Iowa

Yes

Julie Lovelady Iowa Medicaid Enterprise
Deputy Director
Iowa Department of Human Services
100 Army Post Road
Des Moines, IA 50315 515-256-4644 jlovela@dhs.state.ia.us

Genetic testing is considered medically necessary to establish a molecular diagnosis of an inheritable disease when ALL of the following are met:

1. The member displays clinical features or phenotype of a defined genetic condition; AND
2. The testing is necessary to establish a diagnosis for symptoms/conditions of unknown etiology; AND
3. The result of the test will directly impact the clinical decision-making or clinical outcome for the member; AND
4. The testing method is considered scientifically valid for the identification of a specific genetic condition; AND
5. Documentation is provided from a genetic counselor or physician with genetic expertise (e.g., medical geneticist, pediatric neurologist, developmental pediatrician) who supports the recommendation for testing based on a review of risk factors, clinical scenario, and family history AND that appropriate genetic counseling has been delivered.
6. For testing codes noted below, all relevant coverage criteria need to be met.

These criteria may not apply to testing for familial cancer syndromes. Separate criteria are used for BRCA 1 and 2 testing and the 21-gene RT-PCR assays. Other tests for familial cancer syndromes will be subject to criterion 1-6 below, but will also be assessed for consistency with best medical practice. Criteria published by the National Cancer Care Network (NCCN) and the Centers for Medicare and Medicaid Services may apply to the evaluation of testing for familial cancer syndromes, when available.

Genetic testing is not covered to determine a specific diagnosis or syndromes when such diagnoses would not definitively alter the medical treatments of the member. Genetic testing is not covered to determine the likelihood of associated medical conditions occurring in the future, when diagnosis of these conditions would not rely upon having the genetic diagnosis. Genetic testing is not a covered service for the purposes of determining current or future family planning. Genetic testing is not covered for the purpose of investigating if a condition might affect the member’s children or other family members if the diagnosis does not directly affect the medical treatment of the member.

The Children’s Health Insurance Program (CHIP) is offered through the Healthy and Well Kids in Iowa program, also known as Hawki. Hawki covers diagnostic genetic testing for uninsured children of working families.

All genetic molecular testing must be accompanied by pre AND post test genetic counseling with a physician or a certified genetic counselor, which discusses the possible risks and benefits of early detection and prevention modalities.

IC §641‐ 4.3(136A) IAC §441‐78.1

IC §641‐ 4.3(136A) IAC §441‐78.1

Required

https://dhs.iowa.gov/ime/providers/forms

https://dhs.iowa.gov/ime/providers/csrp/fee-schedule https://secureapp.dhs.state.ia.us/MedicaidFeeSched/X10.xml

Coeverage is available.

Testing for BRCA 1 and BRCA 2 mutations may be medically necessary when ONE of the following criteria is met:

• Individual from a family with a known BRCA 1 or 2 mutation; OR
• Personal history of breast cancer plus one or more of the following:
  • Diagnosed at or younger than 45 years of age.
  • Diagnosed between 46-50 years of age with:
    • An additional breast cancer primary at any age.
    • More than one close blood relative with breast cancer at any age.
    • More than one close blood relative with high-grade prostate cancer
      (Gleason score >7).
    • An unknown or limited family history.
    • Diagnosed younger than 60 years of age with triple negative breast cancer.
    • Diagnosed at any age AND more than one close blood relative with:
• Breast cancer diagnosed younger than 50 years of age, OR
• Ovarian carcinoma, OR
• Male breast cancer, OR
• Metastatic prostate cancer, OR
• Pancreatic cancer.
• OR two or more additional diagnoses of breast cancer at any age in patient and/or close blood relatives.
• Ashkenazi Jewish ancestry.
• Personal history of ovarian, fallopian tube, and primary peritoneal cancer; OR
• Personal history of male breast cancer; OR
• Personal history of pancreatic cancer; OR
• Personal history of metastatic prostate cancer; OR
• Personal history of high-grade prostate cancer (Gleason score > 7) at any age with ONE of the following:
  • More than one close blood relatives with ovarian carcinoma, pancreatic cancer or metastatic prostate cancer at any age OR breast cancer younger
    than 50 years of age, OR
  • More than two close blood relatives with breast OR prostate cancer (any grade) at any age, OR
  • Ashkenazi Jewish ancestry; OR
• BRCA1/2 pathogenic/likely pathogenic variant detected by tumor profiling on any tumor type in the absence of germline pathogenic/likely pathogenic variant analysis; OR
• Regardless of family history, some individuals with a BRCA-related cancer may benefit from genetic testing to determine eligibility for targeted treatment; OR
• An individual who does not meet the other criteria but with more than one first- or second-degree blood relative meeting any of the above criterial; AND
• All requests for testing must be accompanied by genetic counseling performedby a qualified professional. This includes components of taking a personal and
  family history to assess risk of disease, education about inheritance and resources, and counseling to promote informed choices and psychological implications of undergoing testing.

