Caring for Children with Complex Medical Needs

>> All right, we’ll get restarted now Our next speaker is Dr. Amy Houtrow and she is Associate Professor of Pediatrics and Physical Medicine and Rehabilitation at the University of Pittsburgh and she also represents the AAP Council on Children with Disabilities >> Thank you, all It’s a pleasure to speak to you I have nothing to disclose except that taking care of children with disabilities as best we can is my clinical passion, my research passion and my advocacy passion I want to start out just talking a little bit about what it means to be medically complex So this got kind of definitionally defined about five years ago by Cohen et al and it’s basically about increased service need and increased service use with chronic conditions that are either very complicated or multiple And those children have influences that affect their daily life from those health conditions, so they’re impacted in the form of functional limitations or disabilities And many of these children will need to have technology use, so specialized technology, such as a G-tube or a ventilator or something like that So when we think about this population of kids we know that in general children with special healthcare needs make up about 20% of children, so those are kids that need or use more service use or have disabilities but they tend to be relatively minor conditions that are not particularly complicated, like asthma, ADHD, allergies And then children with disabilities make up about 8%, so those are children who experience limitations in the things that they can do in their day-to-day life related to a health condition And then children who are medically complex make about 1% of children, but they account for a very high amount of resource utilization In fact, up to 30% of healthcare dollars for children will go to this group, and in a hospital based setting especially, tertiary care facilities it’s a really high percentage of cost So from the family perspective a system goal to help take care of these children would be a family centered and coordinated network of community based services that promote the health, development and wellbeing of children and their families And in this graph you can see that all of these interconnected parts are speaking to each other and they’re coordinated and there’s a happy little star with the child in the middle of it Unfortunately, this is much more what it looks like for us today, which is a bunch of gobbly-gook and lack of communication and lack of guidance and organization So this is evidence to me that we really need to be thinking about how to organize care in general for children with medical complexity and especially for children that might be emerging in the population who have congenital Zika When we think about how we would measure our healthcare system to meet their needs the Maternal and Child Health Bureau came up with these metrics So family partnership and decision making and satisfaction with care was their number one, and I think that’s a very important thing to be placing the child and the family the center of what we’re doing The receipt of care in the medical home Having adequate insurance, so basically that means that they don’t have extensive high out-of-pocket expenses and that the care that they can get is accessible and meets their needs, and so that their insurance actually covers those services And then the ease of use of community based resources, so that might be your early intervention services or your school based services And then effective transition planning for the young adult When we look at how we do for individuals who are severely impaired or have severe impacts related to their health conditions we see that we aren’t doing such a great job Some of these we’re doing better, less than half of families feel that they have a partnership, about a third have care in a medical home, but about half of those kids actually have adequate insurance and feel, and three-quarters of them feel that their community based services are relatively easily accessed And then we know we have a lot of work to do in healthcare transition But for children who are severely impacted by their health conditions the real truth of this is that less than 10% of those kids are meeting these health system metrics And so we know the kids who have congenital Zika are very likely to also experience the same sort of healthcare system related issues So I had the pleasure of working with one of my colleagues, Dennis Kuo, to develop our clinical report on the complexity that’s coming out of the Council on Children with Disabilities from the American Academy of Pediatrics And what we set-up was two basic health system goals – to maximize health function and development and family function through coordinated patient and family centered care For me, this is really important that we have the word family in there more than once and that we’re saying the word function and development In addition, another action that we want is to be able to provide proactive rather than reactive care

It’s intended so that critical medical and health events are averted to the extent possible, so children can live successfully in their communities and experience their lives to the fullest and that we are paying attention in an anticipatory way to what the outcomes may be, not just in a reactive way So this whole issue that we were talking about with swallowing function, for example, is a great example So there are young infants with an intact swallow reflex may do relatively well and might not show signs of aspiration or failure to thrive related to intake, but later in their infancy may And so to be paying attention to this in an anticipatory way rather than a reactive way when the child comes in with pneumonia or failure to thrive to a hospital We have a much better chance of helping this child be successful, and so paying attention on the onset and then anticipating what’s coming down the road When you ask families what they need, what they say repeatedly is they want assistance with care coordination So one of the things that came up is that only about a third of kids who are getting care in a medical home for children who are pretty seriously affected by their health conditions, and where we’re really falling down is not the presence of a personal doctor or a nurse, it’s not that usual source of care, it’s things that fall outside of what the primary care person can do in terms of getting coordinated services and referrals when needed In addition, we know that there’s a lot of work to be done in kind of providing family centered care where families feel like partners But they also want timely care, so getting the care when they need it, instead of calling and saying it’s going to take you six months to get into the child neurologist Well, six months is too long to wait when it’s your child And then certainly we have a lot of work to do about improving our communication between providers I think all of us that provide this kind of care have been guilty of asking the parent, so what did the other doctor say? And it’s in part because we don’t have access to those records and it’s in part because we haven’t gone back to look at those records and also maybe those records don’t say adequately enough what we need them to say And so communication between the providers is living at the nexus of the family, they have to be the conduit of that information, and that information means that it is filtered by their feelings and understandings of that information And so instead of collaborating well with our colleagues we’re relying on a family to do that collaboration for us, which I think is a major problem and will continue to be an issue unless we proactively address it And then duplication of services, so in your community getting some radiology or tests and then having that repeated in the tertiary care setting is certainly problematic And then actual access to providers and specialists, whether that be providers in your communities, such as physical therapy, occupational therapy, speech therapy, or whether that’s to your neurologist or your epileptologist or your developmental pediatrician And then certainly decreasing out-of-pocket expenses So as we’ve been more aggressive in terms of tightening insurance opportunities for families, that means many middle class families are actually missing, they’re having high out-of-pocket expenses and missing opportunities for services or equipment that really might benefit them What families experience, these are families of children with medical complexity, is that they’re providing a lot of medical care So that’s not a nurse in their home providing the care, it’s them providing it, so 11 hours a week on average and then two hours a week on average of coordinating care So that’s actually making the appointments, making sure things get paid for, filling out forms and that sort of thing And about half of these families are reporting that they have an unmet need for service, and that might be for specialty service, for durable medical equipment service, for homebased services And about half of them also experience financial burden And, unfortunately, about 40% of them are very dissatisfied with the care And I think when we’re entering an area with a disease and condition where there’s a lot of unknown and there’s a lot of fear we really have to pay attention to what parents have already been saying about the care that they feel they’ve been getting and work to optimize it so that we can meet them and their needs as best we can So in pediatrics the medical home is our foundation of care And basically when it’s operationalized that means having a place where you get care, a personal doctor or nurse that you identify, family centered care which many of us would just call good care, make people feel like they’re partners, they have their voices heard, that they have decision making and shared goal making

