Clinical UM Guideline

This document addresses the use of home phototherapy and the devices used for the treatment of neonatal jaundice that is physiologic (that is, non-pathologic) in nature. In utero, the fetus requires larger amounts of hemoglobin for oxygenation. After birth, the need is reduced and hemoglobin is rapidly destroyed, producing increased levels of bilirubin. Jaundice results when the neonate’s liver is unable to efficiently clear the accumulating bilirubin. Neonatal jaundice is a common occurrence and is frequently treated in the home setting. Infants with very high levels of bilirubin may be managed in the inpatient setting.

Medically Necessary:

Home phototherapy devices for neonatal hyperbilirubinemia are considered medically necessary when:

• The infant is ready to be discharged from the hospital or is already discharged; and
• The infant is eating, voiding and stooling well and is alert; and
• The infant’s jaundice is in the optional range as defined by the American Academy of Pediatrics (AAP) Subcommittee on Hyperbilirubinemia (Clinical Practice Guideline is available at: http://pediatrics.aappublications.org/content/pediatrics/114/1/297.full.pdf); and
• The caregiver(s) is compliant and provides a safe environment; and
• Follow-up evaluations are completed by the physician in the office or by nursing visits in the home; and
• Phototherapy equipment used in the home, such as a fiberoptic blanket or band is provided by a durable medical equipment (DME) provider.

Not Medically Necessary:

Home phototherapy devices for neonatal hyperbilirubinemia are considered not medically necessary when the criteria above have not been met.

Home phototherapy devices for neonatal hyperbilirubinemia are considered not medically necessary when more than one phototherapy device (intensive phototherapy) is used in the home setting.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

Hyperbilirubinemia is the most common condition requiring medical attention in newborns. A total of 50% of term neonates and 80% of preterm neonates develop jaundice in the first week of life. The jaundiced skin and sclera in newborns is the result of accumulation of unconjugated bilirubin. In most infants, unconjugated hyperbilirubinemia reflects a normal transitional phenomenon. However, in some infants, serum bilirubin levels may rise excessively, which can be a cause for concern as unconjugated bilirubin can be neurotoxic. Therefore, the presence of neonatal jaundice frequently requires diagnostic evaluation and treatment.

In the hospital setting, phototherapy is delivered by exposing the infant to fluorescent light. When this type of light source is used, the infant’s eyes are protected from the lights with a mask. The infant is positioned in an incubator wearing only a diaper, exposing as much of the infant’s skin surface as possible to the light source. For those infants with very high bilirubin levels, intensive phototherapy may be used. This type of phototherapy employs two light sources such as fluorescent and fiber optic light.

In the home setting, phototherapy is accomplished by using a blanket or a neck ring that emits fiber optic light. This light is directed below the infant’s head and is less intense than fluorescent light; therefore, masking the infant’s eyes is not necessary. The infant can also be fed without interrupting therapy. If the serum bilirubin level is rising in spite of home phototherapy, the infant may be treated with intensive phototherapy in the inpatient setting.

The American Academy of Pediatrics (AAP) guideline for the Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation (2004) defines “intensive phototherapy” as:

Irradiance in the blue-green spectrum (wavelengths of approximately 430-490 nm) of at least 30 µW/cm² per nm (measured at the infant’s skin directly below the center of the phototherapy unit) and delivered to as much of the infant’s surface area as possible.

This definition is carried over in the subsequent 2009 update titled Hyperbilirubinemia in the newborn infant ≥35 weeks' gestation: an update with clarifications (Maisels, 2009). This more recent document refers the reader to Table 1, which provides guidance for the use of intensive phototherapy and home phototherapy for a range of ages and total serum bilirubin (TSB) concentrations. The subsequent document aligns with the initial recommendation indicating the option for home phototherapy is available for infants with no risk factors when TSB levels are 2-3 mg/dL below the curve.

The 2004 guideline indicates:

Because the devices available for home phototherapy may not provide the same degree of irradiance or surface-area exposure as those available in the hospital, home phototherapy should be used only in infants whose bilirubin levels are in the “optional phototherapy” range (Fig. 3); it is not appropriate for infants with higher bilirubin concentrations. As with hospitalized infants, it is essential that serum bilirubin levels be monitored regularly.

The 2004 guideline also indicates there is no standard for discontinuing phototherapy. The TSB level for discontinuing phototherapy depends on the age of the infant when phototherapy is initiated and the cause of the hyperbilirubinemia. However, phototherapy is usually discontinued when the serum bilirubin level falls below 13 to 14 mg/dL.

The AAP/American College of Obstetrics and Gynecologists (ACOG) guidelines for perinatal care (2017) reference the AAP 2004 guideline within their guidance. They also state that home phototherapy is a therapy option and eligible candidates require proper home care follow-up and supervision including obtaining blood samples to measure TSB levels. This is to allow for close monitoring to ensure TSB levels are decreasing, and to ensure swift intervention in the event that levels are not responding to home phototherapy.