BART testing (for rearrangement) will be covered as a reflex test when BRCA I & II testing is negative.

ALL requests for testing must be accompanied by genetic counseling performed by a qualified professional, such as a certified genetic counselor or oncologist. This must include the following components:

1. Taking a personal and family history to assess risk of disease, AND
2. Education about inheritance and resources, AND
3. Counseling to promote informed choices and the psychological implications of undergoing testing.

Genetic testing for LS is considered medically necessary when ONE of the following criteria is met:

• Presence of a known LS pathogenic variant in the family; OR
• Personal history of a tumor with MMR deficiency determined by PCR, NGS, or IHC diagnosed at any age; OR
• An individual with colorectal or endometrial cancer and ONE the following:
  • Diagnosed younger than 50 years of age; OR
  • A synchronous or metachronous LS-related cancer; OR
  • One first- or second-degree relative with an LS-related cancer diagnosed younger than 50 years of age; OR
  • Two or more first- or second-degree relatives with an LS-related cancer regardless of age; OR
• 4. Family history (same side of family) with ONE of the following:
  • One or more first-degree relative with a colorectal or endometrial cancer diagnosed younger than 50 years of age; OR
  • One or more first-degree relative with a colorectal or endometrial cancer and a synchronous or metachronous LS-related cancer; OR
  • Two or more first- or second-degree relatives with LS-related cancers, including one or more diagnosed younger than 50 years of age; OR
  • Three or more first- or second-degree relatives with LS-related cancers, regardless of age; OR
• An individual with a 5 percent or greater risk of having an MMR gene pathogenic variant based on predictive models (e.g., PREMM5, MMRpro, MMRpredict).

BAC or oligo-based CMA is considered medically necessary for ONE OR MORE OF the following medical indications:

• Multiple congenital anomalies, other than those associated with an obvious, specific, and well-defined genetic syndrome;
• After history, physical examination, pedigree analysis, genetic counseling, and completion of conventional diagnostic studies, a definitive diagnosis remains uncertain;
• Developmental delay (DD) or Intellectual Disability (ID) when all of the following are met:
  • There is no known etiology for the DD/ID (e.g., trauma or infection)
  • The DD/ID is not suspected to be related to an obvious, specific, and well-defined genetic syndrome.
  • After history, physical examination, pedigree analysis, genetic counseling, and completion of conventional diagnostic studies, a definitive diagnosis remains uncertain.
  • The member shows evidence of at least one major OR two or more minor congenital anomalies as defined above.
  • Autism spectrum disorders when accompanied by at least one major OR two or more minor congenital anomalies

SNP microarray analysis is considered medically necessary for certain indications and is only covered when this testing has been non-diagnostic. If member has already had CPT 81228 performed, he/she is only eligible for CPT 81229 if AT LEAST ONE of the following additional criteria is met:

1.  Cosanguinity AND recessive disease are suspected.
2. Uniparental Disomy (UPD – both copies of a chromosome inherited from a single parent) is suspected.
3. Another mechanism is suspected that would not be detected by the oligo microarray.

WES (including trio testing) is considered medically necessary for the evaluation of neurodevelopmental disorders, multiple congenital anomalies, or epilepsy/seizure disorders under certain circumstances.

• Fragile X diagnostic testing is considered medically necessary for males with unexplained intellectual disability, developmental delay, or autism or in females with these conditions when strong clinical suspicion is documented due to phenotype or family history.
• Oncotype DX is considered medically necessary to assess the need for adjuvant chemotherapy in women with recently diagnosed breast cancer within six months of diagnosis under certain criteria.
• Chromosomal microarray analysis is considered medically necessary when ALL of the following criteria are met:
  • Member is 17 years of age or younger; AND
  • Genetic counseling has been provided to the member and their family by a
    qualified health professional; AND
  • The member has ONE of the following:
    • Significant dysmorphic features or congenital anomalies not specific to a well delineated genetic syndrome; OR
    • Diagnosis of ASD; OR
    • Presentation of non-syndromic DD or ID; AND
    • The test results have the potential to impact clinical management.

• Clinical Advisory Committee (CAC) Criteria Material Library, Laboratory Testing
  • https://dhs.iowa.gov/ime/about/advisory_groups/clinical-advisory-group/cac_criteria_material
• Medicaid Provider, Medical Equipment and Supply Dealer
  • https://dhs.iowa.gov/policy-manuals/medicaid-provider
• https://dhs.iowa.gov/sites/default/files/Chromosomal_Microarray_Analysis_2-8-22.pdf?061620221457
• https://dhs.iowa.gov/sites/default/files/Genetic_Testing_for_Hereditary_Breast_and_Ovarian_Cancer_Syndrome_(BRCA1-BRCA2)_2-8-22.pdf?061620221626
• https://dhs.iowa.gov/sites/default/files/Whole_Exome_Sequencing_2.11.22.pdf?061620221729
• https://dphhs.mt.gov/assets/dsd/CMB/CMHBMedicaidServicesProviderManual100121.pdf