Date: June 4, 2008

To: Arizona Physicians IPA 3141 North 3rd Avenue Phoenix, AZ 85013

Re: Patient Request for Zevex Enteralite Infinity Pump: Appeal 081371410

PATIENT was born on Oct. 17, 2004 at only 24 weeks gestation. She weighed 1 lb 9 oz, and was 12 inches long. She was intubated and suffered from Hydrocephalus, grade III and IV IVH (Intraventricular Hemorrhages), PDA (Patent Ductus Arteriosis), BPD (Bronchial Pulmonary Dysplasia ), hearing loss and ROP (Retinopathy of Prematurity). A cranial reservoir was placed to relieve pressure. She was hospitalized for 4 months, and within the next 2 months diagnosed as Failure to Thrive. She has severe reflux. She received nutrition via the NG tube for 10 months. A Mickey G-button and Nissen Fundoplication surgery were performed (Fundo surgery twice). She is not oral at all, receiving 100% of her nutrition via the Mickey G-button. She is DDD, AZLTCs, and AZIP. She also had meningitis last year. She has developmental delays including her speech, gross motor skills, vestibular system, proprioceptive system, and sensory / tactile issues. She has low muscle tone and it was only after months of physical therapy and using a baby walker to build strength that she was able to walk on her own. Being a very fragile child, she was unable to have the social interactions many babies and toddlers experience, so has experienced social delays as well.

She currently weighs 25 lbs and has not had any weight gain in the last 8 months, since November of last year. Her gastric emptying study (2) found Dumping Syndrome, and a recent urine test result found unexplained high ketones (a sign of starvation). The GI specialist at Phoenix Children’s Hospital, Dr. Gary Silber, placed her on 20-hour drip feeds. While we are hoping the slowed rate of nutrition will ultimately allow her body to appropriately process and use the fuel, the 20-hour feeding limitation creates a tremendous impact to her development, mobility and very importantly, the ability to move around safely in her environment.

Being only 3 years old and filled with the desire to be an active toddler, she is nearly immobilized by the Joey Kangaroo pump, bag, and backpack (please see picture). This unit, when loaded with 500ml’s of water weighs 4 lbs, or 16% of her body weight. (To put this into perspective, it would be like a 160lb adult carrying 25.6 lbs all day.) The kangaroo backpack is 16 inches long and hangs down to her calves. It pulls down on her tiny shoulders making it even harder for her to keep her balance, play and walk, even walk

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thru doorways or avoid furniture. Carrying this excessive extra weight is detrimental to the goal of her gaining weight.

The Kangaroo Joey pump leaves her with either zero mobility or at best, a leash the length of the tubing if the Joey pump is mounted on the IV pole. She is constantly tangled in the tubing, wrapping it around her feet, body, and neck as she tries to move around and play, creating a dangerous situation for her. The abnormal pull and friction of the tangled hose on the Mickey G-button causes an additional stressor on a weak link- the Mickey button. Because of her high stomach acid, the balloon frequently deflates due to tiny pinholes.

She is unable to fully participate in games or even take advantage of PT and OT activities while tethered to the Kangaroo backpack or IV pole. This restriction further affects her already delayed development. The pump does not seem to respond well to the increased motion as the movement jostles the bag and somehow traps air bubbles in the hose line below the pump, feeding air into Kaitlyn, and not always causing a pump alarm. Socially, the small gains she has made seem to be slipping away since she is unable to keep up with the other children as she tries to navigate with the hanging tubing and IV pole, or the weight of the backpack. Doctors and physical therapists recommend that people carry no more than 10% to 15% of their body weight in their backpacks. It is widely researched and reported that in older, school aged children, their backpacks should weigh closer to 10% and not exceed 15% of body weight. Girls, who have a lower body mass index are particularly at risk for compression of disks or other back injuries. Backpacks also should not hang more than 4 inches below their waistline (on a school-aged child). (American Academy of Pediatrics, USGovinfo.about.com, U.S. National Library of Medicine, National Institutes of Health , Nemours Center for Children’s Health)

REQUEST: At three years of age, clearly PATIENTshould be carrying the absolute least amount of weight possible, since heavy weight bearing research is not even conducted on children this small and the impact to her small frame and musculature is not known. It is important that PATIENTnot only continue to grow and thrive, but that her physical development, mobility and social skills not be restricted by the Kangaroo backpack in the process.

A smaller more portable pump is offered by Zevex. This Enteralite Infinity pump and super mini backpack filled with 500 ml of water weighs only 2.3 lbs and most importantly is only 9.5 inches long. This is

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almost 40% lighter and this much more manageable backpack has been easily worn by babies only 1 year in age. This allows the freedom to crawl, move, and play and physically develop naturally. Kids can even hang upside down on monkey bars with this backpack.

It is important PATIENTbe allowed an enteral feeding system that delivers nutrition and permits her to grow and develop as normally as possible. All of her support team, Dr’s, and therapists believe this is critical for her health and development. Why should her developmental delays be exacerbated unnecessarily? Why should her progress be halted or even regress when a product is available which would permit her to develop these critical skills?

It is imperative that a pediatrician with a background in habitation review this request.

We look forward to your quick response.Regards,Parents of PATIENT“PATIENT” Last name

Attachments:Medical documentation from Phoenix Children’s Hospital Dr. Gary Silber including letter of Medical Necessity, prescription for Zevex pumpLetter from Heidi Spann, OTPicture of baby 1 yr wearing a Zevex backpackPicture of PATIENTwearing Kangaroo backpackLetter of Concern- Nurse Preferred HomecareAdd for ZevexDocumentation showing backpack should be closer to 10% of body weight in school-aged children

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