Friday, January 30, 2015

No co pay for well visits! But then there's the small print...

It is recommended that at least once a year children be seen for a well visit. It is important that your child's doctor see him regularly when well and not just when sick so we have time to get to know him better and keep up with how he's doing. It might seem time consuming and wasteful, but well visits help track growth, development, safety issues, and much more. Your kids need to come in even if the school doesn't require shots or a form. Now that well visits usually don't involve a co pay, they can be free (or included in the cost of your insurance premium), so there is one more reason for you to bring your child in for well care.

For years we have had the poster below in our exam rooms. It explains what it covered in a well visit and what insurance companies might define as extra services that families must pay.

We have a lot of insurance information on our website. We also send a pre-visit email to all patients who have registered on our website portal. This email contains a lot of important information, including billing and insurance issues that commonly come up at well checks. Our parent handbook that is available in each room includes common billing codes and the amount we charge for each. I have blogged about insurance time and time again. 

Sometimes parents are upset to learn that we can't go over the laundry list of problems that day due to limited time. Well visits have a number of things to cover, and there is limited time for any given appointment. We want to spend adequate time on each concern.

If we do have time to address some or all of the additional issues, parents are usually happy for the convenience. But many are surprised that their Explanation of Benefit (EOB) from their insurance company includes a bill to the family.

Why is this?

Insurance has agreed that preventative well visits promote overall good health and save them money in the long run, so they are willing to have their clients have free well care in order to encourage them to go to those visits.

Insurance is also smart and in the game to make money. They know that many people save up questions to ask at the yearly visit to avoid going in at other times. They are fine with that, but they don't think they should foot the bill for it. If you ask about acne, warts, asthma, and more at a well visit, they know those aren't well topics. They want you to pay the same co pay that would have been expected if you made a separate visit for each issue. Makes sense from a business perspective, right? People often call insurance to complain, and get some version of "your doctor's office billed it wrong" and ask us to change the code.

We didn't bill wrong! We coded for work done. Period. What they are saying is that we billed for some "sick" codes that were addressed at that visit and they don't include "sick" codes in free well care. Or maybe the recommended screening test (such as for autism or depression) is something they don't cover. (This is happening less since the ACA mandates, thankfully.)

Some of the issues that have sick codes are easy to separate from the well visit. To me it is easy if there is a new prescription, that could be a stand alone visit. If your child has an ear infection or if we decide to start a prescription for acne, those easily could have been appointments you schedule separately, but got the convenience of covering it at your well visit.

It is more of a grey area when the prescription is simply a refill and we don't spend a lot of time going over risks of the medicine, how to use it, when to follow up, and all the other "stuff" we do with a new prescription or diagnosis. My EHR (Electronic Health Record) just sees that there was a note or prescription linked to that diagnosis and picks up the code to send to the insurance company along with the other codes from the visit. Some refills really are just a formality, such as for an allergy medicine. Others, such as for asthma, depression, or ADHD, really require assessment to be sure it is the right prescription and proper documentation of that information every time there is is a refill. Those that require school paperwork to authorize a nurse to give medicine at school take more time than a normal well visit. Sometimes there's a fine line between the two.

Some issues are very difficult to say are separate from the well visit. For instance, if a child is overweight, there is a code that gets sent to insurance when we document in the EHR (electronic health record) the assessment of overweight or obese (or some version of a growth issue). We must pick this assessment this to properly document our conversation and advice. Maybe this even leads to extra labs to check on cholesterol or diabetes risks. Growth and nutrition should be discussed at every well visit, so this is part of the well visit, but when the growth is abnormal we might spend more time on it. Does it deserve a sick code and separate charge? This is an often debated topic among pediatricians (and with their patient families when parents get billed). I don't know the answer. If we were lawyers and billed on time, I suspect the bill would be higher than a straight forward well check. But we don't bill on time for these type of visits. People expect that a visit is a visit and it's all-inclusive. It's just not that simple.

I sometimes make the decision to simply not document something we discuss. Typically is is a minor issue that I don't think will need follow up, or I presume if it needs follow up it will get documented at that follow up. This can cause frustration though if a parent calls later and the phone nurse has no idea what advice I gave because there's no indication in the chart it was discussed. And it can be embarrassing when the parent comes in to talk to me about it and I've completely forgotten the previous discussion. There are consequences to trying to be nice when I know the family doesn't want to get charged for something...

Monday, January 26, 2015

Common constipation treatment studies worrying you?