And then getting referrals when needed and care coordination So I’d like to take the idea of the medical home and implant it in a health neighborhood, and I think this is particularly important because the primary care doctor can’t possibly do this all on their own and their staffing resources are not set-up to be successful at doing this all on their own So I’m from Pittsburgh, so is Mr. Rogers, so this is particularly fitting So if this is your doctor’s office or your medical home this looks great for you because, well, here’s some public transportation to get you to your appointment, and over here is a school and the early intervention office is right nearby And, lucky for you, if your child has an acute event the tertiary care primary care children’s hospital is really not that far away from you And so your health neighborhood really works very well And I actually want to spend a little bit of time talking about health and medical because really when we’re thinking about the resources that these children will need they far exceed what we just typically put under our medical umbrella And community resources in particular don’t necessarily identify themselves as medical services, but are very instrumental to the optimization of the health and wellbeing of these children So this tells me the health neighborhood looks really pretty great, but what if you live out here? Then it doesn’t look so great because you live in a more rural area, you might have less access It might take you a really long time to get to your provider or you might not be able to do that because of transportation problems And when we think about kids that may be affected by congenital Zika we’re talking about a part of the country in the South with a lot of rural areas and a lot of families living in poverty, and that heightens for me the concerns about our ability to actualize the health neighborhood effectively for these children So it’s a little bit of a call to action in recognizing where we’re going to find our problems So the idea of the medical neighborhood was really about linking primary care with specialists, and that’s the collaborative agreement And then when you think about it if you’re a specialist you think about linking in with primary care, and often when you’re a primary care provider you’re not only thinking about linking in with a specialist but all of your other community resources that are available But it really emphasizes this idea of a transfer of information and an agreement about accountability, so you can delineate care expectations This is mine, that is yours, so it’s the neurologist who is going to manage the seizures, but if the developmental pediatrician or the neurodevelopmental pediatrician or the pediatric rehab doctor who will manage the therapy is in the bracing and all of those sorts of things So an appropriate delineation means that we can do our best jobs for that child and helps us identify the right people to do their best jobs, and ultimately that helps us as a team be more successful So I want to spend a little bit of time talking in more depth about care coordination So this is from Jeanne McAllister and she did a big project with the Lucile Packard Foundation and out of that came a lot of documentation that I’ll share with you So care coordination is a patient and family centered assessment driven continuous team based activity designed to meet the bio, psych, social needs of children and youth while enhancing person and family caregiving skills and capabilities And, unfortunately, we know this is inadequately delivered for a lot of our kids, and this is really quite aspirational because many of us talk about care coordination just being like getting someone to this appointment and getting it coordinated with their imaging appointment that they have right before So when you think about care coordination one really important piece about that and I think very appropriate for the children that will be in our practices with congenital Zika and other children who may develop later findings is developing an appropriate care plan which is really based on a partnership between families and their providers and having established and shared goals It provides very succinct medical summaries and establishes relationships and then really does clarify who’s action belongs to whom and develops a plan of action so that issues that have already been raised can be adequately addressed So from the provider perspective thinking about who might benefit from a care plan is really important So definitely the children who have congenital Zika, children with medical complexity in general are a great population and a practice to start with And then you may think about it for children who are at high risk

And in a practice it’s important that everyone does understand the value of having a care plan and it’s not laborious, that it turns out to be helpful And then using multifaceted assessment tools, so getting in from interviews and from testing and potentially laboratory testing or on developmental screening and developmental tests and using all of those together to develop the shared goals and then linking other providers in as necessary into the process because the primary care medical home can’t alone implement a care plan for a very complicated patient Medical summaries are exceptionally helpful, especially when a patient shows up to an Emergency Department or is receiving care in a new place, and also establishing and negotiating action So this is mine and that is yours, and how are we going to carry it through And then you need to make this plan accessible to the people who need it, and so if it sits in your medical record that doesn’t speak to another medical record then what value does it have? So families need to be empowered to carry it and use it and share it And then as a provider ultimately from a quality improvement perspective you really want to be able to track what you’re doing, track how you’ve been using that care plan and then it’s a living document so that you can change it and update it as needed and use it as an approach to care for these children One particularly important thing that I’ve been talking about is connections or connectivity with the right people and doing their jobs And so one way to do this is to develop a plan or a map that has the child and the family at the center and then uses this mapping system to identify areas where there may be gaps or where services are particularly robust or duplicative and try to work within that care map So this one, for example, has a category of financial supports, medical specialists, community and state services Informal support, so that could be your church or your community group Childcare, whether the child is in school or in daycare, and then school based programming and services because many children get their services through the school system So this is a great example of a care map, and many of you may have seen this already So Rich Antonelli and Cristin Lind worked together in the primary care, care coordination, medical home world, and she has allowed this to be shared with multiple people But what you can see is her son, Gabe, in the middle and their family surrounding it and a whole bunch of services So what we’re talking about is a very complicated map and things that offshoot from other pieces of the map So, for example, for her transportation to school was a very big issue and one that took up a lot of space on her map, in addition to the services and community resources they used and the providers that they used But one of the things that I think is important about this and important for us as clinicians is to take away that we’re not just talking about what we’re doing in our clinic and we’re not just talking about what we’re doing diagnostically or what we’re doing in our hospitals, this is much broader than that and we recognize that families live in this model of much more extensive services and needs and resources and that it’s not just where we sit as the locus This brings me to the idea of interdisciplinary care So interdisciplinary care is team based and we use shared goals and objectives So multidisciplinary care just means you’re all in the same place and lots of multidisciplinary care clinics exist this way, especially for kids who have a specific complicating condition But the ideal is much more of a transdisciplinary model where there are shared goals or objectives, or a transdisciplinary model where not only do we have these shared goals and objectives but we have overlap of our responsibilities And it’s very challenging to actualize that effectively, and so here I’m presenting the kind of intermediary, the interdisciplinary care model So it usually does involve very extensive care coordination and should have database management associated with it Many times there is a nursing leadership, as well as physician leadership, and the nursing leadership they might actually know what’s going on with patients and families in a much more robust way than the physicians would and it may have multiple specialists So this interdisciplinary care can really be focused in a way to meet the needs of the child and family because you’re team based and you have shared goals and objectives Ultimately we often focus on specific types of conditions or conditions that are a group of conditions, cerebral palsy being one of them, where it’s a group of conditions that make up that diagnosis of children who are similarly affected And those teams are built around what those typical needs of the population are

