Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

The patient is a male infant born on 11/10/03. The patients mother was noted to have received prenatal care and her pregnancy was complicated by pregnancy-induced hypertension. Her estimated date of confinement (EDC) was 12/14/03. Given this EDC, the patient was born at 35 weeks, 0 days gestational age.The patient was delivered by urgent cesarean section on 11/10/03. The patient had APGAR scores of 8 at 1 minute and 8 at 5 minutes. Birth weight was 1.734 kg. For a child of 35 weeks gestational age, this birth weight would place the child between 1 and 2 standard deviations below the mean birth weight for his gestational age.Maturational assessment of gestational age (New Ballard Score) was performed and estimated the patient to be 34 weeks gestational age; the patients birth weight, length, and head circumference were all in the 25-50 percentiles based on 34 weeks gestation, and therefore, the patient was felt to be appropriate for gestational age (AGA).The patient was admitted into the NICU due to prematurity and low birth weight. His NICU hospital course was fairly unremarkable. He never required mechanical ventilation and was on room air from 11/10/03 to his date of discharge on 11/27/03. He was not discharged on any medications for the management of bronchopulmonary dysplasia or chronic lung disease. The submitted medical record indicates that he did not have known abnormalities of his airways, congenital heart disease, respiratory tract disease, or neuromuscular disorders. The medical record indicates that there is no smoking in the home.The patients provider indicated that the patient was at risk for RSV infection due to 35-week gestation, low birth weight, and birth at less than six months before RSV season. The patient was given a dose of Synagis on 11/22/03, with the recommendation that monthly doses of Synagis be continued. The patient was given subsequent doses of Synagis on 1/7/04 and 2/4/04. It is not clear from the submitted medical records if any further doses of Synagis were provided. As of 1/12/04, the patient appeared to be doing well - he was gaining weight and did not appear to have any significant ongoing medical illnesses or concerns.A request has been made for reimbursement for the Synagis injections at issue. The Health Plan has denied the request on the basis that Synagis injections were not medically indicated.The patient is a premature infant born at 35 weeks gestational age by EDC estimation (or 34 weeks gestational age based on maturational assessment).  His birth weight of 1.734 kg is appropriate for gestational age (within two standard deviations of the mean) regardless of whether 34 or 35 weeks gestational age is used for this assessment. Review of the submitted documentation reveals no evidence of chronic lung disease, congenital heart disease, airway abnormalities, immunodeficiency, or other chronic respiratory illness or major medical concern. There is no documentation of additional social or environmental factors that would increase the patients risk of RSV infection.The American Academy of Pediatrics (AAP) has specific recommendations regarding which infants should be considered for immunizations with Synagis during RSV season. For generally healthy premature infants born between 32-35 weeks gestational age, (i.e., infants without chronic lung disease, congenital heart disease, immunodeficiency, or cystic fibrosis), the AAP recommends Synagis prophylaxis for infants with two or more of the following risk factors: childcare attendance, school-aged siblings, exposure to environmental air pollutants, congenital abnormalities of the airways, or severe neuromuscular disease. No evidence has been provided that the patient met two or more of these risk factors.Furthermore, Synagis has not been shown to decrease mortality in preterm infants who receive prophylaxis. In fact, none of the five published randomized, controlled, clinical trials have demonstrated a significant decrease in mortality rate attribution to RSV infection in infants who receive prophylaxis. In the largest trial (the Impact-RSV Study Trial), which included 1502 premature infants, mortality was very low and there was no statistically significant difference in mortality rate between groups (mortality was 1.0% in placebo group vs. 0.4% in Synagis group; p> 0.05).However, there is a significant decrease of the rate of hospitalizations for preterm infants treated with Synagis. Although an additional reduction in the risk of hospitalization could likely have been achieved by Synagis prophylaxis in the patient, his overall risk of serious sequelae was still very low regardless of whether he received Synagis; therefore, Synagis was not a medical necessity for this patient. There is no evidence the patient had any major medical condition(s) that would increase his risk of serious RSV infection compared to other similarly healthy 32-35 week gestational age premature infants. Based upon the information set forth above, I have determined that the injections at issue were not medically necessary for the treatment of the patients medical condition. The Health Plans denial should be upheld.