Headlines recently have announced that a common treatment used for constipation is being studied for safety in children. Several parents have asked me about it, and I know many more are probably worried but just haven't asked yet, so I thought I'd share my thoughts on the subject.

miralax, constipation

This common treatment, polyethylene glycol 3350 or PEG 3350 (brand name Miralax), has been used by many kids over many years -- often for long periods of time. It works well and is my first choice of medical treatments if dietary and habit changes don't help a child's constipation, and while they're working on dietary and habit changes. It is well tolerated by kids, unlike most other medical treatments. It has been used since 2000, and since I finished by pediatric residency in 1999, I can remember the alternatives we used previously. Many of them were difficult to get kids to take due to poor taste or grittiness. When Miralax was first available, treatment of constipation improved significantly due to the tolerance and acceptance by kids. 

Constipation is common. 

Very common. It causes pain, poor eating habits, fear of toileting, and sometimes even ER trips and CT scans. It can last months to years in some kids, so it is not a minor issue when kids suffer from it. I encourage first changing the diet, but if that fails, or if it is too significant of a problem, PEG 3350 is my go to medicine. I have recommended it for years without any known side effects or complications, other than the kids who have too loose of stools on it, which usually responds to continuing the medicine to release the large stool mass that has built up. 

I was quite surprised to see that researchers are starting a study on the drug. It surprised me not only because I've never heard valid concerns about the safety or efficacy of the medicine (I have seen some really weird stuff online, but nothing that is valid), but also because I've never seen headlines that a study is starting. Usually headlines report results of studies. Why is this hitting the press now? I have no idea. 

What does the research show?

I have recommended PEG 3350 for many years without concerns for safety -- first as a prescription medicine and now as an over the counter recommendation. As a pediatrician I know that many (if not most) of the medicines we use in children are not tested in children before they come to market. This is due to many reasons, but I suspect the biggest is cost. If a drug company spends money getting a medicine tested in adults and then again in kids, it doubles their cost. Historically once something is approved in adults, physicians start to use them in children. New rules encourage pediatric testing, but all the drugs previously used in children will not need to undergo this testing.

Many of the news articles say that studies have not been done in children, but this isn't true. This 2014 research article reviews the history of PEG 3350 and compares to other medicines used in pediatric constipation in addition to showing safe blood electrolyte levels while on PEG 3350 long term. In 2001 a study was published showing safe and effective pediatric dosing. A 2003 study showed safety and better tolerance than previously used medications for constipation. A study specifically looking in children under 18 months of age showed safety. A 2009 Canadian study shows its safety in children. If you look at the references of any of these studies, you will find more. The only side effects noted are related to diarrhea, cramping, bloating -- all things that would be expected with a large stool mass blocking the new, softer, water filled stools from coming out. Once the large stool mass is out, these symptoms resolve.  

So, what is PEG 3350 anyway? 

It's a water-soluble, inactive ingredient that is not absorbed from the gut in measurable amounts. It binds to water, which keeps water in the stool, softening the stool. From what I know, it is non-toxic and has no effect on the body. The first branded product, MiraLax, was somewhat misnamed because it is not a stimulant laxative. It does not interact with the muscular propulsion of the gut. It is an osmotic laxative, keeping water in the stool, which makes it softer and easier to pass. 

PEG is used in many products, not just stool softeners. It is found in ointments and pills to allow them to be more easily dissolved in water. PEG can also be found in common household products such as certain brands of skin creams and tooth paste. 

What is the FDA approved use of PEG?

PEG 3350 is approved for treatment of constipation in adults for up to 7 days. Approval is based on studies available at the time a medicine is approved. Companies generally don't invest money in studies to expand uses after approval because they know that the products will be used in broader ways without the specific indication. They don't want to spend money they don't need to spend, which makes sense from a business perspective. Many commonly used medications are not specifically FDA approved for use in children less than 16 years due to difficulties and expense in testing drugs on minors.

How do we know it works?

There have been several studies in children and the collective experience of pediatricians around the world showing improved tolerability over other treatments for constipation because PEG 3350 has no taste, odor, or texture. It has been shown to be either as effective or more effective than other constipation treatments. See the links to these studies above. Until children can keep stools soft with adequate amounts of water, fruits, vegetables, and fiber, long term use of PEG is well tolerated. 

How long can PEG be used in children?

This is a very difficult thing to study because the longer a study follows their subjects, the more subjects are lost to follow up. There have been studies of up to 30 months that showed safe use. Blood electrolytes, liver and kidney tests were all reassuring that PEG is safe during the study. Pediatric gastroenterologists and general pediatricians have often recommended even longer periods of time without any known side effects.

What is the new study looking at?

The FDA is looking at the safety of other molecules in the PEG 3350. PEG 3350 is a very large molecule that ins't absorbed by the gut, but there are concerns that smaller compounds could be found as impurities in the manufacturing process of PEG 3350 or formed when PEG 3350 is broken down within the body. The FDA is investigating if these smaller compounds are absorbed by the gut and accumulated in the bodies of children taking PEG 3350. Some families have reported concerns to the FDA that some neurologic or behavioral symptoms in children may be related to taking PEG 3350. It is unclear whether these side-effects are due to PEG 3350. This study is the first step towards trying to determine if there is truly a link.

