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Coverage criteria policies

Genetic Testing for Cancer Predisposition

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required for genetic testing for cancer predisposition, except for sequence analysis and analysis of common duplication/deletion variants of the BRCA1 and/or BRCA2 genes.

For genetic testing related to reproductive planning, see the Genetic Testing: Carrier Screening, Prenatal Screening, Prenatal Diagnosis, and Infertility Evaluation coverage policy.

For genetic testing related to cancer management, see the Genetic Testing: Molecular Profiling for Cancer Management coverage policy.

For pharmacogenetic testing, see the Genetic Testing: Pharmacogenetics coverage policy.

Genetic testing for cancer predisposition syndromes other than those specified below under Definitions is subject to a review for medical necessity, based on current clinical literature and expert recommendations, unless listed as an indication that is not covered.

Coverage

Indications that are covered

Sequence analysis and analysis of common duplication/deletion variants of the BRCA1 and/or BRCA2 genes are covered when criteria 1-5 below are met:

  1. The test is expected to directly impact management of a cancer predisposition syndrome (see list of syndromes below under Definitions).
  2. The member has a personal history consistent with the cancer predisposition syndrome being evaluated or a first-, second-, or third-degree blood relative has been diagnosed with the cancer predisposition syndrome being evaluated.
  3. The test is ordered by a board-certified genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist.
  4. The member has received genetic counseling with a board-certified genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist who is not affiliated with the commercial testing laboratory, if applicable.
  5. The genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist certifies that the member meets any applicable National Comprehensive Cancer Network category 1, 2A, or 2B guidelines for genetic testing and/or for management of individuals with positive test results.

Single-site or site-specific testing for a known familial mutation is covered when criteria 1-5 below are met:

  1. The test is expected to directly impact management of a cancer predisposition syndrome (see list of syndromes below under Definitions).
  2. The member has a first-, second-, or third-degree blood relative in whom a known pathogenic or suspected pathogenic mutation has been identified in the gene to be evaluated.
  3. The test is ordered by a board-certified genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist.
  4. The member has received genetic counseling with a board-certified genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist who is not affiliated with the commercial testing laboratory, if applicable.
  5. The genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist certifies that the member is at-risk for a specified cancer predisposition syndrome known to be associated with the familial mutation.

Single-gene analysis (other than BRCA1 or BRCA2 analysis or testing for a known familial mutation, as described above) is covered when criteria 1-5 below are met:

  1. The test is expected to directly impact management of a cancer predisposition syndrome (see list of syndromes below under Definitions).
  2. The member has received genetic counseling with a board-certified genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist who is not affiliated with the commercial testing laboratory, if applicable.
  3. The test is ordered by a board-certified genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist.
  4. The genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist certifies that the member meets any applicable National Comprehensive Cancer Network category 1, 2A, or 2B guidelines for genetic testing and/or for management of individuals with positive test results.
  5. The genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist certifies that the member is at-risk for a specified cancer predisposition syndrome known to be associated with pathogenic mutation(s) in a single gene.

Genetic testing for cancer predisposition using a multiple-gene panel is covered when criteria 1-5 below are met:

  1. The test is expected to directly impact management of a cancer predisposition syndrome (see list of syndromes below under Definitions).
  2. The member has received genetic counseling with a board-certified genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist who is not affiliated with the commercial testing laboratory, if applicable.
  3. The test is ordered by a board-certified genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist.
  4. The genetic counselor, advanced practice registered nurse in genetics or oncology, oncologist, or medical geneticist certifies that the member meets any applicable National Comprehensive Cancer Network category 1, 2A, or 2B guidelines for genetic testing and/or for management of individuals with positive test results.
  5. The genetic counselor, advanced practice registered nurse in genetics, or medical geneticist certifies that the member is at-risk for a specified cancer predisposition syndrome known to be associated with pathogenic mutation(s) in multiple genes.

Indications that are not covered

  1. Genetic testing is not covered and is considered not medically necessary when test results will not directly impact the treatment or management of a condition or provide a unifying diagnosis for a previously unidentified condition because the testing is not expected to restore or maintain the member’s health, prevent deterioration of the member’s condition, nor prevent the reasonably likely onset of a health problem or detect an incipient problem.
  2. The following services are not covered and are considered not medically necessary because they are not within the practice parameters of the general medical community:
    1. Comparative analysis using short tandem repeat (STR) markers, which is considered integral to the primary procedure and ineligible for separate coverage
    2. Direct-to-consumer genetic testing
    3. Genetic testing for acquired disorders (those of non-genetic etiology, such as a condition caused by an identified environmental factor).
    4. Genetic testing which was not ordered by a licensed healthcare provider or physician (see Definitions) who has established a direct patient care relationship with the member to be tested.
    5. Genetic testing that is provided solely to satisfy data collection and analysis needs and that will not be used in direct clinical management.
  3. Repeat testing of a unique analyte using the identical method of analysis is not covered and is considered not medically necessary because it is not considered an appropriate frequency of care.
  4. Multiple-gene panels which include genes not associated with the specific condition, features, characteristics, or symptoms under evaluation, or including genes not associated with conditions within the ordering provider’s differential diagnosis list for the affected member, are not covered and are considered not medically necessary because they are not considered an appropriate type of service for the member’s condition.
  5. Large genomic rearrangement analysis (deletion/duplication analysis for uncommon variants) of the BRCA1 and/or BRCA2 genes (e.g. BART™, BRCAnalysis® Rearrangement Test, BRCAvantage™ Rearrangements) is not covered and is considered not medically necessary, because it is not considered an appropriate type of service for the member’s condition.
  6. Single nucleotide polymorphism (SNP) genotyping assays for cancer risk assessment are not covered and are considered experimental/investigational.

