Genetic Testing Pre-authorization Requirements
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This document governs McLaren Health Plan's requirement that providers obtain pre-authorization for all genetic testing (including prenatal) and describes information the ordering practitioner must supply. It affects all McLaren Health Plan providers who order genetic tests.
No material clinical or coverage changes in this revision.
Coverage Criteria
Pre-authorization documentation questions
Pre-authorization requests must include answers to ALL of the following questions to support medical necessity evaluation:
Responses to all items are required information for the pre-authorization review.
This policy does not list discrete item-by-item coverage criteria beyond the requirement that pre-authorization documentation include answers to the specified set of questions. Pre-authorization requests must include responses to the full set of 11 items used by McLaren Medical Management to evaluate medical necessity, including test appropriateness, evidence of technical and clinical performance, diagnostic context, impact on management, limitations, ethical/legal/safety issues, laboratory certification or FDA clearance, test type (targeted vs. multi-gene), family variant status, prior testing history, and confirmation that an appropriately trained ordering practitioner will ensure face-to-face genetic counseling accompanies testing.
If the required information is not provided with the pre-authorization request or the responses do not satisfy McLaren Medical Management's medical necessity evaluation, the request may be denied. McLaren requires pre-authorization for all genetic testing (including prenatal testing), and absence of the answers to the 11 required questions or failure to demonstrate that testing meets the criteria referenced (e.g., relevance to management, validated test performance, appropriate laboratory certification, and provider qualifications) risks denial of coverage.
Provider Actions and Requirements
Pre-authorization required for all genetic testing
Pre-authorization is required for all genetic testing, including prenatal genetic testing. Referrals and pre-authorization requests are accepted from both PCPs and specialist providers.
Provide complete justification using established criteria
Ordering practitioners must use the 11-question framework and provide complete answers with the pre-authorization request; MHP uses external medical necessity criteria (e.g., Hayes, Apollo) together with the 11 questions to evaluate requests.
- MHP utilizes Hayes and Apollo Medical Necessity Criteria and the '11 Questions to Ask When Making Genetic Testing Coverage Decisions' when evaluating requests.
Information required with pre-authorization request (11 questions)
The ordering practitioner must provide answers to all 11 specified questions listed in the policy as part of the pre-authorization submission to support medical necessity review.
- 1. Is this test appropriate for this patient?
- 2. Is the technical and clinical performance of the genetic test supported by peer-reviewed published research?
- 3. Does a definitive diagnosis remain uncertain despite a comprehensive workup including history, exam, pedigree analysis, genetic counseling, and conventional studies?
- 4. Will the test result impact or alter the medical management of the patient?
- 5. What are the limitations of the test?
- 6. Are there any major ethical, legal or safety issues of concern with the test?
- 7. Has the genetic test been cleared or approved by the U.S. FDA or will it be performed in a CLIA-certified laboratory?
- 8. Is this a targeted test or a multi-gene panel?
- 9. Has a pathogenic variant been identified in an affected family member?
- 10. Is this the first time this test is being performed on this patient?
- 11. Has the genetic test been ordered by a medical professional with genetics training who will ensure face-to-face genetic counseling accompanies testing?
Failure to obtain pre-authorization may result in denial
Requests for genetic testing submitted without prior authorization may be denied because MHP requires pre-authorization for all genetic testing, including prenatal testing.
Require face-to-face genetic counseling when ordered by genetics-trained providers
When testing is ordered by a provider with genetics training, face-to-face genetic counseling by appropriately trained professionals must accompany the testing.
- Examples of providers with genetics training include a medical geneticist, developmental-behavioral pediatrician, condition-specific subspecialist, or a neonatologist in the NICU.
Who may submit referrals and pre-authorization requests
Referrals and pre-authorization requests are accepted from both PCPs and specialist providers, though tests are ideally ordered by a medical professional with genetics training.
- If you have questions or need medical necessity criteria, contact Medical Management at (888) 327-0671.
Definitions
Eligibility Requirements
Pre-authorization documentation should state whether a pathogenic variant has been identified in an affected family member. This corresponds to question 9 in the required 11-item checklist and is used to determine the relevance of targeted testing and the probability that testing will yield actionable results.
Pre-authorization requests must indicate whether this is the first time the test is being performed on the patient (question 10) and whether a pathogenic variant has been identified in an affected family member (question 9). These items help reviewers understand prior testing history and the potential diagnostic yield of repeat versus targeted testing.
Background
Genetic testing may be either a targeted single-gene test or a multi-gene panel, and results can affect diagnosis and medical management. McLaren Medical Management evaluates requests using external medical necessity resources (for example, Hayes and Apollo) and the referenced framework of 11 questions to determine appropriateness and clinical utility.
Not Covered
The policy does not name specific genetic tests that are categorically not covered. Instead, all genetic tests require pre-authorization, and coverage is determined based on the information provided in the pre-authorization request and the medical necessity evaluation.
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