If my child is on PEG 3350, should I stop?

I cannot stress enough that the studies are not completed yet, so it is much too soon to say if there will be a link or not. I have years of experience with many children, and I have not seen any neurologic or behavioral problems caused by PEG 3350. It is important to note that many children with neurologic or behavioral problems are more likely to become constipated, so are more likely to need a medical treatment for constipation. This is an issue that pre-dates the medicine, so it is not caused by the medicine. Generally if the stools are softer, you can more easily work with the behavioral issues causing the constipation, such as loss of appetite/poor diet and failure to sit on the toilet long enough to empty the stool from the rectum. If you decide it is time to stop the medicine, be sure to discuss this with your child's doctor to keep them in the loop about how things are going!

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Note: Originally published 1/26/15 and edited 2/19/17 to fix broken image link.

Addendum 3/11/17: 

Thank you to a Facebook post by Dr. Johns, a pediatric GI fellow (in training to be a pediatric gastroenterologist) for sharing this link to the 2014 guideline for constipation diagnosis and management from the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition: Evaluation and Treatment of Functional Constipation in Infants and Children: Evidence-Based Recommendations From ESPGHAN and NASPGHAN. In short: not many studies are required to diagnose functional constipation after a thorough history and exam. The common things we recommend (fiber, water, probiotics) don't have any proof that they work. There is evidence that PEG works. 

Tuesday, January 20, 2015

Why does the school nurse say the vaccines don't count?

Every once in awhile we see a child who needs vaccines because previous doses don't count. This can be due to many things, especially if they were on alternate vaccine schedules and the dosing wasn't spread out correctly, or if they got the vaccines in a state that has a larger window of time allowable than we do. 
From the back of the Kansas Immunization Requirements form

Our office only gives the MMR, Varicella, and Hepatitis A vaccines on or after the birthday (except for travel exceptions as explained below) for this reason. We are also very careful to not give the second Hepatitis A vaccine if it hasnt been 6 months since the first dose. We have about 1-2 kids a year who move in from out of state and are told they got a vaccine too soon and it needs to be repeated. In Kansas there is a 4 day window before the first birthday that allows the "1 year vaccines", but some states allow for earlier vaccines and others don't have a window. I included this in a blog a couple years ago, which briefly discusses why early vaccines don't work. Since this issue comes up often enough, I'd like to discuss why some vaccines are spaced they way they are.

Vaccines are made in different ways and the body responds to them in different ways. 

  • Live attenuated vaccines are made from weakened virus that teaches the body to recognize the real virus but doesn't cause the symptoms of the virus. Examples of this type are the measles, mumps, rubella, and varicella. Many people respond to the first dose of these, but a second dose is given to help those who missed the response the first time. The second dose doesn't boost the first, but it gives a person a second chance at making immunity. 
  • Inactivated virus vaccines are made by killing the virus and using it to make the vaccine. Several doses are needed to build immunity to these. An example of this is the inactivated polio vaccine. 
  • Toxoid vaccines prevent diseases caused by bacteria that produce toxins in the body. The toxins are weakened into toxoids so they cannot cause illness and put into the vaccine. When the immune system receives a vaccine containing a toxoid, it learns how to fight off the natural toxin. The diphtheria and tetanus portions of the DTaP vaccine is an example of toxoid vaccine. Several shots are needed to build and continue immunity over time.
  • Subunit vaccines include only parts of the virus or bacteria (subunits) in the vaccine. Because these vaccines contain only the essential antigens and not all the other molecules that make up the germ, side effects are less common. The pertussis (whooping cough) component of the DTaP vaccine is an example of a subunit vaccine.
  • Conjugate vaccines fight a type of bacteria that have antigens with an outer coating of sugar-like substances called polysaccharides. This type of coating disguises the antigen, making it hard for a young child’s immature immune system to recognize it and respond to it. Conjugate vaccines are effective for these types of bacteria because they connect (or conjugate) the polysaccharides to antigens that the immune system responds to very well. This linkage helps the immature immune system react to the coating and develop an immune response. An example of this type of vaccine is the Haemophilus influenzae type B (Hib) vaccine.
  • Passive immunization is a bit different than any of the above. Either catching a disease or getting any of the above vaccines stimulates your immune system to make memory cells to fight of that specific germ if it comes in contact with it. Passive immunity results when a person is given someone else’s antibodies. The protection offered by passive immunization is short-lived, usually lasting only a few weeks or months, but it helps protect right away. The Synagis (RSV) vaccine given to high risk infants is one of these vaccines. 

Why are vaccines repeatedly given?

Vaccines interact with the T and B cells of our immune system to make memory cells. If you want to learn more, see How Vaccines Work for a really cool slide show from The College of Physicians of Philadelphia.

