Oklahoma

Yes

Traylor Rains, Oklahoma Medicaid Director

Oklahoma Health Care Authority
4345 N. Lincoln Blvd.
Oklahoma City, OK 73105
Phone: 405-522-7300
8 a.m. – 5 p.m. Monday – Friday

For immediate assistance contact the call center:
(405) 522-6205 or
(800) 522-0114

https://oklahoma.gov/ohca/contact-us.html

Genetic testing and other molecular pathology services are covered when medically
necessary as per Oklahoma Administrative Code (OAC) 317:30-5-2(a)(1)(FF). Genetic
testing may be considered medically necessary when the following conditions are met:

1. The member displays clinical features of a suspected genetic condition, is at direct risk
   of inheriting the genetic condition in question (e.g., a causative familial variant has been
   identified) or has been diagnosed with a condition where identification of specific
   genetic changes will impact treatment or management; and
2. Clinical studies published in peer-reviewed literature have established strong evidence
   that the result of the test will positively impact the clinical decision-making or clinical
   outcome for the member; and
3. The testing method is proven to be scientifically valid for the identification of a specific
   genetically-linked inheritable disease or clinically important molecular marker; and
4. A medical geneticist, physician, or licensed genetic counselor provides documentation
   that supports the recommendation for testing based on a review of risk factors, clinical
   scenario, and family history.

1. Oklahoma Medicaid cannot cover services for family members, even if the result may impact the treatment/diagnosis of a member. Therefore, comparator testing is not a covered service.
2. CYP2D6 testing is not covered as part of a pharmacogenetic testing panel for any indication, including psychotropic or pain medication prescribing.
3. Pharmacogenetic multi-gene testing panels are not considered medically necessary and are not covered services at this time.
4.  Intellectual disability/autism multi-gene sequencing panels are not considered medically necessary and are not covered services at this time when intellectual disability/autism is not accompanied by other congenital anomalies.

Genetic and Molecular pathology procedures are medical laboratory procedures involving the analyses of nucleic acid (i.e., DNA, RNA) to detect variants in genes. Gene variants may be
indicative of germline (constitutional disorders) or somatic (e.g., neoplasia) conditions.

Oklahoma requires genetic counselors to be state licensed.
Below is a recommended sequence for completing your application for Licensed Genetic Counselor (LGC):

1. Obtain fingerprint cards from your local law enforcement agency or, if that is not possible, by contacting CHSLicensing@health.ok.gov with your name and mailing address.
2. Each applicant for licensure must have a background check completed by the Oklahoma State Bureau of Investigation (OSBI). Fingerprint cards take four (4) to six (6) weeks to process. The process time is determined by the OSBI and cannot be expedited by this office. Therefore, we thank you in advance for your patience.
3. Complete your part of the three Document of Recommendation forms and distribute them to the appropriate third parties, then retrieve the signed documents from the third party for submission to the Department.
4. Request that an official copy of your university transcript (graduate course work only), showing completion of your genetic counseling degree, be mailed to you from the university registrar. The transcript must be in a sealed envelope with the registrar’s stamp over the flap. Include the unopened envelope from the registrar in your application packet.
5. Please be aware that transcripts cannot be reviewed and fingerprint cards cannot be processed unless you submit them, along with your application form and application fee.
6. Complete the application form and the license request form and affix the $300.00 license fee in the form of a personal check, money order, or cashier’s check, payable to the “LGC Revolving Fund.” Please do not mail cash.
7. Assemble all the above materials and submit them in one envelope to:
   Oklahoma State Department of Health
   Consumer Health Service
   PO Box 268815
   Oklahoma City, OK 73126-8815
   If Applicable:

• Provide verification of active candidate status from the American Board of Genetic Counseling (ABGC).
• Provide verification of board certification from the ABGC or the American Board of Medical Genetics (ABMG).

Link to the application for licensure: https://oklahoma.gov/content/dam/ok/en/health/health2/aem-documents/protective-health/consumer-health-services/licensed-genetic-counselor/ols-lgc-application-packet-20180306.pdf

OAC 317:30-5-211.14 Nutritional support

Enteral nutrition supplies must be determined by a provider to be medically necessary and documented in the member’s plan of care as medically necessary and used for medical purposes. Requests by qualified providers for enteral nutrition supplies in and of itself shall not constitute medical necessity. The Oklahoma Health Care Authority (OHCA) shall serve as the final authority pertaining to all determinations of medical necessity.

Enteral nutrition. Enteral nutrition administered only via gravity, syringe, or pump is covered for children and adults at home. Refer to pharmacy policy related to coverage of food supplements at Oklahoma Administrative Code (OAC) 317:30-5-72.1(2)(C). For enteral nutrition authorization guidelines, see OAC 317:30-5-211.20.

Parenteral nutrition. The member must require intravenous feedings to maintain weight and strength commensurate with the member’s overall health status. Adequate nutrition must not be possible by dietary adjustment and/or oral supplements.
1. The member must have a permanent impairment. Permanence does not require a determination that there is no possibility that the member’s condition may improve sometime in the future. If the judgment of the attending physician, substantiated in the medical record, is that the condition is of long and indefinite duration (ordinarily at least three (3) months), the test of permanence is met. Parenteral nutrition will be denied as a non-covered service in situations involving temporary impairments.
2. The member must have a condition involving the small intestine, exocrine glands, or other conditions that significantly impair the absorption of nutrients. Coverage is also provided for a disease of the stomach and/or intestine that is a motility disorder and impairs the ability of nutrients to be transported through the GI system, and other conditions as deemed medically necessary. There must be objective medical evidence supporting the clinical diagnosis.
3. Re-certification of parenteral nutrition will be required as medically necessary and determined by the Oklahoma Health Care Authority (OHCA) medical staff.

Long-term care facility enteral and parenteral nutrition: Enteral and parenteral nutrition products supplied to long-term care facility residents are included in the long-term care facility per diem rate.

Claim submission requirements: A written signed and dated order must be received by the supplier before a claim is submitted to the OHCA. If the supplier bills an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary. The ordering physician is expected to see the member within thirty (30) days prior to the initial certification or required re-certification. If the physician does not see the member within this time frame, the physician must document the reason why and describe what other monitoring methods were used to evaluate the member’s parenteral nutrition needs.

Some genetic tests require prior authorization and others do not. Any test indicated with a red circle in the Genetic Molecular Pathology Guidelines requires a PA.

https://oklahoma.gov/content/dam/ok/en/okhca/docs/providers/types/molecular-pathology/Genetic%20Molecular%20Pathology%20Guideline%203-7-2023.pdf

https://oklahoma.gov/ohca/providers/molecular-pathology.html

https://oklahoma.gov/ohca/providers/claim-tools/fee-schedule.html

Yes

Comprehensive BRCA1 and BRCA2 full sequencing analysis and deletion/duplication
analysis may be considered necessary for members meeting at least one of the following
NCCN criteria:

1. Personal history of breast cancer and one or more of the following:
   1. Diagnosed at age ≤ 45
   2. Diagnosed at ≤ 50 with at least one of the following:
      1. An additional breast cancer primary
      2. ≥ 1 close blood relative with breast cancer at any age
      3. ≥ 1 close blood relative with prostate cancer (Gleason score ≥ 7)
      4. An unknown or limited family history
   3. Diagnosed at age ≤ 60 with a triple negative breast cancer
   4. Diagnosed at any age with at least one of the following:
      1. ≥ 1 close blood relative with breast cancer diagnosed ≤ 50
      2. ≥ 1 close blood relative with ovarian carcinoma
      3. ≥ 1 close blood relative assigned male at birth with breast cancer
      4. ≥ 1 close blood relative with metastatic prostate cancer or pancreatic
         cancer
      5. ≥ 2 additional diagnoses of breast cancer at any age in patient and/or in
         close blood relatives
   5. Ashkenazi Jewish ethnicity with a negative test for common variants (CPT
      81212)
2. Personal history of ovarian carcinoma
3. Personal history of breast cancer in an individual assigned male at birth
4. Personal history of metastatic prostate cancer
5.  Personal history of high-grade prostate cancer (Gleason score ≥ 7) at any age with
   at least one of the following:
   1. ≥ 1close blood relative with ovarian carcinoma, pancreatic cancer, or
      metastatic prostate cancer
   2.  ≥ 1 close blood relative with breast cancer ≤ 50
   3. Two or more relatives with breast or prostate cancer (any grade)
   4. Ashkenazi Jewish ancestry

Coverage for testing of unaffected family members is limited to testing for the
identified familial variant (CPT 81215 or 81217) unless no affected family member
is available for testing and one of the following applies:

The member has a first- or second-degree relative that meets any of the
above criteria

Note: “Close blood relatives” includes first-, second-, and third-degree relatives on the
same side of the family.

When more than one gene is analyzed, coverage is limited to the single, most
appropriate panel testing CPT code. See the separate criteria in this section for
multi-gene hereditary cancer testing panels.

When a familial variant has already been identified, coverage for unaffected family
members is limited to testing for the identified familial variant.

CFTR common variant testing is covered as a first-line diagnostic test in infants with an elevated immunoreactive trypsinogen (IRT) value on newborn screening.CFTR full gene sequencing and/or duplication/deletion testing may be considered medically necessary for confirmatory diagnostic testing in members meeting at least one of the following criteria:

1. Infants with suspected Cystic Fibrosis (CF) based on elevated IRT value on newborn screening when the CFTR common mutation test identified less than two pathogenic CFTR mutations
2. Members with clinical signs and symptoms suggestive of CF when the CFTR common mutation test identified less than two pathogenic CFTR mutations

Multi-gene panel testing for hereditary cancer syndromes may be considered medically necessary for:

1. Members meeting Lynch Syndrome testing criteria as described earlier in the Lynch Syndrome section.
2. Members meeting Hereditary Breast and Ovarian Cancer Syndrome testing criteria as described earlier in the Hereditary Breast and Ovarian Cancer Syndrome section.

Familial Adenomatosis Polyposis testing is covered when medically necessary. APC full sequencing analysis and deletion/duplication analysis may be considerednecessary for members with a personal history of at least 20 colonic polyps. Coverage for testing of unaffected family members is limited to testing for the identified familial variant (CPT 81202).

Cowden Syndrome coverage is also available when medically necessary. PTEN gene analysis for Cowden Syndrome may be considered medically necessary formembers meeting at least one of the following NCCN criteria:

1. Individual meeting clinical diagnostic criteria for Cowden Syndrome/PHTS by having one of the following:
   1. Three or more major criteria, with one of those criteria being macrocephaly, Lhermitte-Duclos disease, of GI hamartomas
   2. Two major and three minor criteria
2. Individual with a personal history of:
   1. Bannayan-Riley Ruvalcaba syndrome (BRRS) OR
   2. Adult Lhermitte-Duclos disease (cerebellar tumors) OR
   3. Autism spectrum disorder and macrocephaly OR
   4. Two or more biopsy-proven trichilemmomas OR
   5.  Two or more major criteria (one must be macrocephaly) OR
   6. Three major criteria, without macrocephaly OR
   7. One major and at least three minor criteria OR
   8.  At least four minor criteria
3. At-risk individual with a relative with a clinical diagnosis of CS/PHTS or BRRS for whom testing has not been performed
   1. The at-risk individual must have any one major criterion OR two minor criteria

Major Criteria:

• Breast Cancer
• Endometrial cancer
• Follicular thyroid cancer
• Multiple GI hamartomas or ganglioneuromas
• Macrocephaly (megalocephaly) (i.e., 97%, 58cm in adult individuals assigned
  female at birth, 60cm in adult individuals assigned male at birth)
• Macular pigmentation of glans penis
• Mucocutaneous lesions: (One biopsy-proven trichilemmoma, Multiple palmoplantar keratosis, Multifocal or extensive oral mucosal papillomatosis or Multiple cutaneous facial papules (often verrucous))