So if you’re running a spina bifida clinic, for example, you would have an urologist, but you don’t have your urologist in your cerebral palsy clinic But you may, if you’re thinking about how to build a team based care approach for children who have congenital Zika, be needing to pull in because of the high rates of certain problems an ophthalmologist into your clinic or an epileptologist into your clinic Many of these team based clinics are run out of developmental pediatrics or neurodevelopmental pediatrics or in some centers, like mine, through our pediatric rehabilitation medicine And there’s quite a bit of overlap between those disciplines, but thinking about optimizing the function and health and wellbeing One of the things that’s really valuable that comes out of team based care is the ability to do team based care conferencing, and that should be goal directed and goal driven and you should be working to identify barriers and then how to solve those problems so that you have coordinated effort So that one person is not off doing one thing and another person is not trying to solve basically that same problem through another mechanism Because families have told us duplicative care is not helpful to them I really am just going to end up on thinking about functional outcomes and interdisciplinary care and how that relates to it So this is really well aligned with the 2004 definition of child’s health that came out of the Institute of Medicine, in which children’s health should be defined as the extent to which an individual child or a group of children are able or enabled to develop and realize their potential, satisfy their needs, develop the capacities that allow them to interact successfully with their biological, physical and social environments And you saw Jeanie McAllister’s definition of care coordination and that really maps very well to this, as well, and so does obviously thinking about the health neighborhood So, in particular, this gives us an opportunity to think about the whole child in the context of their family and helps us think about capacity building So from a developmental expectation perspective I hope that we stop just using the term developmental delay because that’s not what we’re talking about for this population of children These children will have lifelong disability, and thinking about optimizing their ability to function as successfully and participate in their environment, as well as possible, should be our goal And we need to be sure that we’re making accommodations when needed And some of it might not be abundantly clear as to when accommodations may be necessary, so having team members, whether it be from developmental medicine or rehab medicine or therapy, physical therapy, occupational therapy, speech therapy involved might really help develop a mechanism by which you can really give the best, most robust care so children can be as successful as possible And one of the things that comes out of pediatrics is the need for us to figure out how that we can actually get this to be feasible for primary care providers and subspecialty providers to do And so I’m actually just ending on some recommendations about coding There certainly may be a role for these families for home visits and home visits are reimbursable and they have various codes that are different than your office visits You can also do preventative medicine counseling and this is particularly relevant for the potentially asymptomatic child who may develop something It’s not preventative counseling about something that already exists, so if you are obese you cannot charge preventative counseling about obesity, it already exists as a diagnosis So these would be for things not yet diagnosed And then the administration and interpretation of health risk assessment, which may be particularly important as we think about screening and monitoring From a care coordination standpoint and more related to complex care in general there’s a lot of different codes for physician level supervision for care coordination, and medical team conferencing, which we bill, we do not get reimbursed for it And then care planning and oversight for children who are receiving homecare and many of these are based on minutes Additionally, there’s a billing capability for complex care coordination by a clinical staff that’s directed by the physician and you can do this on a monthly basis and it can include face-to-face time or not face-to-face time by the physician and then additional staff time is additionally codeable and reimbursable And then for the children that we’re talking about specifically for this conference there’s a lot of central nervous system assessments that can be coded, in addition to whatever you’re doing in your visit And some of us may be doing psychological testing, developmental testing, and neurobehavioral status exams in our clinical setting which are also ability to be coded and then billed for, as well as even just paper based emotional assessments And then particularly relevant here is vision screening, which is also an available service The last thing that I wanted to talk about is that I anticipate

that we’re talking about a high need of durable medical equipment for the population of babies born with congenital Zika, and what that means is that increases the need for encounter based documentation to get these services delivered So a year ago we came with the MACRA rule about a necessary face-to-face encounter for physicians who are MPs, clinical nurse specialists and PAs within six months before ordering durable medical equipment and that needs to document that need And so a family can’t call you and say, oh, now my child needs X, Y and Z without adequate documentation for it to be paid for This really came out of CMS and issues in the elderly population for expensive durable medical equipment, like scooters, for people who are on Medicare And so it’s a trickle down impact on kids, but it’s particularly relevant that we’re thinking about function and outcomes for these children in a way that we’re documenting as such so that we can then support their medical equipment needs because these are what lets people live successfully at home, lets children interact with their social environments as best as possible So I want to thank you very much for your time and happy to take questions [ Applause ] >> So Amy, Susan Hyman, could you comment on what Ed said earlier about the potential progression of this disorder, that primary care providers are going to be in the position to talk about palliative care, and I didn’t hear you talk about that in the context of comfort and training in the medical home? >> Yes, I think that’s a really important thing and something that many primary care physicians don’t have a lot of experience in training with And so it’s often left to the tertiary care team based clinic to do those things But I think what families want is from their pediatrician who they trust and know very well to be able to talk about and anticipate And I think that issue about anticipation is particularly challenging because in addition to the kind of fear that exists about a new and unknown condition and the lore in the media and information that may not be accurate, so there’s a lot of emotional stuff at stake in addition to the emotions of knowing that your infant or baby is progressing in a way that really is concerning from a health and wellbeing perspective And this I think is also complicated by the extreme irritability issue And I think that that will take a lot of very close attention and a lot of psychological support for families that may not be readily available in certain health neighborhoods and so hopefully can be accessed But I think engaging and thinking about palliative care, not from cancer, you’re going to die in six months sort of way, but in a much more let’s think about comfort and what our goals are It’s essential to be incorporating those into our goal setting And that’s an excellent point and what I didn’t really spend a lot of time talking about, Gabe’s care map, is there’s a lot of legal issues that were at play and making decisions ahead of time about resuscitation and intervention that need to be documented and planned and discussed before it gets to the point where those interventions have already been delivered And that’s an excellent point and certainly I think our pediatric palliative care colleagues would really embrace the idea of being more engaged as we think about this especially in the infant period Thank you [ Applause ] >> So as I think most of you know there have been some pre-meeting discussions that have been ongoing And there are three groups, the first group that’s going to be presenting is Dr. Wanda Barfield, and I’ll let you talk about what your group is >> Good morning, everyone I’m Dr. Wanda Barfield I’m the Director of the Division of Reproductive Health at CDC in the National Center for Chronic Disease Prevention And our group, group one, is also led by Sara Oliver, who is an EIS Officer in the National Center for Immunization and Respiratory Diseases And, as it’s been said before, this response is incredibly complex and involves many different folks from different parts of the organization So we’ve so far had two meetings with experts to think about the issue of the initial management and care of infants with suspected congenital Zika virus infection

And I think it’s important to note that there’s a current interim guidance and given all of the evidence that continues to evolve there’s an opportunity for us to think about further guidance based on new information So the last guidance was updated on February 26th, 2016 and that had the considerations for revisions or expansion based on new recommendations So what we’re going to think about within this group one with regard to current guidance is the population So we have newborns who are suspected to be infected perinatally and these are infants with suspected congenital Zika virus infection but also those infants with microcephaly or intracranial calcifications detected prenatally and at birth But I think what we’ve learned here so far is that there really is this spectrum And so what do we need to consider particularly in terms of the assessment of this population? The evaluation includes physical examination and lab evaluation, imaging studies and additional testing, and then the management including specialty and subspecialty consultation, and inpatient care with outpatient referral And one of the considerations we wanted to think about is the opportunity to certainly create continuity within the inpatient and outpatient environments So, again, this is the interim guidance, and I don’t want to go into detail for all the recommendations But the first figure talks about sort of a diagnostic path to think about infants whose mother have traveled or resided in an area with transmission during pregnancy And, again, this is an evolving issue and it may be that we’re now starting to see changes within the US in terms of this evaluation But for the group here, the microcephaly or intracranial calcifications, we know what we’ve learned from our presenters today is that there could again be a spectrum And some of the things that we wanted to consider in our discussion was given the current guidelines what are some of the pieces of information that need to be updated or revised So, again, just thinking about the consideration of the population, so who are the infants that we’re talking about? If we’re talking about infants who are at risk for congenital infection and they’re seen initially in the hospital what kind of diagnostic evaluation needs to be done at that point And then another discussion that had come up from individuals in our group were what about infants who may be born in more remote areas and what are some of the considerations in terms of initial hospitalization versus transfer, and how should we also think about infants say, for example, within the first month or within the first weeks or first days based on how they might be seen And, again, we’re fortunate as information is evolving that we’re now starting to define congenital Zika syndrome, however, there’s still things that may need to be taken into consideration as we try to evaluate these infants And then what other signs and symptoms could be considered symptomatic, perhaps we don’t see an infant with a lot of features of microcephaly, however, if there are some of the features that were described today in terms of abnormal cry and other features how could we look at potential symptoms that would still fall within congenital Zika syndrome And then what clinical problems may need to be addressed in the inpatient setting, given the family’s location and resources for referral, and how can we avoid misdiagnosing newborns that may be attributable to other causes We also want to think about how we’re going to appropriately counsel parents as we assess their infants Individuals talked about the concerns and issues related to ethics, issues of difficult discussions with families, how do we support families in the context of their infants Other considerations for clinical and laboratory evaluation that was discussed by the group included whether an infant had ultrasound, that’s currently being recommended be conducted if a fetal ultrasound demonstrates microcephaly And what other assessments, including CT or MRI, should be conducted at that time And do all infants with a mother who has traveled or resided to an area with Zika virus transmission during pregnancy need an initial evaluation besides the assessment for microcephaly and intracranial calcifications

So, of course, we’ve heard about the need for eye exams, hearing and other labs And then do infants need direct testing of their blood and serum if core blood is available, particularly if they’ve been at risk, and we need to reevaluate the current recommendations and see if there’s further testing that should be done Other questions that individuals raised was should Dengue testing occur in areas where there’s no known transmission, in terms of thinking about the amount of blood and serum that may need to be taken for infants, what things should be taken into consideration CSF testing was also discussed, if that should be incorporated into the evaluation of an infant with suspected congenital Zika virus infection who may not have obvious symptoms of a syndrome And should testing of other body fluids, which was raised earlier this morning, to include urine, saliva and also blood spot was mentioned, as well, and other laboratory testing given that these infants have CNS abnormalities what other assessments including endocrine evaluation or immune function testing should be taken into consideration, as well In terms of further management and follow-up, the other consideration is what other specialists should be included in the inpatient setting We heard earlier today about perhaps the need for pulmonology, also the need of perhaps surgical or surgical subspecialty support, that may need to be taken into consideration for these infants who may be very medically complex And then another discussion was that there are infants who are going to be located where there may be limited resources and so should these infants be transferred for further evaluation and management And then given the potential limits of some tests we may need to think about the timing of evaluation And we did hear from Dr Ventura about the assessment that they’re doing in terms of retinal evaluation and timing, so are there certain times that we can think about, again, so that there’s an opportunity for families to coordinate their evaluation And then what are the challenges of reporting these congenitally exposed infants to state, local and territory health departments for inclusion in the US Zika Pregnancy Registry Currently, we get information that comes with regard to maternal testing and labs and as we think also about infant assessment and an infant follow-up we’re going to need to think about how that information may be reported so that we can continue to follow infants through their care Other considerations, we’ve heard from Dr. Trevathan about the complex neurologic issues and how can we assess those issues in terms of management Also, other comorbid conditions could occur, like infants could be affected with preterm birth or have sepsis and how are we going to also assess those comorbid conditions, and would those conditions would the management differ We’ve had some discussion about whether surgical interventions could be potentially different or not, and so these are things that we’re taking into consideration Also, more recently given the case that we heard about in Utah I think it’s important for us to think about the handling of body fluids And we do know from information at least for congenital CNV that that’s something that may be persistent for quite a long time, from months to years So should there be additional consideration in terms of infection control And then what other considerations should we think about So for group one we’re really thinking about defining the population of newborns for further evaluation with that initial birth that may include an assessment for infants who do not appear to be affected, but then that group that does appear to be at risk for congenital Zika syndrome, and however we do want to think about avoiding unnecessary workup and evaluation And then resources may be limited in certain areas, so we need to consider the timing of some lab and imaging studies and the location and availability in terms of pediatric resources And then to maintain continuity of care, referrals need to be made for long-term care and evaluation, and we don’t want infants and children

to be lost to follow-up And those that have no evidence of abnormalities need to be followed, and that will be addressed by group three So as we are having these discussions over the next couple of days we want to think about how each of the groups will be able to connect and relate to each other so that we have a comprehensive assessment So I just want to thank the group one contributors Again, as was mentioned by Fan Tait, it really has been amazing to see how responsive people have been and people were more than willing and able to participate in phone calls that were done with fairly short notice, and we just want to appreciate everyone’s contributions And thank you, all, for your support Thank you [ Applause ] >> I may be the only one who is confused, how does this relate to the Registry, the recommendations in the Registry? >> So the current Registry gets information that’s reported to states about infants, as well as pregnant women and newborns However, in terms of the potential continuity of care and more information for follow-up that’s still part of what the Registry is doing But this is more clinical care and guidance for infants with suspected Zika virus infection >> But at this time the recommendation would be if you identified a patient you would refer them to the Registry? >> Ideally, yes, but that would go through the state health department [ Inaudible ] >> Yes, I think that just in terms of as the message goes out >> Yes >> … that there has to be clarity of what’s being asked because you’re asking people to both refer to the Registry so we learn things, but at the same time to follow the guidelines for clinical care >> Yes, your point is really well taken Yes? >> Excellent presentation, and I want to praise you for emphasizing the importance of longitudinal follow-up and engaging the families to understand the reason why But currently in many of the state’s programs with children with special healthcare needs that direct engagement, sending out visiting nurses, making sure there is care coordination, making sure that their knowledge of available and where you need to go for regional resources is not taking place And I would strongly suggest that this be an opportunity to really tighten up those fragmented services because this would not only be the appropriate thing to do scientifically, but it’s the only way you’re going to get more positive community responses and not misinformation and panic >> Yes, I think that that’s a really important issue and I’m hoping that the expertise of Amy Houtrow and others can help us to really address this I think Zika is not unique in the creation of challenges for children and it may uncover some of the issues that really do need to be addressed in terms of creating continuity of care for these infants, and there will be substantial barriers that need to be addressed and uncovered >> And I will just share with the audience is that 30 years ago when I started my physician career I got – I had the experience of seeing all the children who were graduates of the 1964 congenital Rubella epidemic who were turning 21, so I started practice in ’85, these children turned 21 in ’85 And the parents were most grateful

