mp-231 - mp-231 - Medical Policies
Fetal Echocardiography and Magnetocardiography
Policy Number: MP-231
Latest Review Date: September 2022
Fetal echocardiography may be considered medically necessary for use in cases where one of the following indications for high risk of congenital heart disease are present:
Fetal Risk Factors:
- Extracardiac abnormality (e.g., congenital lung lesions, diaphragmatic hernia);
- Chromosomal abnormality;
- Fetal cardiac arrhythmia;
- Non-immune hydrops;
- Question of cardiac anomaly on prior sonogram;
- Intrauterine growth retardation;
- Suspicion of twin-twin transfusion syndromes;
- Monochorionic twins.
Maternal Risk Factors:
- Family history of CHD (parent or sibling);
- Metabolic disorders (e.g., diabetes mellitus, phenylketonuria [PKU]);
- Teratogenic exposure (e.g. alcohol, amphetamines, anticonvulsives, lithium paroxetine (Paxil);
- Exposure to prostaglandin synthetase inhibitors (e.g., ibuprofen, salicylic acid, indomethacin);
- Maternal seizure disorder and not currently taking anti-seizure medication;
- Maternal autoimmune disorders (e.g., collagen vascular disease, systemic lupus erythematosus [SLE], Sjögren’s);
- Maternal infection (e.g. rubella);
- Familial inherited disorders (Ellisvan, Creveld, Marfan, Noonan’s, etc.);
- In vitro Fertilization;
- Autoimmune antibodies (anti Ro/ Anti La).
Fetal echocardiography is considered not medically necessary when there are no indications of a cardiac abnormality found on a routine antepartum ultrasound or the mother or fetus does not have one of the indications listed above.
Repeat fetal echocardiography may be considered medically necessary for:
- Structural heart disease with potential hemodynamic compromise;
- Tachycardia other than sinus tachycardia;
- A ductus arteriosus dependent lesion.
Repeat fetal echocardiography is considered not medically necessary when done for an indication not listed above.
Fetal magnetocardiography is considered investigational in all situations.
DESCRIPTION OF PROCEDURE OR SERVICE:
Fetal Echocardiography (FE)
General Antepartum obstetrical ultrasound has become a standard part of gestational care and is commonly used for the determination of fetal age, size, gender or well-being and for the detection of congenital anomalies. A variety of maternal or fetal disorders may result in abnormality of the fetal cardiovascular system to a degree which requires evaluation at a level above and beyond that attainable with standard antepartum obstetrical ultrasound. In these circumstances, a fetal echocardiogram may be performed.
Fetal echocardiography is a non-invasive technique for diagnosing and assessing cardiac abnormalities in the fetus. It is performed using a two-dimensional (2-D) high-resolution ultrasound system, which usually also has other capabilities, including M-mode, pulsed Doppler and color doppler mapping.
These techniques are used to define the structural and functional aspects of the cardiac abnormality. While 2-D echocardiography can detect structural changes, Doppler echocardiography is used to measure flow velocity, direction of flow, pressure differences, and cardiac output. Diagnosis of fetal arrhythmia requires M-mode echocardiography; pulsed Doppler echocardiography is also used.
The standard fetal echocardiographic examination utilizes all modalities of diagnostic ultrasound including 2-dimensional (B-mode) imaging, Doppler, and Doppler color flow mapping. Ultrasound energy expenditures increase with each modality used and are most intense when Doppler color flow mapping is applied to a small region of interest, as is commonly the case when examining the structures of the fetal heart. Hence special consideration should be given to the use of ultrasound energy in the developing fetus. While theoretical concerns exist, to date there have been no confirmed harmful effects detected. Those performing fetal echocardiography should be aware of these effects and should limit power output and time of exposure to no more than that which is absolutely necessary to complete the examination.
The optimal timing for performance of a transabdominal fetal echocardiogram is 18 to 22 weeks gestation. Images can be more difficult to obtain after 30 weeks gestation, as the ratio of fetal body mass-to-amniotic fluid increases. Acquiring images of the fetal heart at 15 to 18 weeks is possible; however performing a comprehensive cardiac evaluation study at this age can be difficult.
Fetal Magnetocardiography (FM)
Fetal magnetocardiography is another non-invasive technique to assess a fetus’ heart. FM converts electrical signals from the heart into magnetic signals that look similar to a traditional electrocardiogram. The recording allows the assessment of PQRST abnormalities thus possibly leading to decreased fetal death. It is proposed that this is a more effective method of assessing cardiac abnormalities than the FE; however, the equipment is not widely available and requires careful shielding and skilled technical experience.
The most recent update was with a review of the literature through September 13, 2022.
Summary of Evidence
For individuals who receive fetal echocardiography, the evidence consists of systematic reviews and prospective studies. Relevant outcomes are fetal morbidity and mortality and accuracy of echos. Fetal echocardiography (FE) has been shown to be medically important in several ways. First, the early diagnosis of CHD with FE has been shown to lead to the detection of associated extracardiac fetal anomalies. Second, the prenatal diagnosis of major CHD may have implications for the optimal route, location, or timing of delivery, and may bring critically ill infants to medical attention quicker than they would have been without a prenatal diagnosis. Many studies have suggested improved outcome in infants diagnosed prenatally with CHD in comparison with those not diagnosed until after birth. These studies suggest that early diagnosis can lead to improved preoperative hemodynamic status, less end-organ dysfunction, less preoperative morbidity and mortality, and less long-term morbidity. The evidence is sufficient to determine the effects of the technology on health outcomes.
Fetal Magnetocardiography (FM)
For individuals who receive fetal magnetocardiography, the evidence consists of systematic reviews, a retrospective review, and observational studies. Relevant outcomes are fetal morbidity, fetal mortality, and alterations in management of current pregnancy. One study stated that FM is a more effective method of assessing fetal well-being with a higher resolution compared to cardiotocography and FE; however, the authors conclude by stating FM is an experimental method. A retrospective study of 215 pregnancies reviewed FM tracings and identified 35 changes in pregnancy management. The equipment is not widely available, requires careful shielding and requires skilled technical support. The evidence is insufficient to determine the effects of the technology on health outcomes.
PRACTICE GUIDELINES AND POSITION STATEMENTS
American Institute of Ultrasound in Medicine
In 2019, the AIUM updated their practice parameter for fetal echocardiography. They state that “indications for fetal echocardiography are often based on a variety of parental and fetal risk factors for congenital heart disease…. For fetuses suspected of having an abnormal fetal heart at the time of a basic or detailed anatomic ultrasound examination, referral for fetal echocardiography is indicated, as the risk of significant disease is high. For low risk for CHD, cardiac screening ultrasound is primarily used to examine the fetal heart as a part of a standard second trimester obstetric ultrasound examination”.
The following is a list of common fetal and maternal conditions associated with an increased risk of CHD:
- Maternal Indications
- Pregestational diabetes regardless of the hemoglobin A1C level
- Gestational diabetes diagnosed in the first or early second trimester
- Autoimmune antibodies, anti-Ro (SSA)/anti-La (SSB)
- In vitro fertilization, including intracytoplasmic sperm injection
- Phenylketonuria (unknown status or a periconceptional phenylalanine level > 10 mg/dL)
- Autoimmune disease with anti-Sjogren syndrome– related antigen A antibodies and with a prior affected fetus
- First-degree relative of a fetus with CHD (parents, siblings, or prior pregnancy)
- First- or second-degree relative with disease of Mendelian inheritance and a history of childhood cardiac manifestations
- Retinoid exposure
- First-trimester rubella infection
- Fetal Indications
- Suspected cardiac structural anomaly
- Suspected abnormality in cardiac function
- Hydrops fetalis
- Persistent fetal tachycardia (heart rate >180 bpm)
- Persistent fetal bradycardia (heart rate <120 bpm) or suspected heart block
- Frequent episodes or a persistently irregular cardiac rhythm
- Major fetal extracardiac anomaly
- Nuchal translucency of 3.5mm r greater or at or above the 99th percentile for gestational age
- Fetal chromosomal anomaly
- Monochorionic twins.
The Heart Rhythm Society
The Heart Rhythm Society has an Expert Consensus Statement currently under development.
Fetal echocardiography, complete heart block, fetal cardiovascular system, echocardiography, echocardiogram, congenital heart disease, CHD, fetal magnetocardiography
APPROVED BY GOVERNING BODIES:
In March 2016, the Echo fMCG™ (Tristan Technologies) received FDA 510(k) approval for use as a tool that non-invasively measures and displays the magnetic signals produced by the electric currents in the heart of human beings of any age or in the heart of a fetus in utero. It is used for magnetocardiography and echocardiography.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply. Refer to member’s benefit plan.
Echocardiography, fetal, cardiovascular system, real time with image documentation (2-D) with or without M-mode recording;
; follow-up or repeat study
Doppler echocardiography, fetal, pulsed wave and/or continuous wave with spectral display; complete
; follow-up or repeat study
Doppler color flow velocity, mapping
Recording of fetal magnetic cardiac signal using at least 3 channels; patient recording and storage, data scanning with signal extraction, technical analysis and result, as well as supervision, review, and interpretation of report by a physician or other.
Recording of fetal magnetic cardiac signal using at least 3 channels; patient recording, data scanning, with raw electronic signal transfer of data and storage
Recording of fetal magnetic cardiac signal using at least 3 channels; signal extraction, technical analysis, and result
Recording of fetal magnetic cardiac signal using at least 3 channels; review, interpretation, report by physician or other qualified health care professional
- American Heart Association. Fetal echocardiogram test. 2018. Available at: www.heart.org/en/health-topics/congenital-heart-defects/symptoms--diagnosis-of-congenital-heart-defects/fetal-echocardiogram-test.
- American Heart Association. Fetal echocardiography. www.american heart.org.
- Association for Medical Ultrasound (AIUM). AIUM practice parameter for the performance of fetal echocardiography. 2019. Available at: https://www.aium.org/resources/guidelines/fetalEcho.pdf
- Björkhem G, Jorgensen C, Hanseus K. Parental reaction to fetal echocardiography. J Matern Fetal Med 1997; 6(20): 87-92.
- Hrtankova M, Biringer K, Sivakova J, et al. Fetal magnetocardiography: a promising way to diagnose feta arrhythmia and to study fetal heart rate variability. Ceska Gynekol. 2015 Jan; 80(1): 58-63.
- Douglas PS, Foster E, Gorcsan III, J et al. ACC/AHA Clinical Competence Statement on Echocardiography. A report of the American college of Cardiology/American Heart Association/American College of Physicians-American Society of Internal Medicine Task Force on Clinical Competence. JACC 2003; 41(4):687-708.
- Ekholm E, Palo P, Ekblad H, Pitkanen O. Fetal arrhythmias. Duodecim. 2014; 130(2):152-60.
- Food and Drug Administration. Magnetocardiograph. Available at: www.accessdata.fda.gov/cdrh_docs/pdf15/k151135.pdf.
- Forbus GA, Atz AM, Shirali GS. Implications and limitations of an abnormal fetal echocardiogram. Am J Cardiol 2004; 94: 688-689.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Kan N, Silverman ED, Kingdom J, et al. Serial echocardiography for immune-medicated heart disease in the fetus: results of a risk based prospective surveillance strategy. Prenat Diagn. 2017 Apr; 37(4): 375-382.
- Levine JC, Alexander ME. Overview of the general approach to diagnosis and treatment of fetal arrhythmias. Up to Date. Available at: www.uptodate.com/contents/overview-of-the-general-approach-to-diagnosis-and-treatment-of-fetal-arrhythmias?source=search_result&search=fetal%20magnetocardiography&selectedTitle=1~150#H8167758. Accessed October 2017.
- Rychik J, Ayres N, et al. American Society of Echocardiography guidelines and standards for performance of the fetal echocardiogram. J Am Soc Echocardiogr 2004; 17: 803-810.
- Medical Policy Reference Manual. Fetal echocardiography. 4.01.01 2003.
- Sklansky M, Tang A, et al. Maternal psychological impact of fetal echocardiography. J Am Soc Echocardiogr 2002; 15(2): 429-432.
- Wacker-Gussmann A, Strasburger JF, Wakai RT. Contribution of fetal magnetocardiography to diagnosis, risk assessment, and treatment of fetal arrhythmia. J Am Heart Assoc. 2022 Aug 2;11(15):e025224.
- Zuskar DM. The psychological impact of prenatal diagnosis of fetal abnormality: strategies for investigation and intervention. Women Health 1987; 12(1): 91-103.
Medical Policy Group, June 2005 (2)
Medical Policy Administration Committee, July 2005
Available for comment July 28-September 10, 2005
Medical Policy Group, June 2008 (1)
Medical Policy Administration Committee, July 2008
Available for comment July 15-August 28, 2008
Medical Policy Group, June 2009 (2)
Medical Policy Administration Committee, July 2009
Available for comment July 2-August 15, 2009
Medical Policy Group, October 2017 (4): Updates to Description, Policy, Key Points, Key Words, Approved by Governing Bodies, and References; removed policy statements pertaining to effective dates of service July 28, 2005 and June1, 2008; added indications for coverage for fetal electrocardiography; added investigational statement for Fetal Magnetocardiography.FM was previously on IV listing and now moved to policy; Added CPT codes pertaining to FM under current coding section.
Medical Policy Administration Committee, October 2017
Medical Policy Group, November 2019 (4): Updates to Key Points and References. No change to policy statement.
Medical Policy Group, January 2020 (4): Reviewed by concensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.
Medical Policy Group, April 2020 (4): Updates to Key Points and References. No change to policy statement.
Medical Policy Group, August 2021 (4): Removed policy statements effective for dates of service on or after July 1, 2009 through October 14, 2017. Policy statement updated to remove “not medically necessary,” no change to policy intent. Updates to References.
Medical Policy Gorup, September 2022 (4): Updates to Description, Key Points 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.