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 therapy
• BRCA1/2 genotyping related to rucaparib therapy
• CFTR genotyping related to ivacaftor therapy
• CFTR genotyping related to lumacaftor therapy
• CYP2C9 genotyping related to siponimod therapy
• CYP2D6 genotyping related to eliglustat therapy
• CYP2D6 genotyping related to tetrabenazine therapy
• HLA-B*1502 genotyping related to carbamazepine therapy
• HLA-B*1502 genotyping related to 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.

Pharmacogenetic testing other than as described below is also 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

Single-gene testing related to the following therapies is covered when any criteria below are met:

• 6-mercaptopurine: TPMT genotyping is covered for inflammatory bowel disease.
• Abacavir: HLA-B*5701 genotyping is covered. (Prior authorization is not required.)
• Allopurinol: HLA-B*5801 genotyping is covered. (Prior authorization is not required.)
• Azathioprine: TPMT genotyping is covered for inflammatory bowel disease.
• Capecitabine: DPYD genotyping is covered for unusually early, severe, treatment-related toxicity in the first few therapy cycles.
• Carbamazepine: HLA-B*1502 genotyping is covered. (Prior authorization is not required.)
• Eliglustat: CYP2D6 genotyping is covered. (Prior authorization is not required.)
• Fluorouracil: DPYD genotyping is covered for unusually early, severe, treatment-related toxicity in the first few therapy cycles.
• Irinotecan: UGT1A1 genotyping is covered for elevated serum bilirubin or Gilbert syndrome.
• Ivacaftor: CFTR genotyping is covered. (Prior authorization is not required.)
• Lumacaftor: CFTR genotyping is covered. (Prior authorization is not required.)
• Olaparib: BRCA1/2 genotyping is covered. (Prior authorization is not required.)
• Phenytoin: HLA-B*1502 genotyping is covered. (Prior authorization is not required.)
• Rucaparib: BRCA1/2 genotyping is covered. (Prior authorization is not required.)
• Siponimod: CYP2C9 genotyping is covered. (Prior authorization is not required.)
• Tetrabenazine: CYP2D6 genotyping is covered. (Prior authorization is not required.)

Indications that are not covered

1. 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 genotyping 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
2. The following services are not covered and 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 for acquired disorders (those of non-genetic etiology, such as a condition caused by an identified environmental factor).
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. Predictive genetic testing for asymptomatic members under 18 years of age for conditions generally accepted as having an onset in adulthood.
7. Repeat testing of a unique analyte (genetic substance) using the same method of analysis.
8. Multiple-gene panels that include genes not associated with ruling out potential causes for the clinical condition, features, characteristics, or symptoms being evaluated.
3. 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.

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:

E75.22 Gaucher disease

G10 Huntington’s disease

G35 Multiple sclerosis

Prior authorization is required for all other 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.

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, 4/5/19; Annual Review 4/11, 2/12, 2/13, 2/14, 2/15, 5/15, 2/16, 2/17, 2/18, 2/19

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