that the health departments had helped in facilitating accurate diagnosis, but they damned health departments for abandoning their children in an era before we had preschool support, staff line supports, and other kinds of things And so I think that’s a historic lesson that is important to understand and to make sure that we don’t pretend that we don’t have any resources and legislative power to do some of the things that are necessary for this >> Yes, so I think that some of this discussion will also be continued in group two, as well as group three So I think these are really great points >> Renate Savich from the University of Mississippi What do we know about the sensitivity of the current testing and the turnaround time? And I can just see a problem with maybe some of these babies will be discharged before the results come back or were convinced that it really is Zika and it’s a false negative You know, what kind of guidance do we have at this moment for the medical community? >> Yes, I think your point is really well taken in terms of timing, and perhaps Marc Fisher may be able to address some of this But with regard to some of the testing that’s going to CDC versus commercial labs there is a variation in terms of the time for return of information and it will affect the continuity of care and decision making So I think at this time it’s really variable Yes? >> So the turnaround time depends on the type of testing we’re talking about and the laboratory it’s going to, PCR testing has a fairly rapid turnaround time, can be performed within the same day The IGM antibody testing takes two days to complete, but if confirmatory testing is performed with PRNTs that could take up to an additional five to seven days to complete So if you’re performing PCR first and that’s negative, and then you go on to IGM testing, the full battery of testing could take a week-and-a-half to two weeks to complete at a public health laboratory Commercial laboratories may have quicker turnaround with regard to PCR As far as sensitivity, we don’t know At this point we would expect that an infant that was infected congenitally, the ones who have consistent clinical findings, most of them were born to women who were living in other countries and infected in other countries during early pregnancy, and the mothers are diagnosed either by PCR or IGM during their acute illness and the babies are still IGM positive at the time they’re born Most of the babies have not been, that I know of, PCR positive at birth There have been babies in other countries, a couple of reports of perinatally infected babies where PCR testing was useful So it really depends on the timing of the infection and the specific situation that’s being assessed as to what will be the appropriate testing And the specimens that will be tested I think is still being worked out At this point we recommend testing on serum for PCR and IGM and then CSF when indicated, but I think evaluation of urine has been discussed and needs to be considered >> Yes, and Sara Oliver and I are working with other experts and the pregnancy and birth defects team to think about diagnostic testing that should be considered So that’s evolving, as well, and I think those points are really important in terms of the timing issue that you raised >> As part of diagnostic testing would there be consideration of taking advantage of a new modality, let’s say like optical coherence tomography of retinas to centralize that so that the link between the lab values and some of the biomarkers, both CNS and ocular, could occur? >> I’m not really familiar with that technology Certainly would be open to any input But I think another broader issue that was brought up more practically speaking was telemedicine opportunities, particularly with regard to assessment of the retina and given what we may know in terms

of potential limited resources geographically >> And I would build on the ways that ophthalmologists, pediatric ophthalmologists from regional centers have figured out how to follow the diverse group not analogous to this population, of retinopathy of prematurity and retinopathy of prematurity in developing countries, because they’ve really worked hard to develop some of that telemedicine capability And thank you so much for bringing that up >> Thank you >> The ROP is active, so it’s an active disease and you have to do the telemedicine according to follow these babies because they can progress to blindness In these cases the progression it will be from let’s say a nerve, from a pink nerve to a pale nerve, but the disease cannot as long as we are following now, the scar is not increasing, there’s no progression in terms of aggression to the eye So I think that telemedicine is important, the documentation is important for sure, but not with the sense of, okay, we need to follow because maybe these babies they need to be referred to a tertiary center for care, treatment, what I mean Also, OCT, as you are mentioning, we have done in eight cases OCT, and it’s very hard to do OCT in babies They do not cooperate, they are crying, like I said We took maybe one whole day to have those images, and they do not bring us so much information for general care, it’s more an ophthalmological curiosity let’s say to see where the aggression of the virus or the toxins that the virus releases, we still don’t know what’s causing these lesions, what layers of the retina are being affected But not for, I don’t think this for general – to make it as part of the guideline, this is not really necessary for all babies It’s really hard to do in all babies >> Thank you >> So just to keep us moving along on time, our next speaker is going to be Dr. Jan Cragan, she’s from the National Center on Birth Defects and Developmental Disabilities, and she’s going to be talking about the work from group two >> Thank you, Sonja And I want to introduce my co-lead for this group, Dr. Liliane Louis, who is the IS Officer in the National Center on Environmental Health So our group was tasked with looking at outpatient care and follow-up through the first year of life for infants with anomalies thought to be associated with congenital Zika virus infection And so these were infants that have laboratory evidence of infection with Zika virus or with an unspecified flavivirus and to also have microcephaly or at least one of the other anomalies that’s thought to be associated with congenital Zika infection And we were tasked with looking at care, you know, the best type of care for pediatric providers in the primary care setting, but also looking at providers who are working in settings with limited resources So those without pediatric subspecialty readily available or where parents have to travel to get care, for example So currently the guidelines on the CDC website talk about long-term follow-up for infants with positive or inconclusive Zika virus test results, that include an additional hearing screen at six months of age, an audiology follow-up of abnormal newborn hearing screening It calls for continued evaluation of developmental characteristics and milestones, as well as head circumference through the first year of life And consultation with appropriate medical specialists, such as pediatric, neurology, development and behavioral pediatrics, physical and speech therapy if any abnormalities are noted and as concerns arise And so as we listened to people talk on the pre-conference calls and got some individual feedback by e-mail from folks there were some general concepts or approaches that seemed to emerge One of these was that care of the newborn with anomalies thought to be associated with Zika infection is a continuum

