Genetic Testing for Lynch Syndrome MP9487 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes-as shown below Pre and post test genetic counseling is required for any individual ongoing genetic testing. For ASO members pre and post-genetic counseling is not required. Please reference the ASO Summary Plan Description (SPD). A first-degree relative is defined as an individual s parents, full siblings, and children. A second-degree relative is defined as an individual s grandparents, grandchildren, aunts, uncles, nephews, nieces and half-siblings. A third-degree relative is defined as first cousins, great-aunts, great-uncles, great-grandchildren, or great-grandparents. Medicare Policy: BadgerCare Plus Policy: Dean Health Plan covers when Medicare also covers the benefit Prior authorization is dependent on the member s Medicare coverage. Prior authorization is not required for Medicare Cost (Dean Care Gold) and Medicare Supplement (Select) when this service is provided by participating providers. Prior authorization is required if a member has Medicare primary and Dean Health Plan secondary coverage. This policy is not applicable to our Medicare Replacement product (Dean Advantage). Dean Health Plan covers when BadgerCare Plus also covers the benefit. Dean Health Plan Medical Policy: 1.0 Genetic testing for Lynch Syndrome (EPCAM, MLH1, MSH2, MSH6, and PMS2) requires prior authorization through the Quality and Care and is considered medically necessary when one (1) of the following (1.1 to 1.6) are met: Genetic Testing for Lynch Syndrome 1 of 5
1.1 First degree, second degree or third degree relative of person with known EPCAM, MLH1, MSH2, MSH6 or PMS2 gene mutation by DNA sequence testing, when testing is targeted to the known familial mutation; OR. 1.2 Personal history of colorectal cancer or endometrial cancer with high microsatellite instability or pathologic immunohistochemistry on cancer tissue testing, when testing is targeted to the gene(s) of suspicion based on the results of the tumor testing; OR. 1.3 Personal history in which the revised Bethesda guidelines are met and one of the following are met: 1.3.1 Colorectal cancer diagnosed under age 50; OR 1.3.2 Presence of synchronous (simultaneous), metachronous (diagnosed at different times) colorectal, or other Lynch syndrome related cancer**, regardless of age; OR 1.3.3 Colorectal cancer with the MSI-H histology diagnosed in an individual who is under age 60; OR 1.3.4 Colorectal cancer diagnosed in a patient with one or more first-degree relatives with a Lynch syndrome related cancer**, with one of the cancers diagnosed under age 50; OR 1.3.5 Colorectal cancer diagnosed in a patient with two or more first- or seconddegree relatives with a Lynch syndrome related cancer**, regardless of age. 1.4 Individual with endometrial cancer diagnosed before age 50. 1.5 Individual with 5% risk of Lynch syndrome on a mutation prediction model (i. e. MMRpro, PREMM(1,2,6) or MMRpredict). 1.6 An individual without a personal history of cancer who has family history of ANY of the following, and none of the affected relatives are available for genetic testing: 1.6.1 At least one first degree relative with colorectal or endometrial cancer diagnosed before age 50; OR 1.6.2 At least one first-degree relative with colorectal or endometrial cancer and another synchromous or metachronous Lynch sysndrome related cancer**; OR 1.6.3 At least two first or second degree relatives with Lynch syndromerelated cancers, with one that was diagnosed prior to age 50; OR 1.6.4 At least three first or second degree relatives with Lynch syndrome related cancers** at any age. 2.0 When testing for Lynch syndrome is considered medically necessary, Dean Health Plan will cover the following Lynch syndrome genes with associated CPT codes: Genetic Testing for Lynch Syndrome 2 of 5
EPCAM (81479,81403), MLH1 (81292,81294), MSH2 (81295,81297 ), MSH6 (81298,81300), PMS2 ( 81317,81319 ). 3.0 Dean Health Plan considers multigene hereditary cancer panels that accompany Lynch syndrome genes experimental and investigational and there are not medically necessary. There is insufficient published evidence to support their clinical utility and validity. The only Lynch syndrome panels that are considered medically necessary are the five genes noted above exclusively. NOTE:** Lynch-related cancers: colorectal, endometrial, keratocanthoma, stomach, ovarian, small bowel, ureter or renal pelvis, sebaceous adenoma or carcinoma, hepatobiliary, pancreas, brain cancer. CPT/HCPCS Codes Related to MP9487 * The list of codes (and their descriptors, if any) is provided for informational purposes only and may not be all inclusive or current. Listing of a code in this medical policy does not imply that the service described by the code is a covered or non-covered service. Benefit coverage for any service is determined by the member s policy of health coverage with Dean Health Plan. Inclusion of a code above does not imply any right to reimbursement or guarantee claim payment. Other medical policies may also apply. 81162 BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full and full duplication/deletion analysis 81201 APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; full gene sequence 81203 APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; 81288 MLH1 (mutl homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary promoter methylation analysis 81292 MLH1 (mutl homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary 81293 MLH1 (mutl homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary Genetic Testing for Lynch Syndrome 3 of 5
81294 MLH1 (mutl homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary 81295 MSH2 (muts homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary 81296 MSH2 (muts homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary 81297 MSH2 (muts homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary 81298 MSH6 (muts homolog 6 [E. coli]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full 81299 MSH6 (muts homolog 6 [E. coli]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; known 81300 MSH6 (muts homolog 6 [E. coli]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; 81301 Microsatellite instability analysis (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) of markers for mismatch repair deficiency (eg, BAT25, BAT26), includes comparison of neoplastic and normal tissue, if performed 81317 PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (eg, hereditary 81318 PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (eg, hereditary 81319 PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (eg, hereditary 81403 Molecular Pathology Procedure Level 4 Genetic Testing for Lynch Syndrome 4 of 5
81435 Hereditary colon cancer disorders (eg, Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis); genomic panel, must include sequencing of at least 10 genes, including APC, BMPR1A, CDH1, MLH1, MSH2, MSH6, MUTYH, PTEN, SMAD4, and STK11 81436 Hereditary colon cancer disorders (eg, Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis); duplication/deletion analysis panel, must include analysis of at least 5 genes, including MLH1, MSH2, EPCAM, SMAD4, and STK11 81479 Unlisted molecular pathology procedure Originated: Revised: Reviewed: Date(s) Committee/Source April 3, 2017 December 20, 2017 June 20, 2018 December 20, 2017 June 20, 2018 Published/Effective: 07/01/2018 Genetic Testing for Lynch Syndrome 5 of 5