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Coverage criteria policies

Genetic Testing: 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

All genetic testing for cancer predisposition requires prior authorization, except for the following services:

  • Single-site or site-specific testing for a known familial genetic alteration, when associated with procedure codes from Code Table 1 below.
  • BRCA1 and/or BRCA2 testing, when associated with procedure codes from Code Table 1 below.

The scope of this coverage policy includes, but is not limited to, these services:

  • Section 1: Single-site or site-specific testing
  • Section 2: BRCA1 and/or BRCA2 testing
  • Section 3: Single-gene testing
  • Section 4: Multiple-gene panel testing

Genetic testing for cancer predisposition syndromes that are not listed under Definitions are also subject to review for medical necessity, based on current clinical literature and expert recommendations.

Coverage

Indications that are covered

Section 1

Single-site or site-specific testing (prior authorization is not required when associated with procedure codes from Code Table 1 below)

Single-site or site-specific testing for a known familial genetic alteration is covered.

Section 2

BRCA1 and/or BRCA2 testing (prior authorization is not required when associated with procedure codes from Code Table 1 below)

BRCA1 and/or BRCA2 testing is covered.

Section 3

Single-gene testing (prior authorization is required)

Single-gene testing for cancer predisposition is covered when:

  1. The test is expected to directly impact management of the condition being evaluated.
  2. An oncologist or medical geneticist; an advanced practice registered nurse in oncology or genetics; or a licensed genetic counselor (who is not affiliated with the commercial testing laboratory) must:
    1. Order the test.
    2. Provide the member with genetic counseling before the test is performed.
    3. Certify that the member meets any applicable National Comprehensive Cancer Network (NCCN) category 1, 2A, or 2B guidelines for testing and/or management of individuals with positive results.
    4. Certify that the member is at risk for a specified cancer predisposition syndrome (see Definitions) associated with pathogenic mutation(s) in a single gene.

Section 4

Multiple-gene panel testing (prior authorization is required)

Multiple-gene panel testing for cancer predisposition is covered when:

  1. The test is expected to directly impact management of the condition being evaluated.
  2. An oncologist or medical geneticist, an advanced practice registered nurse in oncology or genetics; or a licensed genetic counselor (who is not affiliated with the commercial testing laboratory) must:
    1. Order the test.
    2. Provide the member with genetic counseling before the test is performed.
    3. Certify that the member meets any applicable National Comprehensive Cancer Network (NCCN) category 1, 2A, or 2B guidelines for testing and/or management of individuals with positive results.
    4. Certify that the member is at risk for a specified cancer predisposition syndrome (see Definitions) associated with pathogenic mutation(s) in multiple genes.

Indications that are not covered

  1. Genetic testing is considered not medically necessary when test results will not provide a diagnosis or unifying diagnosis or directly impact the treatment or management of the condition being evaluated.
  2. The following services are considered not medically necessary:
    1. Comparative analysis using short tandem repeat (STR) markers that is billed separately, as it is considered to be included as part of the genetic testing.
    2. Direct-to-consumer genetic testing.
    3. Genetic testing when the cause of the member’s clinical condition, features, characteristics, or symptoms can be better explained by non-genetic factors, such as a known exposure to a toxic substance.
    4. Genetic testing that 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.
    6. Repeat testing of a unique analyte (genetic substance) using the same method of analysis.
    7. Multiple-gene panels that include genes not associated with ruling out potential causes for the clinical condition, features, characteristics, or symptoms being evaluated or that include genes not associated with the treatment or management of the condition being evaluated.
    8. Predictive genetic testing for asymptomatic members under 18 years of age for conditions generally accepted as having an onset in adulthood.
  3. Single nucleotide polymorphism (SNP) genotyping assays for cancer risk assessment are considered experimental/investigational.

