© 2018, GENASSIST, Inc.    

By Keith S. Wexler, MBA, CFO, Business Development Director, GENASSIST, Inc.

Paul Wexler, M.D., F.A.C.O.G., Medical Director, GENASSIST, Inc.

Clinical Professor, Department of OB/GYN, University of Colorado Health Sciences Center

Clinical Professor, Division of Genetics/Dept. of Pediatrics, Univ. of Colorado/The Children’s Hospital

Background:  Since November 2017, insurance companies have started to require a “Pre Determination Genetic Letter” by a medical provider (usually who has to be contracted with the specific insurance company) to decide whether a breakthrough technology is “investigational” or “experimental” or an accepted standard of care.

Case Study: We were cold called by a patient who discovered that her father was diagnosed with ALS (Amyotrophic Lateral Sclerosis) and would like to be tested to see if she had inherited the ALS gene.

ALS can be inherited in an autosomal dominant manner which means that the patent has a 50% lifetime risk of inheriting the disease if her father has it. The main reason that the patient desired testing was to see whether or not she was a carrier of the ALS gene.

The patient has a “closed panel” health plan and she was told that she needed to take the following steps to get a predetermination letter for her insurance.

The insurance needs the letter to decide if they will pay for all, part or none of the ALS testing and whether the ALS testing is recognized by the insurance as a “Standard of Care” or “Experimental”:

  • The patient needed to meet with a genetic counselor or healthcare provider and get a predetermination letter regarding her chances of inheriting ALS.
  • The predetermination letter would then be reviewed by the insurance plan, which could take 4-6 weeks.
  • If the insurance approves the ALS testing, the order would have to come from a doctor who was a participating provider for the insurance plan and the testing would have to be sent to a participating laboratory under their insurance plan. The insurance plan would not take a written order from a genetic counselor, midwife, nurse etc.
  • Even if the insurance company approved the test, since the patient had a large deductible, the burden for paying for the test fell on the patient since the insurance company applied all medical charges towards the patient’s deductible at 100% until the entire deductible was met.


Analysis: The dilemma for the patient was that the only genetic counseling program that the patient could see under her “closed panel” plan could not see her for over 9 months.

The patient had two choices; delay her consult and eventual testing for at least 9 months or go out of plan and pay for the consult herself and the ALS testing herself.

When the patient finally gets her predetermination review by insurance, the patient was concerned that she would have to begin the insurance process all over again with a new insurance plan that begins again each calendar year.

With the changes in healthcare and the increasing number of patients that are inquiring about the risks when a specific genetic diagnosis in a family member is made, patients are having problems navigating the healthcare maze. This dilemma is not unique to “closed panel” plans.

We are seeing delays in the time that a patient would like to be seen and when they can actually get into a genetic program (usually 6-9 months some states have as long as a 40 month wait to see a geneticist for rare genetic diseases).

The problem is further compounded by the fact that many genetic healthcare providers have chosen not to bill insurance (concierge) or have not been invited to participate with insurance plans.