intensive care in which they are in a critical life support system will spend time in intensive care and a long time in intermediate care as their feeders and growers waiting to get out of the newborn intensive care unit.

So as we start our process, we have the discussion about what level of care this infant appears to be in and what level of care you project this infant to be in.

The second approach is a consistent process with tasks done at specific times by specific people in order to get the information that you need to successfully work toward an improved outcome for a given infant.

Let me just run through these with you. This we’ve already talked about: a high risk maternity program which, in fact, will identify that the mom goes to the appropriate facility.

If we start here, this is birth of a high-risk newborn; either in the appropriate facility or in a facility that you don’t know anything about, what we then do is have an onsite assessment by a very special person. I say very special person because it’s a person who is bilingual and bicultural. It’s a nurse who not only knows the world of newborn intensive care but also knows the world of discharge planning; case management and integration back into the family and back into the community.

He/she goes onsite to collect a core of information that we have identified that we need to plug back into our regression analysis, so that we, in fact, can severity risk adjust what that baby looks like. So, when we talk to the neonatologists, we are comparing apples to apples. Because as you know, every time you talk to a doctor, it’s my patient is sicker than whoever you are talking about. But if you have 50 patients or 100 patients with that same profile, you get beyond that, so you again can talk a common language.

That information is brought back to Paradigm and at that point there is a decision as to whether or not we will have an MD-to-MD discussion or wait until we have a post onsite conference. But the MD-to-MD discussion is a collaborative discussion by a practicing neonatologist to the neonatologist that is presently taking care of that infant. Typically it is someone that is published or well known in the neonatal community, so that most of the time we don’t get blown off. Most of the time, somebody will answer the phone and most of the time somebody will talk with us.

The rest of this process identifies specific areas in which we will have specific conferences to have a case conceptualization conference in this situation, to try to project the trajectory of care that we think this infant is going to go through. So, we go back and look at our database, we go back and have all of this artificial intelligence information, but then we overlay that with a clinical discussion of both myself and our neonatal consultant and their discussion that they have had with the attending person, to try to identify where we think this infant is going and develop an outcome plan.

Then over time, have specific meetings to identify where we’re going looking at the outcome achievement, to project where the infant is going and be sure that that infant gets integrated back into their community. So, in fact, with a little bit of good fortune and a lot of hard work, they won’t be admitted to a hospital again.

I am not comfortable with these numbers, simply because this is trying to look at a whole hodge-podge of almost 15,000 infants and what their length of stay is, matching them with the critical levels of infants that we take care of. We put this slide together about four months ago. It’s a little bit old, and I didn’t realize before I came that one of the databases that was used in here was one that I’m terribly fond of.

So we are continuing to work toward this but there is no question in my mind, we are now over the past year, and I have been with Paradigm a little over a year, we are not at a 155 babies that the average length of stay is significantly different than the national length of stay.

Now that I have given you that piece of propaganda, let me just stop and open the floor to answers that you might have. Thank you.

Q: My question is regarding your management of the neonate and the facility in that you have a lot of physician-to-physician interaction. What if, as you had mentioned earlier, it is difficult to get the outcomes at any given facility, what if the facility that the neonate is in is of a poor quality, and how can you as a management or a physician-to-physician interaction counteract that?

Koffler: When I started in the world of neonatology, I was 6 ft. 4 in., I had all dark hair, and it came down to here. I had to take care of my little world. When I started in this world, one of my frustrations was, “can’t we just take that kid and move him to someplace that I know about that is better?”

Until we have enough information, I haven’t been allowed to do that. So what we look toward doing is having an opportunity for that facility to have a learning moment, or learning moments, by talking with, again, a nationally known neonatologist, who in fact can feedback and hopefully do mentoring as we look at things. It is not always easy.

Sometimes we are limited in fact by the health plans themselves and sometimes we are just limited by the fact that it is not easy to move a baby. You would prefer not to have to move a baby and so we try to do the best that we can to improve the outcome for that given baby in that facility. But the goal is to get beyond this event-based situation.

The goal would be to get to some kind of population relationship and management with the health plan so that we can have an effect in a given set of nurseries and have credibility. What has happened for us in the last year is of those 155 infants that we talked about, we have had them in 35 different states in about 50 different facilities. You can’t have a long-term relationship in that kind of approach. It is better than not having any at all, but we are striving in fact to get a more population-based relationship so that there is a trust.

Doctors don’t trust anybody who calls them on the phone and says, “Hey, I’m from insurance company A, B, or C,” because it all goes back to money rather than care, and we are trying to get beyond that.

Q: In regard to your one-year follow-up on the neonate where Paradigm follows them as well, are there any key focuses that you are looking at as you, I guess, mentor that child through the health plan case management process?

Koffler: Right now we are responsible. We are fiscally responsible for 30 days post discharge. We are in the process of developing an outcome matrix that we are working on with the developmental specialist to look at that infant at four, eight and twelve months. The difficulty we found, as we started to put this together, is we are no longer involved in the picture anymore, and if there has been a disconnect between the family and their health plan or their given payer, that is the first thing that comes back to us.

“Why didn’t you take care of this, that, and the other thing?”

So we are trying to figure out how to structure that to get information. I have an advisory board of neonatologists from across the country who has said, “Herb you really need to look at a year,” and I’d really like to look at a year, but we don’t have good information about readmission data and other information that happens over the first year. We are in the process of trying to collect that. That is a very good question.

Q: Dr. Koffler, that kind of falls along with the question that I had for you too, because one of the key indicators in utilizing Paradigm is the attempt to reduce that re-admission rate, that immediate turnaround back into that pediatric setting, rather than maintaining that child a little bit longer in the neonatal ICU, so that that transition to home is much smoother. In that maybe three-month period of time following discharge, has Paradigm been able to produce some drops in the readmission rate based on a national average? Do you have any statistics or information related to that?

Koffler: There is no good information on the national average. We have anecdotal information on situations, in fact, in which we prevented readmissions just simply by the fact that the mom has the number of our network manager, can call her and talk with her about what the problems are or she now has connections in the community to be able to talk with somebody there so the answer to that is.

Yes, we have decreased readmissions in two ways. One, no one is pushing somebody to get the infant out too early. We want to make sure that everything is stable and in place. I’m going to tell you something that I think you’re going to think it is unbelievable, but it’s true. There are nurseries across the country that only discharge infants on Tuesdays and Thursdays. They don’t want to discharge them on Friday because, “What happens if something happens over the weekend,” which really means there hasn’t been very good discharge planning, and they don’t want to discharge them on Monday because the docs who are off the weekend come in on Monday and have too much to do.

There is no reason for that. You can clearly smooth that out over time and decrease days of stay for an infant who in fact should be home.

Q (cont.): A listing of those facilities would be helpful.

Koffler: That will cost you.

Q: A couple of questions for you. First, I’m still a little fuzzy. I would like to hear some more examples of how you save length of stay, because you have a 24-week-old birth, and they are going to have to stay until they are at least four pounds for thermal regulation. How do you really impact on that except that these, hopefully, few institutions where they only discharge on Tuesdays and Thursdays? The second part of that is, where do you think you make the biggest impact? Is it on the very low birth weight babies where you make the greatest impact in length of stay? Is it only babies in units that are not at academic institutions? Which ones are the ones that you really make the difference for?

Koffler: Great questions. For the first one, as we develop or attempt to develop a relationship with a baby in “Sunrise Hospital,” one of the first things we try to do is find out what their admitting and discharge protocol is. There are some protocols that identify this infant can’t get discharged until he is 2,200 grams or until he is 2,000 grams. And just having a neonatologist have a discussion with the neonatologists as to why do you do that changes the relationship. Just the opportunity for the attending neonatologists to say, “I don’t do that because mothers are stupid…because we can’t get support systems…. because all of these other inane responses that we have kids who go out and have problems.”

We can get beyond all of that by saying, “We will work with you and your discharge planners, in addition to your discharge planners, collaboratively any way we can, to make sure that infant is going to safe and sound in a good situation when they go home.”

So that discussion…there aren’t nurseries across the country that discharge kids at 1,800 grams. They have different policies, and you have to know what the policy is and then be able to ask the question why and then respond back to it.

Your second question I just forgot. When I was a practicing neonatologist and I got called by an insurance company, and they said, “How long do you think the baby is going to be there?” It was easy.

I said, “They will be discharged somewhere around their due date. Don’t call me again.”

So what can you say when you are on the other end of the phone and you have all of these discussions that come up by the neonatologists talking to you about you’re going to be on the front page, you’re going to be on the news, etc., etc., or you don’t know what you’re talking about.

I think across the board just having…every neonatologist has an idea as to the critical level of care for that given baby and where they think it is going. For the most part, we’ve never had to really process that and put it down on paper, and just the fact of having a discussion with the neonatologists in getting organized, in my opinion, makes a difference. Now there’s going to be a sentinel effect that is going to happen for every baby in that nursery, and again from my world as a neonatologist, that’s great.

Q: Dr. Koffler, for the cases that you pick up for your Paradigm outcome plan, the model that you had shown us earlier, you have, and maybe this will help you as well, some specific criteria that you look for of the cases that would really fit into that model from both a quality perspective for your outcomes, as well as a cost containment return back to the payer. I don’t think we’ve had an opportunity in this dialogue to really discuss a little bit of what that criteria look like.

