Covered and Noncovered Services : Covered Services and Requirements

Emerging Molecular Pathology and Diagnostic Genetic Testing

Coverage Policy

Genetic testing is a covered service for Wisconsin Medicaid and BadgerCare Plus members when such testing is part of either routine or targeted clinical screening that has been determined to have a clinically useful impact on health outcomes. Resources used to make these determinations may include guidelines developed and endorsed by entities such as the NCCN, the ACMG, and the ACOG where those guidelines are published and are evidence based.

Screening tests requiring PA will be evaluated individually with regard to their impact on clinical outcomes. Genetic testing is a rapidly evolving science and evidence of clinical utility for many tests is still being established. The maximum allowable fee schedule provides the most current information on coverage of genetic testing codes.

ForwardHealth will consider authorizing these genetic tests on a case-by-case basis when clinical utility for the requested test has been established and in accordance with medical necessity as defined in Wis. Admin. Code § DHS 101.03(96m) and HealthCheck "Other Services" published policy where applicable.

All physicians and other professionals who prescribe, refer, or order services for Wisconsin Medicaid and BadgerCare Plus members are required to be Medicaid-enrolled.

Clinically Useful Criteria

Wisconsin Medicaid and BadgerCare Plus consider genetic testing medically necessary when the testing yields results that can be used specifically to develop a clinically useful approach or course of treatment or to cease unnecessary treatments or monitoring. Clinically useful tests allow providers to treat current symptoms significantly affecting a member's health or to manage the treatable progression of an established disease.

Tests will not be reimbursable for Wisconsin Medicaid and BadgerCare Plus members if the sole outcome would be labeling the disorder or categorizing symptoms that cannot or should not be treated.

Documentation

All providers who receive payment from Wisconsin Medicaid, including state-contracted managed care organizations, are required to maintain records that fully document the basis of charges upon which all claims for payment are made, according to Wis. Admin. Code § DHS 106.02(9)(a). Records should clearly support the services rendered and the procedure codes being submitted on claims.

PA

Wisconsin Medicaid and BadgerCare Plus require PA for some genetic testing in order for the testing to be covered. This requirement is in addition to meeting all other program requirements for covered services.

Genetic Counseling Requirement

The provider ordering the testing is required to either be, or arrange for consultation with, a provider who has relevant education or training in genetics, such as a genetics counselor, a geneticist, or a physician/nurse practitioner specialist with knowledge of the genetic factors of disease within his or her specialty and the genetic testing process.

Providers who provide genetic counseling should supply the following:

• Interpretation of the patient and family medical histories to assess the chance of disease occurrence
• Education about inheritance, testing, management, prevention, and resources
• Discussion of the ethical, legal, and psychosocial aspects of genetic testing
• Support to make informed decisions

Physicians or APNPs who provide counseling should follow CPT guidelines, reporting E&M codes on professional claims as appropriate.

Guidelines for Breast Cancer Susceptibility Gene Testing (Excluding Familial Variant Testing)

BRCA 1 and 2 testing requires PA. The PA requests will be adjudicated by Wisconsin Medicaid and BadgerCare Plus according to the guidelines established by the NCCN. Wisconsin Medicaid and BadgerCare Plus require PA for all BRCA tests except familial variant testing.

Documentation Requirements for Genetic Testing Services Not Requiring PA

Wisconsin Medicaid and BadgerCare Plus do not require PA for the following tests, but the rendering provider is required to keep documentation that applicable criteria are met. In addition to test-specific criteria, genetic counseling prior to testing and informed patient choice must be documented in the ordering provider's clinical record.

Familial Variants

Some genetic tests focus on known familial variants within a patient's family that may relate to an increased risk of disease or disorder. The laboratory must be provided with a copy of the official laboratory results on a family member showing the variant in order for a laboratory to conduct these tests. For covered familial variant testing identified by individualized CPT procedure codes, Wisconsin Medicaid and BadgerCare Plus consider the family member's result with the variant as adequate evidence of the medical necessity of the test, and PA is not required. Documentation of the family member's result is required to be maintained by the laboratory, but providers are not required to submit those results along with the claim for familial variant testing.

Fetal Aneuploidy Testing Using Cell-Free Fetal Deoxyribonucleic Acid

Wisconsin Medicaid and BadgerCare Plus cover fetal aneuploidy testing using cell-free fetal DNA in maternal blood tests without PA in cases that meet the guidelines published by the ACOG. DNA-based noninvasive prenatal tests of fetal aneuploidy are proven and medically necessary as screening tools for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), and trisomy 13 (Patau syndrome).

The use of expanded noninvasive prenatal testing panels, which includes additional testing for some micro-deletion syndromes, is not reimbursable.

Other Tests Allowed Based on ACMG Guidelines

Wisconsin Medicaid and BadgerCare Plus cover the following tests without PA, in cases which meet guideline criteria published by the ACMG:

• Cytogenomic constitutional (genome-wide) microarray analysis
• FMR1 gene analysis for Fragile X syndrome
• GJB2 gene analysis for nonsyndromic hearing loss

Documentation must be maintained by the provider that demonstrates adherence to ACMG guidelines.

Panel Versus Component Coding

In adherence with correct coding guidelines, it is not appropriate to report two or more procedures to describe a service when a single, comprehensive procedure exists that more accurately describes the complete service performed by a provider. ForwardHealth expects providers who perform all components of a genomic sequencing procedure and other molecular multianalyte assays to request PA and submit claims only for the associated panel code.

Reporting Tier 2 and Unlisted Molecular Pathology Codes

Within the CPT procedure code set reserved for molecular pathology is a group of Tier 2 molecular pathology codes that cover a wide range of specific tests based upon the complexity of those tests. Both ordering providers and performing laboratories are required to use CPT procedure codes 81400-81408 only for the tests specifically listed in the descriptions of those codes. If a particular test does not have a specific Tier 1 code and is not listed in the description of any Tier 2 code, providers are required to use CPT procedure code 81479 (Unlisted molecular pathology procedure). PA is required for all Tier 2 molecular pathology codes.