Iowa

Elizabeth Matney
Medicaid Director
Iowa Medicaid Enterprise
1305 E Walnut Street
Des Moines, IA 50319
Phone: (515) 256-4640

https://medicaiddirectors.org/wp-content/uploads/2023/06/Public_DirectorsList_June2023-1.pdf

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

1. The member displays clinical features or phenotype of a defined genetic condition;
2. The testing is necessary to establish a diagnosis for symptoms/conditions of unknown etiology
3. The result of the test will directly impact the clinical decision-making or clinical outcome for the member
4. The testing method is considered scientifically valid for the identification of a specific genetic condition
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 medically necessary to determine a specific diagnosis or syndrome when
such diagnoses would not definitively alter the medical treatments of the member.
Genetic testing is not medically necessary to determine the likelihood of associated medical
conditions occurring in the future when the diagnosis of the condition can be made by other
testing.

Genetic testing is not medically necessary 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.

Genetic testing is not medically necessary for members without a medical condition or at risk
for any condition which can only be confirmed with genetic tests.

To be eligible for licensure to practice genetic counseling in Iowa, an applicant must hold and maintain active certification as a genetic counselor by the American Board of Genetic Counseling, as a genetic counselor by the American Board of Medical Genetics and Genomics, or as a medical geneticist by the American Board of Medical Genetics and Genomics, or the successor to any of the aforementioned organizations.

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

Iowa Administrative Code (IAC) 441-78.10(3)c(2) to 78.10(3)c(3)3.
IAC 441-78.28(1)c(1) to 78.28(1)c(3).

Daily enteral nutrition therapy is considered reasonable and necessary when the member has ONE of the following:

1. A metabolic or digestive disorder that prevents the member from obtaining the necessary nutritional value from usual foods in any form and cannot be managed by avoidance of certain food products; OR
2. Severe pathology of the body that will not allow ingestion or absorption of sufficient nutrients from regular food to maintain weight and strength commensurate with the member’s general condition; OR
3. A medication-induced nutritional deficiency; OR
4. Milk or food allergies are covered indications only for children under 5 years of age; OR
5. Metabolic formulas as an oral supplement are approvable for a member with a diagnosis affecting their ability to adequately metabolize nutrients needed to maintain a healthy nutritional status regardless of percentage of daily caloric intake; OR
6. Food thickener may be approved through prior authorization for a member with a diagnosis supporting the need for thickened liquids as evidenced by the results of a swallow study; OR
7. Pump rental may be approved if any of the following are present: a. The member has a medical diagnosis that necessitates the use of a pump versus gravity; OR b. The member has a jejunostomy or nasogastric feeding tube; OR c. The member is receiving an oil based enteral formula; OR d. The administration rate is <100 ml/hr

Required

Yes

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

1. Member from a family with a known BRCA 1 or 2 mutation; OR
2. Personal history of breast cancer and ONE or more of the following:
   1. Diagnosed at or younger than 45 years of age; OR
   2. Diagnosed between 46-50 years of age with:
      1. An additional breast cancer primary at any age; AND
      2. More than one close blood relative with breast cancer at any age; AND
      3. More than one close blood relative with high-grade prostate cancer (Gleason
         score >7); AND
      4. An unknown or limited family history; OR
   3. Diagnosed younger than 60 years of age with triple negative breast cancer, OR
   4. Diagnosed at any age AND more than one close blood relative with:
      1. Breast cancer diagnosed younger than 50 years of age, OR
      2. Ovarian carcinoma, OR
      3. Male breast cancer, OR
      4. Metastatic prostate cancer, OR
      5. Pancreatic cancer; OR
   5. Two or more additional diagnoses of breast cancer at any age in member and/or
      close blood relatives; OR
   6. Ashkenazi Jewish ancestry; OR
3. Personal history of ovarian, fallopian tube, and primary peritoneal cancer; OR
4. Personal history of male breast cancer; OR
5. Personal history of pancreatic cancer; OR
6. Personal history of metastatic prostate cancer; OR
7. Personal history of high-grade prostate cancer (Gleason score >7) at any age with ONE
   of the following:
   1. 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
   2. More than two close blood relatives with breast OR prostate cancer (any grade) at
      any age, OR
   3. Ashkenazi Jewish ancestry; OR
8. 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
9. Regardless of family history, some members with a BRCA-related cancer may benefit
   from genetic testing to determine eligibility for targeted treatment; OR
10. A member 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
11. All requests for testing must be accompanied by genetic counseling performed by 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.

