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Coverage criteria policies

Genetic Testing: Pharmacogenetics

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 pharmacogenetic testing, except for the following services when associated with procedure and primary diagnosis codes from the list below (under Codes):

  • BRCA1/2 genotyping related to olaparib or rucaparib therapy
  • CFTR genotyping related to ivacaftor or lumacaftor therapy
  • CYP2D6 genotyping related to eliglustat or tetrabenazine therapy
  • HLA-B*1502 genotyping related to carbamazepine or phenytoin therapy
  • HLA-B*5701 genotyping related to abacavir therapy
  • HLA-B*5801 genotyping related to allopurinol therapy

Medication coverage is outside the scope of this coverage policy.

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

Pharmacogenetic testing other than as described below 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

  • BRCA1/2 genotyping related to olaparib or rucaparib therapy
  • CFTR genotyping related to ivacaftor or lumacaftor therapy
  • CYP2D6 genotyping related to eliglustat or tetrabenazine therapy
  • HLA-B*1502 genotyping related to carbamazepine or phenytoin therapy
  • HLA-B*5701 genotyping related to abacavir therapy
  • HLA-B*5801 genotyping related to allopurinol therapy
  • DPYD genotyping related to fluoropyrimidine (fluorouracil or capecitabine) therapy in members with unusually early, severe, treatment-related toxicity in the first few therapy cycles
  • TPMT genotyping related to 6-mercaptopurine or azathioprine therapy for inflammatory bowel disease
  • TYMS genotyping related to fluoropyrimidine (fluorouracil or capecitabine) therapy in members with unusually early, severe, treatment-related toxicity in the first few therapy cycles
  • UGT1A1 genotyping related to irinotecan therapy in members with elevated serum bilirubin or Gilbert syndrome

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. The following services are considered experimental/investigational because reliable evidence does not permit conclusions concerning safety, effectiveness, or effect on health outcomes:
    1. APOE genotyping
    2. COMT genotyping
    3. KIF6 genotyping
    4. MTHFR genotyping
    5. NUDT15 genotyping
    6. Serotonin receptor (HTR2A and HTR2C) genotyping
    7. SLCO1B1 genotyping
    8. VKORC1 genotyping
    9. Genotyping of CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP2B6, CYP1A2, or of any other gene in the Cytochrome p450 (CYP450) families for any indication except as described under Indications that are Covered
    10. Multiple-gene pharmacogenetic panels for all indications, including, but not limited to, multiple-gene panels involving one or more genes from the Cytochrome p450 (CYP450) families
    11. Pharmacogenetic testing to inform the selection or dose of medication therapy for management of depression, mood disorders, psychosis, anxiety, attention deficit disorder (ADD)/attention deficit hyperactivity disorder (ADHD), and/or substance use disorder

Definitions

Cytochrome P450 (CYP450) includes multiple genes which affect the metabolism of a variety of drug classifications.

Genotyping is the process of determining which genetic variants an individual possesses.

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

Pharmacogenetic tests (pharmacogenomic tests) analyze genes to identify patients who are likely to respond to a specific drug, those who may not respond, and those likely to have adverse reactions.

Physician is a licensed medical doctor or doctor of osteopathy.

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

These services do not require prior authorization when associated with pharmacogenetic testing:

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

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 14-20del 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

81221

CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; known familial variants

81222

CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; duplication/deletion variants

81223

CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; full gene sequence

81370

HLA Class I and II typing, low resolution (eg, antigen equivalents); HLA-A, -B, -C, -DRB1/3/4/5, and -DQB1

81371

HLA Class I and II typing, low resolution (eg, antigen equivalents); HLA-A, -B, and -DRB1 (eg, verification typing)

81372

HLA Class I typing, low resolution (eg, antigen equivalents); complete (ie, HLA-A, -B, and -C)

81373

HLA Class I typing, low resolution (eg, antigen equivalents); one locus (eg, HLA-A, -B, or -C), each

81374

HLA Class I typing, low resolution (eg, antigen equivalents); one antigen equivalent (eg, B*27), each

81375

HLA Class II typing, low resolution (eg, antigen equivalents); HLA-DRB1/3/4/5 and -DQB1

81376

HLA Class II typing, low resolution (eg, antigen equivalents); one locus (eg, HLA-DRB1, -DRB3/4/5, -DQB1, -DQA1, -DPB1, or -DPA1), each

81377

HLA Class II typing, low resolution (eg, antigen equivalents); one antigen equivalent, each

81378

HLA Class I and II typing, high resolution (ie, alleles or allele groups), HLA-A, -B, -C, and -DRB1

81379

HLA Class I typing, high resolution (ie, alleles or allele groups); complete (ie, HLA-A, -B, and -C)

81380

HLA Class I typing, high resolution (ie, alleles or allele groups); one locus (eg, HLA-A, -B, or -C), each

81381

HLA Class I typing, high resolution (ie, alleles or allele groups); one allele or allele group (eg, B*57:01P), each

81382

HLA Class II typing, high resolution (ie, alleles or allele groups); one locus (eg, HLA-DRB1, -DRB3/4/5, -DQB1, -DQA1, -DPB1, or -DPA1), each

81383

HLA Class II typing, high resolution (ie, alleles or allele groups); one allele or allele group (eg, HLA-DQB1*06:02P), each

These services do not require prior authorization when associated with either of these primary diagnoses: E75.22 Gaucher disease or G10 Huntington’s disease.