Minor Criteria:

• Autism spectrum disorder
• Colon cancer
• At least three esophageal glycogenic acanthoses
• Lipomas
• Intellectual disability (i.e., IQ less than 76)
• Papillary or follicular variant of papillary thyroid cancer
• Thyroid structural lesions (e.g., adenoma, nodules(s), goiter)
• Renal cell carcinoma
• Single GI hamartoma or ganglioneuroma
• Testicular lipomatosis
• Vascular anomalies (including multiple intracranial developmental venous anomalies)

Comprehensive Lynch Syndrome testing, including full sequencing analysis and
deletion/duplication analysis of MLH1, MSH2, MSH6, and PMS2, may be considered
necessary for members meeting at least one of the following NCCN criteria:

1. An individual with colorectal or endometrial cancer at any age with tumor showing
   evidence of mismatch repair (MMR) deficiency, either by microsatellite instability
   (MSI) or loss of MMR protein expression
2. An individual with colorectal or endometrial cancer and any of the following:
   1. Diagnosed less than 50 years of age
   2. Another synchronous or metachronous Lynch Syndrome (LS)-related cancer
      (e.g., colorectal, endometrial, gastric, ovarian, pancreas, ureter and renal
      pelvis, biliary tract, brain, small intestinal cancers, sebaceous gland
      adenomas, and keratoacanthomas)
   3. At least one first-degree or second-degree relative with LS-related cancer
      diagnosed less than 50 years of age
   4. At least two first-degree or second-degree relatives with LS-related cancers
      regardless of age
3.  An individual with a colorectal tumor with MSI-high histology
4. Family history of any of the following:
   1. At least one first-degree relative with colorectal or endometrial cancer
      diagnosed less than 50 years of age
   2.  At least one first-degree relative with colorectal or endometrial cancer and
      another synchronous or metachronous LS-related cancer
   3. At least two first-degree or second-degree relatives with LS-related cancer,
      including at least one diagnosed less than 50 years of age
   4. At least three first-degree or second-degree relatives with LS-related
      cancers, regardless of age
5. An individual with at least a 5% risk of having an MMR gene pathogenic variant
   based on predictive models (i.e., PREMM5, MMRpro, or MMRpredict)

Microarray testing may be considered medically necessary as a first-line test for the following indications:

1. At least one major congenital anomaly or multiple congenital anomalies, other than those associated with an obvious, specific, and well-defined genetic syndrome
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)
   2. The DD/ID is not suspected to be related to an obvious, specific, and welldefined genetic syndrome
3. Autism spectrum disorders

Microarray testing for cancer indications may be considered medically necessary when recommended by the NCCN guidelines for molecular profiling of specific tumor types

Multi-gene panel testing for members with clinical features that are highly suggestive of a particular genetic condition or group on conditions that is/are genetically heterogeneous may be considered medically necessary.

Panel testing may be considered medically necessary for members with clinical features of Marfan syndrome, Loeys Dietz syndrome, or Ehler Danlos syndrome type IV when a diagnosis cannot be established based on clinical criteria alone.

Targeted tumor sequencing panels including 5-50 genes may be considered medically necessary for members with solid organ or hematolymphoid neoplasms when NCCN guidelines recommend testing for variants in at least 5 genes.

Targeted panel testing may be considered medically necessary for confirmatory diagnostic testing in members with clinical features suggestive of Noonan spectrum disorder(s).

CYP2D6 testing may be considered medically necessary for members meeting at least one
of the following criteria:

1. Members receiving doses (or considering receiving doses) of Pimozide of more than
   4mg/day in adults or 0.05mg/kg/day for children
2. Members receiving doses (or considering receiving doses) of tetrabenazine
   (Xenazine) of more than 50mg/day
3. Members with Gaucher disease type I who are considering treatment with eliglustat
   (Cerdelga)

NUDT15 testing may be considered medically necessary for members prior to beginning thiopurine therapy.