So there’s a need for medical homes, subspecialty care and coordination of community resources that begins really at birth The evaluation, the plans that are made, the consultations that happen in that newborn period need to be continued and followed through over the next months and built upon A second concept was that the disease manifestation and management can vary from infant to infant, so clearly not all of these infants have the same abnormalities, they’re all not going to need exactly the same care, that really we need to develop some guidance that can be customized to the individual patient Another concept had to do with the fact that the systems available for care can vary from state to state, so qualifications for Medicaid or early intervention services differ A child may qualify for those services in one state, but not in another depending on what their condition is And also that there are available family to family health information centers where families with children with disabilities help new families dealing with these issues navigate the healthcare system and draw on that kind of support Another approach was the need to utilize and link existing guidelines and infrastructure and to avoid reinventing the wheel So, for example, use of standardized preventative pediatric healthcare schedules, such as the AAP Bright Futures Program, to utilize standardized developmental screening tools As you’ve already heard, to build on the existing protocols for evaluation and referral of infants, for example with retinopathy of prematurity, not for the same care but that those referral patterns and the specialists involved may have a basis to help with the Zika infants, as well Similarly, building on the early hearing detection and intervention programs, recommendations about referrals for any child with an abnormal hearing screen needs to be referred for vision screening and other types of testing, as well And then there was the realization that there’s need for ongoing monitoring for new manifestations and progression of existing symptoms So, as we’ve already talked about, worsening of neurologic impairment over time, new onset of seizures that may not have previously been apparent, continued failure of head growth, development of microcephaly over time So we organized our thinking around several different domains or just areas of care that are needed for these infants One of these was the medical home, and there was the realization that you need to provide general pediatric care for these infants as you would for any other child, so that they get the childhood regular immunizations Dental care is another thing that comes to mind We need to ensure that there’s coordination of specialty care and planning for care of existing conditions and, as I said, that begins in the newborn period We need to provide ongoing monitoring for new conditions or progression of existing ones Need to facilitate and refer families for support and link them with community resources And then to assist in the planning for longer term care We heard a little bit about palliative care if that’s needed In terms of growth, nutrition and feeding there’s the need for frequent measurement of weight, length and head circumference throughout the first year There’s a need for assessment of swallowing impairment and is the baby going to be able to manage solid foods and when will that happen And then watch for the risk of aspiration and gastroesophageal reflux In terms of development, again, we wanted to ensure that the planned follow-up with developmental or behavioral specialists or referrals to early intervention noted at birth is continued and that you facilitate initiation of that care There’s the need to perform regular developmental assessment, including motor and behavioral development throughout the first year to monitor for deterioration of existing function, emergence of additional developmental abnormalities or comorbid conditions And that developmental screening, and I would say it’s really more of developmental assessment and not just screening, but the assessment of these children’s development needs to be done using a standardized instrument In terms of hearing, one of the issues brought up was

that audio-acoustic emissions and auditory brainstem response testing really assessed somewhat different things And ABR is perhaps more focused on hearing loss that occurs as a relative CNS neurologic impairment And so we don’t really know yet which is the best way to assess hearing impairment in these infants, and it may be that both types of testing need to be done at some point to really understand what’s going on There’s the need again to ensure that the planned follow-up with an audiologist is done if there’s an abnormal newborn’s hearing screen And to obtain an additional hearing screen at six months of life even if the screening at birth was normal In terms of vision, again, ensure the planned follow-up with ophthalmologists for abnormal findings and if an exam is not performed at birth then referral for an eye exam including a retinal evaluation after hospital discharge In terms of neurologic symptoms, we wanted to be sure that follow-up with the neurologist is conducted as identified We feel there should be periodic assessment for new neurologic symptoms or progression of existing ones even if the initial neurologic evaluation was normal So watching for new onset seizures, as you’ve heard, and those can manifest in subtle ways such as infantile spasms or partial seizures And then there’s the need to discuss plans with the neurologist for management of ongoing symptoms So, for example, if a child is on medication for seizures what does the primary pediatrician do if there are breakthrough seizures, as the child grows does the dose need to be adjusted, those kinds of issues In terms of mobility, this can involve contractors, arthrogryposis, hypertonia, hypotonia or specific anomalies, such as club foot Again, ensured plan for follow-up with physical therapy, occupational therapy and rehabilitation specialists for abnormalities noted at birth and as new ones occur One suggestion was to build on the existing network of care for infants with cerebral palsy who will have many of these same referrals, they may get different care but if you have those referral patterns set and you know who to call on, you know who to refer some of the Zika infants to, as well And then ensure that there’s orthopedic care for the club foot or any other limb anomalies that are present And then there were a few areas, other thoughts that we had One was assessing whether these infants are at increased risk for infection, and that emphasized the need to obtain routine childhood immunizations But there is a precaution for pertussis containing vaccines in the setting of progressive or unstable neurologic disorders, uncontrolled seizures or progressive encephalopathy until those conditions are stabilized, so that’s something that needs to be thought about in some of these Zika infants, as well In terms of respiratory status, monitoring for apnea, aspiration, frequent infections and other complications In terms of endocrine dysfunction, which has been related to abnormal CNS development, there’s the potential for an increased risk for hypothalamic dysfunction leading to pituitary deficiency and this can manifest with hypothyroidism, growth hormone deficiency or central adrenal insufficiency We thought about bowel and bladder care, which is maybe not such an issue over the first year of life, but in just monitoring patterns and looking at ultimate plans for toilet training, if that’s going to be possible The irritability of these infants and management of sleep disruption, probably both for the infant and the family And then the importance of reporting infant outcomes at two months, six months and 12 months of age as is asked by the US Zika Pregnancy Registry There are specific forms to be filled out and follow-up for each of these infants in the Registry, that usually gets reported to the health department which then reports to the Registry And I think we felt that needed to be done, as well, and not get lost in all the care that’s going on So what we hope to accomplish this afternoon is to try to identify some of the specific tests and timing of evaluations over those first 12 months, with the goal of hopefully developing perhaps a timeline of care for practitioners and for parents to look at the things that need to be assessed, you know, what’s coming up next The parents can be prepared for all the things

that are being looked at We want to outline content that might help the development of toolkits for providers and parents if that’s going to happen And then one additional item was to try to quantify the additional time for care and reporting that’s going to be required of providers and list the appropriate CPT codes and modifiers that will help them be reimbursed for those So I also want to thank all the members of the work group that have contributed so far and those that provided information for our consideration And, with that, I think I’ll stop Thanks [ Applause ] >> That was great Thank you I know that there were early discussions about [inaudible] CPT codes, and I wonder if anybody has an update on that discussion? >> I’ll have to ask people from AAP Go ahead, Cindy? The group didn’t get further than just recognizing that that was something that needed to be addressed >> I think, Bonnie, at least initially when we were talking about CPT codes specifically related to Zika per se, but all the rest of the things that we are talking about, as you know so well, already have the appropriate codes and we have not moved forward on the other [ Inaudible ] >> There were a couple of discussions, but as you know it would take – we’ll be looking at that still, but it takes awhile to move something like that forward but it’s a good point >> So, again, Renate Savich What is known about the long-term course of particularly the babies that have severe microcephaly? Do we anticipate that they will pass away from apnea? I mean I notice you talked about apnea monitoring, are we going to tell the families rush to the ER and intubate your baby and this will get better or is this the natural progression? I want to worry – you know, I worry a little bit that we don’t give them a false message that if you do everything right things will be fine when there may be a natural progression, like a trisomy 18 or a severe encephalic And I think this is causing some ethical consternation among neonatologists about how aggressive should we be when we don’t know, but I mean if there were another baby that had some of these CNS findings in some situations we might not be particularly aggressive or at least offer that to the families And I don’t know that we’re offering so much nonintervention And what’s the right answer? I don’t know that either, but I think that has to be brought up during this day-and-a-half Or what the MFM community should be offering to families, as well >> I think we don’t really have answers for that longer term, you know, how long infants are going to live, what may be the complicating factors that contribute to death of those that die, you know, how can we predict that based on the findings early on We didn’t talk about that a lot yet in the group I think that’s an excellent point We did mention planning for longer term care and that would, of course, include some anticipatory counseling about the possible outcomes That’s an important point, but I’d say we really don’t know quite how to frame that yet >> Hi. Katie Beckman in the Administration for Children and Families I apologize if my comments that I’m about to make have been addressed elsewhere, but I haven’t – I don’t think I’ve heard them quite yet I’ve heard about a care plan beginning at birth and I’m a bit concerned about a lack of discussion about education and support of the family during prenatal care And the reason I mention this is because I think it’s a little too late to begin that care planning at birth Those beginning months are critical for attachment to develop and, as many of you know, with the irritability, with crying, difficult to soothe, feed, forming that attachment and building self-ethicacy as new parents is incredibly difficult Risk for postnatal depression is incredibly high And I think we really need to take it seriously, that we’re not just caring for the child but we’re caring for the family as a whole

