Letters of Medical Necessity – BRACAnalysis

The genetic basis of HBOC is a germline (inherited) mutation in either the BRCA1 or BRCA2 genes. Normally, the proteins produced by the BRCA1 or BRCA2 genes prevent cells from becoming malignant by aiding in the repair of mutations in other genes through a process known as double-stranded DNA repair. Therefore, an inherited mutation in either of these genes, also known as tumor suppressor genes, greatly increases the probability of malignant transformation and cancer. Approximately 7% of breast cancer and 11 – 15% of ovarian cancer cases are caused by BRCA1 or BRCA2, which are inherited in an autosomal dominant pattern.

When assessing hereditary cancer risk, a patient’s personal and family history is collected to investigate the risk for HBOC. Once a patient is identified as being at increased risk of HBOC, genetic test results provide the most accurate means of cancer risk assessment for a patient.

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Guidelines for Letters of Medical Necessity (LMNs)

A healthcare provider may include a LMN with a pre-authorization request, claim submission, or appeal to facilitate the insurance review process for the benefit of the patient. Our experience with insurance companies is such that we encourage healthcare providers to cover as many of the following points as possible that are applicable to the patient:

  • Explanation that the requested genetic test has been ordered by a physician
  • Explanation of the medical necessity for the test requested
  • If family history is cited, give as much family history as possible, including specifics about relationship to patient, cancer site, age of cancer diagnosis (alternatively, a detailed three-generation pedigree that contains this information could be attached and referred to in the body of the letter)
  • Patient’s diagnosis and prognosis, including age of onset and specific location of cancer
  • Explanation that the genetic test is recognized as appropriate for inclusion in this patient’s treatment regimen
  • Treatment plan, including specific statements about anticipated impact of the genetic test on the medical management of patient.

We remind you to read through the entire letter to make sure it makes sense for each patient. Please call 800-469-7423 if Myriad Customer Service may provide further assistance or answer questions.

Sample LMNs for BRACAnalysis®:

Tips for Saving and Modifiying Sample LMNs:

This is a Microsoft Word document that is saved as “read-only” to preserve the original wording. To customize, simply use the “save as” command from the “File” menu, which will prompt you to rename the document to something besides the original name. Your newly named document is no longer “read-only” and can be modified as you wish.

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