Coverage is available.

These criteria (general genetic testing 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.

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:

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 is met:
   1. Presence of a known LS pathogenic variant in the family; OR
   2. Personal history of a tumor with MMR deficiency determined by PCR, NGS, or IHC
      diagnosed at any age; OR
   3. An individual with colorectal or endometrial cancer and ONE the following:
   4. Diagnosed younger than 50 years of age; OR
   5.  A synchronous or metachronous LS-related cancer; OR
   6. One first- or second-degree relative with an LS-related cancer diagnosed younger
      than 50 years of age; OR
4.  Two or more first- or second-degree relatives with an LS-related cancer regardless
   of age; OR
5. Family history (same side of family) with ONE of the following:
   1. One or more first-degree relative with a colorectal or endometrial cancer diagnosed
      younger than 50 years of age; OR
   2. One or more first-degree relative with a colorectal or endometrial cancer and a
      synchronous or metachronous LS-related cancer; OR
   3. Two or more first- or second-degree relatives with LS-related cancers, including one
      or more diagnosed younger than 50 years of age; OR
   4. Three or more first- or second-degree relatives with LS-related cancers, regardless
      of age; OR
6.  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).
   All criteria are Level of Evidence Category 2A per NCCN.

Chromosomal microarray analysis is considered medically necessary when ALL the following
are met:

1. Member is 17 years of age or younger; AND
2. Genetic counseling has been provided to the member and their family by a qualified
   health professional; AND
3. The member has ONE of the following:
   1. Significant dysmorphic features or congenital anomalies not specific to a well
      delineated genetic syndrome; OR
   2. Diagnosis of ASD; OR
   3. Presentation of non-syndromic DD or ID; AND
4.  The test results have the potential to impact clinical management.

Cytogenomic Constitutional (Genome-Wide) Microarray Analysis; Interrogation of Genomic
Regions for Copy Number Variants (e.g., bacterial artificial chromosome [BAC] or oligo-based
comparative genomic hybridization [CGH] Microarray Analysis).

1. BAC or oligo-based CMA is considered medically necessary for ONE or more of the
   following medical indications:
   1. 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; OR
   2. Developmental delay (DD) or intellectual disability (ID) when ALL of the following
      are met:
      1. There is no known etiology for the DD/ID (e.g., trauma or infection); AND
      2. The DD/ID is not suspected to be related to an obvious, specific, and welldefined genetic syndrome. After history, physical examination, pedigree analysis,
         genetic counseling, and completion of conventional diagnostic studies, a definitive
         diagnosis remains uncertain; AND
      3. The member shows evidence of at least one major or two or more minor
         congenital anomalies as defined above: OR
   3. Autism spectrum disorders when accompanied by at least one major or two or
      more minor congenital anomalies.

Cytogenomic Constitutional (Genome-Wide) Microarray Analysis; Interrogation of Genomic
Regions for Copy Number and Single Nucleotide Polymorphism (SNP) Variants for
Chromosomal Abnormalities:

1. SNP microarray analysis is considered medically necessary for the indications listed for
   CPT 81228 above and is only covered when this testing has been non-diagnostic. If
   member has already had CPT 81228 performed, the member is only eligible for CPT
   81229 if at least ONE of the following additional criteria is met:
2. Cosanguinity AND recessive disease are suspected; OR
3. Uniparental disomy (UPD – both copies of a chromosome inherited from a single
   parent) is suspected; OR
4. Another mechanism is suspected that would not be detected by the oligo microarray
   (81228).

Coverage is available.

cfDNA-based prenatal screening for fetal aneuploidy (trisomy 13, 18, and 21) is considered
medically necessary when BOTH the following have been met:

1. The member has received genetic counseling from a qualified health professional; AND
2. Members with a current single gestation pregnancy.
   cfDNA-based prenatal screening for fetal aneuploidy (trisomy 13, 18, and 21) is NOT medically
   necessary for twin or multiple gestation pregnancies due to limited or inconsistent scientific
   evidence (Evidence level B per ACOG Guidelines).

The following indications are considered investigational:

1. cfDNA screening for fetal sex chromosome aneuploidies.
2. cfDNA screening for microdeletions.

