Appeal type: unknown
Decision: unknown

The rules say that in summary, genetic testing of the CYP2D6 gene is considered medically necessary to guide medical treatment and/or dosing for individuals for whom initial therapy is planned with:

-Amitriptyline or nortriptyline for treatment of depressive disorders
-Tetrabenazine doses greater than 50mg/day, re-initiation of therapy with doses greater than 50mg/day

There is insufficient evidence to demonstrate that genetic testing for this gene improves clinical outcomes. Consequently, this testing is considered investigational outside of the specified covered indications. You can find this rule in Local Coverage Determination (LCD): Pathology and Laboratory: CPY2C19, CYP2D6, CYP2C9 and VKORC1 Genetic Testing (L35660).

The rules say that in summary, genetic testing of the CYP2C19 gene is considered medically necessary for patients with ACS undergoing PCI who are initiating or reinitiating Clopidogrel (Plavix) therapy. There is insufficient evidence to demonstrate that testing for the CYP2C19 gene improves clinical outcomes. Consequently, genetic testing for the CYP2C19 gene outside of the specified covered indications is considered investigational. You can find this rule in Local Coverage Determination (LCD): Pathology and Laboratory: CPY2C19, CYP2D6, CYP2C9 and VKORC1 Genetic Testing (L35660).

The rules say that CYCP2C9 and VKORC1 gene testing is covered only when provided to Medicare beneficiaries who are candidates for anticoagulation therapy with warfarin who:

-Have not been previously tested for CYP2CY9 or VKORC1 alleles; and 
-Have received fewer than five days of warfarin 
in the anticoagulation regimen for which the testing is ordered; and 
-Are enrolled in a prospective, randomized, controlled clinical study when that study meets the standards.

You can find this rule in Local Coverage Determination (LCD): Pathology and Laboratory: CPY2C19, CYP2D6, CYP2C9 and VKORC1 Genetic Testing (L35660).The rules say that in summary, genetic testing of the CYP2D6 gene is considered medically necessary to guide medical treatment and/or dosing for individuals for whom initial therapy is planned with:

-Amitriptyline or nortriptyline for treatment of depressive disorders
-Tetrabenazine doses greater than 50mg/day, re-initiation of therapy with doses greater than 50mg/day

There is insufficient evidence to demonstrate that genetic testing for this gene improves clinical outcomes. Consequently, this testing is considered investigational outside of the specified covered indications. You can find this rule in Local Coverage Determination (LCD): Pathology and Laboratory: CPY2C19, CYP2D6, CYP2C9 and VKORC1 Genetic Testing (L35660).

The rules say that in summary, genetic testing of the CYP2C19 gene is considered medically necessary for patients with ACS undergoing PCI who are initiating or reinitiating Clopidogrel (Plavix) therapy. There is insufficient evidence to demonstrate that testing for the CYP2C19 gene improves clinical outcomes. Consequently, genetic testing for the CYP2C19 gene outside of the specified covered indications is considered investigational. You can find this rule in Local Coverage Determination (LCD): Pathology and Laboratory: CPY2C19, CYP2D6, CYP2C9 and VKORC1 Genetic Testing (L35660).

The rules say that CYCP2C9 and VKORC1 gene testing is covered only when provided to Medicare beneficiaries who are candidates for anticoagulation therapy with warfarin who:

-Have not been previously tested for CYP2CY9 or VKORC1 alleles; and 
-Have received fewer than five days of warfarin 
in the anticoagulation regimen for which the testing is ordered; and 
-Are enrolled in a prospective, randomized, controlled clinical study when that study meets the standards.

You can find this rule in Local Coverage Determination (LCD): Pathology and Laboratory: CPY2C19, CYP2D6, CYP2C9 and VKORC1 Genetic Testing (L35660).