In 2020, Chang and Waite published the results of a retrospective cohort study evaluating home phototherapy for neonatal hyperbilirubinemia. A total of 1324 infants born at ≥ 35 weeks gestation met inclusion criteria. The primary endpoint was hospitalization for inpatient phototherapy during or within 24 hours of completion of home phototherapy. The mean initial TSB was 16.9 ± 2.5 mg/dl, the mean duration of treatment was 53 hours (interquartile range [IQR], 44-72 hours; range, 15-280 hours), the median number of home nursing visits was 4 (IQR, 4-5; range, 3-13). All infants were treated with the BiliBed^® (Medela, McHenry, IL) and a total of 414 (31.3%) infants were treated with both the BiliBed and a fiberoptic pad. The mean rate of TSB decline was similar for infants that were treated using BiliBed only versus the BiliBed and fiberoptic pad (0.08 ± 0.06 mg/dL/hour versus 0.09 ± 0.07 mg/dL/hour; p=0.14). A total of 25 infants were admitted to the hospital, 15 were admitted for rising TSB levels and 3/15 caregivers were not compliant with home phototherapy due to “fussiness.” A total of 14/15 infants with rising TSB levels had TSB above the treatment threshold (mean 3.7 ± 2.6 mg/dL above). The remaining 10 admissions were a result of parental request (n=3), other clinical concern (n=6), and power outage (n=1); 5 of these admissions had TSB above the treatment threshold and 5 were below. A second course of treatment was required for 18 infants (1.4%; 95% confidence interval [CI], 0.9-2.1%). Starting home phototherapy at or above the AAP treatment threshold was a risk factor for admission or repeat home therapy. If the infant was less than 96 hours of age at initial treatment then a longer duration of phototherapy was required. A potential bias was physician selection of families to participate with home phototherapy. The results may not be generalizable due to the equipment used and the large selection of phototherapy options available. In conclusion, this study adds to the growing body of literature demonstrating the efficacy of home phototherapy as an effective treatment for neonatal hyperbilirubinemia.

In 2020, Chu and colleagues published the results of a systematic review and meta-analysis to determine if home based phototherapy is as effective as hospital-based phototherapy. A total of 4 studies met inclusion criteria with 259 infants included, 138 infants received home phototherapy and 121 received hospital-based phototherapy. The rate of TSB decrease was not different in home-based phototherapy versus hospital-based phototherapy (standard mean deviation [SMD] = 32; 95% CI, -0.22-0.86; p=0.04). There was no significant difference in the duration of treatment between home-based phototherapy and hospital-based phototherapy (SMD = 0.59; 95% CI, 0.28-0.90; p=0.06). This meta-analysis further confirms the efficacy of home-based phototherapy as an effective alternative to hospital-based phototherapy for the reduction of TSB concentrations with comparable durations of therapy.

Peer Reviewed Publications:

1. Chang PW, Waite WM. Evaluation of home phototherapy for neonatal hyperbilirubinemia. J Pediatr. 2020; 220:80-85.
2. Chu L, Qiao J, Xu C. Home-based phototherapy versus hospital-based phototherapy for treatment of neonatal hyperbilirubinemia: a systematic review and meta-analysis. Clin Pediatr (Phila). 2020; 59(6):588-595.
3. Moerschel SK, Cianciaruso LB, Tracy LR. A practical approach to neonatal jaundice. Am Fam Physician. 2008; 77(9):1255-1262.
4. Tan KL. Comparison of the efficacy of fiberoptic and conventional phototherapy for neonatal hyperbilirubinemia. J Pediatr. 1994; 125(4):607-612.
5. Tan KL. Efficacy of bidirectional fiber-optic phototherapy for neonatal hyperbilirubinemia. Pediatrics. 1997; 99(5):E13.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Clinical Practice Guideline. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004; 114(1):297-316.
2. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Guidelines for perinatal care. 8th ed. Elk Grove Village (IL): AAP; Washington, DC: American College of Obstetricians and Gynecologists; 2017.
3. Kumar P, Chawla D, Deorari A. Light-emitting diode phototherapy for unconjugated hyperbilirubinaemia in neonates. Cochrane Database Syst Rev. 2011;(12):CD007969.
4. Maisels MJ1, Bhutani VK, Bogen D, et al. Hyperbilirubinemia in the newborn infant ≥35 weeks' gestation: an update with clarifications. Pediatrics. 2009; 124(4):1193-1198.
5. Malwade US, Jardine LA. Home- versus hospital-based phototherapy for the treatment of non-haemolytic jaundice in infants at more than 37 weeks' gestation. Cochrane Database Syst Rev. 2014;(6):CD010212.
6. Okwundu CI, Okoromah CA, Shah PS. Prophylactic phototherapy for preventing jaundice in preterm or low birth weight infants. Cochrane Database Syst Rev. 2012;(1):CD007966.

1. National Institutes of Health. Newborn jaundice. Updated May 25, 2021. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/001559.htm. Accessed on August 4, 2022.

BiliBed
BiliBlanket^®
Bili-lite^™
Hyperbilirubinemia
Neonatal Jaundice
Phototherapy

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. 

Federal and State law, as well as contract language, and Coverage Guidelines take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card.

Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan’s or line of business’s members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

© CPT Only – American Medical Association