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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 09/18/1995 Title: Fetal Surgery in Utero
Revision Date: 10/01/2015 Document: BI115:00
CPT Code(s): 59070, 59072, 59074, 59076, 59897
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

Surgical procedures on the unborn fetus are high profile interventions, but have mostly not been shown to be scientifically supportable. Most such procedures are still considered by QualChoice to be experimental or investigational.


Medical Statement
  1. In utero fetal surgery is considered medically necessary for any of the following indications:
    • Amnioinfusion (59070) as treatment of oligohydramnios (P01.2);
    • Vesico-amniotic shunting (59076) as a treatment of urinary tract obstruction (Q64.31-Q64.39);
    • In utero resection of malformed pulmonary tissue (59897), or placement of a thoraco-amniotic shunt (59076) as a treatment of either of the following:
      • congenital cystic adenomatoid malformation (Q89.9); or
      • extra lobar pulmonary sequestration (Q33.2 - Q33.3, Q33.6);
    • In utero removal of sacro-coccygeal teratoma (59897) (O33.7).
  2. QualChoice considers the following applications of in utero fetal surgery experimental and investigative:
    • Laser ablation of anastomotic vessels (59897) in twin-twin transfusion  syndrome (O43.021-O43.029);
    • In utero repair of neural tube defects (59897) for spinabifida (O35.0XX1 -  O35.0XX9); Fetal tracheal occlusion (59897) for congenital diaphragmatic hernia (Q79.0)
    • Surgical repair of diaphragmatic hernia (Q79.0, Q79.1).
  3. QualChoice considers other applications of in utero surgery experimental and investigative.

 

Codes Used In This BI:

 

59070 Transabdom Amnioinfus w/US

59072 Umbilical Cord Occlude w/US

59074 Fetal Fluid Drainage w/US

59076 Fetal Shunt Placement w/US

59897 Fetal Invas PX w/US


Background

Fetal surgery in utero has been attempted for various congenital anomalies including congenital diaphragmatic hernia (CDH), spina bifida and urinary tract abnormalities.

Congenital diaphragmatic hernia is a defect in the diaphragm of a developing fetus, which results in abdominal viscera protrusion into the chest, displacing the lungs and heart in the thoracic cavity. CDHs are usually repaired after delivery; however, two primary methods for treating CDH in utero have emerged in an attempt to overcome pulmonary hypoplasia and persistent pulmonary hypertension in infants who are more severely affected: (1) surgical repair of the herniated diaphragm, and (2) ligation of the fetal trachea, with subsequent stimulation of lung growth.

 

Surgical treatment of spina bifida usually occurs within 24 hours of birth; however, in utero repair has been used as a method to decrease nerve damage and improve outcomes at birth. Lower urinary tract obstruction has a significant impact on neonatal and child health. Pulmonary hyperplasia and renal impairment could be direct or indirect consequences of this condition leading to significant morbidity and mortality. Vesico-amniotic fetal shunting, open fetal surgery and more recently endoscopic fetal surgery for this condition are available as possible options of fetal intervention. Vesico-amniotic shunting has the advantage of bypassing the obstruction, however it is often associated with complications. Open fetal surgery is not usually recommended because of the complications and high fetal loss rate. Endoscopic surgery to visualize and treat the cause of lower urinary tract obstruction has been tried. Fetal endoscopic surgery is in its infancy.

 

Twin-twin transfusion syndrome is the most common complication of monochorionic pregnancies affecting between 5 and 15 % of such pregnancies and accounts for 15 - 77 % of perinatal mortality in twins. No single therapy is associated with a uniformly improved outcome for the involved twins and success is primarily related to gestational age and severity at diagnosis. Treatment options for severe cases include digitalization, ligation of the umbilical cord, serial amniocenteses, septostomy, laser occlusion of placental vessels, and selective feticide. Other congenital anomalies that are amenable to in utero treatment include myelomeningocele, cystadenomatoid malformation of the lung and saccro-coccygeal teratoma, shunts for uropathies and thoracic fluids.

 

Findings of recent studies indicated that the effectiveness of in utero approach in treating congenital diaphragmatic hernia (CDH) has not been established. Downard and Wilson (2003) noted that antenatal maternal steroid administration and fetal surgery are not proven interventions for CDH.. Adzick and Kitano (2003) stated that fetuses diagnosed with left CDH before 26 weeks` gestation with associated liver herniation and a low right lung to head circumference ratio have a reduced prognosis with conventional therapy after birth, but in utero therapeutic approaches have yet to show a comparative survival benefit. Adzik and Kitano stated that a prospective randomized trial is required to critically evaluate the efficacy of fetal tracheal occlusion for severe diaphragmatic hernia. Heerma, et al. (2003) reported on comparative autopsy in 16 cases of congenital diaphragmatic hernia with fetal intervention (12 cases tracheal occlusion; 4 cases hernia repair) with 19 cases of congenital diaphragmatic hernia without fetal intervention. The investigators concluded that tracheal occlusion did not prevent development of lung pathology associated with pulmonary hypoplasia.

 

A prospective randomized controlled trial of fetal tracheal occlusion for congenital diaphragmatic hernia found no differences in outcomes between subjects assigned to fetal endoscopic tracheal occlusion or standard care (Harrison, et al., 2003). Enrollment was stopped after 24 women carrying fetuses with severe congenital diaphragmatic hernia had been enrolled because of the unexpectedly high survival rate with standard care and the conclusion of the data safety monitoring board that further recruitment would not result in significant differences between the groups. Eight of 11 fetuses (73 percent) in the tracheal-occlusion group and 10 of 13 (77 percent) in the group that received standard care survived to 90 days of age. The authors concluded that tracheal occlusion did not improve survival or morbidity rates in this cohort of fetuses with congenital diaphragmatic hernia. In an accompanying editorial, Wenstrom (2003) argued that there are several reasons why antenatal tracheal occlusion may not result in a better outcome than conventional therapy. Wenstrom reasoned that, with new diagnostic technologies, congenital diaphragmatic defects of varying degrees of severity, from mild to severe, are now routinely identified antenatally, and affected neonates receive care at tertiary centers that offer highly specialized treatments for respiratory disease, including extracorporeal membrane oxygenation, high-frequency oscillatory ventilation, inhaled nitric oxide, exogenous surfactant, and others. As a result, the current survival rate for all cases of isolated congenital diaphragmatic hernia - from mild to severe - approaches 70 percent without fetal surgery, and neonates who do not require extracorporeal life support (approximately half of those with isolated congenital diaphragmatic hernia) have a survival rate of at least 80 percent. Wenstrom argued that another reason why antenatal intervention may not result in a better outcome than conventional therapy is that any potential benefit may be negated by the substantial fetal morbidity associated with the surgical procedure itself. Most pregnancies subjected to antenatal fetal surgery end in preterm delivery. Wenstrom noted that, in the study by Harrison et al., premature rupture of the membranes and preterm delivery occurred in 100 percent of those receiving antenatal treatment. The mean age at delivery was 30.8 weeks in the treated group, an age at which morbidity related to prematurity is likely. In addition, because birth occurred, on average, just six weeks after the procedure, appropriate catch-up lung growth may not yet have occurred. Wenstrom concluded that “[t]he study by Harrison et al. also illustrates the critical importance of randomized clinical trials in evaluating new therapies - even heroic procedures performed in only a small fraction of neonates - before they are adopted as part of standard practice.”

 

A Hayes Medical Technology Directory Report published in October of 2012 reviewed the literature regarding intrauterine fetal surgery (IUFS) for congenital diaphragmatic hernia (CDH) through 2012, and concluded that there was insufficient evidence to support the practice.  Besides the literature noted above, two studies by Ruano et al from the same RCT were reviewed and compared to previous literature.  While Harrison’s study showed a 75% overall survival rate, Ruano showed a 50% survival in the IUFS group compared to a 4.8% survival in standard care.  It seems likely, then, that the reported survival advantage of IUFS in Ruano was a result of low survival in the control group rather than being evidence in favor of IUFS.


Reference
  1. Scott JR, Di Saia PJ, Hammond CB, et al, eds. Danforth`s Obstetrics and Gynecology. Philadelphia, PA: Lippincott Williams & Wilkins;1999:228-230.
  2. Adzick NS, Sutton LN, Cromblehome TM, et al. Successful fetal surgery for spina bifida. Lancet. 1998;352:1675-1676.
  3. Quintero RA, Bornick PW, Allen MH, Johnson PK. Selective laser photocoagulation of communicating vessels in severe twin-twin transfusion syndrome in women with an anterior placenta. 2001;97(3):477-481.
  4. Odibo AO, Macones GA. Management of twin-twin transfusion syndrome: Laying the foundation for future interventional studies. Twin Res. 2002;5(6):515-520.
  5. Ropacka M, Markwitz W, Blickstein I. Treatment options for the twin-twin transfusion syndrome: A review. Twin Res. 2002;5(6):507-514.
  6. Evans MI, Harrison MR, Flake AW, Johnson MP. Fetal therapy. Best Pract Res Clin Obstet Gynaecol. 2002;16(5):671-683.
  7. Coleman BG, Adzick NS, Crombleholme TM, et al. Fetal therapy: State of the art. J Ultrasound Med. 2002;21(11):1257-1288.
  8. Quintero RA, Martinez JM, Bermudez C, et al. Fetoscopic demonstration of perimortem feto-fetal hemorrhage in twin-twin transfusion syndrome. Ultrasound Obstet Gynecol. 2002;20(6):638-639.
  9. Quintero RA, Dickinson JA, Morales WJ, et al. Stage-based treatment of twin-twin transfusion syndrome. Am J Obstet Gynecol. 2003;188(5):1333-1340.
  10. Tsao K, Albanese CT, Harrison MR. Prenatal therapy for thoracic and mediastinal lesions. World J Surg. 2003;27(1):77-83.
  11. Martinez JM, Bermudez C, Becerra C, et al. The role of Doppler studies in predicting individual intrauterine fetal demise after laser therapy for twin-twin transfusion syndrome. Ultrasound Obstet Gynecol. 2003;22(3):246-251.
  12. Walsh DS, Adzick NS. Fetal surgery for spina bifida. Semin Neonatal. 2003;8(3):197-205.
  13. Adzick NS, Kitano Y. Fetal surgery for lung lesions, congenital diaphragmatic hernia, and sacro-coccygeal teratoma. Semin Pediatric Surg. 2003;12(3):154-167.
  14. Sydorak RM, Harrison MR. Congenital diaphragmatic hernia: Advances in prenatal therapy. Clin Perinatal. 2003;30(3):465-479.
  15. Au-Yeung JY, Chan KL. Prenatal surgery for congenital diaphragmatic hernia. Asian J Surg. 2003;26(4):240-243.
  16. Downard CD, Wilson JM. Current therapy of infants with congenital diaphragmatic hernia. Semin Neonatal. 2003;8(3):215-221.
  17. Harrison MR, Keller RL, Hawgood SB, et al. A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. N Engl J Med. 2003;349(20):1916-1924.
  18. Heerema AE, Rabban JT, Sydorak RM, et al. Lung pathology in patients with congenital diaphragmatic hernia treated with fetal surgical intervention, including tracheal occlusion. Pediatric Dev Pathol. 2003 Nov 5 [Epub ahead of print]
  19. Wenstrom KD. Fetal surgery for congenital diaphragmatic hernia. N Engl J Med. 2003;349(20):1887-1888.
  20. Ruano R, Yoshisake CT, da Silva MM, et al.  A randomized controlled trial of fetal endoscopic tracheal occlusion versus postnatal management of severe isolated congenital diaphragmatic hernia.  Ultrasound Obstet Gynecol. 2012;39(1):20-27
  21. Ruano R, da Silva MM, Campos JA, et al.  Fetal pulmonary response after fetoscopic tracheal occlusion for severe isolated congenital diaphragmatic hernia.

Obstet Gynecol. 2012a;119(1):93-101.

  1. Hayes Medical Technology Report.  In Utero Fetal Surgery for Congenital Diaphragmatic Hernia.  Published October 23, 2012, accessed October 29, 2012.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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