Insurance Company Name
Address
City, State
Date of claim
Re: Ambry Genetics Corporation, Letter of Medical Necessity for Hereditary Pancreatitis
Patient First, Last Name
DOB
ID Number
Dear Medical Director,
This letter is in regards to my patient and your subscriber, First, Last Name to request full coverage
for hereditary pancreatitis predisposition genetic testing to be performed by Ambry Genetics
Corporation (TIN 33-0892453 / NPI 1861568784), a CAP approved and CLIA certified laboratory located
at 15 Argonaut, Aliso Viejo, CA 92656.
There are currently at least 4 genes that have been identified as significant risk factors in recurrent
acute and or chronic pancreatitis. These include: the cystic fibrosis transmembrane conductance
regulator gene, CFTR; the cationic trypsinogen gene, PRSS1; the pancreatic secretory trypsin inhibitor
gene, SPINK1; and the chymotrypsin C gene, CTRC.
My patient is suspicious of having an underlying genetic cause for his, her recurrent attacks of
pancreatitis. Clinical diagnosis ICD9 codes: include all that apply. My patient’s clinical symptoms and
the results of the routine diagnostic tests already performed suggest of a diagnosis of hereditary
pancreatitis. However, the only way to confirm this diagnosis is to perform genetic testing on this
patient.
Genetic testing plays an important role in making a definitive diagnosis and in guiding the
management of chronic pancreatitis. An accurate diagnosis of the underlying cause of the pancreatitis
will allow for the most appropriate medical management based on the gene mutations that are
identified. Mutations in the different genes will indicate a different course of treatment as follows.
PRSS1 gene mutations that alter either of the calcium regulatory regions markedly increase
sensitivity to calcium-mediated activation or enzyme survival. Therefore strategies to minimize the rise
in intra-acinar cell calcium concentrations are warranted. These include minimizing stimulation of the
acinar cells by giving digestive enzymes and possibly gastric acid suppression and optimizing acinar
cell calcium regulation by reducing intracellular stress with anti-oxidants, avoidance of alcohol, and
attention to metabolic factors such as serum calcium levels.
CFTR mutations markedly reduce the ability to flush digestive enzymes out of the pancreatic duct.
Therefore strategies to reduce the risk of damage within the pancreatic duct focus on maximizing fluid
flow through the duct. This may include avoiding gastric acid suppression in order to increase release
of secretin, and using high-quality, acid-resistant digestive enzyme supplements such as Creon.
Utilizing this testing, a significant number of patients will actually be diagnosed with a form of Cystic
Fibrosis and then it is unlikely that these strategies will be effective. However, these patients should be
triaged immediately for CF care which would also change medical management regarding pulmonary
functions.
Heterozygous mutations in SPINK1 and CTRC have been linked to worsening of the pancreatitis
phenotype, and to markedly increasing the risk of pancreatitis with most CFTR mutations. Strategies
to minimize the effects of these mutations must therefore be linked to the strategies of limiting the
effect of trypsinogen mutation or CFTR mutations.
A positive test result would provide a definitive cause for this patient’s pancreatitis and would
ensure this patient is being treated appropriately. I am specifying Ambry Genetics because this
laboratory has highly sensitive and cost-effective testing for hereditary pancreatitis along with the
largest database of tested patients to insure the most accurate and informative test interpretation. I
recommend that you support this request for coverage of diagnostic genetic testing for pancreatitis for
my patient.
Genetic testing will be performed through Ambry Genetics Corporation given its long-standing
experience with next-generation sequencing, consistent variant analysis, detailed results reporting and
continuous support from highly trained medical directors and genetic counselors.
I recommend that you support this request for coverage of diagnostic genetic testing for hereditary
pancreatitis predisposition for my patient. Genetic testing can take up to four months to complete and
the laboratory will not bill until testing is concluded. Therefore, we are requesting that the
authorization be valid for 6 months.
Thank you for your time and please don’t hesitate to contact me with any questions.
Sincerely,
Ordering Clinician Signature ________________________________ Date ______________
(MD/DO, Clinical Nurse Specialist, Nurse-Midwives, Nurse Practitioner, Physician Assistant, Genetic
Counselor*)
*Authorized clinician requirements vary by state