Koffler: There are four separate groups of babies that we look at, and I’m probably not going to get them right at the moment, but starting with the infant 1,500 grams and less, so any infant 1,500 grams or less we know is going to be in an intensive care unit for a long time. Let me just give you some rough numbers. A 28-week gestation baby will weigh around 1,000 grams. If you go in four-week increments, 28, 32, 36, 40, it will go 1,000 grams, 1,500 grams, 2,500 grams, and 3,500 grams. So we are talking now about kids who are 32-weeks-gestation or younger, and we know that they are going to be in probably until at least 35- to 36-weeks gestation and, for some of the big babies who are post-term, longer.

So we start with the kids 1,500 grams or less, and then they are subgrouped into whether or not they have congenital anomalies or surgical problems, or not. Then we go to the large babies who have complex medical disease that need surgical and/or ECMO interventions and have a different relationship to look at those critically ill big babies.

Then there are infants who are sub grouped into whether or not they have specific birth defects. And the fourth group I just blocked on, but basically we are talking about big kids with major medical problems, surgical, cardiac, other birth defects, little kids with or without congenital anomalies who have respiratory, gastrointestinal, neurological diseases.

I’ve got marketing people that send me all kinds of stuff on this.

Q: Just a practical question, you say you send in a skilled nurse to whatever hospital it is. First of all, with a broad geographic distribution, how do you do that, and how do you gain access to the hospital and the patient’s chart, because they won’t let just anybody walk in and do that?

Koffler: Actually the nurse talks to that facility before they get there, because, often, they have to bring their nursing licenses. I think most states do not query you as to whether or not you are licensed in that given state, but they want to make sure you are legitimate. So the network manager, in fact, often has to bring her nursing license, identify that it is up-to-date, talk to somebody in the facility to make sure that they will let her in and then she will try to meet the family and go to the bedside and get the information and also try to meet the neonatologists.

I would think that happens in less than 50 percent of the time, because the neonatologists don’t know us, and they don’t want to have anything to do with anybody who is coming in to look over their shoulder. But yes, that person needs special credentials and needs to be able to come into a facility and not be inappropriate, if you will.

Q (cont.): I am surprised you get access routinely.

Koffler: I would say we get access more than 90 percent of the time.

Q (cont.): And then as far as the distribution of your network managers on a national basis, you’ve got coverage throughout the country?

Koffler: There is coverage throughout the country. Often what happens is, for instance, right now, our biggest relationship is in Philadelphia, so we have people identified there full-time, but we just developed a relationship with Blue Cross/Blue Shield of Georgia in Atlanta. We don’t have anybody identified there, because we are just getting off the ground, and so one of our skilled nurses from Philadelphia flies down to Atlanta to do that review. We will guarantee that we will be there within 48 hours of our call. There are a lot of people on planes going around the country. I would like to do it a little bit differently, but you can’t do that until you have a critical mass of business.

We’ll take time for one more question, and then we will need to quit.

Q: What do you think about some of these early discharge programs that send babies home a little sooner than most neonatal intensive care units do?

Koffler: Well, there are two kind of early discharge programs. There are the ones that just try to coordinate the care to make sure that everything is lined up and, in fact, the infant won’t stay there inappropriately too long. The discussion as to whether or not an infant should go home with the parent’s gavage feeding them. Is that what you are talking about?

Q: Both of them really.

Koffler: Well, I think the second part is people are saying, “Well, we can do a lot of this stuff at home. We can send the baby home on a ventilator. We can send the baby home on an isolette. We can send the baby home with the parents feeding them.”

I can just tell you that, when we first started talking about sending babies home on oxygen, I looked at it from my perspective as a parent, and I said, “I can’t do that.”

I just couldn’t take my baby home. Moms taught me that they could. They do a pretty darn good job. So I think it really depends on the family that you are dealing with and the clinical status of that given baby. If we are talking about, now you don’t have a coordinated suck/swallow in the newborn until you are around 34-weeks gestation. So even the nurses in your unit that can nipple a brick cannot nipple that baby at less than 34-weeks gestation. But you know, somewhere between 34- and 36-weeks, they are going to mature, and they are probably going to do fine. If I had to pick between sending a baby home a week early with the mom gavage feeding it or leaving the baby for a couple more days and working that through, I would leave the baby for a couple more days. But it depends on the mom. It depends on the baby. It depends on how far away they live. It depends on the relationship with their other support system. And so you have to be able to look at all of that.

Q:  All right, thank you Dr. Koffler.

Koffler: My pleasure.