DMC Care Provider Bulletin

DATE:

/

10/01/2012

TO: / DMC Care Obstetrician and Gynecologist Providers
SUBJECT: / Genetic Testing: Cystic Fibrosis

Please add to your Provider Manual and share this information with your Staff:

Cystic Fibrosis Genetic Testing Requires Prior Authorization

Genetic testing for cystic fibrosis (CF) is covered as medically necessary for ANY of the following indications:

  • Confirmation of a diagnosis in ANY of the following situations:
  1. Individual who exhibits symptoms of CF but has a negative sweat test
  2. Infant with meconium ileus or other symptoms indicative of CF who is too young to
  3. produce adequate volumes of sweat for a sweat chloride test
  4. Infant with an elevated immunoreactive trypsinogen (IRT) value on newborn screening
  5. Male with congenital bilateral absence of vas deferens (CBAVD)
  • Preconception or prenatal genetic testing to determine carrier status of a Member who is pregnant or a prospective biologic parent with the capacity and desire to reproduce when ALL of the following criteria is met:

1. Must be in stages of early pregnancy (< 20weeks gestation)

2. Test results must be used to inform decisions regarding childbearing or need for

fetal diagnosis

3. Testing will only be covered for the male partner if the female has positive test

results for CF

  • Prenatal testing of a fetus (i.e., amniocentesis or chorionic villus sampling [CVS]) in EITHER of the following situations:
  1. embryo or at-risk fetus when either parent has a diagnosis of CF, is a known carrier of a cystic fibrosis transmembrane regulator (CFTR) mutation, or has a family history of CF
  2. fetus when fetal echogenic bowel has been identified on ultrasound

All individuals undergoing genetic testing for any reason should have both pre-and post-test genetic counseling with a physician or a licensed or certified genetic counselor.

Exclusion:

Genetic testing for CF is not covered for ANY the following indications because it is not medically necessary (this list may not be all-inclusive):

  • carrier screening in the general population
  • routine genetic mutation screening in a newborn*
  • routine prenatal screening
  • testing using extended mutation panels (i.e., mutation panels that extend beyond the standard mutation panel recommended by the ACMG)

*There is insufficient evidence in the published, peer-reviewed, scientific literature to support the use of routine genetic screening for CF in all newborns.

If you have any questions, concerns or need additional information please contact DMC Care Provider Services Department at 866.494.1247.

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