Download Sample COLARIS AP LMNs

Sample LMNs
COLARIS AP®
 SAMPLE LMN #1 – For patients with a sibling with MYH-associated polyposis
due to known mutations in MYH

SAMPLE LMN #2 – For patients with a family history of polyposis but no specific
mutation(s) in either APC or MYH have been identified

SAMPLE LMN #3 – For patients with a clinical diagnosis of familial adenomatous
polyposis (FAP)  100 colorectal adenomatous polyps

SAMPLE LMN #4 – For patients with a suspected diagnosis of familial
adenomatous polyposis 20-99 colorectal adenomatous polyps

SAMPLE LMN #5 – For patients with colorectal adenomatous polyps and a
negative APC result

SAMPLE LMN #6 – For patients with a family history of an APC mutation

SAMPLE LMN #7 – Southern Blot reflex – For patients with a negative APC
sequencing result
GUIDELINES FOR LETTERS OF MEDICAL NECESSITY (LMNs)
A healthcare provider may include an 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 threegeneration 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.
TIPS FOR SAVING AND MODIFYING 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 and customized as you wish.
Adopted 09/05
COLARIS AP® – SAMPLE LMN #1
For patients with a sibling with MYH-associated polyposis
due to known mutations in MYH
[Date]
ATTN: [Physician Name, M.D.]
[Insurance Company/Institution]
[Street Address]
[City, State, Zip]
Re:
[Patient Name or ID/Claim Number]
Dear Medical Director:
I am writing to request coverage for the cost of this patient’s analysis for known familial
mutations in the MYH gene. Biallelic mutations in the MYH gene are associated with
multiple colorectal adenomas and a high risk of colorectal cancer. In addition, patients
may present with extracolonic disease similar to patients with familial adenomatous
polyposis (FAP), including duodenal polyposis.
Current medical management recommendations suggest that individuals who have
inherited two mutations in the MYH gene be managed similarly to individuals who carry
an APC gene mutation, including frequent colonoscopies and upper GI endoscopy, with
the option of colectomy. The presence of both familial MYH mutations (a positive test
result) will indicate the need for intensive colorectal cancer screening at an earlier age
and on a more frequent basis. If both of the familial mutations are not identified, general
population screening guidelines would apply instead. Based on the more aggressive
surgical and screening recommendations that result from these risks, I am
recommending genetic testing for the known familial MYH gene mutations previously
identified in another family member.
Thank you for your consideration of this case. Please feel free to contact me directly if I
can be of any further assistance in your decision for coverage.
Sincerely,
[Physician Signature]
Adopted 09/05
COLARIS AP® – SAMPLE LMN #2
For patients with a family history of polyposis but no specific
mutation(s) in either APC or MYH have been identified
[Date]
ATTN: [Physician’s name, M.D.]
[Insurance Company/Institution]
[Street Address]
[City, State, Zip]
Re:
[Patient Name or ID/Claim number]
Dear Medical Director:
I am writing to request coverage for analysis of the APC and MYH genes for
__________________________________________________due to a personal history
of ________________________________________________________ diagnosed at
age(s) ______________________________. Additional family history includes:
Relationship___________________ Cancer or Adenoma ___________ Age____
Relationship___________________ Cancer or Adenoma ___________ Age____
Relationship___________________ Cancer or Adenoma ___________ Age____
Mutations in the APC gene are responsible for Familial Adenomatous Polyposis (FAP),
which is characterized by a proliferation of adenomatous polyps throughout the colon
and rectum. Carriers of APC mutations have a greater than 90% chance of colorectal
cancer before age 50 unless a prophylactic colectomy is performed. Individuals who
carry an APC gene mutation also are at significant risk to develop extracolonic cancers
following their prophylactic colectomy. The risk of an extracolonic cancer in individuals
with FAP is 11% by age 50 and 52% by age 75.
Inherited mutations in the MYH gene have been shown to be significantly associated
with the presence of multiple colorectal adenomas and cancer. Current medical
management recommendations suggest that individuals who have inherited two
mutations in the MYH gene be managed similarly to individuals who carry an APC gene
mutation, including frequent colonoscopies with the option of colectomy.
Based on these cancer risks and the aggressive surgical and screening
recommendations that result from these risks, I am recommending genetic testing for
mutations in the APC and MYH genes.
[include as appropriate]
According to the American Gastroenterological Association Medical Position Statement,
APC gene testing is “the screening test of choice” and is indicated for “those 10 years or
older at risk for FAP” (AGA Position Statement, Gastroenterology 121:195-197, 2001).
These guidelines also state that screening of the colon and rectum for polyps should