And that really needs to be seamless support from prenatal through the lifespan >> Thank you We’ll take that recommendation, particularly about prenatal counseling, as well >> Sharon Lehman, Ophthalmology I would just counsel that you have a follow-up for the audiologic care, but you have no follow-up scheduled for ophthalmology I would just rethink that, and I’m happy to talk with your group about that Many of the things that are going to go wrong are not going to be evident at that first retinal exam And everybody is focusing on the retina here and that’s a done deal, it’s really the neurologic visual impairment that’s going to – and there are interventions that are specific to CVI that can be used So I would suggest that you rethink that and have a three to six month or however you want to coordinate it, but there needs to be follow-up with the ophthalmologist >> Yes, this was just sort of the initial kind of topics that we brought up Our discussion this afternoon is going to be more to that point of, okay, when do these things needs to be assessed and that’s a very good one We didn’t mean that this was the recommendation for eye care >> Michael Agus, I’m from Boston and representing AAP Critical Care, as well as Endocrinology So just on the critical care part for group one, we have been talking about the AAP guideline on withdrawal of care or not offering advanced care And so I think that’s certainly something that our group can kind of talk about for the initial inpatient phase On the endocrine side, though, I just wanted to – I appreciated the fact that you have some testing that you’re planning to schedule over the first year, but I would just caution that some of the central deficiencies originating in the pituitary by the time they get recognized with frankly low levels, certainly in the severe group I’m not sure what we can do, but if there is really the spectrum then there’s going to be a group that we can really intervene and make a big difference on And so I wonder if there’s a way to schedule or kind of recruit some kind of cohort for provocative testing to look at the hypothalamic, pituitary, say thyroid or growth hormone axis so that we can with provocative testing kind of actively pick those up in some subset and maybe establish some kind of prevalence and then go back into the more general community with better screening and interventions >> That’s a great idea Thank you >> Thank you, Jan The third discussion is going to be led by Dr. Kate Russell and she is an EIS Officer, an Epidemic Intelligence Service Officer, at CDC and has done a major amount of the planning for this meeting, so >> Okay, good morning I will be presenting on the discussions of group three, which focused on the outpatient care and follow-up for infants with congenital Zika virus infection but without apparent abnormalities at birth So the first thing that I wanted to mention is that the majority of the information that we know so far, which is already limited, about congenital Zika virus infection has really focused on infants with microcephaly or infants with other neurologic manifestations that have been present at birth and we really don’t know much yet about what manifestations there might be for infants who are asymptomatic at birth or really about the long-term affects of congenital Zika virus infection The things that we can look at to sort of to help us determine what our recommendations should be would be the affect of Zika virus, as Dr. Trevathan mentioned this morning, on the actual neuro progenitor cells and migration which would make us concerned that there could be neurologic sequelae that develop over time The other things that our group sort of looked at to take into consideration were the affects of other congenital infections that can lead to delayed sequelae So we do know that congenital CMV, for example, can lead to delayed hearing loss as well as other neurologic outcomes, chorioretinitis, et cetera Congenital toxoplasmosis, congenital HIV can both lead to delayed neurologic sequelae So even though our information about asymptomatic congenital Zika virus infection is limited

we can use this knowledge to help determine how we might think about management and follow-up for infants without apparent abnormalities at birth So using that information our group came up with these four domains of care to focus on for these infants And those were growth and developmental screening, vision, hearing and family support and engagement So we recognize that engagement of caregivers is key, particularly for the early detection of developmental delay Based on information available to date early signs of delay associated with congenital Zika virus infection may include feeding issues, hypo or hypertonicity, inability to self-regulate, irritability, poor visual tracking and, or lack of response to voice or sounds Any recommendations for screening for developmental delay should be in line with current AAP developmental screening recommendations, which currently include monitoring of infant’s development at all well child visits, as well as standardized screenings at ages nine, 18 and 24 months, or for any caregiver or primary care provider concerns Our group discussed that recommendations should emphasize the routine monitoring of growth, including head circumference and development at each well child visit and emphasize the use of clinical judgments for referrals Our group considered the potential recommendation of using a standardized screening tool, such as the Ages and Stages Questionnaire, prior to the recommended nine month standard screening for infants with congenital Zika virus infection Referrals should be made based on concerns or failed screenings and include referrals to early intervention services, specialists, therapy and supportive services Information should be provided to caregivers to enable them to monitor their child’s development and inform them on resources available if concerns arise Finally, recommendations should make use of existing infrastructure in place for developmental screening and support for children with developmental delay In terms of vision screening the affect congenital Zika virus infection on vision outside of infants with associated brain abnormalities, such as microcephaly, is not currently known Also, when developing recommendations we need to consider that subspecialty services, such as pediatric ophthalmology, may not be easily accessible We again discussed the recommendations should stress adherence to current recommendations for eye exams of infants at every well visit We discussed whether or not recommendations should be made for repeat comprehensive eye exam by pediatric ophthalmologists at six months of age for all infants versus referral only if concerns arise Again, assuming that these infants have had a normal eye exam at birth For hearing, again, the impact of congenital Zika virus infection remains unknown, including the impact of congenital Zika virus infection on hearing loss outside of microcephaly, the possibility of progressive hearing loss, and whether associated hearing loss may be central or peripheral All infants should already be receiving a newborn hearing screen and infants who fail this screening should be referred Our group discussed whether or not infants who pass their initial newborn hearing screen needed a repeat hearing screen at six months of age or repeat screening only if concerns arise We also discussed what hearing tests should be recommended, if any, keeping in mind that evoked response testing is better for detecting central hearing loss but audio-acoustic emissions testing may be more accessible and that it can be done in some pediatric offices Finally, our group recognized the need for both family support and engagement Caregivers are a critical component, both in care delivery as well as early identification of any delays or abnormalities These families will be uncertain about the diagnosis of congenital Zika virus infection and to the impact on their child’s health Recommendations should focus on empowering families to be active participants in their child’s care This will require providing caregivers with information on what to look for, as well as resources available should they have concerns Recommendations should utilize systems currently in place to provide support and resources to families Our group suggests considering development of a toolkit for primary care providers to give to families to find the support they need This toolkit would not reinvent the wheel, rather gather currently available resources such as those listed here In summary, we felt that there were four areas to focus recommendations for infants with congenital Zika virus infection but no apparent abnormalities at birth Growth and development, vision, hearing, and family support Any recommendations should stress the importance of current guidelines for monitoring growth and development We should be utilizing systems and resources currently in place to engage and empower caregivers Remaining questions include the risks and benefits

