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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules state Covered Indications: 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 50 mg/day, or re-initiation of therapy with doses greater than 50 mg/day. Limitations: There is insufficient evidence to demonstrate that genetic testing for the CYP2D6 gene improves clinical outcomes. Consequently, genetic testing for the CYP2D6 gene is considered investigational and therefore is not reasonable and necessary including but not limited to the following medications: Antidepressants other than those listed in the covered indications for the CYP2D6 gene. Antipsychotics. Codeine. Donepezil. Galantamine. Tamoxifen. You can find this information in Medicare's Local Coverage Determination (LCD): CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing (L35698). The rule say Covered Indications: Molecular pathology procedures (Tier 1 and Tier 2) may be eligible for coverage when ALL of the following criteria are met: Alternative laboratory or clinical tests to definitively diagnose the disorder/identify the condition are unavailable or results are clearly equivocal; AND Availability of a clinically valid test, based on published peer reviewed medical literature; AND Testing assay(s) are Food and Drug Administration (FDA) approved/cleared or if LDT (lab developed test) or LDT protocol or FDA modified test(s) the laboratory documentation should support assay(s) analytical validity and clinical utility; AND Results of the testing must directly impact treatment or management of the beneficiary; AND For testing panels, including but not limited to, multiple genes or multiple conditions, and in cases where a tiered approach/method is clinically available, testing would be covered ONLY for the number of genes or test that are reasonable and necessary to establish a diagnosis; AND Individual has not previously received genetic testing for the disease/condition. (In general, diagnostic genetic testing for a disease should be performed once in a lifetime.) Limitations: Any procedures required prior to cell lysis (e.g., microdissection) should be reported separately and utilization must be clearly supported based on the application and clinical utility. Such claims may be subject to prepayment medical review. For testing for quality assurance please refer to NCCI Policy Manual for Medicare Services, Chapter 10, Pathology/Laboratory Services. Screening services such as pre-symptomatic genetic tests and services used to detect an undiagnosed disease or disease predisposition are not a benefit and are not covered. Similarly, the costs of tests/examinations that assess the risk of a condition unless the risk assessment clearly and directly effects the management of the patient may not be reimbursed. A specific genetic test may only be performed once in a lifetime per beneficiary for inherited conditions; however, when medically reasonable and necessary, genetic testing may be done on acquired conditions such as malignancies (including separate malignancies developing at different times) as they are treated and are being followed, in order to assess response or other relevant clinical criteria. Likewise, there are situations where medical record and literature documentation are able to demonstrate that serial testing can be reasonably predicted to provide additional clinically useful information. When the record documents that this information, such as confirmed significant response to current therapy, is likely to assist in modifying treatment, serial testing can be considered reasonable and necessary and eligible for coverage. You can find this information in Medicare's Local Coverage Determination (LCD): Molecular Pathology Procedures (L34519).
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