begin approximately at age 10. Therefore, genetic testing of at-risk family members for
Adopted 09/05
APC mutations is recommended by 8-12 years of age. The information gained from
genetic testing will therefore likely have a significant impact on the patient’s short- and
long-term medical management. A negative genetic test in the relative of a known
mutation carrier can alleviate the need for annual lifetime surveillance (sigmoidoscopy)
commencing in childhood.
Myriad Genetic Laboratories performs comprehensive analysis of the APC and MYH
genes. Sequence analysis is the most sensitive clinical test to look for predisposition
mutations and is one of the most complex clinical diagnostic tests that exists today. The
technical challenge of traditional DNA analysis represented as "usual and customary"
should not apply to the complex analysis involved with APC and MYH analysis.
Thank you for your consideration of this case. Please feel free to contact me directly if I
can be of any further assistance in your decision for coverage.
Sincerely,
[Physician Signature]
Adopted 09/05
COLARIS AP® – SAMPLE LMN #3
For patients with a clinical diagnosis of familial adenomatous polyposis (FAP)
 100 colorectal adenomatous polyps
[Date]
Attn: [Physician Name, M.D.]
[Insurance Company/Institution]
[Street Address]
[City, State, Zip]
Re: [Patient Name or ID/Claim Number]
Dear Medical Director:
I am writing to request coverage for analysis of the APC and MYH genes for
__________________________________________________due to a personal history
of ________________________________________________________ diagnosed at
age(s) ______________________________. The number of adenomatous colorectal
polyps detected in this patient (##) thus far is suggestive of mutations in the APC or
MYH genes. Mutations in the APC gene are responsible for Familial Adenomatous
Polyposis (FAP), which is characterized by a proliferation of adenomatous polyps
throughout the colon and rectum. Carriers of APC mutations have a greater than 90%
chance of colorectal cancer before age 50 unless a prophylactic colectomy is
performed. Individuals who carry an APC gene mutation also are at significant risk to
develop extracolonic cancers following prophylactic colectomy. The risk of an
extracolonic cancer in individuals with FAP is 11% by age 50 and 52% by age 75.
These risks warrant specific screening for cancers rarely seen in the general population
including duodenal cancer.
Biallelic mutations in the MYH gene are associated with the presence of multiple
colorectal adenomas and cancer. In addition, patients may present with extracolonic
disease similar to patients with familial adenomatous polyposis (FAP), including
duodenal polyposis. Current medical management recommendations suggest that
individuals who have inherited two mutations in the MYH gene be managed similarly to
individuals who carry an APC gene mutation, including frequent colonoscopies and
upper GI endoscopy, with the option of colectomy.
Based on the above stated cancer risks and the aggressive surgical and screening
recommendations that result from these risks, I am recommending genetic testing for
mutations in the APC and MYH genes to confirm the diagnosis of FAP. According to
the American Gastroenterological Association Medical Position Statement, “APC gene
testing is indicated to confirm the diagnosis of FAP” (AGA Position Statement,
Gastroenterology 121:195-197, 2001). The information gained from genetic testing will
have a significant impact on both the patients’ short- and long-term medical
management.
[include as appropriate]
Adopted 09/05
According to the American Gastroenterological Association Medical Position Statement,
APC gene testing is “the screening test of choice” and is indicated for “those 10 years or
older at risk for FAP” (AGA Position Statement, Gastroenterology 121:195-197, 2001).
These guidelines also state that screening of the colon and rectum for polyps should
begin approximately at age 10. Therefore, genetic testing of at-risk family members is
recommended by 8-12 years of age. The information gained from genetic testing will
therefore likely have a significant impact on the patient’s short- and long-term medical
management. A negative genetic test in the relative of a known mutation carrier can
alleviate the need for annual lifetime surveillance (sigmoidoscopy) commencing in
childhood.
Myriad Genetic Laboratories performs comprehensive analysis of the APC and MYH
genes. Sequence analysis is the most sensitive clinical test to look for predisposition
mutations and is one of the most complex clinical diagnostic tests that exists today. The
technical challenge of traditional DNA analysis represented as "usual and customary"
should not apply to the complex analysis involved with APC and MYH analysis.
Thank you for your consideration of this case. Please feel free to contact me directly if I
can be of any further assistance in your decision for coverage.
Sincerely,
[Physician Signature]
Adopted 09/05
COLARIS AP® – SAMPLE LMN #4
For patients with a suspected diagnosis of familial adenomatous polyposis
20-99 colorectal adenomatous polyps
[Date]
ATTN: [Physician Name, M.D.]
[Insurance Company/Institution]