of additional developmental vision and hearing screening, as well as determining how best to provide information and resources to healthcare providers and caregivers on what to look for and how to address concerns Thank you to all of the group and participants who contributed to these slides And are there any questions? [ Applause ] >> Comments or questions? >> I’ll just make a quick comment and then a question I think many of us, although we may not have said it yet and this is a good time to say it since Dr. Russell is presenting, but I think it’s been very impressive how EIS has really been a key, taking a key role in this response and that there’s so many great EIS Officers involved from around the agency, it really is very refreshing and I know it’s made the response a lot better So thank you very much >> Thank you [ Applause ] >> So just a comment So speakers throughout the morning have talked about early intervention – oh, Don Bailey from International – about the role of early intervention in all of this And I think it’s going to be interesting to see how that plays out in different states So, as you know, we have different criteria for getting into early intervention You either have to have a documented developmental delay, you have to have a condition that is clearly known to result in a delay, like Down’s Syndrome, and in some states an at risk category And so clearly for babies who are born with Zika related microcephaly they’re going to fit into the established conditions criteria But this group of babies is not An so it’s going to be interesting to see whether some states decide this is a risk category, like low birth weight or something like that, that would be tracked and be immediately eligible for early intervention or others might not be And it gets back, harkens back to the discussion about question about case definitions and diagnosis and so forth So there’s a lot of socio-political dynamics that are going to occur here, as well as the medical dynamics It’ll be interesting to see how that plays out >> Yes. Thank you And I think a lot of it is going to fall on sort of families and primary caregivers to be really very observant and be advocates for these infants and sort of have a lower threshold for sort of what they’re looking for because there are so many unknowns Thank you Yes? >> So I’m just wondering, so this group would be those mothers who either traveled to an area that was endemic or assuming it comes to the United States, have the physical findings, the mothers of Zika virus infection during their pregnancy, they’re tested positive, prenatal testing has been done with ultrasound or whatever, and the baby looks totally fine So any estimate of how large that group would be or any indications >> Great question >> … for whether the baby should go through further testing if there’s no abnormal fetal ultrasound? And it sort of goes into the congenital group one, but >> Yes, and that’s something we’re going to be talking about more and I think group one will be talking about more, as well, is that sort of initial evaluation We would want to focus any guidance on sort of long-term follow-up and care on infants that have some evidence for congenital Zika virus and infection, and we’ve heard a lot about how much evidence do you need and exactly how difficult the interpretation of testing is and I would say that based on that I think we need to make guidance that’s focused on not just confirmed congenital Zika virus infection, but also this sort of probable, these probable cases that maybe have sort of difficult to interpret testing But we would want to sort of focus these longer term recommendations on children that have some laboratory evidence of congenital Zika virus infection As to predicting how many, I’m not sure Yes? >> I just, to respond to that, putting on my AAP hat, developmental screening and monitoring is recommended to all providers and it’s EPSTD required And since we don’t know how common it is, we do know how common other high risk conditions are

All children should be screened and monitored >> Yes, there are many, many reasons to do developmental screening for these infants, for all infants >> [ Inaudible ] and the guidelines are here to suport everything they have said [ inaudible ] we’re kinda late on that >> Yes Dr, Maldonado >> [ Inaudible ] related to that what is the population and risk, and I think we know generally how many people travel to countries that are affected And I know that number is going to go up, but if you calculate we can estimate how many pregnant women are traveling into these areas I think you would be a general ideal I mean I would imagine that it wouldn’t be in the millions, but there’s definitely a fair number But I think as Susan mentioned if you follow a routine– >> Hi. Katie Beckman again I think it’s really important to consider the role of early care and education in the monitoring piece for developmental and behavioral screening Children spend 50, 60 hours a week in early care and education settings and sometimes those providers are – I mean a lot of times they’re an incredibly valuable intersection point In addition, families build trust with those providers An so I think there’s a really important intersection, especially since there are children with developmental and behavioral vulnerabilities who are not yet or may never be eligible for early intervention and so the training of those providers is really important in this >> Yes, I agree >> Yes, this is Camila at CDC I want to piggyback on what Katie was saying So I was actually thinking the same thing, but I also not only want to include the early care and education providers but I think one thing that I appreciated in your presentation is that you are really looking at existing systems that serve young children Because I think when you think about over 50% of children are seen in WIC clinics, and I think kind of if we really can from a capacity building standpoint make sure that the clinicians are aware of what those existing systems are and that there’s an outreach to WIC to those, help me grow, to whatever the state capacity system is beyond the early intervention system, where these kids may not be eligible but go to where they are I appreciate that >> Thank you >> Yes, excellent presentation And I think your emphasis on getting the message out to the primary care community is very important, but the lesson that I experienced because I practiced in the early ’90s in Rhode Island when screening for congenital newborn hearing loss was instituted is classic management plans in the community, Blue Cross Blue Shield, et cetera, in the State of Rhode Island at that time did not cover hearing aids, hearing aid follow-up, a whole group of things That situation has been exacerbated, the states have gone to Medicaid managed care carve outs and this access to essential health services for individuals at risk is pretty fragmented currently And so your guidelines are most helpful in getting this set The second comment I would make is that Dr. Bailey’s eloquent statement that the microcephalic children will be well served by early intervention, that may be true in the State of North Carolina, it is not true in many states The states are confused at times with single established conditions and they are confused what to exactly do in their roles for care coordination in EI for children, whether they have spina bifida or CP or microcephaly or Down’s Syndrome And so I would just highlight that But most important neither EI nor the community system are very good when there’s early unilateral sensory neuro hearing loss And our experience with congenital CMV is that we have

to track and manage these kind of disorders and embedded in picking up abnormal hearing loss should be a linkage to both the treatable conditions that may not be Zika And, again, I don’t want to go into zebras, which are can children have both congenital Zika and congenital CMV, I don’t want to go there >> Not make it more complicated >> That’s both out there Thank you >> Great. Thank you very much for your comments >> Any more comments? >> I would just clarify that I said that they would be eligible for early intervention, not that they would be getting outstanding services >> Hi. I’m Manda Hall, I’m the Title V MCH Director from Texas And I just think as we’re thinking about that and we’re thinking about systems in states that engaging the Title V MCH and children with special healthcare needs services programs across the United States is going to be important as you’re looking at these systems of care