Definitions

Cancer predisposition syndromes, for purposes of this coverage policy, include:

  • Ataxia-Telangiectasia Syndrome
  • Birt-Hogg-Dube Syndrome
  • Familial Adenomatous Polyposis/Attenuated Familial Adenomatous Polyposis
  • Familial Pancreatic Adenocarcinoma
  • Hereditary Breast and Ovarian Cancer Syndrome
  • Hereditary Diffuse Gastric Cancer
  • Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) Syndrome
  • Hereditary Papillary Renal Carcinoma
  • Hereditary Paraganglioma/Pheochromocytoma Syndrome
  • Juvenile Polyposis Syndrome
  • Li-Fraumeni Syndrome
  • Lynch Syndrome
  • Malignant Melanoma
  • Multiple Endocrine Neoplasia, Type 1
  • Multiple Endocrine Neoplasia, Type 2A or Type 2B/Familial Medullary Thyroid Cancer
  • MUTYH-Associated Polyposis
  • Peutz-Jeghers Syndrome
  • PTEN Hamartoma Tumor Syndrome/Cowden Syndrome
  • Retinoblastoma
  • Von Hippel-Lindau Disease

First-degree relative is an individual’s parent, sibling, or child

Healthcare provider is any licensed non-physician (excluding naturopathic providers).

Known familial mutation is a genetic alteration that has already been identified in a blood relative.

Large genomic rearrangement analysis is evaluation of one or more genes for uncommon alterations that may not be identified using routine gene analysis techniques.

Physician is a licensed medical doctor or doctor of osteopathy.

Second-degree relative is an individual’s grandparent, grandchild, aunt, uncle, nephew, niece, or half-sibling.

Third-degree relative is an individual’s first cousin, great-grandparent, great-grandchild, great-aunt, great-uncle, grandniece, grandnephew, half-aunt, half-uncle, half-nephew, or half-niece.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

CPT Codes

Codes

Description

S3840

DNA analysis for germline mutations of the RET proto-oncogene for susceptibility to multiple endocrine neoplasia type 2

S3841

Genetic testing for retinoblastoma

S3842

Genetic testing for Von Hippel-Lindau disease

81162

BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and full duplication/deletion analysis

81201

APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; full gene sequence

81202

APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; known familial variants

81203

APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; duplication/deletion variants

81210

BRAF (v-raf murine sarcoma viral oncogene homolog B1) (eg, colon cancer), gene analysis, V600E variant

81211

BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants in BRCA1 (ie, exon 13 del 3.835kb, exon 13 dup 6kb, exon 14-20 del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb)

81212

BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; 185DELAG, 5385INSC, 6174DELT VARIANTS

81213

BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; uncommon duplication/deletion variants

81214

BRCA1 (breast cancer 1) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants (ie, EXON 13 DEL 3.835KB, EXON 13 DUP 6KB, EXON 14-20 DEL 26KB, EXON 22 DEL 510BP, EXON 8-9 DEL 7.1KB)

81215

BRCA1 (breast cancer 1) (eg, hereditary breast and ovarian cancer) gene analysis; known familial variant

81216

BRCA2 (breast cancer 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis

81217

BRCA2 (breast cancer 2) (eg, hereditary breast and ovarian cancer) gene analysis; known familial variant

81288

MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis

81292

MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81293

MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants

81294

MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81295

MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81296

MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants

81297

MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81298

MSH6 (mutS homolog 6 [E. coli]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81299

MSH6 (mutS homolog 6 [E. coli]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants

81300

MSH6 (mutS homolog 6 [E. coli]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81317

PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81318

PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants

81319

PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81321

PTEN (phosphatase and tensin homolog) (eg, Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; full sequence analysis

81322

PTEN (phosphatase and tensin homolog) (eg, Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; known familial variant

81323

PTEN (phosphatase and tensin homolog) (eg, Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; duplication/deletion variant

81432

Hereditary breast cancer-related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); genomic sequence analysis panel, must include sequencing of at least 10 genes, including BRCA1, BRCA2, CDH1, MLH1, MSH2, MSH6, PALB2, PTEN, STK11, and TP53

81433

Hereditary breast cancer-related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); duplication/deletion analysis panel, must include analyses for BRCA1, BRCA2, MLH1, MSH2, and STK1

81435

Hereditary colon cancer disorders (eg, Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis); genomic sequence analysis 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

81437

Hereditary neuroendocrine tumor disorders (eg, medullary thyroid carcinoma, parathyroid carcinoma, malignant pheochromocytoma or paraganglioma); genomic sequence analysis panel, must include sequencing of at least 6 genes, including MAX, SDHB, SDHC, SDHD, TMEM127, and VHL

81438

Hereditary neuroendocrine tumor disorders (eg, medullary thyroid carcinoma, parathyroid carcinoma, malignant pheochromocytoma or paraganglioma); duplication/deletion analysis panel, must include analyses for SDHB, SDHC, SDHD, and VHL

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

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Policy activity

  • 07/01/1996 - Date of origin
  • 09/01/2018 - Effective date
Review date
  • 07/2018
Revision date
  • 09/01/2018

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