AMCHP 2005 ANNUAL CONFERENCE
DELIVERING RESULTS, IMPROVING PREGNANCY & BIRTH
February 19-23, 2005
KAY JOHNSON: The good news is that I had one of my safe for all audiences screen savers on. This is a quote from Mary Idleman that was running behind Michelle there, about service being the rent we pay for living. I'm sure you've heard a little bit of that kind of talk yesterday at lunch.
I want to talk to you a little bit about the work that I've been doing related to newborn screening programs. And specifically about a set of case studies, I've been asking states what's going on in this very big time of change. And what you're going to hear today is a way to frame that in the context of policy and financing.
The work was guided. It was actually funded by the Genetic Services branch, with Michelle as its chief. And my project officer is Lauren Raskin. Lauren Raskin Ramos, I forget to change your name in the slide, who is now happily married with a new name and is the director of Maternal and Child Health issues for the Association of State and Territorial Officials, ASTO. This is primarily work produced for MCH and ASTO and will come out in an ASTO issue brief. You can see a variety of state leaders from the state health officers and the MCH folks and the newborn screening program managers as well as lab directors, all either giving permission or aiding, abetting in some way in this, including some fairly detailed interviews.
The way I start when I think about this is the fact that very early on newborn screening was a medical recommendation, and yet it was not a fully implemented or adopted. As many things that are recommended, medical practice are not fully implemented or adopted, until parents and their advocates, including the March of Dimes, put pressure to have legislation adopted on a state‑by‑state basis to make it mandatory. And I think Neil sometimes known as Tony Holtsman here, the quote captures for me the essence of what this all means; and it's that only state public health agencies with their authority, sometimes known in public health as their police powers, their right to do things on a mandatory basis that no other entity has a right to do in our federal system, that they can implement systems that would mandate screening for all infants. You'll notice there are very few things that are mandated. Virtually nothing can be mandated federally. If things are going to be mandated like newborn screening and immunizations, it happens at the state level. And then that they could ensure the quality and availability of testing, that's on a statewide basis, that they could have those relationships with all the providers, and provide follow‑up, looking at a population basis. So it's a very unique role, I see, for the states in this.
And right now the challenge is, as Michelle has started to describe, about additional pressure to add new tests and equipment, about bringing their staff skills up to speed to get them in line with the new technology, and about doing more effective follow‑up with families once you do that. And I think those are some of the themes you're going to hear from all three of us today.
And thinking about how to frame this, I went to the report from the National Newborn Screening Task Force. I actually have it over there. I'll wave it later, published as a supplement to the Journal of Pediatrics and basically the outline around policy that this national task force recommended was to focus on a whole system, not just on getting the test work done in the laboratory, to make sure that policies are adequate to support funding that both professionals and consumers should be involved. That there should be appropriate mandates, accompanied by appropriate privacy protections and that the new criteria for adding tests would sort of be coming along naturally in this time of change and that program guidelines should be in place so that everyone knows what's actually going on in these programs, because they've taken on a whole new sense of importance with new genetic knowledge. What needs to be financed, they basically said there are three things that need to be financed and they're not all financed through the newborn screening dollars. We need to finance screening, short‑term follow‑up and diagnosis or sometimes thought of as initial follow‑up and diagnosis, that's the part that's typically funded by the newborn screening program. But then as we're all committed to, this task force said: Comprehensive care and treatment, that we have an obligation, if we're going to screen children and identify conditions, to help particularly those who don't have the fiscal resources to do so to get comprehensive care and treatment that they in effect become in our way of thinking about them children with special healthcare needs and that there would be quality assurance and evaluation as a routine obligation of the states.
Very quickly, as I started thinking about this, and the more I talked to states the more it became clear to me that there were three prevailing myths about newborn screening financing. One is the sort of the notion that the programs are fully funded by fees. This is not real, for two reasons. One there are five states in the District of Columbia who don't collect fees to do newborn screening. So they're not doing it that way at all. And then if you look at the other states, in general, the fees typically only cover the testing or the lab costs. They don't all even cover the kind of initial follow‑up you'd want, and then if you get even through the diagnosis part, and some of the linkages, and just the work that goes on in Title V agencies has often not been covered. The second myth is that because this is so different than our other public health programs, you tend to think of it and say, well, there are, these are tax dollars. These are public dollars. Well, by and large they're not public dollars. By and large, they are funds that are coming through private insurance, through direct payments, through a whole variety, an estimated two‑thirds of the money is private money.
Because we're relying heavily on a fee system, and the third myth is that newborn screening is paid for by third‑party ‑‑ you can see how the three things fit together. What we know is that the fees are not always adequately covered by insurance or Medicaid and the fees are going up, that happens more. And that where Medicaid reimburses directly, as is typical in other areas, it doesn't reimburse even for the full level of the fee. Yet there may be a way for states to have better relationships to ensure that. These are old data. We're making an effort and I'm going to show you a little bit about that to try to get some better data. Distribution of the funds, as they were reported by the GAO, you can see fees is the big chunk. The maternal and child health Bloc grant, the more orange chunk. See if I can get a pointer, this more orange chunk. Medicaid, other states typically general revenues, and this other little bit of federal money coming from other resources.
