Clinical Policy Title: Home phototherapy for hyperbilirubinemia

Clinical Policy Title: Home phototherapy for hyperbilirubinemia Clinical Policy Number: 11.02.04 Effective Date: January 1, 2016 Initial Review Date: August 19, 2015 Most Recent Review Date: August 17, 2017 Next Review Date: August 2018 Policy contains: Treatment for hyperbilirubinemia (jaundice). Criteria for home phototherapy for jaundice. Related policies: None. ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas considers the use of home phototherapy for hyperbilirubinemia to be clinically proven and, therefore, medically necessary when the following criteria are met: The infant is at least 35 weeks gestation and born over 2,500 grams. The bilirubin level is < 20 mg/dl (term infants) or < 18 mg/dl (pre-term infants). The infant s elevated bilirubin is not due to any primary hepatic disorder. The infant has no risk factors and is otherwise ready for discharge after appropriate lab tests. Arrangements have been made for a home visit within 48 hours of discharge. Limitations: All other uses of home phototherapy for hyperbilirubinemia are not medically necessary. Alternative covered services: 1

None. Background Hyperbilirubinemia is a disorder affecting newborns, marked by an elevated level of bilirubin in the blood. This condition occurs when red blood cells break down, rendering newborns less able to excrete bilirubin. Hyperbilirubinemia causes jaundice, marked by a yellow color of the infant s skin, eyes, and other tissues. The infant also may be lethargic and feed poorly. Hyperbilirubinemia is a common condition among newborns, affecting 60 percent of full-term births and 80 percent of premature births. It is diagnosed by measuring bilirubin levels, red blood cell counts, and blood type testing for Rh incompatibility (Coomb s test). It typically is treatable, although it can cause seizures and brain damage, known as kernicterus. The goal of hyperbilirubinemia therapy is to reduce bilirubin from dangerous levels. There are several forms of therapy; one common method is phototherapy, which involves a blue spectrum light. Treatment is continual, and includes exposure of all of the skin directly to the light. Hospital phototherapy for hyperbilirubinemia, which has been used since the 1950s, employs a fluorescent light. The infant is placed in an incubator, wearing only a diaper, and the eyes must be covered. When intensive phototherapy is required, a fiber optic light can be used. Home administration of phototherapy uses a less intensive method that emits a fiber optic light. A blanket or neck ring is used to direct the light below the infant s head, and thus covering the eyes is not needed. In most cases, home administration is effective in reducing serum bilirubin levels, but a small proportion of infants require readmission to the hospital. A study of 126 infants whose bilirubin was at least 17 ml/dl showed that compared to placebo, phototherapy reduced bilirubin levels significantly (Martinez, 1993). The American Academy of Pediatrics (AAP) recommends universal screening of all newborns using total serum bilirubin or transcutaneous bilirubin, or screening of high-risk newborns (AAP, 2004). These methods are helpful in identifying infants whose bilirubin level is likely to exceed the 95 th percentile (Maisels, 2009a). However, the U.S. Preventive Services Task Force is opposed to universal screening, citing a lack of evidence that this approach improves outcomes (USPSTF, 2009), which has been documented since (Darling, 2017). An update to the AAP guideline recommends a more structured approach to managing and follow up of hyperbilirubinemia, according to risk factors (Maisels, 2009b). A diagnosis of jaundice or with a bilirubin value greater than expected from theaap nomograms in the first 24 hours after delivery suggests a potentially serious form of the disease, and treatment should begin immediately (AAP, 1994). Diagnosis at least 24 hours after delivery, which accounts for most cases, can result from various factors, such as infections or breast milk-related problems. Criteria for when treatment of hyperbilirubinemia should commence varies by the infant s age and bilirubin level. A subcommittee of the AAP made recommendations in 2004 for treatment, shown below 2