Definitions

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

  • Ataxia-telangiectasia syndrome
  • Birt-Hogg-Dube syndrome
  • Cowden/PTEN hamartoma tumor syndrome
  • Familial adenomatous polyposis/Attenuated Familial Adenomatous Polyposis
  • Familial medullary thyroid cancer (multiple endocrine neoplasia type 2B)
  • Familial pancreatic adenocarcinoma
  • Hereditary breast and ovarian cancer syndrome
  • Hereditary diffuse gastric cancer
  • Hereditary leiomyomatosis and renal cell cancer syndrome
  • Hereditary papillary renal carcinoma
  • Hereditary paraganglioma/pheochromocytoma syndrome
  • Juvenile polyposis syndrome
  • Li-Fraumeni syndrome
  • Lynch syndrome
  • Malignant melanoma
  • Multiple endocrine neoplasia (types 1 and 2A)
  • MUTYH-associated polyposis
  • Peutz-Jeghers syndrome
  • Retinoblastoma
  • Von Hippel-Lindau disease

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

Known familial genetic alteration is a genetic change that has already been found in one or more blood relatives.

Physician is a licensed medical doctor or doctor of osteopathy.

Relatives

  • First-degree relatives include parents, full siblings, and offspring.
  • Second-degree relatives are grandparents, grandchildren, aunts, uncles, nephews, nieces, half-siblings, and double-cousins.
  • Third-degree relatives are first cousins, great-grandparent, and great-grandchildren.

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.

The services listed in Code Table 1 do not require prior authorization.

Code Table 1

Codes

Description

81162

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

81163

BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis

81164

BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (ie, detection of large gene rearrangements)

81165

BRCA1 (BRCA1, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis

81166

BRCA1 (BRCA1, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (ie, detection of large gene rearrangements)

81167

BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (ie, detection of large gene rearrangements)

81202

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

81212

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

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

81293

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

81296

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

81299

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

81318

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

81322

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

The services listed in Code Table 2 require prior authorization. This list may not be all-inclusive.

Code Table 2

Codes

Description

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; duplication/deletion variants