Some vaccines, such as the DTaP, need several doses to help the body develop a strong immunity against the germs, and later boosters are required to maintain that level of protection. Other vaccines, such as the MMR, require more than one dose to insure that most people develop the protection. 

We're traveling Internationally and my 6 month old got an MMR that "doesn't count" -- Why?

It is recommended for infants 6-11 months to get an early MMR if they travel internationally due to high measles risk. These kids all need another MMR at 12+ months and again at 4-6 years, just like everyone else. If a baby gets an MMR at 11 months and not again until pre-K, they still need another one at least 28 days from the 2nd MMR because the ones between 6 and 11 months aren't reliable.

Sometimes maternal antibodies (fighter cells from mom that got into baby during pregnancy) inhibit the body from being able to build its own antibodies well against a vaccine. (But they are good because as long as they're in the baby's body, they fight off those germs!) If a disease has a low incidence, it is acceptable to let the maternal antibodies do their job for the first year. By the first birthday most maternal antibodies have left the infant, so a vaccine can be used to build the baby's immunity. If there is a high risk of exposure, as there is for measles in many parts of the world, it is recommended to give the vaccine as early as 6 months in case the maternal antibodies are already too low for infant protection. If the levels are still high, the vaccine won't work, but the baby should still be protected against the disease from mom's antibodies. At some point the maternal antibodies go away, we just don't know when, so the baby who gets the MMR early needs another dose after his birthday to be sure he's making his own antibodies once mom's go away. The second dose can be anytime at least 28 days after the first, but we traditionally give it between 4-6 years, with the kindergarten shots. (And yes, I realize there are some measles outbreaks in the US, but the experts have not said to start giving that extra dose to babies who are staying here yet. If you are worried, talk to your doctor.)

Saturday, January 17, 2015

My child won't eat... what should I do?

I hear from worried parents often that their kids won't eat. There are many reasons for this. Usually as long as a child is hydrated, gaining weight appropriately, and getting a variety of nutrients, I am not worried.

Some reasons kids don't eat:

  • They're really getting enough food, parents just have unrealistic expectations. This is very common. Portion sizes are smaller than many parents think. They vary with age and size of a child as well as his activity level. If your child is growing well and has plenty of energy throughout the day, why should he eat more? Kids tend to eat small meals frequently and even on holidays they don't overeat like the adults tend to do. When offering snacks, think of them as mini meals to help balance out the nutrients of the day. Don't let them snack all day long though or they'll never really be hungry. Schedule meals and snacks and allow water in between. We have an obesity epidemic in this country, so if you're comparing your child to another child, chances are that your thin child is healthy and normal, but the other one is one of the 30% who is overweight. Or maybe not. It doesn't matter. Just be sure your child is getting a proper variety of nutrients, he should determine how much to eat. Talk to his doctor about his growth at regularly scheduled well visits (more often if you're concerned) to be sure it's appropriate.
  • They're sick and it's temporary. When kids are sick they lose their appetites. This is normal. It usually returns with a vengeance when they're feeling better. They need to drink to stay hydrated and can eat what they feel up to it, but don't force it. See their doctor if you're worried.
  • It's a new food and they just aren't sure yet. I encourage that kids over 3 years old take one bite of a food. Kids often hear me say, "taste a bite without a fight." The bite needs to be enough that they taste it. If they like it they can keep eating. If they don't want more, resist trying to convince them to eat more. Allowing them to take ownership of the decision of what to eat empowers them. Kids like power, right. Give it to them while modeling healthy eating behaviors yourself. They learn from what you do, not what you say -- and not from what they're forced to do. When preparing a new dish, include familiar foods they like to balance out the meal so they can enjoy at least something on the plate.
  • They're picky eaters. Aren't they all? Most kids go through phases where they love a food then they suddenly dislike it. They might dislike a certain texture or a whole food group. While there are kids with real problems eating, most picky eaters can be encouraged to eat a healthy variety of foods as described above. Some children really suffer from being overly restrictive. Children with autism, sensory problems, food allergies, and other issues are not included in this "typical" picky eater category. A great series of blogs on picky eaters (typical and more concerning) is found on Raise Healthy Eaters
  • They're more interested in something else. Make meals an event in itself. Sit together and talk. Turn off the television. Put away your phone. Have everyone focus on the meal, which includes the food and the conversation. Try to keep the conversation pleasant and not about the food. Take the pressure off eating!

In general, parents should choose what foods kids are offered so that there's a balance of nutrients, but kids determine how much they eat. If they're hungry, they'll eat. If they're not hungry, they shouldn't eat. Learning to eat when not hungry is something that causes many of us to struggle with weight. Most kids are able to limit intake to needs. Don't force them to change that great quality!

For more, see my other blogs on the subject: