Latest Review Date: December 2023

Category: Surgery                                                                  

POLICY:

Vesico-amniotic shunting as a treatment of urinary tract obstruction may be considered medically necessary in fetuses under the following conditions:

• Evidence of hydronephrosis due to bilateral urinary tract obstruction; AND
• Progressive oligohydramnios; AND
• Adequate renal function; AND
• No other lethal abnormalities or chromosomal defects.

Open in utero resection of malformed pulmonary tissue or placement of a thoracoamniotic shunt may be considered medically necessary under following conditions:

• Congenital cystic adenomatoid malformation or bronchopulmonary sequestration is identified; AND
• The fetus is at 32 weeks gestation or less; AND
• There is evidence of fetal hydrops, placentomegaly, and/or the beginnings of severe pre-eclampsia (i.e., the maternal mirror syndrome) in the mother.

In utero removal of sacrococcygeal teratoma may be considered medically necessary under following conditions:

• The fetus is at 32 weeks’ gestation or less; AND
• There is evidence of fetal hydrops, placentomegaly, and/or the beginnings of severe pre-eclampsia (i.e., the maternal mirror syndrome) in the mother.

In utero repair of myelomeningocele may be considered medically necessary under following conditions:

• The fetus is at less than 26 weeks’ gestation; AND
• Myelomeningocele is present with an upper boundary located between T1 and S1 with evidence of hindbrain herniation.

In utero treatment of Twin Reversed Arterial Perfusion (TRAP) may be considered medically necessary under the following conditions:

• Pump twin hydrops or heart failure
• Abnormal pump twin Doppler velocimetry studies
• ≥ 50%
• Polyhydramnios
• Monochorionic pregnancy

In utero repair of myelomeningocele is considered not medically necessary  in the following situations:

• Fetal anomaly unrelated to myelomeningocele; OR
• Severe kyphosis; OR
• Risk of preterm birth (e.g., short cervix or previous preterm birth); OR
• Maternal body mass index of 35 or more.

Other applications of fetal surgery is considered investigational, including but not limited to, temporary tracheal occlusion as a treatment of congenital diaphragmatic hernia, or treatment of congenital heart defects.

DESCRIPTION OF PROCEDURE OR SERVICE:

Fetal surgery is used for specific congenital abnormalities that are associated with a poor post-natal prognosis. Prenatal surgery typically involves opening the gravid uterus, surgically correcting the abnormality, and returning the fetus to the uterus and restoring uterine closure. Minimally invasive procedures through single or multiple fetoscopic port incisions have also been developed.

Most fetal anatomic malformations are best managed after birth. However, advances in methods of prenatal diagnosis, particularly prenatal ultrasound, have led to a new understanding of the natural history and physiologic outcomes of certain congenital anomalies. Fetal surgery is the logical extension of these diagnostic advances, related in part to technical advancement in anesthesia, tocolysis, and hysterotomy.

This policy will pertain to fetal surgery performed for the following clinical conditions.

Fetal Urinary Tract Obstruction

Although few cases of prenatally diagnosed urinary tract obstruction require prenatal intervention, bilateral obstruction can lead to distention of the urinary bladder and is often associated with serious disease such as pulmonary hypoplasia secondary to oligohydramnios. Therefore, fetuses with bilateral obstruction, oligohydramnios, adequate renal function reserve, and no other lethal or chromosomal abnormalities may be candidates for fetal surgery. The most common surgical approach is decompression through percutaneous placement of a shunt or stent. Vesico-amniotic shunting bypasses the obstructed urinary tract, permitting fetal urine to flow into the amniotic space. The goals of shunting are to protect the kidneys from increased pressure in the collecting system and to assure adequate amniotic fluid volume for lung development.

Congenital Cystic Adenomatoid Malformation (CCAM) or Bronchopulmonary Sequestration (BPS)

CCAM, also referred to as congenital pulmonary airway malformations (CPAMs), and BPS are the two most common congenital cystic lung lesions, and share the characteristic of a segment of lung being replaced by abnormally developing tissue. CCAMs can have connections to the pulmonary tree and contain air, while BPS does not connect to the airway and has blood flow from the aorta rather than the pulmonary circulation. In more severe cases, the malformations can compress adjacent normal lung tissue and distort thoracic structure. CCAM lesions typically increase in size in mid-trimester and then in the 3rd trimester either involute or compress the fetal thorax resulting in hydrops in the infant and sometimes mirror syndrome (a severe form of pre-eclampsia) in the mother. Mortality is close to 100% when lesions are associated with fetal hydrops (abnormal accumulation of fluid in two or more fetal compartments). These patients may be candidates for prenatal surgical resection of a large mass or placement of a thoraco-amniotic shunt to decompress the lesion.

Sacrococcygeal Teratoma

Sacroccoccygeal teratoma (SCT) is both a neoplasm with autonomous growth and a malformation made up of multiple tissues foreign to the region of origin and lacking organ specificity. It is the most common tumor of the newborn and generally carries a good prognosis in infants born at term. However, in utero fetal mortality approaches 100% with large or vascular tumors, which may become larger than the rest of the fetus. In this small subset, SCT is associated with fetal hydrops, which is related to high output heart failure secondary to arteriovenous shunting. In some cases, mothers of fetuses with hydrops can develop mirror syndrome.

Twin Reversed Arterial Perfusion (TRAP)

TRAP is a condition that occurs in monochorionic twins.  One twin (known as the pump twin) develops normally, but the other twin (known as the acardia twin) lacks a functioning cardiac system.  The pump twin supplies the acardiac twin with blood through the umbilical artery.  In normal development, the umbilical artery carries blood away from the fetus to the placenta. The acardia twin is completely dependent upon circulatory support from the pump twin in utero; however, this fetus has no potential for survival out of the uterus.  Due to the added demand from the pump twin, this fetus is at risk for heart failure and other complications that could lead to preterm delivery or death.  With no intervention, the pump twin will die in at least 55% of cases.  In utero treatment improves survival rates to 80-90%.

Myelomeningocele

Myelomeningocele is a neural tube defect in which the spinal cord forms abnormally and is left open, exposing the meninges and neural tube to the intrauterine environment. Myelomeningocele is the most common cause of spina bifida, and depending on the location results in varying degrees of neurologic impairment to the legs and bowel and bladder function, brain malformation (i.e., hindbrain herniation), cognitive impairment, and disorders of cerebrospinal fluid circulation, i.e., hydrocephalus requiring placement of a ventriculoperitoneal shunt. Traditional treatment consists of surgical repair after term delivery, primarily to prevent infection and further neurologic dysfunction. Fetal surgical repair to cover the exposed spinal canal has been proposed as a means of preventing the deleterious exposure to the intrauterine environment with the hope of improving neurologic function and decreasing the incidence of other problems related to the condition.

Congenital Diaphragmatic Hernia (CDH)

CDH results from abnormal development of the diaphragm which permits abdominal viscera to enter the chest, frequently resulting in hypoplasia of the lungs. CDH can vary widely in severity, depending on the size of the hernia and the timing of herniation. For example, late herniation after 25 weeks of gestation may be adequately managed postnatally. In contrast, liver herniation into the chest prior to 25 weeks of gestation is associated with a poor prognosis, and these fetuses have been considered candidates for fetal surgery. Temporary tracheal occlusion using a balloon is being evaluated for the treatment of CDH. Occluding the trachea of a fetus prevents the normal efflux of fetal lung fluid, which results in a build-up of secretions in the pulmonary tree and increases the size of the lungs, gradually pushing abdominal viscera out of the chest cavity and back into the abdominal cavity. It is believed that this, in turn, will promote better lung maturation. Advances in imaging have resulted in the ability to detect less severe lesions, which has resulted in a decrease in mortality rates for defects detected during pregnancy. Due to these changes over time, concurrent controls are needed to adequately compare pre- and post-natal approaches.

Cardiac Malformations

In utero interventions are being investigated for several potentially lethal congenital heart disorders, including critical aortic stenosis with evolving hypoplastic left heart syndrome (HLHS), HLHS with intact atrial septum, and critical pulmonary stenosis or pulmonary atresia. Critical pulmonary stenosis or atresia with intact ventricular septum is characterized by a very narrow pulmonary valve without a connection between the right and left ventricles. Pulmonary atresia with intact ventricular septum can evolve into right ventricular hypoplasia; fetal pulmonary valvuloplasty may result in biventricular circulation. Critical aortic stenosis with impending HLHS is a very narrow aortic valve that develops early during gestation that may result in HLHS, a complex spectrum of cardiac anomalies characterized by hypoplasia of the left ventricle and aorta, with atretic, stenotic, or hypoplastic atrial and mitral valves. In utero aortic balloon valvuloplasty relieves aortic stenosis with the goal of preserving left ventricular growth and halting the progression to HLHS. HLHS with intact trial septum is a variant of HLHS that occurs in about 22% of all HLHS cases in which blood flow across the foramen ovale is restricted, leading to left atrial hypertension and damage to the pulmonary vasculature, parenchyma, and lymphatics. For HLHS with intact atrial septum, fetal balloon atrial septostomy is designed to reduce the left atrial restriction.

KEY POINTS:

The most recent update was with a review of the literature through December 7, 2023.

Summary

For pregnancies diagnosed with congenital abnormalities (i.e. vesico amniotic shunting for urinary tract obstruction, malformed pulmonary tissue, sacrococcygeal teratoma, myelomeningocele, and TRAP) and fetal surgery is recommended, the evidence includes meta-analyses, systematic reviews, retrospective reviews, and case series. Relevant outcomes include intrauterine fetal demise and morbidity, maternal morbidity, and fetal outcomes. Due to a number of factors, including the rarity of the conditions and the small number of centers specializing in fetal interventions, the evidence on fetal surgery is limited. RCTs are not available due to the rarity and seriousness of these congenital abnormalities; however, literature suggests that fetal interventions could improve outcomes in selected cases. The evidence is sufficient to determine the effects of the technology on health outcomes.

For pregnancies diagnosed with other conditions, including congenital diaphragmatic hernia (CDH) and heart defects, the evidence includes RCTs and systematic reviews. For CDH, the development of a device that uses a balloon for fetal endoscopic tracheal occlusion (FETO) is being investigated.  There are still several unknowns for this procedure which include the optimal gestational age for surgery, severity level for treatment, and timing for the release of the balloon. Complications such as fetal death, placental abruption, preterm labor and preterm births have been reported with this procedure.  For congenital heart defects, there are reports of high complication rates along with high morbidity and mortality. The available evidence is insufficient to demonstrate the technologies provide improved health outcomes. For these and other applications of fetal surgery that are currently considered investigational, additional studies are needed to identify appropriate candidates and to evaluate longer term outcomes compared with postnatal management.

Practice Guidelines and Position Statements

The American College of Obstetricians and Gynecologist (ACOG)

In September 2017 (reaffirmed in 2022), ACOG, in collaboration with the Society for Maternal Fetal Medicine, published a Committee Opinion regarding Maternal Fetal Surgery for Myelomeningocele.  They recommended the following:

• Open maternal–fetal surgery for myelomeningocele repair has been demonstrated to improve a number of important pediatric outcomes at the expense of procedure-associated maternal and fetal risks.
• Women with pregnancies complicated by fetal myelomeningocele who meet established criteria for in utero repair should be counseled in nondirective fashion regarding all management options, including the possibility of open maternal–fetal surgery.
• Interested candidates for fetal myelomeningocele repair should be referred for further assessment and consultation to a fetal therapy center that offers this intervention and possesses the expertise, multi-disciplinary team, services, and facilities to provide detailed information regarding maternal–fetal surgery and the intensive care required for patients who choose to undergo open maternal–fetal surgery.

They concluded by stating:

“Open maternal–fetal surgery for myelomeningocele repair is a major procedure for the woman and her affected fetus. Although there is demonstrated potential for fetal and pediatric benefit, there are significant maternal implications and complications that may occur acutely, postoperatively, for the duration of the pregnancy, and in subsequent pregnancies. It is a highly technical procedure with potential for significant morbidity and possibly mortality, even with the best and most experienced surgeons. Maternal–fetal surgery for myelomeningocele repair should only be offered to carefully selected patients at facilities with an appropriate level of personnel and resources.”

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force has not addressed fetal surgery for prenatally diagnosed malformations.

KEY WORDS:

Congenital Cystic Adenomatoid Malformation, Fetal Surgery, Congenital Diaphragmatic Hernia, Fetal Surgery, Extralobar Pulmonary Sequestration, In Utero Fetal Surgery, Sacrococcygeal Teratoma, Temporary Tracheal Occlusion, Thoraco-amniotic Shunt, Urinary Tract Obstruction, Vesico-amniotic Shunting, Myelomeningocele, TRAP, twin reversed arterial perfusion, FETO, fetal endoscopic tracheal occlusion

APPROVED BY GOVERNING BODIES:

Not applicable

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING: 

CPT Codes:

HCPCS:

REFERENCES:

1. Adzick NS, Thom EA, Spong CY et al. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med 2011; Feb 9. [Epub ahead of print]
2. American College of Obstetricians and Gynecologists Committee on Ethics and the American Academy of Pediatrics Committee on Bioethics. Committee opinion no. 501: Maternal-fetal intervention and fetal care centers. Obstet Gynecol 2011; 118(2 Pt 1):405-10.
3. American College of O, Gynecologists. ACOG Committee opinion no. 550: maternal-fetal surgery for myelomeningocele. Obstet Gynecol. Jan 2013; 121(1):218-219.
4. American College of Obstetricians and Gynecologists.  ACOG Committee Opinion. Number 720, September 2017 (reaffirmed 2019).  Available at: https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Maternal-Fetal-Surgery-for-Myelomeningocele.
5. Bennett KA, Carroll MA, Shannon CN, et al. Reducing perinatal complications and preterm delivery for patients undergoing in utero closure of fetal myelomeningocele: further modifications to the multidisciplinary surgical technique. J Neurosurg Pediatr. Jul 2014; 14(1):108-114.
6. Bicudo Diniz AM, Manso PH, Santos MV, et al. A systematic review of benefits and risks of fetal surgery for congenital cardiac defects such as pulmonary valve stenosis and critical aortic stenosis.  Braz J Cardiovasc Surg. 2023 May 4;38(3):398-404.
7. Bowman RM, McLone DG, Grant JA et al. Spina bifida outcome: a 25-year prospective. Pediatr Neurosurg 2001; 34(3):114-20.
8. Bruner JP, Tulipan N, Reed G, et al.  Intrauterine repair of spina bifida:  Preoperative predictors of shunt-dependent hydrocephalus. Am J Obstet Gynecol 2004; 190(5):1305-12.
9. Chaturvedi RR, Ryan G, Seed M, et al. Fetal stenting of the atrial septum: technique and initial results in cardiac lesions with left atrial hypertension. Int J Cardiol. Oct 3 2013; 168(3):2029-2036.
10. Cohen AR, Couto J, Cummings JJ et al. Position statement on fetal myelomeningocele repair. Am J Obstet Gynecol 2013.
11. Cortes RA, Keller RL, Townsend T, et al. Survival of severe congenital diaphragmatic hernia has morbid consequences. J Pediatr Surg 2005; 40(1):36-45.
12. Danzer E, Finkel RS, Rintoul NE et al. Reversal of hindbrain herniation after maternal-fetal surgery for myelomeningocele subsequently impacts on brain stem function. Neuropediatrics 2008; 39(6):359-62.
13. Danzer E, Gerdes M, Bebbington MW et al. Lower extremity neuromotor function and short-term ambulatory potential following in utero myelomeningocele surgery. Fetal Diagn Ther 2009; 25(1):47-53.
14. Danzer E, Gerdes M, Begbbingotn MW et al. Preschool neurodevelopmental outcome of children following fetal myelomeningocele closure. Am J Obstet Gynecol 2010; 202(5):450.e1-9.
15. Deprest J, Jani J, Lewi L, et al. Fetoscopic surgery: Encouraged by clinical experience and boosted by instrument innovation. Semin Fetal Neonatal Med 2006; 11(6):398-412.
16. Deprest JA, Benachi A, Gratacos E, et al. Randomized Trial of fetal surgery for moderate left diaphragmatic hernia. N Engl J Med. 2021 Jul 8; 385(2): 119-129.
17. Deprest JA, Nicolaides KH, Benachi A, et al. Randomized trial of fetal surgery for severe left diaphragmatic hernia. N Engl J Med. 2021 Jul 8;385(2):107-118.
18. Fayoux P, Hosana G, Devisme L et al. Neonatal tracheal changes following in utero fetoscopic balloon tracheal occlusion in severe congenital diaphragmatic hernia. J Pediatr Surg 2010; 45(4):687-92.
19. Flake AW, Crombleholme TM, Johnson MP, et al. Treatment of severe congenital diaphragmatic hernia by fetal tracheal occlusion: Clinical experience with fifteen cases.  Am J Obstet Gynecol 2000; 183(5):1059-66.
20. Golombeck K, Ball RH, Lee H, et al. Maternal morbidity after maternal-fetal surgery. Am J Obstet Gynecol 2006; 194(3):834-9.
21. 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):1916-24.
22. Hedrick HL, Flake AW, Crombleholme TM, et al. Sacrococcygeal teratoma: prenatal assessment, fetal intervention and outcomes. J Pediatr Surg 2004 Mar; 39(3):430-8.
23. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
24. Jelin E, Hirose S, Rand L, et al. Perinatal outcome of conservative management versus fetal intervention for twin reversed arterial perfusion sequence with a small acardiac twin. Fetal Diagn Ther. 2010;27(3): 138-41.
25. Johnson MP, Sutton LN, Rintoul N, et al. Fetal myelomeningocele repair: Short-term clinical outcomes. Am J Obstet Gynecol 2003; 189(2):482-7.
26. Kalish BT, Tworetzky W, Benson CB, et al. Technical challenges of atrial septal stent placement in fetuses with hypoplastic left heart syndrome and intact atrial septum. Catheter Cardiovasc Interv. Jul 1 2014; 84(1):77-85.
27. Kilby M, Khan K, Morris K, et al. PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial. BJOG. Jul 2007; 114(7):904-905, e901-904.
28. Kohl T, Hering R, Bauriedel G, et al. Fetoscopic and ultrasound-guided decompression of the fetal trachea in a human fetus with Fraser syndrome and congenital high airway obstruction syndrome (CHAOS) from laryngeal atresia. Ultrasound Obstet Gynecol 2006; 27(1):84-8.
29. Lee H, Bebbington M, Crombleholme TM. The north American fetal therapy network registry data on outcomes of radiofrequency ablation for twin reversed arterial perfusion sequence. Fetal Diagn Ther. 2013;33(4):224-9.
30. Marantz P, Aiello H, Grinenco S et al. Foetal aortic valvuloplasty: experience of five cases. Cardiol Young 2013; 23(05):675-81.
31. Mayer S, Weisser M, Till H et al. Congenital myelomeningocele – do we have to change our management? Cerebrospinal Fluid Res 2010; 7:17.
32. McElhinney DB, Marshall AC, Wilkins-Haug LE et al. Predictors of technical success and postnatal biventricular outcome after in utero aortic valvuloplasty for aortic stenosis with evolving hypoplastic left heart syndrome. Circulation 2009; 120(15):1482-90.
33. Moldenhauer JS, Soni S, Rintoul NE, et al. Fetal Myelomeningocele Repair: The Post-MOMS Experience at the Children's Hospital of Philadelphia. Fetal Diagn Ther. Aug 15 2014.
34. Morris RK, Malin GL, Khan KS et al. Systematic review of the effectiveness of antenatal intervention for the treatment of congenital lower urinary tract obstruction. BJOG 2010; 117(4):382-90.
35. Morris RK, Malin GL, Quinlan-Jones E, et al. The Percutaneous shunting in Lower Urinary Tract Obstruction (PLUTO) study and randomised controlled trial: evaluation of the effectiveness, cost-effectiveness and acceptability of percutaneous vesicoamniotic shunting for lower urinary tract obstruction. Health Technol Assess. Dec 2013; 17(59):1-232.
36. Morris RK, Malin GL, Quinlan-Jones E et al. Percutaneous vesicoamniotic shunting versus conservative management for fetal lower urinary tract obstruction (PLUTO): a randomised trial. Lancet 2013; 382(9903):1496-506.
37. Papadopulos NA, Papadopoulos MA, Kovacs L, et al. Fetal surgery and cleft lip and palate: current status and new perspectives. Br J Plast Surg 2005; 58(5):593-607.
38. Pedra SR, Peralta CF, Crema L, et al. Fetal interventions for congenital heart disease in Brazil. Pediatr Cardiol. Mar 2014; 35(3):399-405.
39. Peranteau WH and Adzick NS. Prenatal surgery for myelomeningocele. Curr Opin Obstet Gynecol. 2016 Apr, 28(2):111-8.
40. Rocha LA, Byrne FA, Keller RL, et al. Left heart structures in human neonates with congenital diaphragmatic hernia and the effect of fetal endoscopic tracheal occlusion. Fetal Diagn Ther. 2014; 35(1):36-43.
41. Ruano R, Duarte SA, Pimenta EJdA, et al. Comparison between Fetal Endoscopic Tracheal Occlusion Using a 1.0-mm Fetoscope and Prenatal Expectant Management in Severe Congenital Diaphragmatic Hernia. Fetal Diagnosis and Therapy. 2011; 29(1):64-70.
42. Ruano R, Yoshisaki 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):20-7.
43. Saccone G, D’Alessandr P, Escolino M, et al. Antenatal intervention for congenital fetal lower urinary tract obstruction (LUT): a systematic review and meta-analysis. J MAtern Fetal Neonatal Med. 2018 Dec 2:1-161.
44. Schidlow DN, Tworetzky W, Wilkins-Haug LE. Percutaneous fetal cardiac interventions for structural heart disease. Am J Perinatol. Aug 2014; 31(7):629-636.
45. Shan W, Wu Y, Huang G, et al. Foetal endoscopic tracheal occlusion for severe congenital diaphragmatic hernia--a systemic review and meta-analysis of randomized controlled trials. J Pak Med Assoc. Jun 2014; 64(6):686-689.
46. Tubbs RS, Chambers MR, Smyth MD, et al. Late gestational intrauterine myelomeningocele repair does not improve lower extremity function. Pediatr Neurosurg 2003; 38(3):128-32.
47. Van Mieghem T, Al-Ibrahim A, Deprest J, et al. Minimally invasive therapy for fetal sacrococcygeal teratoma: case series and systematic review of the literature. Ultrasound Obstet Gynecol. Jun 2014; 43(6):611-619.
48. Vinit N, Gueneuc A, Bessieres B, et al. Fetal cystoscopy and vesicoamniotic shunting in lower urinary tract obstruction: Long term outcome and current limitations. Fetal Diagn Ther. 2019 Aug 9:1-10.
49. Walsh WF, Chescheir NC, Gillam-Krakauer M et al. Maternal-fetal surgical procedures. Comparative Effectiveness Technical Briefs, No. 5. Rockville (MD): Agency for Healthcare Research and Quality (US) 2011 Apr. Report No. 10(11)-EHC059-EF. Available online at: www.ncbi.nlm.nih.gov/books/NBK54520/pdf/TOC.pdf.
50. White SB, Tutton SM, Rilling WS, et al. Percutaneous in utero thoracoamniotic shunt creation for fetal thoracic abnormalities leading to nonimmune hydrops. J Vasc Interv Radiol. Jun 2014; 25(6):889-894.

POLICY HISTORY:

Medical Policy Group, February 2010 (3)

Medical Policy Administration Committee, February 2010

Available for comment February 23-April 8, 2010

Medical Policy Group, April 2011: Revised Policy section; Added 2011 Key Points; Added References

Medical Policy Administration Committee, May 2011

Available for comment May 11 – June 27, 2011

Medical Policy Group, March 2012 (3): Updated Key Points and References

Medical Policy Panel, December 2012

Medical Policy Group, December 2012 (3): Updated Key Points and References, added Summary section.  Policy statement remains unchanged

Medical Policy Panel, January 2014

Medical Policy Group, January 2014 (3):  Updated Description, Key Points and References; no change in policy statement

Medical Policy Panel, December 2014

Medical Policy Group, January 2015 (3):  2014 Updates to description, Key Points and References; no change in policy statement

Medical Policy Panel, January 2016

Medical Policy Group, January 2016 (4): Policy reviewed with no updates. Effective January 27, 2016: Active policy, but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, November 2019 (4): Updates to Policy section, Key Points, References, Coding, and Key Words. Twin reversed arterial perfusion is considered medically necessary with criteria added to policy section. TRAP and twin reversed arterial perfusion added to key words. Added CPT 59072.

Medical Policy Adminisitration Committee, December 2019

Available for Comment November 14, 2019 through December 30, 2019

Medical Policy Group, December 2020 (4):  Reviewed by consensus.  No change to policy statements.

Medical Policy Group, December 2021 (4): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Policy statement for other applications for fetal surgery updated to remove “not medically necessary,” no change to policy intent. Policy statement for myelomeningocele updated to remove “investigational”, no change to policy intent.

Medical Policy Group, December 2022 (4): Reviewed by consensus.  No new published perr reviewed literature available that would alter the coverage statements in this policy.  Removed policy statements for dates of service prior to November 15, 2019. 

Medical Policy Group, December 2023 (4): Updates to Description, Key Points, Key Words (FETO, fetal endoscopic tracheal occlusion), Benefit Applications, and References.  No change to policy statements.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.