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

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

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

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

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

81323

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

81400

MOLECULAR PATHOLOGY PROCEDURE LEVEL 1

81401

MOLECULAR PATHOLOGY PROCEDURE LEVEL 2

81402

MOLECULAR PATHOLOGY PROCEDURE LEVEL 3

81403

MOLECULAR PATHOLOGY PROCEDURE LEVEL 4

81404

MOLECULAR PATHOLOGY PROCEDURE LEVEL 5

81405

MOLECULAR PATHOLOGY PROCEDURE LEVEL 6

81406

MOLECULAR PATHOLOGY PROCEDURE LEVEL 7

81407

MOLECULAR PATHOLOGY PROCEDURE LEVEL 8

81408

MOLECULAR PATHOLOGY PROCEDURE LEVEL 9

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

81479

Unlisted molecular pathology procedure

81599

Unlisted multianalyte assay with algorithmic analysis

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

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

  1. American Society of Breast Surgeons. (2017). Consensus guideline on hereditary genetic testing for patients with and without breast cancer. Columbia, MD: American Society of Breast Surgeons.
  2. Choueiri, T. K. (2016). Hereditary kidney cancer syndromes. In: M. B. Atkins, & M. E. Ross (Eds.). UpToDate. Waltham, MA: UpToDate.
  3. Chung, D. C., & Adar, T. (2015a). Clinical manifestations and diagnosis of familial adenomatous polyposis. In: P. Rutgeerts, & S. Grover (Eds.). UpToDate. Waltham, MA: UpToDate.
  4. Chung, D. C., & Adar, T. (2015b). Juvenile polyposis syndrome. In: J. T. Lamont, B. Goff, & S. Grover (Eds.). UpToDate. Waltham, MA: UpToDate.
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  6. ECRI Institute. (2016a). BRACAnalysis Test (Myriad Genetics, Inc.) for assessing risk of hereditary breast and ovarian cancer.  Plymouth Landing, PA: ECRI Institute.
  7. ECRI Institute. (2016b). BreastNext Comprehensive Testing Panel (Ambry Genetics Corp.) for assessing risk of hereditary breast and ovarian cancer.  Plymouth Landing, PA: ECRI Institute.
  8. ECRI Institute. (2016c). Colaris Genetic Test (Myriad Genetics, Inc.) for assessing risk of hereditary colorectal and uterine cancers. Plymouth Landing, PA: ECRI Institute.
  9. ECRI Institute. (2016d). Genetic testing for screening or diagnosing Von Hippel-Lindau syndrome.  Plymouth Landing, PA: ECRI Institute.
  10. ECRI Institute. (2016e). Melaris Genetic Test (Myriad Genetics, Inc.) for assessing risk of hereditary melanoma. Plymouth Landing, PA: ECRI Institute.
  11. ECRI Institute. (2016f). myRisk Hereditary Cancer Panel (Myriad Genetics, Inc.) for identifying inherited cancer risk. Plymouth Landing, PA: ECRI Institute.
  12. ECRI Institute. (2016g). Panexia (Myriad Genetics, Inc.) for determining risk of hereditary pancreatic cancer.  Plymouth Landing, PA: ECRI Institute.
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  14. Evans, D. G. (2016). Li-Fraumeni syndrome. In: P. Y. Wen & M. E. Ross (Eds.). UpToDate. Waltham, MA: UpToDate.
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  16. Grover, S., & Stoffel, E. (2016). MUTYH-associated polyposis. In: J. T. Lamont, & K. M. Robson (Eds.). UpToDate. Waltham, MA: UpToDate.
  17. Hampel, H., Bennett, R. L., Buchanan, A., Pearlman, R., Wiesner, G. L., & Guideline Development Group, American College of Medical Genetics and Genomics Professional Practice and Guidelines Committee and National Society of Genetic Counselors Practice Guidelines Committee. (2015). A practice guideline from the American College of Medical Genetics and Genomics and the National Society of Genetic Counselors: Referral indications for cancer predisposition assessment. Genetics in Medicine, 17, 70-87.
  18. Hayes, Inc. (2016). Breast Ovarian Cancer Panel (GeneDx).  Philadelphia, PA: Hayes, Inc.
  19. Hayes, Inc. (2017a). Genetic testing for PTEN hamartoma tumor syndrome (PHTS). Philadelphia, PA: Hayes, Inc.
  20. Hayes, Inc. (2017b). myRisk Hereditary Cancer (Myriad). Philadelphia, PA: Hayes, Inc.
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  29. Plon, S. R., & Jonasch, E. (2016). Clinical features, diagnosis, and management of von Hippel-Lindau disease. In: M. B. Atkins, H. V. Firth, R. D. Perrone, A. Gajjar, M. E. Geffner, & M. E. Ross (Eds.). UpToDate. Waltham, MA: UpToDate.
  30. Ricker, C., Culver, J. O., Lowstuter, K., Sturgeon, D., Sturgeon, J. D., Chanock, C. R., . . . Gruber, S. B. (2016). Increased yield of actionable mutations using multi-gene panels to assess hereditary cancer susceptibility in an ethnically diverse clinical cohort. Cancer Genetics, 209, 130-137.
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  33. Stanich, P. P., & Lindor, N. M. (2016). PTEN hamartoma tumor syndrome, including Cowden syndrome. In: J. T. Lamont, B. A. Raby, C. Bridgemohan, & D. M. F. Savarese (Eds.). UpToDate. Waltham, MA: UpToDate.
  34. Syngal, S., Brand, R. E., Church, J. M., Giardiello, F. M., Hampel, H. L., Burt, R. W., & American College of Gastroenterology. (2015). ACG clinical guideline: Genetic testing and management of hereditary gastrointestinal cancer syndromes. American Journal of Gastroenterology, 110, 223-262.
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  37. Van der Post, R. S., Vogelaar, I. P., Carneiro, F., Guilford, P., Huntsman, D., Hoogerbrugge, N., . . . Fitzgerald, R. C. (2015). Hereditary diffuse gastric cancer: Updated clinical guidelines with an emphasis on germline CDH1 mutation carriers. Journal of Medical Genetics, 52, 361-374.
  38. Win, A. K., & Lindor, N. M. (2016). Lynch syndrome (hereditary nonpolyposis colorectal cancer): Clinical manifestations and diagnosis. In: J. T. Lamont & S. Grover (Eds.). UpToDate. Waltham, MA: UpToDate.

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Policy activity

  • 07/01/1996 - Date of origin
  • 03/21/2019 - Effective date
Review date
  • 07/2018
Revision date
  • 03/18/2019

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