[Street Address]
[City, State, Zip]
Re:
[Patient Name or ID/Claim Number]
Dear Medical Director:
I am writing to request coverage for analysis of the APC and MYH genes for
__________________________________________________due to a personal history
of ________________________________________________________ diagnosed at
age(s) ______________________________. Additional family history includes:
Relationship___________________ Cancer or Adenoma ___________ Age____
Relationship___________________ Cancer or Adenoma ___________ Age____
Relationship___________________ Cancer or Adenoma ___________ Age____
The number of adenomatous colorectal polyps detected in this patient (##) thus far is
suggestive of mutations in the APC and MYH genes. Mutations in the APC gene are
responsible for Familial Adenomatous Polyposis (FAP), which is characterized by a
proliferation of adenomatous polyps throughout the colon and rectum. The clinical
features of some individuals and families with mutations in the APC gene can be less
dramatic (fewer numbers of polyps, later age of polyp onset, etc.). Therefore, the
number of adenomatous colorectal polyps detected in this patient (##) thus far, is
suggestive of a mutation in the APC gene. Carriers of APC mutations have a greater
than 90% chance of colorectal cancer before age 50 unless a prophylactic colectomy is
performed. Individuals who carry an APC gene mutation also are at significant risk to
develop extracolonic cancers following prophylactic colectomy. The risk of an
extracolonic cancer in individuals with FAP is 11% by age 50 and 52% by age 75.
These risks warrant specific screening for cancers rarely seen in the general population
including duodenal cancer.
Biallelic mutations in the MYH gene are associated with the presence of multiple
colorectal adenomas and cancer. In addition, patients may present with extracolonic
disease similar to patients with familial adenomatous polyposis (FAP), including
duodenal polyposis. Current medical management recommendations suggest that
individuals who have inherited two mutations in the MYH gene be managed similarly to
individuals who carry an APC gene mutation, including frequent colonoscopies and
upper GI endoscopy, with the option of colectomy.
Based on the above stated cancer risks and the aggressive surgical and screening
recommendations that result from these risks, I am recommending genetic testing for
mutations in the APC and MYH genes to confirm a diagnosis of polyposis. The
Adopted 09/05
information gained from genetic testing will have a significant impact on both the
patients’ short- and long-term medical management.
[include as appropriate]
According to the American Gastroenterological Association Medical Position Statement,
APC gene testing is “the screening test of choice” and is indicated for “those 10 years or
older at risk for FAP” (AGA Position Statement, Gastroenterology 121:195-197, 2001).
These guidelines also state that screening of the colon and rectum for polyps should
begin approximately at age 10. Therefore, genetic testing of at-risk family members is
recommended by 8-12 years of age. The information gained from genetic testing will
therefore likely have a significant impact on the patient’s short- and long-term medical
management. A negative genetic test in the relative of a known mutation carrier can
alleviate the need for annual lifetime surveillance (sigmoidoscopy) commencing in
childhood.
Myriad Genetic Laboratories performs comprehensive analysis of the APC and MYH
genes. Sequence analysis is the most sensitive clinical test to look for predisposition
mutations and is one of the most complex clinical diagnostic tests that exists today. The
technical challenge of traditional DNA analysis represented as "usual and customary"
should not apply to the complex analysis involved with APC and MYH analysis.
Thank you for your consideration of this case. Please feel free to contact me directly if I
can be of any further assistance in your decision for coverage.
Sincerely,
[Physician Signature]
Adopted 09/05
COLARIS AP® – SAMPLE LMN #5
For patients with colorectal adenomatous polyps and a negative APC result
[Date]
ATTN: [Physician Name, M.D.]
[Insurance Company/Institution]
[Street Address]
[City, State, Zip]
Re: [Patient Name or ID/Claim Number]
Dear Medical Director:
I am writing to request coverage for analysis of the APC and MYH genes for
__________________________________________________due to a personal history
of ________________________________________________________ diagnosed at
age(s) ______________________________. The number of adenomatous colorectal
polyps detected in this patient (##) thus far, is suggestive of mutations in the MYH gene.
Biallelic mutations in the MYH gene are associated with the presence of multiple
colorectal adenomas and cancer. In addition, patients may present with extracolonic
disease similar to patients with familial adenomatous polyposis (FAP), including
duodenal polyposis.
Current medical management recommendations suggest that individuals who have
inherited two mutations in the MYH gene be managed similarly to individuals who carry
