Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Encounter for antenatal screening, unspecified
Treatment: Fetal Biophysical Profile (76819)
The insurer denied the Fetal Biophysical Profile (76819).
The denial is upheld. 

The patient is a female (gravida 1, para 0) who was 33.2 weeks gestation.  She had the diagnosis of uterine size date discrepancy so she underwent a growth ultrasound that also included a biophysical profile.  The anatomy was normal.  Growth was normal in the 52nd percentile.  The biophysical profile was 8 out of 8.

No, the proposed Fetal Biophysical Profile (76819) was not medically necessary.

According to Manning, the fetal biophysical profile score (BPS or BPP) refers to the sonographic assessment of four discrete biophysical variables:
1) Fetal movement 2) Fetal tone 3) Fetal breathing 4) Amniotic fluid volume 5) Results of nonstress testing.

Each of these five parameters is given a score of 0 or 2 points, depending upon whether specific criteria are met.  The presence of these biophysical variables implies absence of significant central nervous system hypoxemia/acidemia at the time of testing.  By comparison, a compromised fetus typically exhibits loss of accelerations of the fetal heart rate (FHR), decreased body and breathing movements, hypotonia, and, less acutely, decreased amniotic fluid volume.  The clinical value of the cumulative fetal biophysical profile score (BPS) is that it is noninvasive, easily learned and performed, and an accurate means for predicting the presence of significant fetal acidemia, which is the most common cause of fetal death or damage.  Seventy to 90 percent of late fetal deaths display evidence of chronic or acute and chronic compromise prior to demise.  Sonographic detection of signs of fetal compromise can allow appropriate intervention that ideally will prevent adverse fetal sequelae.

Although the use of biophysical testing schemes to monitor high-risk pregnancies has become routine, this practice pattern has evolved with limited high quality scientific data to support its use.  Moreover, there are no randomized trials on which to base recommendations for the best initial testing approach for specific types of high-risk pregnancies, the optimal timing of test initiation, the frequency of testing based on test results, conditions that may affect test results, and the effect of gestational age.

The American College of Obstetricians and Gynecologists (ACOG) recommends antepartum fetal surveillance of pregnancies in which the risk of antepartum fetal demise is increased.  An American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin states that women with high-risk factors for significant fetal acidemia should undergo antepartum fetal surveillance with tests such as the biophysical profile score (BPS) and nonstress test.

According to the American College of Obstetricians and Gynecologists (ACOG), antepartum fetal surveillance results have not been definitively demonstrated to improve perinatal outcome, and therefore, all indications for antepartum testing must be considered somewhat relative.  In general, antepartum fetal surveillance has been used in pregnancies in which the risk of antepartum fetal demise is increased.

Maternal conditions: 1) Pregestational diabetes mellitus 2) Hypertension 3) Systemic lupus erythematosus 4) Chronic renal disease 5) Antiphospholipid syndrome 6) Hyperthyroidism (poorly controlled) 7) Hemoglobinopathies (sickle cell, sickle cell hemoglobin C, or sickle cell thalassemia disease) 8) Cyanotic heart disease.

Pregnancy-related conditions: 1) Gestational hypertension 2) Preeclampsia 3) Decreased fetal movement 4) Gestational diabetes mellitus (poorly controlled or medically treated) 5) Oligohydramnios 6) Fetal growth restriction 7) Late term or post-term pregnancy 8) Isoimmunization 9) Previous fetal demise (unexplained or recurrent risk) 10) Monochorionic multiple gestation (with significant growth discrepancy.

There are no large clinical trials to guide the frequency of testing, and thus, the optimal frequency remains unknown; it depends on several factors and should be individualized and based on clinical judgment.  If the indication for testing is not persistent (e.g., a single episode of decreased fetal movement followed by reassuring testing in an otherwise uncomplicated pregnancy), testing need not be repeated.  When the clinical condition that prompted testing persists, the test should be repeated periodically to monitor for continued fetal well-being until delivery.  If the maternal medical condition is stable and test results are reassuring, tests of fetal well-being (nonstress testing [NST], biophysical profile [BPP], modified biophysical profile [BPP], or contraction stress test [CST]) are typically repeated at weekly intervals; however, in the presence of certain high-risk conditions, some investigators have performed more frequent testing, although the optimal regimen has not been established.

In pregnancies complicated by fetal growth restriction, the optimal interval for fetal growth assessment and the optimal surveillance regimen have not been established.  Most growth-restricted fetuses can be adequately evaluated with serial ultrasonography every 3-4 weeks; ultrasonographic assessment of growth should not be performed more frequently than every two weeks because the inherent error associated with ultrasonographic measurements can preclude an accurate assessment of interval growth.  Any significant change in maternal or fetal status requires further reevaluation.

In review of the medical record, plan documents and current literature, there are not any well conducted randomized controlled trials or well conducted cohort trials that provide evidence for the use of the biophysical profile (BPP) in this clinical setting.  The patient has a size date discrepancy and an ultrasound was the appropriate technique for evaluation; however, once the growth was established as normal there was not an indication for the biophysical profile (BPP).  The patient does not meet any of the indications listed on the CareCore National list or the American College of Obstetricians and Gynecologists (ACOG) list of maternal or fetal indications for fetal testing.  Therefore, this procedure has not been proven to provide benefit in this clinical situation.  It is not the standard of medical practice, and therefore, not medically necessary.