Non-invasive prenatal testing for trisomy 21, 18, and 13 may be considered medically
necessary for pregnant individuals at high risk of aneuploidy as defined by one or more of
the following criteria:

1. Maternal age 35 years and over at delivery
2. Fetal ultrasound finding indicating an increased risk of aneuploidy, specifically for trisomies 13, 18, or 21
3. History of prior pregnancy with a trisomy detectable by cfDNA screening (trisomies 13, 18, or 21)
4. Positive screening results for aneuploidy including a first trimester, sequential, integrated, or quadruple screen
5. Parental balanced Robertsonian translocation with increased risk of fetal trisomy 13 or 21

Whole exome sequencing (WES) may be considered medically necessary for members
with complex clinical features when all of the following criteria have been met:

1. Exome sequencing results will have a direct outcome on treatment and/or management for the member
2. The clinical features of the member strongly implicate a genetic etiology, as evidenced by at least one of the following:
   1. Multiple abnormalities affecting unrelated organ systems
   2. At least two of the following:
      1. Abnormality affecting a single organ system
      2. Significant intellectual disability, symptoms of a complex neurodevelopmental disorder, or a severe neuropsychiatric condition
      3. Period of unexplained developmental regression (unrelated to autism or epilepsy)
3. No other circumstances, such as environmental exposures, injury, or infection, can explain the clinical features
4. Clinical features do not fit a well-described syndrome for which single-gene testing is available
5. The member’s clinical features would qualify him/her for multiple single-gene tests, and WES results may eliminate the need for multiple and/or invasive procedures, follow-up, or screening that would be recommended in the absence of testing

Reanalysis of previously obtained uninformative WES is considered medically necessary when at least 18 months has passed since last analysis and any of the following criteria is met:

1. There has been onset of additional symptoms that broadens the phenotype assessed during the original exome evaluation;
2. There has been a birth or diagnosis of a similarly affected first-degree relative that has expanded the clinical picture;
3. New Scientific knowledge suggests a previously unknown link between the patient’s findings and specific genes/pathogenic or likely pathogenic variants.

Genetic counseling services are covered for pregnant and/or up to 60 days postpartum SoonerCare members and Soon-to-be-Sooners members while they are still pregnant. Mother’s coverage ends at the time of delivery.
The following are service limitations and conditions:

1. Up to 6 total units per pregnancy including 60 days postpartum care (1 unit = 30 minutes)
2. Member must be referred by obstetrician/gynecologists or pediatrician
3. Services must be provided in office or outpatient setting
4. No separate reimbursement for inpatient services
5. Genetic counselors who are employed by or remunerated by another provider may not bill the SoonerCare program directly for services if that billing would result in duplicate payment for the same service
6. Services must be medically necessary

Single-gene testing may be appropriate for members with clinical features highly suggestive of a specific condition that can be confirmed or ruled out with a single-gene test. For members with clinical features that may be compatible with a number of genetic conditions and/or a genetic condition that may be caused by a number of genes, panel testing may be a more appropriate option.

Hereditary hypercoagulability testing for the F2 20210G>A variant and/or the F5 Leiden variant may be considered medically necessary for members meeting at least one of the following criteria:

1. Adolescents with spontaneous thrombosis
2. Neonates / children with non-catheter-related venous thrombosis or stroke
3. Members with recurrent VTE

Fragile X diagnostic testing may be considered medically necessary for individuals with unexplained intellectual disability, developmental delay, or autism.
Fragile X premutation carrier testing may be considered medically necessary for members
with at least one of the following:

1. Family history of Fragile X-related disorders
2. Family history of undiagnosed intellectual disability
3. Premature ovarian insufficiency

GJB2 and GJB6 gene analysis may be considered medically necessary for members with nonsyndromic hearing loss that is suspected to be hereditary.

HFE gene analysis of common variants may be considered medically necessary for members with abnormal iron studies and/or evidence of liver disease.