an APC gene mutation, including frequent colonoscopies and upper GI endoscopy, with
the option of colectomy. Based on the aggressive screening recommendations that
result from these risks, I am recommending genetic testing for mutations in the MYH
gene to confirm a diagnosis of polyposis. The information gained from genetic testing
will have a significant impact on both the patients’ short- and long-term medical
management.
Mutations in the APC gene have been ruled out in this patient. Mutations in the APC
gene are a common cause of adenomatous polyps throughout the colon and rectum.
Thank you for your consideration of this case. Please feel free to contact me directly if I
can be of any further assistance in your decision for coverage.
Sincerely,
[Physician Signature]
Adopted 09/05
COLARIS AP® – SAMPLE LMN #6
Family history of an APC mutation
[Date]
ATTN: [Physician Name, M.D.]
[Insurance Company/Institution]
[Street Address]
[City, State, Zip]
Re: [Patient Name or ID/Claim Number]
Dear Medical Director:
I am requesting coverage for the cost of this patient’s analysis for a known familial
mutation in the APC gene. [Patient Name or ID] is a [ ] year old [wo]man with a
family history significant for Familial Adenomatous Polyposis (FAP) due to the presence
of a known genetic mutation. Mutations in the APC gene are responsible for Familial
Adenomatous Polyposis (FAP), which is characterized by a proliferation of
adenomatous polyps throughout the colon and rectum. Carriers of APC mutations have
a greater than 90% chance of colorectal cancer before age 50 unless a prophylactic
colectomy is performed. Individuals who carry an APC gene mutation also are at
significant risk to develop extracolonic cancers following their prophylactic colectomy.
The risk of an extracolonic cancer in individuals with FAP is 11% by age 50 and 52% by
age 75.
According to the American Gastroenterological Association Medical Position Statement,
APC gene testing is “the screening test of choice” and is indicated for “those 10 years or
older at risk for FAP” (AGA Position Statement, Gastroenterology 121:195-197, 2001).
These guidelines also state that screening of the colon and rectum for polyps should
begin approximately at age 10. Therefore, genetic testing of at-risk family members for
APC mutations is recommended by 8-12 years of age. The information gained from
genetic testing will therefore likely have a significant impact on the patient’s short- and
long-term medical management. A negative genetic test in the relative of a known
mutation carrier can alleviate the need for annual lifetime surveillance (sigmoidoscopy)
commencing in childhood.
Myriad Genetic Laboratories is CLIA-approved to perform single site mutation analysis
of the APC gene. Single site mutation analysis is the most sensitive clinical test to look
for specific mutations in this gene.
Thank you for your consideration of this case. Please feel free to contact me directly if I
can be of any further assistance in your decision for coverage.
Sincerely,
[Physician Signature]
Adopted 09/05
COLARIS AP® – SAMPLE LMN #7
For patients with a negative APC sequencing result
[Date]
ATTN: [Physician Name, M.D.]
[Insurance Company/Institution]
[Street Address]
[City, State, Zip]
Re:
[Patient Name or ID/Claim Number]
Dear Medical Director:
This patient has a significant personal and/or family history of Familial Adenomatous
Polyposis – FAP (≥ 100 adenomatous colorectal polyps in an individual) [or Attenuated
Familial Adenomatous Polyposis – AFAP (between 20 and 99 adenomatous colorectal
polyps in an individual)]. Individuals with FAP or AFAP are at significantly elevated risk
for several cancers including, but not limited to, colorectal and duodenal cancer.
FAP (or AFAP) is most commonly caused by inherited mutations in the APC
(Adenomatous Polyposis Coli) gene. Based on the diagnosis of FAP (or AFAP) in this
individual/family, Ms./Mr. _____ underwent genetic testing for mutations in the APC
gene in xx/xxxx (date). No cancer risk-related mutation was identified. At the time Ms./
Mr. _____ underwent genetic testing of the APC gene, the available technology
included full gene sequencing. While the majority of mutations responsible for FAP (or
AFAP) can be detected with this technology, additional technology is now available to
detect other types of mutations in the APC gene. Ms./Mr. wishes to pursue this
additional testing in order to determine whether or not she/he carries an APC gene
mutation.
If Ms./Mr. ______ were identified as an APC mutation carrier, her/his short- and longterm medical management decisions would be substantially impacted. Specifically,
Ms./Mr. _____ would (e.g. consider removal of their colon prior to developing colorectal
cancer preventing the disease).
This test is performed by Myriad Genetic Laboratories, Inc. for a total cost of $xxx.xx.
Thank you for considering this request on behalf of Ms./Mr. ______ and please do not
hesitate to contact us directly at xxx.xxx.xxxx if we can be of further assistance in your
decision to cover this test.
Please contact me if I can provide you with any additional information.
Sincerely,
[Physician Signature]
Adopted 09/05