(AAP, 2004). This statement updated a similar policy statement from the AAP in 1994 (AAP, 1994). Age of infant Consider treatment Recommend treatment < 24 hours if rising rapidly ------- 25 48 hours > 12 mg/dl > 15 mg/dl 49 72 hours > 15 mg/dl > 18 mg/dl > 72 hours > 17 mg/dl > 20 mg/dl Hyperbilirubinemia can be treated in the hospital setting or (since about 1980) at home under certain conditions. Treatment is typically halted when the serum bilirubin falls below 13 14 mg/dl of blood, usually after 1 3 days of therapy. Searches AmeriHealth Caritas searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on July 13, 2017. Search terms were home phototherapy hyperbilirubinemia. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Phototherapy for hyperbilirubinemia is a common method of treating the disease. However, only a modest amount of information exists to compare efficacy of this versus other therapies. The common understanding among experts is that treatments are highly effective in lowering serum bilirubin levels to 3

normal within days, preventing further disease. While phototherapy for hyperbilirubinemia has been administered at home for years, little evidence exists in the medical literature comparing efficacy of home versus hospital use. One study compared hospital-based to home-based phototherapy (62 and 55 infants). Average time needed to reduce serum bilirubin to normal levels was similar in each group (2.8 days), and no major complications or hospital readmissions were reported (Eggert, 1985). Another report found similar decreases in serum bilirubin, but a longer duration in therapy was needed for the home group (Slater, 1984). A report of 260 infants undergoing home phototherapy over a three-year period found that average serum bilirubin at home fell from 14.19 to 10.97 mg/dl during therapy. While 17 of these patients (6%) required hospital readmission, no complications were reported, and patient satisfaction was 100% (Grabert, 1986). After home phototherapy for hyperbilirubinemia became commonly-used after the 1980s, few articles on the efficacy of the treatment were published. Research conducted in Malaysia compared hospitalbased to home-based phototherapy in 36 infants, matched for race, starting total serum bilirubin level, birth weight, and age of baby at phototherapy initiation. The average daily decrease in serum bilirubin concentration was significantly greater in the home group than the hospital group (p<.05), and mean duration was significantly less (1.17 vs. 1.72 days, p<.01) in the home group. Each group reported complications in 4 of 18 patients (Zainab, 2004). A systematic review of 42 studies, and a Cochrane review found no studies that compared outcomes in these two settings (Woodgate, 2011; Malwade, 2014). On study assessed 50 patients given home phototherapy or conventional blue-light fluorescent phototherapy (CFP) to treat hyperbilirubinemia in neonates. The average rate of decrease in bilirubin levels was not significantly greater (0.20 to 0.17 mg/dl/hours) after 24 hours, indicating that home based therapy is as effective as conventional therapy (Yilmaz, 2015). A study that compared hospital-based to home-based phototherapy (62 and 55 infants) found that average time needed to reduce serum bilirubin to normal levels was similar in each group (2.8 days), and no major complications or hospital readmissions were reported (Eggert, 1985). Another report found similar decreases in serum bilirubin, but a longer duration in therapy was needed for the home group (Slater, 1984). Research conducted in Malaysia compared hospital-based to home-based phototherapy in 36 infants, matched for race, starting total serum bilirubin level, birth weight, and age of baby at phototherapy initiation. The average daily decrease in serum bilirubin concentration was significantly greater in the home group than the hospital group (P <.05), and mean duration was significantly less (1.17 versus 1.72 days, P <.01) in the home group. Each group reported complications in 4 of 18 patients (Zainab, 2004). After home phototherapy for hyperbilirubinemia became commonly used after the 1980s, a few non- 4

controlled articles on the efficacy of the treatment were published. A report of 260 infants undergoing home phototherapy over a three-year period found that average serum bilirubin at home fell from 14.19 to 10.97 mg/dl during therapy. While 17 of these patients (6 percent) required hospital readmission, no complications were reported, and patient satisfaction was 100 percent (Grabert, 1986). A Cochrane search from 2014 could not uncover high quality evidence that supported or refuted use of home-based therapy for uncomplicated jaundice among newborns over 37 weeks of gestation (Malwade, 2014). In addition, a Hayes Inc. search found no data comparing the efficacy of conventional and fiber optic phototherapy in the home setting for hyperbilirubinemia (Hayes, 2016). Various phototherapy units can be used in the home setting for infants with elevated bilirubin levels. Any comparisons of efficacy of these models are limited. A review of 22 infants receiving home phototherapy with a fiber optic cummerbund, versus 26 infants with a conventional four-bulb light found little difference in the average daily reduction in bilirubin or in maternal satisfaction (Schuman, 1992). There are various models of home phototherapy units available for use, raising the question of potential differences in accuracy between models. One review found that the BiliChek unit consistently documented a negative bias compared with serum bilirubin values; the bias increased as the serum bilirubin level rises. If a value of 14 mg/dl or less obtained using the BiliChek had been used as the cutoff for termination of phototherapy, 45% of newborns would have had therapy terminated prematurely (Reyes, 2008). Policy updates: Four peer-reviewed references were added to this policy in 2017. Summary of clinical evidence: Citation Yilmaz (2015) Lightweight phototherapy versus conventional blue light fluorescent phototherapy Malwade (2014) Home versus hospital-based treatment for uncomplicated newborn jaundice American Academy of Pediatrics (2004) Content, Methods, Recommendations Fifty newborns with hyperbilirubinemia given each type of therapy. Reduction of bilirubin slightly greater for lightweight therapy. Meta-analysis using Medline, Cinahl, and Embase. No studies met criteria comparing home- and hospital-based therapy. Update of 1994 AAP practice guideline. 5

Citation Guideline for managing infants with hyperbilirubinemia Grabert (1986) Review of experience with home phototherapy Eggert (1985) Hospital versus home phototherapy for infants with hyperbilirubinemia Slater (1984) Content, Methods, Recommendations Newborns with hyperbilirubinemia should be treated with phototherapy or exchange transfusion. Many infants can be managed as outpatients; those with phototherapy can receive supplements of formula or expressed breast milk. Home phototherapy group experience with 260 newborns, April 1982 to February 1985. Average days on hospital phototherapy (0.81); average days home phototherapy (2.44). Average serum bilirubin at home during therapy fell from 14.19 to 10.97 mg/dl. No complications, 17 re-hospitalizations, 100% patient satisfaction. Infants with hyperbilirubinemia treated at home (n=62) and the hospital (n=55). Average days decrease in serum bilirubin to normal levels was similar (2.8 days). No reports of major complications or hospital readmission. Savings of $18,000 in 62 infants treated at home versus hospital. Hospital versus home phototherapy for infants with hyperbilirubinemia Infants with hyperbilirubinemia treated at home (n=33) and the hospital (n=25). Average days decrease in serum bilirubin was similar in the two groups. Duration of phototherapy at home was longer. References Professional society guidelines/other: Academy of Breastfeeding Medicine Protocol Committee. Guidelines for management of jaundice in the breastfeeding infant equal to or greater than 35 weeks gestation. Breastfeed Med. 2010;5(2):87 93. Ip S, Glicken S, Kulig J, et al. Management of neonatal hyperbilirubinemia. Rockville MD: Agency for Healthcare Research and Quality, November 2002. AHRQ Publication 03-E011. http://archive.ahrq.gov/clinic/tp/neonataltp.htm. Accessed July 13, 2017. American Academy of Pediatrics, Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004;114(1):297 316. American Academy of Pediatrics, Provisional Committee on Quality Improvement, Subcommittee on Hyperbilirubemia (AAP). Practice parameter: Management of hyperbilirubinemia in the healthy term newborn. Pediatrics. 1994;94(4):558 62. U.S. Preventive Services Task Force (USPSTF). Screening of infants for hyperbilirubinemia to prevent chronic bilirubin encephalopathy. October 2009. 6

http://www.uspreventiveservicestaskforce.org/page/document/recommendationstatementfinal/hype rbilirubinemia-screening-infants. Accessed July 13, 2017. Peer-reviewed references: Brown AK, Kim MH, Wu PY, et al. Efficacy of phototherapy in prevention and management of neonatal hyperbilirubinemia. Pediatrics. 1985;75(2 Pt 2):393 400. Darling EK, Ramsay T, Manuel D, Sprague AE, Walker MC, Guttmann A. Association of universal bilirubin screening with socioeconomic disparities in newborn follow-up. Acad Pediatr. 2017;17(2):135 43. Eggert LD, Pollary RA, Folland DS, Jung AL. Home phototherapy treatment of neonatal jaundice. Pediatrics. 1985;76:579. French S. Phototherapy in the home for jaundiced neonates. Clayton, Victoria: Centre for Clinical Effectiveness (CCE). 2003. 15. Centre for Clinical Effectiveness (CCE). Grabert BE, Wardwell C, Harburg SK. Home phototherapy. An alternative to prolonged hospitalization of the full-term, well newborn. Clin Pediatr (Phila). 1986;25(6):291 94. Hayes, Inc. Comparative Effectiveness of Fiberoptic Phototherapy for Hyperbilirubinemia in Preterm Infants. Lansdale PA: Hayes, Inc. Medical Technology Directory, March 31, 2016. First published as a Health Technology Brief May 30, 2007. Ludwig MA. Phototherapy in the home setting. J Pediatr Health Care. 1990;4(6):304 08. Maisels MJ, Deridder JM, Dring EA, Balasubramaniam M. Routine transcutaneous bilirubin meaasurements combined with clinical risk factors improve the prediction of subsequent hyperbilirubinemia. J Perinatol. 2009a;29(9):612 17. Maisels MJ, Bhutani VK, Bogen D, Newman TB, Stark AR, Watchko JF. Hyperbilitrubinemia in the newborn infant? or =35 weeks gestation: an update with clarifications. Pediatrics. 2009b;124(4):1193 98. Malwade US, Jardine LA. Home versus hospital-based phototherapy for the treatment of nonhaemolytic jaundice in infants at more than 37 weeks gestation. Cochrane Database Syst Rev. 2014;(6):CD10202. Martinez JC, Maisels MJ, Otheguy L, et al. Hyperbilirubinemia in the breast-fed newborn: a controlled trial of four interventions. Pediatrics. 1993;91(2):470 73. Reyes CA, Stednitz DR, Hahn C, Mutchie KD, McCullough SR, Kronberg K. Evaluation of the bilichek 7

being used on hyperbilirubinemia newborns undergoing home phototherapy. Arch Pathol Lab Med. 2008;132(4):684 89. Schuman AJ, Karush G. Fiberoptic vs conventional home phototherapy for neonatal hyperbilirubinemia. Clin Pediatr (Phila). 1992;31(6):345 52. Slater L, Brewer MF. Home versus hospital phototherapy for term infants with hyperbilirubinemia: a comparative study. Pediatrics. 1984;73:315. Woodgate P, Jardine LA. Neonatal jaundice. BMJ Clin Evid 2011;2011. Pii.0319. Yilmaz A, Ozkiraz S, Akcan AB, et al. Low-cost home-use light-emitting-diode phototherapy as an alternative to conventional methods. J Trop Pediatr. 2015;61(2):113 18. Zainab K, Adina S. Effectiveness of home versus hospital phototherapy for term infants with uncomplicated hyperbilirubinemia: a pilot study in Pahang, Malaysia. Med J Malaysia. 2004;59(3):395 401. CMS National Coverage Determinations (NCDs) No NCDs identified at the writing of this policy. Local Coverage Determinations (LCDs) No LCDs identified at the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill in accordance with those manuals. CPT Code Description Comment N/A ICD-10 Code Description Comment P59.0 Neonatal jaundice associated with preterm deliver P59.9 Neonatal jaundice NOS HCPCS Level II Code E0202 S9098 Description Phototherapy (bilirubin) light with photometer Home visit, phototherapy services (e.g., Bili-Lite), including equipment rental, nursing services, blood draw, supplies and other services; per diem Comment 8