So what did we learn? We went out to say what have states been doing about in the face of budget shortfalls, consumer demand, rapid technology change and the pressure to privatize. We selected states that are a mixture of a whole variety of factors related to geography and what they've been doing and where they, not exactly best practice states, but good examples of the kinds of things that have been going on. Here are the states. You can see down the left‑hand column, if you're not good on your two‑state identifiers it's California , Maryland , Minnesota , Mississippi , New York , Oklahoma and Oregon . I didn't put any confusing A states in there. You can see by and large those states now, and this has changed, this table changed I updated it last week, but most of these states are having a fairly full panel of the biologic testing and the hearing testing as Michelle mentioned.
This is just a little example of the fee changes. Actually, this would be through the end of 2004. The effective fees, and you can see that in general they have gone up. But on a per test basis, they haven't gone up much.
Where do the sources of funding, where is the money coming from? Again here just the fees you saw on the previous slide, all but New York and this bunch are using the fee‑based approach. Maryland and New York in particular were noted, it's not that there's no state money ever slips into these other programs, but as a deliberate strategy, Maryland and New York more likely to use state funding. Maryland , New York and Oklahoma , more likely to use maternal and child health Bloc grant funding as a deliberate strategy. Others said to me basically we're not routinely using it. It's not that it has no impact or we used to but we don't anymore. And then who is deliberately using Medicaid as a direct source of funding, rather than as Medicaid pays for the birth and the fee comes out of the birth fee. We're actually billing Medicaid for newborn screening and the money is coming into the program.
So what's going on in California ? Their finance approach is that the fees paid for the program up to diagnosis. They're charging about $60 for the test. And hospitals can charge and then keep a $6 extra fee for collecting the blood. Then they face huge challenges. Half a million births when they make a change in the program it affects a half million babies and they have to get everything up to scale in there. They had success with a pilot project on tandem masspectrometry, which is or multi‑plex technology as Michelle referred to them, abbreviated as MSMS. They'll never align in your brain. You have to memorize them. It's like words that aren't spelled phonetically. It's tandem masspectrometry, abbreviated not as TMS; it's abbreviated MS/MS. People call it multi‑plex. We'll do that all the rest of the time.
The delay, they had a delay in expanding their test panel due to the kind of state budget pressures. I'm sure some of you followed the Arnold Schwarzenegger fighting the Legislature over the California budget kind of battles. They've now succeeded. Their model is a mixture of, they have strong public health agency management, and some public health laboratory capacity but most of their capacity is that they're contracting out with public health labs, excuse me, with private labs across the state, sort of in a regionalized approach in California.
In Maryland , I'm going to go lightly on this one, because Susan will be covering it. But they're generally the fees are covering the lab costs and they're using their Bloc grant dollars to make a richer program and short and long‑term follow‑up. They have challenges they're facing right now where a large private company known as Pediatrics is competing directly with the state laboratory. They are taking very seriously the challenge of effective parent informing and consent, because as you will learn, it is mandatory there. They're also having to do two screens as a part of their general approach, and this means a lot more follow‑up for many more families with those obligations they've taken on. And they, just as about everyone else, face state budget pressures.
In interviewing Minnesota officials they told me they hit the restart program on their button. They financed their new approach with a fee increase. And they say they're focusing on the family as customer ‑‑ this is sort of a reinventing government type model. They created a new public private partnership with the state lab doing the initial or the old core screening, with the Mayo Clinic lab doing the tandem masspectrometry screening and some of the specialty care and the University of Minnesota being involved in some of the care coordination as well as specialty care. And they're really aggressively trying to structure their linkages to the medical home providers. I think much more seriously than anyone else is doing that as a deliberate strategy. It's not that it might not be going on elsewhere.
In Mississippi , the Legislature mandated that they move to comprehensive screening. They doubled their fee and more than doubled the number of tests that they were providing. They added both private insurance and Medicaid direct payments to their approach. And they did this as a result of pressure from parents and others to the Legislature and that the recommendation of an advisory committee. They did not have state lab capacity. They had been using Tennessee 's lab, but Tennessee 's lab wasn't moving fast enough. So they now contract with and found the desired services and price they were looking for at pediatrics.
They also added, took some of this money and set it aside for more public health nurses as follow‑up staff in every health district in the state.
In New York , they have not a fee based approach and they've had a tremendous amount of high level, high visibility celebrity advocacy with these people going to the New York Post and going to the Governor Pitaki and making it happen. They have again a large scale effort. A quarter of a million births, which they estimate will yield another 3,800 positive screens for which there will have to be initial follow‑up. And they're trying to develop some innovative links to both the primary and the specialty care physicians. Lab managed program in New York .
In Oklahoma, they again lead a fee increase to do more testing, but also direct billing of Medicaid and private insurance and got a stronger legislative commitment to financing that actually is in the legislation about making the money happen. They really relied a lot on their HRSA grants to make the staffing and the core work come together. And were pressured for these changes by some of the same forces. They've just come on line with their expansion and they too saw the need for more public health staff for follow‑up, very specifically, based in the maternal and child health program in Oklahoma .
In Oregon , they're using a fee‑based budget approach. They added a large number of disorders in 2001, and they now have a task force looking at adding more including cystic fibrosis. The other factor we looked at in Oregon is that their public health laboratory is a regional vendor for Oregon and these other four states, Alaska , Hawaii , Idaho and Nevada . They have a lot of unique challenges. They also are serving Guam and some military bases in Korea , and the unique challenge is figuring out how to get the samples from remote areas of Alaska or from Hawaii to the lab in Oregon are interesting, and they figured out some web‑based technology and some economies of scale.
So what should they do? They did these things that we talked about earlier, by and large. They focused on a system. They expanded the number of conditions. They invested in state of the art testing, they financed more follow‑up, particularly through public health. They engaged parents and advisors in constructive and real meaningful ways, and they negotiated quality and right now for the moment they escaped the bullet around major public concern about privacy issues.
They said to me we did this in a climate that was already ripe for change. We did it because, and this column on the left, there was a federal system support through a variety of things here, and she can't say it but I can say these things would not have happened without the leadership of Michelle Puryear and without her able assistance of Deputy Marie Mann and without the lead and permission of Peter VanDyck and others at HRSA. This helped create the climate for change on the government side and on the outside parents March of Dimes in particular and then the professionals acting in all kinds of varieties at the state level. This is a classic inside/outside advocacy approach, where the outside people are pressing and the federal people are responding, and the pendulum is swinging back and forth to actually make change happen.
There's a lot more that will happen at the same time. Adding this lab capacity as everyone said to me is simple, compared to the fiscal ethical and system of care decisions that have to be made. It's easy to turn on, turn the switch and add the equipment and the lab, it's hard to then figure out how you make it work for families.
Newborn screening is going to follow in the wake of genetic sciences and the technology is driving the change and states are going to have to keep figuring out how to adapt and it isn't always easy. And finally introducing profit into newborn screening programs is in some ways changed everything.
What does it mean when a private lab takes the money but they don't take the public health responsibilities? And to me this is very much analogous to what happened in Medicaid managed care, when managed care plans initially took responsibilities and took all the money for the Medicaid clients and yet there were local health departments still with responsibilities that they could not meet. But the money had shifted away. And so it really requires oversight, I think both by state health departments and by state legislatures. The fiscal pressures in the interest of time I won't say much about that. I think you all know, they are there. This is very preliminary and a challenging slide to read in a short time. We asked states about the sources of money and here you have fees, Medicaid, state general revenue, Title V and other. These data are based on results from 30 states. We asked them, who is getting the money? And in this column it's the most of the money is going to the lab. Here it's going for initial follow‑up. These are not exclusive categories in this group, follow‑up and/or case management, administrative resources and other purposes within the program.
What happened to their money? Was it decreasing in the past five years? You can say that's generally not true. Was it increasing in the last five years? You can see that for 26 of the 30 states responding, that was true. And this dark blue bar there was no change and finally I could not get it to make ‑‑ could not get PowerPoint to make a space but here who was pressing them to change the newborn screening program? The turquoise bar it's either the Legislature or the Governor. In this bar it's the department of health. Here it is the advisors to the department of health, whether it's consumers or professionals and here it's external advocacy that they identified as the change.
So in conclusion, I would just say I'd like to use a quote from one of the newborn screening leaders in Mississippi who I thought captured it very well saying that: Without a broad inclusive panel of tests established by states, parents may go from doctor to doctor, seeking a diagnosis for their child, and generating costs in the medical care system without being prepared for the outcome. Without suspecting that their child has a congenital condition or without knowing what that condition may be. This person went on to say to me: If you miss a child and you miss the opportunity for intervention, the costs are much higher.
And I would add to that, I've heard from families in saying even if our child, even if this in some way tells us our child's years of potential life are not what we expected, even if there's not treatment available for this, we want to know this. We feel we have a right to know this.
And program managers have to look at all of the costs and make judgments that balance the interests of the individual child and the public and I think that's really what we're grappling with right now. And finally, the reminder we're just not spending taxpayer money. This isn't just another public health program where all of the money comes from the public side. If people are paying either through their private insurance or fees directly to have a service and the state is administering that money, doesn't it change our sense of responsibility on the fiscal end?
So, finally, just what are the goals for newborn screening today from my own perspective? Every baby, regardless where born, should have access to newborn screening services. That's almost a direct quote from my interview with Susan Panny. Every child receives screening, diagnosis and the necessary follow‑up treatment; that we need a new consensus on the criteria for adding tests to newborn screening programs. I'm hoping that this is going to be achieved in a short run as new recommendations come out, and, of course, that newborn screening programs meet quality standards. So let me stop there and turn it over to Susan.