Whole Exome Sequencing (WES) (including trio testing) is considered medically necessary for the evaluation of
neurodevelopmental disorders, multiple congenital anomalies, or epilepsy/seizure disorders
when ALL the following are met:

1. Member is 17 years of age or younger; AND
2.  Pretest genetic counseling has been completed by a qualified health provider such as a
   board certified genetic counselor or physician with expertise in clinical genetics; AND
3. A letter supporting medical necessity of requested testing has been submitted, which
   contains ALL the following:
   1. Differential diagnosis; AND
   2. Results of previous testing; AND
   3. Statement that a genetic etiology is the most likely explanation of the members symptoms; AND
   4. Predicted impact on the member’s plan of care; AND
4. A genetic etiology is the most likely explanation for the phenotype as demonstrated by
   TWO or more of the following:
   1. Presence of multiple congenital abnormalities; OR
   2. Presence of developmental delay or intellectual disability for which first tier testing has not established a diagnosis (single gene testing or chromosomal microarray
      analysis); OR
   3. Presence of a severe neuropsychiatric condition (schizophrenia, bipolar disorder,
      Tourette syndrome); OR
   4. Periods of unexplained developmental regression in which the member loses an
      acquired function or fails to progress beyond a plateau following a period of normal
      development; OR
   5. Presence of epilepsy or a seizure disorder for which a genetic etiology is suspected
      and standard medical evaluation has not been diagnostic; AND
5. No other causative circumstance such as environmental exposure, injury, or infection can account for the clinical presentation; AND
6. The testing would result in an impact on the member’s health outcomes.
   WES reanalysis of previously obtained standard WES for one of the above medically necessary
   indications (i.e., unexplained neurodevelopmental disorders, multiple congenital anomalies, or
   epilepsy/seizure disorder in children) is considered medically necessary when ONE of the
   following criteria is met:
   1. Additional symptoms have presented in the member that broaden the phenotype
      assessed during the original exome evaluation; OR
   2. The birth or diagnosis of a similarly affected first-degree relative that has expanded the
      clinical picture.

Due to insufficient evidence of efficacy, WES is considered investigational for all other
indications, including but not limited to the following:

1. Evaluation of fetal demise.
2. Molecular profiling of tumors for the diagnosis, prognosis, or management of cancer.
3. Preimplantation genetic testing in embryos.
4. Screening asymptomatic individuals for genetic disorders.
5. When used for any of the following diagnoses: cardiovascular disease, neurologic
   disorders (other than those noted above), or immunodeficiency disorders.

FMR1 (Fragile X mental retardation 1) gene analysis; evaluation to detect abnormal (e.g.,
expanded) alleles:

1. Fragile X carrier testing billed under code 81243 is not considered medically necessary
   for general population screening (e.g., screening in the absence of symptoms or family
   history).
   1. Fragile X diagnostic testing is considered medically necessary for males with
      unexplained ID, DD, or autism or in females with these conditions when strong
      clinical suspicion is documented due to phenotype or family history.
   2. Codes specific for members with high-risk pregnancies such as women older than 35
      years of age or part of an ethnic or religious population known to carry a high risk
      of defective genes will be considered for approval where there is adequate
      documentation of their risk and the testing is specific for that risk.

https://hhs.iowa.gov/sites/default/files/Genetic%20Testing.pdf

https://medicalboard.iowa.gov/genetic-counselors#:~:text=To%20be%20eligible%20for%20licensure,medical%20geneticist%20by%20the%20American

https://hhs.iowa.gov/sites/default/files/Genetic%20Testing%20for%20Hereditary%20Breast%20and%20Ovarian%20Cancer%20Syndrome%20%28BRCA1-BRCA2%29.pdf

https://hhs.iowa.gov/sites/default/files/Genetic_Testing_for_Lynch_Syndrome_10.19.22.pdf

https://hhs.iowa.gov/sites/default/files/Chromosomal%20Microarray%20Analysis.pdf

https://hhs.iowa.gov/sites/default/files/Comm519.pdf?092120211338

https://hhs.iowa.gov/hawki

https://hhs.iowa.gov/sites/default/files/Whole%20Exome%20Sequencing.pdf

https://hhs.iowa.gov/sites/default/files/Enteral_Products_and_Supplies_10.19.22.pdf

https://hhs.iowa.gov/sites/default/files/Non-Invasive%20Prenatal%20Testing%20for%20Aneuploidy%20Using%20Cell%20Free%20DNA.pdf