Prior authorization is required for all other primary diagnoses.

Codes

Description

0028U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, copy number variants, common variants with reflex to targeted sequence analysis

0070U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, common and select rare variants (ie, *2, *3, *4, *4N, *5, *6, *7, *8, *9, *10, *11, *12, *13, *14A, *14B, *15, *17, *29, *35, *36, *41, *57, *61, *63, *68, *83, *xN)

0071U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, full gene sequence

0072U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D6-2D7 hybrid gene)

0073U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D7-2D6 hybrid gene)

0074U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, non-duplicated gene when duplication/multiplication is trans)

0075U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 5’ gene duplication/multiplication)

0076U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 3’ gene duplication/multiplication)

81226

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN)

These services require prior authorization:

Codes

Description

0029U

Drug metabolism (adverse drug reactions and drug response), targeted sequence analysis (ie, CYP1A2, CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP4F2, SLCO1B1, VKORC1 and rs12777823)

0030U

Drug metabolism (warfarin drug response), targeted sequence analysis (ie, CYP2C9, CYP4F2, VKORC1, rs12777823)

0031U

CYP1A2 (cytochrome P450 family 1, subfamily A, member 2)(eg, drug metabolism) gene analysis, common variants (ie, *1F, *1K, *6, *7)

0032U

COMT (catechol-O-methyltransferase)(drug metabolism) gene analysis, c.472G>A (rs4680) variant

0033U

HTR2A (5-hydroxytryptamine receptor 2A), HTR2C (5-hydroxytryptamine receptor 2C) (eg, citalopram metabolism) gene analysis, common variants (ie, HTR2A rs7997012 [c.614-2211T>C], HTR2C rs3813929 [c.-759C>T] and rs1414334 [c.551-3008C>G])

0034U

TPMT (thiopurine S-methyltransferase), NUDT15 (nudix hydroxylase 15)(eg, thiopurine metabolism), gene analysis, common variants (ie, TPMT *2, *3A, *3B, *3C, *4, *5, *6, *8, *12; NUDT15 *3, *4, *5)

0070U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, common and select rare variants (ie, *2, *3, *4, *4N, *5, *6, *7, *8, *9, *10, *11, *12, *13, *14A, *14B, *15, *17, *29, *35, *36, *41, *57, *61, *63, *68, *83, *xN)

0071U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, full gene sequence

0072U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D6-2D7 hybrid gene)

0073U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D7-2D6 hybrid gene)

0074U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, non-duplicated gene when duplication/multiplication is trans)

0075U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 5’ gene duplication/multiplication)

0076U

CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 3’ gene duplication/multiplication)

0078U

Pain management (opioid-use disorder) genotyping panel, 16 common variants (ie, ABCB1, COMT, DAT1, DBH, DOR, DRD1, DRD2, DRD4, GABA, GAL, HTR2A, HTTLPR, MTHFR, MUOR, OPRK1, OPRM1), buccal swab or other germline tissue sample, algorithm reported as positive or negative risk of opioid-use disorder

81225

CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *8, *17)

81227

CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *5, *6)

81230

CYP3A4 (cytochrome P450 family 3 subfamily A member 4) (eg, drug metabolism), gene analysis, common variant(s) (eg, *2, *22)

81231

CYP3A5 (cytochrome P450 family 3 subfamily A member 5) (eg, drug metabolism), gene analysis, common variant(s) (eg, *2A, *4, *5, *6)

81232

DPYD (dihydropyrimidine dehydrogenase) (eg, 5-fluorouracil/5-FU and capecitabine drug metabolism), gene analysis, common variant(s) (eg, *2A, *4, *5, *6)

81283

IFNL3 (interferon, lambda 3) (eg, drug response), gene analysis, rs12979860 variant

81291

MTHFR (5,10-methylenetetrahydrofolate reductase) (eg, hereditary hypercoagulability) gene analysis, common variants (eg, 677T, 1298C)

81328

SLCO1B1 (solute carrier organic anion transporter family, member 1B1) (eg, adverse drug reaction), gene analysis, common variant(s) (eg, *5)

81335

TPMT (thiopurine S-methyltransferase) (eg, drug metabolism), gene analysis, common variant(s), (eg, *2, *3)

81346

TYMS (thymidylate synthetase) (eg, 5-fluorouracil/5-FU drug metabolism), gene analysis, common variant(s) (eg, tandem repeat variant)

81350

UGT1A1 (UDP glucuronosyltransferase 1 family, polypeptide A1) (eg, irinotecan metabolism), gene analysis, common variants (eg, *28, *36, *37)

81355

VKORC1 (vitamin K epoxide reductase complex, subunit 1) (eg, warfarin metabolism), gene analysis, common variants (eg, -1639G>A, c.173+1000C>T)

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

81479

Unlisted molecular pathology procedure

81599

Unlisted multianalyte assay with algorithmic analysis

G9143

Warfarin responsiveness testing by genetic technique using any method, any number of specimen(s)

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

  • 10/18/2010 - Date of origin
  • 09/01/2018 - Effective date
Review date
  • 02/2018
Revision date
  • 09/01/2018

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