Wednesday, June 2, 2010

GENETIC TESTING CODE MODIFIERS - Neo plasia - 0A - 0M

This listing of modifiers is intended for reporting with molecular laboratory procedures related to genetic testing. Genetic test modifiers should be used in conjunction with CPT and HCPCS codes to provide diagnostic granularity of service to enable provider to submit complete and precise genetic testing information without altering test descriptors. These modifiers are categorized by mutation.

The first (numeric) digit indicates the disease category and the second (alpha) digit denotes gene type. Introductory guidelines in the molecular diagnostic and molecular cytogenetic code sections of CPT provide further guidance in interpretation and application of genetic test modifiers.

Neoplasia (solid tumor)

0A BRCA1 (Hereditary breast/ovarian cancer)
0B BRCA2 (Hereditary breast cancer)
0C Neurofibromin (Neurofibromatosis, type 1)
0D Merlin (Neurofibromatosis, type 2)
0E c-RET (Multiple endocrine neoplasia, types 2A/B,
familial medullary thyroid carcinoma
0F VHL (Von Hippel Lindau disease)
0G SDHD (Hereditary paraganglioma)
0H SDHB (Hereditary paraganglioma)
0I Her-2/neu
0J MLH1 (HNPCC)
0K MSH2 (HNPCC)
0L APC (Hereditary polyposis coli)
0M Rb (Retinoblastoma)
1Z Solid tumor, not otherwise specified

Neoplasia (lymphoid/hematopoetic)

2A AML1 – also ETO (Acute myeloid leukemia)
2B BCR – also ABL (Chronic myeloid, acute lymphoid leukemia)
2C CGF1
2D CBF beta (Leukemia)
2E ML (Leukemia)
2F PML/RAR alpha (Promyeleocytic leukemia)
2G TEL (Leukemia)
2H bcl-2 (Lymphoma)
2I bcl-1 (Lymphoma)
2J c-yc (Lymphoma)
2K lgH (Lymphoma/leukemia)
2Z Lymphoid/hematopoetic neoplasia not otherwise specified



 GENETIC AND MOLECULAR TESTING - Medicaid Guide

The following standards of coverage and prior authorization and documentation requirements apply to beneficiaries served by Fee-for-Service Medicaid. For beneficiaries enrolled in a Medicaid Health Plan, the provider must check with the beneficiary’s plan for coverage and prior authorization requirements.


STANDARDS OF COVERAGE

Whenever possible, Michigan Medicaid follows Medicare guidelines. Medicare does not cover a genetic test for a clinically affected individual for purposes of medical research, family planning, disease risk assessment of other family members or when the treatment and surveillance of the beneficiary will not be affected, or in any other circumstance that does not directly affect the diagnosis or treatment of the beneficiary.

Genetic testing is considered a covered benefit when it is medically necessary to establish a molecular diagnosis and treatment of a genetic disease and all of the following are met:

* The testing must be ordered by a physician (MD or DO) who is an enrolled provider.

* The beneficiary has documented clinical features symptomatic of a condition or disease, or is at risk of inheriting the disease based upon personal history, family history, documentation of a genetic mutation and/or ethnic background.

* Following history, physical examination, pedigree analysis, and completion of conventional diagnostic testing, a definitive diagnosis remains uncertain and a genetic diagnosis is suspected.

* The test results will be used to significantly alter the management or treatment of the disease.

* If applicable, the testing method is an FDA-approved method for the identification of a specific genetically-linked inheritable disease as evidenced by the following measures:

* The genotypes to be detected by a genetic test must be shown, by scientifically valid methods, to be associated with the occurrence of the disease;

* The analytical and clinical validity of the test must be established;

* The observations must be independently replicated and subject to peer review; and

* The clinical testing laboratory must be an enrolled provider who is properly certified by CLIA.

Testing is allowed once during the beneficiary’s lifetime per disease for diagnostic purposes. If medically necessary, and on a case-by-case basis, prior authorization may be requested to allow for exceptions to this restriction.

Providers must follow state law (Public Act 368 of 1978, Section 333.17020 Genetic test; informed consent) regarding informed consent for predictive genetic testing. This includes any statutory requirements for pre- or post-testing genetic counseling. There must be made available, upon request, documentation of pre-testing informed consent provided before testing. This documentation must include the limitations of the test, possible outcomes, and methods for communicating and maintaining confidentiality of results.

Genetic testing is not considered a covered benefit for:

* Criteria other than those outlined above.

* Testing to confirm a diagnosis or disorder that can be diagnosed by conventional diagnostic methods.

* Testing for conditions or purposes where the test results would not directly influence the management or treatment of the disease or condition (e.g., a disease without known treatment).

* Testing for informational purposes or management of a beneficiary’s family member.

* Confirmatory testing for validation of laboratory results.

* Screening for investigational or research purposes.

* Minors under the age of 18 for adult onset conditions that have no preventative or therapeutic treatments.

* Testing that has not been performed in a CLIA-certified laboratory.

* The sole purpose of family planning counseling and infertility services.


 PRIOR AUTHORIZATION REQUIREMENTS AND DOCUMENTATION

For genetic testing that requires prior authorization, the following documentation must be submitted prior to the testing being performed:

* Indication for the test.

* Clinical notes that clearly detail the beneficiary’s related signs and symptoms, including relevant family history. A family pedigree analysis must be made available upon request.

* Other related testing or clinical findings of the beneficiary or family member.

* Documentation supporting that the test results will be used to significantly alter the management or treatment of the disease.

* The name and NPI number of the laboratory performing the test.

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