Coverage criteria policies

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.

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.

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

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:

These services do not require prior authorization when associated with any of these primary diagnoses:

These services require prior authorization:

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.

Number P005-03; Approved Medical Director Committee 10/18/10; Revised 4/28/11, 2/23/12, 5/11/15, 3/8/16, 10/27/16, 2/1/17, 2/12/18, 7/19/18; Annual Review 4/2011, 2/2012, 2/2013, 2/2014, 2/2015, 5/2015, 2/2016, 2/2017, 2/2018

References

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23. Hayes, Inc. (2015d). Cytochrome P450 genotyping to predict response to opioid pain medication. Philadelphia, PA: Hayes, Inc.
24. Hayes, Inc. (2015e). STA2R SureGene Test for antipsychotic and antidepressant response. Philadelphia, PA: Hayes, Inc.
25. Hayes, Inc. (2016). SLCO1B1 pharmacogenomic genotyping for statin dosing or selection. Philadelphia, PA: Hayes, Inc.
26. Hayes, Inc. (2017a). CYP2C19 pharmacogenomic genotyping to direct clopidogrel therapy for secondary prevention in patients with a history of stroke and/or transient ischemic attack. Philadelphia, PA: Hayes, Inc.
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