HBA1 / HBA2 gene analysis of common variants may be considered medically necessary for confirmatory diagnostic testing in members with suspected alpha thalassemia.

MECP2 gene analysis may be considered medically necessary for confirmatory diagnostic testing in members with suspected Rett Syndrome.

SNRPN/UBE3A methylation analysis may be considered medically necessary for confirmatory diagnostic testing in members with suspected Prader-Willi or Angelman syndrome.

SERPINA1 gene analysis of common variants may be considered medically necessary for confirmatory diagnostic testing in members with suspected alpha-1 antitrypsin deficiency.

DMD testing may be considered medically necessary for confirmatory diagnostic testing in members with clinical features strongly suggestive of Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD). Carrier testing may also be allowed for testing in individuals assigned female at birth at risk for inheriting a DMD mutation based on family history if an affected family member is not available for testing.

AFF2 testing may be considered medically necessary in members with a family history of expanded CCG repeats in AFF2. AFF2 single-gene testing is not considered medically necessary for members with clinical features of Fragile XE syndrome, such as mild intellectual disability.

Androgen receptor testing may be considered medically necessary in members with clinical features strongly suggestive of spinal and bulbar muscular atrophy.

PMP22 gene analysis may be considered medically necessary for confirmatory diagnostic testing in members with suspected Charcot-Marie-Tooth neuropathy type 1 (CMT1) or Hereditary Neuropathy with liability to Pressure Palsies (HNPP).

Expanded carrier screening for Ashkenazi Jewish associated disorders using a genomic sequence analysis panel may be considered medically necessary for members of Ashkenazi Jewish ancestry. Disorders include Bloom syndrome, Canavan disease, cystic fibrosis, familial dysautonomia, Fanconi anemia group C, Gaucher disease, and TaySachs disease.

HLA testing may be considered medically necessary for HLA matching of donor or recipient for solid organ transplant or hematopoietic stem cell/bone marrow transplant. In addition, HLA testing may be considered medically necessary in the following
circumstances:

1. Low resolution HLA Class I typing of one antigen equivalent (i.e., 81374) may be
   considered medically necessary for diagnostic testing in members with suspected
   ankylosing spondylitis
2. Low or high resolution HLA Class II typing of one locus, allele, or antigen equivalent
   (i.e., 81376, 81377, 81382, 81383) may be considered medically necessary for
   diagnostic testing in members with an unclear diagnosis of celiac disease
3. High resolution HLA Class I typing of one allele or allele group (i.e. 81381) may be
   considered medically necessary for members beginning treatment with abacavir or
   carbamazepine

Multi-gene testing for Long QT Syndrome using the CPT codes described above may be medically necessary for members meeting one of the following:

1. Strong clinical index of suspicion for LQTS based on examination of the patient’s
   clinical history, family history, and expressed electrocardiographic (resting 12-lead
   ECGs and/or provocative stress testing with exercise or catecholamine infusion)
   phenotype
2. Asymptomatic patient with QT prolongation in the absence of other clinical
   conditions that might prolong the QT interval (such as electrolyte abnormalities,
   hypertrophy, bundle branch block, etc., i.e., otherwise idiopathic) on serial 12-lead
   ECGs defined as QTc ≥ 480 ms (prepuberty) or ≥ 500 ms (adults)

https://oklahoma.gov/content/dam/ok/en/okhca/docs/providers/types/molecular-pathology/Genetic%20Molecular%20Pathology%20Guideline%203-7-2023.pdf

https://oklahoma.gov/ohca/providers/types/prenatal-and-perinatal-services/genetic-counselors.html

https://oklahoma.gov/ohca/policies-and-rules/xpolicy/medical-providers-fee-for-service/individual-providers-and-specialties/medical-suppliers/nutritional-support.html

https://oklahoma.gov/ohca/policies-and-rules/xpolicy/medical-providers-fee-for-service/individual-providers-and-specialties/medical-suppliers/enteral-nutrition.html