bmchp.org | 888-566-0008 wellsense.org | 877-957-1300 Medical Policy and InterQual® Criteria Genetic/Genomic Testing and Pharmacogenetics Policy Number: OCA 3.727 Version Number: 39 Version Effective Date: 07/01/21 + Product Applicability All Plan Products Well Sense Health Plan Boston Medical Center HealthNet Plan Well Sense Health Plan MassHealth Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options ◊ Notes: + Disclaimer and audit information is located at the end of this document. ◊ The guidelines included in this Plan policy are applicable to members enrolled in Senior Care Options only if there are no criteria established for the specified service in a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request. Review the member’s product-specific benefit documents at www.SeniorsGetMore.org to determine coverage guidelines for Senior Care Options. Policy Summary The Plan considers genetic and genomic testing to be medically necessary for the diagnosis of genetic disease in children and adults, for the determination of future risk of a suspected disease, for the prediction of drug responses, and/or for the detection of risks of specific diseases to future children when the Plan’s applicable medical policy criteria are met or Plan-adopted InterQual® criteria are met based on the requested genetic test (with InterQual® criteria utilized when criteria are not included in a Plan medical policy). Prior authorization is required. The Plan’s prior authorization requirements are based on the type of genetic test requested, indication(s) for testing, and if the test is ordered, administered, and processed by participating providers and participating laboratories (or non- Genetic/Genomic Testing and Pharmacogenetics + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. 1 of 111 participating providers and non-participating laboratories). Review the Plan’s Preimplantation Genetic Testing medical policy, policy number OCA 3.726, rather than InterQual® criteria for medical guidelines for preimplantation genetic testing; preimplantation genetic testing is a covered service for some BMC HealthNet Plan members, as specified in the member’s applicable benefit document available at www.bmchp.org. Genetic and genomic testing must comply with applicable Plan reimbursement policies and redirection guidelines. For genetic tests ordered, administered, and processed by participating providers and participating laboratories, Plan prior authorization is required for all molecular and chromosomal genetic testing EXCEPT for a limited number of prenatal genetic screening tests when billed with one (1) of the ICD-10 primary pregnancy diagnosis codes listed in either Category 1 (i.e., procedure codes with the prior authorization requirement waived for members with a Plan-specified, routine pregnancy or high-risk pregnancy ICD-10 primary diagnosis code) or Category 2 (i.e., procedure codes with the prior authorization requirement waived for members with a Plan-specified, high-risk pregnancy ICD-10 primary diagnosis code) of the Applicable Coding section of this policy and when the Plan’s applicable medical policy criteria are met or Plan-adopted InterQual® criteria are met (based on the requested testing). The ICD-10 primary pregnancy diagnosis codes waived from the prior authorization requirement are NOT applicable for Senior Care Options members. Prior authorization is REQUIRED for genetic testing for a pregnant member when the applicable procedure code is NOT listed in Category 1 or Category 2 of the Applicable Coding section. Prior authorization is REQUIRED for ALL molecular and chromosomal genetic testing (when testing is NOT provided to a pregnant member). When genetic tests are order, administered, and/or processed by non-participating providers and/or non-participating laboratories (NOT contracted with the Plan), prior authorization is REQUIRED for all genetic testing, including prenatal genetic screening tests; the list of primary diagnosis codes waived from the prior authorization process would NOT apply to non-participating providers and non- participating laboratories. Biochemical genetic tests used to study molecular markers such as the amount or activity level of proteins and/or steroids to indicate changes to DNA or as biomarkers to determine disease progression, tumor behavior, risk of cancer recurrence, and/or diagnose or treat a genetic condition require prior authorization when specified in the Plan’s Code Look-Up Tools, Prior Authorization Matrix, or a Plan medical policy available at www.bmchp.org for services provided to BMC HealthNet Plan members (including Senior Care Options members) and at www.wellsense.org for testing requested for Well Sense Health Plan members. The Plan recommends that adequate pre-test genetic counseling (including but not limited to preparing the member for possible outcomes of testing including positive results) and post-test genetic counseling be provided by a health care professional with expertise in genetics for all genetic testing conducted with Plan members. Genetic counseling provided to a Plan member (and/or guardian if the member is under the age of 18) should be documented in the member’s medical record and conducted by an appropriately trained practitioner with expertise and experience in genetics, including a provider acting within the scope of the practitioner’s license and practice, clinical geneticist, or genetic counselor. Genetic/Genomic Testing and Pharmacogenetics + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. 2 of 111 The Plan complies with coverage guidelines for all applicable state-mandated benefits and federally- mandated benefits that are medically necessary for the member’s condition. It will be determined during the prior authorization process if the genetic test is considered medically necessary or experimental and investigational for the requested indication. The Plan’s Medically Necessary medical policy, policy number OCA 3.14, indicates the product-specific definitions of medically necessary treatment, and the Plan’s Experimental and Investigational Treatment medical policy, policy number OCA 3.12, includes the product-specific definitions of experimental or investigational treatment. Plan- adopted InterQual® criteria and the following medical policies include additional prior authorization guidelines for genetic testing and related services: 1. Chromosomal Microarray Analysis for Unexplained Intellectual Disabilities and/or Multiple Congenital Anomalies medical policy, policy number OCA 3.573, includes guidelines for chromosomal microarray analysis (CMA) when used for the diagnosis of an adult or pediatric member with unexplained intellectual disability, developmental delay, symptoms or findings consistent with an autism spectrum disorder, and/or multiple congenital anomalies; applicable InterQual® criteria must be met for CMA for this indication. The Applicable Coding section of policy number OCA 3.573 includes the Plan’s list of high-risk primary pregnancy diagnosis codes and corresponding procedure codes waived for prior authorization for CMA when testing is used for prenatal genetic screening or other pregnancy-related indications such as fetal demise or stillbirth. When CMA is requested to establish a diagnosis and/or prognosis for a member with a malignancy (testing also known as cytogenomic neoplastia microarray analysis) or any other indication not specified above, InterQual® criteria must be met for the requested indication. If no InterQual® criteria are available for the specified indication for CMA testing, applicable medical necessity criteria and coding guidelines must be met in the Medical Policy Statement, Limitations, and Applicable Coding sections of this Genetics/Genomic Testing and Pharmacogenetics medical policy and Plan Medical Director review is required for individual consideration. 2. Drug Screening/Testing for Drugs of Abuse and/or Controlled Substances medical policies, policy number OCA 3.98 for BMC HealthNet members and policy number OCA 3.99 for Well Sense Health Plan members, include guidelines related to specimen validity testing using DNA authentication in conjunction with drug testing for Plan members. 3. Genetic Testing for Fragile X-Associated Disorders medical policy, policy number OCA 3.571, includes the list of primary pregnancy diagnosis codes and corresponding procedure codes waived for prior authorization; applicable InterQual® criteria are used to determine the medical necessity of requested testing. 4. Genetic Testing for Hereditary Thrombophilia medical policy, policy number OCA 3.728, includes the clinical review criteria used to determine medical necessity of requested testing. Genetic/Genomic Testing and Pharmacogenetics + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts